Federal Register / Vol. 87, No. 19 / Friday, January 28, 2022 / Notices 4609 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued 

21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Total .................................................................. ........................ ........................ 10,372,000 .................................... 299,067 

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

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 2

Information collection activity; 21 CFR section Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average burden per 

recordkeeping Total hours 

Controls for low-acid canned foods; 1.502(b) ......... 2,443 4 9,772 1 ................................ 9,772 

Hazard determinations, controls, and audits; 1.504, 

1.506, 1.511.

56,800 87.74 4,984,036 0.38 (23 minutes) ...... 1,917,174 

Written assurances for food produced under dietary supplement current good manufacturing 

practices; 1.511.

11,701 2.88 33,664 2.25 ........................... 75,744 

Document very small importer/certain small foreign 

supplier status; 1.512(b)(1).

50,450 1 50,450 1 ................................ 50,450 

Written assurances associated with very small importer/certain small foreign supplier; 1.512(b)(3).50,450 2.79 141,084 2.25 ........................... 317,439 

Total .................................................................. ........................ ........................ 5,219,006 .................................... 2,370,579 

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

2Figures have been rounded to the nearest one hundredth. 

Upon evaluation of the information 

collection, we are retaining the 

currently approved burden estimates. 

Dated: January 24, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–01796 Filed 1–27–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–N–0370] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Export of Medical 

Devices; Foreign Letters of Approval 

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 reporting 

requirements for firms that intend to 

export certain unapproved medical 

devices. 

DATES: Submit either electronic or 

written comments on the collection of 

information by March 29, 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 March 29, 

2022. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of March 29, 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– 

2013–N–0370 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; Export of 

Medical Devices; Foreign Letters of 

Approval.’’ Received comments, those 

filed in a timely manner (see 

ADDRESSES), will be placed in the docket 


jspears on DSK121TN23PROD with NOTICES1
4610 Federal Register / Vol. 87, No. 19 / Friday, January 28, 2022 / Notices 

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. 

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. 

Export of Medical Devices; Foreign 

Letters of Approval 

OMB Control Number 0910–0264— 

Extension 

Section 801(e)(2) of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 

381(e)(2)) provides for the exportation of 

an unapproved device under certain 

circumstances if the exportation is not 

contrary to the public health and safety 

and it has the approval of the foreign 

country to which it is intended for 

export. Requesters communicate (either 

directly or through a business associate 

in the foreign country) with a 

representative of the foreign government 

to which they seek exportation, and 

written authorization must be obtained 

from the appropriate office within the 

foreign government approving the 

importation of the medical device. An 

alternative to obtaining written 

authorization from the foreign 

government is to accept a notarized 

certification from a responsible 

company official in the United States 

that the product is not in conflict with 

the foreign country’s laws. This 

certification must include a statement 

acknowledging that the responsible 

company official making the 

certification is subject to the provisions 

of 18 U.S.C. 1001. This statutory 

provision makes it a criminal offense to 

knowingly and willingly make a false or 

fraudulent statement, or make or use a 

false document, in any manner within 

the jurisdiction of a department or 

Agency of the United States. The 

respondents to this collection of 

information are companies that seek to 

export medical devices. FDA’s estimate 

of the reporting burden is based on the 

experience of FDA’s medical device 

program personnel. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR part and/activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Total operating 

and 

maintenance 

costs 

Foreign letter of approval—801(e)(2) ...... 36 1 36 2 72 $8,250 

1There are no capital costs associated with this collection of information. 

Our estimated burden for the 

information collection reflects an 

overall decrease of 27 hours and a 

corresponding increase of three 

responses. We attribute this adjustment 

to an increase in the number of 

respondents and a decrease in the 

average burden per response. 

Dated: January 25, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–01793 Filed 1–27–22; 8:45 am] 

BILLING CODE 4164–01–P 


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