Federal Register / Vol. 89, No. 20 / Tuesday, January 30, 2024 / Proposed Rules 5819 

toxin was accessed, the purpose for 

accessing the toxin, the name of the 

individual accessing the toxin, the date 

the toxin was returned back to storage, 

the name of the individual returning the 

toxin back to storage, and date of final 

disposition of the toxin and by whom; 

(vi) Records created under § 121.16; 

(vii) For intra-entity transfers (sender 

and the recipient are covered by the 

same certificate of registration), name of 

the toxin, the date of the transfer, the 

number of vials or quantity of the toxin 

transferred, the name of the sender, and 

the name of the recipient; and 

(viii) Records created under § 121.19. 

* * * * * 

(8) For select agents or material 

containing select agents or regulated 

nucleic acids that can produce 

infectious forms of any select agent 

virus that have been subjected to a 

validated inactivation procedure or a 

validated viable select agent removal 

procedure: 

(i) A written description of the 

validated inactivation procedure or 

validated viable select agent removal 

procedure used, including validation 

data; 

(ii) A written description of the 

viability testing protocol used; 

(iii) A written description of the 

investigation conducted by the entity’s 

responsible official involving a 

validated inactivation or validated 

viable select agent removal failure and 

the corrective actions taken; 

(iv) The name of each individual 

performing the validated select agent 

inactivation or validated viable select 

agent removal; 

(v) The date(s) the validated 

inactivation or validated viable select 

agent removal was completed; 

(vi) The location where the validated 

inactivation or validated viable select 

agent removal was performed; and 

(vii) A signed certificate that must: 

(A) Include the date(s) the validated 

inactivation or validated viable select 

agent removal was completed. 

(B) Include the validated inactivation 

procedure or validated viable select 

agent removal procedure used. 

(C) Include the name of the principal 

investigator. 

(D) Include an attestation statement 

certifying that the information on the 

certificate is true, complete, and 

accurate, and that the validated 

inactivation or validated viable select 

agent removal was performed as 

described in paragraph (a)(8)(i) of this 

section. 

(E) Be signed by the principal 

investigator or designee within 7 days 

after completion of the validated 

inactivation or validated viable select 

agent removal. Such designee must be 

listed on the entity’s registration and 

have the knowledge and expertise to 

provide scientific and technical 

direction regarding the validated 

inactivation procedure or the validated 

viable select agent removal procedure to 

which the certificate refers. 

(F) Be maintained for as long as the 

material is in the possession of the 

registered individual or entity plus an 

additional 3 years. 

(G) A copy of the certificate must 

accompany all transfers of inactivated or 

select agent removed material including 

intra-entity transfers. 

* * * * * 

(d) All records created in accordance 

with the regulations of this part must be 

maintained for 3 years unless otherwise 

stated. 

§ 121.19 [Amended] 

■ 36. Amend § 121.19, in paragraphs 

(a)(1) introductory text and (b)(1) 

introductory text, by removing the 

words ‘‘telephone, facsimile, or email’’ 

and adding the words ‘‘eFSAP 

information system, telephone, or 

email’’ in their place. 

Done in Washington, DC, this 19th day of 

January 2024. 

Jennifer Moffitt, 

Undersecretary, Marketing and Regulatory 

Programs, USDA. 

[FR Doc. 2024–01501 Filed 1–26–24; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF TRANSPORTATION 

Federal Highway Administration 

23 CFR Part 172 

[FHWA Docket No. FHWA–2023–0046] 

RIN 2125–AG12 

Procurement, Management, and 

Administration of Engineering and 

Design Related Services 

AGENCY: Federal Highway 

Administration (FHWA), U.S. 

Department of Transportation (DOT). 

ACTION: Notice of proposed rulemaking 

(NPRM); request for comments. 

SUMMARY: This proposed rule would 

update the regulations governing the 

procurement, management, and 

administration of engineering and 

design related services directly related 

to a highway construction project that is 

funded through a discretionary grant 

administered by FHWA. The intent of 

the proposed rule is to clarify how the 

regulations apply to recipients other 

than State transportation agencies 

(STA). This proposed rulemaking would 

also make technical changes and 

corrections to improve the 

administration of these regulations. 

