(SUBCHAPTER H—CLAUSES AND FORMS)
authority : 5 U.S.C. 301 ; 40 U.S.C. 121 ( cytosine ) ( 2 ) .
Subpart 352.1—Instructions for Using Provisions and Clauses
352.100 Scope of subpart.
This subpart provides guidance for applying the Department of Health and Human Services provisions and clauses in solicitations, contracts, and orders .
352.101-70 Application of provisions and clauses.
( a ) If a clause is included in the master instrument ( for example, in an indefinite delivery/indefinite measure condense or a blanket purchase agreement ), it is not necessary to besides include the article in a undertaking order or manner of speaking club thereunder.
( bacillus ) When a dollar amount or dollar brink is specified ( e.g., $ 25 million or simplified learning doorway ), the dollar come of the award ( condense or regulate ) includes any options thereunder .
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Subpart 352.2—Texts of Provisions and Clauses
As prescribed in HHSAR 303.808-70, the Contracting Officer shall insert the adopt article :
Anti-Lobbying ( December 18, 2015 )
pursuant to the HHS annual appropriations acts, except for normal and recognized executive-legislative relationships, the Contractor shall not use any HHS contract funds for :
( a ) publicity or propaganda purposes ;
( barn ) The preparation, distribution, or consumption of any kit out, booklet, booklet, publication, electronic communication, radio receiver, television receiver, or television presentation designed to support or defeat the enactment of legislation before the Congress or any State or local legislature or legislative body, except in display to the Congress or any country or local legislature itself ; or designed to support or defeat any proposed or pending regulation, administrative military action, or order issued by the executive branch of any state or local government, except in presentation to the executive outgrowth of any country or local government itself ; or
( speed of light ) requital of wage or expenses of the Contractor, or any agent act for the Contractor, related to any activity designed to influence the enactment of legislation, appropriations, regulation, administrative legal action, or Executive order proposed or pending before the Congress or any country politics, submit legislature or local legislature or legislative consistency, early than for normal and recognized executive-legislative relationships or engagement by an representation or military officer of a state, local, or tribal politics in policymaking and administrative processes within the executive outgrowth of that politics .
( five hundred ) The prohibitions in subsections ( a ), ( boron ), and ( c ) above shall include any activity to advocate or promote any proposed, pending, or future federal, state, or local tax increase, or any proposed, pending, or future necessity for, or restriction on, any legal consumer product, including its sale or market, including, but not limited to, the advocacy or promotion of artillery dominance .
( end of article )
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352.204-70 Prevention and Public Health Fund—Reporting Requirements.
As prescribed in HHSAR 304.7201, insert the follow clause :
prevention And Public Health Fund—Reporting Requirements ( December 18, 2015 )
( a ) pursuant to public jurisprudence this contract requires the contractor to provide products or services or both that are funded from the Prevention and Public Health Fund ( PPHF ), Pub. L. 111-148, secant. 4002. section 220 ( boron ) ( 5 ) requires each contractor to report on its practice of these funds under this contract. These reports will be made available to the populace .
( b ) Semi-annual reports from the Contractor for all shape funded, in whole or in part, by the PPHF, are due no later than 20 days following the end of each 6-month period. The 6-month report periods are January through June and July through December. The inaugural reputation is due no by and by than 20 days after the end of the 6-month period following contract prize. subsequent reports are due nobelium subsequently than 20 days after the end of each report period. If applicable, the Contractor shall submit its final examination report for the remainder of the compress menstruation nobelium by and by than 20 days after the end of the report period in which the contract ended .
( degree centigrade ) The Contractor shall provide the following information in an electronic and Section 508 compliant format to the Contracting Officer .
( 1 ) The Government contract and rate total, as applicable .
( 2 ) The measure of PPHF funds invoiced by the contractile organ for the report period and the accumulative sum invoiced for the contract or order .
( 3 ) A list of all meaning services performed or supplies delivered, including construction, for which the contractor invoiced in the report period .
( 4 ) program or project title, if any .
( 5 ) The Contractor shall report any subcontract funded in hale or in separate with PPHF fund, that is valued at $ 25,000 or more. The Contractor shall advise the subcontractor that the information will be made available to the populace. The Contractor shall report :
( i ) name and address of the subcontractor .
( two ) sum of the subcontract award .
( three ) Date of the subcontract award .
( four ) A description of the products or services ( including construction ) being provided under the subcontract .
( end of article )
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352.208-70 Printing and Duplication.
As prescribed in HHSAR 308.803, the Contracting Officer shall insert the surveil clause :
Printing and Duplication ( December 18, 2015 )
( a ) Unless otherwise specified in this abridge, no impression by the Contractor or any subcontractor is authorized under this narrow. All print required must be performed by the Government Printing Office except as authorized by the Contracting Officer. The Contractor shall submit camera-ready copies to the Contracting Officer ’ s Representative ( COR ). The terms “ printing ” and “ duplicating/copying ” are defined in the Government Printing and Binding Regulations of the Joint Committee on Printing .
( b-complex vitamin ) If necessary for performance of the contract, the Contractor may duplicate or copy less than 5,000 product units of only one page, or less than 25,000 production units in aggregate of multiple pages for the use of a department or means. A production unit is defined as one sheet, size 8.5 adam 11 inches, one side merely, and one color. The pages may not exceed a maximum persona size of 10-3/4 by 14-1/4 inches. This page limit applies to each printing requirement and not for all print requirements under the integral contract .
( degree centigrade ) Approval for all print, deoxyadenosine monophosphate well as duplicating/copying in excess of the state limits, shall be obtained from the COR who will consult with the designated publish services position and provide direction to the contractile organ. The cost of any unauthorized print or duplicating/copying under this contract will be considered an unallowable cost for which the Contractor will not be reimbursed .
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352.211-1 Public Accommodations and Commercial Facilities.
As prescribed in HHSAR 311.7102, the Contracting Officer shall insert the following clause :
public Accommodations and Commercial Facilities ( December 18, 2015 )
The Contractor agrees as follows :
( a ) Except for ad hoc meetings necessary or incidental expense to contract performance, the Contractor shall develop a plan to assure that any event held pursuant to this contract will meet or exceed the minimum handiness standards set forth in 28 CFR depart 36-Nondiscrimination on the Basis of Disability by Public Accommodations and in Commercial Facilities. The Contractor shall submit the plan to the Contracting Officer and must receive blessing anterior to the consequence. The Contractor may submit a consolidated or overcome plan for contracts requiring numerous events in stead of discriminate plans .
( boron ) The Contractor shall manage the shrink in accord with the standards set forth in 28 CFR part 36 .
( end of clause )
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352.211–2 Conference Sponsorship Requests and Conference Materials Disclaimer.
As prescribed in HHSAR 311.7202, the Contracting Officer shall insert the be article :
Conference Sponsorship Request and Conference Materials Disclaimer ( December 18, 2015 )
( a ) If HHS is not the sole supplier of funding under this contract, then, prior to the Contractor claiming HHS conference sponsorship, the Contractor shall submit a written request ( including rationale ) to the Contracting Officer for permission to claim such HHS sponsorship .
( bacillus ) Whether or not HHS is the conference patron, the Contractor shall include the be statement on conference materials, including promotional materials, agendas, and web sites :
“ This league was funded, in wholly or in separate, through a contract ( insert abridge number ) with the Department of Health and Human Services ( HHS ) ( insert appoint of OPDIV or STAFFDIV ). The views expressed in written conference materials and by speakers and moderators at this league, do not necessarily reflect the official policies of HHS, nor does note of trade names, commercial practices, or organizations imply endorsement by the U.S. Government. ”
( c ) Unless authorized in write by the Contracting Officer, the Contractor shall not display the HHS logo on any conference materials .
( end of article )
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352.211-3 Paperwork Reduction Act.
As prescribed in HHSAR 311.7301, the Contracting Officer shall insert the succeed article :
Paperwork Reduction Act ( December 18, 2015 )
( a ) This contract involves a necessity to collect or record information calling either for answers to identical questions from 10 or more persons other than Federal employees, or information from Federal employees which is outside the oscilloscope of their use, for habit by the federal government or disclosure to one-third parties ; consequently, the Paperwork Reduction Act of 1995 ( 44 U.S.C. 3501 et seq. ) shall apply to this shrink. No plan, questionnaire, interview guide or early similar device for collecting information ( whether insistent or single time ) may be used without the Office of Management and Budget ( OMB ) first providing clearance. Contractors and the Contracting Officer ‘s Representative shall be guided by the provisions of 5 CFR function 1320, Controlling Paperwork Burdens on the Public, and seek the advice of the HHS operating division or Office of the Secretary Reports Clearance Officer to determine the procedures for acquiring OMB headroom .
( barn ) The Contractor shall not expend any funds or begin any data collection until the Contracting Officer provides the Contractor with written presentment authorizing the outgo of funds and the solicitation of data. The Contractor shall allow at least 120 days for OMB clearance. The Contracting Officer will consider excessive delays caused by the Government which arise out of causes beyond the see and without the fault or negligence of the Contractor in accordance with the excusable Delays or Default clause of this contract .
( end of clause )
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352.215-70 Late Proposals and Revisions.
As prescribed in HHSAR 315.208, the Contracting Officer shall insert the succeed provision :
former Proposals and Revisions ( December 18, 2015 )
Notwithstanding the procedures contained in FAR 52.215-1 ( coke ) ( 3 ) of the provision of this solicitation entitled Instructions to Offerors–Competitive Acquisition, the Government may consider a proposal received after the date specified for reception if it appears to offer significant price or technical advantage to the Government and it was received before proposals were distributed for evaluation, or within 5 calendar days after the demand meter specified for acknowledge, whichever is earlier .
( end of provision )
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352.216-70 Additional Cost Principles for Hospitals (Profit and Non-Profit).
As prescribed in HHSAR 316.307 ( a ) ( 2 ), the Contracting Officer shall insert the pursue article :
extra monetary value Principles for Hospitals ( net income or Non-Profit ) ( December 18, 2015 )
( a ) Bid and proposal (B&P) costs. ( 1 ) B & P costs are the immediate costs of preparing bids, proposals, and applications for likely Federal and non-Federal contracts, grants, and agreements, including the development of scientific, price, and early data needed to support the bids, proposals, and applications .
( 2 ) B & P costs of the current accounting period are allowable as indirect costs .
( 3 ) B & P costs of past accountancy periods are unallowable in the current time period. however, if the arrangement ‘s established practice is to treat these costs by some other method, they may be accepted if they are found to be fair and equitable .
( 4 ) B & P costs do not include freelancer inquiry and exploitation ( IR & D ) costs covered by the follow paragraph, or pre-award costs covered by paragraph 36 of Attachment B to OMB Circular A-122 .
( bel ) IR&D costs .
( 1 ) IR & D is research and development conducted by an organization which is not sponsored by Federal or non-Federal contracts, grants, or other agreements .
( 2 ) IR & D shall be allocated its harmonious share of indirect costs on the same basis as the allocation of indirect costs to sponsored research and exploitation .
( 3 ) The cost of IR & D, including its proportionate share of indirect costs, is unallowable .
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352.219-70 Mentor-Protégé Program.
As prescribed in HHSAR 319.270-1 ( a ), the Contracting Officer shall insert the stick to provision :
Mentor-Protégé Program ( December 18, 2015 )
( a ) large clientele prime contractors serving as mentors in the HHS Mentor-Protégé Program are eligible for HHS subcontracting plan credit, and shall submit a copy of their HHS Office of Small and Disadvantaged Business Utilization ( OSDBU ) -approved mentor-protégé agreements as separate of their offers. The amount of accredit provided by the Contracting Officer to a mentor firm for protégé firm developmental aid costs shall be calculated on a dollar for dollar basis and reported by the mentor tauten in the Summary Subcontract Report via the Electronic Subcontracting Reporting System ( electron spin resonance ) at hypertext transfer protocol : //www.esrs.gov. The mentor firm and protégé firm shall submit to the Contracting Officer a signed joint instruction agreeing on the dollar measure of the developmental aid the mentor firm provided. ( For case, a mentor firm would report a $ 10,000 subcontract awarded to a protégé firm and provision of $ 5,000 of developmental aid as $ 15,000 of subcontracting plan credit. ) The mentor firm may use this extra credit towards attaining its subcontract plan participation finish under this contract .
( b ) The broadcast consists of—
( 1 ) Mentor firms —large businesses that :
( iodine ) Demonstrate the interest, commitment, and capability to provide developmental aid to little clientele protégé firms ; and
( two ) Have a Mentor-Protégé agreement approved by HHS ’ OSDBU ;
( 2 ) Protégé firms —firms that :
( i ) Seek developmental aid ;
( two ) Qualify as humble businesses, veteran-owned small businesses, service-disabled veteran-owned minor businesses, HUBZone little businesses, small disadvantaged businesses, or woman-owned small businesses ; and
( three ) Have a Mentor-Protégé agreement approved by HHS ’ OSDBU ; and
( 3 ) Mentor-Protégé agreements —joint agreements, approved by HHS ’ OSDBU, which detail the specific terms, conditions, and responsibilities of the mentor-protégé relationship .
( end of provision )
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352.219-71 Mentor-Protégé Program Reporting Requirements.
As prescribed in HHSAR 319.270-1 ( b ), the Contracting Officer shall insert the follow article :
Mentor-Protégé Program report Requirements ( January 2010 )
The Contractor shall comply with all report requirements specified in its Mentor-Protégé agreement approved by HHS ’ OSDBU .
( end of clause )
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352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations.
As prescribed in HHSAR 322.810 ( hydrogen ), the Contracting Officer shall insert the play along clause :
Contractor Cooperation in Equal Employment Opportunity Investigations
( December 18, 2015 )
( a ) In summation to complying with the article at FAR 52.222-26, equal Opportunity, the Contractor shall, in good faith, collaborate with the Department of Health and Human Services ( Agency ) in investigations of adequate Employment Opportunity ( EEO ) complaints processed pursuant to 29 CFR separate 1614. For purposes of this article, the adopt definitions apply :
( 1 ) Complaint means a formal or cozy complaint that has been lodged with Agency management, Agency EEO officials, the peer Employment Opportunity Commission ( EEOC ), or a court of competent jurisdiction .
( 2 ) Contractor employee means all current Contractor employees who work or worked under this contract. The term besides includes current employees of subcontractors who work or worked under this compress. In the case of Contractor and subcontractor employees, who worked under this abridge, but who are no retentive employed by the Contractor or subcontractor, or who have been assigned to another entity within the Contractor ’ s or subcontractor ’ second organization, the Contractor shall provide the Agency with that employee ’ sulfur final know mailing address, e-mail address, and telephone number, if that employee has been identified as a witness in an EEO ailment or investigation .
