Federal Register / Vol. 87, No. 67 / Thursday, April 7, 2022 / Notices 20433 

TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB 

Title of collection OMB control 

No. 

Date approval 

expires 

Reclassification Petitions for Medical Devices ........................................................................................................ 0910–0138 2/28/2025 

Pharmaceutical Distribution Supply Chain .............................................................................................................. 0910–0806 2/28/2025 

Environmental Impact Considerations ..................................................................................................................... 0910–0322 3/31/2025 

Reporting Associated with Food Additive Petitions, Investigational Food Additive Files Exemptions, and Declaration of Color Additives on Animal Food Labels ............................................................................................. 0910–0546 3/31/2025 

Recordkeeping Requirements for Microbiological Testing and Corrective Measures for Bottled Water ............... 0910–0658 3/31/2025 

Generic Clearance for Quantitative Testing for the Development of FDA Communications (CFSAN) .................. 0910–0865 3/31/2025 

Dated: March 30, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–07394 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–2019–N–2778] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Threshold of 

Regulation for Substances Used in 

Food-Contact Articles 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on requests for data 

needed to evaluate requests for 

Threshold of Regulation Exemptions for 

Substances Used in Food-Contact 

Articles. 

DATES: Submit either electronic or 

written comments on the collection of 

information by June 6, 2022. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before June 6, 2022. 

The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of June 6, 2022. 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– 

2019–N–2778 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; 

Threshold of Regulation for Substances 

Used in Food-Contact Articles.’’ 

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 

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 


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20434 Federal Register / Vol. 87, No. 67 / Thursday, April 7, 2022 / Notices 

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: Ila 

S. Mizrachi, Office of Operations, Food 

and Drug Administration, Three White 

Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–7726, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3521), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Threshold of Regulation for Substances 

Used in Food-Contact Articles—21 CFR 

170.39 

OMB Control Number 0910–0298— 

Extension 

Under section 409(a) of the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act) (21 U.S.C. 348(a)), the use of a food 

additive is deemed unsafe unless one of 

the following is applicable: (1) It 

conforms to an exemption for 

investigational use under section 409(j) 

of the FD&C Act; (2) it conforms to the 

terms of a regulation prescribing its use; 

or (3) in the case of a food additive 

which meets the definition of a foodcontact substance in section 409(h)(6) of 

the FD&C Act, there is either a 

regulation authorizing its use in 

accordance with section 409(a)(3)(A) of 

the FD&C Act or an effective notification 

in accordance with section 409(a)(3)(B) 

of the FD&C Act. 

The regulations in § 170.39 (21 CFR 

170.39) established a process that 

provides the manufacturer with an 

opportunity to demonstrate that the 

likelihood or extent of migration to food 

of a substance used in a food-contact 

article is so trivial that the use need not 

be the subject of a food additive listing 

regulation or an effective notification. 

The Agency has established two 

thresholds for the regulation of 

substances used in food-contact articles. 

The first exempts those substances used 

in food-contact articles where the 

resulting dietary concentration would 

be at or below 0.5 part per billion. The 

second exempts regulated direct food 

additives for use in food-contact articles 

where the resulting dietary exposure is 

1 percent or less of the acceptable daily 

intake for these substances. 

To determine whether the intended 

use of a substance in a food-contact 

article meets the threshold criteria, 

certain information specified in 

§ 170.39(c) must be submitted to FDA. 

This information includes the following 

components: (1) The chemical 

composition of the substance for which 

the request is made; (2) detailed 

information on the conditions of use of 

the substance; (3) a clear statement of 

the basis for the request for exemption 

from regulation as a food additive; (4) 

data that will enable FDA to estimate 

the daily dietary concentration resulting 

from the proposed use of the substance; 

(5) results of a literature search for 

toxicological data on the substance and 

its impurities; and (6) information on 

the environmental impact that would 

result from the proposed use. We use 

this information to determine whether 

the food-contact substance meets the 

threshold criteria. 

Description of Respondents: 

Respondents to this information 

collection are individual manufacturers 

and suppliers of substances used in 

food-contact articles (i.e., food 

packaging and food processing 

equipment) or of the articles themselves. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR 170.39 Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Threshold of regulation for substances used in food-contact articles ....................................................................... 7 1 7 48 336 

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

The threshold of regulation process 

offers one advantage over the premarket 

notification process for food-contact 

substances established by section 409(h) 

of FD&C Act (OMB control number 

0910–0495) in that the use of a 

substance exempted by FDA is not 

limited to only the manufacturer or 

supplier who submitted the request for 

an exemption. Other manufacturers or 

suppliers may use exempted substances 

in food-contact articles as long as the 

conditions of use (e.g., use levels, 

temperature, type of food contacted, 

etc.) are those for which the exemption 

was issued. As a result, the overall 

burden on both Agency and the 

regulated industry would be 

significantly less in that other 

manufacturers and suppliers would not 

have to prepare, and we would not have 

to review, similar submissions for 

identical components of food-contact 

articles used under identical conditions. 

Manufacturers and other interested 

persons can easily access an up-to-date 

list of exempted substances which is on 

display at FDA’s Dockets Management 

Staff and on the internet at https://

www.fda.gov/food/packaging-foodcontact-substances-fcs/thresholdregulation-exemptions-substances-usedfood-contact-articles. Having the list of 

exempted substances publicly available 

decreases the likelihood that a company 

would submit a food additive petition or 


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I I I I I 
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: 


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