Federal Register / Vol. 89, No. 180 / Tuesday, September 17, 2024 / Notices 76117 

Accreditation Commission for Health 

Care, Incorporated’s (ACHC’s) term of 

approval for their HHA accreditation 

program expires February 24, 2025. 

II. Approval of Deeming Organizations 

Section 1865(a)(2) of the Act and our 

regulations at § 488.5 require that our 

findings concerning review and 

approval of a national accrediting 

organization’s requirements consider, 

among other factors, the applying 

accrediting organization’s requirements 

for accreditation; survey procedures; 

resources for conducting required 

surveys; capacity to furnish information 

for use in enforcement activities; 

monitoring procedures for provider 

entities found not in compliance with 

the conditions or requirements; and 

ability to provide us with the necessary 

data for validation. 

Section 1865(a)(3)(A) of the Act 

further requires that we publish, within 

60 days of receipt of an organization’s 

complete application, a notice 

identifying the national accrediting 

body making the request, a description 

of the nature of the request, and 

provision of at least a 30-day public 

comment period. We have 210 days 

from the receipt of a complete 

application to publish notice of 

approval or denial of the application. 

The purpose of this proposed notice 

is to inform the public of ACHC’s 

request for continued CMS approval of 

its HHA accreditation program. This 

notice also solicits public comment on 

whether ACHC’s requirements meet or 

exceed the Medicare conditions of 

participation (CoPs) for HHAs. 

III. Evaluation of Deeming Authority 

Request 

ACHC submitted all the necessary 

materials to enable us to make a 

determination concerning its request for 

continued approval of its HHA 

accreditation program. This application 

was determined to be complete on July 

29, 2024. Under section 1865(a)(2) of the 

Act and our regulations at § 488.5 

(Application and re-application 

procedures for national accrediting 

organizations), our review and 

evaluation of ACHC will be conducted 

in accordance with, but not necessarily 

limited to, the following factors: 

• The equivalency of ACHC’s 

standards for HHAs as compared with 

CMS’ HHA CoPs. 

• ACHC’s survey process to 

determine the following: 

++ The composition of the survey 

team, surveyor qualifications, and the 

ability of the organization to provide 

continuing surveyor training. 

++ The comparability of ACHC’s 

processes to those of state agencies, 

including survey frequency, and the 

ability to investigate and respond 

appropriately to complaints against 

accredited HHAs. 

++ ACHC’s processes and procedures 

for monitoring HHAs found out of 

compliance with ACHC’s program 

requirements. These monitoring 

procedures are used only when ACHC 

identifies noncompliance. If 

noncompliance is identified through 

validation reviews or complaint 

surveys, the state survey agency 

monitors corrections as specified at 

§ 488.9(c). 

++ ACHC’s capacity to report 

deficiencies to the surveyed HHAs and 

respond to the HHA’s plan of correction 

in a timely manner. 

++ ACHC’s capacity to provide us 

with electronic data and reports 

necessary for effective validation and 

assessment of the organization’s survey 

process. 

++ The adequacy of ACHC’s staff and 

other resources, and its financial 

viability. 

++ ACHC’s capacity to adequately 

fund required surveys. 

++ ACHC’s policies with respect to 

whether surveys are announced or 

unannounced, to ensure that surveys are 

unannounced. 

++ ACHC’s policies and procedures 

to avoid conflicts of interest, including 

the appearance of conflicts of interest, 

involving individuals who conduct 

surveys or participate in accreditation 

decisions. 

++ ACHC’s agreement to provide us 

with a copy of the most current 

accreditation survey together with any 

other information related to the survey 

as we may require (including corrective 

action plans). 

IV. Collection of Information 

Requirements 

This document does not impose 

information collection requirements, 

that is reporting, recordkeeping or thirdparty disclosure requirements. 

Consequently, there is no need for 

review by the Office Management and 

Budget under the authority of the 

Paperwork Reduction Act of 1995 (44 

U.S.C. chapter 35). 

V. Response to Comments 

Because of the large number of public 

comments we normally receive on 

Federal Register documents, we are not 

able to acknowledge or respond to them 

individually. We will consider all 

comments we receive by the date and 

time specified in the DATES section of 

this notice. Upon completion of our 

evaluation, including evaluation of 

comments received because of this 

notice, we will publish a final notice in 

the Federal Register summarizing our 

response to comments and announcing 

the result of our evaluation. 

The Administrator of the Centers for 

Medicare & Medicaid Services (CMS), 

Chiquita Brooks-LaSure, having 

reviewed and approved this document, 

authorizes Chyana Woodyard, who is 

the Federal Register Liaison, to 

electronically sign this document for 

purposes of publication in the Federal 

Register. 

