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the draft guidance.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
96264 Federal Register / Vol. 89, No. 233 / Wednesday, December 4, 2024 / Notices 

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– 

1993–D–0285 for ‘‘Evaluating Target 

Animal Safety and Effectiveness of 

Antibacterial New Animal Drugs for 

Bovine Mastitis.’’ 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 

its 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 Policy and 

Regulations Staff, Center for Veterinary 

Medicine, Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855. Send one selfaddressed adhesive label to assist that 

office in processing your requests. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the draft 

guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Paulette Salmon, Center for Veterinary 

Medicine, Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–402–6556, 

pauline.salmon@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft revised GFI #49 entitled 

‘‘Evaluating Target Animal Safety and 

Effectiveness of Antibacterial New 

Animal Drugs for Bovine Mastitis.’’ This 

draft guidance replaces final GFI #49, 

issued in April 1996 entitled ‘‘Target 

Animal Safety And Drug Effectiveness 

Studies for Anti-Microbial Bovine 

Mastitis Products (Lactating and NonLactating Cow Products).’’ This draft 

guidance provides recommendations 

and considerations for bovine mastitis 

drug products with antibacterial activity 

that are administered by intramammary 

infusion. However, this guidance may 

also be applicable to mastitis products 

administered by other routes or to 

products using other technologies 

(including those with non-antibacterial 

mechanisms of action). 

This level 1 draft guidance is being 

issued consistent with FDA’s good 

guidance practices regulation (21 CFR 

10.115). The draft guidance, when 

finalized, will represent the current 

thinking of FDA on ‘‘Evaluating Target 

Animal Safety and Effectiveness of 

Antibacterial New Animal Drugs for 

Bovine Mastitis.’’ 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. 

II. Paperwork Reduction Act of 1995 

While this guidance contains no 

collection of information, it does refer to 

previously approved FDA collections of 

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 21 CFR 514 have been 

approved under OMB control number 

0910–0032; 21 CFR 511.1 have been 

approved under OMB control number 

0910–0117. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at https:// 

www.fda.gov/AnimalVeterinary/ 

GuidanceComplianceEnforcement/ 

GuidanceforIndustry/default.htm, 

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

www.regulations.gov. 

Dated: November 25, 2024. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2024–28362 Filed 12–3–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meeting 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 


ddrumheller on DSK120RN23PROD with NOTICES1