Federal Register / Vol. 87, No. 115 / Wednesday, June 15, 2022 / Notices 36135 

TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section; activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total 

hours 

1.914; Waiver petitions ................................................................ 2 1 2 24 48 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

We estimate one waiver petition from 

each of two firms will be submitted and 

respondents will spend 24 hours to 

prepare and submit the petition to FDA. 

TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

21 CFR section; activity Number of 

respondents 

Number of 

disclosures 

per respondent 

Total annual 

disclosures 

Average 

burden per 

disclosure 

Total hours 

1.908; Disclosure of sanitary specifications; operating 

temperature conditions.

226 1 226 0.5833 (∼35 minutes).132 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Finally, we estimate an annual thirdparty disclosure burden of 132 hours, 

assuming each of 226 firms will spend 

an average of 35 minutes, annually, 

disclosing written records as required 

under § 1.908. 

Based on an evaluation of the 

information collection, we have made 

no adjustments to our burden estimate. 

Dated: June 9, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–12914 Filed 6–14–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–D–0705] 

Q9(R1) Quality Risk Management; 

International Council for 

Harmonisation; Draft Guidance for 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 entitled ‘‘Q9(R1) 

Quality Risk Management.’’ The draft 

guidance was prepared under the 

auspices of the International Council for 

Harmonisation (ICH), formerly the 

International Conference on 

Harmonisation. The current Q9 

guideline published in 2006 provides a 

common, harmonized framework for 

Quality Risk Management (QRM) that 

can enable more effective and consistent 

risk-based decisions, both by regulators 

and industry, regarding the quality of 

drug substances and drug products 

across the product lifecycle. This draft 

guidance is a targeted revision that 

addresses four areas for improvement, 

including high levels of subjectivity in 

risk assessments and in QRM outputs; 

product availability risks; lack of 

understanding as to what constitutes 

formality in QRM work; and lack of 

clarity on risk-based decision-making. 

The revisions are intended to update the 

original Q9 guideline based on 

implementation experience to promote 

improved lifecycle management of 

hazards and prevent defects, recalls, and 

shortages. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by July 15, 2022 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– 

2022–D–0705 for ‘‘Q9(R1) Quality Risk 

Management.’’ Received comments will 

be placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ are 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 


jspears on DSK121TN23PROD with NOTICES1
36136 Federal Register / Vol. 87, No. 115 / Wednesday, June 15, 2022 / Notices 

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 Office of 

Communication, Outreach and 

Development, Center for Biologics 

Evaluation and Research (CBER), Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 3128, 

Silver Spring, MD 20993–0002, or 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. The guidance may also be 

obtained by mail by calling CBER at 1– 

800–835–4709 or 240–402–8010. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Regarding the guidance: Rick Friedman, 

Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 4348, Silver Spring, 

MD 20993–0002, 301–796–3268, 

Rick.Friedman@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 guidance for industry entitled ‘‘Q9(R1) 

Quality Risk Management.’’ The 

guidance was prepared under the 

auspices of ICH. ICH has the mission of 

achieving greater regulatory 

harmonization worldwide to ensure that 

safe, effective, high-quality medicines 

are developed, registered, and 

maintained in the most resourceefficient manner. 

By harmonizing the regulatory 

requirements in regions around the 

world, ICH guidelines have 

substantially reduced duplicative 

clinical studies, prevented unnecessary 

animal studies, standardized the 

reporting of important safety 

information, standardized marketing 

application submissions, and made 

many other improvements in the quality 

of global drug development and 

manufacturing and the products 

available to patients. 

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. Additionally, the 

Membership of ICH has expanded to 

include other regulatory authorities and 

industry associations from around the 

world (refer to https://www.ich.org/). 