DATES: Comments must be received on 

or before April 1, 2024. Late comments 

will be considered to the extent 

practicable. 

ADDRESSES: You may submit comments 

by any of the following methods: 

• Fax: (202) 493–2251; 

• Mail: U.S. Department of 

Transportation, Docket Operations, M– 

30, West Building Ground Floor, Room 

W12–140, 1200 New Jersey Avenue SE, 

Washington, DC 20590; 

• Hand Delivery: U.S. Department of 

Transportation, Docket Operations, 

West Building Ground Floor, Room 

W12–140, 1200 New Jersey Avenue SE, 

Washington, DC 20590, between 9 a.m. 

and 5 p.m. ET, Monday through Friday, 

except Federal holidays; or 

• Electronically through the Federal 

eRulemaking Portal: 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

FOR FURTHER INFORMATION CONTACT: Mr. 

John McAvoy, Consultant Services 

Program Manager, FHWA Office of 

Preconstruction, Construction, and 

Pavements, (202) 853–5593, or via email 

at john.mcavoy@dot.gov, or Mr. Lev 

Gabrilovich, Senior Attorney Advisor, 

FHWA Office of the Chief Counsel, 

(202) 366–3813, or via email at 

lev.gabrilovich@dot.gov. Office hours for 

the FHWA are from 8 a.m. to 4:30 p.m., 

ET, Monday through Friday, except 

Federal holidays. 

SUPPLEMENTARY INFORMATION: 

Electronic Access and Filing 

This document and all comments 

received may be viewed online through 

the Federal eRulemaking portal at 

www.regulations.gov. The website is 

available 24 hours each day, 366 days 

this year. Please follow the instructions. 

Electronic submission and retrieval help 

and guidelines are available under the 

help section of the website. 

An electronic copy of this document 

may also be downloaded by accessing 

the Office of the Federal Register’s home 

page at www.FederalRegister.gov, or the 

Government Printing Office’s website at 

www.GovInfo.gov. 

All comments received before the 

close of business on the comment 

closing date indicated above will be 

considered and will be available for 

examination in the docket at the above 

address. Comments received after the 

comment closing date will be filed in 

the docket and will be considered to the 

extent practicable. In addition to late 


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1 49 U.S.C. 6702(a)(2). 

2BIL, sec. 24112(a)(2). 

3 23 U.S.C. 112(a). 

comments, FHWA will also continue to 

file relevant information in the docket 

as it becomes available after the 

comment period closing date and 

interested persons should continue to 

examine the docket for new material. A 

final rule may be published at any time 

after the close of the comment period 

and after FHWA has had the 

opportunity to review the comments 

submitted. 

Background and Legal Authority 

Through this NPRM, FHWA proposes 

to modify existing regulations for the 

administration of engineering and 

design related service contracts to 

clarify how the regulations apply to 

recipients other than STAs that are 

awarded FHWA-administered 

discretionary grants and to make 

technical amendments to improve the 

regulations. The FHWA, through the 

Federal-aid Highway Program (FAHP) 

and other programs administered under 

chapter 1 of title 23, United States Code 

(U.S.C.), provides financial resources 

and technical assistance to State and 

local governments and other public 

authorities for planning, design, 

constructing, operating, preserving, and 

improving public roads and other 

surface transportation infrastructure. 

The primary authority for the 

procurement, management, and 

administration of engineering and 

design related services funded with a 

highway construction grant 

administered under chapter 1 of 23 

U.S.C. is codified at 23 U.S.C. 112(b)(2). 

Generally, each contract for engineering 

and design related services paid for with 

Federal funds and leading to a 

construction project must be awarded in 

accordance with the qualificationsbased selection procedures prescribed 

in the Brooks Act (40 U.S.C. 1101 et 

seq.) and must accept and apply 

consultant indirect cost rates 

established by a cognizant Federal or 

State agency in accordance with the 

Federal Acquisition Regulation (FAR) 

cost principles (48 CFR part 31). The 

FHWA promulgated 23 CFR part 172 as 

a means of implementing the Brooks 

Act. Part 172 defines and illustrates 

specific responsibilities of an STA and 

its subrecipients (entities that receive a 

subaward from their STA). 

