Federal Register / Vol. 89, No. 225 / Thursday, November 21, 2024 / Notices 92131 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2024–N–3609 for ‘‘Development of an 

Enhanced Systematic Process for the 

Food and Drug Administration’s PostMarket Assessment of Chemicals in 

Food; Public Meeting; Extension of the 

Comment Period.’’ Received comments, 

those filed in a timely manner (see 

ADDRESSES), will be placed in the docket 

and, except for those submitted as 

‘‘Confidential Submissions,’’ publicly 

viewable at https://www.regulations.gov 

or at the Dockets Management Staff 

between 9 a.m. and 4 p.m., Monday 

through Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ We 

will review this copy, including the 

claimed confidential information, in our 

consideration of comments. The second 

copy, which will have the claimed 

confidential information redacted/ 

blacked out, will be available for public 

viewing and posted on https://

www.regulations.gov. Submit both 

copies to the Dockets Management Staff. 

If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

FOR FURTHER INFORMATION CONTACT: 

Keronica Richardson, Office of Policy, 

Regulations, and Information, Human 

Foods Program, Food and Drug 

Administration, 5001 Campus Dr., 

College Park, MD 20740, 240–402–2371. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of August 12, 2024, we 

published a notice announcing a public 

meeting entitled ‘‘Development of an 

Enhanced Systematic Process for FDA’s 

Post-Market Assessment of Chemicals in 

Food.’’ The notice explained that the 

public meeting would address a variety 

of topics related to development of an 

enhanced systematic process for FDA’s 

post-market assessment of chemicals in 

food, including: 

• Principles for the post-market 

assessment process, 

• Steps in the post-market assessment 

process, 

• Prioritizing chemicals for postmarket assessment, and 

• Engaging stakeholders throughout 

the post-market assessment process (89 

FR 65633 at 65635). We also provided 

an opportunity for public comment 

during the meeting. The docket for 

public comments was scheduled to 

close on December 6, 2024. 

On September 25, 2024, we hosted the 

public meeting at the FDA White Oak 

Campus. A transcript of the meeting is 

available at https://www.fda.gov/media/ 

182622/download?attachment. 

We have received a request for a 60- 

day extension of the comment period. In 

general, the request explained that trade 

associations representing various parts 

of the food supply chain faced 

significant challenges to providing 

comment by December 6, 2024, and 

noted that the comment period 

overlapped with the holiday season and 

other FDA initiatives. 

We have considered the requests and 

are extending the comment period until 

January 21, 2025. We believe that the 

extension will allow adequate time for 

interested persons to submit comments. 

Dated: November 13, 2024. 

Kimberlee Trzeciak, 

Deputy Commissioner for Policy, Legislation, 

and International Affairs. 

[FR Doc. 2024–27289 Filed 11–20–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Inclusion of Terrain Factors in the 

Definition of Rural Area for Federal 

Office of Rural Health Policy Grants 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Final notice. 

SUMMARY: HRSA’s Federal Office of 

Rural Health Policy (FORHP) is 

modifying the definition of ‘‘rural area’’ 

for the purposes of determining 

geographic eligibility to apply for or 

receive services funded by FORHP’s 

rural health grants. With a data-driven 

methodology, this update to the 

definition of rural area will integrate the 

new Road Ruggedness Score (RRS) 

released in 2023 by the Economic 

Research Service of the U.S. Department 

of Agriculture. This notice responds to 

comments received on proposed 

modifications to HRSA’s FORHP 

definition published in the Federal 

Register on April 26, 2024. 

DATES: All changes will go into effect as 

of November 21, 2024, and will apply to 

FORHP’s Notices of Funding 

Opportunity released in Fiscal Year (FY) 

2025 and future years. 

FOR FURTHER INFORMATION CONTACT: 

Greta Stuhlsatz, Statistician, Policy 

Research Division, FORHP, HRSA, 5600 

Fishers Lane, Rockville, Maryland 

20857; (301) 443–0835 and ruralpolicy@

hrsra.gov. 

