Notice2024-09156
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and Corresponding Statement of Ingredients in Labeling in New Drug Applications and Abbreviated New Drug Applications; Draft Guidance for Industry; Availability
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Published
April 29, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Content and Format of Composition Statements in NDAs and ANDAs and Corresponding Statement of Ingredients in Labeling."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.
Full Text
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<title>Federal Register, Volume 89 Issue 83 (Monday, April 29, 2024)</title>
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[Federal Register Volume 89, Number 83 (Monday, April 29, 2024)]
[Notices]
[Pages 33368-33370]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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Abbreviated New Drug Applications; Draft Guidance for Industry;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the availability of a draft guidance for industry entitled ``Content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
[[Page 33369]]
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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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,
<a href="/cdn-cgi/l/email-protection#da88bbb9b2bfb6f49fa8beb7bbb49abcbebbf4b2b2a9f4bdb5ac"><span class="__cf_email__" data-cfemail="376556545f525b197245535a565977515356195f5f4419505841">[email protected]</span></a>.
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
[[Page 33370]]
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 <a href="https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs">https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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
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