ICH works by involving technical 

experts from both regulators and 

industry parties in detailed technical 

harmonization work and the application 

of a science-based approach to 

harmonization through a 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 November 2021, the ICH Assembly 

endorsed the draft guideline entitled 

‘‘Q9(R1) Quality Risk Management’’ and 

agreed that the guideline should be 

made available for public comment. The 

draft guideline is the product of the 

Quality Expert Working Group of the 

ICH. Comments about this draft 

guidance will be considered by FDA 

and the Quality Expert Working Group. 

FDA is thus announcing the 

availability of a guidance for industry 

entitled ‘‘Q9(R1) Quality Risk 

Management.’’ The current Q9 guideline 

published in 2006 provides a common, 

harmonized framework for Quality Risk 

Management that can enable more 

effective and consistent risk-based 

decisions, both by regulators and 

industry, regarding the quality of drug 

substances and drug products across the 

product lifecycle. This draft guidance is 

a targeted revision that addresses four 

areas for improvement: (1) high levels of 

subjectivity in risk assessments and in 

QRM outputs; (2) product availability 

risks; (3) lack of understanding as to 

what constitutes formality in QRM 

work; and (4) lack of clarity on riskbased decision-making. The revisions 

are intended to update the original Q9 

guideline based on implementation 

experience to promote improved 

lifecycle management of hazards and 

prevent defects, recalls, and shortages. 

This draft guidance has been left in 

the original ICH format. The final 

guidance will be reformatted and edited 

to conform with FDA’s good guidance 

practices regulation (21 CFR 10.115) and 

style before publication. The draft 

guidance, when finalized, will represent 

the current thinking of FDA on ‘‘Q9(R1) 

Quality Risk Management.’’ 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 


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Federal Register / Vol. 87, No. 115 / Wednesday, June 15, 2022 / Notices 36137 

Act of 1995 (PRA) (44 U.S.C. 3501– 

3520) is not required for this guidance. 

The previously approved collections of 

information are subject to review by 

OMB under the PRA. The collection of 

information in 21 CFR part 211 has been 

approved under OMB control number 

0910–0139. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at https:// 

www.regulations.gov, https://

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

guidances-drugs, or https://

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

guidance-compliance-regulatoryinformation-biologics/biologicsguidances, or https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents. 

Dated: June 8, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–12919 Filed 6–14–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Announcement of Intent To Establish 

the 2025 Dietary Guidelines Advisory 

Committee and Solicitation of 

Nominations for Membership 

AGENCY: U.S. Department of Health and 

Human Services (HHS), Office of the 

Assistant Secretary for Health; U.S. 

Department of Agriculture (USDA), 

Food, Nutrition, and Consumer 

Services. 

ACTION: Notice. 

SUMMARY: The Departments of Health 

and Human Services and Agriculture 

announce the intent to establish a 

Dietary Guidelines Advisory Committee 

and invite nominations for the 

Committee. 

DATES: Nominations must be submitted 

by 11:59 p.m. Eastern Time on July 15, 

2022. 

ADDRESSES: Nominations may be 

submitted by email to 

DietaryGuidelines@hhs.gov. 

Alternatively, nominations may be sent 

to: Dietary Guidelines Advisory 

Committee Nominations, Office of 

Disease Prevention and Health 

Promotion (ODPHP), Office of the 

Assistant Secretary for Health (OASH), 

HHS; 1101 Wootton Parkway, Suite 420; 

Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Janet de Jesus, MS, RD, Nutrition 

Advisor, telephone 240–453–8266, 

Office of Disease Prevention and Health 

Promotion, U.S. Department of Health 

and Human Services, 

DietaryGuidelines@hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Authority and Purpose: Section 301 of 

the National Nutrition Monitoring and 

Related Research Act of 1990 (7 U.S.C. 

