[Federal Register Volume 87, Number 223 (Monday, November 21, 2022)]
[Rules and Regulations]
[Pages 70745-70751]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-23961]


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DEPARTMENT OF VETERANS AFFAIRS

48 CFR Parts 801, 802, 808, 816, 835, and 852

RIN 2900-AQ23


VA Acquisition Regulation: Department of Veterans Affairs 
Acquisition Regulation System and Research and Development

AGENCY: Department of Veterans Affairs.

ACTION: Final rule.

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SUMMARY: The Department of Veterans Affairs (VA) is issuing a final 
rule amending the VA Acquisition Regulation (VAAR). This rulemaking 
revises VAAR coverage concerning Department of Veterans Affairs 
Acquisition Regulation System and Research and Development. It also 
revises affected parts concerning Definitions of Words and Terms, 
Required Sources of Supplies and Services, Types of Contracts and 
Solicitation Provisions and Contract Clauses.

DATES: Effective December 21, 2022.

FOR FURTHER INFORMATION CONTACT: Ms. Glacia A. Holbert, Senior 
Procurement Analyst, Procurement Policy and Warrant Management 
Services, 003A2A, 810 Vermont Avenue NW, Washington, DC 20420, (202) 
697-3614. (This is not a toll-free number.)

SUPPLEMENTARY INFORMATION: 

Background

    VA published a proposed rule in the Federal Register at 87 FR 10158 
on February 23, 2022, to amend the VAAR to implement and supplement the 
FAR. VA provided a 60-day comment period for the public to respond to 
the proposed rule and submit comments. The public comment period closed 
on April 25, 2022. VA received two comments from one respondent.
    This rulemaking is issued under the authority of the Office of 
Federal Procurement Policy (OFPP) Act which provides the authority for 
an agency head to issue agency acquisition regulations that implement 
or supplement the FAR.
    The VAAR has been revised to add new policy or regulatory 
requirements, to update existing policy, and to remove any redundant 
guidance where it may exist in affected parts, and to place guidance 
that is applicable only to VA's internal operating processes or 
procedures in the VAAM.
    This rule adopts as a final rule the proposed rule published in the 
Federal Register on February 23, 2022, except for one technical non-
substantive change to update terminology in accordance with FAR final 
rules as shown below.

Discussion and Analysis of Public Comments

    The respondent alleged that the proposed rule could ``. . 
.unlawfully Amend U.S. Code to facilitate illegal land use at the WLA 
VA Soldiers Home.'' This issue has no relevance to the proposed rule. 
The respondent also expressed dismay that Department did not extend the 
``Public a Comment Period on the WLA VA Soldiers Home's ``Master Plan'' 
and ``Community Plan.'' This comment did not have any application to 
AQ23 which deals with the Department of Veterans Affairs Acquisition 
Regulation System and Research and Development. VA appreciates the 
respondent's interest in the rule but the two comments do not pertain 
to the content of the regulation. Therefore, VA is taking no action to 
revise the rule based on these comments.
    VA proposes to make the following changes to the VAAR in this phase 
of its revision and streamlining initiative. For procedural guidance 
cited below that is proposed to be deleted from the VAAR, each section 
cited for removal has been considered for inclusion in VA's internal 
agency operating procedures in accordance with FAR 1.301(a)(2). 
Similarly, delegations of authority that are removed from the VAAR will 
be included in the VAAM as internal agency guidance. The VAAM is being 
created in parallel with these revisions to the VAAR and is not subject 
to the rulemaking process as they are internal VA procedures and 
guidance. The VAAM will not be finalized until corresponding VAAR parts 
are finalized.

Technical Non-Substantive Changes to the Rule

    This rule makes one non-substantive change to the rule to provide 
clarity, eliminate confusion, and to ensure compliance with the Federal 
Acquisition Regulation (FAR). Specifically, VA is revising the section 
covering the ratification of unauthorized commitments to clarify the 
delegation authority level for unauthorized commitments below $25,000.
    VA is revising the final rule at 801.602-3 as reflected in the 
amendatory text as follows:
    ``801.602-3, Ratification of unauthorized commitments.
    (a) This section applies to unauthorized commitments, including any 
commitment made by a contracting officer that exceeds that contracting

[[Page 70746]]

officer's contracting authority and unauthorized commitments made by a 
Government representative who lacked the authority to enter into that 
agreement on behalf of the Government.
    (b) The approving authority and ratification official for 
unauthorized commitments is the HCA. This authority may be delegated to 
the chief of the contracting office or the equivalent for unauthorized 
commitments below $25,000.''

