[Federal Register Volume 89, Number 233 (Wednesday, December 4, 2024)]
[Notices]
[Pages 96261-96263]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-28230]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-D-1334]
Notifying the Food and Drug Administration of a Permanent
Discontinuance in the Manufacture or an Interruption of the Manufacture
of an Infant Formula; Draft Guidance for Industry; Availability; Agency
Information Collection Activities; Proposed Collection; Comment Request
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
availability of a draft guidance for industry entitled ``Notifying FDA
of a Permanent Discontinuance in the Manufacture or an Interruption of
the Manufacture of an Infant Formula.'' Under the Federal Food, Drug,
and Cosmetic Act (FD&C Act), a manufacturer of a critical food (which
includes infant formula) must notify FDA of a permanent discontinuance
or an interruption of the manufacture of a critical food that is likely
to lead to a meaningful disruption in the supply of the food in the
United States. The draft guidance, when finalized, is intended to help
the infant formula industry comply with this notification requirement
as it pertains to infant formula.
DATES: Submit either electronic or written comments on the draft
guidance by February 18, 2025 to ensure that we consider your comment
on this draft guidance before we begin work on the final version of the
guidance. Submit electronic or written comments on the proposed
collection of information in the draft guidance by February 3, 2025.
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-1334 for ``Notifying FDA of a Permanent Discontinuance in
the Manufacture or an Interruption of the Manufacture of an Infant
Formula.'' 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.'' We will review
this copy, including the claimed confidential information, in our
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
[[Page 96262]]
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 this draft guidance to
the Office of Nutrition and Food Labeling, Human Foods Program (HF-
305), Food and Drug Administration, 5001 Campus Dr., College Park, MD
20740. Send one self-addressed adhesive label to assist that office in
processing your request or include a Fax number to which the draft
guidance may be sent. See the SUPPLEMENTARY INFORMATION for electronic
access to the draft guidance.
FOR FURTHER INFORMATION CONTACT:
With regard to the draft guidance: Barbara Little, Office of
Policy, Regulations, and Information; Human Foods Program; Food and
Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-
8808.
With regard to the proposed collection of information: JonnaLynn
Capezzuto, Office of Operations, Food and Drug Administration, Three
White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD
20852, 301-796-3794, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Notifying FDA of a Permanent Discontinuance in the
Manufacture or an Interruption of the Manufacture of an Infant
Formula.'' We are issuing the draft guidance consistent with our good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on the
notification requirement in section 424 of the FD&C Act (21 U.S.C.
350m) as it pertains to infant formula. 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.
Section 424(a)(1) of the FD&C Act requires that a manufacturer of a
critical food notify FDA of a permanent discontinuance in the
manufacture or an interruption of the manufacture of such food that is
likely to lead to a meaningful disruption in the supply of such food in
the United States, and the reasons for such discontinuance or
interruption, as soon as practicable, but not later than 5 business
days after such discontinuance or such interruption. Section 201(ss) of
the FD&C Act (21 U.S.C. 321(ss)) defines a ``critical food'' as a food
that is (1) an infant formula or (2) a medical food as defined in
section 5(b)(3) of the Orphan Drug Act (21 U.S.C. 360ee(b)(3)). The
draft guidance discusses notification under section 424(a)(1) of the
FD&C Act as it pertains to infant formula. The guidance is informed by
FDA's recent experience involving manufacturer interruptions of these
products and our work to improve the resiliency of the infant formula
market. Although this guidance is specific to infant formula,
manufacturers of other types of critical foods are still required to
comply with section 424 of the FD&C Act.
The draft guidance provides FDA's interpretation of key terms used
in section 424(a) of the FD&C Act; discusses what section 424(a) of the
FD&C Act requires the notification to include, as well as information
that FDA recommends the notification include; and provides
recommendations on how manufacturers should notify FDA of a permanent
discontinuance or interruption.
II. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-
3521), Federal Agencies must obtain approval from the Office of
Management and Budget (OMB) for each collection of information they
conduct or sponsor. ``Collection of information'' is defined in 44
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or
requirements that members of the public submit reports, keep records,
or provide information to a third party. Section 3506(c)(2)(A) of the
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a
60-day notice in the Federal Register concerning each proposed
collection of information before submitting the collection to OMB for
approval. To comply with this requirement, FDA is publishing notice of
the proposed collection of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology. FDA invites
comment, in particular, on the accuracy of its estimate regarding the
number of notifications a manufacturer may be expected to submit per
year.
Infant Formula Requirements
OMB Control Number 0910-0256--Revision
Section 424(a)(1) of the FD&C Act requires a manufacturer of a
critical food to notify FDA of a permanent discontinuance or an
interruption of the manufacture of a critical food that is likely to
lead to a meaningful disruption in the supply of the food in the United
States. Section 201(ss) of the FD&C Act defines a ``critical food'' as
a food that is (1) an infant formula or (2) a medical food as defined
in section 5(b)(3) of the Orphan Drug Act. A manufacturer of a critical
food is required to notify FDA of a permanent discontinuance in the
manufacture or an interruption of the manufacture of such food that is
likely to lead to a meaningful disruption in the supply of such food in
the United States, and the reasons for such discontinuance or
interruption, as soon as practicable, but not later than 5 business
days after such discontinuance or such interruption. To help facilitate
the process, FDA accepts notifications via email
([email protected]).
The draft guidance entitled ``Notifying FDA of a Permanent
Discontinuance in the Manufacture or an Interruption of the Manufacture
of an Infant Formula,'' when finalized, will provide FDA's
interpretation regarding the circumstances under which infant formula
manufacturers should notify FDA. The draft guidance provides
recommendations for notifications to
[[Page 96263]]
include certain information and how respondents should notify FDA of a
permanent discontinuance or interruption of supply of infant formula.
Section 424(b) of the FD&C Act requires a manufacturer of a
critical food to develop, maintain, and implement a redundancy risk
management plan that identifies and evaluates risks to the supply of
the food for each establishment in which a critical food is
manufactured. A risk management plan may identify and evaluate risks to
the supply of more than one critical food manufactured at the same
establishment. A risk management plan may also identify mechanisms by
which the manufacturer would mitigate the impacts of a supply
disruption through alternative production sites, alternative suppliers,
stockpiling of inventory, or other means. Records of a risk management
plan are subject to FDA inspection and copying.
Description of Respondents: Respondents to this information
collection are manufacturers of critical foods.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Activity; section 424(a)(1) of the FD&C Act Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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Notification of a permanent discontinuance or an interruption of 8 1 8 2 16
the manufacture of a critical food................................
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
The estimates in table 1 are based on our experience with similar
notification programs. We estimate that each year 5 manufacturers of
infant formula will submit notifications in compliance with section
424(a)(1) of the FD&C Act and following recommendations found in the
draft guidance. We also estimate that each year 3 manufacturers of
medical foods will submit notifications in compliance with section
424(a)(1) of the FD&C Act, for a total of 8 manufacturers of a critical
food. We estimate that each manufacturer will submit 1 notification for
8 total annual notifications (8 manufacturers x 1 notification). Each
submission will take an estimated 2 hours to complete for an annual
reporting burden of 16 hours (8 notifications x 2 hours).
Table 2--Estimated Annual Recordkeeping Burden \1\
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Number of
Activity; section 424(b) of the FD&C Act Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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Risk management plan............................................... 11 1 11 60 660
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
The estimates in table 2 are based on our experience with similar
risk management programs. We estimate that each year 11 manufacturers
of critical foods will create and maintain a risk management plan in
compliance with section 424(b) of the FD&C Act. We estimate that each
risk management plan will take an estimated 60 hours to create and
maintain for an annual recordkeeping burden of 660 hours (11 records x
60 hours).
III. Electronic Access
Persons with access to the internet may obtain an electronic
version of the draft guidance at https://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/guidance-documents-regulatory-information-topic-food-and-dietary-supplements, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.
Dated: November 26, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024-28230 Filed 12-2-24; 11:15 am]
BILLING CODE 4164-01-P