92130 Federal Register / Vol. 89, No. 225 / Thursday, November 21, 2024 / Notices 

88395). FDA considered comments 

received and revised the guidance as 

appropriate in response to the 

comments, including clarifying the 

relationship between 510k Review 

Organizations and EUA Third Party 

Review Organizations, and conflicts of 

interest requirements for personnel of 

Third Party Review Organizations. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on 510(k) Third Party 

Review Program and Third Party 

Emergency Use Authorization (EUA) 

Review. It does not establish any rights 

for any person and is not binding on 

FDA or the public. You can use an 

alternative approach if it satisfies the 

requirements of the applicable statutes 

and regulations. 

II. Electronic Access 

Persons interested in obtaining a copy 

of the guidance may do so by 

downloading an electronic copy from 

the internet. A search capability for all 

Center for Devices and Radiological 

Health guidance documents is available 

at https://www.fda.gov/medical-devices/ 

device-advice-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. This 

guidance document is also available at 

https://www.regulations.gov and https:// 

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents. 

Persons unable to download an 

electronic copy of ‘‘510(k) Third Party 

Review Program and Third Party 

Emergency Use Authorization (EUA) 

Review’’ may send an email request to 

CDRH-Guidance@fda.hhs.gov to receive 

an electronic copy of the document. 

Please use the document number 

GUI01500013 and complete title to 

identify the guidance you are 

requesting. 

III. Paperwork Reduction Act of 1995 

While this guidance contains no new 

collection of information, it does refer to 

previously approved FDA collections of 

information. The previously approved 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (PRA) (44 U.S.C. 

3501–3521). The collections of 

information in the following table have 

been approved by OMB: 

21 CFR part; guidance; or FDA form Topic OMB control 

No. 

‘‘510(k) Third Party Review Program’’ ....................................... 510(k) Third Party Review Program ........................................... 0910–0375 

‘‘Requests for Feedback on Medical Device Submissions: The 

Pre-Submission Program and Meetings with Food and Drug 

Administration Staff’’.

Q-submissions ............................................................................ 0910–0756 

‘‘Emergency Use Authorization of Medical Products and Related Authorities; Guidance for Industry and Other Stakeholders’’.Emergency Use Authorization .................................................... 0910–0595 

‘‘Guidance for Industry and Food and Drug Administration 

Staff; Center for Devices and Radiological Health Appeals 

Processes’’.

CDRH Appeals Processes ......................................................... 0910–0738 

Dated: November 12, 2024. 

Kimberlee Trzeciak, 

Deputy Commissioner for Policy, Legislation, 

and International Affairs. 

[FR Doc. 2024–27085 Filed 11–20–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–3609] 

Development of an Enhanced 

Systematic Process for the Food and 

Drug Administration’s Post-Market 

Assessment of Chemicals in Food; 

Public Meeting; Request for 

Comments; Extension of Comment 

Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting; 

request for comments; extension of 

comment period. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

extending the comment period for the 

notice of public meeting; request for 

comments, published in the Federal 

Register of August 12, 2024. In that 

notice, FDA announced a public 

meeting entitled ‘‘Development of an 

Enhanced Systematic Process for the 

Food and Drug Administration’s PostMarket Assessment of Chemicals in 

Food.’’ FDA hosted the public meeting 

on September 25, 2024, and is now 

extending the comment period to allow 

interested persons additional time to 

submit comments about approaches to 

systematic post-market assessment of 

chemicals in food. 

DATES: FDA is extending the comment 

period announced in the notice of 

public meeting; request for comments 

published August 12, 2024 (89 FR 

65633). Either electronic or written 

comments must be submitted by January 

21, 2025. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

January 21, 2025. Comments received by 

mail/hand delivery/courier (for written/ 

paper submissions) will be considered 

timely if they are received on or before 

that date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

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

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 


lotter on DSK11XQN23PROD with NOTICES1
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 


lotter on DSK11XQN23PROD with NOTICES1