The Infrastructure Investment and 

Jobs Act, (Pub. L. 117–58) also known 

as the ‘‘Bipartisan Infrastructure Law,’’ 

(BIL) provided $550 billion over fiscal 

years 2022 through 2026 in new Federal 

investment in roads, bridges, mass 

transit, water infrastructure, resilience 

improvements, and broadband. The BIL 

provides approximately $350 billion for 

Federal highway programs. 

Statement of the Problem 

Most of the funding in the BIL for 

highway projects is distributed to STAs 

based on formulas specified in Federal 

law. However, the BIL also provides 

funding through a wide range of 

discretionary grant programs, including 

the ‘‘Rebuilding American Infrastructure 

with Sustainability and Equity’’ (RAISE) 

program, the ‘‘Nationally Significant 

Multimodal Freight and Highway 

Projects’’ (INFRA) program, the 

‘‘National Infrastructure Project 

Assistance Program’’ (MEGA), the ‘‘Safe 

Streets and Roads for All’’ (SS4A) 

program, and others. Each of these 

discretionary grant programs has its 

own eligibility requirements, but for 

many programs, entities other than 

STAs are eligible to apply for and 

receive grant awards. For example, 

under the RAISE grant program, in 

addition to STAs, eligible entities 

include U.S. territories, Metropolitan 

Planning Organizations (MPO), federally 

recognized Indian Tribes, local 

governments, and other public 

authorities.1 The SS4A grants are only 

available to MPOs, political 

subdivisions of a State, and federally 

recognized Indian Tribes.2

When a recipient other than an STA 

is awarded a discretionary grant under 

the programs described above, the 

award is made through an executed 

grant agreement with DOT rather than 

as a subaward from the STA. This nonSTA recipient is responsible for 

compliance with all Federal regulations 

pertaining to the grant, including those 

covering the procurement of 

professional services. In their current 

form, the regulations at 23 CFR part 172 

could be interpreted as applying to all 

recipients of discretionary grants 

administered under chapter 1 of 23 

U.S.C., not just STAs. Consequently, 

non-STA recipients would be 

responsible for compliance with part 

172, including the requirement that 

recipients prepare and maintain written 

policies and procedures for the 

procurement, management, and 

administration of engineering and 

design related consultant services. 

However, the requirements of 23 U.S.C. 

112(b)(2), and therefore 23 CFR part 

172, apply only to the procurement, 

management, and administration of 

engineering and design related 

consultant services for projects ‘‘under 

[the] supervision’’ of an STA.3 This 

includes projects administered by 

entities other than STAs when these 

entities are subrecipients of STAs but 

not when these entities are recipients of 

an award directly from DOT, and FHWA 

did not intend for 23 CFR part 172 to 

apply beyond the scope of 23 U.S.C. 

112(b)(2). Non-STA recipients that 

receive or are eligible to receive 

discretionary grant funds directly from 

FHWA do not necessarily have FHWAapproved written policies and 

procedures in place for the procurement 

of professional services that comply 

with 23 CFR part 172, and creating these 

policies and procedures from scratch 

would create an undue burden on nonSTA recipients and FHWA. By 

removing any ambiguity regarding the 

applicability of 23 CFR part 172, this 

NPRM proposes to clarify the 

responsibilities of the non-STA 

recipients to remain compliant with 

Federal regulations while reducing 

unnecessary regulatory burden. 

Section-by-Section Discussion of the 

Proposals 

The FHWA proposes to revise 23 CFR 

part 172–Administration of Engineering 

and Design Related Service Contracts as 

follows: 

Authority Citation 

The FHWA proposes to revise the 

authority citation for 23 CFR part 172 to 

remove the reference to 23 U.S.C. 402. 

Part 172 no longer applies to programs 

and activities authorized under 23 

U.S.C. 402, and the remaining 

authorities cited provide the necessary 

authority for 23 CFR part 172; therefore, 

citation to 23 U.S.C. 402 is unnecessary. 

