Federal Register / Vol. 89, No. 211 / Thursday, October 31, 2024 / Notices 86809 

reflect resident experience rather than 

changing a term that is commonly used 

in abuse investigations by other entities. 

Comment: Three respondents 

recommended modification to the 

psychological abuse complaint code to 

include social media posts and posting 

of photographs. 

Response: The current reporting tips 

include oral, written, or gestured 

language and are sufficient to include 

social media posts. Photos are also 

included in the reporting tips. 

Comment: Three respondents 

recommended adding language to 

complaint types in the category of 

autonomy, choice, and rights to address 

emergence of artificial intelligence to 

monitor residents. 

Response: This issue requires further 

review and will be considered for future 

revisions. 

Comment: One respondent suggested 

adding a reporting tip to complaint type 

F10- Rehabilitation services to instruct 

Ombudsmen how to report contractures 

as gross neglect. 

Response: Further review is needed, 

and this suggestion will be considered 

for future revisions. 

Comment: One respondent 

recommended that instruction be added 

to select staffing as a secondary 

complaint and to broaden the definition 

of staffing. 

Response: The use of secondary 

complaint codes when a resident or 

complainant has not expressed staffing 

as a complaint would be a significant 

change in practice with potential 

unintended consequences. This requires 

further review and may be considered in 

future revisions. The existing definition 

of J03—Staffing is sufficiently inclusive 

of staffing vacancies. 

Comment: Two respondents 

recommended adding language to the 

definition and examples for complaint 

type L01—Resident representative or 

family conflict to include other visitors 

with different types of relationships. 

Response: The complaint type as 

currently defined is specific to the 

nature of the relationships of family 

members and individuals that residents 

choose to be their representative; adding 

others could dilute the meaning of the 

data element. 

Comment: Two respondents requested 

the addition of a new complaint type for 

reporting resident-to-resident 

altercations that are not willful abuse. 

Response: ACL is not adding or 

removing data elements with this 

renewal but will consider this 

recommendation in the future after 

analysis of impact and alternatives 

within the existing collection. 

Comment: Three respondents 

recommended adding a new category of 

complaints and individual complaint 

types about discrimination. 

Response: ACL is not adding or 

removing elements but will seek 

additional input and consider this 

change in the future after analysis of 

impact. 

Comment: Two respondents suggested 

adding a new complaint category to 

allow for short-term collection of data 

for a special purpose. 

Response: ACL is not adding or 

removing elements with this renewal 

but will consider the recommendation 

after analysis of impact and alternatives. 

Comment: One respondent asserted 

that complaint/case terminology in data 

elements S01–S06 is confusing. 

Response: The data elements are text 

fields and provide flexibility for the 

State Ombudsman to describe 

complaints as they determine best. 

Technical assistance will be provided. 

Comment: One respondent requested 

clarification about reporting hours 

donated by volunteers when the 

volunteer receives travel 

reimbursement. 

Response: The Older Americans Act 

allows for reimbursement and travel is 

included in the current examples and 

reporting tips. 

Comment: One respondent requested 

clarification about removal or 

remediation of conflicts of interest. 

Response: How conflicts of interest 

are addressed is a matter of rule (45 CFR 

1324.21(b)) implementation and 

technical assistance will be provided as 

part of broader regulatory guidance. 

Comment: One respondent suggested 

the addition of a code for a specific type 

of expenditure. 

Response: ACL is not adding or 

removing data elements with this 

revision of NORS but will consider this 

change in the future. 

Comment: One respondent suggested 

clarification of local funds expended. 

Response: The instruction is written 

as intended and technical assistance 

will be provided. 

Comment: Four respondents 

recommended changes to routine access 

visitation reporting. 

Response: Routine access visits as 

defined are an important measure of 

resident access to their advocate 

separate from visits to handle 

complaints, as well as a measure of the 

impact of program funding. ACL will 

explore this request further and 

consider a change in the future; data 

elements are not being changed in this 

revision. 

Comment: Three respondents 

commented that instructions are vague 

about how to report the number of 

facilities and that closures have an 

impact on how routine access visits are 

measured on a quarterly basis. 

Response: The examples and tips are 

specific that the count of facilities is as 

of the last day of the federal fiscal year. 

