Federal Register / Vol. 88, No. 174 / Monday, September 11, 2023 / Notices 62379 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Silver Spring, MD 

20903, daphne.guinn@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Clinical Pharmacology Considerations 

for Peptide Drug Products.’’ This draft 

guidance, when finalized, will represent 

FDA’s current thinking on the conduct 

of certain clinical pharmacology studies 

during the development of peptide drug 

products. 

The term ‘‘peptide’’ refers to any 

polymer composed of 40 or fewer amino 

acids. In general, if a peptide meets the 

definition of a drug and does not 

otherwise meet the statutory definition 

of a ‘‘biological product’’ or a ‘‘device,’’ 

it would be regulated as a drug under 

the Federal Food, Drug, and Cosmetic 

Act (FD&C Act) and be subject to all the 

‘‘drug’’ requirements under the FD&C 

Act and FDA’s regulations, including 

the requirement that new drugs must be 

approved under section 505(c) of the 

FD&C Act before they can be marketed 

in interstate commerce. However, 

peptide drug products can have product 

characteristics that may be similar, in 

certain respects, to biological products, 

and as such, there are other FDA 

guidances on biological products that 

discuss scientific principles that could 

also be applicable to peptide drug 

products. 

The ‘‘Clinical Pharmacology 

Considerations for Peptide Drug 

Products’’ draft guidance, when 

finalized, will provide 

recommendations to assist industry in 

the development of peptide drug 

products. Specifically, this guidance 

describes FDA’s recommendations 

regarding clinical pharmacology 

considerations for peptide drug product 

development programs, including organ 

impairment, DDIs, assessing QTc 

prolongation risk, and immunogenicity 

risk and impact on PK, safety, and 

efficacy assessment. This guidance 

provides recommendations on when 

these assessments may be appropriate. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

This draft guidance, when finalized, 

will represent the current thinking of 

FDA on ‘‘Clinical Pharmacology 

Considerations for Peptide Drug 

Products.’’ 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. Paperwork Reduction Act of 1995 

While this guidance contains no 

collection of information, it does refer to 

previously approved FDA collections of 

information. The previously approved 

collections of information are subject to 

review by OMB under the PRA. The 

collections of information in 21 CFR 

part 312 have been approved under 

OMB Control No. 0910–0014. The 

collections of information in 21 CFR 

part 314 have been approved under 

OMB Control No. 0910–0001. The 

collections of information in 21 CFR 

part 201 have been approved under 

OMB Control No. 0910–0572. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at either 

https://www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents, or https://

www.regulations.gov. 

Dated: September 5, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–19456 Filed 9–8–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–3681] 

Request for Nominations of a 

Nonvoting Representative of the 

Interest of the Tobacco Manufacturing 

Industry on the Tobacco Products 

Scientific Advisory Committee 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is requesting 

nominations for a nonvoting 

representative of the interests of the 

tobacco manufacturing industry to serve 

on the Tobacco Products Scientific 

Advisory Committee (TPSAC), in the 

Center for Tobacco Products. 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. A 

nominee may either be self-nominated 

or nominated by an organization. In 

addition, FDA is requesting that any 

industry organizations interested in 

participating in the selection of a 

nonvoting representative of the interests 

of the tobacco manufacturing industry 

to serve on the TPSAC, notify FDA in 

writing. Nominations will be accepted 

for either the representative to serve on 

TPSAC or for the selection group 

effective with this notice. 

DATES: Nomination materials for 

prospective candidates should be sent to 

FDA by October 11, 2023. Concurrently, 

any industry organization interested in 

participating in the selection of an 

appropriate nonvoting member to 

represent the interests of the tobacco 

manufacturing industry must send a 

letter stating that interest to FDA by 

October 11, 2023 (see sections I and II 

of this document for further details). 

ADDRESSES: All nominations for 

nonvoting representatives of the 

interests of the tobacco manufacturing 

industry may be submitted 

electronically by accessing the FDA 

Advisory Committee Membership 

Nomination Portal: https://

www.accessdata.fda.gov/scripts/ 

FACTRSPortal/FACTRS/index.cfm. 

All statements of interest from 

industry organizations interested in 

participating in the selection process of 

nonvoting representatives of the 

interests of the tobacco manufacturing 

industry nomination should be sent to 

Serina Hunter-Thomas (see FOR FURTHER

INFORMATION CONTACT). 

