10158 Federal Register / Vol. 87, No. 36 / Wednesday, February 23, 2022 / Proposed Rules 

I. National Technology Transfer and 

Advancement Act (NTTAA) and 1 CFR 

Part 51 

This rulemaking involves technical 

standards. Therefore, the EPA 

conducted searches through the 

Enhanced NSSN Database managed by 

the American National Standards 

Institute (ANSI) to determine if there are 

voluntary consensus standards (VCS) 

that are relevant to this action. The 

Agency also contacted VCS 

organizations and accessed and 

searched their databases. Searches were 

conducted for the EPA Methods 9, 12, 

and 29 of 40 CFR part 60, appendix A. 

No applicable VCS were identified for 

EPA Methods 12 and 29 for lead. 

During the search, if the title or 

abstract (if provided) of the VCS 

described technical sampling and 

analytical procedures that are similar to 

the EPA’s reference method, the EPA 

considered it as a potential equivalent 

method. All potential standards were 

reviewed to determine the practicality 

of the VCS for this rule. This review 

requires significant method validation 

data which meets the requirements of 

the EPA Method 301 for accepting 

alternative methods or scientific, 

engineering and policy equivalence to 

procedures in the EPA reference 

methods. The EPA may reconsider 

determinations of impracticality when 

additional information is available for 

particular VCS. 

One voluntary consensus standard 

was identified as acceptable alternative 

to EPA test methods for the purposes of 

this rule. The voluntary consensus 

standard ASTM D7520–16, ‘‘Standard 

Test Method for Determining the 

Opacity of a Plume in the Outdoor 

Ambient Atmosphere’’ is an acceptable 

alternative to EPA Method 9 with the 

following conditions: 

1. During the digital camera opacity 

technique (DCOT) certification 

procedure outlined in section 9.2 of 

ASTM D7520–16, you or the DCOT 

vendor must present the plumes in front 

of various backgrounds of color and 

contrast representing conditions 

anticipated during field use such as blue 

sky, trees, and mixed backgrounds 

(clouds and/or a sparse tree stand). 

2. You must also have standard 

operating procedures in place including 

daily or other frequency quality checks 

to ensure the equipment is within 

manufacturing specifications as 

outlined in section 8.1 of ASTM D7520– 

16. 

3. You must follow the record keeping 

procedures outlined in § 63.10(b)(1) for 

the DCOT certification, compliance 

report, data sheets, and all raw 

unaltered JPEGs used for opacity and 

certification determination. 

4. You or the DCOT vendor must have 

a minimum of four (4) independent 

technology users apply the software to 

determine the visible opacity of the 300 

certification plumes. For each set of 25 

plumes, the user may not exceed 15 

percent opacity of anyone reading and 

the average error must not exceed 7.5 

percent opacity. 

5. This approval does not provide or 

imply a certification or validation of any 

vendor’s hardware or software. The 

onus to maintain and verify the 

certification and/or training of the 

DCOT camera, software and operator in 

accordance with ASTM D7520–16 and 

this letter is on the facility, DCOT 

operator, and DCOT vendor. 

The search identified one VCS that 

was potentially applicable for this rule 

in lieu of EPA reference methods. After 

reviewing the available standards, EPA 

determined that one candidate VCS 

(ASTM D4358–94 (1999)) identified for 

measuring emissions of pollutants or 

their surrogates subject to emission 

standards in the rule would not be 

practical due to lack of equivalency, 

documentation, validation data and 

other important technical and policy 

considerations. Additional information 

for the VCS search and determinations 

can be found in the memorandum, 

Voluntary Consensus Standard Results 

for Review of Standards of Performance 

for Lead Acid Battery Manufacturing 

Plants and National Emission Standards 

for Hazardous Air Pollutants for Lead 

Acid Battery, which is available in the 

docket for this action. 

Under 40 CFR 63.7(f) and 40 CFR 

68.3(f) of subpart A of the General 

Provisions, a source may apply to the 

EPA to use alternative test methods or 

alternative monitoring requirements in 

place of any required testing methods, 

performance specifications or 

procedures in the final rule or any 

amendments. The EPA welcomes 

comments on this aspect of the 

proposed rulemaking and, specifically, 

invites the public to identify potentially 

applicable VCS and to explain why such 

standards should be used in this 

regulation. 