Executive Orders 12866 and 13563

    Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess 
the costs and benefits of available regulatory alternatives and, when 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, and other advantages; distributive impacts; 
and equity). E.O. 13563 (Improving Regulation and Regulatory Review) 
emphasizes the importance of quantifying both costs and benefits, 
reducing costs, harmonizing rules, and promoting flexibility. The 
Office of Information and Regulatory Affairs has determined that this 
final rule is not a significant regulatory action under Executive Order 
12866. The Regulatory Impact Analysis associated with this rulemaking 
can be found as a supporting document at www.regulations.gov.

Paperwork Reduction Act

    This final rule contains no provisions constituting a collection of 
information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3521).

Regulatory Flexibility Act

    The Secretary hereby certifies that this final rule would not have 
a significant economic impact on a substantial number of small entities 
as they are defined in the Regulatory Flexibility Act (5 U.S.C. 601-
612). Therefore, pursuant to 5 U.S.C. 605(b), the initial and final 
regulatory flexibility analysis requirements of 5 U.S.C. 603 and 604 do 
not apply.
    This rulemaking does not change VA's policy regarding small 
businesses and does not have a significant economic impact to 
individual businesses. The overall impact of the proposed rule would be 
of benefit to small businesses owned by Veterans or service-disabled 
Veterans as the VAAR is being updated to remove outdated guidance and 
to clarify and simplify the acquisition regulations VA's contractors 
must comply with. VA estimates no substantial cost impact to individual 
businesses will result from these rule updates. In total, this 
rulemaking does not change VA's policy regarding small businesses, does 
not have a substantial economic impact to individual businesses, and 
does not significantly increase or decrease costs small business were 
already required to bear when performing contracts.

Unfunded Mandates

    The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 
1532, that agencies prepare an assessment of anticipated costs and 
benefits before issuing any rule that may result in the expenditure by 
State, local, and tribal Governments, in the aggregate, or by the 
private sector, of $100 million or more (adjusted annually for 
inflation) in any one year. This proposed rule would have no such 
effect on State, local, and tribal Governments or on the private 
sector.

Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
the Office of Information and Regulatory Affairs designated this rule 
as not a major rule, as defined by 5 U.S.C. 804(2).

List of Subjects

48 CFR Part 801

    Administrative practice and procedure, Government procurement, 
Reporting and recordkeeping requirements.

48 CFR Parts 802, 808, and 816

    Government procurement.

48 CFR Part 835

    Administrative practice and procedure, Government procurement, 
Reporting and recordkeeping requirements.

48 CFR Part 852

    Government procurement, Reporting and recordkeeping requirements.

Signing Authority

    Denis McDonough, Secretary of Veterans Affairs, approved this 
document on October 27, 2022, and authorized the undersigned to sign 
and submit the document to the Office of the Federal Register for 
publication electronically as an official document of the Department of 
Veterans Affairs.

Consuela Benjamin,
Regulations Development Coordinator, Office of Regulation Policy & 
Management, Office of General Counsel, Department of Veterans Affairs.

    For the reasons set out in the preamble, VA amends 48 CFR chapter 8 
as follows:

0
 1. Part 801 is revised to read as follows:

PART 801--DEPARTMENT OF VETERANS AFFAIRS ACQUISITION REGULATION 
SYSTEM

Sec.
801.000 Scope of part.
Subpart 801.1--Purpose, Authority, Issuance
801.101 Purpose.
801.103 Authority.
801.104 Applicability.
801.104-70 Exclusions.
801.106 OMB approval under the Paperwork Reduction Act.
Subpart 801.3--Agency Acquisition Regulations
801.301 Policy.
801.304 Agency control and compliance procedures.
Subpart 801.4--Deviations from the FAR
801.403 Individual deviations.
801.404 Class deviations.
Subpart 801.6--Career Development, Contracting Authority, and 
Responsibilities
801.601 General.
801.602-3 Ratification of unauthorized commitments.
801.604 Contracting Officer's Representative (COR).

