62378 Federal Register / Vol. 88, No. 174 / Monday, September 11, 2023 / Notices 

afforded to the provider by the Medicaid 

State agency. Lastly, Medicaid State 

agencies must notify CMS when to 

terminate the withholding; Form 

Number: CMS–R–21 (OMB control 

number: 0938–0287); Frequency: 

Occasionally; Affected Public: State, 

local, or Tribal governments; Number of 

Respondents: 54; Total Annual 

Responses: 27; Total Annual Hours: 81. 

(For policy questions regarding this 

collection contact Stuart Goldstein at 

410–786–0694.) 

2. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: 1915(c) Home 

and Community-Based Services (HCBS) 

Waiver Application; Use: We use the 

application to review and adjudicate 

individual waiver actions. The 

application is also used by States to 

submit and revise their waiver requests. 

Form Number: CMS–8003 (OMB control 

number 0938–0449); Frequency: Yearly; 

Affected Public: State, local, or Tribal 

governments; Number of Respondents: 

47; Total Annual Responses: 71; Total 

Annual Hours: 6,005. (For policy 

questions regarding this collection 

contact Ryan Shannahan at 410–786– 

0295.) 

Dated: September 6, 2023. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2023–19500 Filed 9–8–23; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–D–3391] 

Clinical Pharmacology Considerations 

for Peptide Drug Products; Draft 

Guidance for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a draft 

guidance for industry entitled ‘‘Clinical 

Pharmacology Considerations for 

Peptide Drug Products.’’ This guidance 

describes FDA’s recommendations 

regarding clinical pharmacology 

considerations for peptide drug product 

development programs, including 

hepatic impairment, drug-drug 

interactions (DDIs), assessing QTc 

prolongation risk, and immunogenicity 

risk and impact on the 

pharmacokinetics (PK), safety, and 

efficacy assessment. The intent of this 

draft guidance, when finalized, is to 

assist industry in the conduct of these 

development programs. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by December 11, 2023 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance at any time as follows: 

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 

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– 

2023–D–3391 for ‘‘Clinical 

Pharmacology Considerations for 

Peptide Drug Products.’’ Received 

comments 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.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its 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. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002. Send one self-addressed adhesive 

label to assist that office in processing 

your requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Daphne Guinn, Center for Drug 


ddrumheller on DSK120RN23PROD with NOTICES1
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