J. Executive Order 12898: Federal 

Actions To Address Environmental 

Justice in Minority Populations and 

Low-Income Populations 

The EPA believes that this action does 

not have disproportionately high and 

adverse human health or environmental 

effects on minority populations, lowincome populations, and/or indigenous 

peoples, as specified in Executive Order 

12898 (59 FR 7629, February 16, 1994). 

The documentation for this decision 

is contained in section V.C and V.E of 

this preamble. As discussed in section 

V.E of this preamble, we performed a 

demographic analysis for the lead acid 

battery manufacturing source category, 

which is an assessment of the proximity 

of individual demographic groups living 

close to the facilities (within 50 km and 

within 5 km). Results of the 

demographic analysis indicate that the 

following groups above the national 

average: Hispanics, Ages 18–64, People 

living below the Poverty Level, 25 years 

old or greater without a High School 

Diploma, and People living in Linguistic 

Isolation. However, based on analyses of 

emissions and available ambient 

monitoring data (described in section 

IV.A of this preamble), we conclude 

ambient Pb concentrations near the 

facilities are all below the National 

Ambient Air Quality Standard (NAAQS) 

for Pb and therefore the sources are not 

likely to pose significant risks to human 

health. 

Janet G. McCabe, 

Deputy Administrator. 

[FR Doc. 2022–03396 Filed 2–22–22; 8:45 am] 

BILLING CODE 6560–50–P 

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: Proposed rule. 

SUMMARY: The Department of Veterans 

Affairs (VA) is proposing to amend and 

update its VA Acquisition Regulation 

(VAAR) in phased increments to revise 

or remove any policy superseded by 

changes in the Federal Acquisition 

Regulation (FAR), to remove procedural 

guidance internal to VA into the VA 

Acquisition Manual (VAAM), and to 

incorporate any new agency specific 

regulations or policies. These changes 

seek to streamline and align the VAAR 

with the FAR and remove outdated and 

duplicative requirements and reduce 

burden on contractors. The VAAM 

incorporates portions of the removed 

VAAR as well as other internal agency 

acquisition policy. VA will rewrite 

certain parts of the VAAR and VAAM, 

and as VAAR parts are rewritten, will 

publish them in the Federal Register. 


khammond on DSKJM1Z7X2PROD with PROPOSALS
Federal Register / Vol. 87, No. 36 / Wednesday, February 23, 2022 / Proposed Rules 10159 

VA will combine related topics, as 

appropriate. 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: Comments must be received on 

or before April 25, 2022 to be 

considered in the formulation of the 

final rule. 

ADDRESSES: Comments may be 

submitted through 

www.Regulations.gov. Comments 

received will be available at 

regulations.gov for public viewing, 

inspection or copies. 

FOR FURTHER INFORMATION CONTACT: Mr. 

Rafael Taylor, Senior Procurement 

Analyst, Procurement Policy and 

Warrant Management Services, 003A2A, 

810 Vermont Avenue NW, Washington, 

DC 20420, (202) 714–8560. (This is not 

a toll-free number.) 

SUPPLEMENTARY INFORMATION: 

Background 

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. 

VA is proposing to revise the VAAR 

to add new policy or regulatory 

requirements and to remove any 

redundant guidance and guidance that 

is applicable only to VA’s internal 

operating processes or procedures. 

Codified acquisition regulations may be 

amended and revised only through 

rulemaking. All amendments, revisions 

and removals have been reviewed and 

concurred with VA’s Integrated Product 

Team of agency stakeholders. 

The VAAR uses the regulatory 

structure and arrangement of the FAR 

and headings and subject areas are 

consistent with FAR content. The VAAR 

is divided into subchapters, parts (each 

of which covers a separate aspect of 

acquisition), subparts and sections. 

The Office of Federal Procurement 

Policy Act, as codified in 41 U.S.C. 

1707, provides the authority for the 

Federal Acquisition Regulation and for 

the issuance of agency acquisition 

regulations consistent with the FAR. 

When Federal agencies acquire 

supplies and services using 

appropriated funds, the purchase is 

governed by the FAR, set forth at title 

48 Code of Federal Regulations (CFR), 

chapter 1, parts 1 through 53, and the 

agency regulations that implement and 

supplement the FAR. The VAAR is set 

forth at 48 CFR, chapter 8, parts 801 to 

873. 

Discussion and Analysis 

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. 

VAAR Part 801—Department of 

Veterans Affairs Acquisition Regulation 

System 

We propose to revise the authorities 

cited for this part. The authorities cited 

for this part are 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. 1121(c)(3); 41 U.S.C. 