    Authority:  38 U.S.C. 8123; 38 U.S.C. 8153; 38 U.S.C. 8303; 40 
U.S.C. 121(c); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304.


801.000  Scope of part.

    This part includes general Department of Veterans Affairs (VA) 
Acquisition Regulation (VAAR) policies, including information regarding 
the maintenance and administration of the VAAR, acquisition policies 
and practices, and procedures for deviation from the VAAR and the 
Federal Acquisition Regulation (FAR).

Subpart 801.1--Purpose, Authority, Issuance


801.101  Purpose.

    (a) VA established the VAAR to codify and publish uniform policies 
and procedures for VA's acquisition of supplies and services, including 
construction.
    (b) The VAAR implements and supplements the FAR.


801.103  Authority.

    The VA issues the VAAR under the authority of 41 U.S.C. 1707 and 48 
CFR 1.301 through 1.304, and other authorities as cited.


801.104  Applicability.

    The FAR and the VAAR apply to all FAR-based VA actions using 
appropriated funds unless otherwise

[[Page 70747]]

specified in this regulation. Supply Fund monies (38 U.S.C. 8121) and 
General Post Funds (38 U.S.C. 8302) are appropriated funds.


801.104-70  Exclusions.

    (a) Restricted gifts. The FAR and VAAR do not apply to purchases 
and contracts that use General Post Funds if using the FAR and the VAAR 
would infringe upon a donor's right to specify the exact item to be 
purchased and/or the source of supply (38 U.S.C. 8303).
    (b) Procurement of prosthetic appliances. The VA may procure 
prosthetic appliances and necessary services required in the fitting, 
supplying, and training and use of prosthetic appliances by purchase, 
manufacture, contract, or in such other manner as the VA may determine 
to be proper, without regard to any other provision of law (38 U.S.C. 
8123).
    (c) Sharing of health-care resources. (1) To secure health-care 
resources which otherwise might not be feasibly available, or to 
effectively utilize certain other health-care resources, the VA may, 
when the VA determines it to be in the best interest of the prevailing 
standards of the Department medical care program, make arrangements, by 
contract or other form of agreement for the mutual use, or exchange of 
use, of health-care resources between Department health-care facilities 
and any health-care provider, or other entity or individual.
    (2) The VA may enter into a contract or other agreement under 
paragraph (c)(1) of this section if such resources are not, or would 
not be, used to their maximum effective capacity.
    (3)(i) If the health-care resource required is a commercial 
service, the use of medical equipment or space, or research, and is to 
be acquired from an institution affiliated with the Department in 
accordance with 38 U.S.C. 7302, including medical practice groups and 
other entities associated with affiliated institutions, blood banks, 
organ banks, or research centers, the VA may make arrangements for 
acquisition of the resource without regard to any law or regulation 
(including any Executive order, circular, or other administrative 
policy) that would otherwise require the use of competitive procedures 
for acquiring the resource.
    (ii) If the health-care resource required is a commercial service 
or the use of medical equipment or space, and is not to be acquired 
from an entity described in paragraph (c)(3)(i) of this section, any 
procurement of the resource may be conducted without regard to any law 
or regulation that would otherwise require the use of competitive 
procedures for procuring the resource, but only if the procurement is 
conducted in accordance with the simplified procedures prescribed in 
part 873. (38 U.S.C. 8153).


801.106  OMB approval under the Paperwork Reduction Act.

    See VA Acquisition Manual (VAAM) M801.106 for a list of the 
information collection and recordkeeping requirements contained in this 
part that have been approved by the Office of Management and Budget.