( 3 ) Good faith cooperation cited in paragraph ( a ) includes, but is not limited to, making Contractor employees available for :
( one ) Formal and informal interviews by EEO counselors or other Agency officials processing EEO complaints ;
( two ) Formal or informal interviews by EEO investigators charged with investigating complaints of unlawful discrimination filed by Federal employees ;
( three ) Reviewing and signing appropriate affidavits or declarations summarizing statements provided by such Contractor employees during the course of EEO investigations ;
( four ) Producing documents requested by EEO counselors, EEO investigators, Agency employees, or the EEOC in connection with a pending EEO complaint ; and
( five ) Preparing for and providing testimony in depositions or in hearings before the MSPB, EEOC and U.S. District Court .
( b-complex vitamin ) The Contractor shall include the provisions of this article in all subcontract solicitations and subcontracts awarded at any tier under this contract .
( carbon ) failure on the share of the Contractor or its subcontractors to comply with the terms of this clause may be grounds for the Contracting Officer to terminate this contract for default .
( end of clause )
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352.223-70 Safety and Health.
As prescribed in HHSAR 323.7002 , the Contracting Officer shall insert the come article :
Safety and Health ( December 18, 2015 )
( a ) To help ensure the auspices of the life and health of all persons, and to help prevent damage to property, the Contractor shall comply with all Federal, State, and local laws and regulations applicable to the work being performed under this contract. These laws are implemented or enforced by the Environmental Protection Agency, Occupational Safety and Health Administration ( OSHA ) and other regulatory/enforcement agencies at the Federal, State, and local anesthetic levels .
( 1 ) In addition, the Contractor shall comply with the surveil regulations when developing and implementing health and safety operate procedures and practices for both personnel and facilities involving the use or cover of hazardous materials and the lead of research, development, or screen projects :
( i ) 29 CFR 1910.1030, Bloodborne pathogens ; 29 CFR 1910.1450, Occupational exposure to hazardous chemicals in laboratories ; and early applicable occupational health and base hit standards issued by OSHA and included in 29 CFR partially 1910. These regulations are available at hypertext transfer protocol : //www.osha.gov/ .
( two ) Nuclear Regulatory Commission Standards and Regulations, pursuant to the Energy Reorganization Act of 1974 ( 42 U.S.C. 5801 et seq . ). The Contractor may obtain copies from the U.S. Nuclear Regulatory Commissio newton, Washington, DC 20555–0001 .
( 2 ) The following Government guidelines are recommended for developing and implementing health and base hit operational procedures and practices for both personnel and facilities :
( iodine ) biosafety in Microbiological and Biomedical Laboratories, CDC. This publication is available at hypertext transfer protocol : //www.cdc.gov/biosafety/publications/index.htm .
( two ) Prudent Practices for Safety in Laboratories ( 1995 ), National Research Council, National Academy Press, 500 Fifth Street, NW., Lockbox 285, Washington, DC 20055 ( ISBN 0–309–05229–7 ). This publication is available at hypertext transfer protocol : //www.nap.edu/catalog/4911/prudent-practices-in-the-laboratory-handling-and-disposal-of-chemicals .
( b ) Further, the Contractor shall take or cause to be taken extra guard measures as the Contracting Officer, in conjunction with the Contracting Officer ’ s Representative or other appropriate officials, determines to be sanely necessary. If submission with these extra safety measures results in an increase or decrease in the price or time required for performance of any partially of work under this contract, the Contracting Officer will make an equitable alteration in accordance with the applicable “ Changes ” clause set forth in this contract .
( hundred ) The Contractor shall maintain an accurate record of, and promptly report to the Contracting Officer, all accidents or incidents resulting in the exposure of persons to toxic substances, hazardous materials or hazardous operations ; the injury or death of any person ; or damage to property attendant to work performed under the contract resulting from toxic or hazardous materials and resulting in any or all violations for which the Contractor has been cited by any Federal, State or local regulatory/enforcement agency. The report citing all accidents or incidents resulting in the exposure of persons to toxic substances, hazardous materials or hazardous operations ; the injury or death of any person ; or damage to property incidental to work performed under the contract resulting from toxic or hazardous materials and resulting in any or all violations for which the Contractor has been cited shall include a copy of the comment of irreverence and the findings of any inquiry or inspection, and an analysis addressing the affect these violations may have on the work remaining to be performed. The report shall besides department of state the compulsory action ( randomness ), if any, to be taken to correct any misdemeanor ( s ) noted by the Federal, State, or local regulatory/enforcement agency and the meter frame allowed by the agency to accomplish the necessary corrective action .
( five hundred ) If the Contractor fails or refuses to comply with the Federal, State or local regulatory/enforcement representation ’ s directive ( s ) regarding any rape ( sulfur ) and order corrective action ( second ), the Contracting Officer may issue an orderliness stopping all or separate of the work until satisfactory corrective action ( as approved by the Federal, State, or local regulatory/enforcement agencies ) has been taken and documented to the Contracting Officer. No depart of the time lost ascribable to any such stop work ordering shall form the basis for a request for elongation or costs or damages by the Contractor .
( east ) The Contractor shall insert the substance of this article in each subcontract involving toxic substances, hazardous materials, or hazardous operations. The Contractor is responsible for the complaisance of its subcontractors with the provisions of this clause .
( end of article )
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352.223-71 Instructions to Offerors—Sustainable Acquisition.
As prescribed in HHSAR 323.7103, the Contracting Officer shall insert the pursue provision :
Instructions to Offerors—Sustainable Acquisition ( December 18, 2015 )
Offerors must include a sustainable Acquisition design in their technical proposals. The plan must describe their approach and the quality assurance mechanisms in rate for applying FAR 23.1, sustainable acquisition Policy ( and early Federal laws, regulations and Executive Orders governing sustainable learning purchasing ) to this learning. The Plan shall clearly identify those products and services included in Federal sustainable learning preference programs by categorizing them along with their respective price/cost in the follow eight groups : Recycled Content, Energy Efficient, Biobased, Environmentally Preferable, Electronic Product Environment Assessment Tool, Water-Efficient, Non-Ozone Depleting Substances, and Alternative Fuel Vehicle and Alternative Fuels .
( end of provision )
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352.224-70 Privacy Act.
As prescribed in HHSAR 324.105 ( a ), the Contracting Officer shall insert the following clause :
Privacy Act ( December 18, 2015 )
This shrink requires the Contractor to perform one or more of the succeed : ( a ) design ; ( b-complex vitamin ) train ; or ( c ) operate a Federal representation arrangement of records to accomplish an agency function in accord with the Privacy Act of 1974 ( Act ) ( 5 U.S.C. 552a(m)(1)) and applicable agency regulations .
The term system of records means a group of any records under the control of any agency from which information is retrieved by the name of the person or by some identify number, symbol, or early identifying particular assigned to the individual. Violations of the Act by the Contractor and/or its employees may result in the imposition of criminal penalties ( 5 U.S.C. 552a(i)) .
The Contractor shall ensure that each of its employees knows the prescribed rules of conduct in 45 CFR partially 5b and that each employee is aware that he/she is subject to criminal penalties for trespass of the Act to the same extent as Department of Health and Human Services employees. These provisions besides apply to all subcontracts the Contractor awards under this shrink which require the purpose, development or operation of the destine organization ( sulfur ) of records ( 5 U.S.C. 552a(m)(1) ). The contract knead instruction :
( a ) Identifies the system ( south ) of records and the design, development, or operation work the Contractor is to perform ; and
( bel ) Specifies the disposal to be made of such records upon completion of compress operation .
( end of clause )
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352.224-71 Confidential Information.
As prescribed in HHSAR 324.105 ( bacillus ), insert the adopt clause :
confidential Information ( December 18, 2015 )
( a ) Confidential Information, as used in this article, means data or datum of a personal nature about an individual, or proprietorship data or datum submitted by or pertaining to an institution or organization .
( b-complex vitamin ) specific information or categories of information that the Government will furnish to the Contractor, or that the Contractor is expected to generate, which are confidential may be identified elsewhere in this contract. The Contracting Officer may modify this sign to identify confidential information from prison term to clock during performance .
( cytosine ) Confidential Information or records shall not be disclosed by the Contractor until :
( 1 ) Written gain notice of at least 45 days shall be provided to the Contracting Officer of the Contractor ‘s intent to release findings of studies or inquiry, to which an agency response may be appropriate to protect the public interest or that of the means .
( 2 ) For data provided by or on behalf of the government ,
( one ) The publication or dissemination of the trace types of information are restricted under this compress : [ INSERT RESTRICTED TYPES OF INFORMATION. If none, indeed state. ]
( two ) The reason ( south ) for restricting the types of information identified in subparagraph ( one ) is/are : [ STATE WHY THE PUBLIC OR GOVERNMENT INTEREST REQUIRES THE RESTRICTION OF EACH TYPE OF INFORMATION. ANY BASIS FOR NONDISCLOSURE WHICH WOULD BE VALID UNDER THE FREEDOM OF INFORMATION ACT IS SUFFICIENT UNDER THIS CLAUSE. ]
( three ) Written progress comment of at least 45 days shall be provided to the Contracting Officer of the Contractor ‘s intent to disseminate or publish information identified in subparagraph ( 2 ) ( i ). The contractor shall not disseminate or publish such information without the written consent of the Contracting Officer .
( vitamin d ) Whenever the Contractor is uncertain with esteem to the confidentiality of or a place concern in information under this contract, the Contractor should consult with the Contracting Officer anterior to any acquittance, disclosure, dispersion, or issue .
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352.226-1 Indian Preference.
As prescribed in HHSAR 326.505 ( a ), the Contracting Officer shall insert the follow clause :
Indian Preference ( December 18, 2015 )
( a ) The Contractor agrees to give preference in employment opportunities under this contract to Indians who can perform required work, careless of long time ( subjugate to existing laws and regulations ), sex, religion, or tribal affiliation. To the extent feasible and reproducible with the efficient performance of this contract, the Contractor further agrees to give predilection in employment and train opportunities under this contract to Indians who are not in full qualified to perform careless of old age ( national to existing laws and regulations ), sex, religion, or tribal affiliation. The Contractor besides agrees to give preference to indian organizations and Indian-owned economic enterprises in the award of any subcontracts to the extent feasible and reproducible with the efficient performance of this contract. The Contractor shall maintain the necessity statistical records to demonstrate complaisance with this paragraph .
( b ) In association with the indian employment preference requirements of this article, the Contractor shall provide reasonable opportunities for train, incident to such employment. such training shall include on-the—job, classroom, or apprenticeship training designed to increase the vocational effectiveness of an amerind employee .
( c ) If the Contractor is ineffective to fill its use and education opportunities after giving full circumstance to Indians as required by this clause, the Contractor may satisfy those needs by selecting non-Indian persons in accordance with the clause of this sign entitled “ equal opportunity. ”
( five hundred ) If no indian organizations or Indian-owned economic enterprises are available under reasonable terms and conditions, including price, for awarding of subcontracts in connection with the workplace performed under this contract, the Contractor agrees to comply with the provisions of this sign involving use of small businesses ; HUBZone little businesses ; service-disabled, veteran-owned small businesses ; 8 ( a ) small businesses ; veteran-owned small businesses ; women-owned belittled businesses ; or modest disadvantage businesses .
( east ) As used in this clause ,
( 1 ) Indian means a person who is a member of an indian tribe. If the Contractor has rationality to doubt that a person seeking employment preference is an amerind, the Contractor shall grant the preference but shall require the individual put up testify within 30 days from the tribe concerned that the person is a extremity of the tribe .
( 2 ) Indian tribe means an indian tribe, pueblo, band, nation, or other organized group or community, including Alaska Native village or regional or village pot as defined in or established pursuant to the Alaska Native Claims Settlement Act ( 85 Stat. 688 ; 43 U.S.C. 1601 ) which the United States recognizes as eligible for the extra programs and services provided to Indians because of its status as Indians .
( 3 ) Indian organization means the governing body of any indian Tribe or entity established or recognized by such governing body in accord with the indian Financing Act of 1974 ( 88 Stat. 77 ; 25 U.S.C. 1451 ) .
( 4 ) Indian-owned economic enterprise means any Indian-owned commercial, industrial, or business activity established or organized for the purpose of net income, provided that such amerind ownership shall constitute not less than 51 percentage of the enterprise, and that ownership shall encompass active operation and control of the enterprise .
( f ) The Contractor agrees to include the provisions of this clause, including this paragraph ( fluorine ) of this clause, in each subcontract awarded at any tier under this contract .
( gram ) In the event of disobedience with this article, the Contracting Officer may terminate the contract in whole or in contribution or may pursue any other remedies authorized by law or by other provisions of the contract .
( end of clause )
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352.226-2 Indian Preference Program.
As prescribed in HHSAR 326.505 ( b ), the Contracting Officer shall insert the postdate clause :
Indian Preference Program ( December 18, 2015 )
( a ) In addition to the requirements of the clause of this contract entitled “ indian Preference, ” the Contractor agrees to establish and conduct an indian preference program which will expand opportunities for Indians to receive preference for employment and trail in connection with the sour performed under this contract, and which will expand the opportunities for amerind organizations and Indian-owned economic enterprises to receive a preference in the award of subcontracts. In this association, the Contractor shall perform the follow :
( 1 ) Designate a affair policeman who will maintain affair with the Government and the Tribe ( s ) on indian preference matters ; supervise conformity with the provisions of this clause ; and administer the Contractor ’ randomness amerind preference program .
( 2 ) Advise its recruitment sources in write and include a statement in all employment advertisements that indian applicants pick up preference in use and aim incident to such employment .
( 3 ) not more than 20 calendar days after award of the contract, post a written notice setting forth the Contractor ’ mho employment needs and related coach opportunities in the tribal office of any reservations on or near the condense influence location. The poster shall include the approximate numbers and types of employees needed ; the approximate dates of employment ; any experience or special skills required for use ; training opportunities available ; and other apposite information necessary to advise prospective employees of any other employment requirements. The Contractor shall besides request the kin ( s ) on or near whose reservation ( s ) the Contractor will perform sign employment to provide aid filling its employment needs and train opportunities. The Contracting Officer will advise the Contractor of the identify, location, and call number of the Tribal officials to contact regarding the mailing of notices and requests for Tribal aid .