1702; 41 U.S.C. 1707; and 48 CFR 

1.301–1.304. The Title 38 authorities are 

cited as they provide the statutory basis 

for the exclusions as outlined in 

801.104–70. We have retained the 

authority from 48 CFR 1.301–1.304 as 

this is the FAR subpart outlining the 

guidance for agency acquisition 

regulations. 

Under subpart 801.1, Purpose, 

Authority, Issuance, we propose to 

revise 801.103, Authority, to add 41 

U.S.C. 1707 (the OFFP Act) as an 

authority to the publishing of this 

regulation. Under 801.104, 

Applicability, we propose to revise the 

text for clarity and to remove an 

unnecessary reference to the VA 

Canteen Service. 

In 801.104–70, Exclusions, we 

propose to retain the first paragraph and 

redesignate it as paragraph (a) which 

explains that the FAR and VAAR do not 

apply to those purchases made using the 

General Post Fund when a donor 

specifies the exact item to be purchased. 

Under 801.104–70, we also propose to 

add paragraph (b) to address the 

statutory exception at 38 U.S.C. 8123, 

Procurement of prosthetic appliances, 

which states: ‘‘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.’’ Finally, under this 

section, we propose to add paragraph (c) 

to address the statutory exception at 38 

U.S.C. 8153, Sharing of health-care 

resources, which allows the VA to 

secure health-care resources which 

otherwise might not be feasibly 

available, or to effectively utilize certain 

other health-care resources, by using 

simplified procedures which were 

codified in VAAR part 873, Simplified 

Acquisition Procedures For Health-Care 

Resources. 

We propose to remove 801.105 (no 

text) and 801.105–2, Arrangement of 

regulations, as the location of this 

guidance has been revised to comport 

with the placement of the corresponding 

FAR guidance. The information that was 

covered here has been moved to 

801.301, Policy. 

In 801.106, OMB approval under the 

Paperwork Reduction Act, we propose 

to delete the chart that contains the 

OMB approval numbers. We propose to 

revise this section to add language 

directing the reader to the VAAM for the 

list of information collection and 

recordkeeping requirements associated 

with the control numbers. Given the 

constant updating of VA’s information 

collection requirements and the OMB 

control numbers, it is more prudent to 

place this information in the VAAM 

which doesn’t require rulemaking for 

updating. 

VA proposes to remove subpart 801.2, 

Administration, as it explains the role of 

the Defense Acquisition Regulations 

Council and the Civilian Agency 

Acquisition Council, which is 

redundant to the FAR. 

We propose to revise the name of 

subpart 801.3 from ‘‘Department 

Acquisition Regulations’’ to ‘‘Agency 

Acquisition Regulations’’ so that the 

title comports with the FAR heading. 

We propose to add 801.301, Policy, 

which states that the VA 

implementation and supplementation of 

the FAR is issued in the VAAR under 

authorization and subject to the 

authority, direction, and control of the 

Secretary of Veterans Affairs. This 

section also explains what the VAAR 

contains and introduces and explains 

the VAAM. 

For 801.304, we propose to revise this 

section to change the title from 

‘‘Department control and compliance 

procedures’’ to ‘‘Agency control and 

compliance procedures’’ to comport 

with the FAR title of this section. We 

also propose to revise the text to reflect 


khammond on DSKJM1Z7X2PROD with PROPOSALS
10160 Federal Register / Vol. 87, No. 36 / Wednesday, February 23, 2022 / Proposed Rules 

the roles and titles currently in use in 

VA. 

We propose to revise the title of 

subpart 801.4 from ‘‘Deviations from the 

FAR and VAAR’’ to ‘‘Deviations from 

the FAR.’’ This change was made to 

conform to the FAR title. 

We propose to revise 801.403, 

Individual deviations, by adding 

language specifying that the Senior 

Procurement Executive (SPE) may 

authorize individual deviations from the 

FAR and VAAR when an individual 

deviation is in the best interest of the 

Government. 

Under 801.404, Class deviations, we 

propose to revise the language to clarify 

that the SPE is the VA authority 

designated to comply with FAR 1.404. 