Subpart 801.3--Agency Acquisition Regulations


801.301  Policy.

    (a)(1) VA implementation and supplementation of the FAR is issued 
in the Veterans Affairs Acquisition Regulation (VAAR) under 
authorization and subject to the authority, direction, and control of 
the Secretary of Veterans Affairs. The VAAR contains--
    (i) Requirements of law;
    (ii) Agency policies;
    (iii) Delegations of FAR authorities;
    (iv) Deviations from FAR requirements; and
    (v) Policies/procedures that have a significant effect beyond the 
internal operating procedures of VA or a significant cost or 
administrative impact on contractors or offerors.
    (2) Relevant internal procedures, guidance, and information (PGI) 
that do not meet the criteria in paragraph (a)(1) of this section are 
issued in the Veterans Affairs Acquisition Manual (VAAM).
    (b) [Reserved]


801.304  Agency control and compliance procedures.

    The Principal Executive Director of VA's Office of Acquisition, 
Logistics and Construction is designated as the Department's Chief 
Acquisition Officer. The Executive Director for the Office of 
Acquisition and Logistics (OAL) is designated as the Department's 
Senior Procurement Executive (SPE). The SPE is responsible for amending 
the VAAR for compliance with FAR 1.304.

Subpart 801.4--Deviations From the FAR


801.403  Individual deviations.

    The SPE may authorize individual deviations from the FAR and VAAR 
in accordance with FAR 1.403 when an individual deviation is in the 
best interest of the Government.


801.404  Class deviations.

    The SPE may authorize class deviations from the FAR and VAAR when a 
class deviation is in the best interest of the Government.

Subpart 801.6--Career Development, Contracting Authority, and 
Responsibilities


801.601  General.

    (a) The Senior Procurement Executive is granted the authority to 
appoint and terminate contracting officers. This authority is further 
delegated to the heads of the contracting activities (HCA) and others 
as appropriate. The SPE may also delegate authority to execute, award, 
and administer contracts, purchase orders, and other agreements to 
other VA officials, such as HCAs and contracting officers. All 
delegations of authority will be made in writing.
    (b) HCAs may authorize the use of ordering officers to order 
supplies and services in accordance with the ordering limits identified 
in the contract or agreement or the specific ordering guide. Ordering 
officers shall be delegated in writing. The written delegation must be 
specific to the contract or agreement and articulate the limitations of 
the delegated authority. Ordering officers shall only place orders 
against the contract or agreement if it is awarded to a single awardee. 
Ordering officers may not negotiate contract terms and conditions, 
determine price reasonableness, or determine best value. If the 
contracting officer determines prior to award that ordering officers 
will be authorized to place orders against a contract or agreement, the 
contracting officer will furnish the contractor with the names of 
individuals delegated ordering officer authority by separate letter 
upon issuance of the contract.


801.602-3  Ratification of unauthorized commitments.

    (a) This section applies to unauthorized commitments, including any 
commitment made by a contracting officer that exceeds that contracting 
officer's contracting authority and unauthorized commitments made by a 
Government representative who lacked the authority to enter into that 
agreement on behalf of the Government.
    (b) The approving authority and ratification official for 
unauthorized commitments is the HCA. This authority may be delegated to 
the chief of the contracting office or the equivalent for unauthorized 
commitments below $25,000.


801.604  Contracting Officer`s Representative (COR).

    When the contracting officer intends to designate a Contracting 
Officer's Representative for a solicitation or contract, the 
contracting officer must

[[Page 70748]]

include the clause in 852. 201-70, Contracting Officer`s 
Representative, in the solicitation and contract.

PART 802--DEFINITIONS OF WORDS AND TERMS

0
 2. The authority citation for part 802 continues to read as follows:

    Authority:  40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 
1702; and 48 CFR 1.301-1.304.

Subpart 802.1--Definitions

0
 3. Section 802.101 is amended by adding the definition ``Ordering 
officer'' in alphabetical order to read as follows:


802.101  Definitions.

* * * * *
    Ordering officer means the VA official authorized to order supplies 
and services against a FAR-based contract or agreement in accordance 
with the ordering limits identified in the contract or agreement or the 
specific ordering guide in accordance with 801.601(b).
* * * * *

PART 808--REQUIRED SOURCES OF SUPPLIES AND SERVICES

0
4. The authority citation for part 808 continues to read as follows:

    Authority:  38 U.S.C. 8127-8128; 40 U.S.C. 121(c); 41 U.S.C. 
1121(c)(3); 41 U.S.C. 1702; and 48 CFR 1.301 through 1.304.

