11266 Federal Register / Vol. 80, No. 40 / Monday, March 2, 2015 / Proposed Rules 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

48 CFR Chapter 3 

Health and Human Services 

Acquisition Regulation 

AGENCY: Department of Health and 

Human Services. 

ACTION: Proposed rule. 

SUMMARY: The Department of Health and 

Human Services (HHS) is proposing to 

amend its Federal Acquisition 

Regulation (FAR) Supplement, the HHS 

Acquisition Regulation (HHSAR), to 

update its regulation to current FAR 

requirements; to remove information 

from the HHSAR that consists of 

material that is internal administrative 

and procedural in nature; to add or 

revise definitions; to correct certain 

terminology; and to delete outdated 

material or material duplicative of the 

FAR. 

DATES: Comments are due on or before 

May 1, 2015. 

ADDRESSES: Submit comments in 

response to Health and Human Services 

Acquisition Regulation, parts 301 

through 370 by any of the following 

methods: 

Regulations.gov: http://

www.regulations.gov. Submit comments 

via the Federal eRulemaking portal by 

entering ‘‘Health and Human Services 

Acquisition Regulation, parts 301 

through 370’’ under the heading ‘‘Enter 

Keyword or ID’’ and selecting ‘‘Search.’’ 

Select the link ‘‘Submit a Comment’’ 

that corresponds with ‘‘Health and 

Human Services Acquisition Regulation, 

parts 301 through 370.’’ Follow the 

instructions provided at the ‘‘Submit a 

Comment’’ screen. Please include your 

name, company name (if any), and 

‘‘Health and Human Services 

Acquisition Regulation, parts 301 

through 370’’ on your attached 

document. 

Fax: 202–260–4823. 

Mail: HHS/ASFR/OGAPA/Division of 

Acquisition, ATTN: Deborah Griffin, 

Room 537H, Hubert Humphrey 

Building, 200 Independence Avenue 

SW., Washington, DC 20201. 

Instructions: Please submit comments 

only and cite Health and Human 

Services Acquisition Regulation, parts 

301 through 370, in all correspondence 

related to this case. All comments 

received will be posted without change 

to http://www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Deborah Griffin, Procurement Analyst, 

Department of Health and Human 

Services, Office of the Assistant 

Secretary for Financial Resources, Office 

of Grants and Acquisition Policy and 

Accountability, Division of Acquisition, 

Deborah.griffin@hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The HHS made substantive changes in 

its Federal Acquisition Regulation 

(FAR) Supplement, the HHS 

Acquisition Regulation or HHSAR, in 

November 2009 (74 FR 62396 on 

November 27, 2009). On April 26, 2010, 

HHS published in the Federal Register 

correcting amendments at 75 FR 2150. 

Since then numerous changes have been 

made to both statutory and regulatory 

(FAR) framework and requirements. 

Some of these new requirements were 

included in specific appropriations acts. 

This proposed rule changes the HHSAR 

to conform to these new requirements 

and to align the requirements with the 

current FAR. In addition, the procedural 

materials that were deemed internal or 

non-regulatory in nature are moved to 

internal procedures. Further changes are 

proposed to permit the various HHS 

operational divisions (OPDIVs) or staff 

divisions (STAFFDIVs) the necessary 

flexibility in meeting their respective 

missions. OPDIV provisions and clauses 

were collected and are tailored for 

department-wide application. 

The updated HHSAR includes HHS 

initiatives designed to change the 

purpose and content of the HHSAR. The 

objective is to improve the efficiency 

and effectiveness of various phases of 

the acquisition lifecycle, creating the 

framework for innovation and 

maximum flexibility. The updated 

HHSAR will contain only requirements 

of law, HHS policies, delegations of 

FAR authorities, deviations from FAR 

requirements, and policies/procedures 

that have a significant effect beyond the 

internal procedures of HHS or a 

significant cost or administrative impact 

on entities pursuing business 

opportunities with HHS. The 

information removed from the HHSAR 

consists of internal administrative and 

procedural information, referred to as 

internal procedures. In addition, the 

information removed does not have a 

significant effect beyond HHS internal 

operating procedures. The internal 

procedures will contain internal 

guidance, procedures, processes, and 

instructions but they will not be 

published in the Code of Federal 

Regulations. This framework which 

separates laws, policies, and other 

requirements impacting our industry 

partners from internal operating 

procedures will enable HHS to more 

rapidly convey internal administrative 

and procedural information to the 

acquisition workforce. 

II. Proposed Rule 

The following summarizes changes to 

the HHSAR. 

Part 301—HHS Acquisition Regulation 

System 

Part 301 is revised as follows: 

The nomenclature of the Contracting 

Officer’s Technical Representative 

(COTR) was changed to Contracting 

Officer’s Representative (COR) 

throughout the HHSAR. The training 

requirements for both Contracting 

Officers and CORs were deleted. The 

use of the term ‘‘project officer’’ has 

been removed throughout the HHSAR. 

The authority citations are corrected for 

all HHSAR parts. 

The prescription at Section 301.106(c) 

(Office of Management and Budget 

approval under the Paperwork 

Reduction Act) regarding the Paperwork 

Reduction Act was moved to Part 311 

and OMB clearance numbers were 

updated. 

Section 301.270 (Executive 

Committee for Acquisition) is deleted as 

unnecessary for the regulation and 

reflecting only internal procedures. 

Subpart 301.4 (Deviations from the 

FAR) is strengthened to enforce the 

appropriate use of deviations. 

Subsection 301.602–3 (Ratification of 

unauthorized commitments), paragraph 

(b), is modified to strengthen the 

language. 

Subpart 301.6 (Career Development, 

Contracting Authority, and 

Responsibilities) is extensively modified 

to make clear that all procurement 

authority stems from the SPE by 

delegation, ultimately, from the Head of 

the Agency, who can delegate authority 

to issue warrants to a level no lower 

than the HCA. The internal procedures 

were deleted. 

Part 302—Definitions of Words and 

Terms 

Part 302 is revised as follows: 

Section 302.101 (Definitions) is 

revised to clarify roles and 

responsibilities with HHS 

organizational changes. Definitions that 

already appear in the FAR were 

removed as duplicative. 

Subparts 302.70 (Common HHSAR 

Acronyms and Abbreviations) and 

302.71 (HHS Standard Templates and 

Formats) are removed as unnecessary. 

Part 303—Improper Business Practices 

and Personal Conflicts of Interest 

Part 303 is revised as follows: 

Subsection 303.104–7 (Violations or 

possible violations of the Procurement 


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Integrity Act) is revised to remove 

internal procedures for processing a 

Procurement Integrity Act violation and 

to remove the requirement for a review 

by a Senior Executive Service employee. 

Section 303.203 (Reporting suspected 

violations of the Gratuities clause) is 

revised to remove internal procedures 

for processing a report of a suspected 

violation. 

Section 303.303 (Reporting suspected 

antitrust violations) is removed as 

internal procedures. 

Subpart 303.4 (Contingent Fees) is 

deleted as unnecessary. 

Subpart 303.10 (Contractor Code of 

Business Ethics and Conduct) is added 

to move Section 303.1003 

(Requirements) to its proper subject 

placement and Section 303.1003 is 

revised to remove internal procedures 

for processing a report of a suspected 

violation of criminal law. 

Part 304—Administrative Matters 

Part 304 is revised as follows: 

Section 304.602 (General) is modified 

to remove the internal procedures 

regarding contract reporting. 

Section 304.604 (Responsibilities) is 

revised to remove the internal 

procedures and to note the importance 

of accuracy and timeliness in the 

Federal Procurement Data System 

reporting. 

Subsection 304.803–70 (Contract/

order file organization and use of 

checklists) is removed as unnecessary. 

Subsection 304.804–70 (Contract 

closeout audits) is removed as 

unnecessary. 

Subpart 304.13 (Personal Identity 

Verification) is removed as unnecessary 

and a policy statement is added for 

clarification. 

Subpart 304.70 (Acquisition 

Instrument Identification Numbering 

System) is revised and renumbered as 

304.16 (Unique Procurement Instrument 

Identifiers). 

Subpart 304.71 (Review and Approval 

of Proposed Contract Actions) and 

Section 304.7100 (Policy) is revised to 

clarify contract reviews and to remove 

internal procedures. 

Subpart 304.72 (Affordable Care Act 

Prevention and Public Health Fund— 

Reporting Requirements) is added to 

address information required by the 

Prevention and Public Health Fund 

(PPHF). 

Part 305—Publicizing Contract Actions 

Part 305 is revised as follows: 

Subpart 305.2 (Synopsis of Proposed 

Contract Actions) is removed as 

unnecessary. 

Section 305.303 (Announcement of 

contract awards), paragraph (a), is 

revised to remove a separate threshold 

for HHS and rely on the FAR. The 

internal procedures are removed. 

Section 305.502 (Authority) is revised 

to remove language redundant to the 

FAR and to specify that published 

advertisements in print media require 

approval above the contracting officer. 

Subpart 305.70 (Publicizing 

Requirements Funded from the 

Affordable Care Act Prevention and 

Public Health Fund) is added. 

Part 306—Competition Requirements 

Part 306 is revised as follows: 

Section 306.202 (Establishing or 

maintaining alternative sources) is 

revised to include reference to the HHS 

Department Competition Advocate. 

Subsection 306.302–1 (Only one 

responsible source and no other 

supplies or services will satisfy agency 

requirements), paragraph (a)(2)(iv), is 

deleted; the information is considered 

internal procedures. Also, information 

is added for the Bioshield Program. 

Subsection 306.302–7 (Public interest) 

is revised to clarify the procedures for 

the signature of the Secretary for a 

determination and findings for public 

interest. 

Section 306.303 (Justifications) is 

deleted; the information is considered 

internal procedures. 

Section 306.304 (Approval of the 

justification) is deleted; the information 

is considered internal procedures. 

Section 306.501 (Requirement) is 

revised to identify the HHS Department 

Competition Advocate. 

Section 306.502 (Duties and 

responsibilities) is deleted; the 

information is considered internal 

procedures. 

Part 307—Acquisition Planning 

Part 307 is revised as follows: 

Sections 307.104 (General 

procedures), 307.104–70 (Acquisition 

strategy), and 307.104–71 (Purpose and 

timing) are deleted. 

Section 307.105 (Contents of written 

acquisition plans) is revised to clarify 

that HHS requires a written acquisition 

plan for all acquisitions above the 

simplified acquisition threshold. 

Subsection 307.108–70 

(Telecommuting of contractor 

employees) is deleted; this language is 

redundant; the FAR language is 

sufficient. 

Subpart 307.70 (Considerations in 

Selecting an Award Instrument) is 

deleted; this information is considered 

internal procedures. 

Subpart 307.71 (Acquisition Plan) is 

deleted; this information is considered 

internal procedures. 

Part 308—Required Sources of Supplies 

and Services 

Part 308 is revised as follows: 

Section 308.404 (Use of Federal 

Supply Schedule) is deleted; the FAR 

language is sufficient. 

Section 308.405–6 (Limited source 

justification and approval) is revised; 

information considered internal 

procedures is removed. 

Subpart 308.8 (Acquisition of Printing 

and Related Supplies) is added to 

provide guidance on Government 

printing and electronic 

communications. 

Part 309—Contractor Qualifications 

Part 309 is revised as follows: 

Section 309.402 (Policy) is deleted. 

Section 309.403 (Definitions) is 

updated to provide current HHS 

definitions. 

Section 309.404 (List of parties 

excluded from Federal procurement and 

non-procurement programs) is revised 

to change the title to System for Award 

Management (SAM) Exclusions. This 

revision reflects the current FAR 

language. 

Section 309.405 (Effect of listing. 

Compelling Reason Determinations) is 

revised to change the title and updated 

to reflect current HHS terminology. 

Sections 309.406 (Debarment) and 

306.407 (Suspension) are revised. 

Section 309.470 (Reporting of 

suspected causes for debarment or 

suspension or the taking of evasive 

actions) is revised to clarify and update 

the contracting officer’s responsibilities 

to report and coordinate suspected 

causes for debarment or suspension or 

the taking of evasive actions. 

Subsection 309.470–1 (Situations 

where reports are required) is revised 

and Subsection 309.470–2 (Contents of 

reports) is deleted; the information 

deleted is considered internal 

procedures. 

Part 310—Market Research 

Part 310 is revised as follows: 

Section 310.001 (Policy) is revised to 

instruct contracting offices to follow the 

FAR. 

Part 311—Describing Agency Needs 

Part 311 is revised as follows: 

Section 311.7000 (Defining electronic 

information technology (EIT) 

requirements) is revised to clarify the 

contracting officer’s role in identifying 

the agency needs for EIT supplies and 

services; information considered 

internal procedures is deleted. 

Section 311.7001 (Section 508 

accessibility standards for HHS Web site 

content and communications materials) 

is moved to Part 339 and updated. 


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Subpart 311.71 (Accessibility of 

Meetings, Conferences, and Seminars to 

Persons with Disabilities) is relocated 

from Part 370. 

Subpart 311.72 (Conference Funding 

and Sponsorship) is relocated from Part 

370. 

Subpart 311.73 (Contractor Collection 

of Information) is relocated from Part 

301. 

Part 312—Acquisition of Commercial 

Items 

Part 312 is revised as follows: 

Section 312.101 (Policy) is revised to 

emphasize that the HHS Strategic 

Sourcing Program shall be utilized 

when possible. 

Section 312.202(d) (Market research 

and description of agency need) is 

revised to identify that the requiring 

activity specifies electronic and 

information technology (EIT) supplies 

and services subject to Section 508 and 

to move Section 508 requirements to 

Part 339. 

Part 313—Simplified Acquisition 

Procedures 

Part 313 is revised as follows: 

Section 313.003 (Policy) is revised by 

moving language related to Section 508 

to Part 339. 

Subpart 313.1 (Procedures) is deleted; 

this language is duplicative of the FAR. 

Section 313.301 (Government-wide 

commercial purchase card), paragraph 

(b), is revised to reference the HHS 

Purchase Card Program; the remaining 

procedural language is removed. 

Section 313.303 (Blanket purchase 

agreements) and Subsection 313.305–5 

(Purchases under blanket purchase 

agreements) are deleted; this 

information is not current. 

Subpart 313.5 (Test Program for 

Certain Commercial Items) is deleted; 

this is considered procedural 

information. 

Part 314—Sealed Bidding 

Part 314 is revised as follows: 

Section 314.103 (Policy) is revised by 

moving language related to Section 508 

to Part 339. 

Subpart 314.2 (Solicitation of Bids) is 

deleted; the FAR language is sufficient. 

Subsection 314.404–1 (Cancellation of 

invitations after opening) in Section 

314.404 (Rejection of bids) is revised to 

retain and clarify the HCA authority for 

rejection of bids and cancellations of 

invitations after opening. 

Section 314.407 (Mistakes in bids) is 

revised to retain and clarify the head of 

the contracting activity authority for 

mistakes in bid both before award and 

afterward and information considered 

internal procedures is removed. 

Part 315—Contracting By Negotiation 

Part 315 is revised as follows: 

The term ‘‘Technical Evaluation 

Panel’’ is removed and replaced with 

‘‘Source Selection Evaluation Team’’ 

throughout this part and material that is 

deemed redundant to the FAR has been 

deleted. 

Section 315.201 (Exchanges with 

industry before receipt of proposals) is 

determined to be internal procedures 

and is removed. 

Subsection 315.204–5 (Part IV— 

Representations and instructions), 

paragraph (c)(2), is deleted and the 

internal procedures are removed. 

Section 315.208 (Submission, 

modification, revision, and withdrawal 

of proposals) is revised to update how 

the Government will handle proposals 

after the exact time specified for receipt. 

Section 315.209 (Solicitation 

Provisions and Contract Clauses) is 

deleted. 

Section 315.304 (Evaluation factors 

and significant subfactors) is revised to 

move the text related to EIT acquisitions 

to Part 339, and the internal procedures 

are removed. 

Section 315.305 (Proposal evaluation) 

is revised and the internal procedures 

are removed. 

Sections 315.306 (Exchanges with 

offerors after receipt of proposals) and 

315.307 (Proposal revisions) are 

removed. 

Section 315.370 (Finalization of 

details with the selected source) is 

deleted as unnecessary; it is redundant 

to FAR 15.206. 

Section 315.371 (Contract preparation 

and award) contains internal procedures 

which are removed. 

Section 315.372 (Preparation of 

negotiation memorandum) contains 

internal procedures which are removed. 

Subsection 315.404–2 (Information to 

support proposal analysis) is revised 

and internal procedures are removed. 

Subsection 315.404–4 (Profit) is 

revised and the internal procedures 

related to developing weighted 

guidelines are removed. 

Section 315.605 (Content of 

unsolicited proposals) is revised to 

clarify the requirements on the 

submitter of an unsolicited proposal. 

The requirement for a certification has 

been deleted and a warranty has been 

added to conform to current Federal 

law. This changes the government’s 

remedy from a criminal sanction to a 

contract remedy. 

Subsection 315.606–1 (Receipt and 

initial review) is revised for clarity. 

Section 315.609 (Limited Use of Data) 

is deleted. 

Subpart 315.70 (Acquisition of 

Electronic Information Technology) is 

moved to Part 339. 

Part 316—Types of Contracts 

Part 316 is revised as follows: 

Section 316.603 (Letter contracts) is 

revised to limit letter contract 

modifications as prescribed in the FAR. 

Section 316.307 (Contract clauses) is 

revised to clarify the application of the 

cost principle in accordance with the 

governing statute. 

Section 316.505 (Ordering) is revised 

to clarify the role of the Competition 

Advocate as the task order ombudsman. 

Subsection 316.603–70 (Procedure for 

requesting authority to issue a letter 

contract) is deleted as unnecessary. 

Subsection 316.603–71 (Approval for 

modifications to letter contracts) is 

moved to 316.603–3 in part and is 

otherwise deleted as unnecessary. 

Subpart 316.7 (Agreements) is deleted 

as unnecessary. 

Part 317—Special Contracting Methods 

Part 317 is revised as follows: 

Section 317.104 (General) is revised to 

identify the Senior Procurement 

Executive as the designated agency 

approving official. 

Subsection 317.105–1 (Uses), 

paragraph (a), is revised to update 

current thresholds for cancellation 

ceilings. 

Section 317.107 (Options) is revised 

to update guidance on the use of options 

for multi-year contracts. 

Section 317.204 (Contracts), 

paragraph (e), is revised to provide 

guidance on contract periods exceeding 

the 5-year limitation provided in FAR 

17.204(e). 

Section 317.207 (Exercise of Options) 

is deleted; the information for current 

Section 508 policy is provided in Part 

339. 

Subpart 317.5 (Interagency 

Acquisitions Under the Economy Act) is 

deleted; this information is considered 

internal procedures. 

Subpart 317.70 (Multi-agency and 

Intra-agency Contracts) is deleted; this 

information is considered internal 

procedures. 

Part 319—Small Business Programs 

Part 319 is revised as follows: 

Section 319.201 (General policy) 

language is revised to align with the 

FAR. 

Subsection 319.202–2 (Locating small 

business sources) is removed as 

unnecessary. 

Subsection 319.270–1 (Mentor Prote ́ge ́

Program) is revised to change the 

section heading to ‘‘Mentor Prote ́ge ́

Program Solicitation provision and 

contract clause.’’ 


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Subpart 319.5 (Set-asides for Small 

Business) is deleted; the FAR coverage 

is sufficient. 

Subpart 319.7 (Subcontracting with 

Small Business, Small Disadvantaged 

Business, and Women-Owned Small 

Business Concerns) is removed as 

unnecessary. 

Part 322—Application of Labor Laws to 

Government Acquisitions 

Part 322 is revised as follows: 

Section 322.810 (Solicitation 

provisions and contract clauses) is 

revised to correct the clause 

prescriptions. 

Part 323—Environment, Energy and 

Water Efficiency, Renewable Energy 

Technologies, Occupational Safety, and 

Drug-Free Workplace 

Part 323 is revised as follows: 

Section 323.7000 (Scope of subpart) is 

revised to clarify the applicable policy 

for safety and health situations. 

Section 323.7001 (Policy) is revised to 

clarify guidance for safety and health 

situations. 

Section 323.7002 (Actions required) is 

revised by removing information 

regarding roles other than the 

contracting officer. 

Subpart 323.71 (Sustainable 

Acquisition Requirements) is revised by 

adding sustainable acquisition 

requirements. This additional 

information provides policy and a new 

provision prescription for offerors to 

describe their approaches for meeting 

the requirements of FAR 23.1 

(Sustainable Acquisition Policy). 

Part 324—Protection of Privacy and 

Freedom of Information 

Part 324 is revised as follows: 

Sections 324.000 (Scope of subpart) 

and 324.102 (General) are removed; this 

information is considered internal 

procedures. 

Section 324.103 (Procedures) is 

revised to change the section heading to 

‘‘Procedures for the Privacy Act’’ and to 

ensure that the statement of work/

performance work schedule specifies 

the system of record and the disposition 

of the system of record. 

Section 324.104 (Restrictions on 

Contractor Access to Government or 

Third Party Information) is added to 

provide information on restrictions on 

contractor access to Government or 

third party information. 

Section 324.105 (Contract clauses) is 

added to prescribe the clause at 

352.224–70 (Privacy Act) and 352.224– 

71 (Confidential Information). 

Subpart 324.2 (Freedom of 

Information Act) is deleted; the FAR is 

sufficient. 

Subpart 324.70 (Health Insurance 

Portability and Accountability Act of 

1996 (HIPAA)) is added to provide 

coverage for the Health Insurance 

Portability and Accountability Act of 

1996 and subtitle D of title IV of the 

Health Information Technology for 

Economic and Clinical Health Act 

(HITECH Act). 

Pursuant to the Health Insurance 

Portability and Accountability Act of 

1996, Public Law 104–191 (August 21, 

1996) and the Health Information 

Technology for Economic and Clinical 

Health (HITECH) Act, enacted as part of 

the American Recovery and Investment 

Act, Public Law 111–5 (February 17, 

2009), the Department issued 

regulations at 45 CFR parts 160 to 164 

(HIPAA Rules). 

The HIPAA Rules apply to ‘‘covered 

entities’’ and in part to ‘‘business 

associates,’’ as defined at 160.103. 

Covered entities are health plans, health 

care clearinghouses, and any health care 

provider who transmits health 

information in electronic form in 

connection with transactions for which 

the Secretary of HHS has adopted 

standards under the HIPAA statute. In 

general, business associates are persons 

or organizations that perform certain 

functions or activities on behalf of, or 

provides certain services to, covered 

entities that involve the use or 

disclosure of protected health 

information. When covered entities use 

contractors to perform services or 

activities that involve protected health 

information, the HIPAA Privacy and 

Security Rules require that covered 

entities enter into an agreement with 

business associates, commonly called 

business associate agreements, which 

must include specified terms set forth in 

these rules. 

A covered entity that is a single legal 

entity and that conducts both covered 

and non-covered functions may elect to 

be a ‘‘hybrid entity,’’ as defined at 

164.103. A covered function is an 

activity that makes a person or 

organization a covered entity. To be a 

hybrid entity, a covered entity must 

designate in writing its operations that 

perform covered functions as one or 

more ‘‘health care components,’’ as 

defined at 164.103. After making this 

designation, most of the requirements of 

the HIPAA rules will apply only to the 

health care components. A covered 

entity that is a hybrid entity must 

include a component that performs 

business associate-like activities within 

its health care component(s) so that 

such component is directly subject to 

the HIPAA Rules. 

The Department is a covered entity. 

However, because the Department has 

elected to be a hybrid entity, most 

Department activities are not subject to 

the HIPAA Rules. At this time, the 

designated HHS’ HCCs fall into the 

following categories: the CMS Medicare 

fee-for-service program, the Indian 

Health Service, the Commissioned 

Corps and the CDC World Trade Center 

Health Program. Even when a covered 

entity is a hybrid entity, the duty to 

enter into agreements or contracts that 

include certain terms remains with the 

covered entity rather than the health 

care component. For operational 

purposes it may be the covered entity’s 

HCC(s) that perform the contract 

function on behalf of the covered entity. 

This proposed rule references the 

terms that the HHS HCCs on behalf of 

the Department must include in their 

contracts with their business associates. 

In complying with the HIPAA Rules, the 

HCCs and their business associates shall 

interpret the HIPAA Rules consistent 

with the Department’s interpretations as 

found on the HHS Office for Civil Rights 

Web site at http://www.hhs.gov/ocr/

privacy. In particular, HCCs should 

reference the Sample Business Associate 

Agreement (BAA) Provisions at http://

www.hhs.gov/ocr/privacy/hipaa/

understanding/coveredentities/

contractprov.html as they develop their 

business associate contracts. 

The required business associate 

contract terms apply where the 

Department is required to enter into a 

business associate contract pursuant to 

the HIPAA Rules. We note that the 

definition of business associate includes 

‘‘subcontractors.’’ However, under 45 

CFR 164.502(e)(1)(i), a covered entity is 

not required to have a business associate 

contract with a subcontractor; this 

would be the responsibility of the 

business associate. Also, under 45 CFR 

164.504(e)(3)(i)(A) and (B), the business 

associate contract terms are not required 

if the business associate is another 

government agency (e.g., a state agency) 

and certain conditions are met. Also, 

under 164.504(e)(3)(ii), the business 

associate contract terms are not required 

where the business associate is required 

by law to perform business associate 

functions or activities on behalf of the 

HCC or to provide certain services to a 

HCC, and certain other conditions are 

met. For example the Department of 

Justice is required by law to provide 

legal services to HHS. 

Part 326—Other Socioeconomic 

Programs 

Part 326 is added as follows: 

Subpart 326.5 (Indian Preference in 

Employment, Training, and 

Subcontracting Opportunities) is added 

to provide information on the Indian 


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preference in employment, training, and 

subcontracting opportunities. This 

information is moved from part 370. 

Subpart 326.6 (Acquisitions Under 

the Buy Indian Act) is added to provide 

information on acquisitions under the 

Buy Indian Act. This information is 

moved from part 370. 

Subpart 326.7 (Acquisitions Requiring 

the Native American Graves Protection 

and Repatriation Act) is added to 

provide information on acquisitions 

requiring the Native American Graves 

Protection and Repatriation Act. This 

information is moved from part 342. 

Part 327—Rights, Data, and Copyrights 

Part 327 is revised as follows: 

Subsection 327.404–70 (Solicitation 

provision and contract clause), is 

revised to clarify that the contractor may 

publish results of its work. 

Part 328—Bonds and Insurance 

Part 328 is deleted; the FAR is 

deemed sufficient. 

Part 330—Cost Accounting Standards 

Part 330 is revised as follows: 

Subsection 330.201–5 (Waiver) is 

revised and internal procedures are 

removed. 

Part 331—Contract Cost Principles and 

Procedures 

Part 331 is revised as follows: 

Section 331.101–70 (Salary Rate 

Limitation) is revised to update how 

HHS appropriated funds are to be used, 

and direct users to Office of Personnel 

Management for the rate tables. 

Section 331.102–70 (Pricing of 

adjustments) contains internal 

procedures and is removed. 

Part 332—Contract Financing 

Part 332 is revised as follows: 

Section 332.402 (General) is revised to 

clarify the HCA responsibility for 

advance payments. 

Section 332.403 (Applicability) is 

deleted as unnecessary. 

Section 332.407 (Interest) is revised 

and internal procedures are removed. 

Section 332.409 (Contracting Officer 

action) and Subsection 332.409–1 

(Recommendation for approval) are 

deleted as unnecessary. 

Section 332.702 (Policy), Section 

332.703 (Contract funding 

requirements), and Subsection 332.703– 

71 (Incrementally funded costreimbursement contracts) are added to 

address contract funding issues. 

Subsection 332.703–70 (Funding 

contracts during a continuing 

resolution) is removed since continuing 

resolution and their associated 

requirements change with each 

resolution. 

Subsection 332.703–71 (Incrementally 

funded cost-reimbursement contracts) is 

added. 

Subsection 332.703–72 (Incremental 

Funding Table) is added to provide a 

contract mechanism to track funding on 

an incrementally funded contract. 

Section 332.704 (Limitation of cost or 

funds) is deleted as unnecessary. 

Section 332.706 (Solicitation 

provision and contract clauses) is added 

to prescribe the clause at 352.232–70 

(Incremental Funding). 

Subsection 332.706–2 (Provision and 

clauses for limitation of cost or funds) 

is added to prescribe additional 

requirements for cost-reimbursement 

contract for severable services using 

incremental funding. 

Part 333—Protests, Disputes, and 

Appeals 

Part 333 is revised as follows: 

Sections 333.102 (General) and 

333.103 (Protests to the agency) are 

revised to remove internal procedures. 

Sections 333.104 (Protests to GAO), 

333.211 (Contracting Officer’s decision), 

333.212 (Contracting Officer’s duties 

upon appeal), 333.212–70 (Formats), 

and 333.213 (Obligation to continue 

performance) are internal procedures 

and are deleted. 

Subsection 333.215–70 (Contract 

clauses) is revised to reference the 

clause at 352.233–72 in all solicitations 

and contracts and to correct the clause 

prescriptions. 

Part 334—Major System Acquisition 

Part 334 is revised as follows: 

Section 334.200 (Definitions) is 

deleted. 

Section 334.201 (Policy) is revised to 

provide the HHS contract value 

thresholds for the requirement of EVMS. 

Section 334.203 (Solicitation 

provisions and contract clauses) and 

Subsection 334.203–70 (HHS 

solicitation provisions and contract 

clauses) are deleted. 

Part 335—Research and Development 

Contracting 

Part 335 is revised as follows: 

Subsection 335.070–1 (Policy) is 

revised to relax the prior mandates in 

order to provide the contracting officer 

more flexibility regarding cost-sharing 

contracts. 

Subsection 335.070–2 (Amount of 

cost-sharing) is revised to provide the 

contracting officer more flexibility 

regarding fees or profits in cost-sharing 

contracts. 

Subsection 335.070–4 (Contract 

award) is deleted as unnecessary. 

Section 335.071 (Special 

determinations and findings affecting 

research and development contracting) 

is deleted as an unnecessary 

determinations and findings. 

Section 335.072 (Key Personnel) is 

added to emphasize the importance of 

Key Personnel in research and 

development contracting. 

Part 336—Construction and ArchitectEngineer Contracts 

Part 336 is added. 

Part 337—Service Contracting—General 

Part 337 is revised as follows: 

Section 337.103 (Contracting Officer 

Responsibility) is revised as follows: 

• Paragraphs (d)(1), (2), and (3), are 

revised to prescribe clauses to comply 

with Federal law. 

• Paragraph (d)(4) is added to provide 

direction to the Indian Health Service 

contracting officers in complying with 

the Indian Child Protection And Family 

Violence Act (25 U.S.C. 3201 et seq.). 

• Paragraph (e) is added to prescribe 

a clause that requires contractors who 

deliver services to beneficiaries of HHS 

programs to do so in a nondiscriminatory fashion. 

• Paragraph (f) is added to prescribe 

the use of the new key personnel clause 

at 352.237–75. 

Section 337.103–70 (Solicitation 

provision and contract clause) is moved 

to Section 337.103 (Contracting Officer 

Responsibility) to align with FAR 

numbering. 

Part 339—Acquisition of Information 

Technology 

Revised Part 339 as follows: 

Section 339.101 (Policy) is revised to 

clarify that contracting officers shall 

collaborate with the requiring activity 

for the acquisition of information 

technology supplies, services, and 

systems. 

Section 339.201 (Clarification) and 

Subsection 339.201–70 (Required 

provision and contract clause) are 

deleted; the information is obsolete. 

Section 339.203 (Approval of 

exceptions) is revised and the title is 

changed to (Applicability) to align with 

the FAR. 

Sections 339.203–70 (Contract 

clauses), 339.204 (Exceptions), 339.204– 

1 (Approval of exceptions), and 339.205 

(Section 508 accessibility standards for 

contracts) are added to provide updated 

information for electronic and 

information technology supplies and 

services and the requirements for 

compliance with Section 508 of the 

Rehabilitation Act. 

Subparts 339.70 (Use of General 

Services Administration Blanket 

Purchase Agreements for Independent 

Risk Analysis Services) and 339.71 


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(Information Security Management) are 

internal procedures and are deleted. 

Part 342—Contract Administration 

Part 342 is revised as follows: 

Section 342.302 (Contract 

administration functions) is revised as 

follows: 

• Paragraph (c)(1) is deleted; 

• Paragraph (c)(2) is deleted and the 

clause prescription is moved to Part 337 

and renumbered; 

• Paragraph (c)(3) is deleted because 

it prescribes the use of clause 352.242– 

71 (Tobacco-Free Facilities) which is 

also deleted; and 

• Paragraph (c)(4) is deleted and the 

clause prescription is moved to Part 326 

and renumbered. 

Section 342.705 (Final indirect cost 

rates) is revised to clarify the HHS 

component named as the cognizant 

Federal agency within HHS. 

Subpart 342.70 (Contract Monitoring) 

is revised by removing information from 

Sections 342.7000 (Purpose), 342.7001 

(Contract monitoring responsibilities), 

and 342.7002 (Procedures to be 

followed when a contractor fails to 

perform); this information is considered 

internal procedures. 

Section 342.7003 (Withholding of 

contract payments) is deleted; the FAR 

is sufficient. 

Subpart 342.71 (Administrative 

Actions for Cost Overruns) is removed. 

Part 352—Solicitation Provisions and 

Contract Clauses 

Part 352 is revised as follows: 

Clause 352.201–70 (Paperwork 

Reduction Act) is re-numbered 352.211– 

3 and relocated to Part 311. 

Clause 352.202–1 (Definitions) is 

deleted. 

Clause 352.203–70 (Anti-Lobbying) 

related to Subpart 303.8 (Limitation on 

the Payment of Funds to Influence 

Federal Transactions) is updated. 

Clause 352.204–70 (Prevention and 

Public Health Fund—Reporting 

Requirements) is added. 

Clause 352.208–70 (Printing and 

Duplication) is added. 

Clause 352.211–1 (Accessibility of 

meetings, conferences, and seminars to 

persons with disabilities) formerly 

352.270–7 is relocated from part 370. 

Clause 352.211–2 (Conference 

sponsorship request and conference 

materials disclaimer) formerly 352.270– 

1 is relocated from Part 370. 

Clause 352.211–3 (Paperwork 

Reduction Act) formerly 352.201–70 is 

relocated from part 301. 

Clause 352.215–1 (Instructions to 

offerors—competitive acquisition) is 

deleted. 

