[Federal Register Volume 87, Number 193 (Thursday, October 6, 2022)]
[Notices]
[Pages 60689-60691]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-21794]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-0814]


Infant Formula Transition Plan for Exercise of Enforcement 
Discretion: 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 we) is announcing the 
availability of a guidance for industry entitled ``Infant Formula 
Transition Plan for Exercise of Enforcement Discretion: Guidance for 
Industry.'' We are issuing this guidance document to protect public 
health by helping to stabilize the supply of infant formula in the 
United States and to maintain a consistent supply of a variety of 
infant formula products. Under the guidance, we intend to exercise 
enforcement discretion until January 6, 2023, for infant formula 
products that are listed in letters of enforcement discretion that FDA 
has issued or will issue to specific manufacturers, in response to 
information provided under our May 2022 ``Infant Formula Enforcement 
Discretion Policy: Guidance for Industry,'' which remains in effect 
until November 14, 2022. For those manufacturers that wish to continue 
to market specific products in the United States under enforcement 
discretion after January 6, 2023, the guidance further details 
additional steps that manufacturers can take toward lawful marketing of 
such products--and the timeline under which such steps should be 
taken--for FDA to consider the continued exercise of enforcement 
discretion. This guidance document will help infant formula 
manufacturers meet applicable regulatory requirements while ensuring 
that consumers have continued access to formulas that are currently 
fulfilling the needs of infants consuming such products. We are also 
announcing that a proposed collection of information has been submitted 
to the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995 (PRA). The proposed 
collection pertains to the submission of information necessary to 
facilitate FDA's exercise of enforcement discretion, as discussed in 
the guidance document.

DATES: Fax written comments on the collection of information by 
November 7, 2022. FDA is requesting immediate OMB approval of this 
emergency processing. The announcement of the guidance is published in 
the Federal Register on October 6, 2022.

ADDRESSES: You may submit either electronic or written comments on any 
Agency 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,

[[Page 60690]]

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-2022-D-0814 for ``Infant Formula Enforcement Discretion Policy: 
Guidance for Industry.'' 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 
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 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 guidance to the 
Office of Nutrition and Food Labeling, Center for Food Safety and 
Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., 
College Park, MD 20740. Send two self-addressed adhesive labels to 
assist that office in processing your request. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the guidance.

FOR FURTHER INFORMATION CONTACT: Claudine Kavanaugh, Center for Food 
Safety and Applied Nutrition, Office of Nutrition and Food Labeling 
(HFS-830), Food and Drug Administration, 5001 Campus Dr., College Park, 
MD 20740, 240-402-2373; or Philip L. Chao, Center for Food Safety and 
Applied Nutrition, Office of Regulations and Policy (HFS-024), Food and 
Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-
2378.

SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of a guidance for industry 
entitled ``Infant Formula Transition Plan for Exercise of Enforcement 
Discretion: Guidance for Industry.'' We issued the guidance consistent 
with our good guidance practices regulation (21 CFR 10.115). The 
guidance represents the current thinking of FDA on this topic. It does 
not establish any rights for any person and is not binding on FDA or 
the public. You can use an alternate approach if it satisfies the 
requirements of the applicable statutes and regulations.
    The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines infant 
formula as a food which purports to be or is represented for special 
dietary use solely as a food for infants by reason of its simulation of 
human milk or its suitability as a complete or partial substitute for 
human milk (section 201(z) of the FD&C Act (21 U.S.C. 321(z)). Our 
regulations define infants as persons not more than 12 months old (21 
CFR 105.3(e)). Among other requirements, section 412(c)(1)(B) of the 
FD&C Act (21 U.S.C. 350a(c)(1)(B)) and FDA regulations (21 CFR 106.120) 
require an infant formula manufacturer to submit notice (i.e., a new 
infant formula submission) to FDA at least 90 days before a new infant 
formula is introduced or delivered for introduction into interstate 
commerce.
    Infant formula is often used as the sole source of nutrition by a 
vulnerable population during a critical period of growth and 
development. In general, the laws and regulations that apply to food 
also apply to infant formula, but additional requirements that are 
specific to infant formula appear in section 412 of the FD&C Act and in 
our regulations at 21 CFR parts 106 and 107.
    The voluntary recall and facility shutdown conducted by Abbott 
Nutrition in 2022 created a supply disruption with respect to certain 
types of infant formula, which has been exacerbated by the overall 
strains on supply chains during the COVID-19 pandemic. As part of the 
Federal Government's response to the infant formula shortage, on May 
16, 2022, FDA issued the ``Infant Formula Enforcement Discretion 
Policy: Guidance for Industry'' (May 2022 Enforcement Discretion 
Guidance; available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-infant-formula-enforcement-discretion-policy) discussing our intent to consider, on a 
case-by-case basis, the temporary exercise of enforcement discretion 
for the introduction into interstate commerce of infant formula that 
may not meet certain statutory and regulatory requirements; the 
guidance remains in effect until November 14, 2022. The May 2022 
Enforcement Discretion Guidance describes the information that an 
infant formula manufacturer should provide to FDA if the manufacturer 
wishes to have FDA consider the exercise of enforcement discretion 
relating to the introduction