Section 172.1—Purpose and 

Applicability 

Section 172.1 would be amended to 

clarify that the provisions of 23 CFR 

part 172 apply only to STAs and their 

subrecipients. 

Section 172.3—Definitions 

In section 172.3, the definitions for 

the terms ‘‘Consultant’’ and 

‘‘Subconsultant’’ would be modified to 

remove outdated citations to 2 CFR part 

200 that formerly contained definitions 

of ‘‘Recipient’’ and ‘‘Subrecipient.’’ The 

proposed rule would add definitions for 

‘‘Recipient’’ and ‘‘Subrecipient’’ and 

give those terms the same meaning as 

they are defined in 2 CFR 200.1. Finally, 

the definition of ‘‘Contracting agencies’’ 

would be revised to eliminate reference 

to ‘‘other recipients.’’ 

Section 172.5—Program Management 

and Oversight 

Section 172.5 would be amended to 

remove the references to ‘‘recipient’’ 

and ‘‘other recipient’’ to clarify that the 


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regulations apply only to STAs and 

their subrecipients. Also, a reference to 

a provision in 2 CFR part 200 would be 

revised to reflect the current location of 

that provision in 2 CFR part 200. 

Section 172.7—Procurement Methods 

and Procedures 

Section 172.7 would be amended to 

remove the references to ‘‘recipient’’ 

and ‘‘other recipient’’ to clarify the 

applicability of the regulations only to 

STAs and their subrecipients. Also, 

references to a provision in 2 CFR part 

200 would be revised to reflect the 

current location of that provision in 2 

CFR part 200. 

Section 172.9—Procurement Methods 

and Procedures 

Section 172.9 would be amended to 

remove a reference to ‘‘recipient’’ to 

clarify the applicability of the 

regulations only to STAs and their 

subrecipients. A reference to a provision 

in 2 CFR part 200 would be revised to 

reflect the current location of that 

provision in 2 CFR part 200. Also, a 

typographical error in an internal crossreference in § 172.9(a)(3)(iv)(B)(1) will 

be corrected. The regulation in this 

paragraph currently references 

§ 172.5(a)(1)(ii); the corrected reference 

would read § 172.7(a)(1)(ii). 

Section 172.11—Allowable Costs and 

Oversight 

Section 172.11 would be amended to 

remove references to ‘‘recipient’’ and 

‘‘other recipient,’’ and where 

appropriate, substitute ‘‘STA’’ to clarify 

that the regulations apply only to STAs 

and their subrecipients. 

Rulemaking Analyses and Notices 

Executive Order 12866 (Regulatory 

Planning and Review), Executive Order 

13563 (Improving Regulation and 

Regulatory Review), and DOT 

Regulatory Policies and Procedures 

The FHWA has considered the 

impacts of this rule under Executive 

Order (E.O.) 12866 (58 FR 51735, Oct. 

4, 1993), Regulatory Planning and 

Review, as amended by E.O. 14094 

(‘‘Modernizing Regulatory Review’’), 

and DOT’s regulatory policies and 

procedures. This proposed rule 

complies with E.O. 12866 and E.O. 

13563 to improve regulation. The Office 

of Information and Regulatory Affairs 

within the Office of Management and 

Budget (OMB) has determined that this 

rulemaking is not a significant 

regulatory action under section 3(f) of 

E.O. 12866. Accordingly, OMB has not 

reviewed it under that E.O. 

It is anticipated that the proposed rule 

would not be economically significant 

for purposes of E.O. 12866. The 

proposed rule would not have an annual 

effect on the economy of $200 million 

or more. The proposed rule would not 

adversely affect in a material way the 

economy, any sector of the economy, 

productivity, competition, or jobs. In 

addition, the proposed changes would 

not interfere with any action taken or 

planned by another Agency and would 

not materially alter the budgetary 

impact of any entitlements, grants, user 

fees, or loan programs. 

Regulatory Flexibility Act 

In compliance with the Regulatory 

Flexibility Act (Pub. L. 96–354, 5 U.S.C. 