Clause 352.215–70 (Late Proposals 

and Revisions) is revised. 

Clause 352.216–70 (Additional Cost 

Principles) is revised to correct the 

prescription citation. 

Clause 352.219–70 (Mentor-prote ́ge ́

program) is revised. 

Clause 352.222–70 (Contractor 

cooperation in equal employment 

opportunity investigations) is corrected. 

Clause 352.223–70 (Safety and health) 

is updated. 

Provision 352.223–71 (Instructions to 

Offerors—Sustainable Acquisition) is 

added. 

Clause 352.224–70 (Privacy Act) is 

updated. 

Clause 352.224–71 (Confidential 

Information) is added. 

Clauses 352.226–1 (Indian 

Preference), 352.226–2 (Indian 

Preference Program), and 352.226–3 

(Native American Graves Protection and 

Repatriation Act) are added. These 

clauses are moved from Parts 370 and 

342 and renumbered. 

Clause 352.227–70 (Publications and 

Publicity) is revised to clarify that the 

contractor may publish results of its 

work. In addition, paragraph (b) of the 

clause is revised. Paragraph ‘‘c’’ is 

added to clarify the advertising of 

products or services provided under the 

contract. 

Clause at 352.231–70 (Salary Rate 

Limitation) is revised. 

Clause 352.231–71 (Pricing of 

adjustments) is deleted as unnecessary. 

Clause 352.232–70 (Incremental 

funding) is revised. 

Clauses 352.233–70 (Choice of Law 

(overseas)) and 352.233–71 (Litigation 

and claims) are revised. 

Provisions 352.234–1 (Notice of 

Earned Value Management System— 

Pre-Award Integrated Baseline Review) 

and 352.234–2 (Notice of Earned Value 

Management System—Post-Award 

Integrated Baseline Review) are deleted; 

the FAR provisions are sufficient. 

Clauses 352.234–3 (Full Earned Value 

Management System) and 352.234–4 

(Partial Earned Value Management 

System) are deleted; the FAR clauses are 

sufficient. 

Clause 352.236–70 (Design-Build 

Contracts) is added with an Alternate I 

to be used for Fast Track procedures. 

Clauses 352.237–70 (Pro-Children 

Act), 352.237–71 (Crime Control Act— 

reporting of child abuse), and 352.237– 

72 (Crime Control Act—requirement for 

background checks) are updated. 

Clauses 352.237–73 (Indian Child 

Protection and Family Violence Act), 

352.237–74 (Non-discrimination in 

Service Delivery), and 352.237–75 (Key 

Personnel) are added. 

Clause 352.239–70 (Standard for 

Security Configurations) is deleted; the 

clause is obsolete. 

Clause 352.239–71 (Standard for 

Encryption Language) is deleted; the 

clause is obsolete. 

Clause 352.239–72 (Security 

Requirements for Federal Information 

Technology Resources) is deleted; the 

clause is obsolete. 

Provision 352.239–73 (Electronic and 

Information Technology and 

Accessibility Notice) is revised to 

provide updated information for 

electronic and information technology 

supplies and services and the 

requirements for compliance with 

Section 508 of the Rehabilitation Act. 

Clause 352.239–74 (Electronic and 

Information Technology Accessibility) 

is added. 

Clause 352.242–70 (Key Personnel) is 

renumbered as 352.237–75. 

Clause 352.242–71 (Tobacco Free 

Facilities) is deleted. The clause is no 

longer necessary. 

Clause at 352.242–72 (Native 

American Graves Protection and 

Repatriation Act) is renumbered as 

352.236–3. 

Clause 352.242–73 (Withholding of 

Contract Payments) is deleted; the FAR 

is sufficient. 

Clause 352.242–74 (Final decisions on 

audit findings) is deleted; the FAR is 

sufficient. 

Clause 352.270–1 (Accessibility of 

Meetings, Conferences, and Seminars to 

Persons with Disabilities) is moved to 

352.211–1; 

Clause 352.270–2 (Indian preference) 

is moved to 352.226–1. 

Clause 352.270–3 (Indian preference 

program) is moved to 352.226–2. 

Provision 352.270–4a (Notice to 

Offerors, Protection of Human Subjects) 

is revised to update the Federal-wide 

assurance requirement and provide for 

the inclusion of an Alternate to this 

provision. 

Clause at 352.270–4b (Protection of 

Human Subjects) is revised to update 

the Federal-wide assurance 

requirement. 

Provision 352.270–5a (Notice to 

Offerors of Requirement for Compliance 

with the Public Health Service Policy on 

Humane Care and Use of Laboratory 

Animals) is updated. 

Clause 352.270–5b (Care of Live 

Vertebrate Animals) is updated. 

Clause 352.270–6 (Restrictions on Use 

of Human Subjects) is revised to update 

the reference to the Institutional Review 

Board. 

Clause 352.270–7 (Conference 

Sponsorship Request and Conference 

Materials Disclaimer) is moved to 

352.211–2. 

Clause 352.270–8 (Prostitution and 

related activities) is deleted. 


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Clause 352.270–9 (Nondiscrimination for conscience) is 

updated. 

Provision 352.270–10 (Notice to 

Offerors—Protection of Human Subjects, 

Research Involving Human Subjects 

Committee (RIHSC) Approval of 

Research Protocols Required) is added. 

Clause 352.270–11 (Protection of 

Human Subjects, Research Involving 

Human Subjects Committee (RIHSC) 

Approval of Research Protocols 

Required) is added. 

Clause 352.270–12 (Needle Exchange) 

is added. 

Clause 352.270–13 (Continued Ban on 

Funding Abortion and Continued Ban 

on Funding of Human Embryo 

Research) is added. 

Part 353—Forms 

Form HHS 674, Structured Approach 

Profit/Fee Objective is deleted. There 

are no forms; therefore, the part is 

reserved. 

Part 370—Special Programs Affecting 

Acquisition 

Part 370 is revised as follows: 

Subpart 370.1 (Accessibility of 

Meetings, Conferences, and Seminars to 

Persons with Disabilities) is moved to 

part 311. 

Subpart 370.2 (Indian Preference in 

Employment, Training, and 

Subcontracting Opportunities) is moved 

to part 326. 

Subpart 370.3 (Acquisitions Involving 

Human Subjects) is revised to update 

the policy in section 370.301 and the 

Federal-wide assurance in 370.302. 

Section 370.303 (Notice to offerors) is 

revised as follows: 

• Paragraph (a) is revised to provide 

for the inclusion of an Alternate to the 

provision at 352.270–4a (Notice to 

Offerors, Protection of Human Subjects). 

• Paragraph (d) is added to provide a 

prescription for the provision added at 

352.270–10 (Notice to Offerors— 

Protection of Human Subjects, Research 

Involving Human Subjects Committee 

(RIHSC) Approval of Research Protocols 

Required) in FDA solicitations that 

involve human subjects research such 

that the research will be reviewed and 

approved by the Research Involving 

Human Subjects Committee (RIHSC). 

Section 370.304 (Contract clauses) is 

revised as follows: 

• Paragraph (c) is added to provide a 

prescription for the clause added at 

352.270–11 (Protection of Human 

Subjects, Research Involving Human 

Subjects Committee (RIHSC) Approval 

of Research Protocols Required) in FDA 

solicitations that involve human 

subjects research such that the research 

will be reviewed and approved by the 

Research Involving Human Subjects 

Committee (RIHSC). 

• Paragraph (d) is added to provide a 

prescription for the clause added at 

352.270–12 (Needle Exchange). 

• Paragraph (e) is added to provide a 

prescription for the clause added at 

352.270–13 (Continued Ban on Funding 

Abortion and Continued Ban on 

Funding of Human Embryo Research). 

Subpart 370.4 (Acquisitions Involving 

the Use of Laboratory Animals) is 

revised to update the policy in Section 

370.401 (Policy) and the assurances in 

Section 370.402 (Assurances). 

Sections 370.403 (Notice to offerors) 

and 370.404 (Contract clause) are 

revised to correct the provision and 

clause prescriptions. 

Subpart 370.5 (Acquisitions Under 

the Buy Indian Act) is moved to part 

326. 

Subpart 370.6 (Conference Funding 

and Sponsorship) is moved to part 311. 

Subpart 370.7 (Acquisitions under the 

Leadership Act) is revised for editorial 

corrections. 

III. Executive Order 12866 and 13563 

Executive Orders (E.O.s) 12866 and 

13563 direct agencies to assess all costs 

and benefits of available regulatory 

alternatives and, if regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety 

effects, distributive impacts, and 

equity). E.O. 13563 emphasizes the 

importance of quantifying both costs 

and benefits, of reducing costs, of 

harmonizing rules, and of promoting 

flexibility. 

This is not a significant regulatory 

action and, therefore, is not subject to 

review under section 6(b) of Executive 

Order 12866, Regulatory Planning and 

Review, dated September 30, 1993. This 

rule is not a major rule under 5 U.S.C. 

804. 

IV. Regulatory Flexibility Act 

These changes to the HHSAR will not 

have a significant economic impact on 

a substantial number of small entities 

within the meaning of the Regulatory 

Flexibility Act 5 U.S.C. 601, et seq. The 

proposed rule improves HHS 

acquisition by removing duplicative 

regulatory language, provisions and 

clauses, and procedural information, 

and provides departmental level 

regulation and provisions and clauses. 

Businesses, both small and large, can 

respond to uniform acquisition 

regulation, reducing their costs. As a 

result of these changes, the proposed 

rule should have a positive effect on 

small businesses allowing them to more 

readily compete for HHS contracts. 

The Initial Regulatory Flexibility 

Analysis (IRFA) is summarized as 

follows: 

INITIAL REGULATORY FLEXIBILITY 

ANALYSIS 

This initial regulatory flexibility 

analysis has been prepared consistent 

with 5 U.S.C. 603. 

1. Description of the reasons why 

action is being taken. 

The Department of Health and Human 

Services (HHS) is proposing to amend 

its Federal Acquisition Regulation 

(FAR) Supplement, the HHS 

Acquisition Regulation (HHSAR), to 

update its regulation to current FAR 

requirements; to move internal guidance 

which is procedural in nature to 

Procedures, Guidance and Instructions 

(PGI), to add or revise definitions; to 

correct certain terminology and to delete 

outdated material or material 

duplicative of the FAR. 

2. Statement of the objectives of, and 

the legal basis for, the rule. 

HHS made substantive changes in its 

Federal Acquisition Regulation (FAR) 

Supplement, the HHS Acquisition 

Regulation or HHSAR, in November, 

2009, (74 FR 62396 on November 27, 

2009). On April 26, 2010, HHS 

published in the Federal Register 

correcting amendments at 75 FR 2150. 

Since then numerous changes have been 

made to both statutory and regulatory 

(FAR) framework and requirements. 

Some of these new requirements were 

included in specific appropriations acts. 

This publication of the proposed rule 

changes the HHSAR to conform to these 

new requirements and to align the 

requirements with the current FAR. In 

addition, the procedural materials that 

were deemed internal or non-regulatory 

in nature are moved to procedures, 

guidance, and instructions documents. 

Further changes are proposed to permit 

the various HHS operational divisions 

(OPDIVS) or staff divisions 

(STAFFDIVS) the necessary flexibility 

in meeting their respective missions. 

OPDIV provisions and clauses were 

collected and are tailored for 

department-wide application. 

3. Description of and, where feasible, 

an estimate of the number of small 

entities to which the rule will apply. 

HHS awarded approximately 95 

thousand contract actions in FY2014; 

over 44 percent (42,232) of those actions 

were for small businesses acting as 

prime contractors; therefore, it is 

estimated that the rule will apply to 

over 42,000 small entities. The primary 

industry sectors affected are as 

represented in the chart below: 


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HHS FY2014 3-DIGIT NAICS TOTAL SMALL BUSINESS DOLLARS

221 (UTILITIES) ................................................................................................................................................................... $485,385.87 

236 (CONSTRUCTION OF BUILDINGS) ............................................................................................................................ 164,277,302.92 

325 (CHEMICAL MANUFACTURING) Total ....................................................................................................................... 262,207,229.87 

334 (COMPUTER AND ELECTRONIC PRODUCT MANUFACTURING) .......................................................................... 313,625,169.91 

336 (TRANSPORTATION EQUIPMENT MANUFACTURING) ........................................................................................... 66,756,387.08 

339 (MISCELLANEOUS MANUFACTURING) .................................................................................................................... 29,127,192.37 

423 (MERCHANT WHOLESALERS, DURABLE GOODS) ................................................................................................. 33,254,853.30 

424 (MERCHANT WHOLESALERS, NONDURABLE GOODS) ......................................................................................... 21,355,796.73 

443 (ELECTRONICS AND APPLIANCE STORES) ............................................................................................................ 69,190,516.74 

493 (WAREHOUSING AND STORAGE) ............................................................................................................................ 16,489,155.73 

511 (PUBLISHING INDUSTRIES (EXCEPT INTERNET)) ................................................................................................. 49,671,265.41 

517 (TELECOMMUNICATIONS) ......................................................................................................................................... 9,648,511.61 

518 (DATA PROCESSING, HOSTING AND RELATED SERVICES) ................................................................................ 104,142,979.21 

519 (OTHER INFORMATION SERVICES) ......................................................................................................................... 36,729,861.34 

524 (INSURANCE CARRIERS AND RELATED ACTIVITIES) ........................................................................................... 7,734,506.42 

531 (REAL ESTATE) ........................................................................................................................................................... 2,107,755.53 

541 (PROFESSIONAL, SCIENTIFIC, AND TECHNICAL SERVICES) .............................................................................. 2,812,475,258.21 

561 (ADMINISTRATIVE AND SUPPORT SERVICES) ...................................................................................................... 221,619,313.74 

611 (EDUCATIONAL SERVICES) ...................................................................................................................................... 19,831,346.95 

621 (AMBULATORY HEALTH CARE SERVICES) ............................................................................................................. 86,140,044.62 

Total .............................................................................................................................................................................. 4,326,869,833.56 

4. Description and estimate of 

compliance requirements including 

differences in cost, if any, for different 

groups of small entities. 

The proposed rule will improve HHS 

acquisition by removing duplicative 

regulatory language, provisions and 

clauses, and procedures, guidance, and 

information (PGI) from HHS OPDIVS, 

and provides departmental level 

regulation, provisions and clauses, and 

PGI. This will enable businesses, both 

small and large, to respond to a uniform 

acquisition regulation and PGI, reducing 

their costs and decreasing their burden 

for compliance. After removing 

outdated reporting requirements, HHS 

found there were fewer data collections 

with less burden than the current 

HHSAR contains. The remaining 

compliance requirements do not require 

an update to computer software, nor 

does it impose additional recordkeeping 

or reporting responsibilities. As a result 

of these changes, the proposed rule 

should have a positive effect on small 

businesses allowing them to more 

readily compete for HHS contracts. 

There are no differences anticipated for 

the costs for compliance requirements 

for small businesses. 

5. Identification, to the extent 

practicable, of all relevant Federal rules 

which may duplicate, overlap, or 

conflict with the rule. 

The proposed rule does not duplicate, 

overlap, or conflict with any other 

Federal rules. As detailed in #2 above, 

language has been updated to comply 

with current FAR requirements, added 

where appropriate and necessary to 

supplement FAR, and removed where 

duplicative of FAR. 

6. Description of any significant 

alternatives to the rule which 

accomplish the stated objectives of 

applicable statutes and which minimize 

any significant economic impact of the 

rule on small entities. 

There are no viable alternatives. The 

rule is being amended to update the 

regulation to current FAR requirements 

and to delete outdated material so that 

the rule as a whole will be statutorily 

correct. As cited in paragraph 4 above, 

the economic burden on both large and 

small businesses will be decreased. 

Consideration was given to amending 

the HHSAR by prioritizing parts. It was 

determined that this would leave 

regulations in place that were outdated 

and inconsistent with FAR requirements 

governing one aspect of an acquisition, 

while another aspect would be done in 

accordance with updated regulation 

consistent with the FAR. The outdated 

and the updated regulation could be 

contradictory and certainly could result 

in acquisitions open to legal controversy 

leading not only to delays in 

acquisitions, but also improper 

acquisitions. This would be beneficial to 

neither the Government nor industry, 

including small businesses. Therefore, it 

is believed that the approach taken of 

amending of the HHSAR in whole is the 

most practical and benefits both 

Government and industry. 

The Department of HHS, Division of 

Acquisition (DA), will submit a copy of 

the Initial Regulatory Flexibility 

Analysis (IRFA) to the Chief Counsel for 

Advocacy of the Small Business 

Administration. A copy of the IRFA may 

be obtained from the DA. HHS invites 

comments from small business concerns 

and other interested parties on the 

expected impact of this rule on small 

entities. 

HHS will also consider comments 

from small entities concerning the 

existing regulations in subparts affected 

by this rule in accordance with 5 U.S.C. 

610. Interested parties must submit such 

comments separately and should cite 5 

U.S.C. 610 in correspondence. 

V. Paperwork Reduction Act 

A. The Paperwork Reduction Act (44 

U.S.C. chapter 35) applies. The 

proposed rule contains 6 information 

collection requirements. Accordingly, 

HHS has submitted requests for 

approval of the new information 

collection requirements concerning this 

rule to the Office of Management and 

Budget. The information collection 

requirements are discussed as follows: 

1. HHSAR 311.7101(a) 

(Responsibilities) and the clause at 

352.211–1 (Accessibility of meetings, 

conferences and seminars to persons 

with disabilities) require contractors to 

provide a plan describing the 

contractor’s ability to meet the 

accessibility standards in 28 CFR part 

36. 

HHSAR 311.7202(b) (Responsibilities) 

and the clause at 352.211–2 (Conference 

sponsorship request and conference 

materials disclaimer) require contractors 

to provide funding disclosure and a 

content disclaimer statement on 

conference materials. As a result of 

these clauses, HHS contractors 

providing conference, meeting, or 

seminars services are required to 

provide specific information to HHS. 

Public reporting burden for this 

collection of information is estimated to 

average 1 hour per response, including 


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the time for reviewing instructions, 

searching existing data sources, 

gathering and maintaining the data 

needed, and completing and reviewing 

the collection of information. 

The annual reporting burden is 

estimated as follows: 

Respondents: 1,157. 

Responses per respondent: 1. 

Total annual responses: 1,157. 

Preparation hours per response: 1 

hour. 

Total response burden hours: 1,157 

hours. 

Total annual cost of compliance: 

$47,668. 

2. HHSAR 311.7300 (Policy) and the 

clause at 352.211–3 (Paperwork 

Reduction Act) require contractors to 

not proceed with the collection of 

information on surveys, questionnaires, 

and other information requests until the 

contractor is provided an Office of 

Management and Budget (OMB) 

clearance from the contracting officer. 

Public reporting burden for this 

collection of information is estimated to 

average 2.2 hours per response, 

including the time for reviewing 

instructions, searching existing data 

sources, gathering and maintaining the 

data needed, and completing and 

reviewing the collection of information. 

The annual reporting burden is 

estimated as follows: 

Respondents: 20,088,262. 

Responses per respondent: 1. 

Total annual responses: 20,088,262. 

Preparation hours per response: 2.2. 

Total response burden hours: 

9,021,953. 

Total annual cost of compliance: 

$371,704,464. 

3. HHSAR 337.103(d)(3) (Contracting 

Officer Responsibility) and the clause at 

352.237–72 (Crime Control ActRequirement for Background Checks) 

require persons engaged in a covered 

profession or activity under an HHS 

contract or subcontract to report any 

suspected child abuse incident. The 

report requirement is provided by the 

Childhelp USA, National Child Abuse 

Hotline. 

Public reporting burden for this 

collection of information is estimated to 

average 1 hour per response, including 

the time for reviewing instructions, 

searching existing data sources, 

gathering and maintaining the data 

needed, and completing and reviewing 

the collection of information. 

The annual reporting burden is 

estimated as follows: 

Respondents: 40. 

Responses per respondent: 4. 

Total annual responses: 160. 

Preparation hours per response: 1. 

Total response burden hours: 160. 

Total annual cost of compliance: 

$6,592. 

4. HHSAR 337.103(d)(4) (Contracting 

Officer Responsibility) and the clause at 

352.237–73 (Indian Child Protection 

and Family Violence Act) require 

contractors to provide information for a 

background check. 

Public reporting burden for this 

collection of information is estimated to 

average 1 hour per response, including 

the time for reviewing instructions, 

searching existing data sources, 

gathering and maintaining the data 

needed, and completing and reviewing 

the collection of information. 

The annual reporting burden is 

estimated as follows: 

Respondents: 40. 

Responses per respondent: 4. 

Total annual responses: 160. 

Preparation hours per response: 1. 

Total response burden hours: 160. 

Total annual cost of compliance: 

$6,592. 

5 HHSAR 370.301 (Policy), the 

provision at 352.270–4a (Protection of 

Human Subjects), the clause at 352.270– 

4b (Protection of Human Subjects), the 

provision at 352.270–10 (Notice to 

Offerors—Protection of Human Subjects, 

Research Involving Human Subjects 

Committee (RIHSC) Approval of 

Research Protocols Required), and the 

clause at 352.270–11 (Protection of 

Human Subjects—Research Involving 

Human Subjects Committee (RIHSC) 

Approval of Research Protocols 

Required), require contractors to 

provide an acceptable federal-wide 

assurance to HHS when engaging in 

human subject research in performance 

of a contract. 

Public reporting burden for this 

collection of information is estimated to 

average .50 hours per response, 

including the time for reviewing 

instructions, searching existing data 

sources, gathering and maintaining the 

data needed, and completing and 

reviewing the collection of information. 

The annual reporting burden is 

estimated as follows: 

Respondents: 4,644. 

Responses per respondent: 1. 

Total annual responses: 4,644. 

Preparation hours per response: .50. 

Total response burden hours: 2,322. 

Total annual cost of compliance: 

$95,666. 

6. HHSAR 370.401 (Policy), the 

provision at 352.270–5a (Notice to 

Offerors of Requirement for Compliance 

with the Public Health Service Policy on 

Humane Care and Use of Laboratory 

Animals), and the clause at 352.270–5b 

(Care of Live Vertebrate Animals) 

require contractors to provide an 

acceptable animal welfare assurance. 

Public reporting burden for this 

collection of information is estimated to 

average 2.7 hours per response, 

including the time for reviewing 

instructions, searching existing data 

sources, gathering and maintaining the 

data needed, and completing and 

reviewing the collection of information. 

The annual reporting burden is 

estimated as follows: 

Respondents: 36. 

Responses per respondent: 4. 

Total annual responses: 41. 

Preparation hours per response: 2.7. 

Total response burden hours: 111. 

Total annual cost of compliance: 

$4,573. 

B. Public comment is sought 

regarding: Whether the proposed 

collections of information are necessary 

for the proper performance of the 

functions of the Agency, including 

whether the information shall have 

practical utility; the accuracy of the 

burden estimate; ways to enhance the 

quality, utility, and clarity of the 

information to be collected; and ways to 

minimize the burden of the collection of 

information, including through the use 

of automated collection techniques or 

other forms of information technology. 

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, email your request, 

including your address, phone number, 

and document identifier, to 

Information.collectionclearance@

hhs.gov. Written comments and 

recommendations for the proposed 

information collections must be directed 

to the Office of the Secretary, Paperwork 

Clearance Officer at the above email 

address within 60-days of this notice. 

Notwithstanding any other provision 

of the law, no person is required to 

respond to, nor shall any person be 

subject to a penalty for failure to comply 

with, a collection of information subject 

to the requirements of the Paperwork 

Reduction Act, unless that collection of 

information displays a currently valid 

OMB Control Number. 

List of Subjects in 48 CFR Parts 301 

Through 370 

Government procurement. 

Dated: February 10, 2015. 

Angela Billups, 

Associate Deputy Assistant Secretary for 

Acquisition. 

For the reasons stated in the 

preamble, HHS proposes revising 48 

CFR chapter 3, parts 301 through 370, 

as set forth below. 


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Title 48—Federal Acquisition 

Regulations System 

CHAPTER 3—HEALTH AND HUMAN 

SERVICES 

SUBCHAPTER A—GENERAL 

PART 301—HHS ACQUISITION 

REGULATION SYSTEM 

PART 302—DEFINITIONS OF WORDS AND 

TERMS 

PART 303—IMPROPER BUSINESS 

PRACTICES AND PERSONAL 

CONFLICTS OF INTEREST 

PART 304—ADMINISTRATIVE MATTERS 

SUBCHAPTER B—COMPETITION AND 

ACQUISITION PLANNING 

PART 305—PUBLICIZING CONTRACT 

ACTIONS 

PART 306—COMPETITION 

REQUIREMENTS 

PART 307—ACQUISITION PLANNING 

PART 308—REQUIRED SOURCES OF 

SUPPLIES AND SERVICES 

PART 309—CONTRACTOR 

QUALIFICATIONS 

PART 310—MARKET RESEARCH 

PART 311—DESCRIBING AGENCY NEEDS 

PART 312—ACQUISITION OF 

COMMERCIAL ITEMS 

SUBCHAPTER C—CONTRACTING 

METHODS AND CONTRACT TYPES 

PART 313—SIMPLIFIED ACQUISITION 

PROCEDURES 

PART 314—SEALED BIDDING 

PART 315—CONTRACTING BY 

NEGOTIATION 

PART 316—TYPES OF CONTRACTS 

PART 317—SPECIAL CONTRACTING 

METHODS 

SUBCHAPTER D—SOCIOECONOMIC 

PROGRAMS 

PART 319—SMALL BUSINESS PROGRAMS 

PART 322—APPLICATION OF LABOR 

LAWS TO GOVERNMENT 

ACQUISITIONS 

PART 323—ENVIRONMENT, ENERGY AND 

WATER EFFICIENCY, RENEWABLE 

ENERGY TECHNOLOGIES, 

OCCUPATIONAL SAFETY, AND DRUGFREE WORKPLACE 

PART 324—PROTECTION OF PRIVACY 

AND FREEDOM OF INFORMATION 

PART 326—OTHER SOCIOECONOMIC 

PROGRAMS 

SUBCHAPTER E—GENERAL 

CONTRACTING REQUIREMENTS 

PART 327—PATENTS, DATA, AND 

COPYRIGHTS 

PART 328—BONDS AND INSURANCE 

PART 330—COST ACCOUNTING 

STANDARDS 

PART 331—CONTRACT COST PRINCIPLES 

AND PROCEDURES 

PART 332—CONTRACT FINANCING 

PART 333—PROTESTS, DISPUTES, AND 

APPEALS 

SUBCHAPTER F—SPECIAL CATEGORIES 

OF CONTRACTING 

PART 334—MAJOR SYSTEM ACQUISITION 

PART 335—RESEARCH AND 

DEVELOPMENT CONTRACTING 

PART 336—CONSTRUCTION AND 

ARCHITECT–ENGINEER CONTRACTS 

PART 337—SERVICE CONTRACTING— 

GENERAL 

PART 339—ACQUISITION OF 

INFORMATION TECHNOLOGY 

SUBCHAPTER G—CONTRACT 

MANAGEMENT 

PART 342—CONTRACT ADMINISTRATION 

SUBCHAPTER H—CLAUSES AND FORMS 

PART 352—SOLICITATION PROVISIONS 

AND CONTRACT CLAUSES 

PART 353—FORMS 

SUBCHAPTERS I, J, K AND L

[RESERVED] 

SUBCHAPTER M—HHS 

SUPPLEMENTATIONS 

PART 370—SPECIAL PROGRAMS 

AFFECTING ACQUISITION 

SUBCHAPTER A—GENERAL 

PART 301—HHS ACQUISITION 

REGULATION SYSTEM 

Subpart 301.1 Purpose, Authority, and 

Issuance 

Sec. 

301.101 Purpose. 

301.103 Authority. 

301.106 Office of Management and Budget 

approval under the Paperwork Reduction 

Act. 

Subpart 301.2—[Reserved] 

Subpart 301.4—Deviations From the FAR 

301.401 Deviations. 

Subpart 301.6—Career Development, 

Contracting Authority, and Responsibilities 

301.602 Contracting Officers. 

301.602–3 Ratification of unauthorized 

commitments. 

301.603 Selection, appointment, and 

termination of appointment of contracting 

officers. 

301.603–1 General. 

Authority: 5 U.S.C. 301; 40 U.S.C. 

121(c)(2). 

Subpart 301.1—Purpose, Authority, 

and Issuance 

301.101 Purpose. 

(a) The Department of Health and 

Human Services (HHS) Acquisition 

Regulation (HHSAR) establishes 

uniform HHS acquisition policies and 

procedures that implement and 

supplement the Federal Acquisition 

Regulation (FAR). 

(b)(1) The HHSAR contains HHS 

policies that govern the acquisition 

process or otherwise control acquisition 

relationships between HHS’ contracting 

activities and contractors. The HHSAR 

contains— 

(i) Requirements of law; 

(ii) HHS-wide policies; 

(iii) Deviations from FAR 

requirements; and 

(iv) Policies that have a significant 

effect beyond the internal procedures of 

HHS or a significant cost or 

administrative impact on contractors or 

offerors. 

(2) Relevant internal procedures, 

guidance, and information not meeting 

the criteria in paragraph (b)(1) of this 

section are issued by HHS in other 

announcements, internal procedures, 

guidance, or information. 

301.103 Authority. 

(b) The Assistant Secretary for 

Financial Resources (ASFR) prescribes 

the HHSAR under the authority of 5 

U.S.C. 301 and section 205(c) of the 

Federal Property and Administrative 

Services Act of 1949, as amended (40 

U.S.C. 121(c)(2)), as delegated by the 

Secretary). 

(c) The HHSAR is issued in the Code 

of Federal Regulations (CFR) as chapter 

3 of title 48, Department of Health and 

Human Services Acquisition Regulation. 

It may be referenced as ‘‘48 CFR chapter 

3.’’ 

301.106 Office of Management and Budget 

approval under the Paperwork Reduction 

Act. 

(a) The Paperwork Reduction Act of 

1980 (44 U.S.C 3501 et seq.) imposes a 

requirement on Federal agencies to 

obtain approval from the Office of 

Management and Budget (OMB) before 

collecting the same information from 10 

or more members of the public. 

(b) The following OMB control 

numbers apply to the information 

collection and recordkeeping 

requirements contained in this chapter: 

HHSAR Segment OMB Control 

No. 

311.7101(a) ............................ TBD 

311.7300 ................................ TBD 

327.404–70(c) ........................ TBD 

337.103(d)(3) ......................... TBD 

337.103(d)(4) ......................... TBD 

370.301 .................................. TBD 

370.401 .................................. TBD 

352.211–1 .............................. TBD 

352.211–3 .............................. TBD 

352.227–71 ............................ TBD 

352.237–72 ............................ TBD 

352.237–73 ............................ TBD 

352.270–4a ............................ TBD 

352.270–4b ............................ TBD 

352.270–10 ............................ TBD 

352.270–11 ............................ TBD 

352.270–5a ............................ TBD 

352.270–5b ............................ TBD 


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Subpart 301.2—[Reserved] 

Subpart 301.4—Deviations from the 

FAR 

301.401 Deviations. 

Contracting officers are not permitted 

to deviate from the FAR or HHSAR 

without seeking proper approval. With 

full acknowledgement of FAR 1.102(d) 

regarding innovative approaches, any 

deviation to FAR or the HHSAR requires 

approval by the Senior Procurement 

Executive (SPE). 

Subpart 301.6—Career Development, 

Contracting Authority, and 

Responsibilities 

301.602 Contracting Officers. 

301.602–3 Ratification of unauthorized 

commitments. 

(b) Policy. (1) The Government is not 

bound by agreements with, or 

contractual commitments made to, 

prospective contractors by individuals 

who do not have delegated contracting 

authority. Unauthorized commitments 

do not follow the appropriate process 

for the expenditure of Government 

funds. Consequently, the Government 

may not be able to ratify certain actions, 

putting a contractor at risk for taking 

direction from a Federal official other 

than the contracting officer. See FAR 

1.602–1. Government employees 

responsible for unauthorized 

commitments are subject to disciplinary 

action. Contractors perform at their own 

risk when accepting direction from 

unauthorized officials. Failure to follow 

statutory and regulatory processes for 

the expenditure of Government funds is 

a very serious matter. 

(2) The head of the contracting 

activity (HCA) is the official authorized 

to ratify an unauthorized commitment. 

No other re-delegations are authorized. 

(c) Limitations. (5) The HCA shall 

coordinate the request for ratification 

with the Office of General Counsel, 

General Law Division and submit a copy 

to the Department SPE. 

301.603 Selection, appointment, and 

termination of appointment of contracting 

officers. 

301.603–1 General. 

(a) The Agency head has delegated 

broad authority to the Chief Acquisition 

Officer, who in turn has further 

delegated this authority to the SPE. The 

SPE has further delegated specific 

acquisition authority to the Operating 

and Staff Division heads and the HCAs. 

The HCA (non-delegable) shall select, 

appoint, and terminate the appointment 

of contracting officers. 

(b) To ensure proper control of 

redelegated acquisition authorities, 

HCAs shall maintain a file containing 

successive delegations of HCA authority 

through the contracting officer level. 

PART 302—DEFINITIONS OF WORDS 

AND TERMS 

Subpart 302.1—Definitions 

Sec. 

302.101 Definitions. 

Authority: 5 U.S.C. 301; 40 U.S.C. 

121(c)(2). 

Subpart 302.1—Definitions 

302.101 Definitions. 

(a) Agency head or head of the 

agency, unless otherwise stated, means 

the head of the Staff Division 

(STAFFDIV) or Operating Division 

(OPDIV). 

(b) Contracting Officer’s 

Representative (COR) is a Federal 

employee designated in writing by a 

contracting officer to act as the 

contracting officer’s representative in 

monitoring and administering specified 

aspects of contractor performance after 

award of a contract or order. In 

accordance with local procedures, 

STAFFDIV or OPDIVs may designate 

CORs for firm fixed-price contracts or 

orders. COR’s responsibilities may 

include verifying that: 

(1) The contractor’s performance 

meets the standards set forth in the 

contract or order; 

(2) The contractor meets the contract 

or order’s technical requirements by the 

specified delivery date(s) or within the 

period of performance; and 

(3) The contractor performs within 

cost ceiling stated in the contract or 

order. CORs must meet the training and 

certification requirements specified in 

301.604. 

(c) Head of the Contracting Activity 

(HCA) is an official having overall 

responsibility for managing a 

contracting activity—i.e., the 

organization within a STAFFDIV or 

OPDIV or other HHS organization which 

has been delegated broad authority 

regarding the conduct of acquisition 

functions. 

