Federal Register / Vol. 87, No. 19 / Friday, January 28, 2022 / Notices 4607 

access by user authentication controls, 

intrusion detection, and firewalls. 

Routine system security scans are run to 

detect web and architecture 

vulnerabilities. 

• Physical Safeguards: The facility 

housing OCC information systems is a 

secure data center and can only be 

accessed by authorized infrastructure 

staff from HHS and NIH. The facility 

maintains fire suppression and 

detection devices/systems (e.g., 

sprinkler systems, handheld fire 

extinguishers, fixed fire hoses, and/or 

smoke detectors) that are activated in 

the event of a fire. Servers and other 

computer equipment used to process 

identifiable data are located in secured 

areas and use physical access devices 

(e.g., keys, locks, combinations, and 

card readers) and/or security guards to 

control entries into the facility. 

RECORD ACCESS PROCEDURES: 

An individual seeking access to 

records about him or her in this system 

of records must submit a written request 

to the System Manager/Policy 

Coordinating Official at the address 

specified in the ‘‘System Manager’’ 

section above. The requester must verify 

his or her identity by providing either 

a notarization of the request or a written 

certification that the requester is who or 

she claims to be and understands that 

the knowing and willful request for 

access to a record pertaining to an 

individual from an agency under false 

pretenses is a criminal offense under the 

Privacy Act, subject to a fine of up to 

five thousand dollars. Requesters may 

also ask for an accounting of disclosures 

that have been made of their records, if 

any. 

CONTESTING RECORD PROCEDURES: 

An individual seeking to amend a 

record about him or her in this system 

of records must submit a written request 

to the System Manager indicated above, 

verify his or her identity in the same 

manner as is required for an access 

request, and reasonably identify the 

record and specify the information 

being contested, the corrective action 

sought, and the reasons for requesting 

the correction, along with any 

supporting documentation. The right to 

contest records is limited to information 

that is incomplete, incorrect, untimely, 

or irrelevant. 

NOTIFICATION PROCEDURES: 

An individual who wishes to know if 

this system of records contains records 

about him or her must submit a written 

request to the System Manager indicated 

above, and must verify his or her 

identity in the same manner as is 

required for an access request. 

EXEMPTIONS PROMULGATED FOR THE SYSTEM: 

None. 

HISTORY: 

80 FR 17893 (Apr. 2, 2015), 83 FR 

6591 (Feb. 14, 2018). 

[FR Doc. 2022–01771 Filed 1–27–22; 8:45 am] 

BILLING CODE 4184–81–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–D–5225] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Foreign Supplier 

Verification Programs for Food 

Importers 

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 the information 

collection requirements associated with 

our Foreign Supplier Verification 

Programs for Food Importers. 

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– 

2017–D–5225 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; Foreign 

Supplier Verification Programs for Food 

Importers.’’ 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 


jspears on DSK121TN23PROD with NOTICES1
4608 Federal Register / Vol. 87, No. 19 / Friday, January 28, 2022 / Notices 

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: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–5733, 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. 

Foreign Supplier Verification Programs 

(FSVP) for Food Importers—21 CFR 

Part 1, Subpart L 

OMB Control Number 0910–0752— 

Extension 

This information collection supports 

FDA regulations in 21 CFR part 1, 

subpart L (21 CFR 1.500 through 1.514), 

which help to implement section 805 of 

the Federal Food, Drug, and Cosmetic 

Act (FD&C Act) (21 U.S.C. 384a). 

Section 805 authorizes the Agency’s 

FSVP and establishes requirements 

applicable to imported food. 

Respondents to the information 

collection are importers, as defined in 

section 805(a)(1) of the FD&C Act. The 

regulations are intended to provide 

verification that imported food is 

produced in compliance with statutory 

requirements that include the 

implementation of appropriate riskbased preventive controls. The 

regulations also establish that importers 

of foods must develop, maintain, and 

follow an FSVP that provides adequate 

assurances a foreign supplier is 

producing the food in compliance with 

processes and procedures that provide 

at least the same level of public health 

protection as those required under 

section 418 of the FD&C Act (21 U.S.C. 

350g) (regarding hazard analysis and 

risk-based preventive controls for 

certain foods) or 419 (21 U.S.C. 350h) 

(regarding standards for produce safety), 

if either is applicable, and the 

implementing regulations, and is 

producing the food in compliance with 

sections 402 (21 U.S.C. 342) (regarding 

adulteration) and 403(w) (21 U.S.C. 

343(w)) (if applicable) (regarding 

misbranding with respect to labeling for 

the presence of major food allergens) of 

the FD&C Act. The regulations also 

provide for certain exemptions. To 

assist respondents with understanding 

the requirements we have developed 

Agency guidance, available at: https://

www.fda.gov/food/food-safetymodernization-act-fsma/fsma-final-ruleforeign-supplier-verification-programsfsvp-importers-food-humans-andanimals. 

Specifically, regulations in 21 CFR 

1.501 set forth the applicability of 

requirements for FSVP, while 

regulations in sections 1.502 through 

1.508, prescribe specific activities for 

developing, maintaining, and following 

an FSVP; as well as for evaluating 

compliance and for identifying and 

correcting hazards. Finally, regulations 

in section 1.509 identify required data 

elements applicable to food products 

offered for importation into the United 

States, while regulations in 1.510 govern 

required records, providing that records 

be made available to FDA upon request 

and that records be maintained 

electronically. On May 10, 2021, FDA 

launched the FSVP Importer Portal for 

FSVP Records Submission as a means 

for importers to upload FSVP records 

electronically and submit them to the 

Agency, after receiving a request for 

records from FDA. The portal may be 

found at https://www.access.fda.gov/, 

and a user guide is available at https:// 

www.fda.gov/media/148312/download. 

We estimate the burden for the 

information collection as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Exemption for food for research; 1.501(c) ............... 36,360 40 1,454,400 0.083 (5 minutes) ...... 120,715 

Identifier for filing with U.S. Customs and Border 

Protection; 1.509.

56,800 157 8,917,600 0.02 (1.2 minutes) ..... 178,352 


jspears on DSK121TN23PROD with NOTICES1
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