Routine access is based upon the count 

of facilities as of the last day of the fiscal 

year. The data element is defined as 

intended, routine access does not 

include facilities that open after the first 

quarter or close before the fourth quarter 

of the fiscal year. Technical assistance 

will be provided. 

Comment: One respondent requested 

a new data element for reporting facility 

closures. 

Response: At this time ACL is not 

adding or removing elements but will 

consider this change in the future after 

analysis of impact and alternatives. 

Comment: Two respondents requested 

new Ombudsman program staffing data 

elements—statewide turnover rates, 

years of experience of Ombudsman 

representatives, and the staff-to-bed 

ratio of staff. 

Response: At this time ACL is not 

adding or removing elements but will 

consider this change in the future after 

analysis of potential methods of 

collection. 

Estimated Program Burden 

ACL estimates the burden of this 

collection of information as follows: 

Fifty-two grantees report to ACL using 

NORS. 

a. Number of respondents—52 

b. Frequency of response—1 

c. Total annual responses—52 

d. Hours per response—214 

e. Total burden hours—11,153 

Dated: October 28, 2024. 

Maura Calsyn, 

Principal Deputy Administrator for the 

Administration for Community Living, 

performing the delegable duties of the 

Administrator and the Assistant Secretary for 

Aging. 

[FR Doc. 2024–25358 Filed 10–30–24; 8:45 am] 

BILLING CODE 4154–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–D–0093] 

M13A Bioequivalence for ImmediateRelease Solid Oral Dosage Forms; 

International Council for 

Harmonisation; Guidance for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 


lotter on DSK11XQN23PROD with NOTICES1
86810 Federal Register / Vol. 89, No. 211 / Thursday, October 31, 2024 / Notices 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a final 

guidance for industry entitled ‘‘M13A 

Bioequivalence for Immediate-Release 

Solid Oral Dosage Forms’’ and the 

supplemental document entitled ‘‘M13A 

Bioequivalence for Immediate-Release 

Solid Oral Dosage Forms: Questions and 

Answers.’’ The guidance and 

supplemental questions and answers 

document were prepared under the 

auspices of the International Council for 

Harmonisation of Technical 

Requirements for Pharmaceuticals for 

Human Use (ICH). The guidance 

describes the scientific and technical 

aspects of study design and data 

analysis to support bioequivalence (BE) 

assessment of orally administered 

immediate-release solid oral dosage 

forms of pharmaceutical drugs, such as 

tablets, capsules, and granules/powders 

for oral suspension. The supplemental 

questions and answers document 

provides clarity to concepts covered in 

the guidance and rationales behind to 

facilitate implementation. The guidance 

is intended to provide globally 

harmonized scientific recommendations 

for conducting BE studies during both 

the development and postapproval 

phases of immediate-release solid oral 

dosage forms. The guidance replaces the 

draft guidance ‘‘M13A Bioequivalence 

for Immediate-Release Solid Oral 

Dosage Forms’’ issued on February 1, 

2023. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on October 31, 2024. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances 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– 

2023–D–0093 for ‘‘M13A 

Bioequivalence for Immediate-Release 

Solid Oral Dosage Forms’’ and ‘‘M13A 

Bioequivalence for Immediate-Release 

Solid Oral Dosage Forms Questions and 

Answers.’’ 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 this guidance to the Division 

of Drug Information, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002. Send one self-addressed 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: 

Regarding the guidance: Lei Zhang, 

Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 75, Rm. 4724, Silver Spring, 

MD 20993–0002, Leik.Zhang@

fda.hhs.gov. 

Regarding the ICH: Jill Adleberg, 

Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 6364, Silver Spring, 

MD 20993–0002, 301–796–5259, 

Jill.Adleberg@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a final guidance for industry entitled 

‘‘M13A Bioequivalence for ImmediateRelease Solid Oral Dosage Forms’’ and 

the supplemental document entitled 

‘‘M13A Bioequivalence for ImmediateRelease Solid Oral Dosage Forms: 

Questions and Answers.’’ The guidance 

and supplemental questions and 

answers document were prepared under 

the auspices of ICH. ICH seeks to 

achieve greater regulatory 

harmonization worldwide to ensure that 

safe, effective, high-quality medicines 

are developed, registered, and 


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Federal Register / Vol. 89, No. 211 / Thursday, October 31, 2024 / Notices 86811 

maintained in the most resourceefficient manner. 