Under subpart 801.6, Career 

Development, Contracting Authority 

and Responsibilities, we propose to 

revise 801.601, General, to reflect that 

that the SPE has authority to appoint 

contracting officers under FAR 1.603 

and this authority is further delegated to 

the heads of the contracting activities 

(HCAs). This revision also removes the 

reference to VA’s Contracting Officer 

Certification Program (COCP) which no 

longer exists. We also propose to revise 

the section to remove the material 

pertaining to purchase card holders and 

to add coverage that HCAs may 

authorize ordering officers to place 

orders against a contract or agreement 

under certain circumstances. 

Under 801.602, Contracting officers, 

we propose to remove this section as the 

policy regarding bills of lading and the 

authorization to sell personal property 

is outdated and the coverage including 

the responsibilities delegated to 

contracting officers is not required in 

the regulation. 

We propose to remove 801.602–2, 

Responsibilities, and move this internal 

guidance to the VA Acquisition Manual 

(VAAM). 

We propose to revise 801.602–3, 

Ratification of unauthorized 

commitments, to update the authorities 

within the VA designated to ratify 

unauthorized commitments. This 

section incorporates the language from 

Class Deviation—VAAR 801.602–3, 

Ratification of Unauthorized 

Commitments, dated May 3, 2013. We 

propose to delete the procedural 

guidance from this section and move it 

to the VAAM. 

We propose to remove 801.602–70, 

General review requirements, and add it 

to the VAAM as it contains VA’s 

internal procedures. 

We propose to remove 801.602–71, 

Basic review requirements, and add it to 

the VAAM as it contains VA’s internal 

procedures. 

We propose to remove the following 

three sections: 801.602–72, Exceptions 

and additional review requirements; 

801.602–73, Review requirements for 

scarce medical specialist contracts and 

contracts for health care resources; and 

801.602–74, Review requirements for an 

interagency agreement. The three 

sections contain policy requiring 

reviews at the Departmental level, 

inconsistent with current VA policy in 

this area. 

We propose to remove 801.602–75, 

Review requirements—OGC, and the 

corresponding table and add it to the 

VAAM as it contains VA’s internal 

procedures and review thresholds. A 

class deviation to update this policy was 

signed April 12, 2017. 

We propose to delete the sections 

listed below as they contain policy 

requiring reviews at the Departmental 

level, inconsistent with current VA 

policy in this area. Various sections are 

also specific to only one administration/ 

organization which is inconsistent with 

the objective to establish policies and 

procedures at the departmental level. 

The sections slated for removal as 

described above are as follows: 

801.602–76 Business clearance review. 

801.602–77 Processing solicitations and 

contract documents for legal or technical 

review—general. 

801.602–78 Processing solicitations and 

contract documents for legal or technical 

review—Veterans Health Administration 

field facilities, Central Office (except Office 

of Construction and Facilities 

Management), the National Acquisition 

Center, and the Denver Acquisition and 

Logistics Center. 

801.602–79 Processing solicitations and 

contract documents for legal or technical 

review—Veterans Benefits Administration. 

801.602–80 Legal and technical review— 

Office of Construction and Facilities 

Management and National Cemetery 

Administration. 

801.602–81 Documents required for 

business clearance reviews. 

801.602–82 Documents to submit for legal 

or technical review—general. 

801.602–83 Documents to submit for legal 

or technical review—contract 

modifications. 

801.602–84 Documents to submit for 

business clearance reviews. 

801.602–85 Results of review. 

We also propose to remove section 

801.603, Selection, appointment, and 

termination of appointment, as this 

information includes internal VA 

procedures and this information is more 

suitable for inclusion in the VAAM. The 

sections slated for removal under this 

section are as follows: 

801.603–1 General. 

801.603–70 Representatives of contracting 

officers. 

801.603–71 Representatives of contracting 

officers; receipt of equipment, supplies, 

and nonpersonal services. 

We propose to renumber and retitle 

the proposed for removal 801.603–70, to 

801.604, and from ‘‘Representatives of 

contracting officers’’ to ‘‘Contracting 

Officer’s Representatives (COR),’’ to 

comport with the FAR heading and 

location. We propose to revise the 

section to remove the text stating that 

contracting officers can name a 

Government employee as a 

representative as it is redundant to 

guidance at FAR 1.602–2(d). We have 

also removed obsolete guidance 

allowing contracting officers to delegate 

their authority to other Government 

contracting officers under centralized 

indefinite delivery type contracts. We 

also removed outdated guidance 

pertaining to centralized contracts for 

blood and other contract practices that 

are managed at the contracting office 

level. We propose to revise the text 

prescribing the clause to match the 

revised section heading. The clause has 

been renumbered from 852.270–1 to 

852.201–70 to be consistent with the 

numbering convention for VA’s clauses. 