SUPPLEMENTARY INFORMATION: This 

notice updates the definition of rural 

area used for HRSA’s FORHP rural 

health grants programs. HRSA 

published a notice in the Federal 

Register on April 26, 2024, seeking 

public comment on proposed 

modifications to the definition of rural 

area for the purposes of determining 

eligibility for its rural health grant 

programs (89 FR 32451). HRSA 

proposed a data-driven methodology to 

update the definition of rural area by 

integrating the new RRS released in 

2023 by the Economic Research Service 

of the U.S. Department of Agriculture. 

The RRS characterizes topographic 

variability, or ruggedness, of roads. A 


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92132 Federal Register / Vol. 89, No. 225 / Thursday, November 21, 2024 / Notices 

technical clarification was also 

proposed in response to terminology 

changes by the U.S. Census Bureau. 

This notice includes a summary of 

responses to the public comments 

received. 

Background 

In FY 2024, HRSA’s FORHP 

considered the following areas to be 

rural for purposes of FORHP’s grant 

programs: 

(1) All non-metro counties, 

(2) All outlying metro counties 

without an Urbanized Area, 

(3) All metro census tracts with RUCA 

codes 4–10, and 

(4) Metro census tracts of at least 400 

square miles in area with population 

density of 35 or less per square mile 

with RUCA codes 2–3. 

In the Federal Register notice 

published April 26, 2024, HRSA 

proposed modifying its existing FORHP 

rural definition by adding census tracts 

of at least 20 square miles in area in 

metropolitan counties with RRS 5 

(highly rugged) and RUCA code 2 or 3 

to FORHP’s definition of rural area. 

Only census tracts that meet all 

criteria—RRS 5 and RUCA 2 or 3 with 

an area of 20 or more square miles— 

would be newly eligible under the 

proposed update. 

In addition to the proposed rugged 

terrain update, in HRSA’s notice, 

FORHP provided a technical 

clarification in response to the U.S. 

Census Bureau’s 2020 terminology 

changes removing urban clusters and 

urbanized areas. FORHP’s FY 2024 

definition excludes outlying 

metropolitan counties with an 

Urbanized Area while the U.S. Census 

Bureau no longer uses this terminology. 

To retain the distinction in FORHP’s 

definition of rural area between urban 

areas with population of 50,000 or more 

and urban areas with a population less 

than 50,000, FORHP will identify and 

categorize urban areas based on 

population size. With this technical 

clarification, HRSA is updating 

FORHP’s rural definition by striking the 

phrase ‘‘outlying metropolitan counties 

without an urbanized area.’’ and 

replacing it with ‘‘outlying metropolitan 

counties with no population from an 

urban area of 50,000 or more people.’’ 

Summary of Comments and Responses 

HRSA received 27 comments in 

response to the notice published April 

26, 2024. Comments responded to both 

the proposed expansion of the 

definition of rural area and the technical 

clarification following the removal of 

urbanized areas and urban clusters by 

the U.S. Census Bureau. Most of the 

comments received (26) were in full or 

partial support of either or both 

components of the change—the 

technical clarification and the expanded 

eligibility criteria to include rugged 

terrain factors. One comment was out of 

scope of this proposal. 

Technical Clarification in Response to 

Census Terminology Changes 

Comment: All comments that 

referenced the technical clarification to 

retain the distinction between urban 

areas with population over and under 

50,000 in FORHP’s definition of rural 

area were supportive of changing 

FORHP’s definition to remove reference 

to Urbanized Areas and instead 

categorize urban areas based on 

population size. 

Response: We thank the commenters 

for their support. After consideration of 

the comments received, we are 

implementing the technical clarification 

as proposed. 

Adding Rugged Terrain Data to the 

Definition of Rural Area 

Many comments were in favor of 

expanding the definition to include 

rugged terrain using the RRS developed 

by the Economic Research Service. We 

thank the commenters for their support. 

Some comments suggested 

modifications or alternatives to the 

proposed change. 

Comment: Some commenters 

suggested expanding the definition by 

including small counties with a high 

density of census tracts that are RRS 3, 

4, and 5. Further, commenters suggested 

we specifically include all census tracts 

in a county that are greater than 20 

square miles in area with RUCA codes 

of 2 or 3 if the county has 12 or fewer 

census tracts and over 80 percent of 

census tracts within the county are RRS 

3–5. 

