Federal Register / Vol. 88, No. 245 / Friday, December 22, 2023 / Notices 88635 

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 (HFV–6), 

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 guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Dorothy Bailey, Center for Veterinary 

Medicine (HFV–50), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–402–0565, 

dorothy.bailey@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of July 15, 

2020 (85 FR 42876), FDA published the 

notice of availability for draft GFI #61 

entitled ‘‘Special Considerations, 

Incentives, and Programs to Support the 

Approval of New Animal Drugs for 

Minor Uses and for Minor Species’’ 

giving interested persons until 

November 12, 2020, to comment on the 

draft guidance. In response to a request 

for an extension, the comment period 

was extended to January 11, 2021 (85 FR 

71659). FDA received 14 comments on 

the draft guidance and those comments 

were considered as the guidance was 

finalized. Changes to the final guidance 

include the following: 

• In our draft guidance we referred to 

Minor Use Determinations. Our 

experience has shown that our 

stakeholders frequently confuse 

‘‘MUMS Determination’’ with ‘‘MUMS 

Designation.’’ Therefore, the final 

guidance substitutes the word 

‘‘Assessment’’ for the word 

‘‘Determination.’’ 

• Section XII.C.3.a.i. ‘‘Anthelmintics 

and Ectoparasiticides for Terrestrial 

Minor Species’’ has been added to the 

final guidance in response to comments 

received requesting additional detail on 

this subject. This section also references 

the relevant ‘‘International Cooperation 

on Harmonisation of Technical 

Requirements for Registration of 

Veterinary Medicinal Products (VICH)’’ 

guidance. 

• CVM received many comments 

pertaining to aquaculture species 

grouping. Due to the complexity of this 

topic, CVM has removed examples of 

aquaculture species groupings in the 

final guidance. We continue to consider 

this topic and intend to work with 

individual drug sponsors wishing to use 

species groupings for new animal drug 

approvals to identify an appropriate 

species grouping strategy and 

subsequent data needs for specific 

projects. 

In addition, editorial changes were 

made to improve clarity. The guidance 

announced in this notice finalizes the 

draft guidance dated July 2020. 

This level 1 guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on ‘‘Special 

Considerations, Incentives, and 

Programs to Support the Approval of 

New Animal Drugs for Minor Uses and 

for Minor Species.’’ 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 part 511 have 

been approved under OMB control 

number 0910–0117; the collections of 

information in 21 CFR part 514 have 

been approved under OMB control 

numbers 0910–0032 and 0910–0284; 

and the collections of information in 21 

CFR part 516 have been approved under 

OMB control numbers 0910–0605. 

III. Electronic Access 

Persons with access to the internet 

may obtain the 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: December 19, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–28287 Filed 12–21–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2023–N–1157; FDA– 

2022–D–0109; FDA–2020–N–0908; FDA– 

2022–D–0814; FDA–2022–D–0745; FDA– 

2023–N–1006; FDA–2023–N–1053; FDA– 

2023–N–2286; FDA–2023–N–1661; FDA– 

2013–N–1119; FDA–2023–N–2986; FDA– 

2009–N–0582; FDA–2023–N–1272; FDA– 

2023–N–2030; FDA–2023–N–1189] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approvals 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is publishing a 

list of information collections that have 

been approved by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995. 

FOR FURTHER INFORMATION CONTACT: 

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: The 

following is a list of FDA information 

collections recently approved by OMB 

under section 3507 of the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3507). 


ddrumheller on DSK120RN23PROD with NOTICES1
88636 Federal Register / Vol. 88, No. 245 / Friday, December 22, 2023 / Notices 

The OMB control number and 

expiration date of OMB approval for 

each information collection are shown 

in table 1. Copies of the supporting 

statements for the information 

collections are available on the internet 

at https://www.reginfo.gov/public/do/ 

PRAMain. An Agency may not conduct 

or sponsor, and a person is not required 

to respond to, a collection of 

information unless it displays a 

currently valid OMB control number. 

