79614 Federal Register / Vol. 89, No. 189 / Monday, September 30, 2024 / Notices 

FOR FURTHER INFORMATION CONTACT: 

William Parham at (410) 786–4669. 

SUPPLEMENTARY INFORMATION: Under the 

Paperwork Reduction Act of 1995 (PRA) 

(44 U.S.C. 3501–3520), federal agencies 

must obtain approval from the Office of 

Management and Budget (OMB) for each 

collection of information they conduct 

or sponsor. The term ‘‘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 publish a 30-day notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension or 

reinstatement of an existing collection 

of information, before submitting the 

collection to OMB for approval. To 

comply with this requirement, CMS is 

publishing this notice that summarizes 

the following proposed collection(s) of 

information for public comment: 

1. Title of Information Collection: 

Program Integrity II; Type of 

Information Collection Request: 

Extension without change of a currently 

approved collection; Use: On March 23, 

2010, the Patient Protection and 

Affordable Care Act (PPACA; Pub. L. 

111–148) was signed into law and on 

March 30, 2010, the Health Care and 

Education Reconciliation Act of 2010 

(Pub. L. 111–152) was signed into law. 

The two laws implement various health 

insurance policies. On June 19, 2013, 

the Department of Health and Human 

Services (HHS) published proposed rule 

CMS–9957–P: Program Integrity: 

Exchanges, SHOP, Premium 

Stabilization Programs, and Market 

Standards (78 FR 37302) (Program 

Integrity Proposed Rule) which, among 

other things, contained third party 

disclosure requirements and data 

collections that supported the oversight 

of premium stabilization programs, 

State Exchanges, and qualified health 

plan (QHP) issuers in Federallyfacilitated Exchanges (FFEs). Parts of the 

proposed rule were finalized as Patient 

Protection and Affordable Care Act; 

Program Integrity: Exchange, Premium 

Stabilization Programs, and Market 

Standards; Amendments to the HHS 

Notice of Benefit and Payment 

Parameters for 2014; Final Rule 

(Program Integrity Final Rule II), 78 FR 

25326 (October 24, 2013). This 

information collection request relates to 

a portion of the information collection 

requirements set forth in the final rule. 

Form Number: CMS–10516 (OMB 

control number: 0938–1277); Frequency: 

Annually; Affected Public: Private 

Sector, State, Local, or Tribal 

Governments; Business or other forprofits, and Not-for Profits; Number of 

Respondents: 457; Number of 

Responses: 457; Total Annual Hours: 

42,771. (For questions regarding this 

collection, contact Andrea Honig at 

(301) 492–4147.) 

William N. Parham, III, 

Director, Division of Information Collections 

and Regulatory Impacts, Office of Strategic 

Operations and Regulatory Affairs. 

[FR Doc. 2024–22345 Filed 9–27–24; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2000–D–0598] 

International Cooperation on 

Harmonisation of Technical 

Requirements for Registration of 

Veterinary Medicinal Products; Studies 

To Evaluate the Safety of Residues of 

Veterinary Drugs in Human Food: 

Genotoxicity Testing (Revision 2); 

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) #116 

(VICH GL23) entitled ‘‘Studies to 

Evaluate the Safety of Residues of 

Veterinary Drugs in Human Food: 

Genotoxicity Testing (Revision 2).’’ This 

draft guidance has been developed for 

veterinary use by the International 

Cooperation on Harmonisation of 

Technical Requirements for Registration 

of Veterinary Medicinal Products 

(VICH). This draft guidance 

recommends a Standard Battery of Tests 

that can be used for the evaluation of 

the genotoxicity of veterinary drug 

residues in food. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by November 29, 2024 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, 

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– 

2000–D–0598 for ‘‘Studies to Evaluate 

the Safety of Residues of Veterinary 

Drugs in Human Food: Genotoxicity 

Testing (Revision 2).’’ 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 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 89, No. 189 / Monday, September 30, 2024 / Notices 79615 

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: Li 

You, Center for Veterinary Medicine, 

Food and Drug Administration, 7500 

Standish Pl., Rockville, MD 20855, 240– 

402–0828, Li.You@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft GFI #116 (VICH GL23) entitled 

‘‘Studies to Evaluate the Safety of 

Residues of Veterinary Drugs in Human 

Food: Genotoxicity Testing (Revision 

2).’’ This draft revised guidance 

recommends a Standard Battery of Tests 

that can be used for the evaluation of 

the genotoxicity of veterinary drug 

residues. The Standard Battery of Tests 

intends to achieve reasonable 

confidence in the assessment of the 

genotoxicity potential of veterinary drug 

residues and to be in harmony with the 

requirements of International Council 

for Harmonisation of Technical 

Requirements for Pharmaceuticals for 

Human Use for testing human drugs for 

genotoxicity. This draft guidance also 

advises on modifications to the 

Standard Battery of Tests and on 

interpretation of test results. The 

objective of this guidance is to ensure 

international harmonization of 

genotoxicity testing of veterinary drug 

residues. 

FDA has participated in efforts to 

enhance harmonization and is 

committed to seeking scientifically 

based harmonized technical procedures 

for pharmaceutical development. One of 

the goals of harmonization is to identify, 

and then reduce, differences in 

technical requirements for drug 

development among regulatory agencies 

in different countries. FDA has actively 

participated in the International 

Conference on Harmonization of 

Technical Requirements for Approval of 

Pharmaceuticals for Human Use to 

develop harmonized technical 

requirements for the approval of human 

pharmaceutical and biological products 

among the European Union, Japan, and 

the United States. The VICH is a parallel 

initiative for veterinary medicinal 

products. The goal of the VICH is to 

develop harmonized technical 

requirements for the approval of 

veterinary medicinal products in the 

European Union, Japan, and the United 

States, and receives input from both 

regulatory and industry representatives. 

The VICH Steering Committee is 

composed of member representatives 

from the European Commission and 

European Medicines Agency; 

AnimalhealthEurope; FDA—Center for 

Veterinary Medicine and U.S. 

Department of Agriculture—Center for 

Veterinary Biologics; the U.S. Animal 

Health Institute; the Japanese Ministry 

of Agriculture, Forestry and Fisheries; 

and the Japanese Veterinary Products 

Association. There are 10 observers to 

the VICH Steering Committee: 1 

representative from government and 1 

representative from industry of 

Australia, New Zealand, Canada, South 

Africa, and the United Kingdom. The 

World Organisation for Animal Health 

is an associate member of the VICH. The 

VICH Secretariat, which coordinates the 

preparation of documentation, is 

provided by HealthforAnimals. 

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 ‘‘Studies to Evaluate 

the Safety of Residues of Veterinary 

Drugs in Human Food: Genotoxicity 

Testing (Revision 2).’’ 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 514 have 

been approved under OMB control 

number 0910–0032. The collections of 

information in 21 CFR part 511 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: September 24, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–22301 Filed 9–27–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–D–4168; FDA–2024– 

D–4169; FDA–2024–D–4170; and FDA– 

2024–D–4171] 

Safety and Performance Based 

Pathway Device-Specific Guidances; 

Guidance for Industry and Food and 

Drug Administration Staff; 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 four final 

device-specific guidance documents for 

the Safety and Performance Based 

Pathway—specifically, ‘‘Air Powered 

Dental Handpieces and Air Motors— 

Performance Criteria for Safety and 


ddrumheller on DSK120RN23PROD with NOTICES1