601–612), FHWA has evaluated the 

effects of this proposed rule on small 

entities, such as local governments and 

businesses. Based on the evaluation, 

FHWA anticipates that this action 

would not have a significant economic 

impact on a substantial number of small 

entities. The proposed rule would 

clarify the applicability of the 

requirements for the procurement, 

management, and administration of 

engineering and design related services 

that use FHWA-administered funding 

and are directly related to a construction 

project. Specifically, the proposed rule 

would clarify that the regulations in 23 

CFR part 172 do not apply to recipients 

of FHWA-administered grants that are 

not STAs. Consequently, the economic 

impact of this proposed rule on small 

entities is expected to be minimal. 

Therefore, FHWA certifies that the 

proposed action would not have a 

significant economic impact on a 

substantial number of small entities. 

Unfunded Mandates Reform Act of 1995 

This proposed rule would not impose 

unfunded mandates as defined by the 

Unfunded Mandates Reform Act of 1995 

(Pub. L. 104–4, 109 Stat. 48). The 

Unfunded Mandates Reform Act of 1995 

(section 202(a)) requires Federal 

Agencies to prepare a written statement, 

which includes estimates of anticipated 

impacts, before proposing ‘‘any rule that 

includes any Federal mandate that may 

result in the expenditure by State, local, 

and tribal governments, in the aggregate, 

or by the private sector, of $100,000,000 

or more (adjusted annually for inflation) 

in any one year.’’ The current threshold 

after adjustment for inflation is $183 

million, using the most current (2023) 

Implicit Price Deflator for the Gross 

Domestic Product. This rule will not 

result in the expenditure by State, local, 

and Tribal governments, in the 

aggregate, or by the private sector, of 

$183 million or more in any one year (2 

U.S.C. 1532). Further, in compliance 

with the Unfunded Mandates Reform 

Act of 1995, FHWA will evaluate any 

regulatory action that might be proposed 

in subsequent stages of the proceeding 

to assess the effects on State, local, and 

Tribal governments and the private 

sector. In addition, the definition of 

‘‘Federal Mandate’’ in the Unfunded 

Mandates Reform Act excludes financial 

assistance of the type in which State, 

local, or tribal governments have 

authority to adjust their participation in 

the program in accordance with changes 

made in the program by the Federal 

Government. The FAHP and other 

FHWA-administered financial 

assistance impacted by this proposed 

rule permit this type of flexibility. 

Executive Order 13132 (Federalism 

Assessment) 

The E.O. 13132 requires Agencies to 

ensure meaningful and timely input by 

State and local officials in the 

development of regulatory policies that 

may have a substantial, direct effect on 

the States, on the relationship between 

the national government and the States, 

or on the distribution of power and 

responsibilities among the various 

levels of government. The FHWA has 

analyzed this proposed rule in 

accordance with the principles and 

criteria contained in E.O. 13132. The 

FHWA has determined that this 

proposed rule would not have sufficient 

federalism implications to warrant the 

preparation of a federalism assessment. 

The FHWA has also determined that 

this proposed rule would not preempt 

any State law or State regulation or 

affect the States’ ability to discharge 

traditional State governmental 

functions. 

Paperwork Reduction Act 

Federal Agencies must obtain 

approval from OMB for each collection 

of information they conduct, sponsor, or 

require through regulations. This 

proposed action does not contain a 

collection of information requirement 

for the purpose of the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501, 

et seq.). 

National Environmental Policy Act 

The FHWA has analyzed this rule 

pursuant to the National Environmental 

Policy Act (NEPA) and has determined 

that it is categorically excluded under 

23 CFR 771.117(c)(20), which applies to 

the promulgation of rules, regulations, 

and directives. Categorically excluded 

actions meet the criteria for categorical 

exclusions under the Council on 

Environmental Quality regulations and 

under 23 CFR 771.117(a) and normally 

do not require any further NEPA 

approvals by FHWA. This proposed rule 


khammond on DSKJM1Z7X2PROD with PROPOSALS
5822 Federal Register / Vol. 89, No. 20 / Tuesday, January 30, 2024 / Proposed Rules 

would clarify the applicability of FHWA 

regulations governing the requirements 

for the procurement, management, and 

administration of engineering and 

design related services that use FHWAadministered grant funding and are 

directly related to a construction 

project. The FHWA does not anticipate 

any adverse environmental impacts 

from this rule; moreover, no unusual 

circumstances are present under 23 CFR 

771.117(b). 