Response: Including census tracts 

greater than 20 square miles with RUCA 

of 2–3 within metropolitan counties is 

consistent with the proposed change. 

The additional county-level criteria 

suggested—limiting the expansion to 

only counties with 12 or fewer census 

tracts and calculating the percentage of 

tracts per county with RRS 3 through 

5—would not achieve the objective of 

the programs or be operationally 

feasible for the purposes of grantmaking. 

First, aggregating measures defined at 

the census tract level to create a single 

county-level estimate would not further 

FORHP’s goal of identifying rural 

census tracts within metropolitan 

counties using the individual 

characteristics and data from those 

tracts to understand local conditions. 

Second, this proposal could introduce 

state and regional inconsistencies 

because county sizes vary widely across 

the United States. In effect, this 

proposal would treat counties and states 

differently based primarily on their 

geographic size. Finally, the complexity 

of the proposed calculation is 

inconsistent with FORHP’s intent to use 

clear, consistent, and data-driven 

criteria that can be easily understood 

and applied nationwide. For these 

reasons, we are finalizing the language 

as proposed. 

Comment: A commenter suggested 

including census tracts with RRS 3 

(slightly rugged) and RRS 4 (moderately 

rugged) in addition to the proposed RRS 

5 tracts in the expanded rural definition. 

Response: Including census tracts 

with RRS 5 that meet the proposed 

criteria for size and RUCA code adds 84 

census tracts and 305,000 people. RRS 

3 and RRS 4 includes census tracts in 

and around major urban areas such as 

Nashville, Tennessee, and census tracts 

in northern New Jersey. Given their 

lesser topographic variation and their 

close proximity to major urban hubs and 

urban amenities, we are not considering 

these RRS 3 and RRS 4 tracts for the 

purpose of our rural area definition and 

are finalizing as proposed. 

Comment: A commenter suggested 

that Hawaii should be exempt from the 

requirement that census tracts with 

rugged terrain be at least 20 square 

miles in area due to the unique 

geography of the state. 

Response: Small census tracts are 

common in densely populated areas in 

all parts of the United States. Applying 

a different standard in one state would 

not further FORHP’s goal of using clear, 

data-driven criteria that can be 

consistently applied nationwide to 

identify rural areas. For these reasons, 

we are not adopting this suggestion. 

Comment: Some commenters 

suggested that road ruggedness should 

be used as a factor for defining rural 

areas, but FORHP should explore, for 

the future, alternative approaches for 

identification of mountainous roads. 

Response: We thank the commenters 

for their support for using road 

ruggedness. FORHP continuously 

monitors ongoing national research and 

analysis efforts related to developing 

new geographic data sources and 

defining rural areas. We welcome 

suggestions for alternative data sets that 

are national in scope and that would 

identify mountainous roads more 

accurately. As new methods and data 

become available, FORHP may consider 

updating the definition. 

Comment: A commenter suggested 

that the definition should focus on 


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Federal Register / Vol. 89, No. 225 / Thursday, November 21, 2024 / Notices 92133 

service area rather than specific 

addresses of providers. 

Response: The purpose of FORHP’s 

rural definition is to delineate the land 

area of the United States as rural or nonrural. The areas identified as rural by 

this definition may include both service 

areas and specific provider addresses. 

After consideration of the public 

comments received, HRSA is 

implementing the rugged terrain 

inclusion in the definition of rural area 

as proposed. FORHP is making this 

change consistent with its program 

authority to award grants to support 

rural health and rural health care 

services. 

Updated Definition of Rural Area 

HRSA is updating FORHP’s rural 

definition to include geographic areas 

meeting any one of the following 

criteria: 

(1) Non-metropolitan counties 

(2) Outlying metropolitan counties with 

no population from an urban area of 

50,000 or more people 

(3) Census tracts with RUCA codes 4– 

10 in metropolitan counties 

(4) Census tracts of at least 400 square 

miles in area with population density 

of 35 or less per square mile with 

RUCA codes 2–3 in metropolitan 

counties 

(5) Census tracts with RRS 5 and RUCA 

codes 2–3 that are at least 20 square 

miles in area in metropolitan counties 

The changes will go into effect as of 

November 21, 2024. These changes will 

apply to FORHP’s Notices of Funding 

Opportunity for FY 2025 and future 

years for programs that require funded 

activities and services be provided in 

rural areas, as defined by HRSA. FORHP 

will ensure information about the 

updated rural definition is available to 

the public on the HRSA website and in 

funding opportunities. These changes 

reflect FORHP’s desire to accurately 

identify rural areas using a data-driven 

methodology that relies on established 

geographic identifiers and standard, 

national-level data sources. 

