Federal Register / Vol. 89, No. 206 / Thursday, October 24, 2024 / Notices 84895 

Ave., Bldg. 71, Silver Spring, MD 

20993–0002, 202–657–8533, 

CBERVRBPAC@fda.hhs.gov, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area). A notice in the 

Federal Register about last-minute 

modifications that impact a previously 

announced advisory committee meeting 

cannot always be published quickly 

enough to provide timely notice. 

Therefore, you should always check the 

FDA’s website at https://www.fda.gov/ 

AdvisoryCommittees/default.htm and 

scroll down to the appropriate advisory 

committee meeting link, or call the 

advisory committee information line to 

learn about possible modifications 

before coming to the meeting. 

SUPPLEMENTARY INFORMATION: 

Agenda: The meeting presentations 

will be heard, viewed, captioned, and 

recorded through an online 

teleconferencing and/or video 

conferencing platform. On December 12, 

2024, under Topic I, the Committee will 

meet in open session to discuss 

Considerations for RSV Vaccine Safety 

in Pediatric Populations. Under Topic 

II, the Committee will meet in open 

session to hear overviews of the LI and 

LR research programs in the Division of 

Viral Products, Office of Vaccines 

Research and Review, and Center for 

Biologics Evaluation and Research. 

After the open session ends for Topic II, 

the meeting will be closed to the public 

for Committee deliberations. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its website prior to the 

meeting, the background material will 

be made publicly available on FDA’s 

website at the time of the advisory 

committee meeting. Background 

material and the link to the online 

teleconference and/or video conference 

meeting will be available at: https://

www.fda.gov/AdvisoryCommittees/ 

Calendar/default.htm. Scroll down to 

the appropriate advisory committee 

meeting link. The meeting will include 

slide presentations with audio and 

video components to allow the 

presentation of materials in a manner 

that most closely resembles an in-person 

advisory committee meeting. 

Procedure: On December 12, 2024, 

from 8:30 a.m. to 3 p.m. Eastern Time 

for Topic I and from 3:10 p.m. to 4:40 

p.m. Eastern Time for Topic II, the 

meeting is open to the public. Interested 

persons may present data, information, 

or views, orally or in writing, on issues 

pending before the Committee. All 

electronic and written submissions 

submitted to the Docket (see ADDRESSES) 

on or before December 4, 2024, will be 

provided to the Committee. Comments 

received on or after December 4, 2024, 

and by December 11, 2024, will be taken 

into consideration by FDA. Oral 

presentations from the public will be 

scheduled between approximately 12:15 

p.m. to 1 p.m. Eastern Time for Topic 

I, and between 4:25 p.m. to 4:40 p.m. 

Eastern Time for Topic II. Those 

individuals interested in making formal 

oral presentations should notify the 

contact person and submit a brief 

statement of the general nature of the 

evidence or arguments they wish to 

present, along with their names, email 

addresses, and direct contact phone 

numbers of proposed participants, and 

an indication of the approximate time 

requested to make their presentation on 

or before 12 p.m. Eastern Time on 

November 25, 2024. Time allotted for 

each presentation may be limited. If the 

number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by November 27, 2024. 

Closed Committee Deliberations: On 

December 12, 2024, the meeting will be 

closed from 4:40 p.m. to 5:30 p.m. to 

permit discussion where disclosure 

would constitute a clearly unwarranted 

invasion of personal privacy (5 U.S.C. 

552b(c)(6)). The recommendations of the 

advisory committee regarding the 

progress of the individual investigators’ 

research programs, along with other 

information, will be discussed during 

this session. We believe that public 

discussion of these recommendations on 

individual scientists would constitute 

an unwarranted invasion of personal 

privacy. 

For press inquiries, please contact the 

Office of Media Affairs at fdaoma@

fda.hhs.gov or 301–796–4540. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with disabilities. 

If you require accommodations due to a 

disability, please contact Sussan Paydar 

or Kathleen Hayes (see FOR FURTHER

INFORMATION CONTACT) at least 7 days in 

advance of the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our website at 

https://www.fda.gov/ 

AdvisoryCommittees/AboutAdvisory

Committees/ucm111462.htm for 

procedures on public conduct during 

advisory committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. 1001 et seq.). This meeting notice 

also serves as notice that, pursuant to 21 

CFR 10.19, the requirements in 21 CFR 

14.22(b), (f), and (g) relating to the 

location of advisory committee meetings 

are hereby waived to allow for this 

meeting to take place using an online 

meeting platform. This waiver is in the 

interest of allowing greater transparency 

and opportunities for public 

participation, in addition to 

convenience for advisory committee 

members, speakers, and guest speakers. 

