Federal Register / Vol. 87, No. 67 / Thursday, April 7, 2022 / Notices 20435 

a notification for the same type of foodcontact application of a substance for 

which the Agency has previously 

granted an exemption from the food 

additive listing regulation requirement. 

Based on a review of the information 

collection since our last request for 

OMB approval, we have made no 

adjustments to our burden estimate. 

Dated: March 31, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–07389 Filed 4–6–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–D–0055] 

M7(R2) Addendum: Application of the 

Principles of the ICH M7 Guideline to 

Calculation of Compound-Specific 

Acceptable Intakes; 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 ‘‘M7(R2) 

Addendum: Application of the 

Principles of the ICH M7 Guideline to 

Calculation of Compound-Specific 

Acceptable Intakes; International 

Council for Harmonisation; Draft 

Guidance for Industry.’’ The draft 

guidance was prepared under the 

auspices of the International Council for 

Harmonisation of Technical 

Requirements for Pharmaceuticals for 

Human Use (ICH). The draft guidance 

adds monographs for seven new 

compounds to the M7 Guideline which 

outlines considerations for assessment 

and control of DNA reactive (mutagenic) 

impurities to limit potential 

carcinogenic risk. The compounds are: 

Acetaldehyde, dibromoethane, 

epichlorohydrin, ethyl bromide, 

formaldehyde, styrene, and vinyl 

acetate. The addendum is intended to 

update the M7 Guideline in line with 

the ICH process for its maintenance and 

includes other revisions. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by May 9, 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draft guidance before it begins work on 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–0055 for ‘‘M7(R2) Addendum: 

Application of the Principles of the ICH 

M7 Guideline to Calculation of 

Compound-Specific Acceptable 

Intakes.’’ 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, or 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. 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: 


khammond on DSKJM1Z7X2PROD with NOTICES
20436 Federal Register / Vol. 87, No. 67 / Thursday, April 7, 2022 / Notices 

Regarding the guidance: Aisar 

Atrakchi, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 22, Rm. 4118, Silver Spring, 

MD 20993–0002, 301–796–1036; or 

Stephen Ripley, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993–0002, 240– 

402–7911. 

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 

The Food and Drug Administration 

(FDA or Agency) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘M7(R2) Addendum: 

Application of the Principles of the ICH 

M7 Guideline to Calculation of 

Compound-Specific Acceptable Intakes; 

International Council for 

Harmonisation; Draft Guidance for 

Industry.’’ The draft 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 September 2021, the ICH Assembly 

endorsed the draft guideline entitled 

‘‘M7(R2) Addendum: Application of the 

Principles of the ICH M7 Guideline to 

Calculation of Compound-Specific 

Acceptable Intakes’’ and agreed that the 

guideline should be made available for 

public comment. The draft guideline is 

the product of the Safety Expert 

Working Group of the ICH. Comments 

about this draft will be considered by 

FDA and the Safety Expert Working 

Group. 

The draft guidance adds monographs 

for seven new compounds to the M7 

Guideline which outlines 

considerations for assessment and 

control of DNA reactive (mutagenic) 

impurities to limit potential 

carcinogenic risk. The compounds are: 

Acetaldehyde, dibromoethane, 

epichlorohydrin, ethyl bromide, 

formaldehyde, styrene, and vinyl 

acetate. The addendum is intended to 

update the M7 Guideline in line with 

the ICH process for its maintenance and 

includes other revisions. 

This draft guidance has been left in 

the original ICH format. It contains only 

a list of revisions to the M7(R1) 

Guideline as well as the monographs for 

seven new compounds submitted for 

public consultation. The final guidance 

will include a complete, integrated 

M7(R2) Guideline and Addendum and 

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 ‘‘M7(R2) Assessment and 

Control of DNA Reactive (Mutagenic) 

Impurities in Pharmaceuticals To Limit 

Potential Carcinogenic Risk’’ and its 

Addendum. 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 draft 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 parts 312 and 

314 have been approved under OMB 

control numbers 0910–0014 and 0910– 

0001, and the collection of information 

under 21 CFR parts 210 and 211 have 

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/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: April 1, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–07395 Filed 4–6–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–N–0907] 

Medical Device User Fee Amendments; 

Public Meeting; Request for Comments 

AGENCY: Food and Drug Administration, 

Health and Human Services (HHS). 

ACTION: Notice of public meeting; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is announcing a virtual public 

meeting entitled ‘‘Medical Device User 

Fee Amendments.’’ The purpose of the 

meeting is to discuss proposed 

recommendations for the 


khammond on DSKJM1Z7X2PROD with NOTICES