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
32172 Federal Register / Vol. 87, No. 103 / Friday, May 27, 2022 / Notices 

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. Send one self-addressed adhesive 

label to assist that office in processing 

your requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Elaine Chang, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, Rm. 2169, 

Silver Spring, MD 20993–0002, 240– 

402–2628. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a 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 GnRH analogues to treat 

advanced prostate cancer. 

This guidance finalizes the draft 

guidance of the same title issued on July 

18, 2019 (84 FR 34400). FDA considered 

comments received on the draft 

guidance as the guidance was finalized. 

Changes from the draft to the final 

guidance included clarifying the scope 

of the guidance in the introduction 

section, adding recommendations on 

safety monitoring, and broadening 

recommendations on the appropriate 

trial population to include metastatic as 

well as biochemically recurrent disease 

rather than only metastatic. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on ‘‘Advanced Prostate 

Cancer: Developing GonadotropinReleasing Hormone Analogues.’’ 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 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 the 

OMB under the PRA. The collections of 

information in 21 CFR part 210 and 211, 

21 CFR part 314, and 21 CFR part 601 

have been approved under OMB control 

numbers 0910–0139, 0910–0001, and 

0910–0338, respectively. The 

collections of information in 21 CFR 

part 312 have been approved under 

OMB control number 0910–0014. The 

collections of information in 21 CFR 

201.56 and 201.57 for the content and 

format of labeling for human 

prescription drug and biological 

products have been approved under 

OMB control number 0910–0572. The 

collections of information in 21 CFR 

part 58 for good laboratory practice have 

been approved under OMB control 

number 0910–0119. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at either 

https://www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents, or https://

www.regulations.gov. 

Dated: May 23, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–11410 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–2022–N–0589] 

General and Plastic Surgery Devices 

Panel of the Medical Devices Advisory 

Committee; Notice of Meeting; 

Establishment of a Public Docket; 

Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; establishment of a 

public docket; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) announces a 

forthcoming public advisory committee 

meeting of the General and Plastic 

Surgery Devices Panel of the Medical 

Devices Advisory Committee. The 

general function of the committee is to 

provide advice and recommendations to 

FDA on regulatory issues. The meeting 

will be open to the public. FDA is 

establishing a docket for public 

comment on this document. 

DATES: The meeting will be held 

virtually on July 28, 2022, from 9 a.m. 

to 5:45 p.m. Eastern Time and July 29, 

2022, from 9 a.m. to 4 p.m. