[Federal Register Volume 89, Number 83 (Monday, April 29, 2024)]
[Notices]
[Pages 33368-33370]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-09156]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-D-1461]


Content and Format of Composition Statement and Corresponding 
Statement of Ingredients in Labeling in New Drug Applications and 
Abbreviated New Drug Applications; Draft Guidance for Industry; 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the availability of a draft guidance for industry entitled ``Content 
and Format of Composition Statements in NDAs and ANDAs and 
Corresponding Statement of Ingredients in Labeling.'' This guidance is 
intended to assist new drug application (NDA) and abbreviated new drug 
application (ANDA) applicants in submitting an accurate and complete 
composition statement in their applications and corresponding statement 
of ingredients in the labeling, when applicable. This guidance 
describes best practices for writing the composition statement and 
corresponding statement of ingredients in labeling. This guidance 
recommends how applicants can provide complete information with the 
goal of minimizing the number of assessment cycles and communications 
that are necessary for approval, as well as ensuring product labels are 
written clearly.

DATES: Submit either electronic or written comments on the draft 
guidance by June 28, 2024 to ensure that the Agency considers your 
comment on this

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draft guidance before it begins work on the final version of the 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-2024-D-1461 for ``Content and Format of Composition Statements in 
NDAs and ANDAs and Corresponding Statement of Ingredients in 
Labeling.'' 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: Rachel Erdman, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 75, Rm. 1715, 301-348-3984, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Content and Format of Composition Statements in NDAs and 
ANDAs and Corresponding Statement of Ingredients in Labeling.'' Section 
505(b)(1)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 
U.S.C. 355(b)(1)(A)) requires, among other things, that an NDA includes 
``a full list of the articles used as components of such drug'' and ``a 
full statement of the composition of such drug.'' Further, the 
regulations at Sec.  314.50(d)(1)(ii)(a) (21 CFR 314.50(d)(1)(ii)(a)) 
require NDA holders to provide a ``list of all components used in the 
manufacture of the drug product (regardless of whether they appear in 
the drug product) and a statement of the composition of the drug 
product . . .'' An ANDA applicant is also required to list all 
components used in the manufacture of the drug product and a statement 
of the composition of the drug product (Sec.  314.50(d)(1)(ii)(a)) and 
must also identify and characterize the inactive ingredients (21 CFR 
314.94(a)(9)(ii)).
    This guidance is intended to assist NDA and ANDA applicants in 
submitting an accurate and complete composition statement in their 
applications and corresponding statement of ingredients in labeling 
when applicable (21 CFR 201.100 requires labeling for certain drug 
products to include information on inactive ingredients). This guidance 
describes best practices for writing the composition statement and 
corresponding statement of ingredients in labeling. This guidance 
recommends how applicants can provide complete information with the 
goal of minimizing the number of assessment cycles and communications 
that are necessary for approval, as well as ensuring product labels are 
clear. This guidance includes examples of common, recurring problems 
identified during FDA's preliminary and substantive assessment of NDAs 
and ANDAs with respect to the content and format of the composition 
statement in NDAs and ANDAs and the corresponding statement of 
ingredients in labeling.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on ``Content and 
Format of Composition Statements in NDAs and ANDAs and Corresponding 
Statement of Ingredients in Labeling.'' It does not establish any 
rights for any person and is not binding on FDA or the public. You can 
use an

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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 
the Office of Management and Budget (OMB) under the Paperwork Reduction 
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information 
in 21 CFR part 314 relating to the submission of NDAs and ANDAs, as 
well as related postapproval submissions (including annual reports) and 
drug master files have been approved under OMB control number 0910-
0001. The collections of information in 21 CFR 201.56 and 201.57 
pertaining to the content and format requirements of labeling for 
prescription drug products have been approved under OMB control number 
0910-0572.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at 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: April 24, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-09156 Filed 4-26-24; 8:45 am]
BILLING CODE 4164-01-P