4316 Federal Register / Vol. 89, No. 15 / Tuesday, January 23, 2024 / Notices 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

State Enforcement Notifications—21 

CFR 100.2(d) 

OMB Control Number 0275—Extension 

This information collection supports 

Agency regulations. Specifically, section 

310(b) of the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) (21 U.S.C. 

337(b)) authorizes a State to enforce 

certain sections of the FD&C Act in their 

own name and within their own 

jurisdiction. However, before doing so, 

a State must provide notice to FDA 

according to § 100.2 (21 CFR 100.2). The 

information required in a letter of 

notification under § 100.2(d) enables us 

to identify the food against which a 

State intends to take action and to 

advise that State whether Federal 

enforcement action against the food has 

been taken or is in process. With certain 

narrow exceptions, Federal enforcement 

action precludes State action under the 

FD&C Act. 

We estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section; activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

100.2(d); notification ............................................................ 1 1 1 10 10 

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. 

The estimated reporting burden for 

§ 100.2(d) is minimal because 

enforcement notifications are seldom 

used by States. During the last 3 years, 

we have not received any new 

enforcement notifications; therefore, we 

estimate that one or fewer notifications 

will be submitted annually. Although 

we have not received any new 

enforcement notifications in the last 3 

years, these information collection 

provisions should be extended to 

provide for the potential future need of 

a State government to submit 

enforcement notifications informing us 

when it intends to take enforcement 

action under the FD&C Act against a 

particular food located in the State. 

Dated: January 18, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–01238 Filed 1–22–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–0008] 

Request for Nominations From 

Industry Organizations Interested in 

Participating in the Selection Process 

for Nonvoting Industry 

Representatives and Request for 

Nominations for Nonvoting Industry 

Representatives on the Cellular, 

Tissue, and Gene Therapies Advisory 

Committee 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

requesting that any industry 

organizations interested in participating 

in the selection of a nonvoting industry 

representative to serve on the Cellular, 

Tissue, and Gene Therapies Advisory 

Committee (CTGTAC) for the Center for 

Biologics Evaluation and Research 

notify FDA in writing. FDA is also 

requesting nominations for a nonvoting 

industry representative(s) to serve on 

the CTGTAC. A nominee may either be 

self-nominated or nominated by an 

organization to serve as a nonvoting 

industry representative. Nominations 

will be accepted for current vacancies 

effective with this notice. 

DATES: Any industry organization 

interested in participating in the 

selection of an appropriate nonvoting 

member to represent industry interests 

must send a letter stating that interest to 

FDA by February 22, 2024 (see sections 

I and II of this document for further 

details). Concurrently, nomination 

materials for prospective candidates 

should be sent to FDA by February 22, 

2024. 

ADDRESSES: All statements of interest 

from industry organizations interested 

in participating in the selection process 

of nonvoting industry representative 

nominations should be sent via email to 

Cicely Reese or Marie DeGregorio (see 

FOR FURTHER INFORMATION CONTACT). All 

nominations for nonvoting industry 

representatives must be submitted 

electronically by accessing the FDA 

Advisory Committee Membership 

Nomination Portal at: https://www.

accessdata.fda.gov/scripts/FACTRS

Portal/FACTRS/index.cfm. Information 

about becoming a member of an FDA 

advisory committee can also be obtained 

by visiting FDA’s website at: https://

www.fda.gov/AdvisoryCommittees/ 

default.htm. 

FOR FURTHER INFORMATION CONTACT: 

Cicely Reese or Marie DeGregorio, 

Center for Biologics Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 71, Rm. 1232, Silver Spring, 

MD 20993–0002, 240–620–9987, email: 

CBERCTGTAC@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

Agency intends to add a nonvoting 

industry representative(s) to the 

following advisory committee: 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 89, No. 15 / Tuesday, January 23, 2024 / Notices 4317 

I. Cellular, Tissue, and Gene Therapies 

Advisory Committee 

The Committee reviews and evaluates 

available data relating to the safety, 

effectiveness, and appropriate use of 

human cells, human tissues, gene 

transfer therapies, and 

xenotransplantation products, which are 

intended for transplantation, 

implantation, infusion, and transfer in 

the prevention and treatment of a broad 

spectrum of human diseases and in the 

reconstruction, repair, or replacement of 

tissues for various conditions. The 

Committee also considers the quality 

and relevance of FDA’s research 

program, which provides scientific 

support for the regulation of these 

products, and makes appropriate 

recommendations to the Commissioner 

of Food and Drugs. 