FOR FURTHER INFORMATION CONTACT: 

Serina Hunter-Thomas, Office of 

Science, Center for Tobacco Products, 

Food and Drug Administration, 

Document Control Center, 10903 New 

Hampshire Ave., Bldg. 71, Rm. G335, 

Silver Spring, MD 20993–0002, 1–877– 

287–1373 (choose Option 5), email: 

TPSAC@fda.hhs.gov. 

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. 

SUPPLEMENTARY INFORMATION: FDA is 

requesting nominations for a nonvoting 

representative of the interests of the 

tobacco manufacturing industry on the 

TPSAC. 

I. General Description of the Committee 

Duties 

The TPSAC advises the Commissioner 

of Food and Drugs (the Commissioner) 

or designee in discharging 

responsibilities related to the regulation 

of tobacco products. The TPSAC 

reviews and evaluates safety, 

dependence, or health issues relating to 

tobacco products and provides 

appropriate advice, information, and 

recommendations to the Commissioner. 


ddrumheller on DSK120RN23PROD with NOTICES1
62380 Federal Register / Vol. 88, No. 174 / Monday, September 11, 2023 / Notices 

II. Nomination Procedure 

Individuals may self-nominate and/or 

an organization may nominate one or 

more individuals to serve as a nonvoting 

representative of the interests of the 

tobacco manufacturing industry. Under 

part 14 (21 CFR part 14), nominations 

must include a current re ́sume ́ or 

curriculum vitae for each nominee, 

including current business address and/ 

or home address, telephone number, 

and email address if available. 

Nominations must also specify the 

advisory committee for which the 

nominee is recommended and must 

acknowledge that the nominee is aware 

of the nomination unless selfnominated. The nomination should be 

sent to the FDA Advisory Committee 

Membership Nomination Portal (see 

ADDRESSES) within 30 days of 

publication of this document (see 

DATES). FDA will forward all 

nominations to the organizations 

expressing interest in participating in 

the selection process. (Persons who 

nominate themselves as nonvoting 

industry representatives will not 

participate in the selection process.) 

III. Selection Procedure 

The Agency is also seeking names of 

organizations to participate in the 

selection of the nonvoting 

representative of the interests of the 

tobacco manufacturing industry. Any 

industry organization interested in 

participating in the selection of an 

appropriate nonvoting member to 

represent industry interests should 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 30 days, FDA will send a 

letter to each organization that has 

expressed an interest in participating in 

the selection group, attaching a 

complete list of all organizations 

participating in selection; and a list of 

all non-voting nominees along with 

their current re ́sume ́s. The letter will 

also state that it is the responsibility of 

the interested organizations on the 

selection group to confer with one 

another and to select a candidate and an 

alternative as backup, within 60 days 

after the receipt of the FDA letter, to 

serve as the nonvoting member to 

represent industry interests for the 

TPSAC. 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. 

This notice is issued under the 

Federal Advisory Committee Act (5 

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

to advisory committees. 

Dated: September 6, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–19499 Filed 9–8–23; 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 From 

Industry Organizations Interested in 

Participating in the Selection Process 

for Nonvoting Industry 

Representatives and Request for 

Nominations for Nonvoting Industry 

Representatives on the Vaccines and 

Related Biological Products 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 nonvoting industry 

representatives to serve on the Vaccines 

and Related Biological Products 

Advisory Committee (VRBPAC) 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 VRBPAC. 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 October 11, 2023 (see sections 

I and II of this document for further 

details). Concurrently, nomination 

materials for prospective candidates 

should be sent to FDA by October 11, 

2023. 

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 

Sussan Paydar (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/ 

FACTRSPortal/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: 

Sussan Paydar or Valerie Vashio, Center 

for Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

1333, Silver Spring, MD 20993–0002, 

202–657–8533, email: CBERVRBPAC@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

Agency intends to add a nonvoting 

industry representative(s) to the 

following advisory committee: 

I. Vaccines and Related Biological 

Products Advisory Committee 

The Committee reviews and evaluates 

data concerning the safety, 

effectiveness, and appropriate use of 

vaccines and related biological products 

that are intended for use in the 

prevention, treatment, or diagnosis of 

human diseases, and as required, any 

other products for which the Food and 

Drug Administration has regulatory 

responsibility. 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 (the Commissioner). 

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 


ddrumheller on DSK120RN23PROD with NOTICES1