PART 303—IMPROPER BUSINESS 

PRACTICES AND PERSONAL 

CONFLICTS OF INTEREST 

Subpart 303.1—Safeguards 

Sec. 

303.101 Standards of conduct. 

303.101–3 Agency regulations. 

303.104–7 Violations or possible violations 

of the Procurement Integrity Act. 

Subpart 303.2—Contractor Gratuities to 

Government Personnel 

303.203 Reporting suspected violations of 

the Gratuities clause. 

Subpart 303.6—Contracts With Government 

Employees or Organizations Owned or 

Controlled by Them 

303.602 Exceptions. 

Subpart 303.7—Voiding and Rescinding 

Contracts 

303.704 Policy. 

Subpart 303.8—Limitation on the Payment 

of Funds to Influence Federal Transactions 

303.808–70 Solicitation provision and 

contract clause. 

Subpart 303.10—Contractor Code of 

Business Ethics and Conduct 

303.1003 Requirements. 

Authority: 5 U.S.C. 301; 40 U.S.C. 

121(c)(2). 

Subpart 303.1—Safeguards 

303.101 Standards of conduct. 

303.101–3 Agency regulations. 

(a)(3) The HHS Standards of Conduct 

are prescribed in 45 CFR part 73. 

303.104–7 Violations or possible 

violations of the Procurement Integrity Act. 

(a)(1) The contracting officer shall 

submit to the head of the contracting 

activity (HCA) for review and 

concurrence the determination (along 

with supporting documentation) that a 

reported violation or possible violation 

of the statutory prohibitions has no 

impact on the pending award or 

selection of a contractor for award. 

(2) The contracting officer shall refer 

the determination that a reported 

violation or possible violation of the 

statutory prohibitions has an impact on 

the pending award or selection of a 

contractor, along with all related 

information available, to the HCA. The 

HCA shall— 

(i) Refer the matter immediately to the 

Associate Deputy Assistant Secretary 

(DAS) for Acquisition for review, who 

may consult with the appropriate legal 

office representative and the Office of 

Inspector General as appropriate; and 

(ii) Determine the necessary action in 

accordance with FAR 3.104–7(c) and 

(d). The HCA shall obtain the approval 

or concurrence of the Associate DAS for 

Acquisition before proceeding with an 

action. 

(b) The HCA (non-delegable) shall act 

with respect to actions taken under the 

Federal Acquisition Regulation (FAR) 

clause at 52.203–10, Price or Fee 

Adjustment for Illegal or Improper 

Authority. 


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Subpart 303.2—Contractor Gratuities 

to Government Personnel 

303.203 Reporting suspected violations of 

the Gratuities clause. 

HHS personnel shall report suspected 

violations of the clause at FAR 52.203– 

3, Gratuities, to the Contracting Officer, 

who will in turn report the matter to the 

OGC Ethics Division for disposition. 

Subpart 303.6—Contracts With 

Government Employees or 

Organizations Owned or Controlled by 

Them 

303.602 Exceptions. 

The HCA (non-delegable) is the 

official authorized to approve an 

exception to the policy stated in FAR 

3.601. 

Subpart 303.7—Voiding and 

Rescinding Contracts 

303.704 Policy. 

(a) For purposes of implementing FAR 

subpart 3.7, the HCA (non-delegable) 

shall exercise the authorities granted to 

the ‘‘agency head or designee.’’ 

Subpart 303.8—Limitation on the 

Payment of Funds to Influence Federal 

Transactions 

303.808–70 Solicitation provision and 

contract clause. 

The contracting officer shall insert the 

clause at 352.203–70, Anti-lobbying, in 

solicitations and contracts that exceed 

the simplified acquisition threshold. 

Subpart 303.10—Contractor Code of 

Business Ethics and Conduct 

303.1003 Requirements. 

(b) The contracting officer, when 

notified of a possible contractor 

violation, in accordance with FAR 

3.1003(b), shall notify the Office of 

Inspector General and the HCA. 

(c)(2) The contracting officer shall 

specify the title of HHS’ OIG hotline 

poster and the Web site where the 

poster can be obtained in paragraph 

(b)(3) of the clause at FAR 52.203–14. 

PART 304—ADMINISTRATIVE 

MATTERS 

Subpart 304.6—Contract Reporting 

Sec. 

304.602 General. 

304.604 Responsibilities. 

Subpart 304.13—Personal Identity 

Verification 

304.1300 Policy. 

Subpart 304.16 Unique Procurement 

Instrument Identifiers 

304.1600 Scope of subpart. 

Subpart 304.70—[Reserved] 

Subpart 304.71—Review and Approval of 

Proposed Contract Actions 

304.7100 Policy. 

Subpart 304.72 Affordable Care Act 

Prevention and Public Health Fund— 

Reporting Requirements 

Sec. 

304.7200 Scope of subpart. 

304.7201 Procedures. 

304.7202 Contract clause. 

Authority: 5 U.S.C. 301; 40 U.S.C. 

121(c)(2). 

Subpart 304.6—Contract Reporting 

304.602 General. 

Follow internal department 

procedures for reporting information to 

the Federal Procurement Data System 

(FPDS) and for resolving technical or 

policy issues relating to FPDS contract 

reporting. 

304.604 Responsibilities. 

The Department of Health and Human 

Services (HHS) acquisition officials and 

staff shall report their contract 

information in FPDS accurately and 

timely. 

Subpart 304.13—Personal Identity 

Verification 

304.1300 Policy. 

To ensure compliance with Homeland 

Security Presidential Directive-12: 

Policy for a Common Identification 

Standard for Federal Employees and 

Contractors (HSPD–12) and the 

Presidential Cross Agency Priority for 

strong authentication, contracting 

officers shall provide in each 

acquisition those HSPD–12 

requirements necessary for contract 

performance. 

Subpart 304.16—Unique Procurement 

Instrument Identifiers 

304.1600 Scope of subpart. 

This subpart provides guidance for 

assigning identification numbers to 

solicitation or contract actions. The 

Senior Procurement Executive shall be 

responsible for establishing a numbering 

system within the department that 

conforms to Federal Acquisition 

Regulation subpart 4.16. 

Subpart 304.70—[Reserved] 

Subpart 304.71—Review and Approval 

of Proposed Contract Actions 

304.7100 Policy. 

In accordance with internal Operating 

Division or Staff Division policy the 

head of the contracting activity (nondelegable) shall establish review and 

approval procedures for proposed 

contract actions to ensure that— 

(a) Contractual documents are in 

conformance with law, established 

policies and procedures, and sound 

business practices; 

(b) Contract actions properly reflect 

the mutual understanding of the parties; 

and 

(c) The contracting officer is informed 

of deficiencies and items of 

questionable acceptability, and takes 

corrective action. 

Subpart 304.72—Affordable Care Act 

Prevention and Public Health Fund— 

Reporting Requirements 

304.7200 Scope of subpart. 

This subpart implements Section 220 

of Pub. L. 112–74, FY 2012 Labor, HHS 

and Education Appropriations Act, 

which requires, semi-annual reporting 

on the use of funds from the Prevention 

and Public Health Fund (PPHF), Pub. L. 

111–148, sec. 4002. Contractors that 

receive awards (or modifications to 

existing awards) with a value of $25,000 

or more funded, in whole or in part, 

from the Prevention and Public Health 

Fund, shall report information specified 

in the clause at 352.204–70, including, 

but not limited to— 

(a) The dollar amount of contractor 

invoices; 

(b) The supplies delivered and 

services performed; and 

(c) Specific information on 

subcontracts with a value of $25,000 or 

more. 

304.7201 Procedures. 

(a) In any contract action funded in 

whole or in part by the PPHF, the 

contracting officer shall indicate that the 

contract action is being made under the 

PPHF, and indicate which products or 

services are funded under the PPHF. 

This requirement applies whenever 

PPHF funds are used, regardless of the 

contract instrument. 

(b) To maximize transparency of 

PPHF funds that shall be reported by the 

contractor, the contracting officer shall 

structure contract awards to allow for 

separately tracking PPHF funds. For 

example, the contracting officer may 

consider awarding dedicated separate 

contracts when using PPHF funds or 

establishing contract line item number 

structures to prevent commingling of 

PPHF funds with other funds. 

(c) Contracting officers shall ensure 

that the contractor complies with the 

reporting requirements of 352.204–70, 

Prevention and Public Health Fund— 

Reporting Requirements. Upon receipt 

of each report, the contracting officer 

shall review it for completeness, address 


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any clarity or completeness issues with 

the contractor, and submit the final 

approved report in Section 508 

compliant format to an Assistant 

Secretary for Public Affairs point-ofcontact for posting on HHS’ PPHF Web 

site at http://www.hhs.gov/open/

recordsandreports/prevention/

index.html no later than 30 days after 

the end of the reporting period. If the 

contractor fails to comply with the 

reporting requirements, the contracting 

officer shall exercise appropriate 

contractual remedies. 

(d) The contracting officer shall make 

the contractor’s failure to comply with 

the reporting requirements a part of the 

contractor’s performance information 

under FAR subpart 42.15. 

304.7202 Contract clause. 

Insert the clause at 352.204–70, 

Prevention and Public Health Fund— 

Reporting Requirements, in all 

solicitations and contract actions 

funded in whole or in part with PPHF 

funds, except classified solicitations and 

contracts. This includes, but is not 

limited to, awarding or modifying 

orders against existing or new contracts 

issued under FAR subparts 8.4 and 16.5 

that will be funded with PPHF funds. 

Contracting officers shall include this 

clause in any existing contract or order 

that will be funded with PPHF funds. 

This clause is not required for any 

contract or order which contains a prior 

version of the clause at 352.204–70. 

SUBCHAPTER B—COMPETITION AND 

ACQUISITION PLANNING 

PART 305—PUBLICIZING CONTRACT 

ACTIONS 

Subpart 305.3—Synopses of Contract 

Awards 

Sec. 

305.303 Announcement of contract awards. 

Subpart 305.5—Paid Advertisements 

305.502 Authority. 

Subpart 305.70—Publicizing Requirements 

Funded From the Affordable Care Act 

Prevention and Public Health Fund 

305.7001 Scope. 

305.7002 Applicability. 

305.7003 Publicizing preaward. 

305.7004 Publicizing postaward. 

Authority: 5 U.S.C. 301; 40 U.S.C. 

121(c)(2). 

Subpart 305.3—Synopses of Contract 

Awards 

305.303 Announcement of contract 

awards. 

(a) Public announcement. The 

contracting officer shall report awards, 

not exempt under Federal Acquisition 

Regulation (FAR) 5.303, to the Office of 

the Assistant Secretary for Legislation 

(Congressional Liaison Office.) 

Subpart 305.5—Paid Advertisements 

305.502 Authority. 

Written approval at least one level 

above the contracting officer shall be 

obtained prior to placing advertisements 

or notices in newspapers. 

Subpart 305.70—Publicizing 

Requirements Funded From the 

Affordable Care Act Prevention and 

Public Health Fund 

305.7001 Scope. 

Pursuant to appropriations acts, this 

subpart prescribes requirements for 

posting presolicitation and award 

notices for actions funded in whole or 

in part from the Prevention and Public 

Health Fund (PPHF). The requirements 

of this subpart enhance transparency to 

the public. 

305.7002 Applicability. 

This subpart applies to all actions 

funded in whole or in part by the PPHF. 

305.7003 Publicizing preaward. 

Notices of all proposed contract 

actions, funded in whole or in part by 

the PPHF, shall be identified on HHS’ 

Prevention and Public Health Fund Web 

site at http://www.hhs.gov/open/

recordsandreports/prevention/

index.html no later than 1 day after 

issuance of the solicitation or other 

request for proposal or quotation 

document. When applicable, the notice 

shall provide a link to the full text; for 

example, a link to the FedBizOpps 

notice required by FAR 5.201. 

305.7004 Publicizing postaward. 

Notices of contract actions exceeding 

$25,000, funded in whole or in part by 

the PPHF, shall be identified on HHS’ 

PPHF Web site at http://www.hhs.gov/

open/recordsandreports/prevention/

index.html no later than 5 days after the 

contract action occurs. 

PART 306—COMPETITION 

REQUIREMENTS 

Subpart 306.2—Full and Open Competition 

After Exclusion of Sources 

Sec. 

306.202 Establishing or maintaining 

alternative sources. 

Subpart 306.3—Other Than Full and Open 

Competition 

306.302 Circumstances permitting other 

than full and open competition. 

306.302–1 Only one responsible source and 

no other supplies or services will satisfy 

agency requirements. 

306.302–7 Public interest. 

Subpart 306.5—Competition Advocates 

306.501 Requirement. 

Authority: 5 U.S.C. 301; 40 U.S.C. 

121(c)(2). 

Subpart 306.2—Full and Open 

Competition after Exclusion of 

Sources 

306.202 Establishing or maintaining 

alternative sources. 

(a) The reference to the ‘‘agency head’’ 

in FAR 6.202(a) shall mean the 

Department Competition Advocate (CA). 

(b)(1) The contracting officer shall 

prepare the required determination and 

findings (D&F). See FAR 6.202(b)(1) 

based on the data provided by program 

personnel. The appropriate CA (nondelegable) shall sign the D&F. 

Subpart 306.3—Other Than Full and 

Open Competition 

306.302 Circumstances permitting other 

than full and open competition. 

306.302–1 Only one responsible source 

and no other supplies or services will 

satisfy agency requirements. See FAR 

6.302–1. 

For acquisitions covered by 42 U.S.C. 

247d–6a(b)(2)(A), ‘‘available from only 

one responsible source’’ shall be 

deemed to mean ‘‘available from only 

one responsible source or only from a 

limited number of responsible sources’’. 

306.302–7 Public interest. 

(a) Authority. (2) Agency head, in this 

instance, means the Secretary. 

(c) Limitations. The contracting officer 

shall prepare a written request for 

approval and provide it through 

appropriate acquisition channels, 

including the head of the contracting 

activity and Associate Deputy Assistant 

Secretary for Acquisition, to the 

Secretary. The request shall include a 

D&F for the Secretary’s signature that 

contains all pertinent information to 

support the justification for using the 

authority in 41 U.S.C. 3304(a)(7), and a 

letter for the Secretary’s signature 

notifying Congress of the determination 

to award a contract under that authority. 

Subpart 306.5—Competition 

Advocates 

306.501 Requirement. 

The Department Competition 

Advocate for Health and Human 

Services (HHS) is located in the 

Division of Acquisition. 

PART 307—ACQUISITION PLANNING 

Sec. 

307.105 Contents of written acquisition 

plans. 


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Authority: 5 U.S.C. 301; 40 U.S.C. 

121(c)(2). 

307.105 Contents of written acquisition 

plans. 

Federal Acquisition Regulation 7.105 

specifies the content requirements for a 

written Acquisition Plan (AP). The 

Department of Health and Human 

Services requires a written AP for all 

acquisitions above the simplified 

acquisition threshold. 

PART 308—REQUIRED SOURCES OF 

SUPPLIES AND SERVICES 

Subpart 308.4—Federal Supply Schedules 

Sec. 

308.405–6 Limited source justification and 

approval. 

Subpart 308.8—Acquisition of Printing and 

Related Supplies 

308.800 Scope of subpart. 

308.801 Definitions. 

308.802 Policy. 

Authority: 5 U.S.C. 301; 40 U.S.C. 

121(c)(2). 

Subpart 308.4—Federal Supply 

Schedules 

308.405–6 Limited source justification and 

approval. 

(d)(1) As required by Federal 

Acquisition Regulation (FAR) 8.405–1 

or 8.405–2, the responsible program 

office must provide a written 

justification whenever it requests an 

acquisition under the Federal Supply 

Service program that restricts 

consideration of the number of schedule 

contractors or to an item peculiar to one 

manufacturer. 

Subpart 308.8—Acquisition of Printing 

and Related Supplies 

308.800 Scope of subpart. 

This subpart provides the Department 

of Health and Human Services (HHS) 

policy for the acquisition of Government 

printing and related supplies. The HHS 

Office of the Assistant Secretary for 

Public Affairs is responsible for the 

review and clearance of print and 

electronic publications, printing and 

related supplies, audiovisual products, 

and communication service contracts. 

See FAR 8.802 for exceptions. 

308.801 Definitions. 

The terms ‘‘printing’’ and 

‘‘duplicating/copying’’ are defined in 

the Government Printing and Binding 

Regulations of the Joint Committee on 

Printing. The regulations are available at 

http://www.gpo.gov. 

308.802 Policy. 

In accordance with FAR 8.802(b), the 

Central Printing and Publications 

Management Organization at Program 

Support Center is the HHS designated 

central printing authority. 

308.803 Solicitation provision and 

contract clause. 

The contracting officer shall insert the 

clause at 352.208–70, Printing and 

Duplication, in all solicitations, 

contracts, and orders over the simplified 

acquisition threshold, unless printing or 

increased duplication is authorized by 

statute. 

PART 309—CONTRACTOR 

QUALIFICATIONS 

Subpart 309.4—Debarment, Suspension, 

and Ineligibility 

Sec. 

309.403 Definitions. 

309.404 System for Award Management 

(SAM) exclusions. 

309.405 Effect of listing (compelling reason 

determinations). 

309.406 Debarment. 

309.406–3 Procedures. 

309.407 Suspension. 

309.407–3 Procedures. 

309.470 Reporting of suspected causes for 

debarment or suspension or the taking of 

evasive actions. 

309.470–1 Situations where reports are 

required. 

Authority: 5 U.S.C. 301; 40 U.S.C. 

121(c)(2). 

Subpart 309.4—Debarment, 

Suspension, and Ineligibility 

309.403 Definitions. 

The following definitions apply to 

this subpart: 

Acquiring agency’s head or designee, 

as used in this subpart is the head of the 

contracting activity (HCA). The HCA 

may make the required justifications or 

determinations and take the necessary 

actions specified in FAR 9.405, 9.406, 

and 9.407, only after obtaining the 

written approval of the Suspension or 

Debarment Official, as appropriate. 

Suspension and Debarment Official 

means the Deputy Assistant Secretary 

for Grants and Acquisition Policy and 

Accountability. 

309.404 System for Award Management 

(SAM) exclusions. 

(c) For actions made by HHS pursuant 

to FAR 9.406 and 9.407, the Office of 

Recipient Integrity Coordination shall 

perform the actions required by FAR 

9.404(c). 

309.405 Effect of listing (compelling 

reason determinations). 

(a) The HCA (non-delegable) may, 

with the written concurrence of the 

Suspension and Debarment Official, 

make the determinations referenced in 

FAR 9.405(a) regarding contracts. 

(1) If a contracting officer considers it 

necessary to award a contract, or 

consent to a subcontract with a debarred 

or suspended contractor, the contracting 

officer shall prepare a determination, 

including all pertinent documentation, 

and submit it through appropriate 

acquisition channels to the HCA. The 

documentation shall include the date by 

which approval is required and a 

compelling reason for the proposed 

action. Compelling reasons for award of 

a contract or consent to a subcontract 

with a debarred or suspended contractor 

include the following: 

(i) Only the cited contractor can 

provide the property or services, and 

(ii) The urgency of the requirement 

dictates that HHS conduct business with 

the cited contractor. 

(2) If the HCA decides to approve the 

requested action, the HCA shall request 

the concurrence of the Suspension and 

Debarment Official and, if given, shall 

inform the contracting officer in writing 

of the determination within the required 

time period. 

309.406 Debarment. 

309.406–3 Procedures. 

Refer all matters appropriate for 

consideration by an agency Suspension 

and Debarment Official as soon as 

practicable to the appropriate 

Suspension and Debarment Official 

identified in 309.403. Any person may 

refer a matter to the Suspension and 

Debarment Official. 

309.407 Suspension. 

309.407–3 Procedures. 

Refer all matters appropriate for 

consideration by an agency Suspension 

and Debarment Official as soon as 

practicable to the appropriate 

Suspension and Debarment Official 

identified in 309.403. Any person may 

refer a matter to the Suspension and 

Debarment Official. 

309.470 Reporting of suspected causes 

for debarment or suspension or the taking 

of evasive actions. 

309.470–1 Situations where reports are 

required. 

The contracting officer shall report to 

the HCA and the Associate Deputy 

Assistant Secretary for Acquisition 

whenever the contracting officer— 

(a) Knows or suspects that a 

contractor is committing or has 

committed any of the acts described in 

FAR 9.406–2 or 9.407–2; or 

(b) Suspects a contractor is attempting 

to evade the prohibitions of debarment 

or suspension imposed under FAR 

9.405, or any other comparable 

regulation, by changes of address, 


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multiple addresses, formation of new 

companies, or by other devices. 

PART 310—MARKET RESEARCH 

Sec. 

310.001 Policy. 

Authority: 5 U.S.C. 301; 40 U.S.C. 

121(c)(2). 

310.001 Policy. 

The HHS contracting offices shall 

conduct market research as prescribed 

in Federal Acquisition Regulation part 

10. 

PART 311—DESCRIBING AGENCY 

NEEDS 

Subpart 311.70—Section 508 Accessibility 

Standards 

Sec. 

311.7000 Defining electronic information 

technology Requirements (see part 339). 

Subpart 311.71—Accessibility of Meetings, 

Conferences, and Seminars to Persons with 

Disabilities 

311.7100 Policy. 

311.7101 Responsibilities. 

311.7102 Contract clause. 

Subpart 311.72—Conference Funding and 

Sponsorship 

311.7200 Policy. 

311.7201 Funding and sponsorship. 

311.7202 Contract clause. 

Subpart 311.73—Contractor Collection of 

Information 

311.7300 Policy. 

311.7301 Contract clause. 

Authority: 5 U.S.C. 301; 40 U.S.C. 

121(c)(2). 

Subpart 311.70—Section 508 

Accessibility Standards 

311.7000 Defining electronic and 

information technology requirements (see 

part 339). 

The contracting officer shall ensure 

that requiring activities specify agency 

needs for electronic and information 

technology (EIT) supplies and services, 

and document market research 

document EIT requirements, and 

identify the applicable Section 508 

accessibility standards. See FAR 

11.002(f) and subpart 39.2. 

Subpart 311.71—Accessibility of 

Meetings, Conferences, and Seminars 

to Persons with Disabilities 

311.7100 Policy. 

(a) It is HHS policy that all meetings, 

conferences, and seminars be accessible 

to persons with disabilities. For the 

purpose of this policy, accessibility is 

defined as both physical access to 

meeting, conference, and seminar sites, 

and access to aids and services enabling 

individuals with sensory disabilities to 

fully participate in meetings, 

conferences, and seminars. 

(b) This policy applies to all contracts 

requiring contractors to conduct 

meetings, conferences, or seminars open 

to the public or involving HHS 

personnel, but not ad hoc meetings 

necessary or incidental to contract 

performance. 

311.7101 Responsibilities. 

(a) The contractor shall submit a plan 

assuring that any meeting, conference, 

or seminar held will meet or exceed the 

minimum accessibility standards set 

forth in 28 CFR part 36. 

(b) The contracting officer 

representative (COR) shall obtain, 

review, and approve the contractor’s 

plan submitted in response to paragraph 

(a) of the contract clause at 352.211–1, 

Accessibility of Meetings, Conferences, 

and Seminars to Persons with 

Disabilities; a consolidated or master 

plan for contracts requiring numerous 

meetings, conferences, or seminars is 

acceptable. Prior to approving the plan, 

the COR shall consult with the 

operating division (OPDIV) or other 

designated organization responsible for 

monitoring compliance with the 

Architectural Barriers Act of 1968 and 

the Americans with Disabilities Act of 

1990, to ensure that the contractor’s 

plan meets the accessibility 

requirements of the contract clause. The 

COR shall request the responsible 

organization review and determine the 

adequacy of the contractor’s plan, and 

respond to the COR, in writing, within 

10 working days of receiving the 

request. 

311.7102 Contract clause. 

The contracting officer shall insert the 

clause at 352.211–1, Accessibility of 

Meetings, Conferences, and Seminars to 

Persons with Disabilities, in 

solicitations, contracts, and orders 

requiring the contractor to conduct 

meetings, conferences, or seminars in 

accordance with 311.7100(b). 

Subpart 311.72—Conference Funding 

and Sponsorship 

311.7200 Policy. 

HHS policy requires that all 

conferences the agency funds or 

sponsors shall: be consistent with HHS 

missions, objectives, and policies; 

represent an efficient and effective use 

of taxpayer funds; and withstand public 

scrutiny. 

311.7201 Funding and sponsorship. 

Funding a conference through a HHS 

contract does not automatically imply 

HHS sponsorship, unless the conference 

is funded entirely by the agency. Also, 

HHS staff attendance or participation at 

a conference does not imply HHS 

conference sponsorship. Accordingly, 

for non-conference contracts funded 

entirely by HHS prior to a contractor 

claiming HHS sponsorship, the 

contractor must provide the contracting 

officer a written request for permission 

to designate HHS the conference 

sponsor. The OPDIV or STAFFDIV 

(operating division or staff division) 

head, or designee, shall approve such 

requests. The determination on what 

constitutes a ‘‘conference contract’’ or a 

‘‘non-conference contract’’ shall be 

made by the contracting officer. 

311.7202 Contract clause. 

To ensure that a contractor: 

(a) Properly requests approval to 

designate HHS the conference sponsor, 

where HHS is not the sole provider of 

conference funding; and 

(b) Includes an appropriate Federal 

funding disclosure and content 

disclaimer statement for conference 

materials, the contracting officer shall 

include the clause at 352.211–2, 

Conference Sponsorship Request and 

Conference Materials Disclaimer, in 

solicitations, contracts, and orders 

providing funding which partially or 

fully supports a conference. 

Subpart 311.73—Contractor Collection 

of Information 

311.7300 Policy. 

In accordance with the Paperwork 

Reduction Act (PRA), contractors shall 

not proceed with collecting information 

from surveys, questionnaires, or 

interviews until the COR obtains an 

Office of Management and Budget 

clearance and the contracting officer 

issues written approval to proceed. For 

any contract involving a requirement 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 

scope of their employment, for use by 

the Federal government or disclosure to 

third parties, the contracting officer 

must comply with the PRA of 1995 (44 

U.S.C. 3501 et seq.). 

311.7301 Contract clause. 

The contracting officer shall insert the 

clause at 352.211–3, Paperwork 

Reduction Act, in solicitations, 

contracts, and orders that require a 

contractor to collect the same 

information from 10 or more persons. 


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PART 312—ACQUISITION OF 

COMMERCIAL ITEMS 

Subpart 312.1—Acquisition of Commercial 

Items—General 

Sec. 

312.101 Policy. 

Subpart 312.2—Special Requirements for 

the Acquisition of Commercial Items 

312.202(d) Market research and 

description of agency need. 

Authority: 5 U.S.C. 301; 40 U.S.C. 

121(c)(2). 

Subpart 312.1—Acquisition of 

Commercial Items—General 

312.101 Policy. 

Contracting offices shall use the HHS 

Strategic Sourcing Program to the 

maximum extent possible. See HHSAR 

part 307 (Acquisition Planning). 

Subpart 312.2—Special Requirements 

for the Acquisition of Commercial 

Items 

312.202(d) Market research and 

description of agency need. 

Whenever a requiring activity 

specifies electronic and information 

technology (EIT) supplies and services 

subject to Section 508 of the 

Rehabilitation Act of 1973, as amended, 

the requiring activity shall acquire 

commercially available supplies and 

services to the maximum extent possible 

while ensuring Section 508 compliance. 

See part 339. 

SUBCHAPTER C—CONTRACTING 

METHODS AND CONTRACT TYPES 

PART 313—SIMPLIFIED ACQUISITION 

PROCEDURES 

Sec. 

313.003 Policy. 

Subpart 313.3—Simplified Acquisition 

Methods 

313.301 Government-wide commercial 

purchase card. 

Authority: 5 U.S.C. 301; 40 U.S.C. 

121(c)(2). 

313.003 Policy. 

Electronic and information 

technology (EIT) supplies and services 

acquired pursuant to Federal 

Acquisition Regulation part 13 shall 

comply with Section 508 of the 

Rehabilitation Act of 1973, as amended. 

See part 339. 

Subpart 313.3—Simplified Acquisition 

Methods 

313.301 Government-wide commercial 

purchase card. 

(b) Make all HHS transactions 

utilizing the Government-wide 

commercial purchase card in 

accordance with the HHS Purchase Card 

Program. 

PART 314—SEALED BIDDING 

Subpart 314.1—Use of Sealed Bidding 

Sec. 

314.103 Policy. 

Subpart 314.4—Opening of Bids and Award 

of Contract 

314.404 Rejection of bids. 

314.404–1 Cancellation of invitations after 

opening. 

314.407 Mistakes in bids. 

314.407–3 Other mistakes disclosed before 

award. 

314.407–4 Mistakes after award. 

Authority: 5 U.S.C. 301; 40 U.S.C. 

121(c)(2). 

Subpart 314.1—Use of Sealed Bidding 

314.103 Policy. 

Electronic and information 

technology (EIT) supplies and services 

acquired using sealed-bid procedures 

shall comply with Section 508 of the 

Rehabilitation Act of 1973, as amended. 

See part 339. 

Subpart 314.4—Opening of Bids and 

Award of Contract 

314.404 Rejection of bids. 

314.404–1 Cancellation of invitations after 

opening. 

(c) The head of the contracting 

activity (HCA) shall make the agency 

head determinations specified in FAR 

14.404–1. 

314.407 Mistakes in bids. 

314.407–3 Other mistakes disclosed 

before award. 

(e) The HCA has the authority to make 

determinations under paragraphs (a), 

(b), (c), and (d) of FAR 14.407–3. 

314.407–4 Mistakes after award. 

(c) The HCA has the authority to make 

administrative determinations in 

connection with alleged post-award 

mistakes. 

PART 315—CONTRACTING BY 

NEGOTIATION 

Subpart 315.2—Solicitation and Receipt of 

Proposals and Information 

Sec. 

315.204–5 Part IV—Representations and 

instructions. 

315.208 Submission, modification, 

revision, and withdrawal of proposals. 

Subpart 315.3—Source Selection 

315.303–70 Policy. 

315.304 Evaluation factors and significant 

subfactors. 

315.305 Proposal evaluation. 

Subpart 315.4—Contract Pricing 

315.404 Proposal analysis. 

315.404–2 Information to support proposal 

analysis. 

Subpart 315.6—Unsolicited Proposals 

315.605 Content of unsolicited proposals. 

315.606 Agency procedures. 

315.606–1 Receipt and initial review. 

Authority: 5 U.S.C. 301; 40 U.S.C. 

121(c)(2). 

Subpart 315.2—Solicitation and 

Receipt of Proposals and Information 

315.204–5 Part IV—Representations and 

instructions. 

(c) Section M, Evaluation factors for 

award. (1) The requiring activity shall 

develop technical evaluation factors and 

submit them to the contracting officer as 

part of the acquisition plan or other 

acquisition request documentation for 

inclusion in a solicitation. The requiring 

activity shall indicate the relative 

importance or weight of the evaluation 

factors based on the requirements of an 

individual acquisition. 

(2) Only a formal amendment to a 

solicitation can change the evaluation 

factors. 

315.208 Submission, modification, 

revision, and withdrawal of proposals. 

(b) In addition to the provision in 

Federal Acquisition Regulation (FAR) 

52.215–1, Instructions to Offerors— 

Competitive Acquisition, if the head of 

the contracting activity (HCA) 

determines that biomedical or 

behavioral R & D acquisitions are 

subject to conditions other than those 

specified in FAR 52.215–1(c)(3), the 

HCA may authorize for use in 

competitive solicitations for R & D, the 

provision at 352.215–70, Late Proposals 

and Revisions. This is an authorized 

FAR deviation. 

(2) When the provision at 352.215–70 

is included in the solicitation and if the 

HCA intends to consider a proposal or 

proposals received after the exact time 

specified for receipt, the contracting 

officer, with the assistance of cost or 

technical personnel as appropriate, shall 

determine in writing that the proposal(s) 

meets the requirements of the provision 

at 352.215–70. 


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Subpart 315.3—Source Selection 

315.303–70 Policy. 

(a) If an operating division (OPDIV) is 

required by statute to use peer review 

for technical review of proposals, the 

requirements of those statutes, any 

implementing regulatory requirements, 

the Federal Advisory Committee Act, 

and as applicable, any approved 

Department of Health and Human 

Services (HHS) Acquisition Regulation 

(HHSAR) deviation(s) from this subpart 

take precedence over the otherwise 

applicable requirements of this subpart. 

(b) The statutes that require such 

review and implementing regulations 

are as follows: National Institutes of 

Health—42 U.S.C. 289a and 42 CFR part 

52h; Substance Abuse and Mental 

Health Services Administration—42 

U.S.C. 290aa–3, and Agency for 

Healthcare Research and Quality—42 

U.S.C. 299c–1. 

315.304 Evaluation factors and significant 

subfactors. 

When acquiring Electronic and 

Information Technology supplies and 

services (EIT) using negotiated 

procedures, contracting officers shall 

comply with Section 508 of the 

Rehabilitation Act of 1973, as amended. 

315.305 Proposal evaluation. 

(c) Use of non-Federal evaluators. (1) 

Except when peer review is required by 

statute as provided in 315.303–70(a), 

decisions to disclose proposals to nonFederal evaluators shall be made by the 

official responsible for appointing 

Source Selection Evaluation Team 

members in accordance with OPDIV 

procedures. The avoidance of 

organizational and personal conflicts of 

interest must be taken into 

consideration when making the decision 

to use non-Federal evaluators. 

(2) When a solicited proposal will be 

disclosed outside the Government to a 

contractor or a contractor employee for 

evaluation purposes, the following or 

similar conditions shall be part of the 

written agreement with the contractor 

prior to disclosure: 

CONDITIONS FOR EVALUATING 

PROPOSALS 

The contractor agrees that it and its 

employees, as well as any 

subcontractors and their employees (in 

these Conditions, ‘‘evaluator’’) will use 

the data (trade secrets, business data, 

and technical data) contained in the 

proposal for evaluation purposes only. 

The foregoing requirement does not 

apply to data obtained from another 

source without restriction. Any notice 

or legend placed on the proposal by 

either HHS or the offeror shall be 

applied to any reproduction or abstract 

provided to the evaluator or made by 

the evaluator. Upon completion of the 

evaluation, the evaluator shall return to 

the Government the furnished copy of 

the proposal or abstract, and all copies 

thereof, to the HHS office which 

initially furnished the proposal for 

evaluation. The evaluator shall not 

contact the offeror concerning any 

aspects of a proposal’s contents. 