TABLE 1.—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB 

Title of collection OMB control 

No. 

Date approval 

expires 

Generic Clearance for Qualitative Data to Support Social and Behavioral Research for Food, Dietary Supplements, Cosmetics, and Animal Food and Feed .................................................................................................. 0910–0891 9/30/2026 

Medical Devices—Voluntary Improvement Program ............................................................................................... 0910–0922 9/30/2026 

Submission of Petitions: Food Additive, Color Additive (Including Labeling), Submission of Information to a 

Master File in Support of Petitions, and Electronic Submission Using FDA Form 3503 .................................... 0910–0016 10/31/2026 

Infant Formula Requirements .................................................................................................................................. 0910–0256 10/31/2026 

Biologics License Applications; Procedures & Requirements ................................................................................. 0910–0338 10/31/2026 

Medical Devices; Reports of Corrections and Removals ........................................................................................ 0910–0359 10/31/2026 

Customer/Partner Satisfaction Service Surveys ..................................................................................................... 0910–0360 10/31/2026 

Voluntary National Retail Food Regulatory Program Standards ............................................................................ 0910–0621 10/31/2026 

Expanded Access to Investigational Drugs for Treatment Use .............................................................................. 0910–0814 10/31/2026 

Food Canning Establishment Registration, Process Filing and Recordkeeping for Acidified and Thermally Processed Low-Acid Foods ......................................................................................................................................... 0910–0037 11/30/2026 

Color Additive Certification ...................................................................................................................................... 0910–0216 11/30/2026 

Reporting and Recordkeeping Requirements for Reportable Food ........................................................................ 0910–0643 11/30/2026 

Prescription Drug Advertisements; Presentation of Advertisements in Television and Radio ............................... 0910–0686 11/30/2026 

Submission to CDRH Allegations of Regulatory Misconduct Associated with Medical Devices ............................ 0910–0769 11/30/2026 

Importation of Prescription Drugs ............................................................................................................................ 0910–0888 11/30/2026 

Dated: December 19, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–28290 Filed 12–21–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Document Identifier: OS–0990–new] 

Agency Father Generic 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, 

Improving Customer Experience (OMB 

Circular A–11, Section 280 

Implementation). 

DATES: Comments on the ICR must be 

received on or before February 20, 2024. 

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-New-60D 

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: Improving 

Customer Experience (OMB Circular A– 

11, Section 280. 

Type of Collection: Father Generic 

ICR. 

OMB No.: 0990–XXXX, Office within 

Office of the Secretary, Assistant 

Secretary Administration. 

Abstract: The Department of Health 

and Human Services, Office of the 

Secretary, Assistant Secretary 

Administration is requesting approval 

by OMB on a new Father Generic 

Information Collection Request. OMB 

Circular A–11 Section 280 established 

government-wide standards for mature 

customer experience organizations in 

government and measurement. To 

enable Federal programs to deliver the 

experience taxpayers deserve, they must 

undertake three general categories of 

activities: conduct ongoing customer 

research, gather and share customer 

feedback, and test services and digital 

products. 

These data collection efforts may be 

either qualitative or quantitative in 

nature or may consist of mixed 

methods. Additionally, data may be 

collected via a variety of means, 

including but not limited to electronic 

or social media, direct or indirect 

observation (i.e., in person, video and 

audio collections), interviews, 

questionnaires, surveys, and focus 

groups. HHS will limit its inquiries to 

data collections that solicit strictly 

voluntary opinions or responses. Steps 

will be taken to ensure anonymity of 

respondents in each activity covered by 

this request. 

The results of the data collected will 

be used to improve the delivery of 

Federal services and programs. It will 

include the creation of personas, 

customer journey maps, and reports and 

summaries of customer feedback data 

and user insights. It will also provide 

government-wide data on customer 

experience that can be displayed on 

performance.gov to help build 

transparency and accountability of 

Federal programs to the customers they 

serve. 

Implementation). 


ddrumheller on DSK120RN23PROD with NOTICES1