Federal Register / Vol. 88, No. 178 / Friday, September 15, 2023 / Notices 63587 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the draft 

guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Steven Fleischer, Center for Veterinary 

Medicine (HFV–110), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–402–0809, 

Steven.Fleischer@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft GFI #282 entitled ‘‘Informed 

Consent Forms for Studies that Enroll 

Client-Owned Companion Animals.’’ As 

used in this guidance, informed consent 

is a documented process by which an 

owner or owner’s agent voluntarily 

confirms the owner’s willingness to 

allow their animal(s) to participate in a 

particular study, after having been 

informed of all aspects of the study that 

may be relevant to the owner’s decision 

to participate. A sponsor or investigator 

should ensure the owner is provided 

with adequate information and time to 

allow for an informed decision about 

voluntary participation in a clinical 

investigation. This draft guidance 

provides recommendations on ICFs 

used for studies that enroll client-owned 

companion animals (dogs, cats, and 

horses). CVM recommends all studies 

conducted with client-owned 

companion animals use an ICF and be 

conducted in accordance with GCP 

guidelines. 

This level 1 draft guidance is being 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 The draft guidance, when 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 ‘‘Informed Consent 

Forms for Studies that Enroll ClientOwned Companion 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. Therefore, clearance by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (PRA) (44 U.S.C. 3501– 

3521) is not required for this guidance. 

The previously approved collections of 

information are subject to review by 

OMB under the PRA. The collections of 

information in 21 CFR part 514 and 

section 571 of the Federal Food, Drug, 

and Cosmetic Act 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 11, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–19951 Filed 9–14–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–3721] 

Quality Management Maturity Program 

for Drug Manufacturing 

Establishments; Establishment of a 

Public Docket; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of establishment of a 

public docket; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the establishment of a 

docket to solicit comments that will 

assist the Agency in developing a 

Quality Management Maturity (QMM) 

program for establishments 

manufacturing human drugs, including 

biological products, regulated by the 

Center for Drug Evaluation and Research 

(CDER). 

DATES: Submit either electronic or 

written comments on the notice by 

December 14, 2023 to ensure that the 

Agency considers your comment. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments may not be 

considered. Electronic comments must 

be submitted on or before December 14, 

2023. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of December 14, 2023. 

Comments received by mail/hand 

delivery/courier (for written/paper 

submissions) will be considered timely 

if they are postmarked or the delivery 

service acceptance receipt is on or 

before that date. 

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–N–3721 for ‘‘Quality Management 

Maturity Program for Drug 

Manufacturing Establishments; 

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.’’ The 


ddrumheller on DSK120RN23PROD with NOTICES1
63588 Federal Register / Vol. 88, No. 178 / Friday, September 15, 2023 / Notices 

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. 

FOR FURTHER INFORMATION CONTACT: 

Djamila Harouaka, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 4160, 

Silver Spring, MD 20993–0002, 240– 

402–0224, CDER-QMM@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Drug manufacturers can achieve 

higher levels of QMM by successfully 

integrating business and manufacturing 

operations with quality practices and 

technological advancements to optimize 

manufacturing process performance and 

product quality, enhance supply chain 

reliability, and foster proactive 

continual improvement. CDER is 

developing a voluntary program to 

promote QMM at drug manufacturing 

establishments. The goals of this 

program are: (1) to foster a strong quality 

culture mindset; (2) recognize 

establishments that have advanced 

quality management practices and 

acknowledge establishments that strive 

to continually improve those practices; 

(3) identify areas where quality 

management practices can be enhanced 

and provide suggestions for growth 

opportunities; and (4) minimize risks to 

product availability to assure reliable 

market supply. 

The QMM assessment is designed to 

appraise an establishment’s quality 

culture mindset, behaviors, and 

commitment to adopting best practices 

to effectively meet the needs of patients 

and consumers. QMM assessments 

would not be used to evaluate 

compliance with current good 

manufacturing practice (CGMP). 

QMM assessments would be 

conducted by trained assessors, who 

would engage directly with 

establishments, either onsite or in a 

hybrid (onsite/remote) environment, for 

2 to 5 business days. The QMM 

assessment will cover five practice 

areas: (1) management commitment to 

quality; (2) business continuity; (3) 

advanced pharmaceutical quality 

system; (4) technical excellence; and (5) 

employee engagement and 

empowerment. Within each practice 

area, the assessors would explore key 

elements to better understand an 

establishment’s QMM. Examples of 

elements covered under each practice 

area could include: management review 

and resource management (management 

commitment to quality practice area), 

supply planning and demand 

forecasting (business continuity practice 

area), data governance and process 

optimization (technical excellence 

practice area), effectiveness of the 

corrective action and preventive action 

process (advanced pharmaceutical 

quality system practice area), and 

rewards and recognition (employee 

engagement practice area). Each 

establishment’s responses, executed 

practices, and behaviors would be 

assessed using a standardized 

assessment protocol and an objective 

rubric, which is currently under 

development, to help identify areas of 

strength and potential areas with 

opportunities for improvement. 