No participant will be prejudiced by 

this waiver, and that the ends of justice 

will be served by allowing for this 

modification to FDA’s advisory 

committee meeting procedures. 

Dated: October 18, 2024. 

Eric Flamm, 

Acting Associate Commissioner for Policy. 

[FR Doc. 2024–24713 Filed 10–23–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–2177] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Current Good 

Manufacturing Practice, Hazard 

Analysis, and Risk-Based Preventive 

Controls for Human Food, and Current 

Good Manufacturing Practice, Hazard 

Analysis, and Risk-Based Preventive 

Controls for Animal Food 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by November 

25, 2024. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

www.reginfo.gov/public/do/PRAMain. 

Find this particular information 

collection by selecting ‘‘Currently under 

Review—Open for Public Comments’’ or 

by using the search function. The OMB 


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84896 Federal Register / Vol. 89, No. 206 / Thursday, October 24, 2024 / Notices 

control number for this information 

collection is 0910–0751. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–5733, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Current Good Manufacturing Practice 

and Hazard Analysis, and Risk-Based 

Preventive Controls for Human Food— 

21 CFR part 117; Current Good 

Manufacturing Practice and Hazard 

Analysis, and Risk-Based Preventive 

Controls for Animal Food—21 CFR part 

507 

OMB Control Number 0910–0751— 

Extension 

This information collection supports 

implementation of section 418 of the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) (21 U.S.C. 350g). Section 

418(a) requires the owner, operator, or 

agent in charge of a facility to evaluate 

hazards that could affect food 

manufactured, processed, packed, or 

held by the facility; identify and 

implement preventive controls; monitor 

the performance of those controls; and 

maintain records demonstrating 

compliance. Section 418(b) through (i) 

of the FD&C Act contains more specific 

requirements applicable to facilities, 

including corrective actions (section 

418(e)), verification (section 418(f)), a 

written plan and documentation 

(section 418(h)), and reanalysis of 

hazards (section 418(i)). Finally, section 

301(uu) of the FD&C Act (21 U.S.C. 

331(uu)) prohibits ‘‘[t]he operation of a 

facility that manufactures, processes, 

packs, or holds food for sale in the 

United States if the owner, operator, or 

agent in charge of such facility is not in 

compliance with section 418 [of the 

FD&C Act].’’ FDA has issued regulations 

in part 117 (21 CFR part 117) governing 

human food, while regulations 

governing food for animals are found in 

part 507 (21 CFR part 507). The purpose 

of the regulations is to prevent the 

introduction of adulterated and/or 

misbranded products into the 

marketplace and ensure the safety of 

both human foods and animal foods in 

accordance with sections 402 and 403 of 

the FD&C Act (21 U.S.C. 342 and 343). 

Generally, domestic and foreign food 

facilities that are required to register in 

accordance with section 415 of the 

FD&C Act (21 U.S.C. 350d) must comply 

with these requirements, unless an 

exemption applies. It is important to 

note that applicability of the current 

good manufacturing practice 

requirements for animal food is 

dependent upon whether a facility is 

required to register, while the 

applicability of the current good 

manufacturing practice requirements for 

human food is not dependent upon 

whether a facility is required to register. 

Respondents to the information 

collection are those who manufacture, 

prepare, pack, or hold food intended for 

humans or animals. 

The regulations include 

recordkeeping necessary to demonstrate 

compliance with the requirements; 

however, respondents that meet the 

definition of a ‘‘qualified facility,’’ 

under §§ 117.3 and 507.3, are subject to 

reporting. To be subject to the modified 

requirements set forth in part 117, 

subpart D and part 507, subpart D for 

human food and animal food, 

respectively, respondents must attest to 

their status. To assist respondents in 

this regard, we have developed Forms 

FDA 3942a (Quality Facility Attestation: 

Human Food) and 3942b (Quality 

Facility Attestation: Animal Food), 

available for downloading from our 

website at https://www.fda.gov/food/ 

registration-food-facilities-and-othersubmissions/qualified-facilityattestation. 

Information collected will assist FDA 

in determining facility compliance with 

current good manufacturing practice 

requirements and in ensuring that food 

safety systems include hazard analysis 

and risk-based preventive controls. 

Records will be examined during food 

facility inspections and in the event of 

an outbreak or other food safety incident 

involving the food manufactured at the 

facility. 