Subpart 315.4—Contract Pricing 

315.404 Proposal analysis. 

315.404–2 Information to support proposal 

analysis. 

(a)(2) When some or all information 

sufficient to determine the 

reasonableness of the proposed cost or 

price is already available or can be 

obtained from the cognizant audit 

agency, or by other means including 

data obtained through market research 

(See FAR part 10 and HHSAR part 310) 

the contracting officer may request lessthan-complete field pricing support 

(specifying in the request the 

information needed) or may waive in 

writing the requirement for audit and 

field pricing support by documenting 

the file to indicate what information 

will be used. When field-pricing 

support is required, contracting officers 

shall make the request through the HCA. 

Subpart 315.6—Unsolicited Proposals 

315.605 Content of unsolicited proposals. 

(d) Warranty by offeror. To ensure 

against contacts between HHS personnel 

and prospective offerors that would 

exceed the limits of advance guidance 

set forth in FAR 15.604 and potentially 

result in an unfair advantage to an 

offeror, the prospective offeror of an 

unsolicited proposal must include the 

following warranty in any unsolicited 

proposal. Contracting officers receiving 

an unsolicited proposal without this 

warranty shall not process the proposal 

until the offeror is notified of the 

missing language and given an 

opportunity to submit a proper 

warranty. If no warranty is provided in 

a reasonable time, the contracting officer 

shall reject the unsolicited proposal, 

notify the offeror of the rejection, and 

document the actions in the file. 

UNSOLICITED PROPOSAL 

WARRANTY BY OFFEROR 

This is to warrant that— 

(a) This proposal has not been 

prepared under Government 

supervision; 

(b) The methods and approaches 

stated in the proposal were developed 

by this offeror; 

(c) Any contact with Department of 

Health and Human Services personnel 

has been within the limits of 

appropriate advance guidance set forth 

in FAR 15.604; and 

(d) No prior commitments were 

received from HHS personnel regarding 

acceptance of this proposal. 

Date: llllllllllllllll

Organization: llllllllllll

Name: lllllllllllllll

Title: lllllllllllllll

(This warranty shall be signed by a 

responsible management official of the 

proposing organization who is a person 

authorized to contractually obligate the 

organization.) 

315.606 Agency procedures. 

(a) The HCA is responsible for 

establishing procedures to comply with 

FAR 15.606(a). 

(b) The HCA or designee shall be the 

point of contact for coordinating the 

receipt and processing of unsolicited 

proposals. 

315.606–1 Receipt and initial review. 

(d) OPDIVs may consider an 

unsolicited proposal even though an 

organization initially submitted it as a 

grant application. However, OPDIVs 

shall not award contracts based on 

unsolicited proposals that have been 

rejected for grant awards due to lack of 

scientific merit. 

PART 316—TYPES OF CONTRACTS 

Subpart 316.3—Cost-Reimbursement 

Contracts 

Sec. 

316.307 Contract clauses. 

Subpart 315.5—Indefinite Delivery 

Contracts 

316.505 Ordering. 

Subpart 316.6—Time-and Materials, LaborHour, and Letter Contracts 

316.603 Letter Contracts. 

316.603–3 Limitations. 

Authority: 5 U.S.C. 301; 40 U.S.C. 

121(c)(2). 

Subpart 316.3—Cost-Reimbursement 

Contracts 

316.307 Contract clauses. 

(a)(1) If a contract for research and 

development is with a hospital (profit or 

nonprofit), the contracting officer shall 

modify the ‘‘Allowable Cost and 

Payment’’ clause at FAR 52.216–7 by 

deleting from paragraph (a) the words 

‘‘Federal Acquisition Regulation (FAR) 

subpart 31.2’’ and substituting ‘‘45 CFR 

part 75.’’ 


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(2) The contracting officer shall also 

insert the clause at 352.216–70, 

Additional Cost Principles, in 

solicitations and contracts with a 

hospital (profit or non-profit) when a 

cost-reimbursement contract is 

contemplated. 

Subpart 316.5—Indefinite-Delivery 

Contracts 

316.505 Ordering. 

(b)(8) The Department of Health and 

Human Services (HHS) Competition 

Advocate is the task-order and deliveryorder ombudsman for the department. 

Ombudsmen for each of the HHS 

contracting activities shall be designated 

in writing by the head of the contracting 

activity. See part 306. 

Subpart 316.6—Time-and-Materials, 

Labor-Hour, and Letter Contracts 

316.603 Letter contracts. 

316.603–3 Limitations. 

An official one level above the 

contracting officer shall make the 

written determination, to be included in 

the contract file, that no other contract 

type is suitable and to approve all letter 

contract modifications. No letter 

contract or modification can exceed the 

limits prescribed in FAR 16.603–2(c). 

PART 317—SPECIAL CONTRACTING 

METHODS 

Subpart 317.1—Multi-Year Contracting 

Sec. 

317.104 General. 

317.105 Policy. 

317.105–1 Uses. 

317.107 Options. 

317.108 Congressional notification. 

Subpart 317.2—Options 

317.204 Contracts. 

Authority: 5 U.S.C. 301; 40 U.S.C. 

121(c)(2). 

Subpart 317.1—Multi-Year Contracting 

317.104 General. 

(b) The Senior Procurement Executive 

(SPE) is the agency approving official 

for determinations under Federal 

Acquisition Regulation (FAR) 17.104(b). 

317.105 Policy. 

317.105–1 Uses. 

(a) Each head of the contracting 

activity determination to use multi-year 

contracting, as defined in FAR 17.103, 

is limited to individual acquisitions 

where the full estimated cancellation 

ceiling does not exceed 20 percent of 

the total contract value over the multiyear term or $12.5 million, whichever is 

less. Cancellation ceiling provisions 

shall conform to the requirements of 

FAR 17.106–1(c). The determination is 

not delegable and shall address the 

issues in FAR 17.105–1(a). 

(b)(1) SPE approval is required for 

any— 

(i) Individual determination to use 

multi-year contracting with a 

cancellation ceiling in excess of the 

limits in 317.105–1(a); or 

(ii) Class determination (see FAR 

subpart 1.7). 

(2) A determination involving a 

cancellation ceiling in excess of the 

limits in 317.105–1(a) shall present a 

well-documented justification for the 

estimated cancellation ceiling. When 

the estimated cancellation ceiling 

exceeds $12.5 million, the 

determination shall accompany a draft 

congressional notification letter 

pursuant to FAR 17.108 and 317.108. 

317.107 Options. 

When included as part of a multi-year 

contract, use of options shall not extend 

the performance of the original 

requirement beyond 5 years. Options 

may serve as a means to acquire related 

services (severable or non-severable) 

and, upon their exercise, shall receive 

funding from the then-current fiscal 

year’s appropriation. 

317.108 Congressional notification. 

(a) The SPE is the agency head for the 

purposes of FAR 17.108(a). Upon SPE 

approval of the determination required 

by 317.105–1(b)(1), the SPE will finalize 

and sign the congressional notification 

letter and provide it to the appropriate 

House and Senate committees. 

Subpart 317.2—Options 

317.204 Contracts. 

(e)(1) Information technology 

contracts. Notwithstanding FAR 

17.204(e), the 5-year limitations apply 

also to information technology contracts 

unless a longer period is authorized by 

statute. 

(2) Requests to exceed 5-year 

limitation. A request to exceed the 5- 

year limitation specified in FAR 

17.204(e) must provide all the following 

information: 

(i) Clearly explain the contract(s) and 

organization(s) covered by the request. 

(ii) Support the need for and 

reasonableness of the extension. 

(3) Approval authority. Requests to 

exceed the 5-year limitations specified 

in FAR 17.204(e) must be approved by: 

(i) The HCA; and 

(ii) The HHS SPE. 

SUBCHAPTER D—SOCIOECONOMIC 

PROGRAMS 

PART 319—SMALL BUSINESS 

PROGRAMS 

Subpart 319.2—Policies 

Sec. 

319.201 General policy. 

319.270–1 Mentor Prote ́ge ́ Program 

Solicitation provision and contract 

clause. 

Authority: 5 U.S.C. 301; 40 U.S.C. 

121(c)(2). 

Subpart 319.2—Policies 

319.201 General policy. 

(d) The functional management 

responsibilities for HHS’ small business 

program are delegated to the Office of 

Small and Disadvantaged Business 

Utilization (OSDBU) Director. 

(e)(1) The Department of Health and 

Human Services (HHS) OSDBU Director 

shall exercise full management 

authority over the small business 

program. The small business specialist 

(SBS) shall review and make 

recommendations for all acquisitions, 

unless exempted by statute, that are not 

being set aside for small business in 

accordance with Federal Acquisition 

Regulation (FAR) 19.502. The review 

must take place prior to issuing the 

solicitation. 

(2) Within the Indian Health Service 

(IHS), the primary SBSs are responsible 

for IHS’ overall implementation of the 

HHS small business program; however, 

each IHS contracting office will assign 

a small business technical advisor 

(SBTA) to perform those functions and 

responsibilities necessary to implement 

the small business program. The 

primary IHS SBS shall assist and 

provide guidance to respective SBTAs. 

319.270–1 Mentor Prote ́ge ́ Program 

Solicitation provision and contract clause. 

(a) The contacting officer shall insert 

the provision at 352.219–70, MentorProte ́ge ́ Program, in solicitations that 

include the clause at FAR 52.219–9, 

Small Business Subcontracting Plan. 

The provision requires offerors to 

provide the Contracting Officer a copy 

of their HHS Office of OSDBU-approved 

mentor-prote ́ge ́ agreement in response 

to a solicitation. 

(b) The contacting officer shall insert 

the clause at 352.219–71, MentorProte ́ge ́ Program Reporting 

Requirements, in contracts that include 

the clause at FAR 52.219–9, Small 

Business Subcontracting Plan, and 

which are awarded to a contractor with 

an HHS OSDBU-approved mentorprote ́ge ́ agreement. 


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PART 322—APPLICATION OF LABOR 

LAWS TO GOVERNMENT 

ACQUISITIONS 

Subpart 322.8—Equal Employment 

Opportunity 

Sec. 

322.810 Solicitation provisions and 

contract clauses. 

Authority: 5 U.S.C. 301; 40 U.S.C. 

121(c)(2). 

Subpart 322.8—Equal Employment 

Opportunity 

322.810 Solicitation provisions and 

contract clauses. 

(h) The contracting officer shall insert 

the clause at 352.222–70, Contractor 

Cooperation in Equal Employment 

Opportunity Investigations, in 

solicitations, contracts, and orders that 

include the clause at FAR 52.222–26, 

Equal Opportunity. 

PART 323—ENVIRONMENT, ENERGY 

AND WATER EFFICIENCY, 

RENEWABLE ENERGY 

TECHNOLOGIES, OCCUPATIONAL 

SAFETY, AND DRUG-FREE 

WORKPLACE 

Subpart 323.70—Safety and Health 

Sec. 

323.7000 Scope of subpart. 

323.7001 Policy. 

323.7002 Actions required. 

Subpart 323.71—Sustainable Acquisition 

Requirements 

323.7100 Policy. 

323.7101 Applicability. 

323.7102 Procedures. 

323.7103 Solicitation Provision. 

Authority: 5 U.S.C. 301; 40 U.S.C. 

121(c)(2). 

323.7000 Scope of subpart. 

This subpart provides procedures for 

administering safety and health 

requirements. 

323.7001 Policy. 

The contracting officer shall follow 

the guidance in this subpart when 

additional requirements for safety and 

health are necessary for an acquisition. 

323.7002 Actions required. 

Contracting activities. The contracting 

officer shall insert the clause at 

352.223–70, Safety and Health, or a 

clause substantially the same, in 

solicitations and contracts that involve 

hazardous materials or hazardous 

operations for the following types of 

requirements: 

(a) Services or products. 

(b) Research, development, or test 

projects. 

(c) Transportation of hazardous 

materials. 

(d) Construction, including 

construction of facilities on the 

contractor’s premises. 

Subpart 323.71—Sustainable 

Acquisition Requirements 

323.7100 Policy. 

This subpart provides procedures for 

sustainable acquisitions and use of the 

following: Designated recycled content; 

energy efficient, environmentally 

preferred, Electronic Product 

Environmental Assessment Tool 

(EPEAT)-registered, bio-based, water 

efficient, non-ozone depleting products 

and services; and alternate fuel vehicles 

and fuels. The Department of Health 

and Human Services (HHS) has 

designated product and service codes 

for supplies and services having 

sustainable acquisition attributes. See 

FAR part 23. 

323.7101 Applicability. 

It is HHS policy to include a 

solicitation provision and to include an 

evaluation factor for an offeror’ 

Sustainable Action Plan when acquiring 

sustainable products and services. This 

applies only to new contracts and orders 

above the micro-purchase threshold. 

Such contracts and orders include, but 

are not limited to: Office supplies; 

construction, renovation or repair; 

building operations and maintenance; 

landscaping services; pest management; 

electronic equipment, including leasing; 

fleet maintenance; janitorial services; 

laundry services; cafeteria operations; 

and meetings and conference services. If 

using a product or service code 

designated for supplies or services 

having sustainable acquisition 

attributes, but a review of the 

requirement determines that no 

opportunity exists to acquire sustainable 

acquisition supplies or services, 

document the determination in the 

contract file and make note in the 

solicitation. 

323.7102 Procedures. 

(a) When required by the solicitation, 

offerors or quoters must include a 

Sustainable Acquisition Plan in their 

technical proposal addressing the 

environmental products and services for 

delivery under the resulting contract. 

(b) The contracting officer shall 

incorporate the final Sustainable 

Acquisition Plan into the contract. 

(c) The contracting officer shall 

ensure that sustainability is included as 

an evaluation factor in all applicable 

new contracts and orders when the 

acquisition utilizes a product or service 

code designated by HHS for supplies or 

services having sustainable acquisition 

attributes. 

323.7103 Solicitation Provision. 

The contracting officer shall insert the 

provision at 352.223–71, Instruction to 

Offerors—Sustainable Acquisition, in 

solicitations above the micro-purchase 

threshold when the acquisition utilizes 

a product or service code designated by 

HHS as having sustainable acquisition 

attributes. 

PART 324—PROTECTION OF PRIVACY 

AND FREEDOM OF INFORMATION 

Subpart 324.1—Protection of Individual 

Privacy 

Sec. 

324.103 Procedures for the Privacy Act. 

324.104 Restrictions on Contractor Access 

to Government or Third Party 

Information. 

324.105 Contract clauses. 

Subpart 324.70—Health Insurance 

Portability and Accountability Act of 1996 

(HIPAA) 

324.7000 Scope of subpart. 

324.7001 Policy on Compliance with 

HIPAA Business Associate Contract 

Requirements. 

Authority: 5 U.S.C. 301; 40 U.S.C. 

121(c)(2). 

Subpart 324.1—Protection of Individual 

Privacy 

324.103 Procedures for the Privacy Act. 

(a) The contracting officer shall 

review all acquisition request 

documentation to determine whether 

the requirements of the Privacy Act of 

1974 (5 U.S.C. 552a) are applicable. The 

Privacy Act requirements apply when a 

contract or order requires the contractor 

to design, develop, or operate any 

Privacy Act system of records on 

individuals to accomplish an agency 

function. When applicable, the 

contracting officer shall include the two 

Privacy Act clauses required by FAR 

24.104 in the solicitation and contract or 

order. In addition, the contracting 

officer shall include the two FAR 

Privacy Act clauses, and other pertinent 

information specified in this subpart, in 

any modification which results in the 

Privacy Act requirements becoming 

applicable to a contract or order. 

(b) The contracting officer shall 

ensure that the statement of work or 

performance work statement (SOW or 

PWS) specifies the system(s) of records 

or proposed system(s) of records to 

which the Privacy Act and the 

implementing regulations are applicable 

or may be applicable. The contracting 

officer shall send the contractor a copy 

of 45 CFR part 5b, which includes the 

rules of conduct and other Privacy Act 

requirements. 

(c) The contracting officer shall 

ensure that the contract SOW or PWS 


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specifies for both the Privacy Act and 

the Federal Records Act the disposition 

to be made of the system(s) of records 

upon completion of contract 

performance. The contract SOW or PWS 

may require the contractor to destroy 

the records, remove personal identifiers, 

or turn the records over to the 

contracting officer. If there is a 

legitimate need for a contractor to keep 

copies of the records after completion of 

a contract, the contractor must take 

measures, as approved by the 

contracting officer, to keep the records 

confidential and protect the individuals’ 

privacy. 

(d) For any acquisition subject to 

Privacy Act requirements, the requiring 

activity prior to award, or the COR, after 

award, shall prepare and have 

published in the Federal Register a 

‘‘system notice,’’ describing the 

Department of Health and Human 

Services’ (HHS) intent to establish a 

new system of records on individuals, to 

make modifications to an existing 

system, or to disclose information in 

regard to an existing system. The 

requiring activity shall attach a copy of 

the system notice to the acquisition plan 

or other acquisition request 

documentation. If a system notice is not 

attached, the contracting officer shall 

inquire about its status and shall obtain 

a copy from the requiring activity for 

inclusion in the contract file. If a notice 

for the system of records has not been 

published in the Federal Register, the 

contracting officer may proceed with the 

acquisition but shall not award the 

contract until the system notice is 

published and the contracting officer 

verifies its publication. 

324.104 Restrictions on Contractor 

Access to Government or Third Party 

Information. 

The contracting officer shall establish 

the restrictions that govern the 

contractor employees’ access to 

Government or third party information 

in order to protect the information from 

unauthorized use or disclosure. 

324.105 Contract clauses. 

(a) The contracting officer shall insert 

the clause at 352.224–70, Privacy Act, in 

solicitations, contracts, and orders that 

require the design, development, or 

operation of a system of records to 

notify the contractor that it and its 

employees are subject to criminal 

penalties for violations of the Privacy 

Act (5 U.S.C. 552a(i)) to the same extent 

as HHS employees. The clause also 

requires the contractor to ensure each of 

its employees knows the prescribed 

rules of conduct in 45 CFR part 5b and 

each contractor employee is aware that 

he or she is subject to criminal penalties 

for violations of the Privacy Act. These 

requirements also apply to all 

subcontracts awarded under the 

contract or order that require the design, 

development, or operation of a system 

of records. 

(b) The contracting officer shall insert 

the clause at 352.224–71, Confidential 

Information, in solicitations, contracts, 

and orders that require access to 

Government or to third party 

information. 

Subpart 324.70—Health Insurance 

Portability and Accountability Act of 

1996 

324.7000 Scope of subpart. 

All individually identifiable health 

information that is Protected Health 

Information or ‘‘PHI’’, as defined in 45 

CFR 160.103 shall be administered in 

accordance with the Health Insurance 

Portability and Accountability Act of 

1996 (HIPAA) as amended, subtitle D of 

title IV of the Health Information 

Technology for Economic and Clinical 

Health Act (HITECH Act), and the 

corresponding implementing 

regulations at 45 CFR parts 160 and 164. 

The term ‘‘HIPAA’’ is used in this part 

to refer to the HIPAA and HITECH 

statutes and the implementing 

regulations. HIPAA includes standards 

and implementation specifications for 

the security and privacy of certain 

individually identifiable health 

information known as Protected Health 

Information (PHI). 

324.7001 Policy on Compliance with 

HIPAA business associate contract 

requirements. 

‘‘HIPAA’’ refers to the provisions of 

part C of title XI of the Social Security 

Act, 42 U.S.C. 1320d et seq., section 264 

of the Health Insurance Portability and 

Accountability Act of 1996, as amended, 

and subtitle D of title IV of the Health 

Information Technology for Economic 

and Clinical Health Act (HITECH Act), 

as amended, and the HIPAA Rules at 45 

CFR parts 160 through 164. HHS is a 

HIPAA ‘‘covered entity’’ that is a 

‘‘hybrid entity’’ as these terms are 

defined at §§ 160.103 and 164.103 

respectively. As such, only the portions 

of HHS that the Secretary has 

designated as ‘‘health care components’’ 

(HCC) as defined at § 164.103, are 

subject to HIPAA. HHS’ HCCs may 

utilize persons or entities known as 

‘‘business associates,’’ as defined at 

§ 160.103. Generally, ‘‘business 

associate’’ means a ‘‘person’’ as defined 

by § 160.103 (including contractors, and 

third-party vendors, etc.) if or when the 

person or entity: 

(a) Creates, receives, maintains, or 

transmits ‘‘protected health 

information’’ (PHI), as the term is 

defined at 160.103, on behalf of an HHS 

HCC to carry out HHS HIPAA-covered 

functions; or 

(b) Provides certain services to an 

HHS HCC that involves PHI. Where the 

Department as a covered entity is 

required by 45 CFR 164.502(e)(1) and 

164.504(e) and, if applicable, 

§§ 164.308(b)(3) and 164.314(a), to enter 

into a HIPAA business associate 

contract, the relevant HCC contracting 

officer, acting on behalf of the 

Department, shall ensure that such 

contract meets the requirements at 

§ 164.504(e)(2) and, if applicable, 

§ 164.314(a)(2). 

PART 326—OTHER SOCIOECONOMIC 

PROGRAMS 

Subpart 326.5—Indian Preference in 

Employment, Training, and Subcontracting 

Opportunities 

Sec. 

326.501 Statutory requirements. 

Subpart 326.6—Acquisitions Under the Buy 

Indian Act 

326.600 Scope of subpart. 

326.601 Policy. 

326.602 Definitions. 

326.603 Requirements. 

326.604 Competition. 

326.605 Responsibility determinations. 

Subpart 326.7—Acquisitions Requiring the 

Native American Graves Protection and 

Repatriation Act 

326.700 Scope of subpart. 

326.701 Applicability. 

Authority: 5 U.S.C. 301; 40 U.S.C. 

121(c)(2). 

Subpart 326.5—Indian Preference in 

Employment, Training, and 

Subcontracting Opportunities 

326.501 Statutory requirements. 

Any contract or subcontract pursuant 

to subchapter II, chapter 14, title 25 

United States Code, the Act of April 16, 

1934 (48 Stat. 596), as amended, or any 

other Act authorizing Federal contracts 

with or grants to Indian organizations or 

for the benefit of Indians, shall, to the 

greatest extent feasible, comply with 

Section 7(b) of the Indian SelfDetermination and Education 

Assistance Act, Pub. L. 93–638, 88 Stat. 

2205, 25 U.S.C. 450e(b) which provides 

preferences and opportunities for 

training and employment in connection 

with the administration of such 

contracts, and preference in the award 

of subcontracts in connection with the 

administration of such contracts to 

Indian organizations and to Indianowned economic enterprises as defined 


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in section 1452 of title 25, United States 

Code. 

326.502 Definitions. 

For purposes of this subpart, the 

following definitions shall apply: 

(a) Indian means a person who is a 

member of an Indian tribe. If the 

contractor has reason to doubt that a 

person seeking employment preference 

is an Indian, the contractor shall grant 

the preference but shall require the 

individual provide evidence within 30 

days from the tribe concerned that the 

person is a member of the tribe. 

(b) Indian tribe means an Indian tribe, 

pueblo, band, nation, or other organized 

group or community, including any 

Alaska Native Village or regional or 

village corporation 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 special 

programs and services because of its 

status as Indian. 

(c) Indian organization means the 

governing body of any Indian tribe, or 

entity established or recognized by such 

governing body, in accordance with the 

Indian Financing Act of 1974 (88 Stat. 

77, 25 U.S.C. 1451). 

(d) Indian-owned economic enterprise 

means any Indian-owned commercial, 

industrial, or business activity 

established or organized for the purpose 

of profit, provided that such Indian 

ownership shall constitute not less than 

51 percent of the enterprise, and the 

ownership shall encompass active 

operation and control of the enterprise. 

(e) Indian reservation includes Indian 

reservations, public domain Indian 

allotments, former Indian reservations 

in Oklahoma, and land held by 

incorporated 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.) 

(f) On or near an Indian reservation 

means on a reservation or reservations 

or within that area surrounding an 

Indian reservation(s) where a person 

seeking employment could reasonably 

commute to and from in the course of 

a work day. 

326.503 Compliance enforcement. 

The contracting officer shall promptly 

investigate and resolve written 

complaints of noncompliance with the 

requirements of the clauses at 352.226– 

1, Indian Preference and 352.226–2, 

Indian Preference Program filed with 

the contracting activity. 

326.504 Tribal preference requirements. 

(a) When the contractor will perform 

work under a contract on an Indian 

reservation, the contracting officer may 

supplement the clause at 352.226–2, 

Indian Preference Program by adding 

specific Indian preference requirements 

of the tribe on whose reservation the 

contractor will work. The contracting 

activity and the tribe shall jointly 

develop supplemental requirements for 

the contract. Supplemental preference 

requirements shall represent a further 

implementation of the requirements of 

section 7(b) of Pub. L. 93–638 and 

require the approval of the affected 

program director and the appropriate 

legal office, or a regional attorney, 

before the contracting officer adds them 

to a solicitation and resultant contract. 

Any supplemental preference 

requirements the contracting officer 

adds to the clause at 352.226–2, Indian 

Preference Program shall also clearly 

identify in the solicitation the 

additional requirements. 

(b) Nothing in this part shall preclude 

tribes from independently developing 

and enforcing their own tribal 

preference requirements. Such 

independently-developed tribal 

preference requirements shall not, 

except as provided in paragraph (a) of 

this section, become a requirement in 

contracts covered under this subpart, 

and shall not conflict with any Federal 

statutory or regulatory requirement 

concerning the award and 

administration of contracts. 

326.505 Applicability. 

The contracting officer shall insert the 

clause at 352.226–1, Indian Preference, 

and the clause at 352.226–2, Indian 

Preference Program, in contracts to 

implement section 7(b) of Pub. L. 93– 

638 for all Department of Health and 

Human Services (HHS) activities. 

Contracting activities shall use the 

clauses as follows, except for those 

exempted solicitations and contracts 

issued and or awarded pursuant to Title 

I of Pub. L. 93–638 (25 U.S.C. 450 et 

seq.): 

(a) The contracting officer shall insert 

the clause at 352.226–1, Indian 

Preference, in solicitations, contracts, 

and orders when— 

(1) The award is (or will be) pursuant 

to an act specifically authorizing such 

awards with Indian organizations; or 

(2) The work is specifically for the 

benefit of Indians and is in addition to 

any incidental benefits which might 

otherwise accrue to the general public. 

(b) The contracting officer shall insert 

the clause at 352.226–2, Indian 

Preference Program, in solicitations, 

contracts, and orders when— 

(1) The dollar amount of the 

acquisition is expected to equal or 

exceed $650,000 for non-construction 

work or $1.5 million for construction 

work; 

(2) The solicitation, contract, or order 

includes the Indian Preference clause; 

and 

(3) The contracting officer makes the 

determination, prior to solicitation, that 

performance will take place in whole or 

in substantial part on or near an Indian 

reservation(s). In addition, the 

contracting officer may insert the Indian 

Preference Program clause in 

solicitations, contracts, and orders 

below the $650,000 or $1.5 million level 

for non-construction or construction 

contracts, respectively, but which meet 

the requirements of paragraphs (b)(2) 

and (3) of this section, and in the 

opinion of the contracting officer, offer 

substantial opportunities for Indian 

employment, training, and 

subcontracting. 

Subpart 326.6—Acquisitions Under the 

Buy Indian Act 

326.600 Scope of subpart. 

This subpart sets forth the policy on 

preferential acquisition from Indians 

under the negotiation authority of the 

Buy Indian Act. This subpart applies 

only to acquisitions made by or on 

behalf of Indian Health Service (IHS). 

326.601 Policy. 

(a) IHS shall utilize the negotiation 

authority of the Buy Indian Act to give 

preference to Indians whenever 

authorized and practicable. The Buy 

Indian Act, 25 U.S.C. 47, prescribes the 

application of the advertising 

requirements of 41 U.S.C. 6101 to the 

acquisition of Indian supplies. As 

specified in 25 U.S.C. 47, the Buy 

Indian Act provides that, so far as 

practicable, the Government shall 

employ Indian labor and, at the 

discretion of the Secretary of the 

Interior, purchase products of Indian 

industry (including, but not limited to 

printing, notwithstanding any other 

law) from the open market. 

(b) Due to the transfer of authority 

from the Department of the Interior to 

HHS, the Secretary of HHS may use the 

Buy Indian Act to acquire products of 

Indian industry in connection with the 

maintenance and operation of Indian 

hospital and health facilities, and for the 

overall conservation of Indian health. 

This authority is exclusively delegated 

to IHS and is not available for use by 

any other HHS component (unless that 

component makes an acquisition on 

behalf of IHS). However, the Buy Indian 

Act itself does not exempt IHS from 

meeting the statutorily mandated small 

business goals. 


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(c) Subsequent legislation, 

particularly Pub. L. 94–437 and Pub. L. 

96–537, emphasize using the Buy Indian 

Act negotiation authority. 

326.602 Definitions. 

(a) Buy Indian contract means any 

contract involving activities covered by 

the Buy Indian Act and negotiated 

under the provisions of 41 U.S.C. 3104 

and 25 U.S.C. 47 between an Indian firm 

and a contracting officer representing 

IHS. 

(b) Indian means a member of any 

tribe, pueblo, band, group, village, or 

community recognized by the Secretary 

of the Interior as being Indian or any 

individual or group of individuals 

recognized by the Secretary of the 

Interior or the Secretary of HHS. The 

Secretary of HHS in making 

determinations may take into account 

the determination of the tribe with 

which affiliation is claimed. 

(c) Indian firm means a sole 

enterprise, partnership, corporation, or 

other type of business organization 

owned, controlled, and operated by: 

(1) One or more Indians (including, 

for the purpose of sections 301 and 302 

of Pub. L. 94–437, former or currently 

federally recognized Indian tribes in the 

State of New York); or 

(2) By an Indian firm (as defined in 

paragraph (1) of this definition); or 

(3) A nonprofit firm organized for the 

benefit of Indians and controlled by 

Indians (see 326.601(a)). 

(d) Product of Indian industry means 

anything produced by Indians through 

either physical labor or intellectual 

effort involving the use and application 

of their skills. To classify as a product 

of Indian industry, the total cost of the 

item’s production must equal or exceed 

51 percent Indian effort. 

326.603 Requirements. 

(a) Indian ownership. Indian 

ownership shall constitute at least 51 

percent of an Indian firm during the 

period covered by a Buy Indian 

contract. 

(b) Joint ventures. An Indian firm may 

enter into a joint venture with other 

entities for specific projects as long as 

the Indian firm is the managing partner. 

However, the contracting officer shall 

approve the joint venture prior to the 

award of a contract under the Buy 

Indian Act. 

(c) Bonds. In the case of contracts for 

the construction, alteration, or repair of 

public buildings or public works, the 

Miller Act (40 U.S.C. 3131 et seq.) and 

Federal Acquisition Regulation (FAR) 

Part 28 require performance and 

payment bonds. Bonds are not required 

in the case of contracts with Indian 

tribes or public nonprofit organizations 

serving as governmental 

instrumentalities of an Indian tribe. 

However, bonds are required when 

dealing with private business entities 

owned by an Indian tribe or members of 

an Indian tribe. The contracting officer 

may require bonds of private business 

entities that are joint ventures with, or 

subcontractors of, an Indian tribe or a 

public nonprofit organization serving as 

a governmental instrumentality of an 

Indian tribe. A bid guarantee or bid 

bond is required only when a 

performance or payment bond is 

required. 

(d) Indian preference in employment, 

training and subcontracting. Contracts 

awarded under the Buy Indian Act are 

subject to the requirements of section 

7(b) of the Indian Self-Determination 

and Education Assistance Act 25 U.S.C. 

450e, which requires giving preference 

to Indians in employment, training, and 

subcontracting. The contracting officer 

shall include the Indian Preference 

clause specified in 326.505(a) in all Buy 

Indian solicitations and resultant 

contracts. The contracting officer shall 

use the Indian Preference Program 

clause specified in 326.505(b). The 

contracting officer shall follow all 

requirements specified in subpart 326.2 

which apply to a Buy Indian acquisition 

(e.g., 326.604 and 326.605). 

(e) Subcontracting. A contractor shall 

not subcontract more than 50 percent of 

the work under a prime contract 

awarded pursuant to the Buy Indian Act 

to non-Indian firms. For this purpose, 

contract work does not include the 

provision of materials, supplies, or 

equipment. 

(f) Wage rates. The contracting officer 

shall include a determination of the 

minimum wage rates by the Secretary of 

Labor as required by the Davis-Bacon 

Act (40 U.S.C. 276a) in all contracts 

awarded under the Buy Indian Act for 

over $2,000 for construction, alteration, 

or repair, including painting and 

decorating, of public buildings and 

public works, except contracts with 

Indian tribes or public nonprofit 

organizations serving as governmental 

instrumentalities of an Indian tribe. The 

contracting officer shall include the 

wage rate determination in contracts 

with private business entities, even 

when owned by an Indian tribe or a 

member of an Indian tribe and in 

connection with joint ventures with, or 

subcontractors of, an Indian tribe or a 

public nonprofit organization serving as 

a governmental instrumentality of an 

Indian tribe. 

326.604 Competition. 

(a) Contracts awarded under the Buy 

Indian Act are subject to competition 

among Indians or Indian firms to the 

maximum extent practicable. When the 

contracting officer determines that 

competition is not practicable, a 

justification and approval is required in 

accordance with subpart 306.3. 

(b) The contracting officer shall: 

synopsize and publicize solicitations in 

the Government point of entry and 

provide copies of the synopses to the 

tribal office of the Indian tribal 

government directly concerned with the 

proposed acquisition as well as to 

Indian firms and others having a 

legitimate interest. The synopses shall 

state that the acquisitions are restricted 

to Indian firms under the Buy Indian 

Act. 

326.605 Responsibility determinations. 

(a) The contracting officer may award 

a contract under the Buy Indian Act 

only if it is determined that the 

contractor will likely perform 

satisfactorily and properly complete or 

maintain the contracted project or 

function. 

(b) The contracting officer shall make 

the written determination specified in 

paragraph (a) of this section prior to the 

award of a contract. The determination 

shall reflect an analysis of FAR 9.104– 

1 standards. 

Subpart 326.7—Acquisitions Requiring 

the Native American Graves Protection 

and Repatriation Act 

326.700 Scope of subpart. 

Public Law 101–601, dated November 

16, 1990, also 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. 

326.701 Applicability. 

The contracting officer shall insert the 

clause at 352.226–3, Native American 

Graves Protection and Repatriation Act, 

in solicitations, contracts, and orders 

requiring performance on tribal lands or 

those for construction projects on 

Federal or tribal lands. 