II. Selection Procedure 

Any industry organization interested 

in participating in the selection of an 

appropriate nonvoting member to 

represent industry interests should send 

a letter via email stating that interest to 

the FDA contact (see FOR FURTHER

INFORMATION CONTACT) within 30 days of 

publication of this document (see 

DATES). Within the subsequent 30 days, 

FDA will send a notification to each 

organization that has expressed an 

interest, attaching a complete list of all 

such organizations; and a list of all 

nominees along with their current 

re ́sume ́s. The letter will also state that 

it is the responsibility of the interested 

organizations to confer with one another 

and to select a candidate, within 60 

days after the receipt of the FDA letter, 

to serve as the nonvoting member to 

represent industry interests for the 

committee. The interested organizations 

are not bound by the list of nominees in 

selecting a candidate. However, if no 

individual is selected within 60 days, 

the Commissioner will select the 

nonvoting member to represent industry 

interests. 

III. Application Procedure 

Individuals may self-nominate, and/or 

an organization may nominate one or 

more individuals to serve as a nonvoting 

industry representative. Nomination 

must include a current, complete 

re ́sume ́ or curriculum vitae for each 

nominee, including current business 

address and telephone number, email 

address if available, and a signed copy 

of the Acknowledgement and Consent 

form available at the FDA Advisory 

Committee Membership Nomination 

Portal (see ADDRESSES) within 30 days of 

publication of this document (see 

DATES). Nominations must also specify 

the advisory committee for which the 

nominee is recommended. Nominations 

must also acknowledge that the 

nominee is aware of the nomination 

unless self-nominated. FDA will 

forward all nominations to the 

organizations expressing interest in 

participating in the selection process for 

the committee. Persons who nominate 

themselves as nonvoting industry 

representatives will not participate in 

the selection process. 

FDA seeks to include the views of 

women and men, members of all racial 

and ethnic groups, and individuals with 

and without disabilities on its advisory 

committees and, therefore, encourages 

nominations of appropriately qualified 

candidates from these groups. 

This notice is issued under the 

Federal Advisory Committee Act (5 

U.S.C. 1001 et seq.) and 21 CFR part 14, 

relating to advisory committees. 

Dated: January 17, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–01154 Filed 1–22–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–1262] 

Notice of Approval of Product Under 

Voucher: Rare Pediatric Disease 

Priority Review Voucher 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

issuance of approval of a product 

redeeming a priority review voucher. 

The Federal Food, Drug, and Cosmetic 

Act (FD&C Act) authorizes FDA to 

award priority review vouchers to 

sponsors of approved rare pediatric 

disease product applications that meet 

certain criteria. FDA is required to 

publish notice of the issuance of priority 

review vouchers as well as the approval 

of products redeeming a priority review 

voucher. FDA has determined that 

VEOZAH (fezolinetant), approved May 

12, 2023, meets the criteria for 

redeeming a priority review voucher. 

FOR FURTHER INFORMATION CONTACT: 

Cathryn Lee, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993–0002, 

301–796–1394, email: Cathryn.Lee@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: FDA is 

announcing the approval of a product 

redeeming a rare pediatric disease 

priority review voucher. Under section 

529 of the FD&C Act (21 U.S.C. 360ff), 

FDA will report the issuance of rare 

pediatric disease priority review 

vouchers and the approval of products 

for which a voucher was redeemed. 

FDA has determined that VEOZAH 

(fezolinetant) meets the redemption 

criteria. 

For further information about the Rare 

Pediatric Disease Priority Review 

Voucher Program and for a link to the 

full text of section 529 of the FD&C Act, 

go to https://www.fda.gov/ForIndustry/ 

DevelopingProductsforRare

DiseasesConditions/RarePediatric

DiseasePriorityVoucherProgram/ 

default.htm. For further information 

about VEOZAH (fezolinetant), go to the 

‘‘Drugs@FDA’’ website at https://

www.accessdata.fda.gov/scripts/cder/ 

daf/. 

Dated: January 17, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–01163 Filed 1–22–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Submission to OMB for 

Review and Approval; Public Comment 

Request; The National Health Service 

Corps Loan Repayment Programs 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

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 March 25, 2024. 

ADDRESSES: Submit your comments to 

paperwork@hrsa.gov or mail the HRSA 

Information Collection Clearance 

Officer, Room 14N39, 5600 Fishers 

Lane, Rockville, Maryland 20857. 


khammond on DSKJM1Z7X2PROD with NOTICES