Executive Order 13175 (Tribal 

Consultation) 

The FHWA has analyzed this 

proposed action under E.O. 13175, 

dated November 6, 2000, and believes 

that this proposed action would not 

have substantial direct effects on one or 

more Indian Tribes, would not impose 

substantial direct compliance costs on 

Indian Tribal governments, and would 

not preempt Tribal law. This proposed 

rule would clarify the applicability of 

FHWA regulations governing the 

requirements for the procurement, 

management, and administration of 

engineering and design related services 

that use FHWA-administered grant 

funding and are directly related to a 

construction project. As such, this 

proposed rule would not impose any 

direct compliance requirements on 

Indian Tribal governments nor would it 

have any economic or other impacts on 

the viability of Indian Tribes. Therefore, 

a Tribal summary impact statement is 

not required. 

Executive Order 12898 (Environmental 

Justice) 

The E.O. 12898 requires that each 

Federal Agency make achieving 

environmental justice part of its mission 

by identifying and addressing, as 

appropriate, disproportionately high 

and adverse human health or 

environmental effects of its programs, 

policies, and activities on minorities 

and low-income populations. The 

FHWA has determined that this 

proposed rule does not raise any 

environmental justice issues. 

Regulation Identification Number 

A regulation identification number 

(RIN) is assigned to each regulatory 

action listed in the Unified Agenda of 

Federal Regulations. The Regulatory 

Information Service Center publishes 

the Unified Agenda in April and 

October of each year. The RIN number 

contained in the heading of this 

document can be used to cross-reference 

this action with the Unified Agenda. 

List of Subjects in 23 CFR Part 172 

Government procurement, Grant 

programs—transportation, Highways 

and roads. 

Shailen P. Bhatt, 

Administrator, Federal Highway 

Administration. 

For the reasons stated in the 

preamble, FHWA proposes to amend 

title 23, Code of Federal Regulations, 

part 172, as follows: 

PART 172—PROCUREMENT, 

MANAGEMENT, AND 

ADMINISTRATION OF ENGINEERING 

AND DESIGN RELATED SERVICES 

■ 1. The authority citation for part 172 

is revised to read as follows: 

Authority: 23 U.S.C. 106, 112, 114(a), 302, 

and 315; 40 U.S.C. 1101 et seq.; 48 CFR part 

31; 49 CFR 1.48(b); and 2 CFR part 200. 

■ 2. Amend § 172.1 by revising the 

fourth sentence and adding a sentence 

at the end of the section. The revision 

and addition read as follows: 

§ 172.1 Purpose and applicability. 

* * * State transportation agencies 

(STA) shall ensure that subrecipients 

comply with the requirements of this 

part and the Uniform Administrative 

Requirements, Cost Principles and 

Audit Requirements For Federal Awards 

rule. * * * The provisions of this part 

shall only apply to State transportation 

agencies and their subrecipients. 

■ 3. Amend § 172.3 as follows: 

■ a. Revise the definitions for 

Consultant and Contracting agencies; 

■ b. Add a definition in alphabetical 

order for Recipient; 

■ c. Revise the definition of 

Subconsultant; and 

■ b. Add a definition in alphabetical 

order for Subrecipient. 

The revisions and additions read as 

follows: 

§ 172.3 Definitions. 

* * * * * 

Consultant means the individual or 

firm providing engineering and design 

related services as a party to a contract 

with a recipient or subrecipient of 

Federal assistance. 

* * * * * 

Contracting agencies means a State 

transportation agency or a procuring 

agency of the State acting in conjunction 

with and at the direction of the State 

transportation agency and all 

subrecipients that are responsible for 

the procurement, management, and 

administration of engineering and 

design related services. 

* * * * * 

Recipient has the same meaning as 

defined in 2 CFR 200.1. 