Subpart 808.4--Federal Supply Schedules

0
5. Add section 808.470 to read as follows:


808.470  Ordering Officers.

    In accordance with 801.601, when authorized, ordering officers may 
place orders for supplies and services against agreements or task or 
delivery orders established by a contracting officer against Federal 
Supply Schedules within the ordering limits identified in the contract 
or agreement or the specific ordering guide when funding is available. 
Ordering officers shall only place orders against the order or 
agreement if it is awarded to a single awardee. The contracting officer 
that awarded the Blanket Purchase Agreements (BPA) or order will 
provide the contractor a list of authorized ordering officers. Any 
modifications to the agreement or order must be performed by a 
contracting officer.

PART 816--TYPES OF CONTRACTS

0
6. The authority citation for part 816 continues to read as follows:

    Authority:  40 U.S.C. 121(c); 41 U.S.C. 1121(c)(3); 41 U.S.C. 
1702; and 48 CFR 1.301 through 1.304.

Subpart 816.5--Indefinite-Delivery Contracts

0
7. Add section 816.570 to read as follows:


816.570  Ordering officers.

    In accordance with 801.601, when authorized, ordering officers may 
place orders for supplies and services against established Indefinite-
Delivery Contracts within the ordering limits identified in the 
contract or the specific ordering guide when funding is available. 
Ordering officers shall only place orders against the contract if it is 
awarded to a single awardee. When a contracting officer appoints an 
ordering officer in writing after award, the contracting officer will 
furnish the contractor with an updated list of individual ordering 
officers authorized to place orders against the contract. Ordering 
officers may not negotiate contract terms and conditions, determine 
price reasonableness, or determine best value.

0
8. Part 835 is added to subchapter F to read as follows:

PART 835--RESEARCH AND DEVELOPMENT CONTRACTING

Sec.
835.001-70 Veterans Affairs (VA) definitions.
835.003-70 VA policy.
835.003-71 Research misconduct.
835.003-72 Protection of human subjects.
835.003-73 Animal welfare.
835.003-74 Facilities.
835.003-75 Acknowledgement of support and disclaimer.
835.010 Scientific and technical reports.

    Authority:  38 U.S.C. 7303; 40 U.S.C. 121(c); 41 U.S.C. 1702 and 
48 CFR 1.301 through 1.304.


835.001-70  Veterans Affairs (VA) definitions.

    Research means a systematic investigation, including research 
development, testing and evaluation, designed to develop or contribute 
to generalized knowledge.
    Research impropriety refers to noncompliance with the laws, 
regulations, and policies regarding human subject protections, 
laboratory animal welfare, research safety, research laboratory 
security, research information security, and research misconduct. It 
does not encompass improper procedures or conduct in areas outside of 
the mandate of the Office of Research Oversight (ORO) (e.g., waste, 
fraud, abuse, or fiscal mismanagement).
    Research misconduct means fabrication, falsification, or plagiarism 
in proposing, performing, or reviewing research, or in reporting 
research results.
    VA facility means a component of the VA national health care 
system, such as a VA Medical Center, VA Health Care System, or VA 
Medical and Regional Office Center.


835.003-70  VA policy.

    (a) Pursuant to 38 U.S.C. 7303, VA is authorized to carry out a 
program of medical research in connection with the provisions of 
medical care and treatment to Veterans.
    (b) The Office of Research Oversight (ORO) serves as the primary 
Veterans Health Administration (VHA) office that advises the Under 
Secretary for Health on all compliance matters related to--
    (1) Human subject protections;
    (2) Laboratory animal welfare;
    (3) Research safety;
    (4) Research laboratory security;
    (5) Research information security;
    (6) Research misconduct; and
    (7) Other research improprieties.


835.003-71  Research misconduct.

    The contracting officer shall insert the clause at 852.235-70, 
Research Misconduct, in all research and development (R&D) 
solicitations and contracts.


835.003-72  Protection of human subjects.

    The contracting officer shall insert the clause at 852.235-71, 
Protection of Human Subjects, in all research and development (R&D) 
solicitations and contracts.


835.003-73  Animal welfare.

    The contracting officer shall insert the clause at 852.235-72, 
Animal Welfare, in all research and development (R&D) solicitations and 
contracts.


835.003-74  Facilities.