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( 4 ) establish and conduct a subcontract plan which gives preference to indian organizations and Indian-owned economic enterprises as subcontractors ( including suppliers ) under this sign. The Contractor shall give public notice of existing subcontracting opportunities and, to the extent feasible and coherent with the efficient performance of this narrow, shall solicit bids or proposals from amerind organizations or Indian-owned economic enterprises only. The Contractor shall request aid and information on indian firms qualified as subcontractors ( including suppliers ) from the Tribe ( s ) on or near whose reservation ( s ) the Contractor will perform contract work. The Contracting Officer will advise the Contractor of the name, placement, and telephone number of the Tribal officials to contact regarding the request for aid and information. public notices and solicitations for existing subcontracting opportunities shall provide an equitable opportunity for indian firms to submit bids or proposals by including—
( one ) A clear description of the supplies or services required, including quantities, specifications, and pitch schedules that facilitate the participation of indian firms ;
( two ) A instruction indicating that indian organizations and Indian-owned economic enterprises will receive preference in accord with section 7 ( b ) of Pub. L. 93–638 ; 88 Stat. 2205 ; 25 U.S.C. 450e(b) ;
( three ) Definitions for the terms “ indian organization ” and “ Indian-owned economic enterprise ” prescribed under the “ indian Preference ” clause of this contract ;
( intravenous feeding ) A argument that the bidder or offeror shall complete certifying that it is an indian organization or Indian-owned economic enterprise ; and
( volt ) A close date for receipt of bids or proposals which provides sufficient fourth dimension for cooking and submission of a invite or marriage proposal. If, after soliciting bids or proposals from indian organizations and Indian-owned economic enterprises, the Contractor receives no responsive bid or satisfactory proposal, the Contractor shall comply with the requirements of paragraph ( five hundred ) of the “ indian Preference ” article of this compress. If the Contractor receives one or more responsive bids or conforming proposals, the Contractor shall award the contract to the gloomy, responsive, creditworthy bidder or conforming crack from a responsible offerer if the price is reasonable. If the Contractor determines the low responsive bid or conforming proposal ’ sulfur price is unreasonable, the Contractor shall attempt to negotiate a reasonable price and award a subcontract. If parties can not agree on a fair price, the Contractor shall comply with the requirements of paragraph ( five hundred ) of the “ indian Preference ” clause of this shrink .
( 5 ) Maintain written records under this contract which demonstrate—
( one ) The numbers of Indians seeking employment for each employment stead available under this sign ;
( two ) The total and types of positions filled by Indians and non-Indians ;
( three ) The total number of Indians employed under this contract ;
( intravenous feeding ) For those positions having both indian and non-Indian applicants, and a non-Indian is selected for employment, the argue ( second ) why the contractor did not select the indian applicant ;
( vanadium ) Actions taken to give preference to amerind organizations and Indian-owned economic enterprises for subcontracting opportunities which exist under this narrow ;
( united states virgin islands ) Reasons why indian subcontractors and or suppliers did not receive preference for each prerequisite where the Contractor determined that such preference was discrepant with effective compress performance ; and
( seven ) The number of indian organizations and Indian-owned economic enterprises contacted, and the act receiving subcontract awards under this abridge .
( 6 ) submit to the Contracting Officer for approval a quarterly report summarizing the Contractor ’ south indian preference plan and indicating the count and types of available positions filled by Indians and non-Indians, and the dollar amounts of all subcontracts awarded to indian organizations and Indian-owned economic enterprises, and to all other firms .
( 7 ) uphold records pursuant to this article and keep them available for revue by the Government for one year after final payment under this abridge, or for such longer period in accord with requirements of any other article of this contract or by applicable law or regulation .
( b ) For purposes of this article, the follow definitions of terms shall apply :
( 1 ) The terms Indian, Indian tribe, Indian organization, and Indian-owned economic enterprise are defined in the clause of this shrink entitled Indian Preference .
( 2 ) Indian reservation includes indian reservations, public knowledge domain indian allotments, former indian reservations in Oklahoma, and domain held by corporate Native groups, regional corporations, and village corporations under the provisions of the Alaska Native Claims Settlement Act ( 85 Stat. 688 ; 43 U.S.C. 1601 et seq . )
( 3 ) On or near an Indian reservation means on a reservation or reservations or within that sphere surrounding an indian reservation ( south ) where a person seeking employment could reasonably expect to commute to and from in the course of a cultivate day .
( vitamin c ) nothing in the requirements of this article shall preclude indian tribes from independently developing and enforcing their own indian preference requirements. such requirements must not conflict with any Federal statutory or regulative necessity dealing with the award and government of contracts .
( five hundred ) The Contractor agrees to include the provisions of this clause, including this paragraph ( five hundred ), in each subcontract awarded at any tier under this contract and to notify the Contracting Officer of such subcontracts .
( einsteinium ) In the consequence of disobedience with this clause, the Contracting Officer may terminate the contract in solid or in function or may pursue any other remedies authorized by law or by early provisions of the condense .
( end of article )
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352.226-3 Native American Graves Protection and Repatriation Act.
As prescribed in HHSAR 326.701, the Contracting Officer shall insert the following article :
Native American Graves Protection and Repatriation Act
( December 18, 2015 )
( a ) Public Law 101–601 , dated November 16, 1990, besides known as the native American Graves Protection and Repatriation Act, imposes certain responsibilities on individuals and organizations when they discover native american cultural items ( including human remains ) on Federal or tribal lands .
( b ) In the event the Contractor discovers native american cultural items ( including homo remains, associated funerary objects, unassociated funerary objects, sacred objects and cultural birthright ), as defined in the Act during contract operation, the Contractor shall—
( 1 ) immediately end action in the area of the discovery ;
( 2 ) Notify the Contracting Officer of the discovery ; and
( 3 ) Make a fair effort to protect the items discovered before resuming such activity. Upon acknowledge of the Contractor ’ s discovery poster, the Contracting Officer will notify the appropriate authorities as required by the Act .
( coke ) Unless differently specified by the Contracting Officer, the Contractor may resume action in the area on the 31st calendar day following the date that the appropriate authorities certify acknowledge of the discovery notice. The Contracting Officer shall provide to the Contractor the date that the appropriate authorities certify receipt of the discovery notice and the date on which the contractor may resume activities .
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352.227-11 Patent Rights—Exceptional Circumstances.
As prescribed in HHSAR 327.303, the Contracting Officer shall insert the following article :
Patent Rights—Exceptional Circumstances ( Sept 2014 )
This clause applies to all Contractor and subcontractor ( at all tiers ) subject Inventions .
( a ) Definitions. As used in this clause—
Agency means the Agency of the U.S. Department of Health and Human Services that is entering into this contract .
Class 1 Subject Invention means a subject Invention describe and defined in the DEC that will be assigned to a third party assignee, or assigned as directed by the Agency .
Class 2 Subject Invention means a capable Invention identify and defined in the DEC .
Class 3 Subject Invention means a subject invention that does not fall into Class 1 or Class 2 as defined in this clause .
DEC means the Determination of Exceptional Circumstances signed by [ insert approving official ] ____ on ____ [ insert date ] ____ and titled “ [ slip in description ]. ”
Invention means any invention or discovery, which is or may be patentable or differently protectable under Title 35 of United States Code, or any novel kind of plant that is or may be protectable under the Plant Variety Protection Act ( 7 U.S.C. 2321, et seq. )
Made means : When used in relation back to any invention early than a plant assortment, the concept or first actual decrease to commit of such invention ; or when used in relation to a plant variety, that the Contractor has at least tentatively determined that the assortment has been reproduced with recognized characteristics .
Material means any proprietary material, method acting, merchandise, typography, intensify, or device, whether patented or unpatented, which is provided to the Contractor under this contract .
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Nonprofit organization means a university or other initiation of higher education or an constitution of the type described in section 501 ( deoxycytidine monophosphate ) ( 3 ) of the Internal Revenue Code of 1954 ( 26 U.S.C. 501 ( hundred ) ) and excuse from taxation under section 501 ( a ) of the Internal Revenue Code ( 26 U.S.C. 501 ( a ) ) or any nonprofit organization scientific or educational organization qualified under a state nonprofit organization administration legislative act .
Practical application means to manufacture, in the case of a musical composition or product ; to drill, in the case of a summons or method, or to operate, in the case of a machine or system ; and, in each case, under such conditions as to establish that the invention is being utilized and that its benefits are, to the extent permitted by police or Government regulations, available to the public on reasonable terms .
Small business firm means a small business concern as defined at section 2 of public Law 85-536 ( 15 U.S.C. 632 ) and implementing regulations of the Administrator of the Small Business Administration. For the aim of this clause, the size standards for modest business concerns involved in Government procurement and subcontract at 13 CFR 121.3-8 and 13 CFR 121.3-12, respectively, will be used .
Subject Invention means any invention of the Contractor made in the performance of work under this contract .
Third party assignee means any entity or organization that may, as described in the DEC, be assigned Class 1 inventions .
( barn ) Allocation of principal rights. ( 1 ) Retention of pre-existing rights. Third party assignees shall retain all preexistent rights to Material in which the Third party assignee has a proprietary sake .
( 2 ) Allocation of Subject Invention rights. ( iodine ) Disposition of Class 1 Subject Inventions. ( A ) appointment to the Third party assignee or as directed by the Agency. The Contractor shall assign to the Third party assignee designated by the Agency the entire right, title, and interest throughout the world to each Subject Invention, or differently discard of or transfer those rights as directed by the Agency, except to the extent that rights are retained by the Contractor under paragraph ( b-complex vitamin ) ( 3 ) of this article. Any such assignment or other disposal or remove of rights will be subject to a nonexclusive, nontransferable, irrevocable, paid-up license to the U.S. Government to practice or have practiced the Subject Invention for or on behalf of the U.S. throughout the world. Any assignment shall additionally be subject to the “ March-in rights ” of 35 U.S.C. 203. If the Contractor is a U.S. nonprofit organization organization it may retain a royalty free, nonexclusive, nontransferable license to practice the invention for all nonprofit research including for educational purposes, and to permit other U.S. nonprofit organizations to do so .
( B ) [ Reserved ]
( two ) Disposition of Class 2 and 3 Subject Inventions. class 2 discipline Inventions shall be governed by FAR article 52.227-11, Patent Rights-Ownership ( December 2007 ) ( incorporated herein by reference point ). however, the Contractor shall grant a license in the course 2 subject Inventions to the provider of the Material or other party designated by the Agency as arrange forth in Alternate I .
( three ) class 3 subject Inventions shall be governed by FAR clause 52.227-11, Patent Rights-Ownership by the Contractor ( December 2007 ) ( previously incorporated herein by reference point ) .
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( 3 ) Greater Rights Determinations. The Contractor, or an employee-inventor after consultation by the Agency with the Contractor, may request greater rights than are provided in paragraph ( barn ) ( 1 ) of this clause in accordance with the procedures of FAR paragraph 27.304-1 ( c ). In summation to the considerations set forth in paragraph 27.304-1 ( cytosine ), the Agency may consider whether granting the requested greater rights will interfere with rights of the Government or any Third party assignee or differently impede the ability of the Government or the Third party assignee to, for model, develop and commercialize raw compounds, dose forms, therapies, preventive measures, technologies, or other approaches with potential for the diagnosis, prognosis, prevention, and treatment of human diseases .
A request for a determination of whether the Contractor or the employee-inventor is entitled to retain such greater rights must be submitted to the Agency Contracting Officer at the time of the first disclosure of the invention pursuant to paragraph ( c ) ( 1 ) of this clause, or not late than 8 months thereafter, unless a longer period is authorized in writing by the Contracting Officer for good induce shown in spell by the Contractor. Each decision of greater rights under this abridge shall be subject to paragraph ( carbon ) of the FAR article at 52.227-13 ( incorporated herein by reference ), and to any reservations and conditions deemed to be appropriate by the Agency such as the requirement to assign or entirely license the rights to subject Inventions to the Third party assignee .
A decision by the Agency denying a request by the Contractor for greater rights in a subject invention may be appealed within 30 days of the date the Contractor is notified of the determination to an Agency official at a grade above the individual who made the determination. If greater rights are granted, the Contractor must file a apparent application on the invention. Upon request, the Contractor shall provide the file date, serial number and claim, a copy of the patent application ( including an English-language adaptation if filed in a language other than English ), and patent number and issue date for any topic Invention in any nation for which the Contractor has retained title. Upon request, the Contractor shall furnish the Government an irrevocable power to inspect and make copies of the patent application file .
( c ) Invention disclosure by Contractor. The Contractor shall disclose in writing each submit invention to the Agency Contracting Officer and to the Director, Division of Extramural Inventions and Technology Resources ( DEITR ), if directed by the Contracting Officer, as provided in paragraph ( joule ) of this article within 2 months after the inventor discloses it in writing to Contractor personnel responsible for patent matters. The disclosure to the Agency Contracting Officer shall be in the form of a written report and shall identify the compress under which the invention was Made and all inventors. It shall be sufficiently complete in technical detail to convey a clear understand to the extent known at the time of the disclosure, of the nature, aim, process, and the physical, chemical, biological, or electrical characteristics of the invention. The disclosure shall besides identify any publication, on sale ( offer for sale ), or populace practice of the invention and whether a manuscript describing the invention has been submitted for issue, and if then, whether it has been accepted for publication at the time of disclosure .
In addition, after disclosure to the Agency, the Contractor will promptly notify the Contracting Officer and DEITR of the credence of any manuscript describing the invention for publication or of any on sale or public use planned by the Contractor. If the Contractor assigns a capable invention to the Third party assignee, then the Contractor and its employee inventors shall assist the Third party assignee in securing patent protection. All costs of securing the apparent, including the cost of the Contractor ‘s aid, are at the Third party ‘s expense. Any aid provided by the Contractor and its employee inventors to the Third party assignee or other costs incurred in securing patent protective covering shall be entirely at the Third party ‘s expense and not billable to the sign .
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( d ) Contractor action to protect the Third party assignee’s and the Government’s interest. ( 1 ) The Contractor agrees to execute or to have executed and promptly deliver to the Agency all instruments necessary to : Establish or confirm the rights the Government has throughout the earth in subjugate Inventions pursuant to paragraph ( b ) of this article ; convey title to a Third party assignee in accord with paragraph ( barn ) of this article ; and enable the Third party assignee to obtain patent protection throughout the universe in that subject Invention .
( 2 ) The Contractor agrees to require, by written agreement, its employees, other than clerical and nontechnical employees, to disclose promptly in writing to personnel identified as creditworthy for the presidency of patent matters and in a format suggested by the Contractor, each Subject Invention “ Made ” under contract in order that the Contractor can comply with the disclosure provisions of paragraph ( c ) of this article, and to execute all papers necessary to file patent applications on subject Inventions and to establish the Government ‘s rights or a Third party assignee ‘s rights in the subject Inventions. This disclosure format should require, as a minimum, the information required by subparagraph ( coke ) ( 1 ) of this article. The Contractor shall instruct such employees, through employee agreements or other suitable educational programs, on the importance of reporting inventions in sufficient clock to permit the file of patent applications anterior to U.S. or foreign statutory bars .
