66010 Federal Register / Vol. 88, No. 185 / Tuesday, September 26, 2023 / Notices 

1See GFI #213, ‘‘New Animal Drugs and New 

Animal Drug Combination Products Administered 

in or on Medicated Feed or Drinking Water of FoodProducing Animals: Recommendations for Drug 

Sponsors for Voluntarily Aligning Product Use 

Conditions with GFI #209,’’ December 2013. 

(https://www.fda.gov/media/83488/download) 

2See GFI #263, ‘‘Recommendations for Sponsors 

of Medically Important Antimicrobial Drugs 

Approved for Use in Animals to Voluntarily Bring 

Under Veterinary Oversight All Products That 

Continue to be Available Over-the-Counter,’’ June 

2021. (https://www.fda.gov/media/130610/ 

download) 

3See FDA’s 5-year action plan entitled 

‘‘Supporting Antimicrobial Stewardship in 

Veterinary Settings: Goals for Fiscal Years 2019– 

2023.’’ (https://www.fda.gov/media/115776/ 

download) 4See Action item 1.1.2 of the 5-year plan. 

In response to recommendations 

made by FDA in GFI #213,1 as part of 

a strategy to address antimicrobial 

resistance associated with the use of 

antimicrobial drugs in animal 

agriculture, sponsors of all NADAs and 

ANADAs for antimicrobial drugs 

important to human medicine 

(medically important antimicrobial 

drugs) approved for use in or on the 

feed or in the drinking water of foodproducing animals worked with FDA 

over a 3-year period from 2013 to 2016 

to voluntarily withdraw approval of 

indications that were not considered 

necessary for ensuring animal health 

(production indications). In response to 

FDA recommendations made in GFI 

#263,2 sponsors also voluntarily worked 

with FDA to change the marketing 

status of all remaining approved uses of 

such new animal drugs from over-thecounter (OTC) to either by veterinary 

prescription (Rx) or by veterinary feed 

directive, as applicable. 

In September 2016, FDA announced 

that it intended to enter the next phase 

of its efforts to mitigate antimicrobial 

resistance by focusing on medically 

important antimicrobials used in animal 

feed or water that have at least one 

therapeutic indication without a defined 

duration of use. In a notice published in 

the Federal Register of September 14, 

2016 (81 FR 63187), the Agency 

requested comments from the public 

about how to establish appropriately 

targeted durations of use for therapeutic 

products within the scope of GFI #213 

with no currently defined duration of 

use. Public feedback received in 

response to that request for information 

was taken into consideration during 

subsequent development of a concept 

paper released in 2021. 

On September 14, 2018, FDA released 

a 5-year action plan for supporting 

antimicrobial stewardship in veterinary 

settings.3 This plan includes an action 

item intended ‘‘to ensure that all 

medically important antimicrobial drugs 

used in the feed or drinking water of 

food-producing animals have an 

appropriately targeted duration of 

use.’’ 4

In a notice published in the Federal 

Register of January 11, 2021 (86 FR 

1979), FDA requested comments from 

the public on a concept paper that 

outlined a potential framework for how 

sponsors of NADAs and ANADAs for 

products containing medically 

important antimicrobial drugs approved 

for use in or on the feed of foodproducing animals could voluntarily 

work with FDA to change the approved 

conditions of use of these drugs to 

establish appropriately defined 

durations of use for those indications 

that currently have an undefined 

duration of use. The concept paper 

generated invaluable public comment; 

FDA considered all information and 

feedback received on the concept paper 

as it developed this draft guidance. 

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 ‘‘Defining Durations 

of Use for Approved Medically 

Important Antimicrobial Drugs Fed to 

Food-Producing Animals.’’ 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 section 512(n)(1) of the 

Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 360b(n)(1)) have been 

approved under OMB control number 

0910–0669. The collections of 

information in 21 CFR part 514 have 

been approved under OMB control 

number 0910–0032. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at https:// 

www.fda.gov/animal-veterinary/ 

guidance-regulations/guidanceindustry, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents, or https://

www.regulations.gov. 

Dated: September 21, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–20920 Filed 9–25–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Document Identifier: OS–0990–0313–60D] 

Agency Information Collection 

Request; 60-Day Public Comment 

Request 

AGENCY: Office of the Secretary, HHS. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement of the Paperwork 

Reduction Act of 1995, the Office of the 

Secretary (OS), Department of Health 

and Human Services, is publishing the 

following summary of a proposed 

collection for public comment. 

DATES: Comments on the ICR must be 

received on or before November 27, 

2023. 

ADDRESSES: Submit your comments to 

Sherrette.Funn@hhs.gov or by calling 

(202) 264–0041 and PRA@HHS.GOV. 

FOR FURTHER INFORMATION CONTACT: 

When submitting comments or 

requesting information, please include 

the document identifier 0990–0313 and 

project title for reference, to Sherrette A. 

Funn, email: Sherrette.Funn@hhs.gov, 

PRA@HHS.GOV or call (202) 264–0041 

the Reports Clearance Officer. 