    If the contracting officer determines that the facilities to be 
assigned to perform effort on a research and development (R&D) contract 
are critical to the success of the R&D effort, the contracting officer 
shall insert the clause at 852.235-73, Facilities, in the solicitation 
and contract.


835.003-75  Acknowledgement of support and disclaimer.

    The contracting officer shall insert the clause at 852.235-74, 
Acknowledgement of Support and Disclaimer, in all research and 
development (R&D) solicitations and contracts.

[[Page 70749]]

835.010  Scientific and technical reports.

    The contracting officer shall insert the clause at 852.235-75, 
Scientific and Technical Reports, in all research and development (R&D) 
solicitations and contracts.

PART 852--SOLICITATION PROVISIONS AND CONTRACT CLAUSES

0
9. The authority citation for part 852 continues to read as follows:

    Authority:  38 U.S.C. 8127-8128, and 8151-8153; 40 U.S.C. 
121(c); 41 U.S.C. 1121(c)(3), 41 U.S.C. 1303; 41 U.S.C. 1702; and 48 
CFR 1.301 through 1.304.


0
10. Section 852.235-70 is added to read as follows:


852.235-70  Research Misconduct.

    As prescribed at 835.003-71, insert the following clause:

Research Misconduct (DEC 2022)

    (a) The Contractor is responsible for maintaining the integrity of 
research performed pursuant to this contract award including the 
prevention, detection and remediation of research misconduct as defined 
in 835.001-70.
    (b) The Contractor shall notify the Contracting Officer within 7 
business days of any research misconduct allegations received by the 
facility concerning this contract award.
    (c) The Contractor shall conduct an initial inquiry into any 
allegation of research misconduct. If the Contractor determines that 
there is sufficient evidence to proceed to an investigation, the 
Contractor shall notify the Contracting Officer and, unless otherwise 
instructed shall--
    (1) Conduct an investigation to develop a complete factual record 
and an examination of such record leading to either a finding of 
research misconduct and an identification of appropriate remedies, or a 
recommendation that no further action is warranted;
    (2) When the investigation results in a research misconduct 
finding, ensure the matter is adjudicated by a responsible official who 
was not involved in the inquiry or investigation and is 
organizationally separated from the element which conducted the 
investigation. The adjudication shall include a review of the 
investigation record and a recommendation of appropriate corrective 
actions and sanctions; and
    (3) When an investigation is complete, the Contractor shall forward 
to the Contracting Officer a copy of the evidentiary record, the 
investigative report, any recommendations made to the Contractor's 
adjudicating official, the adjudicating official's recommendation and 
notification of any proposed corrective action, and the subject's 
written response, if any. The Contracting Officer will review the 
documentation to determine whether the proposed corrective action can 
proceed.
    (d) The VA may elect to act in lieu of the Contractor in conducting 
an inquiry or investigation into an allegation of research misconduct 
if the Contracting Officer finds that--
    (1) The research organization is not prepared to handle the 
allegation in a manner consistent with this clause and it is believed 
it cannot reasonably conduct the inquiry;
    (2) VA involvement is necessary to ensure the public health, 
safety, and security, or to prevent harm to the public interest; or
    (3) The allegation involves possible criminal misconduct.
    (e) The Contractor shall provide safeguards for information 
received and protect informants, witnesses and respondents of 
allegations as follows:
    (1) The Contractor shall provide safeguards to ensure that 
individuals may bring allegations of research misconduct made in good 
faith to the attention of the Contractor without suffering retribution. 
Safeguards include: protection against retaliation; fair and objective 
procedures for examining and resolving allegations; and diligence in 
protecting positions and reputations.
    (2) The Contractor shall also assure the respondent that their 
rights are protected and that the mere filing of an allegation of 
research misconduct will not result in an adverse action. Safeguards 
include timely written notice regarding substantive allegations against 
them, a description of the allegations and reasonable access to any 
evidence submitted to support each allegation. Respondents must be 
given the opportunity to prepare a response to an allegation and notice 
of any findings of research misconduct.
    (f) Objectivity and expertise. The Contractor shall select 
individual(s) to inquire, investigate, and adjudicate allegations of 
research misconduct who have appropriate expertise and have no 
unresolved conflict of interest. The individual(s) who conducts the 
adjudication must not be the same individual(s) who conducted the 
inquiry or investigation and must be separate organizationally from the 
element that conducted the inquiry or investigation.


