
[Federal Register Volume 88, Number 174 (Monday, September 11, 2023)]
[Notices]
[Pages 62378-62379]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-19456]


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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Draft Guidance for Industry; Availability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.

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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the availability of a draft guidance for industry entitled ``Clinical 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this draft guidance, when finalized, is to assist industry in the 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DATES: Submit either electronic or written comments on the draft 
guidance by December 11, 2023 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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

[[Page 62379]]

Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20903, [email protected].

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/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-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