* * * * * 

Subconsultant means the individual 

or firm contracted by a consultant to 

provide engineering and design related 

or other types of services that are part 

of the services which the consultant is 

under contract to provide to a recipient 

or subrecipient (as defined in of Federal 

assistance. 

Subrecipient has the same meaning as 

defined in 2 CFR 200.1. 

■ 4. Amend § 172.5 by revising 

paragraph (a) introductory text, the third 

sentence of paragraph (a)(4), paragraph 

(b)(1) introductory text, the second and 

third sentences of paragraph (c) 

introductory text, and paragraph (c)(15) 

to read as follows: 

§ 172.5 Program management and 

oversight. 

(a) STA responsibilities. STAs shall 

develop and sustain organizational 

capacity and provide the resources 

necessary for the procurement, 

management, and administration of 

engineering and design related 

consultant services, reimbursed in 

whole or in part with FAHP funding, as 

specified in 23 U.S.C. 302(a). 

Responsibilities shall include the 

following: 

* * * * * 

(4) * * * Nothing in this part shall be 

taken as relieving the STA of its 

responsibility under laws and 

regulations applicable to the FAHP for 

the work performed under any 

consultant agreement or contract 

entered into by a subrecipient. 

(b) * * * 

(1) Adopting written policies and 

procedures prescribed by the awarding 

STA for the procurement, management, 

and administration of engineering and 

design related consultant services in 

accordance with applicable Federal and 

State laws and regulations; or when not 

prescribed, shall include: 

* * * * * 

(c) * * * The FHWA shall approve 

the written policies and procedures, 

including all revisions to such policies 

and procedures, of the STA to assess 

compliance with applicable 

requirements. The STA shall approve 

the written policies and procedures, 

including all revisions to such policies 

and procedures, of a subrecipient to 

assess compliance with applicable 

requirements. * * * 

* * * * * 

(15) Retaining supporting 

programmatic and contract records, as 


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specified in 2 CFR 200.334 and the 

requirements of this part; 

* * * * * 

■ 5. Amend § 172.7 by revising 

paragraph (a)(1)(iv)(F), the first sentence 

of paragraph (a)(1)(v)(E), paragraph 

(b)(1)(i), and the first sentence of 

paragraph (b)(5)(i) to read as follows: 

§ 172.7 Procurement methods and 

procedures. 

(a) * * * 

(1) * * * 

(iv) * * * 

(F) The contracting agency shall retain 

supporting documentation of the 

solicitation, proposal, evaluation, and 

selection of the consultant in 

accordance with this section and the 

provisions of 2 CFR 200.334. 

(v) * * * 

(E) The contracting agency shall retain 

documentation of negotiation activities 

and resources used in the analysis of 

costs to establish elements of the 

contract in accordance with the 

provisions of 2 CFR 200.334. * * * 

* * * * * 

(b) * * * 

(1) * * * 

(i) STAs and their subrecipients shall 

comply with procurement requirements 

established in State and local laws, 

regulations, policies, and procedures 

that are not addressed by or are not in 

conflict with applicable Federal laws 

and regulations, as specified in 2 CFR 

part 1201. 

* * * * * 

(5) * * * 

(i) When FAHP funds participate in a 

consultant services contract, the 

contracting agency shall receive 

approval from FHWA, or the STA, as 

appropriate, before utilizing a 

consultant to act in a management 

support role for the contracting agency; 

unless an alternate approval procedure 

has been approved. * * * 

* * * * * 

■ 6. Amend § 172.9 by revising 

paragraph (a)(3)(iv)(B)(1), paragraph 

(c)(1)(iv), and paragraph (d)(1)(vii) to 

read as follows: 

§ 172.9 Contracts and administration. 