At a November 2, 2022, meeting of the 

Pharmaceutical Science and Clinical 

Pharmacology Advisory Committee, 

FDA sought to determine the support of 

academic and industry experts for 

CDER’s development of a QMM 

program. By a vote of 9–0, the 

committee affirmed that CDER should 

establish a QMM program to incentivize 

investments in mature quality 

management practices . During 

deliberations, committee members 

advised the Agency to continue to seek 

stakeholder input throughout the 

program’s development. Further 

information about the November 2022 

Advisory Committee meeting, including 

event materials, is available on FDA’s 

website at https://www.fda.gov/ 

advisory-committees/advisorycommittee-calendar/november-2-3- 

2022-pharmaceutical-science-andclinical-pharmacology-advisorycommittee-meeting. For further 

information about QMM, relevant 

research, and previously conducted 

pilot programs, please see CDER’s QMM 

web page at https://www.fda.gov/drugs/ 

pharmaceutical-quality-resources/cderquality-management-maturity. FDA has 

verified the website addresses, as of the 

date this document publishes in the 

Federal Register, but websites are 

subject to change over time. 

II. Request for Comments 

FDA is opening a docket to solicit 

additional feedback from the public on 

CDER’s planned, voluntary QMM 

program. The public is invited to 

provide detailed comments on all 

aspects described in this notice. To 

facilitate this input, FDA has developed 

a list of questions. These questions are 

not exhaustive, and FDA welcomes 

other pertinent information the public 

would like to share on this topic. In all 

cases, FDA encourages the public to 

provide the reasoning and specific basis 

for any comments. 

1. If you are a manufacturer, please 

identify the types of drug(s) produced in 

your establishment (e.g., active 

pharmaceutical ingredients, innovator 

drugs, innovator biologics, generics, 

biosimilars, or OTC monograph drugs). 

If you are not a manufacturer, please 

specify whether you are a purchaser, 

payor, pharmacy, healthcare provider, 

patient, regulator, supplier, distributor, 

contract service provider, or other 

(please describe). 

2. What advantages do you anticipate 

that your sector (i.e., your organization 

and others like yours) would gain from 

CDER’s voluntary QMM program? 

3. How would participation in a QMM 

program benefit you or your specific 

organization? 

4. How would you use information 

from a QMM assessment if it were 

provided to your organization? For 

example, if your organization acts as a 

supplier or contract organization, would 

you consider sharing information from a 

QMM assessment with a potential 

client? If your organization enters into 

contracts with purchasers, would you 

consider sharing information from a 

QMM assessment with a purchaser? If 

your organization is a purchaser, would 

you consider requesting information 

from a QMM assessment? 

5. What, if any, unintended 

consequences, roadblocks, or other 

concerns do you anticipate with a 

voluntary QMM program? What barriers 

to participation do you anticipate? 

Please explain. Which of these 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 178 / Friday, September 15, 2023 / Notices 63589 

unintended consequences might be 

unique to stakeholders like you? Why? 

6. FDA anticipates that each 

establishment would be provided with a 

detailed report following their QMM 

assessment. What would you want such 

a report to contain? 

7. With respect to the outcomes of a 

QMM assessment, what are your 

thoughts about making outcomes 

public? Would your thoughts be 

different if the outcomes were generally 

qualitative (e.g., descriptive 

information) versus quantitative (e.g., a 

numerical rating)? 

8. What other feedback would you 

like the FDA to consider for a voluntary 

QMM program? 

III. References 

The following references are on 

display with the Dockets Management 

Staff (see ADDRESSES) and are available 

for viewing by interested persons 

between 9 a.m. and 4 p.m., Monday 

through Friday; these are not available 

electronically at https://

www.regulations.gov as these references 

are copyright protected. Some may be 

available at the website address, if 

listed. FDA has verified the website 

addresses, as of the date this document 

publishes in the Federal Register, but 

websites are subject to change over time. 

1. Maguire, J., A. Fisher, D. Harouaka, N. 

Rakala, et al., 2023, ‘‘Lessons from 

CDER’s Quality Management Maturity 

Pilot Programs,’’ The AAPS Journal, 

25(14), January 10, 2023, https://doi.org/ 

10.1208/s12248-022-00777-z. 

2. Fellows, M., T. Friedli, Y. Li, J. Maguire, 

et al., 2022, ‘‘Benchmarking the Quality 

Practices of Global Pharmaceutical 

Manufacturing to Advance Supply Chain 

Resilience,’’ The AAPS Journal, 24(111), 

October 20, 2022, https://doi.org/ 

10.1208/s12248-022-00761-7. 

Dated: September 12, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–20015 Filed 9–14–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2019–N–4060] 

Medical Devices With Indications 

Associated With Weight Loss 

Guidances; Draft Guidances 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 two draft 

guidances entitled ‘‘Medical Devices 

with Indications Associated with 

Weight Loss—Clinical Study and 

Benefit-Risk Considerations’’ and 

‘‘Medical Devices with Indications 

Associated with Weight Loss—NonClinical Recommendations.’’ These draft 

guidance documents provide 

recommendations regarding clinical 

study design for devices with 

indications for use associated with 

weight loss, include discussion on how 

FDA considers the benefit-risk analysis 

to support such indications, and 

provide recommendations for the nonclinical testing to support premarket 

submissions for these medical devices. 

These draft guidances are not final nor 

are they for implementation at this time. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by November 14, 2023 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– 

2019–N–4060 for ‘‘Medical Devices with 

Indications Associated with Weight 

Loss—Clinical Study and Benefit-Risk 

Considerations’’ and ‘‘Medical Devices 

with Indications Associated with 

Weight Loss—Non-Clinical 

Recommendations.’’ 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 


ddrumheller on DSK120RN23PROD with NOTICES1