( 3 ) If the Contractor is granted greater rights, the Contractor agrees to include, within the specification of any United States non-provisional apparent application it files, and any patent issue thereon, covering a topic Invention the pursue instruction : “ This invention was made with Government documentation under ( identify the Contract ) awarded by ( identify the specific Agency ). The Government has certain rights in the invention. ”
( 4 ) The Contractor agrees to provide a concluding invention instruction and authentication prior to the closeout of the contract listing all subject Inventions or stating that there were none .
( vitamin e ) Subcontracts. ( 1 ) The Contractor will include this article in all subcontracts, regardless of tier, for experimental, developmental, or research sour. At all tiers, the clause must be modified to identify the parties as follows : References to the Government are not changed, and the subcontractor has all rights and obligations of the Contractor in the article. The Contractor will not, as character of the consideration for awarding the compress, obtain rights in the subcontractor ‘s subject Inventions .
( 2 ) In subcontracts, at any tier, the Agency, the subcontractor, and the Contractor agree that the common obligations of the parties created by this clause constitute a contract between the subcontractor and the Agency with respect to the matters covered by the clause ; provided, however, that nothing in this paragraph is intended to confer any legal power under the Contract Disputes Act in connection with proceedings under paragraph ( carbon ) ( 1 ) ( two ) of FAR clause 52.227-13 .
( f ) Reporting on utilization of Subject Inventions in the event greater rights are granted to the Contractor. The Contractor agrees to submit, on request, periodic reports no more frequently than per annum on the use of a subjugate Invention or on efforts at obtaining such use that are being made by the Contractor or its licensees or assignees when a request under subparagraph b.3. has been granted by the Agency. such reports shall include information regarding the status of development, date of first commercial sale or habit, crude royalties received by the Contractor, and such early data and information as the Agency may reasonably specify. The Contractor besides agrees to provide extra reports as may be requested by the Agency in association with any march-in continue undertaken by the Agency in accordance with paragraph ( hydrogen ) of this article. As required by 35 U.S.C. 202 ( c ) ( 5 ), the Agency agrees it will not disclose such information to persons outside the Government without license of the Contractor .
( gram ) preference for United States diligence in the consequence greater rights are granted to the Contractor. Notwithstanding any other provision of this article, the Contractor agrees that neither it nor any assignee will grant to any person the exclusive right to use or sell any capable invention in the United States unless such person agrees that any product embodying the national Invention or produced through the manipulation of the Subject Invention will be manufactured well in the United States. however, in individual cases, the necessity for such an agreement may be waived by the Agency upon a show by the Contractor or its assignee that reasonable but abortive efforts have been made to grant licenses on similar terms to likely licensees that would be probably to manufacture substantially in the United States or that under the circumstances domestic fabricate is not commercially feasible .
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( heat content ) March-in rights in the event greater rights are granted to the Contractor. The Contractor acknowledges that, with respect to any subject Invention in which it has acquired ownership through the exercise of the rights specified in paragraph ( b ) ( 3 ) of this article, the Agency has the correct to require license pursuant to 35 U.S.C. 203 and 210 ( deoxycytidine monophosphate ), and in accord with the procedures in 37 CFR 401.6 and any auxiliary regulations of Agency in effect on the date of contract award .
( one ) Special provisions for contracts with nonprofit organizations in the event greater rights are granted to the Contractor. If the Contractor is a nonprofit organization organization, it shall :
( 1 ) not assign rights to a capable invention in the United States without the written approval of the Agency, except where an assignment is made to an organization that has as one of its chief functions the management of inventions, provided that the assignee shall be subject to the like provisions as the Contractor ;
( 2 ) share royalties collected on a subject invention with the inventor, including Federal employee co-inventors ( but through their agency if the Agency deems it appropriate ) when the Subject Invention is assigned in accord with 35 U.S.C. 202 ( vitamin e ) and 37 CFR 401.10 ;
( 3 ) Use the balance wheel of any royalties or income earned by the Contractor with deference to submit Inventions, after requital of expenses ( including payments to inventors ) incidental to the administration of subject Inventions for the digest of scientific research or department of education ;
( 4 ) Make efforts that are fair under the circumstances to attract licensees of national Inventions that are small commercial enterprise concerns, and give a preference to a minor business refer when licensing a capable invention if the Contractor determines that the small commercial enterprise business has a plan or proposal for marketing the invention which, if executed, is equally arsenic probable to bring the invention to practical lotion as any plans or proposals from applicants that are not minor business concerns ; provided, that the Contractor is besides satisfied that the modest business refer has the capability and resources to carry out its plan or marriage proposal. The decision whether to give a preference in any specific lawsuit will be at the discretion of the Contractor ; and
( 5 ) Allow the Secretary of Commerce to review the Contractor ‘s license platform and decisions regarding humble business applicants, and negociate changes to its license policies, procedures, or practices with the Secretary of Commerce when the Secretary ‘s follow-up discloses that the Contractor could take fair steps to more effectively implement the requirements of paragraph ( iodine ) ( 4 ) of this clause .
( joule ) Communications. All invention disclosures and requests for greater rights shall be sent to the Agency Contracting Officer, as directed by the Contracting Officer. additionally, a copy of all disclosures, collateral licenses to the Government, face page of the patent applications, waivers and early routine communications under this fund agreement at all tiers must be sent to :
[ Insert Agency Address ]
Agency Invention Reporting Web site : hypertext transfer protocol : //public.era.nih.gov/iedison .
Alternate I (Sept 2014). As prescribed in 327.303, the license to Class 2 inventions recited in 352.227-11 ( bacillus ) ( 2 ) ( a ) is as follows :
[ Insert description of license to Class 2 inventions ]
( end of clause )
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352.227-14 Rights in Data—Exceptional Circumstances.
As prescribed in HHSAR 327.409, insert the surveil article with any allow alternates :
Rights in Data—Exceptional Circumstances ( Sept 2014 )
( a ) Definitions. As used in this clause—Definitions may be added or modified in paragraph ( a ) as applicable .
Computer database or database means a collection of recorded data in a form capable of, and for the purpose of, being stored in, processed, and operated on by a computer. The term does not include calculator software .
Computer software — ( i ) Means ( A ) Computer programs that comprise a serial of instructions, rules, routines, or statements, careless of the media in which recorded, that allow or cause a calculator to perform a specific operation or series of operations ; and
( B ) Recorded information comprising source code listings, design details, algorithm, processes, flow charts, formulas, and associate material that would enable the computer platform to be produced, created, or compiled .
( two ) Does not include calculator databases or computer software software documentation .
Computer software documentation means owner ‘s manuals, exploiter ‘s manuals, installation instructions, operating instructions, and other similar items, careless of storage medium, that explain the capabilities of the calculator software or provide instructions for using the software .
Data means recorded data, careless of form or the media on which it may be recorded. The terminus includes technical data and computer software. The term does not include data incidental expense to contract government, such as fiscal, administrative, monetary value or pricing, or management information .
Form, fit, and function data means data relating to items, components, or processes that are sufficient to enable physical and functional exchangeability, and data identifying source, size, shape, coupling and attachment characteristics, functional characteristics, and performance requirements. For calculator software it means data identifying generator, functional characteristics, and performance requirements but specifically excludes the source code, algorithm, processes, formulas, and flow charts of the software .
Limited rights means the rights of the Government in limit rights data as put away in the Limited Rights Notice in Alternate II paragraph ( gram ) ( 3 ) if included in this clause. “ limited rights data ” means data, early than calculator software, that embody trade secrets or are commercial or fiscal and confidential or privileged, to the extent that such data pertain to items, components, or processes developed at individual expense, including minor modifications .
Restricted computer software means computer software developed at private expense and that is a trade unavowed, is commercial or fiscal and confidential or privileged, or is copyrighted calculator software, including minor modifications of the computer software .
Restricted rights, as used in this article, means the rights of the Government in restricted calculator software, as set forth in a Restricted Rights Notice of Alternate III paragraph ( thousand ) ( 4 ) if included in this article, or as otherwise may be provided in a collateral agreement incorporated in and made separate of this contract, including minor modifications of such computer software .
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Technical data means recorded information ( regardless of the shape or method acting of the record ) of a scientific or technical nature ( including computer databases and calculator software documentation ). This terminus does not include calculator software or fiscal, administrative, monetary value or price, or management data or other information incidental to abridge administration. The term includes recorded information of a scientific or technical foul nature that is included in computer databases ( See 41 U.S.C. 403 ( 8 ) ) .
Unlimited rights means the rights of the Government to use, disclose, reproduce, prepare derivative instrument works, distribute copies to the public, and perform publicly and display publicly, in any manner and for any purpose, and to have or permit others to do sol .
( barn ) Allocation of rights. ( 1 ) Except angstrom provided in paragraph ( coulomb ) of this clause, the Government shall have outright rights in—
( iodine ) Data first produced in the performance of this abridge ;
( two ) Form, suit, and officiate data delivered under this contract ;
( three ) Data delivered under this compress ( except for restricted computer software ) that form manuals or instructional and training material for initiation, operation, or routine alimony and repair of items, components, or processes delivered or furnished for habit under this narrow ; and
( intravenous feeding ) All early data delivered under this contract unless provided otherwise for limited rights data or restricted computer software in accordance with paragraph ( gigabyte ) of this clause .
( 2 ) The Contractor shall have the right to—
( one ) Assert copyright in data first produced in the operation of this contract to the extent provided in paragraph ( coke ) ( 1 ) of this clause ;
( two ) Use, release to others, reproduce, distribute, or publish any data first base produced or specifically used by the Contractor in the performance of this contract, unless provided otherwise in paragraph ( vitamin d ) of this article ;
( three ) Substantiate the use of, add, or correct limited rights, restricted rights, or copyright notices and to take other allow action, in accordance with paragraph ( vitamin e ) and ( farad ) of this article ; and
( intravenous feeding ) Protect from unauthorized disclosure and use those data that are limited rights data or restricted calculator software to the extent provided in paragraph ( gravitational constant ) of this article .
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( cytosine ) Copyright — ( 1 ) Data first produced in the performance of this contract. ( one ) Unless provided differently in paragraph ( five hundred ) of this clause, the Contractor may, without anterior approval of the Contracting Officer, insist copyright in scientific and technical foul articles based on or containing data first produced in the performance of this contract and published in academician, technical or professional journals, symposium proceedings, or alike works. The prior, express written permission of the Contracting Officer is required to assert copyright in all early data first produced in the performance of this contract .
( two ) When authorized to assert copyright to the datum, the Contractor shall affix the applicable copyright notices of 17 U.S.C. 401 or 402, and an citation of Government sponsorship ( including shrink number ) .
( three ) For datum other than computer software, the Contractor grants to the Government and others acting on its behalf, a paid-up, nonexclusive, irrevocable, cosmopolitan license in such copyrighted data to reproduce, prepare derivative instrument works, distribute copies to the public, and perform publicly and display publicly by or on behalf of the Government. For computer software, the Contractor grants to the Government, and others acting on its behalf, a paid-up, nonexclusive, irrevocable, cosmopolitan license in such copyrighted calculator software to reproduce, prepare derivative instrument works, and perform publicly and display publicly ( but not to distribute copies to the public ) by or on behalf of the Government .
( 2 ) Data not beginning produced in the performance of this contract. The Contractor shall not, without the anterior written license of the Contracting Officer, incorporate in data delivered under this contract any datum not first produced in the performance of this contract unless the Contractor—
( one ) Identifies the datum ; and
( two ) Grants to the Government, or acquires on its behalf, a license of the same telescope as set away in paragraph ( coulomb ) ( 1 ) of this clause or, if such data are restricted calculator software, the Government shall acquire a copyright license as set away in paragraph ( g ) ( 4 ) of this clause ( if included in this sign ) or as otherwise provided in a collateral agreement incorporated in or made function of this contract .
( 3 ) Removal of copyright notices. The Government will not remove any authoritative copyright notices placed on data pursuant to this paragraph ( c ), and will include such notices on all reproductions of the data .
( d ) Release, publication, and use of data. The Contractor shall have the right to use, release to others, reproduce, stagger, or publish any data foremost produced or specifically used by the Contractor in the performance of this shrink, except—
( 1 ) As prohibited by Federal law or regulation ( for example, export control or national security laws or regulations ) ;
( 2 ) As expressly set forth in this contract ; or
( 3 ) If the Contractor receives or is given access to data necessary for the operation of this narrow that contain restrictive markings, the Contractor shall treat the data in accordance with such markings unless specifically authorized otherwise in writing by the Contracting Officer or in the postdate paragraph.
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( 4 ) In addition to any other provisions, set forth in this contract, the Contractor shall ensure that information concerning possible inventions made under this contract is not prematurely published thereby adversely affecting the ability to obtain apparent protection on such inventions. accordingly, the Contractor will provide the Contracting Officer a copy of any publication or other populace disclosure relating to the exploit performed under this contract at least 30 days in advance of the disclosure. Upon the Contracting Officer ‘s request the Contractor agrees to delay the public disclosure of such data or publication of a specify newspaper for a fair time specified by the Contracting Officer, not to exceed 6 months, to allow for the file of domestic and international patent applications in accordance with Clause 352.227-11, Patent Rights—Exceptional Circumstances ( abbreviated calendar month and year of Final Rule publication ) .
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( 5 ) Data on Material(s). The Contractor agrees that in accordance with paragraph ( five hundred ) ( 2 ), proprietary data on Material ( south ) provided to the Contractor under or through this contract shall be used merely for the function for which they were provided, including screening, evaluation or optimization and for no other determination .
( 6 ) Confidentiality. ( one ) The Contractor shall take all reasonable precautions to maintain confidential Information as confidential, but no less than the steps Contractor takes to secure its own confidential information .
( two ) Contractor shall maintain confidential Information as confidential unless specifically authorized differently in write by the Contracting Officer. Confidential Information includes/does not include [ Government may define confidential information here. ]
( e ) Unauthorized marking of data. ( 1 ) Notwithstanding any other provisions of this contract concerning inspection or acceptance, if any data delivered under this sign are marked with the notices specified in paragraph ( gigabyte ) ( 3 ) or ( 4 ) of this article ( if those alternate paragraphs are included in this clause ), and use of the notices is not authorized by this article, or if the datum bears any early restrictive or limiting markings not authorized by this shrink, the Contracting Officer may cancel or ignore the markings. however, pursuant to 41 U.S.C. 253d, the following procedures shall apply prior to canceling or ignoring the markings .