SUPPLEMENTARY INFORMATION: Interested 

persons are invited to send comments 

regarding this burden estimate or any 

other aspect of this collection of 

information, including any of the 

following subjects: (1) The necessity and 

utility of the proposed information 

collection for the proper performance of 

the agency’s functions; (2) the accuracy 

of the estimated burden; (3) ways to 

enhance the quality, utility, and clarity 

of the information to be collected; and 

(4) the use of automated collection 

techniques or other forms of information 

technology to minimize the information 

collection burden. 

Title of the Collection: National Blood 

Collection & Utilization Survey 

(NBCUS). 

Type of Collection: Revision. 

OMB No.: 0990–0313 Office of the 

Assistant Secretary for Health/HHS. 

Abstract: The Office of the Assistant 

Secretary for Health (OASH) is 

requesting approval for a three-year 

revised information collection request 

(ICR) titled ‘‘National Blood Collection 

& Utilization Survey (NBCUS).’’ The 

NBCUS is a biennial survey that 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 88, No. 185 / Tuesday, September 26, 2023 / Notices 66011 

includes a core of standard questions on 

blood collection, processing, and 

utilization practices. Questions on 

transfusion-transmitted infections, 

transfusion associated circulatory 

overload, acute hemolysis, delayed 

hemolysis, and severe allergic reactions 

are also included in the survey. The 

rapidly changing environment in blood 

supply and demand makes it important 

to have regular, periodic data describing 

the state of U.S. blood collections and 

transfusions for understanding the 

dynamics of blood safety and 

availability. In 2023, two sections were 

removed from the survey related to the 

impact of the COVID–19 pandemic on 

the blood supply during the course of 

2020. 

Survey respondents will consist of 

blood collection centers and hospitals 

that perform blood transfusions, except 

those reporting fewer than 100 inpatient 

surgeries per year. For the purposes of 

this ICR, federal burden is only being 

placed on facilities located within the 

fifty states and the District of Columbia. 

The total estimated burden is 5,106 

hours. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondent Number of 

respondents 

Number 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

hours 

Transfusing Hospitals ...................................................................................... 2754 1 1 hour, 46 min 4,865 

Hospital Blood Banks ...................................................................................... 83 1 1 hour, 46 min 147 

Community-based blood center ....................................................................... 53 1 1 hour, 46 min 94 

Total .......................................................................................................... 2,890 ........................ ........................ 5,106 

Sherrette A. Funn, 

Paperwork Reduction Act Reports Clearance 

Officer, Office of the Secretary. 

[FR Doc. 2023–20865 Filed 9–25–23; 8:45 am] 

BILLING CODE 4150–41–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Diabetes and 

Digestive and Kidney Diseases; 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 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Diabetes and Digestive and Kidney Diseases 

Initial Review Group; Diabetes, 

Endocrinology and Metabolic Diseases B 

Study Section Diabetes, Endocrinology and 

Metabolic Diseases B Study Section. 

Date: October 25–27, 2023. 

Time: 10:00 a.m. to 3:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, NIDDK 

Democracy II, Suite 7000A, 6707 Democracy 

Boulevard, Bethesda, MD 20892 (Virtual 

Meeting). 

Contact Person: Charlene J. Repique, Ph.D., 

Scientific Review Officer, NIDDK/Scientific 

Review Branch, National Institutes of Health, 

6707 Democracy Blvd., Room 7013, 

Bethesda, MD 20892, (301) 594–7791, 

charlene.repique@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.847, Diabetes, 

Endocrinology and Metabolic Research; 

93.848, Digestive Diseases and Nutrition 

Research; 93.849, Kidney Diseases, Urology 

and Hematology Research, National Institutes 

of Health, HHS) 

Dated: September 20, 2023. 

Miguelina Perez, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2023–20753 Filed 9–25–23; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; 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 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel; Genomics Centers for 

Infectious Diseases (U19 Clinical Trial Not 

Allowed). 

Date: October 24–25, 2023. 

Time: 10:00 a.m. to 4:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute of Allergy and 

Infectious Diseases, National Institutes of 

Health, 5601 Fishers Lane, Room 3F21B, 

Rockville, MD 20892 (Virtual Meeting). 

Contact Person: Maryam Feili-Hariri, 

Ph.D., Scientific Review Officer, Scientific 

Review Program, Division of Extramural 

Activities, National Institute of Allergy and 

Infectious Diseases, National Institutes of 

Health, 5601 Fishers Lane, Room 3F21B, 

Rockville, MD 20852, 240–669–5026, 

haririmf@niaid.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.855, Allergy, Immunology, 

and Transplantation Research; 93.856, 

Microbiology and Infectious Diseases 

Research, National Institutes of Health, HHS) 

Dated: September 20, 2023. 

Tyeshia M. Roberson-Curtis, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2023–20867 Filed 9–25–23; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Mental Health; 

Notice of Closed Meeting 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 


lotter on DSK11XQN23PROD with NOTICES1