SUBCHAPTER E—GENERAL 

CONTRACTING REQUIREMENTS 

PART 327—RIGHTS, DATA, AND 

COPYRIGHTS 

Subpart 327.3—Patent Rights Under 

Government Contracts 

Sec. 


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327.303 Solicitation provision and contract 

clause. 

Subpart 327.4—Rights in Data and 

Copyrights 

327.404–70 Solicitation provision and 

contract clause. 

327.409 Solicitation provision and contract 

clause. 

Authority: 5 U.S.C. 301; 40 U.S.C. 

121(c)(2). 

Subpart 327.3—Patent Rights Under 

Government Contracts 

327.303 Solicitation provision and 

contract clause. 

The contracting officer shall insert the 

clause at 352.227–11, Patent Rights— 

Exceptional Circumstances and any 

appropriate alternates in lieu of Federal 

Acquisition Regulation (FAR) 52.227–11 

whenever a Determination of 

Exceptional Circumstances (DEC) 

involving the provision of materials that 

has been executed in accordance with 

Agency policy and procedures calls for 

its use and clause 352.227–11, Patent 

Rights—Exceptional Circumstances, 

appropriately covers the circumstances. 

The contracting officer should reference 

the DEC in the solicitation and shall 

attach a copy of the executed DEC to the 

contract. 

Subpart 327.4—Rights in Data and 

Copyrights 

327.404–70 Solicitation provision and 

contract clause. 

The contracting officer shall insert the 

clause at 352.227–70, Publications and 

Publicity, in solicitations, contracts, and 

orders that involve requirements which 

could lead to the contractor’s publishing 

the results of its work under the 

contract. 

327.409 Solicitation provision and 

contract clause. 

The contracting officer shall insert the 

clause at 352.227–14, Rights in Data— 

Exceptional Circumstances and any 

appropriate alternates in lieu of FAR 

52.227–14 whenever a DEC executed in 

accordance with Agency policy and 

procedures calls for its use. Prior to 

using this clause, a DEC must be 

executed in accordance with Agency 

policy and procedures. The contracting 

officer should reference the DEC in the 

solicitation and shall attach a copy of 

the executed DEC to the contract. 

PART 328—[RESERVED] 

PART 330—COST ACCOUNTING 

STANDARDS 

Subpart 330.2—CAS Program Requirements 

Sec. 

330.201 Contract requirements. 

330.201–5 Waiver. 

Authority: 5 U.S.C. 301; 40 U.S.C. 

121(c)(2). 

Subpart 330.2—CAS Program 

Requirements 

330.201 Contract requirements. 

330.201–5 Waiver. 

The Associate Deputy Assistant 

Secretary for Acquisition shall exercise 

the waiver authority under Federal 

Acquisition Regulation 30.201–5(a)(2). 

Operating Divisions and Staff Divisions 

shall forward waiver requests to the 

Senior Procurement Executive. 

PART 331—CONTRACT COST 

PRINCIPLES AND PROCEDURES 

Subpart 331.1—Applicability 

Sec. 

331.101–70 Salary rate limitation. 

Authority: 5 U.S.C. 301; 40 U.S.C. 

121(c)(2). 

Subpart 331.1—Applicability 

331.101–70 Salary rate limitation. 

(a) Beginning in fiscal year 1990, 

Congress has stipulated in the 

Department of Health and Human 

Services appropriations acts and 

continuing resolutions that, under 

applicable contracts, appropriated funds 

cannot be used to pay the direct salary 

of an individual above the stipulated 

rates. The applicable rates for each year 

are identified at www.opm.gov. 

(b) The contracting officer shall insert 

the clause at 352.231–70, Salary Rate 

Limitation, in solicitations and contracts 

when a cost-reimbursement; fixed-price 

level-of-effort; time-and-materials; or 

labor-hour contract is contemplated. 

PART 332—CONTRACT FINANCING 

Subpart 332.4—Advance Payments for NonCommercial Items 

Sec. 

332.402 General. 

332.407 Interest. 

Subpart 332.5—Progress Payments Based 

on Cost 

332.501 General. 

332.501–2 Unusual progress payments. 

Subpart 332.7—Contract Funding 

332.702 Policy. 

332.703 Contract funding requirements. 

332.703–1 General. 

332.703–71 Incrementally funded costreimbursement contracts. 

332.703–72 Incremental Funding Table. 

332.706 Solicitation provision and contract 

clauses. 

332.706–2 Provision and clauses for 

limitation of cost or funds. 

Authority: 5 U.S.C. 301; 40 U.S.C. 

121(c)(2). 

Subpart 332.4—Advance Payments for 

Non-Commercial Items 

332.402 General. 

(e) The head of the contracting 

activity (HCA) (non-delegable) is the 

person responsible for compliance with 

Federal Acquisition Regulation (FAR) 

32.402(e) and shall determine whether 

advance payments are in accordance 

with FAR 32.402. 

332.407 Interest. 

(d) The HCA (non-delegable) shall 

make the determinations in FAR 

32.407(d). 

Subpart 332.5—Progress Payments 

Based on Cost 

332.501 General. 

332.501–2 Unusual progress payments. 

(a)(3) The HCA (non-delegable) shall 

approve unusual progress payments. 

Subpart 332.7—Contract Funding 

332.702 Policy. 

Departmental employees shall report 

any suspected violation of the AntiDeficiency Act (31 U.S.C. 1341, 13 

U.S.C. 1342, and 31 U.S.C. 1517) 

immediately to the OPDIV Chief 

Financial Officer (CFO), who in turn 

will report the matter to the HHS 

Deputy CFO. 

332.703 Contract funding requirements. 

332.703–1 General. 

(b) The following requirements govern 

all solicitations and contracts using 

incremental funding, as appropriate: 

(1) The contracting officer shall 

consider the estimated total cost of the 

contract, including all planned 

increments of performance when 

determining the requirements that must 

be met before contract execution (e.g., 

Justification and Approvals, clearances, 

and approvals). 

(2) The solicitation and resultant 

contract shall include a statement of 

work or performance work statement 

that describes the total project, covers 

all proposed increments of performance, 

and contains a schedule of planned 

increments of performance. No funding 

increment may exceed 1 year, and the 

services rendered during each 

increment of performance must provide 

a specific material benefit that can stand 

alone if the remaining effort is not 

funded. The resultant contract shall also 

include the corresponding amount of 

funds planned for obligation for each 

increment of performance. 


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* To be inserted after negotiation. 

(3) The contracting officer shall 

request that offerors respond to the 

solicitation with technical and cost 

proposals for the entire project, and 

shall require distinct technical and cost 

break-outs of the planned increments of 

performance. 

(4) Proposals shall be evaluated and 

any discussions and negotiations shall 

be conducted based upon the total 

project, including all planned 

increments of performance. 

332.703–71 Incrementally funded costreimbursement contracts. 

Incremental funding may be used in 

cost-reimbursement contracts for 

severable services only when all of the 

following circumstances are present: 

(a) Funding of increments after the 

initial increment of performance is 

provided from the appropriation 

account available for obligation at that 

time; 

(b) The project represents a bona fide 

need of the fiscal year in which the 

contract is awarded and initially funded 

(i.e., the initial increment of 

performance) and is also a bona fide 

need of each subsequent fiscal year 

whose appropriation will be used; and 

(c) The project’s significance provides 

reasonable assurance that subsequent 

year appropriations will be made 

available to fund the project’s 

continuation and completion. 

332.703–72 Incremental Funding Table. 

The contracting officer shall insert 

substantially the following language in 

Section B: Supplies or Services and 

Prices or Costs, Table 1, in all costreimbursement contracts for severable 

services using incremental funding. The 

language requires the contracting officer 

to: 

(a) Insert the initial funding obligated 

by the award; 

(b) Identify the increment of 

performance covered by the funding 

provided; and 

(c) Specify the start and end dates for 

each increment of performance, as 

required by the ‘‘Limitation of Funds’’ 

clause at FAR 52.232–22. 

Modification of the language is 

permitted to fit specific circumstances 

of the contract, including but not 

limited to language necessary to reflect 

the specific type of cost reimbursement 

contract awarded, but the language may 

not be omitted completely. 

B. lESTIMATED COST— 

INCREMENTALLY FUNDED 

CONTRACT 

(a) The total estimated cost to the 

Government for full performance of this 

contract, including all allowable direct 

and indirect costs, is $lll [insert full 

amount]. 

(b) The following represents the 

schedule * by which the Government 

expects to allot funds to this contract: 

CLIN, Task No., or 

description 

Start date of 

increment of 

performance 

End date of increment 

of performance 

Estimated cost 

($) 

Fee ($) 

(as appropriate) 

Estimated cost plus 

fee ($) 

(as appropriate) 

................................... ................................... ................................... ................................... ...................................

................................... ................................... ................................... ................................... ...................................

................................... ................................... ................................... ................................... ...................................

................................... ................................... ................................... ................................... ...................................

................................... ................................... ................................... ................................... ...................................

................................... ................................... [Total] [Total] [Total] 

(c) Total funds currently obligated 

and available for payment under this 

contract are $lll [insert amount 

funded to date]. 

(d) The contracting officer may issue 

unilateral modifications to obligate 

additional funds to the contract and 

make related changes to paragraphs (b) 

and/or (c) above. 

(e) Until this contract is fully funded, 

the requirements of the clause at FAR 

52.232–22, Limitation of Funds, shall 

govern. Once the contract is fully 

funded, the requirements of the clause 

at FAR 52.232–20, Limitation of Cost, 

govern. 

332.706 Solicitation provision and 

contract clauses. 

332.706–2 Provision and clauses for 

limitation of cost or funds. 

(b) In addition to the clause at FAR 

52.232–22, Limitation of Funds, the 

contracting officer shall insert the 

provision at 352.232–70, Incremental 

Funding, in all solicitations when a 

cost-reimbursement contract for 

severable services using incremental 

funding is contemplated. The provision 

requires the contracting officer to insert 

a specific increment of performance that 

the initial funding is expected to cover. 

PART 333—PROTESTS, DISPUTES, 

AND APPEALS 

Subpart 333.1—Protests 

Sec. 

333.102 General. 

333.103 Protests to the agency. 

Subpart 333.2—Disputes and Appeals 

333.203 Applicability. 

333.209 Suspected fraudulent claims. 

333.215–70 Contract clauses. 

Authority: 5 U.S.C. 301; 40 U.S.C. 

121(c)(2). 

Subpart 333.1—Protests 

333.102 General. 

(g)(1) The Office of General Counsel— 

General Law Division serves as the 

liaison for protests lodged with the 

Government Accountability Office 

(GAO); is designated as the office 

responsible for all protests within the 

Department of Health and Human 

Services (HHS); and serves as the 

notification point with GAO for all 

protests. 

(2) The contracting officer will follow 

the direction of the Operating Division’s 

(OPDIV) protest control officer for 

responding to protests whether they are 

filed with GAO or directly with the 

contracting officer. 

333.103 Protests to the agency. 

(f)(1) Protests to the contracting officer 

must be in writing. The contracting 

officer is authorized to make the 


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determination, using the criteria in FAR 

33.104(b), to award a contract 

notwithstanding the protest after 

obtaining the concurrence of the 

contracting activity’s protest control 

officer and consulting with the 

appropriate legal office. 

Subpart 333.2—Disputes and Appeals 

333.203 Applicability. 

(c) The Civilian Board of Contract 

Appeals (CBCA) is the authorized 

‘‘Board’’ to hear and determine disputes 

for the Department. 

333.209 Suspected fraudulent claims. 

The contracting officer shall submit 

any instance of a contractor’s suspected 

fraudulent claim to the Office of 

Inspector General for investigation. 

333.215–70 Contract clauses. 

(a) The contracting officer shall insert 

the clause at 352.233–70, Choice of Law 

(Overseas), in solicitations and contracts 

when performance will be outside the 

United States, its possessions, and 

Puerto Rico, except as otherwise 

provided in a government-togovernment agreement. 

(b) The contracting officer shall insert 

the clause at 352.233–71, Litigation and 

Claims, in solicitations and contracts 

when a cost-reimbursement, time-andmaterials, or labor-hour contract is 

contemplated (other than a contract for 

a commercial item.) 

SUBCHAPTER F—SPECIAL CATEGORIES 

OF CONTRACTING 

PART 334—MAJOR SYSTEM 

ACQUISITION 

Subpart 334.2—Earned Value Management 

System 

Sec. 

334.201 Policy. 

334.202 Integrated Baseline Reviews (IBRs). 

Authority: 5 U.S.C. 301; 40 U.S.C. 

121(c)(2). 

Subpart 334.2—Earned Value 

Management System 

334.201 Policy. 

The Department of Health and Human 

Services applies the earned value 

management system requirement as 

follows: 

(a) For cost or incentive contracts and 

subcontracts valued at $20 million or 

more, the contractor’s earned value 

management system shall comply with 

the guidelines in the American National 

Standards Institute/Electronic Industries 

Alliance Standard 748, Earned Value 

Management Systems (ANSI/EIA–748). 

(b) For cost or incentive contracts and 

subcontracts valued at $50 million or 

more, the contractor shall have an 

earned value management system that 

has been determined by the cognizant 

Federal agency to be in compliance with 

the guidelines in ANSI/EIA–748. 

(c) For cost or incentive contracts and 

subcontracts valued at less than $20 

million— 

(1) The application of earned value 

management is optional at the 

discretion of the program/project 

manager and is a risk-based decision 

that must be supported by a cost/benefit 

analysis; and 

(2) A decision to apply earned value 

management shall be documented in the 

contract file. 

(d) For firm-fixed-price contracts and 

subcontracts of any dollar value the 

application of earned value management 

is discouraged. 

334.202 Integrated Baseline Reviews 

(IBRs). 

(a) An IBR normally should be 

conducted as a post-award activity. A 

pre-award IBR may be conducted only 

if— 

(1) The acquisition plan contains 

documentation that demonstrates the 

need and rationale for a pre-award IBR, 

including an assessment of the impact 

on the source selection schedule and the 

expected benefits; 

(2) The use of a pre-award IBR is 

approved in writing by the head of the 

contracting activity prior to the issuance 

of the solicitation; 

(3) The source selection plan and 

solicitation specifically addresses how 

the results of a pre-award IBR will be 

used during source selection, including 

any weight to be given to it in source 

evaluation; and 

(4) Specific arrangements are made, 

and budget authority is provided, to 

compensate all offerors who prepare for 

or participate in a pre-award IBR; and 

the solicitation informs prospective 

offerors of the means for and conditions 

of such compensation. 

PART 335—RESEARCH AND 

DEVELOPMENT CONTRACTING 

Sec. 

335.070 Cost-sharing. 

335.070–1 Policy. 

335.070–2 Amount of cost-sharing. 

335.070–3 Method of cost-sharing. 

335.071 [Reserved] 

335.072 Key personnel. 

Authority: 5 U.S.C. 301; 40 U.S.C. 

121(c)(2). 

335.070 Cost-sharing. 

335.070–1 Policy. 

(a) Contracting activities should 

encourage contractors to contribute to 

the cost of performing research and 

development (R&D), through the use of 

cost-sharing contracts, where there is a 

probability that the contractor will 

receive present or future benefits from 

participation as described in FAR 

16.303. Examples include increased 

technical know-how, training for 

employees, acquisition of equipment, 

development of a commercially viable 

product that can be sold in the 

commercial market and use of 

background knowledge in future 

contracts. Cost-sharing is intended to 

serve the mutual interests of the 

Government and its contractors by 

helping to ensure efficient utilization of 

the resources available for the conduct 

of R&D projects and by promoting sound 

planning and prudent fiscal policies of 

the contractor. The Government’s 

interest includes positive impact on the 

community at large. 

(b) The contracting officer should use 

a cost-sharing contract for R&D 

contracts, unless the contracting officer 

determines that a request for costsharing would not be appropriate. 

(c) Any determination made by a 

contracting officer as described in this 

section shall be evidenced by 

appropriate documentation in the 

contract file. 

335.070–2 Amount of cost-sharing. 

When cost-sharing is appropriate, the 

contracting officer shall use the 

following guidelines to determine the 

amount of cost participation by the 

contractor: 

(a) The amount of cost participation 

depends on the extent to which the R&D 

effort or results are likely to enhance the 

contractor’s capability, expertise, or 

competitive position, and the value of 

this enhancement to the contractor. 

Therefore, contractor cost participation 

could reasonably range from as little as 

one percent or less of the total project 

cost to more than 50 percent of the total 

project cost. Ultimately, cost-sharing is 

a negotiable item. As such, the amount 

of cost-sharing shall be proportional to 

the anticipated value of the contractor’s 

gain. 

(b) If the contractor will not acquire 

title to, or the right to use, inventions, 

patents, or technical information 

resulting from the R&D project, it is 

normally appropriate to obtain less costsharing than in cases in which the 

contractor acquires these rights. 

(c) If the R&D is expected to be of only 

minor value to the contractor, and if a 

statute does not require cost-sharing, it 

may be appropriate for the contractor to 

make a contribution in the form of a 

reduced fee or profit rather than sharing 

costs of the project. Alternatively a 

limitation on indirect cost rates might 


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be appropriate. See FAR 42.707. See 

also, FAR 16.303. 

(d) The contractor’s participation may 

be considered over the total term of the 

project, so that a relatively high 

contribution in 1 year may be offset by 

a relatively low contribution in another. 

Care must be exercised that the intent to 

cost-share in future years does not 

become illusory. Redetermination of the 

cost sharing arrangement might be 

appropriate depending on future 

circumstances. 

(e) A relatively low degree of costsharing may be appropriate, if an area of 

R&D requires special stimulus in the 

national interest. 

335.070–3 Method of cost-sharing. 

Cost-sharing on individual contracts 

may be accomplished either by a 

contribution of part or all of one or more 

elements of allowable cost of the work 

being performed or by a fixed amount or 

stated percentage of the total allowable 

costs of the project. Contractors shall 

not charge costs contributed to the 

Government under any other instrument 

(e.g., grant or contract), including 

allocations to other instruments as part 

of any independent R&D program. 

335.071 [Reserved] 

335.072 Key personnel. 

If the contracting officer determines 

that the personnel to be assigned to 

perform effort on an R&D contract are 

critical to the success of the R&D effort, 

or were a critical factor in the award of 

the contract, then the contracting officer 

should consider using the key personnel 

clause at 352.237–75, Key Personnel. 

PART 336—CONSTRUCTION AND 

ARCHITECT–ENGINEER CONTRACTS 

Subpart 336.1—General 

Sec. 

336.104 Policy. 

Subpart 336.5—Contract Clause 

336.570 Contract Clause. 

Authority: 5 U.S.C. 301; 40 U.S.C. 

121(c)(2). 

Subpart 336.1—General 

336.104 Policy. 

Contracting officers shall follow the 

policies described in Federal 

Acquisition Regulation 36.104 and the 

guidance promulgated by the 

Department of Health and Human 

Services Facilities Management. 

Subpart 336.5—Contract Clause 

336.570 Contract clause. 

(a) The contracting officer shall insert 

the clause at 352.236–70, Design-Build 

Contracts, in all solicitations and 

contracts for all design-build 

requirements. 

(b) The contracting officer shall use 

Alternate I to the clause at 352.236–70, 

Design-Build Contracts, in all 

solicitations and contracts for 

construction when Fast-Track 

procedures are being used. 

(c) Due to the importance of 

maintaining consistency in the 

contractor’s personnel during designbuild construction, the contracting 

officer should consider including the 

clause at 352.237–75, Key personnel. 

PART 337—SERVICE 

CONTRACTING—GENERAL 

Subpart 337.1—Service Contracts—General 

Sec. 

337.103 Contracting officer responsibility. 

Authority: 5 U.S.C. 301; 40 U.S.C. 

121(c)(2). 

Subpart 337.1—Service Contracts— 

General 

337.103 Contracting officer responsibility. 

(d)(1) The contracting officer shall 

insert the clause at 352.237–70, ProChildren Act, in solicitations, contracts, 

and orders that involve: 

(i) Kindergarten, elementary, or 

secondary education or library services; 

or 

(ii) Health or daycare services that are 

provided to children under the age of 18 

on a routine or regular basis pursuant to 

the Pro-Children Act of 1994 (20 U.S.C. 

6081–6084). 

(2) The contracting officer shall insert 

the clause at 352.237–71, Crime Control 

Act—Reporting of Child Abuse, in 

solicitations, contracts, and orders that 

require performance on Federal land or 

in a federally operated (or contracted) 

facility and involve the professions/

activities performed by persons 

specified in the Crime Control Act of 

1990 (42 U.S.C. 13031) including, but 

not limited to, teachers, social workers, 

physicians, nurses, dentists, health care 

practitioners, optometrists, 

psychologists, emergency medical 

technicians, alcohol or drug treatment 

personnel, child care workers and 

administrators, emergency medical 

technicians and ambulance drivers. 

(3) The contracting officer shall insert 

the clause at 352.237–72, Crime Control 

Act—Requirement for Background 

Checks, in solicitations, contracts, and 

orders that involve providing child care 

services to children under the age of 18, 

including social services, health and 

mental health care, child- (day) care, 

education (whether or not directly 

involved in teaching), and rehabilitative 

programs covered under the Crime 

Control Act of 1990 (42 U.S.C. 13041). 

(4) Contracting officers supporting 

IHS shall insert the clause at 352.237– 

73, Indian Child Protection and Family 

Violence Act in all solicitations, 

contracts, and orders when performance 

of the contract may involve regular 

contact with or control over Indian 

children. The required declaration shall 

also be included in Section J of the 

solicitation and contract. 

(e) The contracting officer shall insert 

the clause at 352.237–74, NonDiscrimination in Service Delivery, in 

solicitations, contracts, and orders to 

deliver services under HHS’ programs 

directly to the public. 

(f) The contracting officer shall insert 

the clause at 352.237–75, Key 

Personnel, in solicitations and contracts 

when the contracting officer will require 

the contractor to designate contractor 

key personnel. 

PART 339—ACQUISITION OF 

INFORMATION TECHNOLOGY 

Subpart 339.1—General 

Sec. 

339.101 Policy. 

Subpart 339.2—Electronic and Information 

Technology 

339.203 Applicability. 

339.203–70 Contract clauses for electronic 

and information technology (EIT) 

acquisitions. 

339.204 Exceptions. 

339.204–1 Approval of exceptions. 

339.205 Section 508 accessibility standards 

for contracts. 

Authority: 5 U.S.C. 301; 40 U.S.C. 

121(c)(2). 

Subpart 339.1—General 

339.101 Policy. 

In addition to the regulatory guidance 

in Federal Acquisition Regulation part 

39, contracting officers shall collaborate 

with the requiring activity to ensure 

information technology (IT) acquisitions 

for supplies, services, and systems meet 

the requirements established by the 

Department of Health and Human 

Services (HHS). 

Subpart 339.2—Electronic and 

Information Technology 

339.203 Applicability. 

(a) Electronic and information 

technology (EIT) supplies and services 

must comply with Section 508 of the 

Rehabilitation Act (the 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 (Access 

Board) Electronic and Information 


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Accessibility Standards (36 CFR part 

1194). Requiring activities must consult 

with their Section 508 Official or 

designee to determine if the contractor 

should be responsible for compliance 

with EIT accessibility standards which 

apply to Web site content and 

communications material (in any 

format, such as reports, documents, 

charts, posters, presentations, or video 

material) that is specifically intended 

for publication on, or delivery via, an 

HHS-owned or -funded Web site, or 

whether these types of deliverables can 

be made compliant by the Government 

through other means. For deliverables 

made compliant by the Government 

through other means, the contract 

should not include accessibility 

standards. 

(1) When conducting a procurement 

and employing the Best Value 

Continuum, the solicitation shall 

include a separate technical evaluation 

factor developed by the Contracting 

Officer, requiring activity, and the 

Operating Division (OPDIV) Section 508 

Official or designee. 

(2) At a minimum, solicitations for 

supplies and services shall require the 

submission of a Section 508 Product 

Assessment Template (See http://

hhs.gov/web/508 for the template). 

Solicitations for services shall include 

any other pertinent information that the 

contracting officer deems necessary to 

evaluate the offeror’s ability to meet the 

applicable Section 508 accessibility 

standards. 

(3) The HHS Operating Division/Staff 

Division (OPDIV/STAFFDIV) Section 

508 Official or designee is responsible 

for providing technical assistance in 

development of Section 508 evaluation 

factors. 

(4) Before conducting negotiations or 

making an award, the contracting officer 

shall provide a summary of the Source 

Selection Evaluation Team’s (SSET) 

assessment of offeror responses to the 

solicitation’s Section 508 evaluation 

factor. This summary shall be submitted 

for review by the Section 508 Official or 

designee. The Section 508 Official or 

designee shall indicate approval/

disapproval of the SSET assessment. 

The contracting officer shall coordinate 

the resolution of any issues raised by 

the Section 508 Official or designee 

with the chair of the SSET or requiring 

activity representative, as appropriate. 

The acquisition process shall not 

proceed until the Section 508 Official or 

designee approves the SSET assessment. 

The contracting officer shall include the 

assessment in the official contract file. 

See 339.204–1 regarding processing 

exception determination requests. 

(b) When acquiring commercial items, 

if no commercially available supplies or 

services meet all of the applicable 

Section 508 accessibility standards, 

OPDIVs or STAFFDIVs shall, under the 

direction and approval of the Section 

508 Official or designee, acquire the 

supplies and services that best meet the 

applicable Section 508 accessibility 

standards. Process exception 

determinations for EIT supplies and 

services not meeting applicable Section 

508 accessibility standards in 

accordance with 339.204–1. 

339.203–70 Contract clauses for electronic 

and information technology (EIT) 

acquisitions. 

(a) The contracting officer shall insert 

the provision at 352.239–73, Electronic 

and Information Technology 

Accessibility Notice, in all solicitations. 

(b) The contracting officer shall insert 

the clause at 352.239–74, Electronic and 

Information Technology Accessibility, 

in all contracts and orders. 

339.204 Exceptions. 

339.204–1 Approval of exceptions. 

(a) Procedures to document exception 

and determination requests are set by 

the OPDIV Section 508 Official. 

(b) In the development of an 

acquisition plan (AP) or other 

acquisition request document, the 

contracting officer shall ensure that all 

Section 508 exception determination 

requests for applicable EIT requirements 

are: 

(1) Documented and certified in 

accordance with the requirements of 

paragraph 4.3, Section 508 Compliance 

Exceptions, of the HHS Section 508 

policy; 

(2) Signed by the requestor in the 

requiring activity; 

(3) approved by the OPDIV Section 

508 Official or designee; and 

(4) Included in the AP or other 

acquisition request document provided 

by the requiring activity to the 

contracting office. 

(c) For instances with an existing 

technical evaluation and no 

organization’s proposed supplies or 

services meet all of the Section 508 

accessibility standards; in order to 

proceed with the acquisition, the 

requiring activity shall provide an 

exception determination request along 

with the technical evaluation team’s 

assessment of the Section 508 

evaluation factor to the designated 

Section 508 Official or designee for 

review and approval or disapproval. 

The contracting officer shall include the 

Section 508 Official’s or designee’s 

approval or disapproval of the exception 

determination request in the official 

contract file and reference it, as 

appropriate, in all source selection 

documents. For further information, see 

HHS Section 508 Policy on http://

hhs.gov/web/508. 

339.205 Section 508 accessibility 

standards for contracts. 

(a) Section 508 of the Rehabilitation 

Act of 1973 (29 U.S.C. 794(d)), as 

amended by the Workforce Investment 

Act of 1998 (Section 508), specifies the 

applicable accessibility standards for all 

new solicitations and new or existing 

contracts or orders, regardless of EIT 

dollar amount. 

(b) The requiring activity shall consult 

with the OPDIV or STAFFDIV Section 

508 Official or designee, as necessary, to 

determine the applicability of Section 

508, identify applicable Section 508 

accessibility standards, and resolve any 

related issues before forwarding a 

request to the contracting or 

procurement office for the acquisition of 

EIT supplies and services—including 

Web site content and communications 

material for which the contractor must 

meet EIT accessibility standards. 

(c) Based on those discussions, the 

requiring activity shall provide a 

statement in the AP (or other acquisition 

request document) for Section 508 

applicability. See 307.105. If Section 

508 applies to an acquisition, include 

the provision at 352.239–73, Electronic 

and Information Technology and 

Accessibility Notice, language in a 

separate, clearly designated, section of 

the statement of work or performance 

work statement, along with any 

additional information applicable to the 

acquisition’s Section 508 accessibility 

standards (e.g., the list of applicable 

accessibility standards of the Access 

Board EIT Accessibility Standards (36 

CFR part 1194)). If an AP does not 

address Section 508 applicability and it 

appears an acquisition involves Section 

508, or if the discussion of Section 508 

applicability to the acquisition is 

inadequate or incomplete, the 

contracting officer shall request the 

requiring activity modify the AP 

accordingly. 

(d) Items provided incidental to 

contract administration are not subject 

to this section. 

(e) The OPDIV Section 508 Official or 

designee may, at his or her discretion, 

require review and approval of 

solicitations and contracts for EIT 

supplies and services. 


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SUBCHAPTER G—CONTRACT 

MANAGEMENT 

PART 342—CONTRACT 

ADMINISTRATION 

Subpart 342.7—Indirect Cost Rates 

Sec. 

342.705 Final indirect cost rates. 

Authority: 5 U.S.C. 301; 40 U.S.C. 

121(c)(2). 

Subpart 342.7—Indirect Cost Rates 

342.705 Final indirect cost rates. 

Contract actions for which the 

Department of Health and Human 

Services is the cognizant Federal 

agency: 

(a) The Financial Management 

Services (FMS), Division of Cost 

Allocation, Program Support Center 

(PSC)), shall establish facilities and 

administration costs, also known as 

indirect cost rates, research patient care 

rates, and, as necessary, fringe benefits, 

computer, and other special costing 

rates for use in contracts awarded to 

State and local governments, colleges 

and universities, hospitals, and other 

nonprofit organizations. 

(b) The National Institutes of Health 

(NIH) Division of Financial Advisory 

Services, shall establish indirect cost 

rates and similar rates for use in 

contracts awarded to for profit 

organizations. 

SUBCHAPTER H—CLAUSES AND FORMS 

PART 352—SOLICITATION 

PROVISIONS AND CONTRACT 

CLAUSES 

Subpart 352.1—Instructions for Using 

Provisions and Clauses 

Sec. 

352.100 Scope of subpart. 

352.101–70 Application of provisions and 

clauses. 

Subpart 352.2—Texts of Provisions and 

Clauses 

352.203–70 Anti-lobbying. 

352.204–70 Prevention and Public Health 

Fund-Reporting Requirements. 

352.208–70 Printing and Duplication. 

352.211–1 Accessibility of meetings, 

conferences, and seminars to persons 

with disabilities. 

352.211–2 Conference sponsorship request 

and conference materials disclaimer. 

352.211–3 Paperwork Reduction Act. 

352.215–70 Late proposals and revisions. 

352.216–70 Additional cost principles. 

352.219–70 Mentor-prote ́ge ́ program. 

352.219–71 Mentor-prote ́ge ́ program 

reporting requirements. 

352.222–70 Contractor cooperation in equal 

employment opportunity investigations. 

352.223–70 Safety and health. 

352.223–71 Instructions to Offerors– 

Sustainable Acquisition. 

352.224–70 Privacy Act. 

352.224–71 Confidential Information. 

352.226–1 Indian preference. 

352.226–2 Indian preference program. 

352.226–3 Native American Graves 

Protection and Repatriation Act. 

352.227–11 Patent Rights—Exceptional 

Circumstances. 

352.227–14 Rights in Data—Exceptional 

Circumstances. 

352.227–70 Publications and publicity. 

352.231–70 Salary rate limitation. 

352.232–70 Incremental Funding. 

352.233–70 Choice of law (overseas). 

352.233–71 Litigation and claims. 

352.236–70 Design-Build Contracts. 

352.237–70 Pro-Children Act. 

352.237–71 Crime Control Act—reporting 

of child abuse. 

352.237–72 Crime Control Act— 

requirement for background checks. 

352.237–73 Indian Child Protection and 

Family Violence Act. 

352.237–74 Non-Discrimination in Service 

Delivery. 

352.237–75 Key personnel. 

352.239–73 Electronic Information and 

Technology Accessibility Notice. 

352.239–74 Electronic Information and 

Technology Accessibility. 

352.270–1 [Reserved] 

352.270–2 [Reserved] 

352.270–3 [Reserved] 

352.270–4a Notice to Offerors, Protection of 

Human Subjects. 

352.270–4b Protection of Human Subjects. 

352.270–5a Notice to Offerors of 

Requirement for Compliance with the 

Public Health Service Policy on Humane 

Care and Use of Laboratory Animals. 

352.270–5b Care of Live Vertebrate 

Animals. 

352.270–6 Restriction on use of Human 

Subjects. 

352.270–7 [Reserved] 

352.270–8 [Reserved] 

352.270–9 Non-discrimination for 

conscience. 

352.270–10 Notice to Offerors—Protection 

of Human Subjects, Research Involving 

Human Subjects Committee (RIHSC) 

Approval of Research Protocols 

Required. 

352.270–11 Protection of Human Subjects, 

Research Involving Human Subjects 

Committee (RIHSC) Approval of 

Research Protocols Required. 

352.270–12 Needle Exchange. 

352.270–13 Continued Ban on Funding 

Abortion and Continued Ban on Funding 

of Human Embryo Research. 

Authority: 5 U.S.C. 301; 40 U.S.C. 

121(c)(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 (e.g., in an indefinite 

delivery/indefinite quantity contract or 

a blanket purchase agreement), it is not 

necessary to also include the clause in 

a task order or delivery order 

thereunder. 

(b) When a dollar amount or dollar 

threshold is specified (e.g., $25 million 

or simplified acquisition threshold), the 

dollar amount of the award (contract or 

order) includes any options thereunder. 

Subpart 352.2—Texts of Provisions 

and Clauses 

352.203–70 Anti-lobbying. 