( i ) The Contracting Officer will make written question to the Contractor affording the Contractor 60 days from receipt of the inquiry to provide written justification to substantiate the propriety of the markings ;
( two ) If the Contractor fails to respond or fails to provide written justification to substantiate the propriety of the markings within the 60-day time period ( or a longer prison term approved in writing by the Contracting Officer for good cause shown ), the Government shall have the correct to cancel or ignore the markings at any time after said time period and the data will no long be made national to any disclosure prohibitions .
( three ) If the Contractor provides written justification to substantiate the propriety of the markings within the period set in paragraph ( east ) ( 1 ) ( one ) of this article, the Contracting Officer will consider such written justification and determine whether or not the markings are to be cancelled or ignored. If the Contracting Officer determines that the markings are authorized, the Contractor will be therefore advise in writing. If the Contracting Officer determines, with concurrence of the Head of the Contracting Activity, that the markings are not authorized, the Contracting Officer will furnish the Contractor a written determination, which decision will become the final Agency decision regarding the appropriateness of the markings unless the Contractor files suit in a court of competent legal power within 90 days of acknowledge of the Contracting Officer ‘s decision. The Government will continue to abide by the markings under this paragraph ( east ) ( 1 ) ( three ) until final resolution of the matter either by the Contracting Officer ‘s determination becoming final ( in which example the Government will thereafter have the mighty to cancel or ignore the markings at any time and the data will no long be made national to any disclosure prohibitions ), or by final examination inclination of the matter by court decision if lawsuit is filed .
( 2 ) The time limits in the procedures set forth in paragraph ( east ) ( 1 ) of this article may be modified in accord with Agency regulations implementing the Freedom of Information Act ( 5 U.S.C. 552 ) if necessity to respond to a request there under .
( 3 ) Except to the extent the Government ‘s action occurs as the resultant role of concluding disposition of the topic by a court of competent legal power, the Contractor is not precluded by this paragraph ( vitamin e ) from bringing a title, in accordance with the Disputes clause of this contract, that may arise as the result of the Government get rid of or ignoring authoritative markings on data delivered under this contract .
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( fluorine ) Omitted or incorrect markings. ( 1 ) Data delivered to the Government without any restrictive markings shall be deemed to have been furnished with unlimited rights. The Government is not liable for the disclosure, use, or reproduction of such data .
( 2 ) If the unmarked data has not been disclosed without restriction outside the Government, the Contractor may request, within 6 months ( or a longer meter approved by the Contracting Officer in writing for good cause shown ) after delivery of the data, permission to have authorized notices placed on the data at the Contractor ‘s expense. The Contracting Officer may agree to do so if the Contractor—
( i ) Identifies the data to which the neglect detect is to be applied ;
( two ) Demonstrates that the omission of the poster was accidental ;
( three ) Establishes that the proposed notification is authorized ; and
( four ) Acknowledges that the Government has no liability for the disclosure, habit, or reproduction of any data made anterior to the addition of the poster or resulting from the omission of the notice .
( 3 ) If data has been marked with an incorrect notice, the Contracting Officer may—
( i ) Permit correction of the comment at the Contractor ‘s expense if the Contractor identifies the data and demonstrates that the compensate notice is authorized ; or
( two ) Correct any wrong notices .
( g ) Protection of limited rights data and restricted computer software. ( 1 ) The Contractor may withhold from delivery qualifying limited rights data or restricted computer software that are not data identified in paragraph ( bel ) ( 1 ) ( one ) through ( three ) of this clause. As a condition to this withholding, the Contractor shall—
( one ) Identify the data being withheld ; and
( two ) supply form, match, and routine data rather .
( 2 ) Limited rights data that are formatted as a calculator database for pitch to the Government shall be treated as specify rights data and not restricted calculator software .
( 3 ) [ Reserved ]
( h ) Subcontracting. The Contractor shall obtain from its subcontractors all data and rights therein necessity to fulfill the Contractor ‘s obligations to the Government under this narrow. If a subcontractor refuses to accept terms affording the Government those rights, the Contractor shall promptly notify the Contracting Officer of the refusal and shall not proceed with the subcontract award without authority in writing from the Contracting Officer .
( one ) kinship to patents or other rights. nothing contained in this clause shall imply a license to the Government under any patent or be construed as affecting the scope of any license or other right otherwise granted to the Government .
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Alternate I (Sept 2014). As prescribed in HHSAR 327.409, substitute the come definition for “ limited rights data ” in paragraph ( a ) of the basic clause :
Limited rights data means data, early than computer software, developed at secret expense that embody trade secrets or are commercial or fiscal and confidential or privileged .
Alternate II (Sept 2014). As prescribed in HHSAR 327.409, insert the keep up paragraph ( guanine ) ( 3 ) in the basic article :
( gravitational constant ) ( 3 ) Notwithstanding paragraph ( deoxyguanosine monophosphate ) ( 1 ) of this clause, the contract may identify and specify the delivery of limited rights data, or the Contracting Officer may require by written request the manner of speaking of express rights datum that has been withheld or would otherwise be entitled to be withheld. If rescue of that data is required, the Contractor shall affix the follow “ Limited Rights Notice ” to the data and the Government will treat the data, subject to the provisions of paragraph ( e ) and ( f ) of this clause, in accordance with the poster :
express Rights Notice ( Sept 2014 )
( a ) These data are submitted with limited rights under Government Contract No. ____ ( and subcontract ____, if allow ). These data may be reproduced and used by the Government with the express limitation that they will not, without written license of the Contractor, be used for purposes of fabricate nor disclosed outside the Government ; except that the Government may disclose these data outside the Government for the adopt purposes, if any ; provided that the Government makes such disclosure subject to prohibition against promote use and disclosure : Agencies may list extra purposes or if none, so state .
( boron ) This notice shall be marked on any reproduction of these data, in wholly or in contribution .
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Alternate III (Sept 2014). As prescribed in HHSAR 327.409, insert the following paragraph ( gravitational constant ) ( 4 ) in the basic article : ( gigabyte ) ( 4 ) ( one ) Notwithstanding paragraph ( thousand ) ( 1 ) of this article, the shrink may identify and specify the delivery of restricted computer software, or the Contracting Officer may require by written request the manner of speaking of restricted computer software that has been withheld or would otherwise be entitled to be withheld. If delivery of that computer software is required, the Contractor shall affix the come “ Restricted Rights Notice ” to the calculator software and the Government will treat the calculator software, subject to paragraphs ( einsteinium ) and ( degree fahrenheit ) of this article, in accord with the poster :
Restricted Rights Notice ( Sept 2014 )
( a ) This computer software is submitted with restrict rights under Government Contract No. ____ ( and subcontract ____, if appropriate ). It may not be used, reproduced, or disclosed by the Government except arsenic provided in paragraph ( b-complex vitamin ) of this notice or as differently expressly stated in the shrink .
( barn ) This computer software may be—
( 1 ) Used or copied for use with the calculator ( randomness ) for which it was acquired, including habit at any Government installation to which the computer ( s ) may be transferred ;
( 2 ) Used or copied for use with a backing calculator if any computer for which it was acquired is inoperative ;
( 3 ) Reproduced for safekeeping ( archives ) or accompaniment purposes ;
( 4 ) Modified, adapted, or combined with other computer software, provided that the modified, adapted, or combined portions of the derivative instrument software incorporating any of the delivered, restricted computer software shall be capable to the lapp restricted rights ;
( 5 ) Disclosed to and reproduced for use by accompaniment avail Contractors or their subcontractors in accordance with paragraph ( bel ) ( 1 ) through ( 4 ) of this notice ; and
( 6 ) Used or copied for manipulation with a surrogate calculator .
( hundred ) Notwithstanding the waive, if this computer software is copyrighted computer software, it is licensed to the Government with the minimal rights set forth in paragraph ( bel ) of this notice .
( vitamin d ) Any other rights or limitations regarding the use, duplicate, or disclosure of this computer software are to be expressly stated in, or incorporated in, the contract .
( e ) This notice shall be marked on any reproduction of this computer software, in whole or in partially .
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( two ) Where it is impractical to include the Restricted Rights Notice on restricted calculator software, the follow short-form notice may be used alternatively :
Restricted Rights Notice Short Form ( Sept 2014 )
Use, reproduction, or disclosure is subject to restrictions set away in Contract No. ____ ( and subcontract, if appropriate ) with ____ ( identify of Contractor and subcontractor ) .
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( three ) If restricted computer software is delivered with the copyright poster of 17 U.S.C. 401, it will be presumed to be licensed to the Government without disclosure prohibitions, with the minimum rights set forth in paragraph ( b ) of this article .
Alternate IV (Sept 2014). As prescribed in HHSAR 327.409, substitute the follow paragraph ( c ) ( 1 ) for paragraph ( hundred ) ( 1 ) of the basic clause :
( deoxycytidine monophosphate ) Copyright — ( 1 ) Data first produced in the performance of the contract. Except as otherwise specifically provided in this compress, the Contractor may assert copyright in any data first produced in the operation of this abridge. When asserting copyright, the Contractor shall affix the applicable copyright notice of 17 U.S.C. 401 or 402, and an recognition of Government sponsorship ( including contract number ), to the data when such data are delivered to the Government, vitamin a well as when the data are published or deposited for adjustment as a print make in the U.S. Copyright Office. For data other than computer software, the Contractor grants to the Government, and others acting on its behalf, a paid-up, nonexclusive, irrevocable, worldwide license for all such data to reproduce, prepare derivative works, spread copies to the public, and perform publicly and display publicly, by or on behalf of the Government. For calculator software, the Contractor grants to the Government and others acting on its behalf, a paid-up, nonexclusive, irrevocable, global license for all such computer software to reproduce, prepare derived function works, and perform publicly and display publicly ( but not to distribute copies to the populace ), by or on behalf of the Government .
Alternate V (Sept 2014). As prescribed in HHSAR 327.409, add the postdate paragraph ( joule ) to the basic clause :
( j ) The Contractor agrees, except as may be otherwise specified in this contract for specific data deliverables listed as not subject to this paragraph, that the Contracting Officer may, up to 3 years after toleration of all deliverables under this shrink, audit at the Contractor ‘s facility any data withhold pursuant to paragraph ( deoxyguanosine monophosphate ) ( 1 ) of this clause, for purposes of verifying the Contractor ‘s affirmation of express rights or restricted rights condition of the data or for evaluating work performance. When the Contractor whose data are to be inspected demonstrates to the Contracting Officer that there would be a possible conflict of interest if a particular representative made the inspection, the Contracting Officer shall designate an surrogate inspector .
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352.227-70 Publications and Publicity.
As prescribed in HHSAR 327.404-70, the Contracting Officer shall insert the follow clause :
Publications and Publicity ( December 18, 2015 )
( a ) Unless differently specified in this contract, the Contractor may publish the results of its work under this compress. The Contractor shall promptly send a transcript of each article submitted for issue to the Contracting Officer ’ s Representative. The Contractor shall besides inform the Contracting Officer ’ s Representative when the article or other publication is published, and furnish a copy of it as finally published .
( boron ) Unless authorized in write by the Contracting Officer, the Contractor shall not display the HHS logo including Operating Division or Staff Division logo on any publications .
( hundred ) The Contractor shall not reference the intersection ( south ) or service ( s ) awarded under this contract in commercial advertising, as defined in FAR 31.205-1, in any manner which states or implies HHS blessing or endorsement of the product ( randomness ) or serve ( s ) provided .
( vitamin d ) The contractor shall include this clause, including this section ( vitamin d ) in all subcontracts where the subcontractor may propose publishing the results of its work under the subcontract .
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352.231-70 Salary Rate Limitation.
As prescribed in HHSAR 331.101-70 ( bel ), the Contracting Officer shall insert the follow article :
wage Rate Limitation ( December 18, 2015 )
( a ) The Contractor shall not use contract funds to pay the direct wage of an individual at a rate in excess of the Federal Executive Schedule Level II in effect on the date the fund was obligated .
( bel ) For purposes of the wage rate limitation, the terms “ target wage, ” “ wage, ” and “ institutional al-qaeda wage, ” have the same mean and are jointly referred to as “ lineal wage, ” in this article. An individual ‘s direct wage is the annual recompense that the Contractor pays for an person ‘s mastermind campaign ( costs ) under the contract. Direct wage excludes any income that an person may be permitted to earn outside of duties to the Contractor. Direct wage besides excludes bang benefits, overhead, and general and administrative expenses ( besides referred to as indirect costs or facilities and administrative costs ). The wage rate limitation does not restrict the wage that an organization may pay an individual working under a Department of Health and Human Services sign or ordain ; it merely limits the fortune of that wage that may be paid with contract funds .
( c ) The wage rate restriction besides applies to individuals under subcontracts .
( five hundred ) If this is a multiple-year shrink or order, it may be discipline to unilateral alteration by the Contracting Officer to ensure that an person is not paid at a rate that exceeds the wage pace limitation provision established in the HHS appropriations act used to fund this contract .
( e ) See the salaries and wages pay tables on the Office of Personnel Management web site for Federal Executive Schedule wage levels .
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352.232-70 Incremental Funding.
As prescribed in HHSAR 332.706-2 ( boron ), the Contracting Officer shall insert the provision provided below in all solicitations when a cost-reimbursement contract for dissociable services using incremental fund is contemplated .
incremental Funding ( December 18, 2015 )
The Government intends to negotiate and award a cost-reimbursement condense using incremental fund as described in the article at FAR 52.232–22, “ Limitation of Funds ”. The initial obligation of funds under the contract is expected to cover [ insert the allow increase of performance ]. The Government intends to obligate extra funds up to and including the full estimated cost of the condense for the remaining periods of performance by unilateral contract alteration. however, the Government is not required to reimburse the Contractor for costs incurred in overindulgence of the sum come obligated, nor is the contractile organ required to perform beyond the level supported by the total sum obligated .
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352.233-70 Choice of Law (Overseas).
As prescribed in HHSAR 333.215-70 ( a ), the Contracting Officer shall insert the follow article :
Choice of Law ( Overseas ) ( December 18, 2015 )
This contract shall be construed in accordance with the substantive laws of the United States of America. By the execution of this compress, the Contractor expressly agrees to waive any rights to invoke the legal power of local national courts where this narrow is performed and agrees to accept the exclusive legal power of the United States Civilian Board of Contract Appeals or the United States Court of Federal Claims for hearing and determination of any and all disputes that may arise under the Disputes clause of this condense .
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352.233-71 Litigation and Claims.
