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 Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2024-D-1334]
 AGENCY: Food and Drug Administration, HHS.
 ACTION: Notice of availability.
 SUMMARY: The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled “Notifying FDA of a Permanent Discontinuance in the Manufacture or an Interruption of the Manufacture of an Infant Formula.”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 The draft guidance, when finalized, is intended to help the infant formula industry comply with this notification requirement as it pertains to infant formula.
 DATES: Submit either electronic or written comments on the draft guidance by February 18, 2025 to ensure that we consider your comment on this draft guidance before we begin work on the final version of the guidance. Submit electronic or written comments on the proposed collection of information in the draft guidance by February 3, 2025.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 
                    ( print 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, 
                        *PRAStaff@fda.hhs.gov.*


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 (
                    *CriticalFoodShortage@fda.hhs.gov*). 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 
                    ( print 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
Activity; section 424(a)(1) of the FD&C Act
Number of
                             respondents
Number of
                             responses per 
                             respondent
Total annual
                             responses
Average
                             burden per 
                             response
Total hoursNotification of a permanent discontinuance or an interruption of the manufacture of a critical food
8
1
8
2
161
                         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 × 1 notification). Each submission will take an estimated 2 hours to complete for an annual reporting burden of 16 hours (8 notifications × 2 hours). Table 2—Estimated Annual Recordkeeping Burden 1
Activity; section 424(b) of the FD&C Act
Number of
                             respondents
Number of
                             responses per 
                             respondent
Total annual
                             responses
Average
                             burden per 
                             response
Total hoursRisk management plan
11
1
11
60
6601
                         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 × 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