(End of clause)

0
11. Section 852.235-71 is added to read as follows:


852.235-71  Protection of Human Subjects.

    As prescribed at 835.003-72, insert the following clause:

Protection of Human Subjects (DEC 2022)

    (a) Research involving human subjects is not permitted under this 
award unless expressly authorized in writing by the Contracting 
Officer. Such authorization will specify the details of the approved 
research involving human subjects and will be incorporated by reference 
into this contract.
    (b) The Federal Policy for the Protection of Human Subjects (the 
``Common Rule''), adopted by VA (see 38 CFR part 16), requires 
Contractors to maintain appropriate policies and procedures for the 
protection of human subjects in research. The Common Rule defines a 
``human subject'' as a living individual about whom an investigator 
conducting research obtains data through intervention or interaction 
with the individual, or identifiable private information. The term 
``research'' means a systematic investigation, including research 
development and/or testing and evaluation, designed to develop or 
contribute to generalized knowledge. The Common Rule also sets forth 
categories of research that may be considered exempt from 15 CFR part 
27. These categories may be found at 15 CFR 27.101.
    (c) Should research involving human subjects be included in the 
proposal, prior to issuance of an award, the Contractor shall submit 
the following documentation to the Contracting Officer:
    (1) Documentation to verify that the Contractor has established a 
relationship with an appropriate Institutional Review Board 
(``cognizant IRB''). An appropriate IRB is one that is located within 
the United States and within the community in which the research will 
be conducted;
    (2) Documentation to verify that the cognizant IRB possesses a 
valid registration with the United States Department of Health and 
Human Services' Office for Human Research Protections (``OHRP'');
    (3) Documentation to verify that the Contractor has a valid 
Federal-wide Assurance (FWA) issued by OHRP.
    (d) Prior to starting any research involving human subjects, the 
Contractor shall submit appropriate documentation to the Contracting 
Officer for institutional review and approval. This documentation may 
include:

[[Page 70750]]

    (1) Copies of the research protocol, all questionnaires, surveys, 
advertisements, and informed consent forms approved by the cognizant 
IRB;
    (2) Documentation of approval for the research protocol, 
questionnaires, surveys, advertisements, and informed consent forms by 
the cognizant IRB;
    (3) Documentation of continuing IRB approval by the cognizant IRB 
at appropriate intervals as designated by the IRB, but not less than 
annually; and/or
    (4) Documentation to support an exemption for the project from the 
Common Rule (Note: this option is not available for activities that 
fall under 45 CFR part 46, subpart C).
    (e) Additionally, if the Contractor modifies a research protocol, 
questionnaire, survey, advertisement, or informed consent form approved 
by the cognizant IRB, the Contractor shall submit a copy of all 
modified material along with documentation of approval for said 
modification by the cognizant IRB to the Contracting Officer for 
institutional review and approval. The Contractor shall not implement 
any IRB approved modification without written approval by the 
Contracting Officer.
    (f) No work involving human subjects may be undertaken, conducted, 
or costs incurred and/or charged to the project, until the Contracting 
Officer approves the required appropriate documentation in writing.
    (g) The Contractor shall bear full responsibility for the 
performance of all work and services involving the use of human 
subjects under this contract 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 be deemed to constitute the 
Contractor or any subcontractor, agent or employee of the Contractor, 
or any other person, organization, institution, or group of any kind 
whatsoever, as the agency or employee of the Government. 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 judgement or otherwise, as an 
independent Contractor without imputing liability on the part of the 
Government for the acts of the Contractor or its employees.
    (h) If at any time during performance of this contract, the 
Contracting Officer determines, in consultation with the Office for 
Protection from Research Risks (OPRR), National Institutes of Health 
(NIH), that the Contractor is not in compliance with any of the 
requirements, the Contracting Officer may immediately suspend the 
research and further payments under this contract until the Contractor 
corrects such noncompliance. Notice of the suspension may be 
communicated by telephone and confirmed in writing. If the Contractor 
fails to complete the corrective action within the period of time 
designated in the Contracting Officer's written notice of suspension, 
the Contracting Officer may, in consultation with OPRR, NIH, terminate 
this contract and the Contractor's name may be removed from the list of 
those Contractors with approved Department of Health and Human Services 
Human Subject Assurances.