By harmonizing the regulatory 

requirements in regions around the 

world, ICH guidelines enhance global 

drug development, improve 

manufacturing standards, and increase 

the availability of medications. For 

example, ICH guidelines have 

substantially reduced duplicative 

clinical studies, prevented unnecessary 

animal studies, standardized the 

reporting of important safety 

information, and standardized 

marketing application submissions. 

The six Founding Members of the ICH 

are the FDA; the Pharmaceutical 

Research and Manufacturers of America; 

the European Commission; the 

European Federation of Pharmaceutical 

Industries Associations; the Japanese 

Ministry of Health, Labour, and Welfare; 

and the Japanese Pharmaceutical 

Manufacturers Association. The 

Standing Members of the ICH 

Association include Health Canada and 

Swissmedic. ICH membership continues 

to expand to include other regulatory 

authorities and industry associations 

from around the world (refer to https:// 

www.ich.org/). 

ICH works by engaging global 

regulatory and industry experts in a 

detailed, science-based, and consensusdriven process that results in the 

development of ICH guidelines. The 

regulators around the world are 

committed to consistently adopting 

these consensus-based guidelines, 

realizing the benefits for patients and for 

industry. 

As a Founding Regulatory Member of 

ICH, FDA plays a major role in the 

development of each of the ICH 

guidelines, which FDA then adopts and 

issues as guidance for industry. FDA’s 

guidance documents do not establish 

legally enforceable responsibilities. 

Instead, they describe the Agency’s 

current thinking on a topic and should 

be viewed only as recommendations, 

unless specific regulatory or statutory 

requirements are cited. 

In the Federal Register of February 1, 

2023 (88 FR 6750), FDA published a 

notice announcing the availability of a 

draft guidance entitled ‘‘M13A 

Bioequivalence for Immediate-Release 

Solid Oral Dosage Forms; International 

Council for Harmonisation.’’ The notice 

gave interested persons an opportunity 

to submit comments by April 3, 2023. 

After consideration of the comments 

received and revisions to the guideline, 

a final draft of the guideline was 

submitted to the ICH Assembly and 

endorsed by the regulatory agencies in 

July 2024. 

This guidance finalizes the draft 

guidance issued on February 1, 2023. 

The final guidance includes clarification 

on the scientific and technical aspects of 

study design and data analysis to 

support BE assessment for orally 

administered immediate-release solid 

oral dosage forms. The supplemental 

questions and answers document 

provides further clarification and 

examples of the technical aspects of the 

main guidance in order to effectively 

implement the guidance. The 

internationally harmonized guidance 

and questions and answers document 

aim to increase the efficiency of drug 

development and accelerate the 

availability of safe and effective orally 

administered immediate-release solid 

oral dosage forms. 

This 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 ‘‘M13A 

Bioequivalence for Immediate-Release 

Solid Oral Dosage Forms’’. The 

guidance and supplemental questions 

and answers document do not establish 

any rights for any person and are 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 314.94 for 

content and format for BE studies 

submitted under abbreviated new drug 

applications have been approved under 

OMB control number 0910–0001. The 

collections of information for the 

implementation of improved quality 

and integrity of the study data 

approaches pertaining to good clinical 

practice have been approved under 

OMB control number 0910–0014. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at https://

www.regulations.gov, https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents, 

https://www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs, or https://

www.fda.gov/vaccines-blood-biologics/ 

guidance-compliance-regulatoryinformation-biologics/biologicsguidances. 

Dated: October 23, 2024. 

Kimberlee Trzeciak, 

Deputy Commissioner for Policy, Legislation, 

and International Affairs. 

[FR Doc. 2024–25355 Filed 10–30–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2007–D–0369] 

Product-Specific Guidances; Revised 

Draft Guidances 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 

additional revised draft product-specific 

guidances. The draft guidances provide 

product-specific recommendations on, 

among other things, the design of 

bioequivalence (BE) studies to support 

abbreviated new drug applications 

(ANDAs). In the Federal Register of 

June 11, 2010, FDA announced the 

availability of a guidance for industry 

entitled ‘‘Bioequivalence 

Recommendations for Specific 

Products’’ that explained the process 

that would be used to make productspecific guidances available to the 

public on FDA’s website. The draft 

guidances identified in this notice were 

developed using the process described 

in that guidance. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by December 30, 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 


lotter on DSK11XQN23PROD with NOTICES1