As prescribed in 303.808–70, the 

Contracting Officer shall insert the 

following clause: 

Anti-Lobbying (Date) 

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; 

(b) The preparation, distribution, or use of 

any kit, pamphlet, booklet, publication, 

electronic communication, radio, television, 

or video presentation designed to support or 

defeat the enactment of legislation before the 

Congress or any State or local legislature or 

legislative body, except in presentation to the 

Congress or any state or local legislature 

itself; or designed to support or defeat any 

proposed or pending regulation, 

administrative action, or order issued by the 

executive branch of any state or local 

government, except in presentation to the 

executive branch of any state or local 

government itself; or 

(c) Payment of salary or expenses of the 

Contractor, or any agent acting for the 

Contractor, related to any activity designed to 

influence the enactment of legislation, 

appropriations, regulation, administrative 

action, or Executive order proposed or 

pending before the Congress or any state 

government, state legislature or local 

legislature or legislative body, other than for 

normal and recognized executive-legislative 

relationships or participation by an agency or 

officer of a state, local, or tribal government 

in policymaking and administrative 

processes within the executive branch of that 

government. 

(d) The prohibitions in subsections (a), (b), 

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 

requirement for, or restriction on, any legal 

consumer product, including its sale or 

marketing, including, but not limited to, the 

advocacy or promotion of gun control. 

(End of clause) 

352.204–70 Prevention and Public Health 

Fund—Reporting Requirements. 

As prescribed in HHSAR 304.7201, 

insert the following clause: 


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Prevention And Public Health Fund— 

Reporting Requirements (Date) 

(a) Pursuant to Public Law 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, sec. 4002. Section 220(b)(5) 

requires each contractor to report on its use 

of these funds under this contract. These 

reports will be made available to the public. 

(b) Semi-annual reports from the 

Contractor for all work 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 reporting periods are 

January through June and July through 

December. The first report is due no later 

than 20 days after the end of the six-month 

period following contract award. Subsequent 

reports are due no later than 20 days after the 

end of each reporting period. If applicable, 

the Contractor shall submit its final report for 

the remainder of the contract period no later 

than 20 days after the end of the reporting 

period in which the contract ended. 

(c) The Contractor shall provide the 

following information in an electronic and 

Section 508 compliant format to the 

Contracting Officer. 

(1) The Government contract and order 

number, as applicable. 

(2) The amount of PPHF funds invoiced by 

the contractor for the reporting period and 

the cumulative amount invoiced for the 

contract or order. 

(3) A list of all significant services 

performed or supplies delivered, including 

construction, for which the contractor 

invoiced in the reporting period. 

(4) Program or project title, if any. 

(5) The Contractor shall report any 

subcontract funded in whole or in part with 

PPHF funding, that is valued at $25,000 or 

more. The Contractor shall advise the 

subcontractor that the information will be 

made available to the public. The Contractor 

shall report: 

(i) Name and address of the subcontractor. 

(ii) Amount of the subcontract award. 

(iii) Date of the subcontract award. 

(iv) A description of the products or 

services (including construction) being 

provided under the subcontract. 

(End of clause) 

352.208–70 Printing and Duplication. 

As prescribed in 308.803, the 

Contracting Officer shall insert the 

following clause: 

Printing and Duplication (Date) 

(a) Unless otherwise specified in this 

contract, no printing by the Contractor 

or any subcontractor is authorized 

under this contract. All printing 

required must be performed by the 

Government Publishing Office except as 

authorized by the Contracting Officer. 

The Contractor shall submit cameraready 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) If necessary for performance of the 

contract, the Contractor may duplicate 

or copy less than 5,000 production units 

of only one page, or less than 25,000 

production units in aggregate of 

multiple pages for the use of a 

department or agency. A production 

unit is defined as one sheet, size 8.5 x 

11 inches, one side only, and one color. 

The pages may not exceed a maximum 

image size of 10–3/4 by 14–1/4 inches. 

This page limit applies to each printing 

requirement and not for all printing 

requirements under the entire contract. 

(c) Approval for all printing, as well 

as duplicating/copying in excess of the 

stated limits, shall be obtained from the 

COR who will consult with the 

designated publishing services office 

and provide direction to the contractor. 

The cost of any unauthorized printing or 

duplicating/copying under this contract 

will be considered an unallowable cost 

for which the Contractor will not be 

reimbursed. 

352.211–1 Accessibility of meetings, 

conferences, and seminars to persons with 

disabilities. 

As prescribed in 311.7102, the 

Contracting Officer shall insert the 

following clause: 

Accessibility of Meetings, Conferences, and 

Seminars to Persons with Disabilities (Date) 

The Contractor agrees as follows: 

(a) Except for ad hoc meetings necessary or 

incidental to contract performance, the 

Contractor shall develop a plan to assure that 

any meeting, conference, or seminar held 

pursuant to this contract will meet or exceed 

the minimum accessibility standards set forth 

in 28 CFR part 36. The Contractor shall 

submit the plan to the Contracting Officer 

Representative for approval prior to initiating 

action. The Contractor may submit a 

consolidated or master plan for contracts 

requiring numerous meetings, conferences, or 

seminars in lieu of separate plans. 

(b) The Contractor shall manage the 

contract in accordance with the standards set 

forth in 28 CFR part 36. 

352.211–2 Conference sponsorship 

request and conference materials 

disclaimer. 

As prescribed in 311.7202, the 

Contracting Officer shall insert the 

following clause: 

Conference Sponsorship Request and 

Conference Materials Disclaimer (Date) 

(a) If HHS is not the sole provider 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. 

(b) Whether or not HHS is the conference 

sponsor, the Contractor shall include the 

following statement on conference materials, 

including promotional materials, agendas, 

and Web sites: 

‘‘This conference was funded, in whole or 

in part, through a contract (insert contract 

number) with the Department of Health and 

Human Services (HHS) (insert name of 

OPDIV or STAFFDIV). The views expressed 

in written conference materials and by 

speakers and moderators at this conference, 

do not necessarily reflect the official policies 

of HHS, nor does mention of trade names, 

commercial practices, or organizations imply 

endorsement by the U.S. Government.’’ 

(c) Unless authorized in writing by the 

Contracting Officer, the Contractor shall not 

display the HHS logo on any conference 

materials. 

(End of clause) 

352.211–3 Paperwork Reduction Act. 

As prescribed in 311.7301, the 

Contracting Officer shall insert the 

following clause: 

Paperwork Reduction Act (Date) 

(a) This contract involves a requirement 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 scope of their 

employment, for use by the Federal 

government or disclosure to third parties; 

therefore, the Paperwork Reduction Act of 

1995 (44 U.S.C. 3501 et seq.) shall apply to 

this contract. No plan, questionnaire, 

interview guide or other similar device for 

collecting information (whether repetitive 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 part 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 clearance. 

(b) The Contractor shall not expend any 

funds or begin any data collection until the 

Contracting Officer provides the Contractor 

with written notification authorizing the 

expenditure of funds and the collection 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 control and without the fault or 

negligence of the Contractor in accordance 

with the Excusable Delays or Default clause 

of this contract. 

(End of clause) 

352.215–70 Late proposals and revisions. 

As prescribed in 315.208, the 

Contracting Officer shall insert the 

following provision: 

Late Proposals and Revisions (Date) 

Deviation 

Notwithstanding the procedures contained 

in FAR 52.215–1(c)(3) of the provision of this 

solicitation entitled Instructions to Offerors— 

Competitive Acquisition, the Government 


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may consider a proposal received after the 

date specified for receipt if it appears to offer 

significant cost or technical advantage to the 

Government and it was received before 

proposals were distributed for evaluation, or 

within 5 calendar days after the exact time 

specified for receipt, whichever is earlier. 

(End of provision) 

352.216–70 Additional cost principles. 

As prescribed in 316.307(a)(2), the 

Contracting Officer shall insert the 

following clause: 

Additional Cost Principles (Date) 

(a) Bid and proposal (B&P) costs. (1) B&P 

costs are the immediate costs of preparing 

bids, proposals, and applications for 

potential Federal and non-Federal contracts, 

grants, and agreements, including the 

development of scientific, cost, and other 

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 accounting periods 

are unallowable in the current period. 

However, if the organization’s established 

practice is to treat these costs by some other 

method, they may be accepted if they are 

found to be reasonable and equitable. 

(4) B&P costs do not include independent 

research and development (IR&D) costs 

covered by the following paragraph, or preaward costs covered by paragraph 36 of 

Attachment B to OMB Circular A–122. 

(b) IR&D costs. (1) IR&D is research and 

development conducted by an organization 

which is not sponsored by Federal or nonFederal contracts, grants, or other 

agreements. 

(2) IR&D shall be allocated its 

proportionate share of indirect costs on the 

same basis as the allocation of indirect costs 

to sponsored research and development. 

(3) The cost of IR&D, including its 

proportionate share of indirect costs, is 

unallowable. 

(End of clause) 

352.219–70 Mentor-prote ́ge ́ program. 

As prescribed in 319.270–1(a), the 

Contracting Officer shall insert the 

following provision: 

Mentor-Prote ́ge ́ Program (Date) 

(a) Large business prime contractors 

serving as mentors in the HHS MentorProte ́ge ́ 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-prote ́ge ́

agreements as part of their offers. The 

amount of credit provided by the Contracting 

Officer to a mentor firm for prote ́ge ́ firm 

developmental assistance costs shall be 

calculated on a dollar for dollar basis and 

reported by the mentor firm in the Summary 

Subcontract Report via the Electronic 

Subcontracting Reporting System (eSRS) at 

www.esrs.gov. The mentor firm and prote ́ge ́

firm shall submit to the Contracting Officer 

a signed joint statement agreeing on the 

dollar value of the developmental assistance 

the mentor firm provided. (For example, a 

mentor firm would report a $10,000 

subcontract awarded to a prote ́ge ́ firm and 

provision of $5,000 of developmental 

assistance as $15,000 of subcontracting plan 

credit.) The mentor firm may use this 

additional credit towards attaining its 

subcontracting plan participation goal under 

this contract. 

(b) The program consists of— 

(1) Mentor firms—large businesses that: 

(i) Demonstrate the interest, commitment, 

and capability to provide developmental 

assistance to small business prote ́ge ́ firms; 

and 

(ii) Have a Mentor-Prote ́ge ́ agreement 

approved by HHS’ OSDBU; 

(2) Prote ́ge ́ firms—firms that: 

(i) Seek developmental assistance; 

(ii) Qualify as small businesses, veteranowned small businesses, service-disabled 

veteran-owned small businesses, HUBZone 

small businesses, small disadvantaged 

businesses, or woman-owned small 

businesses; and 

(iii) Have a Mentor-Prote ́ge ́ agreement 

approved by HHS’ OSDBU; and 

(3) Mentor-Prote ́ge ́ agreements—joint 

agreements, approved by HHS’ OSDBU, 

which detail the specific terms, conditions, 

and responsibilities of the mentor-prote ́ge ́

relationship. 

(End of provision) 

352.219–71 Mentor-prote ́ge ́ program 

reporting requirements. 

As prescribed in 319.270–1(b), the 

Contracting Officer shall insert the 

following clause: 

Mentor-Prote ́ge ́ Program Reporting 

Requirements (January 2010) 

The Contractor shall comply with all 

reporting requirements specified in its 

Mentor-Prote ́ge ́ agreement approved by HHS’ 

OSDBU. 

(End of clause) 

352.222–70 Contractor cooperation in 

equal employment opportunity 

investigations. 

As prescribed in 322.810(h), the 

Contracting Officer shall insert the 

following clause: 

Contractor Cooperation in Equal 

Employment Opportunity Investigations 

(Date) 

(a) In addition to complying with the 

clause at FAR 52.222–26, Equal Opportunity, 

the Contractor shall, in good faith, cooperate 

with the Department of Health and Human 

Services (Agency) in investigations of Equal 

Employment Opportunity (EEO) complaints 

processed pursuant to 29 CFR part 1614. For 

purposes of this clause, the following 

definitions apply: 

(1) Complaint means a formal or informal 

complaint that has been lodged with Agency 

management, Agency EEO officials, the Equal 

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 also includes 

current employees of subcontractors who 

work or worked under this contract. In the 

case of Contractor and subcontractor 

employees—who worked under this contract, 

but who are no longer employed by the 

Contractor or subcontractor, or who have 

been assigned to another entity within the 

Contractor’s or subcontractor’s organization, 

the Contractor shall provide the Agency with 

that employee’s last known mailing address, 

email address, and telephone number, if that 

employee has been identified as a witness in 

an EEO complaint or investigation. 

(3) Good faith cooperation cited in 

paragraph (a) includes, but is not limited to, 

making Contractor employees available for: 

(i) Formal and informal interviews by EEO 

counselors or other Agency officials 

processing EEO complaints; 

(ii) Formal or informal interviews by EEO 

investigators charged with investigating 

complaints of unlawful discrimination filed 

by Federal employees; 

(iii) Reviewing and signing appropriate 

affidavits or declarations summarizing 

statements provided by such Contractor 

employees during the course of EEO 

investigations; 

(iv) Producing documents requested by 

EEO counselors, EEO investigators, Agency 

employees, or the EEOC in connection with 

a pending EEO complaint; and 

(v) Preparing for and providing testimony 

in depositions or in hearings before the 

MSPB, EEOC and U.S. District Court. 

(b) The Contractor shall include the 

provisions of this clause in all subcontract 

solicitations and subcontracts awarded at any 

tier under this contract. 

(c) Failure on the part 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) 

352.223–70 Safety and health. 

As prescribed in 323.7002, the 

Contracting Officer shall insert the 

following clause: 

Safety and Health (Date) 

(a) To help ensure the protection 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 levels. 

(1) In addition, the Contractor shall comply 

with the following regulations when 

developing and implementing health and 

safety operating procedures and practices for 

both personnel and facilities involving the 

use or handling of hazardous materials and 

the conduct of research, development, or test 

projects: 

(i) 29 CFR 1910.1030, Bloodborne 

pathogens; 29 CFR 1910.1450, Occupational 

exposure to hazardous chemicals in 

laboratories; and other applicable 


asabaliauskas on DSK5VPTVN1PROD with PROPOSALS
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occupational health and safety standards 

issued by OSHA and included in 29 CFR part 

1910. These regulations are available at 

http://www.osha.gov. 

(ii) 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 

Commission, Washington, DC 20555–0001. 

(2) The following Government guidelines 

are recommended for developing and 

implementing health and safety operating 

procedures and practices for both personnel 

and facilities: 

(i) Biosafety in Microbiological and 

Biomedical Laboratories, CDC. This 

publication is available at http://

www.cdc.gov/biosafety/publications/

index.htm. 

(ii) 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 http://

www.nap.edu/catalog/4911.html. 

(b) Further, the Contractor shall take or 

cause to be taken additional safety measures 

as the Contracting Officer, in conjunction 

with the Contracting Officer’s Representative 

or other appropriate officials, determines to 

be reasonably necessary. If compliance with 

these additional safety measures results in an 

increase or decrease in the cost or time 

required for performance of any part of work 

under this contract, the Contracting Officer 

will make an equitable adjustment in 

accordance with the applicable ‘‘Changes’’ 

clause set forth in this contract. 

(c) 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 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 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 notice 

of violation and the findings of any inquiry 

or inspection, and an analysis addressing the 

impact these violations may have on the 

work remaining to be performed. The report 

shall also state the required action(s), if any, 

to be taken to correct any violation(s) noted 

by the Federal, State, or local regulatory/

enforcement agency and the time frame 

allowed by the agency to accomplish the 

necessary corrective action. 

(d) If the Contractor fails or refuses to 

comply with the Federal, State or local 

regulatory/enforcement agency’s directive(s) 

regarding any violation(s) and prescribed 

corrective action(s), the Contracting Officer 

may issue an order stopping all or part 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 part of the time lost due to any 

such stop work order shall form the basis for 

a request for extension or costs or damages 

by the Contractor. 

(e) The Contractor shall insert the 

substance of this clause in each subcontract 

involving toxic substances, hazardous 

materials, or hazardous operations. The 

Contractor is responsible for the compliance 

of its subcontractors with the provisions of 

this clause. 

(End of clause) 

352.223–71 Instructions to Offerors— 

Sustainable Acquisition. 

As prescribed in 323.7103, the 

Contracting Officer shall insert the 

following provision: 

Instructions to Offerors—Sustainable 

Acquisition (Date) 

Offerors must include a Sustainable 

Acquisition Plan in their technical proposals. 

The Plan must describe their approach and 

the quality assurance mechanisms in place 

for applying FAR 23.1, Sustainable 

Acquisition Policy (and other Federal laws, 

regulations and Executive Orders governing 

sustainable acquisition purchasing) to this 

acquisition. The Plan shall clearly identify 

those products and services included in 

Federal sustainable acquisition preference 

programs by categorizing them along with 

their respective price/cost in the following 

eight groups: Recycled Content, Energy 

Efficient, Biobased, Environmentally 

Preferable, Electronic Product Environment 

Assessment Tool, Water-Efficient, NonOzone Depleting Substances, and Alternative 

Fuel Vehicle and Alternative Fuels. 

(End of provision) 

352.224–70 Privacy Act. 

As prescribed in 324.105(a), the 

Contracting Officer shall insert the 

following clause: 

Privacy Act (Date) 

This contract requires the Contractor to 

perform one or more of the following: (a) 

design; (b) develop; or (c) operate a Federal 

agency system of records to accomplish an 

agency function in accordance 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 individual or by some 

identifying number, symbol, or other 

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 part 5b and that each 

employee is aware that he/she is subject to 

criminal penalties for violation of the Act to 

the same extent as Department of Health and 

Human Services employees. These 

provisions also apply to all subcontracts the 

Contractor awards under this contract which 

require the design, development or operation 

of the designated system(s) of records (5 

U.S.C. 552a(m)(1)). The contract work 

statement: 

(a) Identifies the system(s) of records and 

the design, development, or operation work 

the Contractor is to perform; and 

(b) Specifies the disposition to be made of 

such records upon completion of contract 

performance. 

(End of clause) 

352.224–71 Confidential Information. 

As prescribed in 324.105(b), insert the 

following clause: 

Confidential Information (Date) 

(a) Confidential Information, as used in 

this clause, means information or data of a 

personal nature about an individual, or 

proprietary information or data submitted by 

or pertaining to an institution or 

organization. 

(b) 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 

contract to identify Confidential Information 

from time to time during performance. 

(c) Confidential Information or records 

shall not be disclosed by the Contractor until: 

(1) Written advance notice of at least 45 

days shall be provided to the Contracting 

Officer of the Contractor’s intent to release 

findings of studies or research, to which an 

agency response may be appropriate to 

protect the public interest or that of the 

agency. 

(2) For information provided by or on 

behalf of the government, 

(i) The publication or dissemination of the 

following types of information are restricted 

under this contract: [INSERT RESTRICTED 

TYPES OF INFORMATION. IF NONE, SO 

STATE.] 

(ii) The reason(s) for restricting the types 

of information identified in subparagraph (i) 

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.] 

(iii) Written advance notice 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. 

(d) Whenever the Contractor is uncertain 

with regard to the confidentiality of or a 

property interest in information under this 

contract, the Contractor should consult with 

the Contracting Officer prior to any release, 

disclosure, dissemination, or publication. 


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352.226–1 Indian Preference. 

As prescribed in 326.505(a), the 

Contracting Officer shall insert the 

following clause: 

Indian Preference (Date) 

(a) The Contractor agrees to give preference 

in employment opportunities under this 

contract to Indians who can perform required 

work, regardless of age (subject to existing 

laws and regulations), sex, religion, or tribal 

affiliation. To the extent feasible and 

consistent with the efficient performance of 

this contract, the Contractor further agrees to 

give preference in employment and training 

opportunities under this contract to Indians 

who are not fully qualified to perform 

regardless of age (subject to existing laws and 

regulations), sex, religion, or tribal affiliation. 

The Contractor also agrees to give preference 

to Indian organizations and Indian-owned 

economic enterprises in the awarding of any 

subcontracts to the extent feasible and 

consistent with the efficient performance of 

this contract. The Contractor shall maintain 

the necessary statistical records to 

demonstrate compliance with this paragraph. 

(b) In connection with the Indian 

employment preference requirements of this 

clause, the Contractor shall provide 

reasonable opportunities for training, 

incident to such employment. Such training 

shall include on-the-job, classroom, or 

apprenticeship training designed to increase 

the vocational effectiveness of an Indian 

employee. 

(c) If the Contractor is unable to fill its 

employment and training opportunities after 

giving full consideration 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 

contract entitled ‘‘Equal Opportunity.’’ 

(d) If no Indian organizations or Indianowned economic enterprises are available 

under reasonable terms and conditions, 

including price, for awarding of subcontracts 

in connection with the work performed 

under this contract, the Contractor agrees to 

comply with the provisions of this contract 

involving utilization of small businesses; 

HUBZone small businesses; service-disabled, 

veteran-owned small businesses; 8(a) small 

businesses; veteran-owned small businesses; 

women-owned small businesses; or small 

disadvantaged businesses. 

(e) As used in this clause, 

(1) Indian means a person who is a 

member of an Indian tribe. If the Contractor 

has reason to doubt that a person seeking 

employment preference is an Indian, the 

Contractor shall grant the preference but 

shall require the individual provide evidence 

within 30 days from the tribe concerned that 

the person is a member 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 

corporation 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 special 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 accordance 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 profit, provided 

that such Indian ownership shall constitute 

not less than 51 percent 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 (f) of this clause, in each 

subcontract awarded at any tier under this 

contract. 

(g) In the event of noncompliance with this 

clause, the Contracting Officer may terminate 

the contract in whole or in part or may 

pursue any other remedies authorized by law 

or by other provisions of the contract. 

(End of clause) 

352.226–2 Indian Preference Program. 

As prescribed in 326.505(b), the 

Contracting Officer shall insert the 

following clause: 

Indian Preference Program (Date) 

(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 training in connection with the work 

performed under this contract, and which 

will expand the opportunities for Indian 

organizations and Indian-owned economic 

enterprises to receive a preference in the 

awarding of subcontracts. In this connection, 

the Contractor shall perform the following: 

(1) Designate a liaison officer who will 

maintain liaison with the Government and 

the Tribe(s) on Indian preference matters; 

supervise compliance with the provisions of 

this clause; and administer the Contractor’s 

Indian preference program. 

(2) Advise its recruitment sources in 

writing and include a statement in all 

employment advertisements that Indian 

applicants receive preference in employment 

and training incident to such employment. 

(3) Not more than 20 calendar days after 

award of the contract, post a written notice 

setting forth the Contractor’s employment 

needs and related training opportunities in 

the tribal office of any reservations on or near 

the contract work location. The notice shall 

include the approximate numbers and types 

of employees needed; the approximate dates 

of employment; any experience or special 

skills required for employment; training 

opportunities available; and other pertinent 

information necessary to advise prospective 

employees of any other employment 

requirements. The Contractor shall also 

request the tribe(s) on or near whose 

reservation(s) the Contractor will perform 

contract work to provide assistance filling its 

employment needs and training 

opportunities. The Contracting Officer will 

advise the Contractor of the name, location, 

and phone number of the Tribal officials to 

contact regarding the posting of notices and 

requests for Tribal assistance. 

(4) Establish and conduct a subcontracting 

program which gives preference to Indian 

organizations and Indian-owned economic 

enterprises as subcontractors (including 

suppliers) under this contract. The 

Contractor shall give public notice of existing 

subcontracting opportunities and, to the 

extent feasible and consistent with the 

efficient performance of this contract, shall 

solicit bids or proposals from Indian 

organizations or Indian-owned economic 

enterprises only. The Contractor shall request 

assistance 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, location, 

and phone number of the Tribal officials to 

contact regarding the request for assistance 

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— 

(i) A clear description of the supplies or 

services required, including quantities, 

specifications, and delivery schedules that 

facilitate the participation of Indian firms; 

(ii) A statement indicating that Indian 

organizations and Indian-owned economic 

enterprises will receive preference in 

accordance with section 7(b) of Pub. L. 93– 

638; 88 Stat. 2205; 25 U.S.C. 450e(b); 

(iii) Definitions for the terms ‘‘Indian 

organization’’ and ‘‘Indian-owned economic 

enterprise’’ prescribed under the ‘‘Indian 

Preference’’ clause of this contract; 

(iv) A statement that the bidder or offeror 

shall complete certifying that it is an Indian 

organization or Indian-owned economic 

enterprise; and 

(v) A closing date for receipt of bids or 

proposals which provides sufficient time for 

preparation and submission of a bid or 

proposal. If, after soliciting bids or proposals 

from Indian organizations and Indian-owned 

economic enterprises, the Contractor receives 

no responsive bid or acceptable proposal, the 

Contractor shall comply with the 

requirements of paragraph (d) of the ‘‘Indian 

Preference’’ clause of this contract. If the 

Contractor receives one or more responsive 

bids or conforming proposals, the Contractor 

shall award the contract to the low, 

responsive, responsible bidder or conforming 

offer from a responsible offeror if the price 

is reasonable. If the Contractor determines 

the low responsive bid or conforming 

proposal’s price is unreasonable, the 

Contractor shall attempt to negotiate a 

reasonable price and award a subcontract. If 

parties cannot agree on a reasonable price, 

the Contractor shall comply with the 

requirements of paragraph (d) of the ‘‘Indian 

Preference’’ clause of this contract. 

(5) Maintain written records under this 

contract which demonstrate— 

(i) The numbers of Indians seeking 

employment for each employment position 

available under this contract; 

(ii) The number and types of positions 

filled by Indians and non-Indians; 


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(iii) The total number of Indians employed 

under this contract; 

(iv) For those positions having both Indian 

and non-Indian applicants, and a non-Indian 

is selected for employment, the reason(s) 

why the Contractor did not select the Indian 

applicant; 

(v) Actions taken to give preference to 

Indian organizations and Indian-owned 

economic enterprises for subcontracting 

opportunities which exist under this 

contract; 

(vi) Reasons why Indian subcontractors 

and or suppliers did not receive preference 

for each requirement where the Contractor 

determined that such preference was 

inconsistent with efficient contract 

performance; and 

(vii) The number of Indian organizations 

and Indian-owned economic enterprises 

contacted, and the number receiving 

subcontract awards under this contract. 

(6) Submit to the Contracting Officer for 

approval a quarterly report summarizing the 

Contractor’s Indian preference program and 

indicating the number and types of available 

positions filled by Indians and non-Indians, 

and the dollar amounts of all subcontracts 

awarded to Indian organizations and Indianowned economic enterprises, and to all other 

firms. 

(7) Maintain records pursuant to this 

clause and keep them available for review by 

the Government for one year after final 

payment under this contract, or for such 

longer period in accordance with 

requirements of any other clause of this 

contract or by applicable law or regulation. 

(b) For purposes of this clause, the 

following 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 

contract entitled Indian Preference. 

(2) Indian reservation includes Indian 

reservations, public domain Indian 

allotments, former Indian reservations in 

Oklahoma, and land held by incorporated 

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 

area surrounding an Indian reservation(s) 

where a person seeking employment could 

reasonably expect to commute to and from in 

the course of a work day. 

(c) Nothing in the requirements of this 

clause shall preclude Indian tribes from 

independently developing and enforcing 

their own Indian preference requirements. 

Such requirements must not conflict with 

any Federal statutory or regulatory 

requirement dealing with the award and 

administration of contracts. 

(d) The Contractor agrees to include the 

provisions of this clause, including this 

paragraph (d), in each subcontract awarded at 

any tier under this contract and to notify the 

Contracting Officer of such subcontracts. 

(e) In the event of noncompliance with this 

clause, the Contracting Officer may terminate 

the contract in whole or in part or may 

pursue any other remedies authorized by law 

or by other provisions of the contract. 

(End of clause) 

352.226–3 Native American Graves 

Protection and Repatriation Act. 

As prescribed in 326.701, the 

Contracting Officer shall insert the 

following clause: 

Native American Graves Protection and 

Repatriation Act (Date) 

(a) Public Law 101–601, dated November 

16, 1990, also 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 

human remains, associated funerary objects, 

unassociated funerary objects, sacred objects 

and cultural patrimony), as defined in the 

Act during contract performance, the 

Contractor shall— 

(i) Immediately cease activity in the area of 

the discovery; 

(ii) Notify the Contracting Officer of the 

discovery; and 

(iii) Make a reasonable effort to protect the 

items discovered before resuming such 

activity. Upon receipt of the Contractor’s 

discovery notice, the Contracting Officer will 

notify the appropriate authorities as required 

by the Act. 

(c) Unless otherwise specified by the 

Contracting Officer, the Contractor may 

resume activity in the area on the 31st 

calendar day following the date that the 

appropriate authorities certify receipt 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. 

352.227–11 Patent Rights—Exceptional 

Circumstances. 

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 described 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 Subject 

Invention described 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 ‘‘[insert description].’’ 

Invention means any invention or 

discovery, which is or may be patentable or 

otherwise protectable under Title 35 of 

United States Code, or any novel variety 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 to any 

invention other than a plant variety, the 

conception or first actual reduction to 

practice of such invention; or when used in 

relation to a plant variety, that the Contractor 

has at least tentatively determined that the 

variety has been reproduced with recognized 

characteristics. 

Material means any proprietary material, 

method, product, composition, compound, or 

device, whether patented or unpatented, 

which is provided to the Contractor under 

this contract. 

Nonprofit organization means a university 

or other institution of higher education or an 

organization of the type described in section 

501(c)(3) of the Internal Revenue Code of 

1954 (26 U.S.C. 501(c)) and exempt from 

taxation under section 501(a) of the Internal 

Revenue Code (26 U.S.C. 501(a)) or any 

nonprofit scientific or educational 

organization qualified under a state nonprofit 

organization statute. 

Practical application means to 

manufacture, in the case of a composition or 

product; to practice, in the case of a process 

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 law 

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 purpose of this 

clause, the size standards for small business 

concerns involved in Government 

procurement and subcontracting 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. 

(b) Allocation of principal rights. (1) 

Retention of pre-existing rights. Third party 

assignees shall retain all preexisting rights to 

Material in which the Third party assignee 

has a proprietary interest. 

(2) Allocation of Subject Invention rights. 

(i) Disposition of Class 1 Subject Inventions. 

(A) Assignment 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 otherwise dispose 

of or transfer those rights as directed by the 

Agency, except to the extent that rights are 

retained by the Contractor under paragraph 

(b)(3) of this clause. Any such assignment or 

other disposition or transfer 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 it may retain a 


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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] 

(ii) Disposition of Class 2 and 3 Subject 

Inventions. Class 2 Subject Inventions shall 

be governed by FAR clause 52.227–11, Patent 

Rights-Ownership (December 2007) 

(incorporated herein by reference). However, 

the Contractor shall grant a license in the 

Class 2 Subject Inventions to the provider of 

the Material or other party designated by the 

Agency as set forth in Alternate I. 

(iii) 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). 

(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 (b)(1) of this clause 

in accordance with the procedures of FAR 

paragraph 27.304–1(c). In addition to the 

considerations set forth in paragraph 27.304– 

1(c), the Agency may consider whether 

granting the requested greater rights will 

interfere with rights of the Government or 

any Third party assignee or otherwise 

impede the ability of the Government or the 

Third party assignee to, for example, develop 

and commercialize new compounds, dosage 

forms, therapies, preventative 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 later than 8 months thereafter, 

unless a longer period is authorized in 

writing by the Contracting Officer for good 

cause shown in writing by the Contractor. 

Each determination of greater rights under 

this contract shall be subject to paragraph (c) 

of the FAR clause 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 exclusively license the rights to Subject 

Inventions to the Third party assignee. 

A determination 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 level above the individual who made the 

determination. If greater rights are granted, 

the Contractor must file a patent application 

on the invention. Upon request, the 

Contractor shall provide the filing date, serial 

number and title, a copy of the patent 

application (including an English-language 

version if filed in a language other than 

English), and patent number and issue date 

for any Subject Invention in any country 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 

Subject 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 

(j) of this clause 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 contract under which the 

invention was Made and all inventors. It 

shall be sufficiently complete in technical 

detail to convey a clear understanding to the 

extent known at the time of the disclosure, 

of the nature, purpose, operation, and the 

physical, chemical, biological, or electrical 

characteristics of the invention. The 

disclosure shall also identify any publication, 

on sale (offer for sale), or public use of the 

invention and whether a manuscript 

describing the invention has been submitted 

for publication, and if so, 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 

acceptance 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 Subject 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 patent, including the 

cost of the Contractor’s assistance, are at the 

Third party’s expense. Any assistance 

provided by the Contractor and its employee 

inventors to the Third party assignee or other 

costs incurred in securing patent protection 

shall be solely at the Third party’s expense 

and not billable to the contract. 

(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 world in 

Subject Inventions pursuant to paragraph (b) 

of this clause; convey title to a Third party 

assignee in accordance with paragraph (b) of 

this clause; and enable the Third party 

assignee to obtain patent protection 

throughout the world 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 responsible for the 

administration 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 clause, 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 (c)(1) of this clause. The 

Contractor shall instruct such employees, 

through employee agreements or other 

suitable educational programs, on the 

importance of reporting inventions in 

sufficient time to permit the filing of patent 

applications prior 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 patent application it files, 

and any patent issuing thereon, covering a 

Subject Invention the following statement: 

‘‘This invention was made with Government 

support 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 final 

invention statement and certification prior to 

the closeout of the contract listing all Subject 

Inventions or stating that there were none. 

(e) Subcontracts. (1) The Contractor will 

include this clause in all subcontracts, 

regardless of tier, for experimental, 

developmental, or research work. 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 clause. The Contractor 

will not, as part of the consideration for 

awarding the contract, obtain rights in the 

subcontractor’s Subject Inventions. 

(2) In subcontracts, at any tier, the Agency, 

the subcontractor, and the Contractor agree 

that the mutual 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 

jurisdiction under the Contract Disputes Act 

in connection with proceedings under 

paragraph (c)(1)(ii) 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 annually on the 

utilization of a Subject Invention or on efforts 

at obtaining such utilization 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 use, gross royalties 

received by the Contractor, and such other 

data and information as the Agency may 

reasonably specify. The Contractor also 

agrees to provide additional reports as may 

be requested by the Agency in connection 

with any march-in proceeding undertaken by 

the Agency in accordance with paragraph (h) 

of this clause. 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 permission of the 

Contractor. 

(g) Preference for United States industry in 

the event greater rights are granted to the 

Contractor. Notwithstanding any other 

provision of this clause, the Contractor agrees 

that neither it nor any assignee will grant to 


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any person the exclusive right to use or sell 

any Subject Invention in the United States 

unless such person agrees that any product 

embodying the Subject Invention or 

produced through the use of the Subject 

Invention will be manufactured substantially 

in the United States. However, in individual 

cases, the requirement for such an agreement 

may be waived by the Agency upon a 

showing by the Contractor or its assignee that 

reasonable but unsuccessful efforts have been 

made to grant licenses on similar terms to 

potential licensees that would be likely to 

manufacture substantially in the United 

States or that under the circumstances 

domestic manufacture is not commercially 

feasible. 

