Federal Register / Vol. 87, No. 103 / Friday, May 27, 2022 / Notices 32169 

costs of the refugee resettlement 

program. ORR must implement the 

methodology at CFR 400.211 each year 

after receipt of its annual appropriation 

to ensure that appropriated funds will 

be adequate for reimbursement to states 

of the costs for assistance provided to 

entering refugees. The estimating 

methodology prescribed in the 

regulations requires the use of actual 

past costs by program component. If the 

methodology indicates that 

appropriated funds are inadequate, ORR 

must take steps to reduce federal 

expenses, such as by limiting the 

number of months of eligibility for 

Refugee Cash Assistance and Refugee 

Medical Assistance. The ORR–2 is a 

single-page financial report that allows 

ORR to collect the necessary data to 

ensure that funds are adequate for the 

projected need and thereby meet the 

requirements of both the Refugee Act 

and ORR regulations. 

Respondents: State governments and 

Replacement Designees. 

ANNUAL BURDEN ESTIMATES

Instrument 

Total 

number of 

respondents 

Total 

number of 

responses per 

respondent 

Average 

burden hours 

per response 

Annual 

burden 

hours 

ORR–2, Cash and Medical Assistance Program Quarterly Report on Expenditures and Obligations .......................................................................... 66 4 1.5 396 

Estimated Total Annual Burden 

Hours: 396. 

Comments: The Department 

specifically requests comments on (a) 

whether the proposed collection of 

information is necessary for the proper 

performance of the functions of the 

agency, including whether the 

information shall have practical utility; 

(b) the accuracy of the agency’s estimate 

of the burden of the proposed collection 

of information; (c) the quality, utility, 

and clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. Consideration will be given 

to comments and suggestions submitted 

within 60 days of this publication. 

Authority: 8 U.S.C. 1522 Sec. 412 and 

8 U.S.C. 524 (Title IV), Sec. 414. 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2022–11409 Filed 5–26–22; 8:45 am] 

BILLING CODE 4184–45–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–N–0557] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Postmarket 

Surveillance of Medical Devices 

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 an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on information 

collection requirements for postmarket 

surveillance of medical devices. 

DATES: Submit either electronic or 

written comments on the collection of 

information by July 26, 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 July 26, 2022. 

The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of July 26, 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–0557 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; 

Postmarket Surveillance of Medical 

Devices.’’ 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 


jspears on DSK121TN23PROD with NOTICES1
32170 Federal Register / Vol. 87, No. 103 / Friday, May 27, 2022 / Notices 

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: 

Amber Sanford, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–8867, 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. 

Postmarket Surveillance of Medical 

Devices—21 CFR Part 822 

OMB Control Number 0910–0449— 

Extension 

Section 522 of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 360l) 

authorizes FDA to require a 

manufacturer to conduct postmarket 

surveillance (PS) of any device that 

meets the criteria set forth in the statute. 

The PS regulation establishes 

procedures that FDA uses to approve 

and disapprove PS plans. The regulation 

provides instructions to manufacturers, 

so they know what information is 

required in a PS plan submission. FDA 

reviews PS plan submissions in 

accordance with 21 CFR 822.15 through 

822.19 of the regulation, which describe 

the grounds for approving or 

disapproving a PS plan. In addition, the 

PS regulation provides instructions to 

manufacturers to submit interim and 

final reports in accordance with 21 CFR 

822.38. Respondents to this collection of 

information are those manufacturers 

that require PS of their products. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR part/activity Number of 

respondents 

Number of 

responses per 

respondent 

Total 

annual 

responses 

Average 

burden per 

response 

Total 

hours 

§§ 822.9 and 822.10; PS submission .................................. 5 1 5 120 600 

§ 822.21; Changes to PS plan after approval ..................... 9 1 9 40 360 

§ 822.28; Changes to PS plan for a device that is no 

longer marketed ............................................................... 1 1 1 8 8 

§ 822.29; Waiver .................................................................. 0 0 0 40 0 

§ 822.30; Exemption request ............................................... 0 0 0 40 0 

§ 822.38; Periodic reports .................................................... 17 3 51 40 2,040 

Total .............................................................................. ........................ ........................ ........................ ........................ 3,008 

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

Explanation of Reporting Burden 

Estimate: The burden captured in table 

1 is based on the data from FDA’s 

internal tracking system. 21 CFR 822.26, 

822.27, and 822.34 do not constitute 

information collection subject to review 

under the PRA because it entails no 

burden other than that necessary to 

identify the respondent, the date, the 

respondent’s address, and the nature of 

the instrument (see 5 CFR 1320.3(h)(1)). 


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Federal Register / Vol. 87, No. 103 / Friday, May 27, 2022 / Notices 32171 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR part/activity Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total 

annual 

records 

Average 

burden per 

recordkeeping 

Total 

hours 

§ 822.31; Manufacturer records ........................................... 5 1 5 20 100 

§ 822.32; Investigator records .............................................. 15 1 15 5 75 

Total .............................................................................. ........................ ........................ ........................ ........................ 175 

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

Explanation of Recordkeeping Burden 

Estimate: FDA expects that at least some 

of the manufacturers will be able to 

satisfy the PS requirement using 

information or data they already have. 

For purposes of calculating burden, 

however, FDA has assumed that each PS 

order can only be satisfied by a 3-year 

clinically based surveillance plan, using 

three investigators. These estimates are 

based on FDA’s knowledge and 

experience with PS. 

We have adjusted our burden 

estimate, which has resulted in a 

decrease to the currently approved 

burden. Our estimated burden for the 

information collection reflects an 

overall decrease of 4,780 hours and a 

corresponding decrease of 13 responses. 

We believe these adjustments more 

accurately reflect the current number of 

requests associated with postmarket 

surveillance of medical devices. 

Dated: May 23, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–11412 Filed 5–26–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2019–D–2808] 

Advanced Prostate Cancer: 

Developing Gonadotropin-Releasing 

Hormone Analogues; 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 final 

guidance for industry entitled 

‘‘Advanced Prostate Cancer: Developing 

Gonadotropin-Releasing Hormone 

Analogues.’’ This guidance describes 

FDA’s current recommendations 

regarding the overall development 

program and clinical trial designs for 

developing gonadotropin-releasing 

hormone (GnRH) analogues to treat 

advanced prostate cancer. This guidance 

finalizes the draft guidance of the same 

title issued in July 2019. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on May 27, 2022. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances 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– 

2019–D–2808 for ‘‘Advanced Prostate 

Cancer: Developing GonadotropinReleasing Hormone Analogues; 

Guidance for Industry.’’ 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:// 


jspears on DSK121TN23PROD with NOTICES1