(a) * * * 

(3) * * * 

(iv) * * * 

(B) * * * 

(1) Through an additional 

qualifications-based selection 

procedure, which may include, but does 

not require, a formal RFP in accordance 

with § 172.7(a)(1)(ii); or 

* * * * * 

(c) * * * 

(1) * * * 

(iv) Access by the STA, subrecipient, 

FHWA, the U.S. Department of 

Transportation’s Inspector General, the 

Comptroller General of the United 

States, or any of their duly authorized 

representatives to any books, 

documents, papers, and records of the 

consultant which are directly pertinent 

to that specific contract for the purpose 

of making audit, examination, excerpts, 

and transcriptions; 

* * * * * 

(d) * * * 

(1) * * * 

(vii) Documenting contract 

monitoring activities and maintaining 

supporting contract records, as specified 

in 2 CFR 200.334. 

* * * * * 

■ 7. Amend § 172.11 by revising 

paragraph (b)(1)(iii) introductory text, 

the second and third sentences of 

paragraph (c)(2) introductory text, the 

second sentence of paragraph (c)(3)(i), 

and the second and third sentences of 

paragraph (d) to read as follows: 

§ 172.11 Allowable costs and oversight. 

* * * * * 

(b) * * * 

(1) * * * 

(iii) When the indirect cost rate has 

not been established by a cognizant 

agency in accordance with paragraph 

(b)(1)(ii) of this section, the STA shall 

perform an evaluation of a consultant’s 

or subconsultant’s indirect cost rate 

prior to acceptance and application of 

the rate to contracts administered by the 

STA or its subrecipients. The evaluation 

performed by STAs to establish or 

accept an indirect cost rate shall provide 

assurance of compliance with the 

Federal cost principles and may consist 

of one or more of the following: 

* * * * * 

(c) * * * 

(2) * * * An STA may employ a riskbased oversight process to provide 

reasonable assurance of consultant 

compliance with Federal cost principles 

on FAHP funded contracts administered 

by the STA or its subrecipients. If 

employed, this risk-based oversight 

process shall be incorporated into STA 

written policies and procedures, as 

specified in § 172.5(c). * * * 

* * * * * 

(3) * * * 

(i) * * * The certification 

requirement shall apply to all indirect 

cost rate proposals submitted by 

consultants and subconsultants for 

acceptance by an STA. * * * 

* * * * * 

(d) * * * FHWA, STAs, and 

subrecipients of FAHP funds may share 

audit information in complying with the 

STA’s or subrecipient’s acceptance of a 

consultant’s indirect cost rates pursuant 

to 23 U.S.C. 112 and this part provided 

that the consultant is given notice of 

each use and transfer. Audit information 

shall not be provided to other 

consultants or any other government 

agency not sharing the cost data, or to 

any firm or government agency for 

purposes other than complying with the 

STA’s or subrecipient’s acceptance of a 

consultant’s indirect cost rates pursuant 

to 23 U.S.C. 112 and this part without 

the written permission of the affected 

consultants. * * * 

[FR Doc. 2024–01705 Filed 1–29–24; 8:45 am] 

BILLING CODE 4910–22–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Docket No. CDC–2020–0024] 

42 CFR Part 73 

RIN 0920–AA71 

Possession, Use, and Transfer of 

Select Agents and Toxins; Biennial 

Review of the List of Select Agents and 

Toxins 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (HHS). 

ACTION: Notice of proposed rulemaking. 

SUMMARY: In accordance with the Public 

Health Service Act, the Department of 

Health and Human Services (HHS) 

Centers for Disease Control and 

Prevention (CDC) reviewed the HHS list 

of select agents and toxins with the 

potential to pose a severe threat to 

public health and safety. HHS/CDC 

proposes to amend the list by removing 

three biological agents, raising one 

toxin’s exclusion amounts, renaming a 

virus, designating a current agent as a 

Tier 1 agent, and removing the 

designation of Tier 1 status from one 

agent. HHS/CDC also proposes to clarify 

language and add requirements as 

discussed below. 

DATES: Submit written or electronic 

comments by April 1, 2024. 

ADDRESSES: You may submit comments, 

identified by Docket No. CDC–2020– 

0024 or Regulation Identifier Number 

(RIN) 0920–AA71, by any of the 

following methods: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

• Mail: Division of Regulatory 

Science and Compliance, Centers for 

Disease Control and Prevention, 1600 

Clifton Road NE, Mailstop H21–4, 


khammond on DSKJM1Z7X2PROD with PROPOSALS