[[Page 60691]]

into interstate commerce (including importation) of infant formula that 
is safe and nutritionally adequate but that may not comply with all FDA 
statutory and regulatory requirements. Consistent with the policies 
described in the May 2022 Enforcement Discretion Guidance, certain 
manufacturers have submitted information to FDA to substantiate the 
safety and nutritional adequacy of specific infant formula products 
and, following FDA's thorough review of the information provided, are 
marketing such products under FDA's exercise of enforcement discretion.
    This guidance sets forth our current thinking on circumstances 
under which we intend to exercise temporary enforcement discretion for 
certain infant formula products beyond November 14, 2022, and to advise 
infant formula manufacturers marketing products in accordance with 
letters of enforcement discretion issued under the May 2022 Enforcement 
Discretion Guidance about: (1) the type of information to provide to 
FDA; and (2) our timing expectations related to such information, if 
they would like us to consider the continued exercise of enforcement 
discretion with respect to their products. This guidance document will 
remain in effect until October 18, 2025, and FDA expects that all 
infant formula products will comply with applicable U.S. requirements 
by the end of the enforcement discretion period.
    We issued this guidance without prior public comment under section 
701(h)(1)(C) of the FD&C Act (21 U.S.C. 371(h)(1)(C)) and 21 CFR 
10.115(g)(2) because we determined that prior public participation is 
not feasible or appropriate, as this guidance provides time-sensitive 
clarifications regarding FDA's intent to exercise enforcement 
discretion with respect to specific formula products that are currently 
fulfilling the needs of infants in the United States.
    As with all FDA guidance documents, the public may comment on the 
guidance at any time.

II. Electronic Access

    Persons with access to the internet may obtain the guidance at 
https://www.fda.gov/FoodGuidances or https://www.regulations.gov. Use 
the FDA website listed in the previous sentence to find the most 
current version of the guidance.

III. Paperwork Reduction Act of 1995

    FDA requested, and OMB has approved, emergency processing of this 
proposed collection of information under section 3507(j) of the PRA (44 
U.S.C. 3507(j) and 5 CFR 1320.13). Immediate implementation of the 
information collection is critical to providing predictability, 
stability, and continuity in the infant formula market, specifically 
with respect to those products currently available to infants in the 
Unites States under FDA's exercise of enforcement discretion. Because 
we believe that routine procedures, which allow for a 60-day comment 
period, would prevent our ability to immediately implement the 
information collection, we requested a waiver from the requirement to 
publish a 60-day notice for the information collection (see 5 CFR 
1320.13(a)(2)(iii)).
    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.
    We estimate the burden of the information collection as follows:

                             Table 1--Estimated One-Time Annual Reporting Burden \1\
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                                                     Number of
 Information collection activity     Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
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Submit information in accordance             115               1             115              24           2,760
 with timing and content
 schedule discussed in guidance
 document for both exempt and
 non-exempt infant formulas.....
Letter of Intent................              15               1              15               5              75
Plan to Meet Applicable Infant                15               1              15              90           1,350
 Formula Requirements...........
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    Total.......................  ..............  ..............  ..............  ..............           4,185
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Our estimate is based on submissions received in response to the 
May 2022 Enforcement Discretion Guidance, for which we account for 115 
respondents, each of whom submitted one request. We assume it requires 
an average of 24 hours to prepare each submission, and therefore 
calculate a total of 2,760 burden hours (115 requests x 24 hours). Of 
those 115 respondents, we have currently issued 12 letters of 
enforcement discretion but may issue additional letters through 
November 14, 2022. We therefore assume that a total of 15 respondents 
will initiate requesting enforcement discretion and final a letter of 
intent. We assume this requires an average of 5 hours to prepare, for a 
total of 75 burden hours (15 letters x 5 hours). We estimate these same 
15 respondents will then submit a compliance plan and assume each plan 
will require an average of 90 hours to prepare, for a total of 1,350 
burden hours (15 plans x 90 hours).

    Dated: September 30, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-21794 Filed 10-5-22; 8:45 am]
BILLING CODE 4164-01-P