Section 418(l)(2)(B)(ii) of the FD&C 

Act directs us to issue guidance on 

documentation required to determine 

status as a qualified facility. 

Accordingly, we issued a guidance for 

industry entitled ‘‘Determination of 

Status as a Qualified Facility Under Part 

117: Current Good Manufacturing 

Practice, Hazard Analysis, and RiskBased Preventive Controls for Human 

Food and Part 507: Current Good 

Manufacturing Practice, Hazard 

Analysis, and Risk-Based Preventive 

Controls for Food for Animals,’’ also 

available for downloading from our 

website at https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents/guidanceindustry-determination-status-qualifiedfacility. The guidance discusses the 

content, format, frequency, and timing 

of submissions. 

In the Federal Register of June 5, 2024 

(89 FR 48172) we published a 60-day 

notice requesting public comment on 

the proposed collection of information. 

Although no comments were received, 

on our own initiative we have modified 

estimates since publication of our 60- 

day notice. Specifically, we have 

modified estimates for certain 

recordkeeping elements associated with 

animal foods in tables 2 and 3. 

We estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section; reporting activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Human Foods: 117.201(c); qualified facility as reported 

on Form FDA 3942a .................................................... 37,134 2 0.5 18,567 0.5 (30 

minutes) 

9,284 

Animal Foods: 507.7(c); qualified facility as reported on 

Form FDA 3942b .......................................................... 1,120 0.5 560 0.5 (30 

minutes) 

280 

Total .......................................................................... ........................ ............................ ........................ ........................ 9,564 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

2 Reporting occurs biennially. 


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Federal Register / Vol. 89, No. 206 / Thursday, October 24, 2024 / Notices 84897 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR section; recordkeeping activity Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total 

annual 

records 

Average 

burden per 

recordkeeping 

Total 

hours 2

Human Foods: Subparts A—Required Records and B—General Provisions 

117.126(c) and 117.170(d); food safety plan and reanalysis ........................................................................... 46,685 1 46,685 110 5,135,350 

117.136; assurance records ............................................ 16,285 1 16,285 0.25 

(15 minutes) 

4,071 

117.145(c); monitoring records ........................................ 8,143 730 5,944,390 0.05 

(3 minutes) 

297,220 

117.150(d); corrective actions and corrections records .. 16,285 2 32,570 1 32,570 

117.155(b); verification records ....................................... 8,143 244 1,986,892 0.05 

(3 minutes) 

99,345 

117.160; validation records .............................................. 3,677 6 22,062 0.25 

(15 minutes) 

5,515 

117.475(c)(7) through (c)(9); supplier records ................ 16,285 10 162,850 4 651,400 

117.180(d); training records for preventive controls 

qualified individual ........................................................ 46,685 1 46,685 0.25 

(15 minutes) 

11,671 

Subpart A—General Provisions 

507.4(d); documentation of animal food safety and hygiene training ................................................................ 7,469 0.75 5,579 0.05 

(3 minutes) 

279 

Subpart C—Hazard Analysis and Risk-Based Preventive Controls 

507.31 through 507.55; food safety plan—including hazard analysis, preventive controls, and procedures for 

monitoring, corrective actions, verification, recall plan, 

validation, reanalysis, modifications, and implementation records ................................................................... 7,469 519 3,876,411 0.1 

(6 minutes) 

387,641 

Subpart E—Supply Chain Program 

507.105 through 507.175; written supply-chain program—including records documenting program .......... 7,469 519 3,876,411 0.1 

(6 minutes) 

387,641 

Subpart F—Requirements Applying to Records That Must Be Established and Maintained 

507.200 through 507.215; general requirements, additional requirements applying to food safety plan, requirements for record retention, use of existing 

records, and special requirements applicable to written assurance ............................................................... 7,469 519 3,876,411 0.1 

(6 minutes) 

387,641 

Total .......................................................................... ........................ ............................ ........................ ........................ 7,400,400 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

2Total hours have been rounded. 

TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

21 CFR section; activity Number of 

respondents 

Number of 

disclosures 

per respondent 

Total 

annual 

disclosures 

Average 

burden per 

disclosure 

Total 

hours 

117.201(e); disclosure of food manufacturing facility address ............................................................................. 37,134 1 37,134 0.25 

(15 minutes) 

9,284 

507.27(b); labeling for the animal food product contains 

the specific information and instructions needed so 

the food can be safely used for the intended animal 

species ......................................................................... 330 10 3,300 0.25 

(15 minutes) 

825 

507.7(e)(1); change labels on products with labels ........ 1,120 4 4,480 1 4,480 

507.7(e)(2); change address on labeling (sales documents) for qualified facilities ......................................... 974 1 974 1 974 


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84898 Federal Register / Vol. 89, No. 206 / Thursday, October 24, 2024 / Notices 

TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1—Continued 

21 CFR section; activity Number of 

respondents 

Number of 

disclosures 

per respondent 

Total 

annual 

disclosures 

Average 

burden per 

disclosure 

Total 

hours 

507.25(a)(2); animal food, including raw materials, other 

ingredients, and rework, is accurately identified .......... 373 312 116,376 0.01 

(36 seconds) 

1,163.76 

507.28(b); holding and distribution of human food byproducts for use as animal food .................................. 40,798 2 81,596 0.25 

(15 minutes) 

20,399 

Total .......................................................................... ........................ ............................ ........................ ........................ 37,125.76 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Based on a review of the information 

collection since our last request for 

OMB approval, we have made no 

adjustments to our burden estimate. 

Dated: October 21, 2024. 

Eric Flamm, 

Acting Associate Commissioner for Policy. 

[FR Doc. 2024–24771 Filed 10–23–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: Public 

Comment Request; Information 

Collection Request Title: 

Environmental Information and 

Documentation 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement for opportunity for public 

comment on proposed data collection 

projects of the Paperwork Reduction Act 

of 1995, HRSA announces plans to 

submit an Information Collection 

Request (ICR), described below, to the 

Office of Management and Budget 

(OMB). Prior to submitting the ICR to 

OMB, HRSA seeks comments from the 

public regarding the burden estimate 

below or any other aspect of the ICR. 

DATES: Comments on this ICR should be 

received no later than December 23, 

2024. 

ADDRESSES: Submit your comments to 

paperwork@hrsa.gov or mail the HRSA 

Information Collection Clearance 

Officer, Room 14NWH04, 5600 Fishers 

Lane, Rockville, Maryland 20857. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and draft 

instruments, email paperwork@hrsa.gov 

or call Joella Roland, the HRSA 

Information Collection Clearance 

Officer, at (301) 443–3983. 

SUPPLEMENTARY INFORMATION: When 

submitting comments or requesting 

information, please include the ICR title 

for reference. 

Information Collection Request Title: 

HRSA Environmental Information and 

Documentation, OMB No. 0915–0324— 

Extension. 

Abstract: HRSA proposes an 

extension of the Paperwork Reduction 

Act approval for the Environmental 

Information and Documentation (EID) 

checklist, which consists of information 

the agency is required to obtain to 

comply with the National 

Environmental Policy Act (NEPA) of 

1969 as amended by the Fiscal 

Responsibility Act of 2023. NEPA 

establishes the federal government’s 

national policy for protection of the 

environment. The EID checklist must be 

completed and submitted by applicants 

for HRSA funds that plan to engage in 

construction or other projects that will 

potentially impact the environment. 

HRSA uses the checklist to ensure that 

decision-making processes are 

consistent with NEPA and other related 

environmental and historic preservation 

laws. The extension will support 

HRSA’s implementation of programs 

with capital improvements that have the 

potential to significantly affect the 

human environment, such as 

construction/expansion and alteration/ 

renovation activities, as defined in the 

associated HRSA program guidance, or 

installation of fixed equipment. 

Need and Proposed Use of the 

Information: Applicants for HRSA funds 

must provide information and assurance 

of compliance with NEPA on the EID 

checklist. This information is reviewed 

during the Pre-Award stage (and/or 

prior to the implementation of the 

project). The information is reviewed in 

the Post-Award stage for project changes 

and the information is reviewed before 

the implementation of the project 

changes. 

Likely Respondents: HRSA applicants 

applying for federal loan guarantees, 

federal construction grants, and 

cooperative agreements. 

Burden Statement: Burden in this 

context means the time expended by 

persons to generate, maintain, retain, 

disclose, or provide the information 

requested. This includes the time 

needed to review instructions; to 

develop, acquire, install, and utilize 

technology and systems for the purpose 

of collecting, validating, and verifying 

information, processing and 

maintaining information, and disclosing 

and providing information; to train 

personnel and to be able to respond to 

a collection of information; to search 

data sources; to complete and review 

the collection of information; and to 

transmit or otherwise disclose the 

information. The total annual burden 

hours estimated for this ICR are 

summarized in the table below. 


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