As prescribed in HHSAR 333.215-70 ( boron ), the Contracting Officer shall insert the follow article :
litigation and Claims ( December 18, 2015 )
( a ) The Contractor shall provide written presentment immediately to the Contracting Officer of any carry through, including any proceeding before an administrative representation, filed against the Contractor arising out of the performance of this contract, including, but not limited to the operation of any subcontract hereinafter ; and any claim against the Contractor the price and expense of which is allowable under the article entitled “ Allowable Cost and Payment. ”
( barn ) Except as otherwise directed by the Contracting Officer, the Contractor shall furnish immediately to the Contracting Officer copies of all pertinent documents received by the Contractor with esteem to such military action or claim. To the extent not in dispute with any applicable policy of policy, the Contractor may, with the Contracting Officer ’ s approval, settle any such action or claim. If required by the Contracting Officer, the Contractor shall consequence an assignment and subrogation in favor of the Government of all the Contractor ’ mho rights and claims ( except those against the Government ) arising out of any such military action or claim against the Contractor ; and authorize representatives of the Government to settle or defend any such action or claim and to represent the Contractor in, or to take charge of, any carry through .
( speed of light ) If the Government undertakes a settlement or defense of an action or claim, the Contractor shall furnish all reasonable aid in effecting a colony or asserting a defense. Where an action against the Contractor is not covered by a policy of policy, the Contractor shall, with the approval of the Contracting Officer, continue with the defensive structure of the action in adept religion. The Government shall not be liable for the expense of defending any military action or for any costs resulting from the loss thence to the extent that the Contractor would have been compensated by indemnity which was required by early terms or conditions of this contract, by law or regulation, or by written guidance of the Contracting Officer, but which the Contractor failed to secure through its own fault or negligence. In any event, unless otherwise expressly provided in this contract, the Government shall not reimburse or indemnify the Contractor for any indebtedness loss, cost, or expense, which the contractor may incur or be submit to by reason of any loss, injury or damage, to the person or to real number or personal property of any one-third parties as may accrue during, or rebel from, the performance of this abridge .
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352.236-70 Design-Build Contracts.
As prescribed in HHSAR 336.570 ( a ), the Contracting Officer shall insert the trace clause :
Design-Build Contracts ( December 18, 2015 )
( a ) General. ( 1 ) The compress constitutes and defines the entire agreement between the Contractor and the Government. This contract includes the standard or special contract clauses and schedules included at the time of award. This contract incorporates by reference book :
( i ) The solicitation in its entirety ( with the exception of instructions to offerors and evaluation criteria which do not become part of the prize document ) ;
( two ) The specifications and statement of workplace ;
( three ) All drawings, cuts and illustrations, included in the solicitation and any amendments during all proposal phases leading up to award ;
( four ) Exhibits and other attachments ; and
( vanadium ) The successful Offeror ‘s accept proposal .
( 2 ) In the event of conflict or inconsistency between any of the requirements of the respective portions of this shrink, precedence shall be given in the pursuit order :
( one ) Betterments : Any portions of the Offeror ‘s proposal which exceed the requirements of the solicitation and which go beyond repair and improve the rate of the property .
( two ) The abridge clauses and schedules included during the solicitation or at the time of award .
( three ) All requirements ( other than betterments ) of the accept proposal .
( four ) Any design products, including but not limited to plans, specifications, engineering studies and analyses, shop drawings, equipment initiation drawings, etc. These are “ deliverables ” under the contract and are not part of the compress itself .
( 3 ) design products must conform to all requirements of the contract, in the order of precession stated here .
( b-complex vitamin ) Responsibility of the contractor for design. ( 1 ) The Contractor shall be creditworthy for the professional quality, technical accuracy, and the coordination of all designs, drawings, specifications, and other non-construction services furnished by the Contractor under this narrow. The Contractor shall, without extra compensation, correct or revise any errors or insufficiency in its designs, drawings, specifications, and other non-construction services and perform any necessary rework or modifications, including any damage to veridical or personal property, resulting from the design erroneousness or omission .
( 2 ) Neither the Government ‘s inspection, approval or toleration of, nor payment for, the services required under this contract shall be construed to operate as a release of any rights under this narrow or of any cause of action arising out of the performance of this shrink. The Contractor shall be and remain liable to the Government in accord with applicable law for all damages to the Government caused by the Contractor ‘s negligent operation of any of these services furnished under this contract .
( 3 ) The rights and remedies of the Government provided for under this sign are in addition to any other rights and remedies provided by law .
( 4 ) If the Contractor is comprised of more than one legal entity each such entity shall be jointly and respectively liable with regard to all rights and remedies of the Government .
( c ) Sequence of design—construction. ( 1 ) After receipt of the Contract Award, the Contractor shall initiate design, comply with all design submission requirements, and obtain Government review of each submission. No construction may be started until the Government reviews the Final Design submission and determines it satisfactory for purposes of beginning construction. The Contracting Officer will notify the contractor when the invention is cleared for construction. The Government will not grant any time extension for any design resubmittal required when, in the impression of the Contracting Officer, the initial submission failed to meet the minimum timbre requirements as typeset forth in the Contract .
( 2 ) If the Government allows the Contractor to proceed with express construction based on pending minor revisions to the reviewed Final Design meekness, no payment will be made for any completed or in-progress construction related to the pending revisions until they are completed, resubmitted, and are satisfactory to the Government .
( 3 ) No requital will be made for any completed or in-progress construction until all required submittals have been made, reviewed, and are satisfactory to the Government .
( five hundred ) Constructor’s role during design. The Contractor ‘s construction management key personnel shall be actively involved during the invention summons to efficaciously integrate the design and structure requirements of this contract. In addition to the distinctive ask construction activities, the builder ‘s participation includes, but is not limited to actions such as : integrating the design schedule into the Master Schedule to maximize the potency of fast-tracking plan and construction ( within the limits, if any, allowed in the contract ), ensuring constructability and economy of the design, integrating the patronize trace and installation drawing process into the plan, executing the material and equipment skill programs to meet critical schedules, efficaciously interfacing the construction Quality Control ( QC ) plan with the invention QC program, and maintaining and providing the design team with accurate, up-to-date redline and as-built documentation. The Contractor shall require and manage the active involvement of identify trade subcontractors in the above activities .
( einsteinium ) Preconstruction conference. ( 1 ) A preconstruction conference will be arranged by the Contracting Officer after prize of contract and before commencement of work. The Contracting Officer or designated spokesperson will notify the Contractor of the clock time, go steady, and placement for the meeting. At this conference, the Contractor shall be oriented with esteem to Government procedures and pipeline of agency, contractual, administrative, and construction matters .
( 2 ) The Contractor shall bring to this league, in completed form, a Certificate of Insurance, plus the following items in either completed or draft imprint :
( one ) Accident Prevention Plan ;
( two ) quality Control Plan ;
( three ) Letter Appointing Superintendent ;
( four ) Transmittal Register ;
( five ) world power of Attorney and Certified Copy of Resolution ;
( six ) Network Analysis System, ( when identified in the shrink
schedule as applicable ) ;
( seven ) list of Subcontractors ;
( eight ) SF 1413 ;
( nine ) performance and Payment Bonds ; and
( adam ) schedule of Values .
( 3 ) A letter of record will be written documenting all items discussed at the conference, and a transcript will be furnished by the Contracting Officer to all in attendance .
( fluorine ) Payment for design under fixed-price design-build contracts. ( 1 ) The Contracting Officer may approve progress payments for influence performed during the visualize design phase up to the maximum amount of _________ ( Contracting Officer to insert percent figure. If none stated, the amount is four (4) percent ) percentage of the contract price.
( 2 ) contractor invoices for payment must be accompanied by satisfactory documentation supporting the amounts for which payments are requested. progress payments approved by the Contracting Officer during the project design phase in no way constitute an credence of running and aesthetic design elements nor acceptance of a concluding settlement sum in the event of a buy-out nor a release of any contractual requirements .
( gravitational constant ) Unscheduled jobsite shutdowns. due to security reasons during the life of this sign the Government may on an unscheduled footing require the contractor to shut down its jobsite for 2 days per class at no extra cost. This shall not constitute a suspension of work under FAR 52.242-14, Suspension of Work
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Alternate I ( December 18, 2015 ) .
When Fast Track procedures are being used, replace paragraph ( hundred ) of the basic clause with the follow :
( c ) Sequence of design build. ( 1 ) After reception of the Contract Award the Contractor shall initiate design, comply with all design submissions requirements and obtain Government reappraisal of each submission. The contractor may begin construction on portions of the work for which the Government has reviewed the final design submission and has determined satisfactory for purposes of beginning construction. The Contracting Officer will notify the contractor when the invention is cleared for construction. The Government will not grant any clock time extension for any purpose resubmittal required when, in the public opinion of the Contracting Officer, the initial submission failed to meet the minimum quality requirements as dress forth in the Contract .
( 2 ) If the Government allows the Contractor to proceed with the construction based on pending minor revisions to the reviewed Final Design submission, no payment will be made for any in-place construction related to the pending revisions until they are completed, resubmitted, and are satisfactory to the Government .
( 3 ) No requital will be made for any in-place construction until all required submittals have been made, reviewed, and are satisfactory to the Government .
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352.237-70 Pro-Children Act.
As prescribed in HHSAR 337.103 ( five hundred ) ( 1 ), the Contracting Officer shall insert the follow clause :
Pro-Children Act ( December 18, 2015 )
( a ) public Law 103-227, Title X, Part C, besides known as the Pro-Children Act of 1994 ( Act ), 20 U.S.C. 7183, imposes restrictions on smoke in facilities where certain federally fund children ‘s services are provided. The Act prohibits smoking within any indoor facility ( or fortune thereof ), whether owned, leased, or contracted for, that is used for the everyday or regular provision of : ( i ) kindergarten, elementary, or secondary education or library services or ( two ) health or day worry services that are provided to children under the historic period of 18. The statutory prohibition besides applies to indoor facilities that are constructed, operated, or maintained with Federal funds .
( barn ) By acceptance of this contract or order, the Contractor agrees to comply with the requirements of the Act. The Act besides applies to all subcontracts awarded under this contract for the specify children ‘s services. accordingly, the Contractor shall ensure that each of its employees, and any subcontractor staff, is made mindful of, understands, and complies with the provisions of the Act. failure to comply with the Act may result in the imposition of a civil monetary penalty in an amount not to exceed $ 1,000 for each misdemeanor and/or the imposition of an administrative complaisance order on the creditworthy entity. Each sidereal day a irreverence continues constitutes a separate irreverence .
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352.237-71 Crime Control Act—Reporting of Child Abuse.
As prescribed in HHSAR 337.103 ( five hundred ) ( 2 ), the Contracting Officer shall insert the pursuit article :
Crime Control Act of 1990—Reporting of Child Abuse ( December 18, 2015 )
( a ) public Law 101-647, besides known as the Crime Control Act of 1990 ( Act ), imposes responsibilities on certain individuals who, while engaged in a master capacity or activity, as defined in the Act, on Federal land or in a federally-operated ( or contracted ) facility, learn of facts that give the individual reason to suspect that a child has suffered an incident of child pervert .
( b-complex vitamin ) The Act designates “ covered professionals ” as those persons engaged in professions and activities in eight different categories including, but not limited to, teachers, sociable workers, physicians, dentists, medical residents or interns, hospital personnel and administrators, nurses, health care practitioners, chiropractors, osteopaths, pharmacists, optometrists, podiatrists, emergency aesculapian technicians, ambulance drivers, alcohol or drug treatment personnel, psychologists, psychiatrists, mental health professionals, child manage workers and administrators, and commercial film and photograph processors. The Act defines the term “ child abuse ” as the physical or genial injury, sexual misuse or exploitation, or negligent treatment of a child .
( degree centigrade ) consequently, any person engaged in a cover profession or activity under an HHS abridge or subcontract, regardless of the function of the contract or subcontract, shall immediately report a distrust child pervert incident in accord with the provisions of the Act. If a child is suspected of being harmed, the appropriate State Child Abuse Hotline, local child protective services ( CPS ), or law enforcement agency shall be contacted. For more information about where and how to file a report, the Childhelp USA, National Child Abuse Hotline ( 1-800-4-A-CHILD ) shall be called. Any brood professional fail to make a timely report of such incidental shall be guilty of a classify B misdemeanor .
( d ) By acceptance of this contract or ordain, the Contractor agrees to comply with the requirements of the Act. The Act besides applies to all applicable subcontracts awarded under this contract. consequently, the Contractor shall ensure that each of its employees, and any subcontractor staff, is made mindful of, understands, and complies with the provisions of the Act .
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352.237-72 Crime Control Act—Requirement for Background Checks.
As prescribed in HHSAR 337.103 ( vitamin d ) ( 3 ), the Contracting Officer shall insert the stick to clause :
Crime Control Act of 1990—Requirement for Background Checks ( December 18, 2015 )
( a ) public Law 101-647, besides known as the Crime Control Act of 1990 ( Act ), requires that all individuals involved with the planning of child manage services to children under the age of 18 undergo a criminal background check. “ Child care services ” include, but are not limited to, social services, health and mental health manage, child ( day ) concern, education ( whether or not directly involved in teaching ), and rehabilitative programs. Any conviction for a sex crime, an crime involving a child victim, or a drug felony, may be grounds for denying employment or for dismissal of an employee providing any of the services listed above .
( bacillus ) The Contracting Officer will provide the necessary information to the Contractor regarding the march for obtaining the background check. The contractor may hire a staff person provisionally anterior to the completion of a background check, if at all times prior to the acknowledge of the backdrop crack during which children are in the worry of the newly-hired person, the person is within the batch and under the supervision of a previously investigated staff person .
( coulomb ) By adoption of this shrink or order, the Contractor agrees to comply with the requirements of the Act. The Act besides applies to all applicable subcontracts awarded under this sign. accordingly, the Contractor shall ensure that each of its employees, and any subcontractor staff, is made aware of, understands, and complies with the provisions of the Act .
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352.237-73 Indian Child Protection and Family Violence Act.
As prescribed in HHSAR 337.103 ( vitamin d ) ( 4 ) the Contracting Officer shall insert the trace clause :
indian Child Protection and Family Violence Act ( December 18, 2015 )
( a ) This contract is discipline to the indian Child Protection and Family Violence Act, Pub. L. 101-630 ( 25 U.S.C. 3201 et seq. ) The duties and responsibilities required by this contract may involve regular contact with or control over indian children. Pub. L. 101-630 prohibits use, including personal Service Contracts, with anyone who has been convicted of any crime of ferocity. Any such conviction should immediately be brought to the care of the Contracting Officer. The contractile organ will be subject to a character investigation, conducted by the indian Health Service, Office of Human Resources. Until such time as the contractor has been notified of completion of the probe, the contractor shall have no unsupervised contact with indian children. In order to initiate this background probe, the contractile organ must provide information as required in this condense or as directed by the Contracting Officer .
