Federal Register / Vol. 89, No. 233 / Wednesday, December 4, 2024 / Notices 96261 

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 the following table have 

been approved by OMB: 

21 CFR part; guidance; or FDA form Topic OMB control No. 

807, subpart E ......................................................................... Premarket notification .............................................................. 0910–0120 

814, subparts A through E ...................................................... Premarket approval ................................................................. 0910–0231 

860, subpart D ......................................................................... De Novo classification process ............................................... 0910–0844 

‘‘Requests for Feedback and Meetings for Medical Device 

Submissions: The Q-Submission Program’’.

Q-submissions and Early Payor Feedback Request Programs for Medical Devices.0910–0756 

800, 801, 809, and 830 ........................................................... Medical Device Labeling Regulations; Unique Device Identification.0910–0485 

820 ........................................................................................... Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation.0910–0073 

822 ........................................................................................... Postmarket Surveillance of Medical Devices .......................... 0910–0449 

50, 56 ....................................................................................... Protection of Human Subjects and Institutional Review 

Boards.

0910–0130 

58 ............................................................................................. Good Laboratory Practice (GLP) Regulations for Nonclinical 

Laboratory Studies.

0910–0119 

Dated: November 25, 2024. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2024–28361 Filed 12–3–24; 8:45 am] 

BILLING CODE 4164–01–P 

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an Infant Formula; Draft Guidance for 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. 

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 


ddrumheller on DSK120RN23PROD with NOTICES1
96262 Federal Register / Vol. 89, No. 233 / Wednesday, December 4, 2024 / Notices 

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 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 89, No. 233 / Wednesday, December 4, 2024 / Notices 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 hours 

Notification of a permanent discontinuance or an interruption of the manufacture of a critical food ......................... 8 1 8 2 16 

1There 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 hours 

Risk management plan ........................................................ 11 1 11 60 660 

1There 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-anddietary-supplements/guidancedocuments-regulatory-informationtopic-food-and-dietary-supplements, 

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments, 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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–1993–D–0285] 

Evaluating Target Animal Safety and 

Effectiveness of Antibacterial New 

Animal Drugs for Bovine Mastitis; Draft 

Guidance for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a draft 

revised guidance for industry (GFI) #49 

entitled ‘‘Evaluating Target Animal 

Safety and Effectiveness of Antibacterial 

New Animal Drugs for Bovine Mastitis.’’ 

This draft guidance provides 

recommendations and considerations 

for bovine mastitis drug products with 

antibacterial activity that are 

administered by intramammary 

infusion. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by February 3, 2025 to ensure that the 

Agency considers your comment on this 

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 

• 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, 


ddrumheller on DSK120RN23PROD with NOTICES1