We propose to remove 801.670, 

Special and limited delegation, for not 

adding value to the regulation. It 

restates guidance that is provided 

elsewhere regarding the delegation of 

authority to award contracts. 

We propose to remove 801.670–1, 

Issuing bills of lading, which rescinds 

the authority to issue bills of lading. 

This is redundant as the authority to 

issue bills of lading was removed from 

the VAAR at 801.602. We propose to 

remove section 801.670–3, as this policy 

is now obsolete. 

We propose to remove 801.670–4, 

National Cemetery Administration, as it 

does not fit the criteria of being 

departmental level policy and it also 

includes information that is no longer 

current. 

We propose to remove 801.670–5, 

Letters of agreement, as it states that the 

authority to utilize letters of agreement 

has been rescinded. This guidance is no 

longer relevant at this time. 

We propose to remove 801.680, 

Contracting authority of the Inspector 

General, as this information is more 

appropriate for the VAAM. 

We propose to remove 801.690, VA’s 

COCP and the following sections: 

801.690–1, Definitions; 801.690–2, 

General; 801.690–3, Responsibilities 

under the COCP; 801.690–4, Selection; 

801.690–5, Requirements for contracting 

authority; 801.690–6, Appointment; 

801.690–7, Termination; 801.690–8, 

Interim appointment provisions; and 

801.690–9, Distribution of Certificates of 


khammond on DSKJM1Z7X2PROD with PROPOSALS
Federal Register / Vol. 87, No. 36 / Wednesday, February 23, 2022 / Proposed Rules 10161 

Appointment. We propose to delete the 

sections listed above as they all describe 

a program, the Contracting Officer’s 

Certification Program (COCP) that no 

longer exists. The guidance previously 

located in 801.690–9, Distribution of 

Certificates of Appointment, has been 

moved to 801.603–3. 

We propose to remove 801.695, VA’s 

Appointment of HCA’s Program, and the 

supporting sections: 801.695–1, Policy; 

801.695–2, Procedures for appointment 

of HCAs; and 801.695–3, Authority of 

the HCA. We propose to remove the 

sections listed above and move them to 

the VAAM as they include information 

that is internal to the VA. 

VAAR Part 802—Definitions of Words 

and Terms 

VA proposes adding the definition of 

Ordering Officer to reflect the 

introduction and usage of the term in 

multiple parts of the VAAR. The 

authorities cited for this part are: 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. 

VAAR Part 808—Required Sources of 

Supplies and Services 

We propose adding a new section, 

808.470, Ordering officers, under 

subpart 808.4, Federal Supply 

Schedules, to convey that ordering 

officers may be authorized to place 

orders under established orders and 

Blanket Purchase Agreements under a 

Federal Supply Schedule award with a 

single awardee. The authorities cited for 

this part are: 38 U.S.C. 8127–8128; 40 

U.S.C. 121(c); 41 U.S.C. 1702; and 48 

CFR 1.301 through 1.304. 

VAAR Part 816—Types of Contracts 

VA proposes to add a new section, 

816.570, Ordering officers, under 

subpart 816.5, Indefinite-Delivery 

Contracts, to convey that ordering 

officers may be authorized to place 

orders under established IndefiniteDelivery Contracts with a single 

awardee. The authorities cited for this 

part are: 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. 

VAAR Part 835—Research and 

Development 

We propose to add a new part 835, 

Research and Development. The 

authorities cited for this part are 38 

U.S.C. 7303, 40 U.S.C. 121(c), 41 U.S.C. 

1702 and 48 CFR 1.301–1.304. We 

propose to add 835.001–70, VA 

definitions, to provide four R&D 

definitions crafted for the VA. We 

propose to add 835.003–70, Policy, in 

which paragraph (a) cites the U.S. Code 

that authorizes VA to execute a medical 

research program to improve the 

medical treatment of our Veterans and 

paragraph (b) states that the Office of 

Research Oversight (ORO) serves as the 

primary VHA office that advises the 

Under Secretary for Health on all 

compliance matters related to: Human 

subject protections; laboratory animal 

welfare, research safety, research 

laboratory security, research 

information security, research 

misconduct, and other research 

improprieties. Also under part 835, we 

propose to add 835.003–71, Research 

misconduct, which requires the 

contracting officer to insert the research 

misconduct clause into all R&D 

solicitations and contracts and 835.003– 

72, Protection of human subjects, which 

requires the contracting officer to insert 

the ‘‘Protection of Human Subject’’ 

clause in all R&D solicitations and 

contracts. 