5341) requires the Secretaries of HHS 

and USDA to publish the Dietary 

Guidelines for Americans (Dietary 

Guidelines) jointly at least every five 

years. The law instructs that this 

publication shall contain nutritional 

and dietary information and guidelines 

for the general public, shall be based on 

the preponderance of scientific and 

medical knowledge current at the time 

of publication, and shall be promoted by 

each federal agency in carrying out any 

federal food, nutrition, or health 

program. The current edition of the 

Dietary Guidelines (2020–2025) 

provides guidance on the entire life 

span, from birth to older adulthood, 

including pregnancy and lactation. The 

Dietary Guidelines for Americans, 2025– 

2030 will continue to provide foodbased dietary guidance across the entire 

lifespan to help meet nutrient needs, 

promote health, and reduce the risk of 

chronic disease. 

The 2025 Dietary Guidelines Advisory 

Committee (Committee) shall be formed 

and governed under the provisions of 

the Federal Advisory Committee Act 

(FACA), Public Law 92–463, as 

amended (5 U.S.C., App), which sets 

forth standards for the formation and 

use of advisory committees. The 

Committee is established to provide 

independent, evidence-based advice 

and recommendations to be considered 

by HHS and USDA in the Departments’ 

development of the Dietary Guidelines 

for Americans, 2025–2030. The 

Committee’s review and advice will 

focus on the scientific questions 

prioritized by HHS and USDA with the 

potential to inform nutrition guidance 

for Americans across the lifespan. 

Formation of the Committee is 

necessary to adequately review the 

science to inform the Dietary Guidelines 

and is in the public interest. 

The Committee is expected to begin 

meeting in early 2023; the Committee 

will meet approximately five times 

during its operation. Pursuant to the 

FACA, all Committee meetings will be 

open to the public. The Committee will 

be established to accomplish a single, 

time-limited task. The Committee will 

develop a scientific report of its 

recommendations that will be submitted 

to the Secretaries of HHS and USDA. 

Upon delivery of its report to the 

Secretaries or when the Committee’s 

charter expires two years after it is filed, 

the activities of the Committee will be 

terminated. 

Structure: The Committee will consist 

of 15 to 20 members, including the 

Chair and Vice-Chairperson. Factors to 

be considered in selecting individuals to 

serve on the Committee include 

educational background, professional 

experience, and demonstrated scientific 

expertise in the issues to be examined 

by the Committee, as well as statutory 

obligations under FACA and desire for 

a balanced and diverse membership. 

Expertise in human nutrition related 

to disease prevention and health 

promotion for the specific scientific 

topics identified by the Departments to 

be examined by the Committee will be 

sought. Expertise will also be sought 

related to health equity and the 

scientific approaches used to review the 

evidence (systematic reviews, food 

pattern modeling, and data analysis). 

Information on the scientific topics is 

available at www.dietaryguidelines.gov. 

Equal opportunity practices regarding 

membership appointments to the 

Committee will be aligned with HHS 

and USDA policies. To the extent 

possible, HHS and USDA will ensure 

the Committee membership is balanced 

in expertise, experience, education, and 

institutional affiliation and is reflective 

of the racial, ethnic, gender, and 

geographic diversity within the United 

States. 

Individuals will be appointed to serve 

as members of the Committee to 

evaluate the scientific evidence, not to 

represent the viewpoints of any specific 

group. Members of the Committee will 

be classified as Special Government 

Employees (SGE)s during their term of 

appointment and, as such, are subject to 

the ethical standards of conduct for 

federal employees. Upon entering the 

position and annually throughout the 

approximate 2-year term of 

appointment, members of the 

Committee will be required to complete 

and submit a report of their financial 

holdings. 

Nominations and Appointments for 

Memberships: Nominees, including selfnominees, will be considered for 

appointment as members of the 

Committee. Only complete nomination 

packages submitted within the allotted 

time period will be considered. To be 

considered for an appointment, 

submission of the following information 

for each nominee is required: (1) a cover 

letter that clearly states the name and 

place of work of the nominee, the 

rationale for the nomination (i.e., which 

specific topics they have expertise in, 

highlighting relevant experience in 

health equity and the scientific 


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