( boron ) As a prerequisite to providing services under this contract, the Contractor is required to complete and sign the declaration found in Section J of this narrow .
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352.237-74 Non-Discrimination in Service Delivery.
As prescribed in HHSAR 337.103 ( e ), the Contracting Officer shall insert the come clause in solicitations and contracts :
non-discrimination In Service Delivery ( December 18, 2015 )
It is the policy of the Department of Health and Human Services that no person otherwise eligible will be excluded from engagement in, denied the benefits of, or subjected to discrimination in the administration of HHS programs and services based on non-merit factors such as race, color, home origin, religion, sex, gender identity, intimate predilection, or disability ( physical or genial ). By acceptance of this abridge, the contractor agrees to comply with this policy in supporting the plan and in performing the services called for under this sign. The contractor shall include this clause in all sub-contracts awarded under this sign for supporting or performing the specified program and services. consequently, the contractile organ shall ensure that each of its employees, and any sub-contractor staff, is made mindful of, understands, and complies with this policy .
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352.237-75 Key Personnel.
As prescribed in HHSAR 337.103 ( degree fahrenheit ), the Contracting Officer shall insert the follow article :
Key Personnel ( December 18, 2015 )
The key personnel specified in this contract are considered to be essential to work performance. At least 30 days anterior to the contractor voluntarily diverting any of the specify individuals to other programs or contracts the Contractor shall notify the Contracting Officer and shall submit a justification for the diversion or refilling and a request to replace the individual. The request must identify the proposed substitution and provide an explanation of how the substitution ‘s skills, experience, and credentials meet or exceed the requirements of the condense ( including, when applicable, human Subjects Testing requirements ). If the employee of the contractor is terminated for campaign or separates from the contractor voluntarily with less than thirty days notice, the Contractor shall provide the maximal notification operable under the circumstances. The Contractor shall not divert, replace, or announce any such change to key personnel without the written accept of the Contracting Officer. The abridge will be modified to add or delete key personnel as necessity to reflect the agreement of the parties .
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352.239-73 Electronic Information and Technology Accessibility Notice.
( a ) As prescribed in HHSAR 339.203-70 ( a ), the Contracting Officer shall insert the be provision :
Electronic and Information Technology Accessibility Notice ( December 18, 2015 )
( a ) section 508 of the Rehabilitation Act of 1973 ( 29 U.S.C. 794d ), as amended by the Workforce Investment Act of 1998 and the Architectural and Transportation Barriers Compliance Board Electronic and Information ( EIT ) Accessibility Standards ( 36 CFR part 1194 ), require that when Federal agencies develop, pander, maintain, or use electronic and information engineering, Federal employees with disabilities have access to and use of information and datum that is comparable to the access and use by Federal employees who are not individuals with disabilities, unless an undue effect would be imposed on the agency. department 508 besides requires that individuals with disabilities, who are members of the populace seeking data or services from a Federal means, have entree to and use of information and data that is comparable to that provided to the public who are not individuals with disabilities, unless an excessive charge would be imposed on the representation .
( bel ) consequently, any offerer responding to this solicitation must comply with established HHS EIT approachability standards. information about department 508 is available at hypertext transfer protocol : //www.hhs.gov/web/508. The complete text of the section 508 Final Provisions can be accessed at hypertext transfer protocol : //www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards .
( cytosine ) The section 508 handiness standards applicable to this solicitation are stated in the article at 352.239-74, Electronic and Information Technology Accessibility .
In order to facilitate the Government ’ s decision whether proposed EIT supplies meet applicable section 508 approachability standards, offerors must submit an HHS department 508 Product Assessment Template, in accord with its completion instructions. The purpose of the template is to assist HHS skill and program officials in determining whether proposed EIT supplies conform to applicable part 508 approachability standards. The template allows offerors or developers to self-evaluate their supplies and document—in detail—whether they conform to a specific section 508 handiness standard, and any afoot redress efforts addressing conformity issues. Instructions for preparing the HHS Section 508 Evaluation Template are available under Section 508 policy on the HHS web site hypertext transfer protocol : //www.hhs.gov/web/508 .
In arrange to facilitate the Government ’ s decision whether proposed EIT services meet applicable section 508 handiness standards, offerors must provide enough information to assist the Government in determining that the EIT services adjust to Section 508 approachability standards, including any afoot redress efforts addressing conformity issues .
( vitamin d ) Respondents to this solicitation must identify any exception to Section 508 requirements. If a offerer claims its supplies or services meet applicable section 508 approachability standards, and it is late determined by the Government, i, after award of a sign or order, that supplies or services delivered do not conform to the described handiness standards, redress of the supplies or services to the flush of conformity specified in the compress will be the province of the Contractor at its expense .
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352.239-74 Electronic and Information Technology Accessibility.
As prescribed in HHSAR 339.203-70 ( b-complex vitamin ), insert the following clause :
Electronic and Information Technology Accessibility ( December 18, 2015 )
( a ) pursuant to Section 508 of the Rehabilitation Act of 1973 ( 29 U.S.C. 794d ), as amended by the Workforce Investment Act of 1998, all electronic and information technology ( EIT ) supplies and services developed, acquired, or maintained under this contract or order must comply with the “ Architectural and Transportation Barriers Compliance Board Electronic and Information Technology ( EIT ) Accessibility Standards ” set forth by the Architectural and Transportation Barriers Compliance Board ( besides referred to as the “ Access Board ” ) in 36 CFR region 1194. data about department 508 is available at hypertext transfer protocol : //www.hhs.gov/web/508. The complete text of Section 508 Final Provisions can be accessed at hypertext transfer protocol : //www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards .
( bacillus ) The segment 508 handiness standards applicable to this narrow or order are identified in the Statement of Work or Specification or Performance Work Statement. The contractor must provide any necessary updates to the submitted HHS Product Assessment Template ( sulfur ) at the goal of each contract or order exceeding the simplified acquisition threshold ( see FAR 2.101 ) when the contract or ordering duration is one year or less. If it is determined by the Government that EIT supplies and services provided by the Contractor do not conform to the described handiness standards in the sign, redress of the supplies or services to the charge of conformity specified in the contract will be the province of the Contractor at its own expense .
( c ) The section 508 approachability standards applicable to this narrow are :
( contract staff must list applicable standards )
( five hundred ) In the event of a modification ( s ) to this contract or rate, which adds new EIT supplies or services or revises the type of, or specifications for, supplies or services, the Contracting Officer may require that the contractor submit a completed HHS Section 508 Product Assessment Template and any other extra information necessary to assist the Government in determining that the EIT supplies or services conform to Section 508 handiness standards. Instructions for documenting handiness via the HHS Section 508 Product Assessment Template may be found under Section 508 policy on the HHS web site : ( hypertext transfer protocol : //www.hhs.gov/web/508 ). If it is determined by the Government that EIT supplies and services provided by the Contractor do not conform to the described handiness standards in the contract, redress of the supplies or services to the level of conformity specified in the compress will be the province of the Contractor at its own expense .
( vitamin e ) If this is an indefinite Delivery compress, a Blanket Purchase Agreement or a basic Ordering Agreement, the task/delivery order requests that include EIT supplies or services will define the specifications and approachability standards for the orderliness. In those cases, the Contractor may be required to provide a completed HHS Section 508 Product Assessment Template and any other extra information necessary to assist the Government in determining that the EIT supplies or services conform to Section 508 approachability standards. Instructions for documenting handiness via the HHS Section 508 Product Assessment Template may be found at hypertext transfer protocol : //www.hhs.gov/web/508. If it is determined by the Government that EIT supplies and services provided by the Contractor do not conform to the described handiness standards in the supply documentation, redress of the supplies or services to the grade of conformity specified in the contract will be the province of the Contractor at its own expense .
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352.270-4a Notice to Offerors, Protection of Human Subjects.
As prescribed in HHSAR 370.303 ( a ), the Contracting Officer shall insert the follow planning :
Notice to Offerors, Protection of Human Subjects ( December 18, 2015 )
( a ) The Department of Health and Human Services ( HHS ) regulations for the protection of human subjects, 45 CFR share 46, are available on the Office for Human Research Protections ( OHRP ) web site at : hypertext transfer protocol : //www.hhs.gov/ohrp/index.html .
These regulations provide a taxonomic means, based on established ethical principles, to safeguard the rights and benefit of human subjects participating in research activities supported or conducted by HHS .
( bel ) The regulations define a human subject as a populate individual about whom an investigator ( whether professional or scholar ) conducting inquiry obtains data or identifiable public information through intervention or interaction with the individual, or identifiable secret information. In most cases, the regulations extend to the use of human organs, tissue, and soundbox fluids from individually identifiable homo subjects ampere well as to graphic, written, or recorded information derived from individually identifiable human subjects. 45 CFR part 46 does not directly regulate the use of autopsy materials; instead, applicable state and local laws govern their use.
( degree centigrade ) Activities which involve human subjects in one or more of the categories set away in 45 CFR 46.101(b) ( 1 ) – ( 6 ) are excuse from complying with 45 CFR part 46. See hypertext transfer protocol : //www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html .
( five hundred ) Inappropriate designations of the noninvolvement of human subjects or of exempt categories of research in a project may result in delays in the inspection of a marriage proposal .
( east ) In accord with 45 CFR part 46 , offerors considered for award shall file an acceptable Federal-wide Assurance ( FWA ) of complaisance with OHRP specifying review procedures and assigning responsibilities for the security of human subjects. The FWA is the entirely character of assurance that OHRP accepts or approves. The initial and continuing revue of a research project by an institutional review board shall ensure that : the risks to subjects are minimized ; risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the cognition that may reasonably be expected to result ; choice of subjects is equitable ; and inform accept will be obtained and documented by methods that are adequate and appropriate. Depending on the nature of the research, extra requirements may apply ; see hypertext transfer protocol : //www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html # 46.111 for extra requirements regarding initial and continuing reappraisal. HHS regulations for the protection of human subjects ( 45 CFR part 46 ), information regarding OHRP registration and assurance requirements/processes, and OHRP contact information is available at the OHRP web site ( at hypertext transfer protocol : //www.hhs.gov/ohrp/assurances/index.html ) .
( f ) Offerors may consult with OHRP only for general advice or guidance concern either regulative requirements or ethical issues pertaining to research involving human subjects. ONLY the contracting policeman may offer data concerning a solicitation .
( gravitational constant ) The offerer shall document in its proposal the approved FWA from OHRP, related to the designated Institutional Review Board ( IRB ) review and overseeing the research. If the offerer does not have an approved FWA from OHRP, the offerer must obtain an FWA before the deadline for marriage proposal meekness. When possible, the offerer shall besides certify the IRB ’ south review and approval of the inquiry. If the offerer can not obtain this certification by the fourth dimension of proposal submission they must include an explanation in their marriage proposal. Never conduct research covered by 45 CFR function 46 prior to receiving certificate of the inquiry ’ s review and blessing by the IRB .
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alternate I ( December 18, 2015 ) .
As prescribed in HHSAR 370.303 ( a ), the Contracting Officer shall substitute the take after paragraph ( gravitational constant ) for paragraph ( gigabyte ) of the basic article .
( g ) The offerer ’ mho proposal shall document that it has an approved or active FWA from OHRP, related to the designated IRB reviewing and overseeing the research. When possible the offerer shall besides certify the IRB has reviewed and approved the research. If the offerer can not make this certification at the time of marriage proposal meekness, its marriage proposal must include an explanation. Never conduct inquiry covered by 45 CFR part 46 prior to receiving authentication of the inquiry ’ s review and blessing by the IRB .
If the offerer does not have an active FWA from OHRP, the offerer shall take all necessary steps to obtain an FWA prior to the deadline for proposal meekness. If the offerer can not obtain an FWA before the marriage proposal submission date, the proposal shall indicate the steps/actions the offerer will take to obtain OHRP blessing within (Contracting Officer must insert a time period in which the FWA must be obtained). Upon obtaining FWA approval, submit the approval notice to the Contracting Officer .
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352.270-4b Protection of Human Subjects.
As prescribed in HHSAR 370.304 ( a ), the Contracting Officer shall insert the come clause :
Protection of Human Subjects ( December 18, 2015 )
( a ) The Contractor agrees that the rights and wellbeing of homo subjects involved in research under this shrink shall be protected in accordance with 45 CFR part 46 and with the Contractor ’ s current Federal-wide assurance ( FWA ) on file with the Office for Human Research Protections ( OHRP ), Department of Health and Human Services. The Contractor far agrees to provide certificate at least per annum that the Institutional Review Board has reviewed and approved the procedures, which involve human subjects in accord with 45 CFR part 46 and the Assurance of Compliance .
( bel ) The Contractor shall bear wax province for the operation of all exercise and services involving the use of human subjects under this contract and shall ensure that work is conducted in a proper manner and equally safely as is feasible. The parties hereto agree that the Contractor retains the veracious to control and direct the performance of all shape under this abridge. nothing in this compress shall create an means or employee relationship between the Government and the Contractor, or any subcontractor, agent or employee of the Contractor, or any other person, organization, institution, or group of any kind any. The Contractor agrees that it has entered into this contract and will discharge its obligations, duties, and undertakings and the work pursuant thereto, whether requiring professional opinion or otherwise, as an autonomous contractor without creating liability on the part of the Government for the acts of the Contractor or its employees .
( coulomb ) Contractors involving early agencies or institutions in activities considered to be engaged in inquiry involving homo subjects must ensure that such other agencies or institutions obtain their own FWA if they are routinely engaged in research involving human subjects or ensure that such agencies or institutions are covered by the Contractors ’ FWA via appointment as agents of the institution or via individual detective agreements ( see OHRP web site at : hypertext transfer protocol : //www.hhs.gov/ohrp/policy/guidanceonalternativetofwa.pdf ) .
( vitamin d ) If at any time during the performance of this shrink the Contractor is not in conformity with any of the requirements and or standards stated in paragraph ( a ) and ( b ) above, the Contracting Officer may immediately suspend, in whole or in partially, knead and far payments under this condense until the Contractor corrects the disobedience. The Contracting Officer may communicate the notice of suspension by telephone with ratification in write. If the Contractor fails to complete corrective action within the period of meter designated in the Contracting Officer ’ s written comment of suspension, the Contracting Officer may, after consultation with OHRP, displace this narrow in whole or in part .
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352.270-5a Notice to Offerors of Requirement for Compliance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals.
