Rule2022-23961
VA Acquisition Regulation: Department of Veterans Affairs Acquisition Regulation System and Research and Development
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
November 21, 2022
Effective
December 21, 2022
Issuing agencies
Veterans Affairs Department
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 223 (Monday, November 21, 2022)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="http://www.regulations.gov">www.regulations.gov</a>.
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 <a href="https://www.aphis.usda.gov/animal_welfare">https://www.aphis.usda.gov/animal_welfare</a>, and the Animal Welfare Information
Center's (AWIC) information for improved animal care and use in
research, testing, and teaching provided at <a href="https://www.nal.usda.gov/awic">https://www.nal.usda.gov/awic</a>;
(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
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</html>Indexed from Federal Register on November 21, 2022.
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