Impact 

Incorporating rugged terrain data into 

the definition of rural area using the 

adopted method adds 84 census tracts 

and approximately 305,000 people to 

the 60.8 million people living in 

FORHP-designated rural areas. This is 

an increase of 0.5 percent in the total 

number of people living in rural areas. 

Table 1 show the number of newly rural 

census tracts by state. 

TABLE 1—NUMBER OF NEWLY RURAL

CENSUS TRACTS BY STATE

State Number 

of tracts 

CA ............................................... 24 

OR .............................................. 16 

NC ............................................... 12 

WA .............................................. 9 

TN ............................................... 7 

CO .............................................. 6 

WV .............................................. 6 

MT ............................................... 2 

AK ............................................... 1 

MD .............................................. 1 

Total ..................................... 84 

Note: Table shows the number of newly 

rural census tracts with RRS 5 and RUCA 

codes 2–3 that are at least 20 square miles in 

area in metropolitan counties. Data in this 

table are based on 2010 census tract geographies and 2020 metropolitan county delineations. For a complete list of impacted census 

tracts see https://www.hrsa.gov/rural-health/ 

about-us/what-is-rural/data-files. 

Carole Johnson, 

Administrator. 

[FR Doc. 2024–27133 Filed 11–20–24; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Human Genome Research 

Institute; Notice of Closed Meeting 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Center for Inherited 

Disease Research Access Committee. 

Date: January 10, 2025. 

Time: 11:30 a.m. to 12:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Address: National Human Genome 

Research Institute, National Institutes of 

Health, 6700B Rockledge Drive, Room 3172, 

Bethesda, MD 20892 (Virtual). 

Contact Person: Barbara J. Thomas, Ph.D., 

Scientific Review Officer, Scientific Review 

Branch, National Human Genome Research 

Institute, National Institutes of Health, 6700B 

Rockledge Drive, Room 3172, Bethesda, MD 

20892, (301) 402–8837, barbara.thomas@

nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.172, Human Genome 

Research, National Institutes of Health, HHS) 

Dated: November 15, 2024. 

David W. Freeman, 

Supervisory Program Analyst, Office of 

Federal Advisory Committee Policy. 

[FR Doc. 2024–27167 Filed 11–20–24; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

In compliance with section 

3506(c)(2)(A) of the Paperwork 

Reduction Act of 1995 concerning the 

opportunity for public comment on 

proposed collections of information, the 

Substance Abuse and Mental Health 

Services Administration (SAMHSA) 

will publish periodic summaries of 

proposed projects. To request more 

information on the proposed projects or 

to obtain a copy of the information 

collection plans, call the SAMHSA 

Reports Clearance Officer at (240) 276– 

0361. 

Comments are invited on: (a) Whether 

the proposed collections of information 

are necessary for the proper 

performance of the functions of the 

agency, including whether the 

information shall have practical utility; 

(b) the accuracy of the agency’s estimate 

of the burden of the proposed collection 

of information; (c) ways to enhance the 

quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques or 

other forms of information technology. 

Proposed Project: Minority AIDS 

Initiative: Substance Use Disorder 

Prevention and Treatment Pilot 

Program (MAI PT Pilot) Data Collection 

Instruments 

The Substance Abuse and Mental 

Health Services Administration’s 

(SAMHSA) Center for Substance Abuse 

Prevention (CSAP) and Center for 

Substance Abuse Treatment (CSAT) are 

requesting approval from the Office of 

Management and Budget (OMB) to 

monitor the Minority AIDS Initiative: 

Substance Use Disorder Prevention and 

Treatment Pilot Program (MAI PT Pilot) 


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