As prescribed in HHSAR 370.403 ( a ), the Contracting Officer shall insert the follow provision :
Notice to Offerors of Requirement for Compliance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals ( December 18, 2015 )
The Public Health Service ( PHS ) policy on Humane Care and Use of Laboratory Animals ( PHS Policy ) establishes a number of requirements for inquiry activities involving animals. Before awarding a condense to an offerer, the organization shall file, with the Office of Laboratory Animal Welfare ( OLAW ), National Institutes of Health ( NIH ), a written Animal Welfare Assurance ( Assurance ) which commits the organization to comply with the provisions of the PHS Policy, the Animal Welfare Act, and the Guide for the Care and Use of Laboratory Animals ( National Academy Press, Washington, DC ). In accordance with the PHS Policy, offerors must establish an Institutional Animal Care and Use Committee ( IACUC ), qualified through the experience and expertness of its members, to oversee the institution ’ randomness animal program, facilities, and procedures. Offerors must provide confirmation of IACUC blessing prior to receiving an award involving populate vertebrate animals. No award involving the habit of animals shall be made unless OLAW approves the Assurance and confirmation of IACUC approval for the proposed animal activities has been provided to the Contracting Officer. Prior to award, the Contracting Officer will notify Contractor ( s ) selected for projects involving know vertebrate animals of the Assurance and verification of IACUC approval requirement. The Contracting Officer will request that OLAW negotiate an acceptable assurance with those Contractor ( second ) and request confirmation of IACUC blessing. For far information, contact OLAW at NIH, 6705 Rockledge Drive, RKL1, Suite 360, MSC 7982 Bethesda, Maryland 20892-7982 ( electronic mail : olaw @ od.nih.gov ; Phone : 301–496–7163 ) .
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352.270-5b Care of Live Vertebrate Animals .
As prescribed in HHSAR 370.404, the Contracting Officer shall insert the succeed clause :
Care of Live Vertebrate Animals ( December 18, 2015 )
( a ) Before undertaking performance of any sign involving animal-related activities where the species is regulated by the United Sates Department of Agriculture ( USDA ), the Contractor shall register with the Secretary of Agriculture of the United States in accord with 7 U.S.C. 2136 and 9 CFR sections 2.25 through 2.28. The Contractor shall furnish testify of the registration to the Contracting Officer .
( boron ) The Contractor shall acquire vertebrate animals used in research from a dealer licensed by the Secretary of Agriculture under 7 U.S.C. 2133 and 9 CFR sections 2.1-2.11 , or from a source that is excuse from licensing under those sections .
( speed of light ) The Contractor agrees that the manage, use, and intended use of any know vertebrate animals in the performance of this contract shall conform with the Public Health Service ( PHS ) policy on Humane Care of Use of Laboratory Animals ( PHS Policy ), the current Animal Welfare Assurance ( Assurance ), the Guide for the Care and Use of Laboratory Animals ( National Academy Press, Washington, DC ) and the apposite laws and regulations of the United States Department of Agriculture ( see 7 U.S.C. 2131 et seq. and 9 CFR subchapter A, Parts 1-4 ). In case of dispute between standards, the more rigorous standard shall govern .
( d ) If at any time during operation of this sign, the Contracting Officer determines, in consultation with the Office of Laboratory Animal Welfare ( OLAW ), National Institutes of Health ( NIH ), that the Contractor is not in complaisance with any of the requirements and standards stated in paragraph ( a ) through ( deoxycytidine monophosphate ) above, the Contracting Officer may immediately suspend, in solid or in depart, work and further payments under this narrow until the Contractor corrects the disobedience. Notice of the pause may be communicated by telephone and confirmed in write. If the Contractor fails to complete corrective action within the period of time designated in the Contracting Officer ’ s written notification of abeyance, the Contracting Officer may, in consultation with OLAW, NIH, end this sign in unharmed or in contribution, and the Contractor ’ s identify may be removed from the list of those contractors with Animal Welfare Assurances .
note : The Contractor may request registration of its facility and a stream list of accredited dealers from the Regional Office of the Animal and Plant Health Inspection Service ( APHIS ), USDA, for the region in which its research facility is located. The location of the appropriate APHIS Regional Office, equally well as data concerning this program may be obtained by contacting the Animal Care Staff, USDA/APHIS, 4700 River Road, Riverdale, Maryland 20737 ( e-mail : ace @ aphis.usda.gov ; web site : hypertext transfer protocol : //www.aphis.usda.gov/wps/portal/aphis/ourfocus/animalwelfare ) .
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352.270-6 Restriction on Use of Human Subjects.
As prescribed in HHSAR 370-304 ( boron ), the Contracting Officer shall insert the come article :
Restriction on Use of Human Subjects ( December 18, 2015 )
pursuant to 45 CFR part 46 , Protection of Human Research Subjects, the Contractor shall not expend funds under this award for research involving homo subjects or engage in any homo subjects inquiry bodily process anterior to the Contracting Officer ’ s acknowledge of a authentication that the research has been reviewed and approved by the Institutional Review Board ( IRB ) registered with OHRP. This restriction applies to all collaborating sites, whether domestic or alien, and subcontractors. The Contractor must ensure complaisance by collaborators and subcontractors .
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352.270-9 Non-Discrimination for Conscience.
As prescribed in HHSAR 370.701, the Contracting Officer shall insert the watch planning :
Non-discrimination for Conscience ( December 18, 2015 )
( a ) Section 301(d) of the United States Leadership Against HIV/AIDS, Tuberculosis, and Malaria Act , as better, provides that an organization, including a faith-based constitution, that is differently eligible to receive aid under section 104A of the Foreign Assistance Act of 1961, under the United States Leadership Against HIV/AIDS, Tuberculosis, and Malaria Act of 2003, under the Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008, or under any amendment to the foregoing Acts for HIV/AIDS prevention, treatment, or care—
( 1 ) Shall not be required, as a condition of receiving such aid, to—
( one ) endorse or utilize a multisectoral or comprehensive approach to combating HIV/AIDS ; or
( two ) Endorse, utilize, make a referral to, become integrate with, or differently participate in any broadcast or bodily process to which the constitution has a religious or moral expostulation .
( 2 ) Shall not be discriminated against under the provisions of law in subparagraph ( a ) for refusing to meet any necessity described in paragraph ( a ) ( 1 ) in this solicitation .
( barn ) accordingly, an offerer who believes this solicitation contains employment requirements requiring it endorse or utilize a multisectoral or comprehensive approach to combating HIV/AIDS, or second, use, make referral to, become desegregate with, or otherwise participate in a course of study or natural process to which it has a religious or moral protest, shall identify those function requirements it excluded in its technical proposal .
( hundred ) The Government acknowledges that an offerer has specific rights, as cited in paragraph ( bel ), to exclude certain work requirements in this solicitation from its proposal. however, the Government reserves the correct to not make an award to an offerer whose proposal does not comply with the salient work requirements of the solicitation. Any exert of that Government right will be made by the Head of the Contracting Activity .
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352.270-10 Notice to Offerors—Protection of Human Subjects, Research Involving Human Subjects Committee (RIHSC) Approval of Research Protocols Required.
As prescribed in HHSAR 370.303 ( five hundred ), the Contracting Officer shall insert the comply provision :
Notice to Offerors—Protection of Human Subjects, Research Involving Human Subjects Committee ( RIHSC ) Approval of Research Protocols Required ( December 18, 2015 )
( a ) All Offerors proposing research expected to involve human subjects shall comply with the regulations set away in 45 CFR Part 46, and with the provisions at HHSAR 352.270-4a .
( bacillus ) The Offeror shall have an acceptable assurance of complaisance on file with the Office for Human Research Protections ( OHRP ), whenever it submits a marriage proposal to the FDA for research expected to involve human subjects. direct questions regarding Federal-wide assurance to OHRP. The Offeror ’ mho marriage proposal shall include a copy of the satisfactory assurance of Compliance .
( deoxycytidine monophosphate ) After the contract has been awarded, the Contractor shall take the follow actions :
( 1 ) The Institutional Review Board ( IRB ) specified in the Offeror ’ s Assurance of Compliance, hereafter referred to as “ the local IRB, ” shall review the proposed research protocol. A letter from the local IRB express that the proposed research protocol has been reviewed and approved, and thus adequately protects the rights and wellbeing of human subjects involved, or a letter stating that the proposed research is nontaxable under 45 CFR 46.101 ( boron ) shall be submitted to the Contracting Officer .
( 2 ) Upon award, the successful Offeror, future “ the Contractor, ” shall submit its proposed research protocol to the FDA ’ s Research Involving Human Subjects Committee ( RIHSC ). The RIHSC or its designee will review and approve the inquiry protocol to assure it adequately protects the rights and benefit of homo subjects involved. The RIHSC or designee will besides determine whether the proposed research is nontaxable under 45 CFR 46.101 ( bel ). The Contractor shall submit, to the Contracting Officer of record, a copy of the RIHSC ’ s or its designee ’ s letter stating that it reviewed and approved the proposed research protocol .
( five hundred ) The Contractor shall not advertise for, recruit, or enroll human subjects, or differently start any inquiry involving human subjects until RIHSC or its designee reviews and approves its inquiry. The contractor may begin other specify aspects of contract performance prior to receiving RIHSC ’ s or designee ’ mho approval of the proposed research protocol. Research involving human subjects may commence immediately upon the Contractor ’ s reception of RIHSC ’ s or designee ’ randomness approval ; however, the Contractor shall submit a transcript of RIHSC ’ s or its designee ’ s approval to the Contracting Officer within three business days of its receipt .
( east ) A Contractor ’ s failure to obtain RIHSC ’ s or its designee ’ s approval of its proposed research may result in termination of its narrow. however, failure to obtain RIHSC ’ s or its designee ’ mho approval during initial review will not mechanically result in ending of the narrow. rather, the Contractor may correct any deficiencies identified during the initial RIHSC or designee review and resubmit the proposed research protocol to RIHSC or its designee for a second review. The Contractor is encouraged to solicit the RIHSC ’ s or its designee ’ mho input during the resubmission process .
( degree fahrenheit ) The Contractor shall seek RIHSC ’ s or its designee ’ south and local IRB revue and approval whenever make modifications, amendments or early changes to the inquiry protocol. such modifications, amendments and changes include, but are not limited to changes in investigators, informed accept forms, and recruitment advertisements. The Contractor may institute changes immediately after receiving both the local IRB and RIHSC or its designee approval ( except when necessity to eliminate apparent contiguous hazards to the subject ) ; however, the Contractor shall submit a copy of the letter evidencing RIHSC ’ s or its designee ‘s approval of the proposed changes to the Contracting Officer within three commercial enterprise days of its receipt .
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352.270-11 Protection of Human Subjects—Research Involving Human Subjects Committee (RIHSC) Approval of Research Protocols Required.
As prescribed in HHSAR 370.304 ( vitamin c ), the Contracting Officer shall insert the follow article :
security of Human Subjects—Research Involving Human Subjects Committee ( RIHSC ) Approval of Research Protocols Required ( December 18, 2015 )
( a ) The Contractor agrees to protect the rights and benefit of human subjects involved in research under this condense by complying with 45 CFR Part 46 and the article at HHSAR 352.270-4b .
( bacillus ) Initial proofread of submission with 45 CFR Part 46 shall consist of :
( 1 ) A copy of a current Federal-wide assurance on file with OHRP. The copy of a current Federal–wide Assurance shall be included with the Contractor ’ s proposal ;
( 2 ) A letter from the Contractor ’ s local IRB ( the Institutional Review Board ( IRB ) specified in the Offeror ’ s Assurance of Compliance ) stating that it has reviewed and approved the proposed research protocol. The letter from the local anesthetic IRB shall be submitted to the Contracting Office ; and
( 3 ) A transcript of a letter from the RIHSC state that it or its designee has reviewed and approved the proposed research protocol. This shall be submitted to the Contracting Officer within three occupation days of its issue .
The Contractor shall not advertise for, recruit, or enroll human subjects, or otherwise start any research involving human subjects under this abridge, until RIHSC has reviewed and approved its inquiry. The contractor may commence other limited aspects of sign performance anterior to receiving RIHSC or its designee blessing of its proposed research protocol. Research involving human subjects may commence immediately upon the Contractor ’ s receipt of RIHSC or its designee approval ; however, the Contractor shall submit a imitate of RIHSC ’ s or its designee ‘s letter of approval to the Contracting Officer within three clientele days of its receipt .
failure to obtain RIHSC or its designee blessing of proposed inquiry protocol may result in the result of this abridge .
( degree centigrade ) The Contractor far agrees that :
( 1 ) The Contractor will provide a letter from RIHSC, at least annually, stating that RIHSC or its designee has reviewed and approved the inquiry protocols for research performed under this sign. This shall be submitted to the Contracting Officer for inclusion body in the contract file .
( 2 ) The Contractor will submit all proposed modifications and amendments to research protocols for research performed under this contract to RIHSC for follow-up and approval. Modifications and amendments include, but are not limited, to changes to consent forms and advertise materials, and the summation or deletion of investigators. Changes may be instituted immediately after the Contractor has received both the local IRB and RIHSC or its designee approval ( except when necessity to eliminate apparent contiguous hazards to the subject ) ; however the Contractor shall submit a copy of the letter evidencing RIHSC ’ s or its designee ‘s approval of the proposed changes to the Contracting Officer within three business days of its acknowledge .
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352.270-12 Needle Exchange.
As prescribed in HHSAR 370.304 ( d ), the Contracting Officer shall insert the stick to clause :
Needle Exchange ( December 18, 2015 )
The Contractor shall not use any funds obligated under this narrow to carry out any program of distributing sterile needles or syringes for the hypodermic syringe injection of any illegal drug .
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352.270-13 Continued Ban on Funding Abortion and Continued Ban on Funding of Human Embryo Research.
As prescribed in HHSAR 370.304 ( vitamin e ), the Contracting Officer shall insert the succeed article :
continued Ban on Funding Abortion and Continued Ban on Funding of Human Embryo Research ( December 18, 2015 )
( a ) The Contractor shall not use any funds obligated under this narrow for any miscarriage .
( b ) The Contractor shall not use any funds obligated under this sign for the follow :
( 1 ) The creation of a human embryo or embryo for research purposes ; or
( 2 ) research in which a homo embryo or embryo are destroyed, discarded, or wittingly subjected to risk of injury of death greater than that allowed for research on fetuses in utero under 45 CFR Part 46 and Section 498 ( b-complex vitamin ) of the Public Health Service Act ( 42 U.S.C. 289g ( b ) ) .
( speed of light ) The terminus “ homo embryo or embryos ” includes any organism, not protected as a human subject under 45 CFR Part 46 as of the date of the act of this Act, that is derived by fertilization, parthenogenesis, cloning, or any other means from one or more homo gametes of homo diploid cells .
( d ) The Contractor shall not use any Federal funds for the cloning of human beings.
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other Sections of the HHSAR :
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