(h) 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 

clause, the Agency has the right to require 

licensing pursuant to 35 U.S.C. 203 and 

210(c), and in accordance with the 

procedures in 37 CFR 401.6 and any 

supplemental regulations of Agency in effect 

on the date of contract award. 

(i) Special provisions for contracts with 

nonprofit organizations in the event greater 

rights are granted to the Contractor. If the 

Contractor is a nonprofit organization, it 

shall: 

(1) Not assign rights to a Subject 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 primary functions the 

management of inventions, provided that the 

assignee shall be subject to the same 

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 accordance with 35 U.S.C. 202(e) 

and 37 CFR 401.10; 

(3) Use the balance of any royalties or 

income earned by the Contractor with respect 

to Subject Inventions, after payment of 

expenses (including payments to inventors) 

incidental to the administration of Subject 

Inventions for the support of scientific 

research or education; 

(4) Make efforts that are reasonable under 

the circumstances to attract licensees of 

Subject Inventions that are small business 

concerns, and give a preference to a small 

business concern when licensing a Subject 

Invention if the Contractor determines that 

the small business concern has a plan or 

proposal for marketing the invention which, 

if executed, is equally as likely to bring the 

invention to practical application as any 

plans or proposals from applicants that are 

not small business concerns; provided, that 

the Contractor is also satisfied that the small 

business concern has the capability and 

resources to carry out its plan or proposal. 

The decision whether to give a preference in 

any specific case will be at the discretion of 

the Contractor; and 

(5) Allow the Secretary of Commerce to 

review the Contractor’s licensing program 

and decisions regarding small business 

applicants, and negotiate changes to its 

licensing policies, procedures, or practices 

with the Secretary of Commerce when the 

Secretary’s review discloses that the 

Contractor could take reasonable steps to 

more effectively implement the requirements 

of paragraph (i)(4) of this clause. 

(j) 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, confirmatory licenses to the 

Government, face page of the patent 

applications, waivers and other routine 

communications under this funding 

agreement at all tiers must be sent to: 

[Insert Agency Address] 

Agency Invention Reporting Web site: 

http://www.iEdison.gov. 

Alternate I (Sept 2014). As prescribed in 

327.303, the license to Class 2 inventions 

recited in 352.227–11(b)(2)(a) is as follows: 

[Insert description of license to Class 2 

inventions] 

(End of clause) 

352.227–14 Rights in Data—Exceptional 

Circumstances. 

As prescribed in 327.409(b)(1), insert 

the following clause with any 

appropriate 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 information 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 

computer software. 

Computer software—(i) Means (A) 

Computer programs that comprise a series of 

instructions, rules, routines, or statements, 

regardless of the media in which recorded, 

that allow or cause a computer to perform a 

specific operation or series of operations; and 

(B) Recorded information comprising 

source code listings, design details, 

algorithms, processes, flow charts, formulas, 

and related material that would enable the 

computer program to be produced, created, 

or compiled. 

(ii) Does not include computer databases or 

computer software documentation. 

Computer software documentation means 

owner’s manuals, user’s manuals, installation 

instructions, operating instructions, and 

other similar items, regardless of storage 

medium, that explain the capabilities of the 

computer software or provide instructions for 

using the software. 

Data means recorded information, 

regardless of form or the media on which it 

may be recorded. The term includes 

technical data and computer software. The 

term does not include information incidental 

to contract administration, such as financial, 

administrative, cost 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 interchangeability, and data 

identifying source, size, configuration, 

mating and attachment characteristics, 

functional characteristics, and performance 

requirements. For computer software it 

means data identifying source, functional 

characteristics, and performance 

requirements but specifically excludes the 

source code, algorithms, processes, formulas, 

and flow charts of the software. 

Limited rights means the rights of the 

Government in limited rights data as set forth 

in the Limited Rights Notice in Alternate II 

paragraph (g)(3) if included in this clause. 

‘‘Limited rights data’’ means data, other than 

computer software, that embody trade secrets 

or are commercial or financial and 

confidential or privileged, to the extent that 

such data pertain to items, components, or 

processes developed at private expense, 

including minor modifications. 

Restricted computer software means 

computer software developed at private 

expense and that is a trade secret, is 

commercial or financial and confidential or 

privileged, or is copyrighted computer 

software, including minor modifications of 

the computer software. 

Restricted rights, as used in this clause, 

means the rights of the Government in 

restricted computer software, as set forth in 

a Restricted Rights Notice of Alternate III 

paragraph (g)(4) if included in this clause, or 

as otherwise may be provided in a collateral 

agreement incorporated in and made part of 

this contract, including minor modifications 

of such computer software. 

Technical data means recorded 

information (regardless of the form or method 

of the recording) of a scientific or technical 

nature (including computer databases and 

computer software documentation). This 

term does not include computer software or 

financial, administrative, cost or pricing, or 

management data or other information 

incidental to contract administration. The 

term includes recorded information of a 

scientific or technical 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 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 so. 

(b) Allocation of rights. (1) Except as 

provided in paragraph (c) of this clause, the 

Government shall have unlimited rights in— 

(i) Data first produced in the performance 

of this contract; 

(ii) Form, fit, and function data delivered 

under this contract; 

(iii) Data delivered under this contract 

(except for restricted computer software) that 

constitute manuals or instructional and 

training material for installation, operation, 

or routine maintenance and repair of items, 

components, or processes delivered or 

furnished for use under this contract; and 

(iv) All other data delivered under this 

contract unless provided otherwise for 

limited rights data or restricted computer 

software in accordance with paragraph (g) of 

this clause. 

(2) The Contractor shall have the right to— 


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(i) Assert copyright in data first produced 

in the performance of this contract to the 

extent provided in paragraph (c)(1) of this 

clause; 

(ii) Use, release to others, reproduce, 

distribute, or publish any data first produced 

or specifically used by the Contractor in the 

performance of this contract, unless provided 

otherwise in paragraph (d) of this clause; 

(iii) Substantiate the use of, add, or correct 

limited rights, restricted rights, or copyright 

notices and to take other appropriate action, 

in accordance with paragraphs (e) and (f) of 

this clause; and 

(iv) Protect from unauthorized disclosure 

and use those data that are limited rights data 

or restricted computer software to the extent 

provided in paragraph (g) of this clause. 

(c) Copyright. (1) Data first produced in the 

performance of this contract. (i) Unless 

provided otherwise in paragraph (d) of this 

clause, the Contractor may, without prior 

approval of the Contracting Officer, assert 

copyright in scientific and technical articles 

based on or containing data first produced in 

the performance of this contract and 

published in academic, technical or 

professional journals, symposia proceedings, 

or similar works. The prior, express written 

permission of the Contracting Officer is 

required to assert copyright in all other data 

first produced in the performance of this 

contract. 

(ii) When authorized to assert copyright to 

the data, the Contractor shall affix the 

applicable copyright notices of 17 U.S.C. 401 

or 402, and an acknowledgment of 

Government sponsorship (including contract 

number). 

(iii) 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 

in such copyrighted data to reproduce, 

prepare derivative 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, 

worldwide license in such copyrighted 

computer software to reproduce, prepare 

derivative 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 first produced in the 

performance of this contract. The Contractor 

shall not, without the prior written 

permission of the Contracting Officer, 

incorporate in data delivered under this 

contract any data not first produced in the 

performance of this contract unless the 

Contractor— 

(i) Identifies the data; and 

(ii) Grants to the Government, or acquires 

on its behalf, a license of the same scope as 

set forth in paragraph (c)(1) of this clause or, 

if such data are restricted computer software, 

the Government shall acquire a copyright 

license as set forth in paragraph (g)(4) of this 

clause (if included in this contract) or as 

otherwise provided in a collateral agreement 

incorporated in or made part of this contract. 

(3) Removal of copyright notices. The 

Government will not remove any authorized 

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, distribute, or 

publish any data first produced or 

specifically used by the Contractor in the 

performance of this contract, except— 

(1) As prohibited by Federal law or 

regulation (e.g., 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 performance 

of this contract 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 following 

paragraphs. 

(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 patent 

protection on such inventions. Accordingly, 

the Contractor will provide the Contracting 

Officer a copy of any publication or other 

public disclosure relating to the work 

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 specified paper for 

a reasonable time specified by the 

Contracting Officer, not to exceed 6 months, 

to allow for the filing of domestic and 

international patent applications in 

accordance with Clause 352.227–11, Patent 

Rights—Exceptional Circumstances 

(abbreviated month and year of Final Rule 

publication). 

(5) Data on Material(s). The Contractor 

agrees that in accordance with paragraph 

(d)(2), proprietary data on Material(s) 

provided to the Contractor under or through 

this contract shall be used only for the 

purpose for which they were provided, 

including screening, evaluation or 

optimization and for no other purpose. 

(6) Confidentiality. (i) 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. 

(ii) Contractor shall maintain Confidential 

Information as confidential unless 

specifically authorized otherwise in writing 

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 

contract are marked with the notices 

specified in paragraph (g)(3) or (4) of this 

clause (if those alternate paragraphs are 

included in this clause), and use of the 

notices is not authorized by this clause, or if 

the data bears any other restrictive or limiting 

markings not authorized by this contract, 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 inquiry to the Contractor affording 

the Contractor 60 days from receipt of the 

inquiry to provide written justification to 

substantiate the propriety of the markings; 

(ii) If the Contractor fails to respond or fails 

to provide written justification to 

substantiate the propriety of the markings 

within the 60-day period (or a longer time 

approved in writing by the Contracting 

Officer for good cause shown), the 

Government shall have the right to cancel or 

ignore the markings at any time after said 

period and the data will no longer be made 

subject to any disclosure prohibitions. 

(iii) If the Contractor provides written 

justification to substantiate the propriety of 

the markings within the period set in 

paragraph (e)(1)(i) of this clause, 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 so notified 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 

determination will become the final Agency 

decision regarding the appropriateness of the 

markings unless the Contractor files suit in 

a court of competent jurisdiction within 90 

days of receipt of the Contracting Officer’s 

decision. The Government will continue to 

abide by the markings under this paragraph 

(e)(1)(iii) until final resolution of the matter 

either by the Contracting Officer’s 

determination becoming final (in which 

instance the Government will thereafter have 

the right to cancel or ignore the markings at 

any time and the data will no longer be made 

subject to any disclosure prohibitions), or by 

final disposition of the matter by court 

decision if suit is filed. 

(2) The time limits in the procedures set 

forth in paragraph (e)(1) of this clause may 

be modified in accordance with Agency 

regulations implementing the Freedom of 

Information Act (5 U.S.C. 552) if necessary to 

respond to a request there under. 

(3) Except to the extent the Government’s 

action occurs as the result of final disposition 

of the matter by a court of competent 

jurisdiction, the Contractor is not precluded 

by this paragraph (e) from bringing a claim, 

in accordance with the Disputes clause of 

this contract, that may arise as the result of 

the Government removing or ignoring 

authorized markings on data delivered under 

this contract. 

(f) 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 time approved 


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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 omitted 

notice is to be applied; 

(ii) Demonstrates that the omission of the 

notice was inadvertent; 

(iii) Establishes that the proposed notice is 

authorized; and 

(iv) Acknowledges that the Government 

has no liability for the disclosure, use, or 

reproduction of any data made prior to the 

addition of the notice 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 notice at the 

Contractor’s expense if the Contractor 

identifies the data and demonstrates that the 

correct notice is authorized; or 

(ii) Correct any incorrect 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 paragraphs (b)(1)(i) through (iii) 

of this clause. As a condition to this 

withholding, the Contractor shall— 

(i) Identify the data being withheld; and 

(ii) Furnish form, fit, and function data 

instead. 

(2) Limited rights data that are formatted as 

a computer database for delivery to the 

Government shall be treated as limited rights 

data and not restricted computer software. 

(3) [Reserved] 

(h) Subcontracting. The Contractor shall 

obtain from its subcontractors all data and 

rights therein necessary to fulfill the 

Contractor’s obligations to the Government 

under this contract. 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 authorization in writing from 

the Contracting Officer. 

(i) Relationship 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. 

(End of clause) 

Alternate I (Sept 2014). As prescribed in 

327.409, substitute the following definition 

for ‘‘limited rights data’’ in paragraph (a) of 

the basic clause: 

Limited rights data means data, other than 

computer software, developed at private 

expense that embody trade secrets or are 

commercial or financial and confidential or 

privileged. 

Alternate II (Sept 2014). As prescribed in 

327.409, insert the following paragraph (g)(3) 

in the basic clause: 

(g)(3) Notwithstanding paragraph (g)(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 delivery of limited rights 

data that has been withheld or would 

otherwise be entitled to be withheld. If 

delivery of that data is required, the 

Contractor shall affix the following ‘‘Limited 

Rights Notice’’ to the data and the 

Government will treat the data, subject to the 

provisions of paragraphs (e) and (f) of this 

clause, in accordance with the notice: 

Limited Rights Notice (Sept 2014) 

(a) These data are submitted with limited 

rights under Government Contract No. __(and 

subcontract __, if appropriate). These data 

may be reproduced and used by the 

Government with the express limitation that 

they will not, without written permission of 

the Contractor, be used for purposes of 

manufacture nor disclosed outside the 

Government; except that the Government 

may disclose these data outside the 

Government for the following purposes, if 

any; provided that the Government makes 

such disclosure subject to prohibition against 

further use and disclosure: Agencies may list 

additional purposes or if none, so state. 

(b) This notice shall be marked on any 

reproduction of these data, in whole or in 

part. 

(End of notice) 

Alternate III (Sept 2014). As prescribed in 

327.409, insert the following paragraph (g)(4) 

in the basic clause: (g)(4)(i) Notwithstanding 

paragraph (g)(1) of this clause, the contract 

may identify and specify the delivery of 

restricted computer software, or the 

Contracting Officer may require by written 

request the delivery 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 

following ‘‘Restricted Rights Notice’’ to the 

computer software and the Government will 

treat the computer software, subject to 

paragraphs (e) and (f) of this clause, in 

accordance with the notice: 

Restricted Rights Notice (Sept 2014) 

(a) This computer software is submitted 

with restricted rights under Government 

Contract No. ____ (and subcontract ____, if 

appropriate). It may not be used, reproduced, 

or disclosed by the Government except as 

provided in paragraph (b) of this notice or as 

otherwise expressly stated in the contract. 

(b) This computer software may be— 

(1) Used or copied for use with the 

computer(s) for which it was acquired, 

including use at any Government installation 

to which the computer(s) may be transferred; 

(2) Used or copied for use with a backup 

computer if any computer for which it was 

acquired is inoperative; 

(3) Reproduced for safekeeping (archives) 

or backup purposes; 

(4) Modified, adapted, or combined with 

other computer software, provided that the 

modified, adapted, or combined portions of 

the derivative software incorporating any of 

the delivered, restricted computer software 

shall be subject to the same restricted rights; 

(5) Disclosed to and reproduced for use by 

support service Contractors or their 

subcontractors in accordance with 

paragraphs (b)(1) through (4) of this notice; 

and 

(6) Used or copied for use with a 

replacement computer. 

(c) Notwithstanding the foregoing, if this 

computer software is copyrighted computer 

software, it is licensed to the Government 

with the minimum rights set forth in 

paragraph (b) of this notice. 

(d) Any other rights or limitations 

regarding the use, duplication, 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 part. 

(End of notice) 

(ii) Where it is impractical to include the 

Restricted Rights Notice on restricted 

computer software, the following short-form 

notice may be used instead: 

Restricted Rights Notice Short Form (Sept 

2014) 

Use, reproduction, or disclosure is subject 

to restrictions set forth in Contract No. __

(and subcontract, if appropriate) with __

(name of Contractor and subcontractor). 

(End of notice) 

(iii) If restricted computer software is 

delivered with the copyright notice 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 clause. 

Alternate IV (Sept 2014). As prescribed in 

327.409, substitute the following paragraph 

(c)(1) for paragraph (c)(1) of the basic clause: 

(c) Copyright—(1) Data first produced in 

the performance of the contract. Except as 

otherwise specifically provided in this 

contract, the Contractor may assert copyright 

in any data first produced in the performance 

of this contract. When asserting copyright, 

the Contractor shall affix the applicable 

copyright notice of 17 U.S.C. 401 or 402, and 

an acknowledgment of Government 

sponsorship (including contract number), to 

the data when such data are delivered to the 

Government, as well as when the data are 

published or deposited for registration as a 

published work 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, 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, 

worldwide license for all such computer 

software to reproduce, prepare derivative 

works, and perform publicly and display 

publicly (but not to distribute copies to the 

public), by or on behalf of the Government. 

Alternate V (Sept 2014). As prescribed in 

327.409, add the following paragraph (j) 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 acceptance of all 

deliverables under this contract, inspect at 


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the Contractor’s facility any data withheld 

pursuant to paragraph (g)(1) of this clause, for 

purposes of verifying the Contractor’s 

assertion of limited rights or restricted rights 

status 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 

alternate inspector. 

(End of clause) 

352.227–70 Publications and publicity. 

As prescribed in 327.404–70(a), the 

Contracting Officer shall insert the 

following clause: 

Publications and Publicity (Date) 

(a) Unless otherwise specified in this 

contract, the Contractor may publish the 

results of its work under this contract. The 

Contractor shall promptly send a copy of 

each article submitted for publication to the 

Contracting Officer’s Representative. The 

Contractor shall also inform the Contracting 

Officer’s Representative when the article or 

other publication is published, and furnish a 

copy of it as finally published. 

(b) Unless authorized in writing by the 

Contracting Officer, the Contractor shall not 

display the HHS logo including Operating 

Division or Staff Division logos on any 

publications. 

(c) The Contractor shall not reference the 

product(s) 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 approval or 

endorsement of the product(s) or service(s) 

provided. 

(d) The contractor shall include this clause, 

including this section (d) in all subcontracts 

where the subcontractor may propose 

publishing the results of its work under the 

subcontract. 

(End of clause) 

352.231–70 Salary rate limitation. 

As prescribed in 331.101–70(b), the 

Contracting Officer shall insert the 

following clause: 

Salary Rate Limitation (Date) 

(a) The Contractor shall not use contract 

funds to pay the direct salary of an 

individual at a rate in excess of the Federal 

Executive Schedule Level II in effect on the 

date the funding was obligated. 

(b) For purposes of the salary rate 

limitation, the terms ‘‘direct salary,’’ 

‘‘salary,’’ and ‘‘institutional base salary,’’ 

have the same meaning and are collectively 

referred to as ‘‘direct salary,’’ in this clause. 

An individual’s direct salary is the annual 

compensation that the Contractor pays for an 

individual’s direct effort (costs) under the 

contract. Direct salary excludes any income 

that an individual may be permitted to earn 

outside of duties to the Contractor. Direct 

salary also excludes fringe benefits, 

overhead, and general and administrative 

expenses (also referred to as indirect costs or 

facilities and administrative costs). 

The salary rate limitation does not restrict 

the salary that an organization may pay an 

individual working under a Department of 

Health and Human Services contract or 

order; it merely limits the portion of that 

salary that may be paid with contract funds. 

(c) The salary rate limitation also applies 

to individuals under subcontracts. 

(d) If this is a multiple-year contract or 

order, it may be subject to unilateral 

modification by the Contracting Officer to 

ensure that an individual is not paid at a rate 

that exceeds the salary rate 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 salary levels. 

(End of clause) 

352.232–70 Incremental Funding. 

As prescribed in 332.706–2(b), the 

Contracting Officer shall insert the 

provision provided below in all 

solicitations when a cost-reimbursement 

contract for severable services using 

incremental funding is contemplated. 

Incremental Funding (Date) 

The Government intends to negotiate and 

award a cost-reimbursement contract using 

incremental funding as described in the 

clause at FAR 52.232–22, ‘‘Limitation of 

Funds’’. The initial obligation of funds under 

the contract is expected to cover [insert the 

appropriate increment of performance]. The 

Government intends to obligate additional 

funds up to and including the full estimated 

cost of the contract for the remaining periods 

of performance by unilateral contract 

modification. However, the Government is 

not required to reimburse the Contractor for 

costs incurred in excess of the total amount 

obligated, nor is the Contractor required to 

perform beyond the level supported by the 

total amount obligated. 

(End of provision) 

352.233–70 Choice of law (overseas). 

As prescribed in 333.215–70(a), the 

Contracting Officer shall insert the 

following clause: 

Choice of Law (Overseas) (Date) 

This contract shall be construed in 

accordance with the substantive laws of the 

United States of America. By the execution 

of this contract, the Contractor expressly 

agrees to waive any rights to invoke the 

jurisdiction of local national courts where 

this contract is performed and agrees to 

accept the exclusive jurisdiction 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 contract. 

(End of clause) 

352.233–71 Litigation and claims. 

As prescribed in 333.215–70(b), the 

Contracting Officer shall insert the 

following clause: 

Litigation and Claims (Date) 

(a) The Contractor shall provide written 

notification immediately to the Contracting 

Officer of any action, including any 

proceeding before an administrative agency, 

filed against the Contractor arising out of the 

performance of this contract, including, but 

not limited to the performance of any 

subcontract hereunder; and any claim against 

the Contractor the cost and expense of which 

is allowable under the clause entitled 

‘‘Allowable Cost and Payment.’’ 

(b) 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 respect to 

such action or claim. To the extent not in 

conflict with any applicable policy of 

insurance, the Contractor may, with the 

Contracting Officer’s approval, settle any 

such action or claim. If required by the 

Contracting Officer, the Contractor shall 

effect an assignment and subrogation in favor 

of the Government of all the Contractor’s 

rights and claims (except those against the 

Government) arising out of any such 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 action. 

(c) If the Government undertakes a 

settlement or defense of an action or claim, 

the Contractor shall furnish all reasonable 

assistance in effecting a settlement or 

asserting a defense. Where an action against 

the Contractor is not covered by a policy of 

insurance, the Contractor shall, with the 

approval of the Contracting Officer, proceed 

with the defense of the action in good faith. 

The Government shall not be liable for the 

expense of defending any action or for any 

costs resulting from the loss thereof to the 

extent that the Contractor would have been 

compensated by insurance which was 

required by other terms or conditions of this 

contract, by law or regulation, or by written 

direction 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 liability 

loss, cost, or expense, which the Contractor 

may incur or be subject to by reason of any 

loss, injury or damage, to the person or to 

real or personal property of any third parties 

as may accrue during, or arise from, the 

performance of this contract. 

(End of clause) 

352.236–70 Design-Build Contracts. 

As prescribed in 336.570(a), the 

Contracting Officer shall insert the 

following clause: 

Design-Build Contracts (Date) 

(a) General. (1) The contract 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: 


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(i) The solicitation in its entirety (with the 

exception of instructions to offerors and 

evaluation criteria which do not become part 

of the award document); 

(ii) The specifications and statement of 

work; 

(iii) All drawings, cuts and illustrations, 

included in the solicitation and any 

amendments during all proposal phases 

leading up to award; 

(iv) Exhibits and other attachments; and 

(v) The successful Offeror’s accepted 

proposal. 

(2) In the event of conflict or inconsistency 

between any of the requirements of the 

various portions of this contract, precedence 

shall be given in the following order: 

(i) Betterments: Any portions of the 

Offeror’s proposal which exceed the 

requirements of the solicitation and which go 

beyond repair and improve the value of the 

property. 

(ii) The contract clauses and schedules 

included during the solicitation or at the time 

of award. 

(iii) All requirements (other than 

betterments) of the accepted proposal. 

(iv) Any design products, including but not 

limited to plans, specifications, engineering 

studies and analyses, shop drawings, 

equipment installation drawings, etc. These 

are ‘‘deliverables’’ under the contract and are 

not part of the contract itself. 

(3) Design products must conform to all 

requirements of the contract, in the order of 

precedence stated here. 

(b) Responsibility of the contractor for 

design. (1) The Contractor shall be 

responsible 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 contract. The 

Contractor shall, without additional 

compensation, correct or revise any errors or 

deficiency in its designs, drawings, 

specifications, and other non-construction 

services and perform any necessary rework or 

modifications, including any damage to real 

or personal property, resulting from the 

design error or omission. 

(2) Neither the Government’s review, 

approval or acceptance of, nor payment for, 

the services required under this contract 

shall be construed to operate as a waiver of 

any rights under this contract or of any cause 

of action arising out of the performance of 

this contract. The Contractor shall be and 

remain liable to the Government in 

accordance with applicable law for all 

damages to the Government caused by the 

Contractor’s negligent performance of any of 

these services furnished under this contract. 

(3) The rights and remedies of the 

Government provided for under this contract 

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 severally liable with respect 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 design is 

cleared for construction. The Government 

will not grant any time extension for any 

design resubmittal required when, in the 

opinion of the Contracting Officer, the initial 

submission failed to meet the minimum 

quality requirements as set forth in the 

Contract. 

(2) If the Government allows the Contractor 

to proceed with limited construction based 

on pending minor revisions to the reviewed 

Final Design submission, 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 payment will be made for any 

completed or in-progress construction until 

all required submittals have been made, 

reviewed, and are satisfactory to the 

Government. 

(d) Constructor’s role during design. The 

Contractor’s construction management key 

personnel shall be actively involved during 

the design process to effectively integrate the 

design and construction requirements of this 

contract. In addition to the typical required 

construction activities, the constructor’s 

involvement includes, but is not limited to 

actions such as: integrating the design 

schedule into the Master Schedule to 

maximize the effectiveness of fast-tracking 

design and construction (within the limits, if 

any, allowed in the contract), ensuring 

constructability and economy of the design, 

integrating the shop drawing and installation 

drawing process into the design, executing 

the material and equipment acquisition 

programs to meet critical schedules, 

effectively interfacing the construction 

Quality Control (QC) program with the 

design QC program, and maintaining and 

providing the design team with accurate, upto-date redline and as-built documentation. 

The Contractor shall require and manage the 

active involvement of key trade 

subcontractors in the above activities. 

(e) Preconstruction conference. (1) A 

preconstruction conference will be arranged 

by the Contracting Officer after award of 

contract and before commencement of work. 

The Contracting Officer or designated 

representative will notify the Contractor of 

the time, date, and location for the meeting. 

At this conference, the Contractor shall be 

oriented with respect to Government 

procedures and line of authority, contractual, 

administrative, and construction matters. 

(2) The Contractor shall bring to this 

conference, in completed form, a Certificate 

of Insurance, plus the following items in 

either completed or draft form: 

(i) Accident Prevention Plan; 

(ii) Quality Control Plan; 

(iii) Letter Appointing Superintendent; 

(iv) Transmittal Register; 

(v) Power of Attorney and Certified Copy 

of Resolution; 

(vi) Network Analysis System, (when 

identified in the contract schedule as 

applicable); 

(vii) List of Subcontractors; 

(viii) SF 1413; 

(ix) Performance and Payment Bonds; and 

(x) Schedule of Values. 

(3) A letter of record will be written 

documenting all items discussed at the 

conference, and a copy will be furnished by 

the Contracting Officer to all in attendance. 

(f) Payment for design under fixed-price 

design-build contracts. (1) The Contracting 

Officer may approve progress payments for 

work performed during the project design 

phase up to the maximum amount of ____ 

(Contracting Officer to insert percent figure. 

If none stated, the amount is four (4) percent) 

percent 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 acceptance of functional 

and aesthetic design elements nor acceptance 

of a final settlement amount in the event of 

a buy-out nor a waiver of any contractual 

requirements. 

(g) Unscheduled jobsite shutdowns. Due to 

security reasons during the life of this 

contract the Government may on an 

unscheduled basis require the contractor to 

shut down its jobsite for 2 days per year at 

no additional cost. This shall not constitute 

a suspension of work under FAR 52.242–14, 

Suspension of Work 

(End of clause) 

Alternate I (Date) When Fast Track 

procedures are being used, replace paragraph 

(c) of the basic clause with the following: 

(c) Sequence of design build. (1) After 

receipt of the Contract Award the Contractor 

shall initiate design, comply with all design 

submissions requirements and obtain 

Government review 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 design is cleared for construction. 

The Government will not grant any time 

extension for any design resubmittal required 

when, in the opinion of the Contracting 

Officer, the initial submission failed to meet 

the minimum quality requirements as set 

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 payment will be made for any inplace construction until all required 

submittals have been made, reviewed, and 

are satisfactory to the Government. 

(End of clause) 

352.237–70 Pro-Children Act. 

As prescribed in 337.103–70(d)(1), the 

Contracting Officer shall insert the 

following clause: 


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Pro-Children Act (Date) 

(a) Public Law 103–227, Title X, Part C, 

also known as the Pro-Children Act of 1994 

(Act), 20 U.S.C. 7183, imposes restrictions on 

smoking in facilities where certain federally 

funded children’s services are provided. The 

Act prohibits smoking within any indoor 

facility (or portion thereof), whether owned, 

leased, or contracted for, that is used for the 

routine or regular provision of: (i) 

Kindergarten, elementary, or secondary 

education or library services or (ii) health or 

day care services that are provided to 

children under the age of 18. The statutory 

prohibition also applies to indoor facilities 

that are constructed, operated, or maintained 

with Federal funds. 

(b) By acceptance of this contract or order, 

the Contractor agrees to comply with the 

requirements of the Act. The Act also applies 

to all subcontracts awarded under this 

contract for the specified children’s services. 

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. 

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 

violation and/or the imposition of an 

administrative compliance order on the 

responsible entity. Each day a violation 

continues constitutes a separate violation. 

352.237–71 Crime Control Act—Reporting 

of Child Abuse. 

As prescribed in 337.103–70(d)(2), the 

Contracting Officer shall insert the 

following clause: 

Crime Control Act of 1990—Reporting of 

Child Abuse (Date) 

(a) Public Law 101–647, also known as the 

Crime Control Act of 1990 (Act), imposes 

responsibilities on certain individuals who, 

while engaged in a professional 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 abuse. 

(b) The Act designates ‘‘covered 

professionals’’ as those persons engaged in 

professions and activities in eight different 

categories including, but not limited to, 

teachers, social workers, physicians, dentists, 

medical residents or interns, hospital 

personnel and administrators, nurses, health 

care practitioners, chiropractors, osteopaths, 

pharmacists, optometrists, podiatrists, 

emergency medical technicians, ambulance 

drivers, alcohol or drug treatment personnel, 

psychologists, psychiatrists, mental health 

professionals, child care workers and 

administrators, and commercial film and 

photo processors. The Act defines the term 

‘‘child abuse’’ as the physical or mental 

injury, sexual abuse or exploitation, or 

negligent treatment of a child. 

(c) Accordingly, any person engaged in a 

covered profession or activity under an HHS 

contract or subcontract, regardless of the 

purpose of the contract or subcontract, shall 

immediately report a suspected child abuse 

incident in accordance 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 covered 

professional failing to make a timely report 

of such incident shall be guilty of a Class B 

misdemeanor. 

(d) By acceptance of this contract or order, 

the Contractor agrees to comply with the 

requirements of the Act. The Act also applies 

to all applicable subcontracts awarded under 

this contract. 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. 

(End of clause) 

352.237–72 Crime Control Act— 

Requirement for Background Checks. 

As prescribed in 337.103–70(d)(3), the 

Contracting Officer shall insert the 

following clause: 

Crime Control Act of 1990—Requirement for 

Background Checks (Date) 

(a) Public Law 101–647, also known as the 

Crime Control Act of 1990 (Act), requires that 

all individuals involved with the provision of 

child care 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 care, child (day) care, education 

(whether or not directly involved in 

teaching), and rehabilitative programs. Any 

conviction for a sex crime, an offense 

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. 

(b) The Contracting Officer will provide the 

necessary information to the Contractor 

regarding the process for obtaining the 

background check. The Contractor may hire 

a staff person provisionally prior to the 

completion of a background check, if at all 

times prior to the receipt of the background 

check during which children are in the care 

of the newly-hired person, the person is 

within the sight and under the supervision of 

a previously investigated staff person. 

(c) By acceptance of this contract or order, 

the Contractor agrees to comply with the 

requirements of the Act. The Act also applies 

to all applicable subcontracts awarded under 

this contract. 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. 

(End of clause) 

352.237–73 Indian Child Protection and 

Family Violence Act. 

As prescribed in 337.103–(d)(4) the 

Contracting Officer shall insert the 

following clause: 

Indian Child Protection and Family Violence 

Act (Date) 

(a) This contract is subject 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 employment, including Personal 

Service Contracts, with anyone who has been 

convicted of any crime of violence. Any such 

conviction should immediately be brought to 

the attention of the Contracting Officer. The 

contractor 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 investigation, 

the contractor shall have no unsupervised 

contact with Indian children. In order to 

initiate this background investigation, the 

contractor must provide information as 

required in this contract or as directed by the 

Contracting Officer. 

(b) 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 contract. 

(End of clause) 

352.237–74 Non-Discrimination in Service 

Delivery. 

As prescribed in 337.103–70(e), the 

Contracting Officer shall insert the 

following clause in solicitations and 

contracts: 

Non-Discrimination in Service Delivery 

(Date) 

It is the policy of the Department of Health 

and Human Services that no person 

otherwise eligible will be excluded from 

participation 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, national origin, religion, sex, gender 

identity, sexual orientation, or disability 

(physical or mental). By acceptance of this 

contract, the contractor agrees to comply 

with this policy in supporting the program 

and in performing the services called for 

under this contract. The contractor shall 

include this clause in all sub-contracts 

awarded under this contract for supporting or 

performing the specified program and 

services. Accordingly, the contractor shall 

ensure that each of its employees, and any 

sub-contractor staff, is made aware of, 

understands, and complies with this policy. 

(End of clause) 

352.237–75 Key Personnel. 

As prescribed in 337.103(f), the 

Contracting Officer shall insert the 

following clause: 

Key Personnel (Date) 

The key personnel specified in this 

contract are considered to be essential to 

work performance. At least 30 days prior to 

the contractor voluntarily diverting any of 

the specified individuals to other programs 

or contracts the Contractor shall notify the 

Contracting Officer and shall submit a 

justification for the diversion or replacement 

and a request to replace the individual. The 

request must identify the proposed 

replacement and provide an explanation of 


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how the replacement’s skills, experience, and 

credentials meet or exceed the requirements 

of the contract (including, when applicable, 

Human Subjects Testing requirements). If the 

employee of the contractor is terminated for 

cause or separates from the contractor 

voluntarily with less than thirty days notice, 

the Contractor shall provide the maximum 

notice practicable under the circumstances. 

The Contractor shall not divert, replace, or 

announce any such change to key personnel 

without the written consent of the 

Contracting Officer. The contract will be 

modified to add or delete key personnel as 

necessary to reflect the agreement of the 

parties. 