In 835.003–73, Animal welfare, we 

propose to add a prescription requiring 

the contracting officer to insert the 

Animal Welfare clause, 852.235–72, in 

all R&D solicitations and contracts. 

Under 835.003–74, Facilities, we 

propose to add a prescription requiring 

contracting officers to insert clause 

852.235–73, Facilities, into R&D 

solicitations and contracts when the 

facilities to be assigned to perform effort 

on an R&D contract are critical to the 

success of the R&D effort or are a critical 

factor in the award of the contract. 

Under 835.003–75, Acknowledgement 

of support and disclaimer, we propose 

to add a prescription requiring 

contracting officers to insert clause 

852.235–74, Acknowledgement of 

Support and Disclaimer, into R&D 

solicitations and contracts. We propose 

to add 835.010, Scientific and technical 

reports, which includes a prescription 

requiring contracting officers to insert 

clause 852.235–75, Scientific and 

Technical Reports, into R&D 

solicitations and contracts. 

VAAR Part 852—Solicitation 

Provisions and Contract Clauses 

In subpart 852.2, Text of Provisions 

and Clauses, we propose to add clause 

852.201–70, Contracting Officer’s 

Representative (COR). This clause 

replaces a clause previously numbered 

as 852.270–1 and entitled 

‘‘Representatives of contracting 

officers.’’ 

We propose to add clause 852.235–70, 

Research Misconduct. This clause 

requires contractors to notify the 

contracting officer if there are any 

allegations of research misconduct. The 

clause also provides procedures for 

contractors to follow if their initial 

inquiry into the allegations requires a 

full investigation. We propose to add 

clause 852.235–71, Protection of Human 

Subjects, which makes clear that 

research involving human subjects is 

not permitted under the award unless 

expressly authorized in writing by the 

contracting officer. 

We propose to add clause 852.235–72, 

Animal Welfare, which should be used 

in all R&D solicitation and contracts and 

directs VA’s contractors to 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. This clause also directs the 

contractor to provide to the contracting 

officer a written plan of providing 

adequate veterinary care to laboratory 

animals, including the frequency of 

visits and provisions for after hours, 

weekend and holiday veterinary 

coverage. We propose to add clause 

852.235–73, Facilities, which stipulates 

that the facilities specified in the 

contract proposal are considered 

essential to the work being performed 

under the contract and that prior to 

changing the facilities, the contractor 

must notify the contracting officer in 

writing of the intent to remove, replace, 

or divert any of the specified facilities 

and the contractor cannot make a 

change in facilities without the 

contracting officer’s written consent. 

Under subpart 852.2, we propose to 

add 852.235–74, Acknowledgement of 

Support and Disclaimer. This clause 

requires the contractor to acknowledge 

the Government’s support in the 

publication of any material based on 

research developed under the contract 

and it also requires contractors to add a 

disclaimer (for all material published 

outside of scientific journals and 

papers), that ‘‘any opinions, findings, 

and conclusions or recommendations 

expressed in this material are those of 

the author(s) and do not necessarily 

reflect the views of the VA.’’ We also 

propose to add clause 852.235–75, 

Scientific and Technical Reports, which 

requires contractors to submit an 

electronic copy of the approved 

scientific technical reports delivered 

under the contract to the National 

Technical Information Service (NTIS). 

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 


khammond on DSKJM1Z7X2PROD with PROPOSALS
10162 Federal Register / Vol. 87, No. 36 / Wednesday, February 23, 2022 / Proposed Rules 