Chyana Woodyard, 

Federal Register Liaison, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2024–21014 Filed 9–16–24; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–D–1492] 

Chemistry, Manufacturing, and 

Controls Technical Section Filing 

Strategies; 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 

guidance for industry (GFI) #227 

entitled ‘‘Chemistry, Manufacturing, 

and Controls (CMC) Technical Section 

Filing Strategies.’’ This draft guidance 

provides recommendations to sponsors 

submitting CMC data submissions to 

new animal drug applications. This 

guidance describes the options for 

soliciting early input from the Center for 

Veterinary Medicine (CVM) and the 

process for submission of components 

of the CMC technical section. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by November 18, 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, 


ddrumheller on DSK120RN23PROD with NOTICES1
76118 Federal Register / Vol. 89, No. 180 / Tuesday, September 17, 2024 / Notices 

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– 

2014–D–1492 for ‘‘Chemistry, 

Manufacturing, and Controls (CMC) 

Technical Section Filing Strategies.’’ 

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 (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 draft 

guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Heather Longstaff, Center for Veterinary 

Medicine (HFV–147), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville MD 20855, 240–402–0651, 

Heather.Longstaff@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

draft GFI #227 entitled ‘‘Chemistry, 

Manufacturing, and Controls (CMC) 

Technical Section Filing Strategies.’’ 

This guidance provides 

recommendations to sponsors 

submitting CMC data submissions to 

new animal drug applications. This 

draft guidance replaces final GFI #227, 

issued September 2015, entitled ‘‘TwoPhased Chemistry, Manufacturing, and 

Controls (CMC) Technical Sections.’’ 

There are several mechanisms to 

receive input from CVM prior to 

submission of the CMC technical 

section, as well as various approaches to 

submitting the CMC technical section 

itself. For review efficiency, CVM 

prefers that full CMC information be 

provided in a single technical section 

submission. 

However, there may be instances 

when submission of the individual 

components of the technical section 

(drug product, drug substance, and 

facility sterile process validation 

information for sterile drug products) 

could reduce the overall time to 

complete a technical section, and 

therefore drug approval. This guidance 

describes the options for soliciting early 

input from CVM and the process for 

submission of components of the CMC 

technical section. 

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 ‘‘Chemistry, 

Manufacturing, and Controls (CMC) 

Technical Section Filing Strategies.’’ 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 

numbers 0910–0032; the collections of 

information in 21 CFR 511.1 have been 

approved under OMB control number 

0910–0117; and the collections of 

information in sections 512(b) and 

512(n) of the Federal Food, Drug, and 

Cosmetic Act have been approved under 

OMB control number 0910–0669. 

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. 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 89, No. 180 / Tuesday, September 17, 2024 / Notices 76119 

Dated: September 10, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–20924 Filed 9–16–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–3924] 

Digital Health Advisory Committee; 

Notice of Meeting; Establishment of a 

Public Docket; Request for 

Comments—Total Product Lifecycle 

Considerations for Generative Artificial 

Intelligence-Enabled Medical Devices 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; establishment of a 

public docket; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) announces a 

forthcoming public advisory committee 

meeting of the Digital Health Advisory 

Committee (the Committee). The general 

function of the Committee is to provide 

advice and recommendations to FDA on 

regulatory issues. The Committee will 

discuss total product lifecycle 

considerations for Generative Artificial 

Intelligence (AI)-enabled devices. The 

meeting will be open to the public. FDA 

is establishing a docket for public 

comment on this topic. 

DATES: The meeting will be held on 

November 20–21, 2024, from 9 a.m. to 

6 p.m. eastern time. 

ADDRESSES: Holiday Inn Gaithersburg, 

Two Montgomery Village Ave., 

Gaithersburg, MD 20879. The hotel’s 

telephone number is 301–948–8900. 

The hotel’s link can be found at: https:// 

www.ihg.com/holidayinn/hotels/us/en/ 

gaithersburg/wasrv/hoteldetail. Answers 

to commonly asked questions including 

information regarding special 

accommodations due to a disability, 

visitor parking, and transportation may 

be accessed at: https://www.fda.gov/ 

AdvisoryCommittees/AboutAdvisory

Committees/ucm408555.htm. 

FDA is establishing a docket for 

public comment on this meeting. The 

docket number is FDA–2024–N–3924. 

The docket will close on January 21, 

2025. Please note that late, untimely 

filed comments will not be considered. 

The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of January 21, 2025. 

Comments received by mail/hand 

delivery/courier (for written/paper 

submissions) will be considered timely 

if they are received on or before that 

date. 

Comments received on or before 

November 1, 2024, will be provided to 

the Committee. Comments received after 

that date will be taken into 

consideration by FDA. In the event that 

the meeting is canceled, FDA will 

continue to evaluate any relevant 

applications or information, and 

consider any comments submitted to the 

docket, as appropriate. 

You may submit comments 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–N–3924 for ‘‘Digital Health 

Advisory Committee; Notice of Meeting; 

Establishment of a Public Docket; 

Request for Comments.’’ Received 

comments, those filed in a timely 

manner (see ADDRESSES), 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.’’ FDA 

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 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 the 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. 

FOR FURTHER INFORMATION CONTACT: 

James Swink, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5221, Silver Spring, 

MD 20993–0002, 301–796–6313, 

James.Swink@fda.hhs.gov, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area). A notice in the 

Federal Register about last-minute 

modifications that impact a previously 


ddrumheller on DSK120RN23PROD with NOTICES1