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[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of an Infant Formula; Draft Guidance for Industry; Availability; Agency 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availability of a draft guidance for industry entitled ``Notifying FDA 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 The draft guidance, when finalized, is intended to help 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DATES: Submit either electronic or written comments on the draft 
guidance by February 18, 2025 to ensure that we consider your comment 
on this draft guidance before we begin work on the final version of the 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collection of information in the draft guidance by February 3, 2025.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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
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