(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 proposed 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 proposed 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 proposed 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 provide needed 

guidance to ensure VA’s contractors 

properly protect and safeguard VA 

sensitive information, which includes 

Veteran’s sensitive personal 

information. This rulemaking adds a 

new VAAR part concerning Acquisition 

of Information Technology that codifies 

information collection burdens. VA’s 

requirement to collect the information is 

the result of existing requirements to 

ensure compliance across the Federal 

government and specifically when VA 

contractors, subcontractors, business 

associates and their employees require 

access to VA information (including VA 

sensitive information) or information 

systems. VA is merely adding existing 

and current regulatory requirements to 

the VAAR and placing guidance that is 

applicable only to VA’s internal 

operation processes or procedures into a 

VA Acquisition Manual. VA estimates 

no substantial cost impact to individual 

businesses will result from these rule 

updates already required to be 

considered by both large and small 

businesses to receive an award from VA 

or another Federal agency. There are 

costs associated with this rulemaking 

pertaining to the codification of an 

information collection request in order 

to comply with VA’s responsibilities 

under the Federal Information Security 

Modernization Act of 2014. Each agency 

of the Federal Government must provide 

security for the information and 

information systems that support the 

operations and assets of the agency, 

including those provided or managed by 

another agency, contractor, or other 

source. By statute, VA is required to 

ensure that its contractors, 

subcontractors, business associates, and 

their employees operating under 

contracts at VA shall be subject to the 

same Federal laws, regulations, policies 

or procedures as VA and VA personnel. 

While this requirement adds some 

burden in annual costs and hours to 

firms already awarded and performing 

contracts at VA, the overall cost is 

considered de minimis, for either large 

or small contractors, in relation to the 

potential impact and harm to Veterans 

and VA information and information 

systems should a contractor not comply. 

Properly setting forth the requirements 

will provide clarity to the public and 

ensure appropriate safeguards are in 

place to ensure protection of VA’s 

information (in particular VA sensitive 

personal information) and information 

systems. 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 which 

required the access, maintenance, 

process, or utilization of VA sensitive 

information or information systems. 

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. 

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 February 3, 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, 

Regulation Development Coordinator, Office 

of Regulation Policy & Management, Office 

of General Counsel, Department of Veterans 

Affairs. 

For the reasons set out in the 

preamble, VA is proposing to amend 48 

CFR parts 801, 802, 808, 816, 835, and 

852 as follows: 

■ 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. 


khammond on DSKJM1Z7X2PROD with PROPOSALS
Federal Register / Vol. 87, No. 36 / Wednesday, February 23, 2022 / Proposed Rules 10163 

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 

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). 

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 


khammond on DSKJM1Z7X2PROD with PROPOSALS
10164 Federal Register / Vol. 87, No. 36 / Wednesday, February 23, 2022 / Proposed Rules 

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 any unauthorized 

commitments is the HCA. The approval 

authority may not be re-delegated. 

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 

include the clause in 852. 201–70, 

Contracting Officer’s Representative, in 

the solicitation and contract. 

PART 802—DEFINITIONS OF WORDS 

AND TERMS 

■ 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 

■ 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 

■ 4. The authority citation for part 808 

is revised to read as follows: 

Authority: 38 U.S.C. 8127–8128; 40 U.S.C. 

121(c); 41 U.S.C. 1702; and 48 CFR 1.301 

through 1.304. 

Subpart 808.4—Federal Supply 

Schedules 

■ 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 

■ 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 

■ 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. 

■ 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 


khammond on DSKJM1Z7X2PROD with PROPOSALS
Federal Register / Vol. 87, No. 36 / Wednesday, February 23, 2022 / Proposed Rules 10165 

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. 

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 

■ 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. 

■ 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 (Date) 

(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) 

■ 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 (Date) 

(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: 

(1) Copies of the research protocol, all 

questionnaires, surveys, advertisements, and 

informed consent forms approved by the 

cognizant IRB; 


khammond on DSKJM1Z7X2PROD with PROPOSALS
10166 Federal Register / Vol. 87, No. 36 / Wednesday, February 23, 2022 / Proposed Rules 

(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) 

■ 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 (Date) 

(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) 

■ 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 (Date) 

(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) 

■ 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 (Date) 

(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) 

■ 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 (Date) 

The Contractor shall submit an electronic 

copy of the approved scientific technical 

reports, not a summary, delivered under this 

contract to the National Technical 

Information Service (NTIS) as delineated at 

FAR 35.010. 

(End of clause) 

852.270–1 [Redesignated as Section 

852.201–70] 

■ 16. Section 852.270–1 is redesignated 

as section 852.201–70 and revised to 

read as follows: 

852.201–70 Contracting Officer’s 

Representative. 

As prescribed in 801.604, insert the 

following provision: 

Contracting Officer’s Representative 

(Date) 

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. 2022–02796 Filed 2–22–22; 8:45 am] 

BILLING CODE 8320–01–P 


khammond on DSKJM1Z7X2PROD with PROPOSALS