(End of clause) 

352.239–73 Electronic Information and 

Technology Accessibility Notice. 

(a) As prescribed in 339.203–70(a), 

the Contracting Officer shall insert the 

following provision: 

Electronic and Information Technology 

Accessibility Notice (Date) 

(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, procure, maintain, or use 

electronic and information technology, 

Federal employees with disabilities have 

access to and use of information and data 

that is comparable to the access and use by 

Federal employees who are not individuals 

with disabilities, unless an undue burden 

would be imposed on the agency. Section 

508 also requires that individuals with 

disabilities, who are members of the public 

seeking information or services from a 

Federal agency, have access to and use of 

information and data that is comparable to 

that provided to the public who are not 

individuals with disabilities, unless an 

undue burden would be imposed on the 

agency. 

(b) Accordingly, any offeror responding to 

this solicitation must comply with 

established HHS EIT accessibility standards. 

Information about Section 508 is available at 

http://www.hhs.gov/web/508. The complete 

text of the Section 508 Final Provisions can 

be accessed at http://www.access-board.gov/ 

sec508/standards.htm. 

(c) The Section 508 accessibility standards 

applicable to this solicitation are stated in the 

clause at 352.239–74, Electronic and 

Information Technology Accessibility. 

In order to facilitate the Government’s 

determination whether proposed EIT 

supplies meet applicable Section 508 

accessibility standards, offerors must submit 

an HHS Section 508 Product Assessment 

Template, in accordance with its completion 

instructions. The purpose of the template is 

to assist HHS acquisition and program 

officials in determining whether proposed 

EIT supplies conform to applicable Section 

508 accessibility standards. The template 

allows offerors or developers to self-evaluate 

their supplies and document—in detail— 

whether they conform to a specific Section 

508 accessibility standard, and any underway 

remediation efforts addressing conformance 

issues. Instructions for preparing the HHS 

Section 508 Evaluation Template are 

available under Section 508 policy on the 

HHS Web site http://hhs.gov/web/508. 

In order to facilitate the Government’s 

determination whether proposed EIT services 

meet applicable Section 508 accessibility 

standards, offerors must provide enough 

information to assist the Government in 

determining that the EIT services conform to 

Section 508 accessibility standards, 

including any underway remediation efforts 

addressing conformance issues. 

(d) Respondents to this solicitation must 

identify any exception to Section 508 

requirements. If a offeror claims its supplies 

or services meet applicable Section 508 

accessibility standards, and it is later 

determined by the Government, i.e., after 

award of a contract or order, that supplies or 

services delivered do not conform to the 

described accessibility standards, 

remediation of the supplies or services to the 

level of conformance specified in the contract 

will be the responsibility of the Contractor at 

its expense. 

(End of provision) 

352.239–74 Electronic and Information 

Technology Accessibility. 

As prescribed in 339.203–70(b), insert 

the following clause: 

Electronic and Information Technology 

Accessibility (Date) 

(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 

(also referred to as the ‘‘Access Board’’) in 36 

CFR part 1194. Information about Section 

508 is available at http://www.hhs.gov/web/

508. The complete text of Section 508 Final 

Provisions can be accessed at http://

www.access-board.gov/sec508/

standards.htm. 

(b) The Section 508 accessibility standards 

applicable to this contract 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(s) at the end of 

each contract or order exceeding the 

simplified acquisition threshold (see FAR 

2.101) when the contract or order 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 accessibility standards in the 

contract, remediation of the supplies or 

services to the level of conformance specified 

in the contract will be the responsibility of 

the Contractor at its own expense. 

(c) The Section 508 accessibility standards 

applicable to this contract are: 

lllllllllllllllllllll

(Contract staff must list applicable 

standards) 

(d) In the event of a modification(s) to this 

contract or order, 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 additional information necessary to 

assist the Government in determining that 

the EIT supplies or services conform to 

Section 508 accessibility standards. 

Instructions for documenting accessibility via 

the HHS Section 508 Product Assessment 

Template may be found under Section 508 

policy on the HHS Web site: (http://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 accessibility standards in the 

contract, remediation of the supplies or 

services to the level of conformance specified 

in the contract will be the responsibility of 

the Contractor at its own expense. 

(e) If this is an Indefinite Delivery contract, 

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 

accessibility standards for the order. In those 

cases, the Contractor may be required to 

provide a completed HHS Section 508 

Product Assessment Template and any other 

additional information necessary to assist the 

Government in determining that the EIT 

supplies or services conform to Section 508 

accessibility standards. Instructions for 

documenting accessibility via the HHS 

Section 508 Product Assessment Template 

may be found at http://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 

accessibility standards in the provided 

documentation, remediation of the supplies 

or services to the level of conformance 

specified in the contract will be the 

responsibility of the Contractor at its own 

expense. 

(End of clause) 

352.270–1 [Reserved] 

352.270–2 [Reserved] 

352.270–3 [Reserved] 

352.270–4a Notice to Offerors, Protection 

of Human Subjects. 

(a) As prescribed in 370.303(a), the 

Contracting Officer shall insert the 

following provision: 

Notice to Offerors, Protection of Human 

Subjects (Date) 

(a) The Department of Health and Human 

Services (HHS) regulations for the protection 

of human subjects, 45 CFR part 46, are 

available on the Office for Human Research 

Protections (OHRP) Web site at: http://

www.hhs.gov/ohrp/index.html. 

These regulations provide a systematic 

means, based on established ethical 

principles, to safeguard the rights and 


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welfare of human subjects participating in 

research activities supported or conducted by 

HHS. 

(b) The regulations define a human subject 

as a living individual about whom an 

investigator (whether professional or student) 

conducting research obtains data or 

identifiable public information through 

intervention or interaction with the 

individual, or identifiable private 

information. In most cases, the regulations 

extend to the use of human organs, tissue, 

and body fluids from individually 

identifiable human subjects as 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. 

(c) Activities which involve human 

subjects in one or more of the categories set 

forth in 45 CFR 46.101(b)(1)–(6) are exempt 

from complying with 45 CFR part 46. See 

http://www.hhs.gov/ohrp/humansubjects/

guidance/45cfr46.html. 

(d) Inappropriate designations of the 

noninvolvement of human subjects or of 

exempt categories of research in a project 

may result in delays in the review of a 

proposal. 

(e) In accordance with 45 CFR part 46, 

offerors considered for award shall file an 

acceptable Federal-wide Assurance (FWA) of 

compliance with OHRP specifying review 

procedures and assigning responsibilities for 

the protection of human subjects. The FWA 

is the only type of assurance that OHRP 

accepts or approves. The initial and 

continuing review 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 knowledge that may 

reasonably be expected to result; selection of 

subjects is equitable; and informed consent 

will be obtained and documented by 

methods that are adequate and appropriate. 

Depending on the nature of the research, 

additional requirements may apply; see 

http://www.hhs.gov/ohrp/humansubjects/

guidance/45cfr46.html#46.111 for additional 

requirements regarding initial and continuing 

review. 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 http://www.hhs.gov/ohrp/assurances/ 

index.html). 

(f) Offerors may consult with OHRP only 

for general advice or guidance concerning 

either regulatory requirements or ethical 

issues pertaining to research involving 

human subjects. ONLY the contracting officer 

may offer information concerning a 

solicitation. 

(g) The offeror shall document in its 

proposal the approved FWA from OHRP, 

related to the designated IRB reviewing and 

overseeing the research. If the offeror does 

not have an approved FWA from OHRP, the 

offeror must obtain an FWA before the 

deadline for proposal submission. When 

possible, the offeror shall also certify the 

IRB’s review and approval of the research. If 

the offeror cannot obtain this certification by 

the time of proposal submission they must 

include an explanation in their proposal. 

Never conduct research covered by 45 CFR 

part 46 prior to receiving certification of the 

research’s review and approval by the IRB. 

(End of provision) 

Alternate I (DATE). As prescribed in 

370.303(a), the Contracting Officer shall 

substitute the following paragraph (g) for 

paragraph (g) of the basic clause. 

(g) The offeror’s 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 offeror shall also certify the IRB 

has reviewed and approved the research. If 

the offeror cannot make this certification at 

the time of proposal submission, its proposal 

must include an explanation. Never conduct 

research covered by 45 CFR part 46 prior to 

receiving certification of the research’s 

review and approval by the IRB. 

If the offeror does not have an active FWA 

from OHRP, the offeror shall take all 

necessary steps to obtain an FWA prior to the 

deadline for proposal submission. If the 

offeror cannot obtain an FWA before the 

proposal submission date, the proposal shall 

indicate the steps/actions the offeror will 

take to obtain OHRP approval 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. 

352.270–4b Protection of Human Subjects. 

(b) As prescribed in 370.304(a), the 

Contracting Officer shall insert the 

following clause: 

Protection of Human Subjects (Date) 

(a) The Contractor agrees that the rights 

and welfare of human subjects involved in 

research under this contract shall be 

protected in accordance with 45 CFR part 46 

and with the Contractor’s current Federalwide Assurance (FWA) on file with the 

Office for Human Research Protections 

(OHRP), Department of Health and Human 

Services. The Contractor further agrees to 

provide certification at least annually that the 

Institutional Review Board has reviewed and 

approved the procedures, which involve 

human subjects in accordance with 45 CFR 

part 46 and the Assurance of Compliance. 

(b) The Contractor shall bear full 

responsibility for the performance of all work 

and services involving the use of human 

subjects under this contract and shall ensure 

that work is conducted in a proper manner 

and as safely as is feasible. The parties hereto 

agree that the Contractor retains the right to 

control and direct the performance of all 

work under this contract. Nothing in this 

contract shall create an agency 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 whatsoever. 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 judgment or 

otherwise, as an independent Contractor 

without creating liability on the part of the 

Government for the acts of the Contractor or 

its employees. 

(c) Contractors involving other agencies or 

institutions in activities considered to be 

engaged in research involving human 

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 designation as agents of the 

institution or via individual investigator 

agreements (see OHRP Web site at: http://

www.hhs.gov/ohrp/policy/

guidanceonalternativetofwa.pdf). 

(d) If at any time during the performance 

of this contract the Contractor is not in 

compliance with any of the requirements and 

or standards stated in paragraphs (a) and (b) 

above, the Contracting Officer may 

immediately suspend, in whole or in part, 

work and further payments under this 

contract until the Contractor corrects the 

noncompliance. The Contracting Officer may 

communicate the notice of suspension by 

telephone with confirmation in writing. If the 

Contractor fails to complete corrective action 

within the period of time designated in the 

Contracting Officer’s written notice of 

suspension, the Contracting Officer may, 

after consultation with OHRP, terminate this 

contract in whole or in part. 

(End of clause) 

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 370.403(a), the 

Contracting Officer shall insert the 

following provision: 

Notice to Offerors of Requirement for 

Compliance With the Public Health Service 

Policy on Humane Care and Use of 

Laboratory Animals (Date) 

The Public Health Service (PHS) Policy on 

Humane Care and Use of Laboratory Animals 

(PHS Policy) establishes a number of 

requirements for research activities involving 

animals. Before awarding a contract to an 

offeror, 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 expertise of its members, to oversee the 

institution’s animal program, facilities, and 

procedures. Offerors must provide 

verification of IACUC approval prior to 

receiving an award involving live vertebrate 

animals. No award involving the use of 

animals shall be made unless OLAW 

approves the Assurance and verification of 

IACUC approval for the proposed animal 

activities has been provided to the 


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Contracting Officer. Prior to award, the 

Contracting Officer will notify Contractor(s) 

selected for projects involving live 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(s) and request verification of 

IACUC approval. For further information, 

contact OLAW at NIH, 6705 Rockledge Drive, 

RKL1, Suite 360, MSC 7982 Bethesda, 

Maryland 20892–7982 (Email: olaw@

od.nih.gov; Phone: 301–496–7163). 

(End of provision) 

352.270–5b Care of Live Vertebrate 

Animals. 

As prescribed in 370.404, the 

Contracting Officer shall insert the 

following clause: 

Care of Live Vertebrate Animals (Date) 

(a) Before undertaking performance of any 

contract 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 

accordance with 7 U.S.C. 2136 and 9 CFRs 

2.25 through 2.28. The Contractor shall 

furnish evidence of the registration to the 

Contracting Officer. 

(b) 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 CFRs 2.1–2.11, or 

from a source that is exempt from licensing 

under those sections. 

(c) The Contractor agrees that the care, use, 

and intended use of any live 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 pertinent 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 

conflict between standards, the more 

stringent standard shall govern. 

(d) If at any time during performance of 

this contract, 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 compliance with any of 

the requirements and standards stated in 

paragraphs (a) through (c) above, the 

Contracting Officer may immediately 

suspend, in whole or in part, work and 

further payments under this contract until 

the Contractor corrects the noncompliance. 

Notice of the suspension may be 

communicated by telephone and confirmed 

in writing. If the Contractor fails to complete 

corrective action within the period of time 

designated in the Contracting Officer’s 

written notice of suspension, the Contracting 

Officer may, in consultation with OLAW, 

NIH, terminate this contract in whole or in 

part, and the Contractor’s name may be 

removed from the list of those contractors 

with Animal Welfare Assurances. 

Note: The Contractor may request 

registration of its facility and a current listing 

of licensed 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, as well as information concerning this 

program may be obtained by contacting the 

Animal Care Staff, USDA/APHIS, 4700 River 

Road, Riverdale, Maryland 20737 (Email: 

ace@aphis.usda.gov; Web site: (http://

www.aphis.usda.gov/animal_welfare). 

(End of clause) 

352.270–6 Restriction on Use of Human 

Subjects. 

As prescribed in 370–304(b), the 

Contracting Officer shall insert the 

following clause: 

Restriction on Use of Human Subjects (Date) 

Pursuant to 45 CFR part 46, Protection of 

Human Research Subjects, the Contractor 

shall not expend funds under this award for 

research involving human subjects or engage 

in any human subjects research activity prior 

to the Contracting Officer’s receipt of a 

certification 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 foreign, and 

subcontractors. The Contractor must ensure 

compliance by collaborators and 

subcontractors. 

(End of clause) 

352.270–7 [Reserved] 

352.270–8 [Reserved] 

352.270–9 Non-Discrimination for 

Conscience. 

As prescribed in 370.701, the 

Contracting Officer shall insert the 

following provision: 

Non-Discrimination for Conscience (Date) 

(a) Section 301(d) of the United States 

Leadership Against HIV/AIDS, Tuberculosis, 

and Malaria Act, as amended, provides that 

an organization, including a faith-based 

organization, that is otherwise eligible to 

receive assistance 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 assistance, to— 

(i) Endorse or utilize a multisectoral or 

comprehensive approach to combating HIV/ 

AIDS; or 

(ii) Endorse, utilize, make a referral to, 

become integrated with, or otherwise 

participate in any program or activity to 

which the organization has a religious or 

moral objection. 

(2) Shall not be discriminated against 

under the provisions of law in subparagraph 

(a) for refusing to meet any requirement 

described in paragraph (a)(1) in this 

solicitation. 

(b) Accordingly, an offeror who believes 

this solicitation contains work requirements 

requiring it endorse or utilize a multisectoral 

or comprehensive approach to combating 

HIV/AIDS, or endorse, utilize, make referral 

to, become integrated with, or otherwise 

participate in a program or activity to which 

it has a religious or moral objection, shall 

identify those work requirements it excluded 

in its technical proposal. 

(c) The Government acknowledges that an 

offeror has specific rights, as cited in 

paragraph (b), to exclude certain work 

requirements in this solicitation from its 

proposal. However, the Government reserves 

the right to not make an award to an offeror 

whose proposal does not comply with the 

salient work requirements of the solicitation. 

Any exercise of that Government right will be 

made by the Head of the Contracting 

Activity. 

(End of provision) 

352.270–10 Notice to Offerors—Protection 

of Human Subjects, Research Involving 

Human Subjects Committee (RIHSC) 

Approval of Research Protocols Required. 

As prescribed in 370.303(d), the 

Contracting Officer shall insert the 

following provision: 

Notice to Offerors—Protection of Human 

Subjects, Research Involving Human 

Subjects Committee (Rihsc) Approval of 

Research Protocols Required (Date) 

(a) All Offerors proposing research 

expected to involve human subjects shall 

comply with the regulations set forth in 45 

CFR part 46, and with the provisions at 

HHSAR 352.270–4a. 

(b) The Offeror shall have an acceptable 

Assurance of Compliance on file with the 

Office for Human Research Protections 

(OHRP), whenever it submits a proposal to 

the FDA for research expected to involve 

human subjects. Direct questions regarding 

Federal-wide Assurance to OHRP. The 

Offeror’s proposal shall include a copy of the 

acceptable Assurance of Compliance. 

(c) After the contract has been awarded, the 

Contractor shall take the following 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 

stating that the proposed research protocol 

has been reviewed and approved, and thus 

adequately protects the rights and welfare of 

human subjects involved, or a letter stating 

that the proposed research is exempt under 

45 CFR 46.101(b) shall be submitted to the 

Contracting Officer. 

(2) Upon award, the successful Offeror, 

hereafter ‘‘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 

research protocol to assure it adequately 

protects the rights and welfare of human 

subjects involved. The RIHSC or designee 

will also determine whether the proposed 


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research is exempt under 45 CFR 46.101(b). 

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. 

(d) The Contractor shall not advertise for, 

recruit, or enroll human subjects, or 

otherwise commence any research involving 

human subjects until RIHSC or its designee 

reviews and approves its research. The 

Contractor may begin other limited aspects of 

contract performance prior to receiving 

RIHSC’s or designee’s approval of the 

proposed research protocol. Research 

involving human subjects may commence 

immediately upon the Contractor’s receipt of 

RIHSC’s or designee’s approval; however, the 

Contractor shall submit a copy of RIHSC’s or 

its designee’s approval to the Contracting 

Officer within three business days of its 

receipt. 

(e) A Contractor’s failure to obtain RIHSC’s 

or its designee’s approval of its proposed 

research may result in termination of its 

contract. However, failure to obtain RIHSC’s 

or its designee’s approval during initial 

review will not automatically result in 

termination of the contract. Instead, 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’s input during the resubmission 

process. 

(f) The Contractor shall seek RIHSC’s or its 

designee’s and local IRB review and approval 

whenever making modifications, 

amendments or other changes to the research 

protocol. Such modifications, amendments 

and changes include, but are not limited to 

changes in investigators, informed consent 

forms, and recruitment advertisements. The 

Contractor may institute changes 

immediately after receiving both the local 

IRB and RIHSC or its designee approval 

(except when necessary to eliminate apparent 

immediate 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 receipt. 

(End of Provision) 

352.270–11 Protection of Human 

Subjects—Research Involving Human 

Subjects Committee (RIHSC) Approval of 

Research Protocols Required. 

As prescribed in 370.304(c), the 

Contracting Officer shall insert the 

following clause: 

Protection of Human Subjects—Research 

Involving Human Subjects Committee 

(Rihsc) Approval of Research Protocols 

Required (Date) 

(a) The Contractor agrees to protect the 

rights and welfare of human subjects 

involved in research under this contract by 

complying with 45 CFR part 46 and the 

clause at HHSAR 352.270–4b. 

(b) Initial proof of compliance 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 IRB shall be 

submitted to the Contracting Office; and 

(3) A copy of a letter from the RIHSC 

stating that it or its designee has reviewed 

and approved the proposed research 

protocol. This shall be submitted to the 

Contracting Officer within three business 

days of its issuance. 

The Contractor shall not advertise for, 

recruit, or enroll human subjects, or 

otherwise commence any research involving 

human subjects under this contract, until 

RIHSC has reviewed and approved its 

research. The Contractor may commence 

other limited aspects of contract performance 

prior to receiving RIHSC or its designee 

approval 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 copy of RIHSC’s or its designee’s 

letter of approval to the Contracting Officer 

within three business days of its receipt. 

Failure to obtain RIHSC or its designee 

approval of proposed research protocols may 

result in the termination of this contract. 

(c) The Contractor further 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 research protocols for research 

performed under this contract. This shall be 

submitted to the Contracting Officer for 

inclusion 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 review and approval. 

Modifications and amendments include, but 

are not limited, to changes to consent forms 

and advertising materials, and the addition 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 

necessary to eliminate apparent immediate 

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 receipt. 

(End of Clause) 

352.270–12 Needle Exchange. 

As prescribed in 370.304(d), the 

Contracting Officer shall insert the 

following clause: 

Needle Exchange (Date) 

The Contractor shall not use any funds 

obligated under this contract to carry out any 

program of distributing sterile needles or 

syringes for the hypodermic injection of any 

illegal drug. 

(End of Clause) 

352.270–13 Continued Ban on Funding 

Abortion and Continued Ban on Funding of 

Human Embryo Research. 

As prescribed in 370.304(e), the 

Contracting Officer shall insert the 

following clause: 

Continued Ban on Funding Abortion and 

Continued Ban on Funding of Human 

Embryo Research (Date) 

(a) The Contractor shall not use any funds 

obligated under this contract for any 

abortion. 

(b) The Contractor shall not use any funds 

obligated under this contract for the 

following: 

(1) The creation of a human embryo or 

embryos for research purposes; or 

(2) Research in which a human embryo or 

embryos are destroyed, discarded, or 

knowingly 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) of the Public Health Service 

Act (42 U.S.C. 289g(b)). 

The term ‘‘human embryo or embryos’’ 

includes any organism, not protected as a 

human subject under 45 CFR 46 as of the 

date of the enactment of this Act, that is 

derived by fertilization, parthenogenesis, 

cloning, or any other means from one or more 

human gametes of human diploid cells. 

(c) The Contractor shall not use any 

Federal funds for the cloning of human 

beings. 

(End of Clause) 

PART 353—FORMS 

Subpart 353.3—[Reserved] 

SUBCHAPTERS I, J, K AND L— 

[RESERVED] 

SUBCHAPTER M—HHS 

SUPPLEMENTATIONS 

PART 370—SPECIAL PROGRAMS 

AFFECTING ACQUISITION 

Subpart 370.1—[Reserved] 

Subpart 370.2—[Reserved] 

Subpart 370.3—Acquisitions Involving 

Human Subjects 

Sec. 

370.300 Scope of subpart. 

370.301 Policy. 

370.302 Federal-wide Assurance (FWA). 

370.303 Notice to offerors. 

370.304 Contract clauses. 

Subpart 370.4—Acquisitions Involving the 

Use of Laboratory Animals 

370.400 Scope of subpart. 

370.401 Policy. 

370.402 Assurances. 

370.403 Notice to offerors. 

370.404 Contract clause. 


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Subpart 370.5—[Reserved] 

Subpart 370.6—[Reserved] 

Subpart 370.7—Acquisitions Under the 

Leadership Act 

370.700 Scope of subpart. 

370.701 Contract clause. 

370.702 Solicitation provision. 

Authority: 5 U.S.C. 301; 40 U.S.C. 

121(c)(2). 

Subpart 370.3—Acquisitions Involving 

Human Subjects 

370.300 Scope of subpart. 

This subpart applies to all research 

activities conducted under contracts 

involving human subjects. See 45 CFR 

46.102(d) and (f). 

370.301 Policy. 

It is the Department of Health and 

Human Services (HHS) policy that the 

contracting officer shall not award a 

contract involving human subjects until 

the prospective contractor provides 

assurance that the activity will undergo 

initial and continuing review by an 

appropriate Institutional Review Board 

(IRB) in accordance with HHS 

regulations at 45 CFR 46.103. The 

contracting officer shall require a 

Federal-wide assurance (FWA), 

approved by the HHS Office for Human 

Research Protections (OHRP), of each 

contractor, subcontractor, or institution 

engaged in human subjects research in 

performance of a contract. OHRP 

administers the assurance covering all 

HHS-supported or HHS-conducted 

activities involving human subjects. 

370.302 Federal-Wide Assurance (FWA). 

(a) OHRP-Approved FWAs are found 

at the following Web site: http://

ohrp.cit.nih.gov/search/

search.aspx?styp=bsc. 

(b) Normally a contractor, 

subcontractor, or institution must 

provide approval of a FWA before a 

contract is awarded. If a contractor, 

subcontractor, or institution does not 

currently hold an approved FWA, it 

shall submit an explanation with its 

proposal and an FWA application prior 

to submitting a proposal. The 

contracting officer, on a case by case 

basis, may make award without an 

approved assurance in consultation 

with OHRP. 

(c) A contractor, subcontractor, or 

institution must submit all FWAs, 

including new FWAs, using the 

electronic submission system available 

through the OHRP Web site at http://

ohrp.cit.nih.gov/efile, unless an 

institution lacks the ability to do so 

electronically. If an institution believes 

it lacks the ability to submit its FWA 

electronically, it must contact OHRP by 

telephone or email (see http://

www.hhs.gov/ohrp/assurances/

index.html) and explain why it is 

unable to submit its FWA electronically. 

370.303 Notice to offerors. 

(a) The contracting officer shall insert 

the provision at 352.270–4a, Notice to 

Offerors, Protection of Human Subjects, 

in solicitations that involve human 

subjects. The contracting officer shall 

use the clause with its Alternate I when 

the agency is prescribing a date later 

than the proposal submission by which 

the offeror must have an approved 

FWA. 

(b) Institutions having an OHRPapproved FWA shall certify IRB 

approval of submitted proposals in the 

manner required by instructions for 

completion of the contract proposal; by 

completion of an OMB Form No. 0990– 

0263, Protection of Human Subjects 

Assurance Identification/IRB 

Certification/Declaration of Exemption 

(Common Rule); or by letter indicating 

the institution’s OHRP-assigned FWA 

number, the date of IRB review and 

approval, and the type of review 

(convened or expedited). The date of 

IRB approval must not be more than 12 

months prior to the deadline for 

proposal submission. 

(c) The contracting officer generally 

will not request FWAs for contractors, 

subcontractors, or institutions prior to 

selecting a contract proposal for 

negotiation. When a contractor submits 

an FWA, it provides certification for the 

initial contract period; no additional 

documentation is required. If the 

contract provides for additional years to 

complete the project, the contractor 

shall certify annually in the manner 

described in 370.303(b). 

(d) For the Food and Drug 

Administration (FDA), the contracting 

officer shall insert the provision at 

352.270–10, Notice to Offerors— 

Protection of Human Subjects, Research 

Involving Human Subjects Committee 

(RIHSC) Approval of Research Protocols 

Required, in solicitations that involve 

human subjects when the research is 

subject to RIHSC review and approval. 

370.304 Contract clauses. 

(a) The contracting officer shall insert 

the clause at 352.270–4b, Protection of 

Human Subjects, in solicitations, 

contracts and orders involving human 

subjects. 

(b) The contracting officer shall insert 

the clause at 352.270–6, Restriction on 

Use of Human Subjects, in contracts and 

orders if the contractor has an approved 

FWA of compliance in place, but cannot 

certify prior to award that an IRB 

registered with OHRP reviewed and 

approved the research, because definite 

plans for involvement of human 

subjects are not set forth in the proposal 

(e.g., projects in which human subjects’ 

involvement will depend upon 

completion of instruments, prior animal 

studies, or purification of compounds). 

Under these conditions, the contracting 

officer may make the award without the 

requisite certification, as long as the 

contracting officer includes appropriate 

conditions in the contract or order. 

(c) For FDA, the contracting officer 

shall insert the clause at 352.270–11, 

Protection of Human Subjects, Research 

Involving Human Subjects Committee 

(RIHSC) Approval of Research Protocols 

Required, in contracts and orders that 

involve human subjects when the 

research is subject to RIHSC review and 

approval. 

(d) The contracting officer shall insert 

the clause at 352.270–12, Needle 

Exchange, in solicitations, contracts, 

and orders involving human subjects. 

(e) The contracting officer shall insert 

the clause at 352.270–13, Continued 

Ban on Funding Abortion and 

Continued Ban on Funding of Human 

Embryo Research, in solicitations, 

contracts, and orders involving human 

subjects. 

Subpart 370.4—Acquisitions Involving 

the Use of Laboratory Animals 

370.400 Scope of subpart. 

This subpart applies to all research, 

research training, biological testing, 

housing and maintenance, and other 

activities involving live vertebrate 

animals conducted under contract. 

Additional information can be found in 

Public Health Service (PHS) Policy on 

Humane Care and Use of Laboratory 

Animals http://grants.nih.gov/grants/

olaw/references/

phspolicylabanimals.pdf. 

370.401 Policy. 

(a) It is HHS policy that contracting 

activities shall not award a contract 

involving live vertebrate animals until 

the Contractor provides acceptable 

assurance the contract work is subject to 

initial and continuing review by an 

appropriate Institutional Animal Care 

and Use Committee (IACUC) as 

described in the PHS Policy at IV.B.6 

and 7. The contracting officer shall 

require an applicable Animal Welfare 

Assurance approved by the Office of 

Laboratory Animal Welfare (OLAW), 

National Institutes of Health (NIH), of 

each contractor, subcontractor, or 

institution having responsibility for 

animal care and use involved in 

performance of the contract. Normally 

the assurance shall be approved before 


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Federal Register / Vol. 80, No. 40 / Monday, March 2, 2015 / Proposed Rules 11311 

award. The contracting officer, on a 

case-by-case basis, may make award 

without an approved assurance in 

consultation with OLAW. For additional 

information see PHS Policy II., IV.A, 

and V.B. 

(b) The OLAW, NIH, is responsible for 

negotiating assurances covering all 

HHS/PHS-supported or HHS/PHSconducted activities involving the care 

and use of live vertebrate animals. 

OLAW shall provide guidance to 

contracting officers regarding adequate 

animal care and use, approval, 

disapproval, restriction, or withdrawal 

of approval of assurances. For 

additional information see PHS Policy 

V.A. 

(c) If using live vertebrate animals, 

HHS policy requires that offerors 

address the points in the Vertebrate 

Animal Section (VAS) of the Technical 

Proposal. Each of the points must be 

addressed in the VAS portion of the 

Technical Proposal. For additional 

information see PHS Policy and use 

Contract Proposal VAS Worksheet. 

http://grants.nih.gov/grants/olaw/

references/phspol.htm#Information

RequiredinApplications-Proposals

forAwardsSubmittedtoPHS and http://

grants.nih.gov/grants/olaw/

VAScontracts.pdf. 

370.402 Assurances. 

(a) Animal Welfare Assurances may 

be one of three types: 

(1) Domestic Assurance (DA). A DA 

describes the institution’s animal care 

and use program, including but not 

limited to the lines of authority and 

responsibility, veterinary care, IACUC 

composition and procedures, 

occupational health and safety, training, 

facilities, and species housed. A DA 

listed in OLAW’s list of institutions 

with an approved DA is acceptable for 

purposes of this policy. 

(2) Inter-institutional Assurance (IA). 

The offeror, its proposed subcontractor, 

or institution shall submit an IA when 

it does not have a proprietary animal 

care and use program, facilities to house 

animals or IACUC, and does not 

conduct animal research on-site. The 

offeror will perform the animal activity 

at an institution with an Animal Welfare 

Assurance named as a performance site. 

An IA approval extends to the full 

period of contract performance (up to 5 

years) limited to the specific award or 

single project. 

(3) Foreign Assurance (FA). The 

Foreign Assurance is required for 

institutions outside the U.S. that receive 

PHS funds directly through a contract 

award. The Foreign Assurance also 

applies to institutions outside the U.S. 

that receive PHS funds indirectly 

(named as a performance site). An FA 

listed in OLAW’s list of institutions 

with an approved FA is acceptable for 

purposes of this policy. 

(b) The contracting officer shall 

forward copies of proposals selected for 

negotiation and requiring an assurance 

to OLAW_at_olawdoa@od.nih.gov, as 

early as possible to secure the necessary 

assurances. 

(c) A contractor providing animal care 

services at an institution with an 

Animal Welfare Assurance, such as a 

Government-owned, Contractoroperated (GOCO) site, does not need a 

separate assurance. GOCO site 

assurances normally cover such 

contractor services. 

370.403 Notice to offerors. 

(a) The contracting officer shall insert 

the provision at 352.270–5a, Notice to 

Offerors of Requirement for Compliance 

with the Public Health Service Policy on 

Humane Care and Use of Laboratory 

Animals, in solicitations involving live 

vertebrate animals. 

(b) Offerors having a DA on file with 

OLAW shall submit IACUC approval of 

the use of animals in the manner 

required by the solicitation, but prior to 

award. The date of IACUC approval 

must not be more than 36 months prior 

to award. 

(c) It is not necessary for offerors 

lacking an Animal Welfare Assurance to 

submit assurances or IACUC approval 

with proposals. OLAW shall contact 

contractors, subcontractors, and 

institutions to negotiate necessary 

assurances and verify IACUC approvals 

when requested by the contracting 

officer. 

370.404 Contract clause. 

The contracting officer shall insert the 

clause at 352.270–5b, Care of Live 

Vertebrate Animals, in solicitations, 

contracts, and orders that involve live 

vertebrate animals. 

Subpart 370.5—[Reserved] 

Subpart 370.6—[Reserved] 

Subpart 370.7—Acquisitions Under the 

Leadership Act 

370.700 Scope of subpart. 

This subpart sets forth the acquisition 

requirements regarding implementation 

of Human Immunodeficiency Virus/

Acquired Immune Deficiency Syndrome 

(HIV/AIDS) programs under the 

President’s Emergency Plan for AIDS 

Relief as established by the United 

States Leadership Against HIV/AIDS, 

Tuberculosis and Malaria Act of 2003, 

as amended (Pub. L. 108–25, Pub. L. 

110–293, Pub. L. 113–56). 

370.701 Solicitation provision. 

The contracting officer shall insert the 

provision at 352.270–9, Nondiscrimination for Conscience, in 

solicitations valued at more than the 

micro-purchase threshold: 

(a) In connection with the 

implementation of HIV/AIDS programs 

under the President’s Emergency Plan 

for AIDS Relief established by the 

United States Leadership Against HIV/ 

AIDS, Tuberculosis and Malaria Act of 

2003, as amended; or 

(b) Where the contractor will receive 

funding under the United States 

Leadership Against HIV/AIDS, 

Tuberculosis and Malaria Act of 2003, 

as amended. In resolving any issues or 

complaints that offerors may raise 

regarding meeting the requirements 

specified in the provision, the 

contracting officer shall consult with the 

Office of Global Health Affairs, Office of 

the General Counsel, the Program 

Manager, and other HHS officials, as 

appropriate. 

[FR Doc. 2015–03391 Filed 2–27–15; 8:45 am] 

BILLING CODE 4150–28–P 


asabaliauskas on DSK5VPTVN1PROD with PROPOSALS