(End of clause)

0
12. Section 852.235-72 is added to read as follows:


852.235-72  Animal Welfare.

    As prescribed in 835.003-73, insert the following clause:

Animal Welfare (DEC 2022)

    (a) The Contractor shall--
    (1) Use the Veterans Affairs (VA), Office of Research Oversight 
(ORO) Laboratory Animal Welfare Checklist;
    (2) Comply with the United States Department of Agriculture (USDA) 
Animal Welfare Act and Animal Welfare Regulations at https://www.aphis.usda.gov/animal_welfare, and the Animal Welfare Information 
Center's (AWIC) information for improved animal care and use in 
research, testing, and teaching provided at https://www.nal.usda.gov/awic;
    (3) Develop and provide to the Contracting Officer a written plan 
of providing adequate veterinary care to laboratory animals, 
including--
    (i) The frequency of visits; and
    (ii) Provisions for after-hours, weekend and holiday veterinary 
coverage.
    (b) The Contracting Officer may immediately suspend the work by 
issuance of a stop work order and suspend further payments under this 
contract for failure to comply with the requirements of this clause.
    (c) The suspension will stay in effect until the Contractor 
complies with the requirements. Failure to complete corrective action 
within the time specified by the Contracting Officer may result in 
termination of this contract.
    (d) The Contractor shall include the substance of this clause, in 
all subcontracts involving research and development, testing, 
evaluation or training that use live vertebrate animals.


(End of clause)

0
13. Section 852.235-73 is added to read as follows:


852.235-73  Facilities.

    As prescribed at 835.003-74, insert the following clause:

Facilities (DEC 2022)

    (a) The facilities specified in the contract are considered 
essential to the work being performed under this contract. Therefore, 
prior to removing, replacing, or diverting any of the listed or 
specified facilities, the Contractor shall--
    (1) Notify the Contracting Officer in writing; and
    (2) Submit justification (including proposed substitutions) in 
sufficient detail to permit evaluation of the potential impact on this 
contract.
    (b) The Contractor shall make no removal, replacement or diversion 
of facilities without the Contracting Officer's written consent.


(End of clause)

0
14. Section 852.235-74 is added to read as follows:


852.235-74  Acknowledgement of Support and Disclaimer.

    As prescribed at 835.003-75, insert the following clause:

Acknowledgement of Support and Disclaimer (DEC 2022)

    (a) The Contractor shall include an acknowledgment of the 
Government's support in the publication of any material based on or 
developed under this contract, stated in the following terms: This 
material is based upon work supported by the (name of contracting 
agency) under this VA contract.
    (b) All material, except scientific articles or papers published in 
scientific journals, must, in addition to any notices or disclaimers by 
the Contractor, also contain the following disclaimer:
    Any opinions, findings, conclusions or recommendations expressed in 
this material are those of the author(s) and do not necessarily reflect 
the views of the VA.


(End of clause)

0
15. Section 852.235-75 is added to read as follows:


852.235-75  Scientific and Technical Reports.

    As prescribed at 835.010, insert the following clause:

Scientific and Technical Reports (DEC 2022)

    The Contractor shall submit an electronic copy of the approved 
scientific technical reports, not a summary, delivered under this 
contract

[[Page 70751]]

to the National Technical Information Service (NTIS) as delineated at 
FAR 35.010.


(End of clause)


852.270-1  [Redesignated]

0
16. Redesignate Section 852.270-1 as section 852.201-70 and revise 
newly redesignated section 852.201-70 to read as follows:


852.201-70  Contracting Officer's Representative.

    As prescribed in 801.604, insert the following provision:

Contracting Officer's Representative (DEC 2022)

    The Contracting Officer reserves the right to designate 
representatives to act for him/her in furnishing technical guidance and 
advice or generally monitor the work to be performed under this 
contract. Such designation will be in writing and will define the scope 
and limitation of the designee's authority. A copy of the designation 
letter shall be furnished to the Contractor.


(End of provision)

[FR Doc. 2022-23961 Filed 11-18-22; 8:45 am]
BILLING CODE 8320-01-P