Federal Register / Vol. 88, No. 238 / Wednesday, December 13, 2023 / Notices 86345 

in the body of your comments and you 

must identify the 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: 

Moon Choi, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 31, Rm. 2417, Silver Spring, 

MD 20993–0002, 301–796–2894, 

GEMDAC@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

Genetic Metabolic Diseases Advisory 

Committee (Committee) reviews and 

evaluates data on the safety and 

effectiveness of marketed and 

investigational human drug and biologic 

products for use in the treatment of 

genetic metabolic diseases and makes 

appropriate recommendations to the 

Commissioner. 

The Committee shall consist of a core 

of nine voting members including the 

Chair. Members and the Chair are 

selected by the Commissioner or 

designee from among authorities 

knowledgeable in the fields of medical 

genetics, manifestations of inborn errors 

of metabolism, small population trial 

design, translational science, pediatrics, 

epidemiology, or statistics and related 

specialties. Members will be invited to 

serve for overlapping terms of up to 4 

years. Non-Federal members of this 

committee will serve either as special 

government employees or non-voting 

representatives. Federal members will 

serve as regular government employees. 

The core of voting members may 

include one technically qualified 

member, selected by the Commissioner 

or designee, who serves as an 

individual, but who is identified with 

consumer interests and is recommended 

by either a consortium of consumeroriented organizations or other 

interested persons. 

In addition to the voting members, the 

Committee may include one non-voting 

representative member who is identified 

with industry interests. There may also 

be an alternate industry representative. 

Elsewhere in this issue of the Federal 

Register, FDA is publishing separate 

documents regarding: (1) Genetic 

Metabolic Diseases Advisory 

Committee: Request for Nominations for 

Voting Members on a Public Advisory 

Committee: Genetic Metabolic Diseases 

Advisory Committee; (2) Request for 

Nomination of Individuals and 

Consumer Organizations for the Genetic 

Metabolic Diseases Advisory 

Committee; and (3) Request for 

Nomination of Individuals and Industry 

Organizations for the Genetic Metabolic 

Diseases Advisory Committee. 

FDA intends to publish in the Federal 

Register a final rule adding the Genetic 

Metabolic Diseases Advisory Committee 

to 21 CFR 14.100. 

Dated: December 7, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–27304 Filed 12–12–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–0008] 

Request for Nominations of Individuals 

and Industry Organizations for the 

Genetic Metabolic Diseases Advisory 

Committee 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

requesting that industry organizations 

interested in participating in the 

selection of a nonvoting industry 

representative to serve on the Genetic 

Metabolic Diseases Advisory Committee 

(the Committee) in the Center for Drug 

Evaluation and Research notify FDA in 

writing. FDA is also requesting 

nominations for a nonvoting industry 

representative to serve on the 

Committee. Nominees recommended to 

serve as a nonvoting industry 

representative may either be selfnominated or nominated by an industry 

organization. Nominations will be 

accepted for the current vacancy 

effective with this notice. 

DATES: Any industry organization 

interested in participating in the 

selection of an appropriate nonvoting 

member to represent industry interest, 

must send a letter stating that interest to 

the FDA by February 12, 2024, (see 

sections I and II of this document for 

details). Concurrently, nomination 

materials for prospective candidates 

should be sent to FDA by February 12, 

2024. 

ADDRESSES: All statements of interest 

from interested industry organizations 

interested in participating in the 

selection process of a nonvoting 

industry representative should be sent 

electronically to Nicholas Marsh (see 

FOR FURTHER INFORMATION CONTACT). All 

nominations for the nonvoting industry 

representative may be submitted 

electronically by accessing the FDA 

Advisory Committee Membership 

Nomination Portal: https://

www.accessdata.fda.gov/scripts/ 

FACTRSPortal/FACTRS/index.cfm or by 

mail to Advisory Committee Oversight 

and Management Staff, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, Rm. 5103, Silver Spring, 

MD 20993–0002. 

Information about becoming a 

member on 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: 

Nicolas Marsh, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 31, Rm. 2418, 

Silver Spring, MD 20993–0002, 240– 

402–5357, email: nicholas.marsh@

fda.hhs.gov. 

For questions relating to the Genetic 

Metabolic Diseases Advisory Committee: 

Moon Choi, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 31, Rm. 2417, Silver Spring, 

MD 20993–0002, 301–796–2894, email: 

GEMDAC@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: FDA is 

requesting nominations for a nonvoting 

industry representative for the Genetic 

Metabolic Diseases Advisory 

Committee. 

Elsewhere in this issue of the Federal 

Register, FDA is publishing separate 

documents regarding: 

1. Genetic Metabolic Diseases Advisory 

Committee; Notice of Establishment 

2. Request for Nominations for Voting 

Members for the Genetic Metabolic 

Diseases Advisory Committee 

3. Request for Nominations of 

Individuals and Consumer 

Organizations for the Genetic 

Metabolic Diseases Advisory 

Committee 


khammond on DSKJM1Z7X2PROD with NOTICES
86346 Federal Register / Vol. 88, No. 238 / Wednesday, December 13, 2023 / Notices 

I. General Description of the Genetic 

Metabolic Diseases Advisory 

Committee’s Duties 

The Committee reviews and evaluates 

data on the safety and effectiveness of 

marketed and investigational human 

drug and biologic products for use in 

the treatment of genetic metabolic 

diseases and makes appropriate 

recommendations to the Commissioner 

of Food and Drugs. 

II. Qualifications 

Persons nominated for the Committee 

should be full-time employees of firms 

that develop human drug and biologic 

products, or consulting firms that 

represent human drug and biologic 

product developers or have similar 

appropriate ties to industry. 

III. Selection Procedure 

Any industry organization interested 

in participating in the selection of an 

appropriate nonvoting member to 

represent industry interest must send a 

letter 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 60 days, FDA will send a 

letter 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 or curriculum 

vitae. The letter will also state that it is 

the responsibility of the interested 

organizations to confer with one another 

and to select a candidate, to represent 

industry interest for the committee, 

within 60 days after the receipt of the 

FDA letter. 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 temporary 

nonvoting members to represent 

industry interests. 

IV. Nomination Procedure 

Individuals may self-nominate and/or 

an organization may nominate one or 

more individuals to serve as a 

temporary nonvoting industry 

representative. Nominations must 

include a cover letter and a current, 

complete re ́sume ́ or curriculum vitae for 

each nominee, including current 

business and/or home address, 

telephone number, and 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). Nominations 

should specify the advisory committee 

for which the nominee is recommended 

within 60 days of publication of this 

document (see DATES). Nominations 

should 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. Only interested industry 

organizations participate in the 

selection process. Persons who 

nominate themselves as nonvoting 

industry representatives will not 

participate in the selection process. 

FDA seeks to include the views of 

members of all gender groups, 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: December 7, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–27303 Filed 12–12–23; 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: Applications 

for Deemed Public Health Service 

Employment With Liability Protections 

Under the Federal Tort Claims Act for 

Health Centers, Deemed Health Center 

Volunteers, and Free Clinic Sponsored 

Individuals, OMB No. 0906–XXXX–New 

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 February 12, 

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. 

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: 

Applications for Deemed Public Health 

Service (PHS) Employment with 

Liability Protections Under the Federal 

Tort Claims Act (FTCA) for Health 

Centers, Deemed Health Center 

Volunteers, and Free Clinic Sponsored 

Individuals, OMB No. 0906–XXXX– 

New. 

Abstract: Section 224(g)–(n) of the 

PHS Act (42 U.S.C. 233(g)–(n)) states 

that entities receiving funds under 

section 330 of the PHS Act and 

specified individuals of that entity may 

be deemed to be PHS employees for the 

purpose of eligibility for liability 

protections, including FTCA coverage, 

for the performance of medical, surgical, 

dental, and related functions within the 

scope of deemed employment upon 

approval of an application for deemed 

employment. The Health Center 

Program and Health Center FTCA 

Program are administered by HRSA. 

Health centers submit deeming 

applications annually to HRSA in the 

prescribed form and manner in order to 

obtain deemed PHS employee status, 

with the associated eligibility for FTCA 

coverage. Such applications must be 

approved by HRSA in a Notice of 

Deeming Action. Deemed health centers 

must resubmit applications annually 

meeting all deeming requirements in 

order to maintain deemed status. 

Volunteer Health Professionals (VHPs) 

Section 224(q) of the PHS Act (42 

U.S.C. 233(q)) extends eligibility for 

deemed PHS employee status to VHPs 

sponsored by deemed health centers 

upon approval of an individual 

sponsorship application for deemed 

PHS employment. The Health Center 

VHP FTCA Program is administered by 

HRSA. In order to maintain deemed 

status for VHPs, deemed health centers 

must submit to HRSA an annual 

deeming sponsorship application on 

behalf of individually named VHPs. For 

liability protections to apply, such 


khammond on DSKJM1Z7X2PROD with NOTICES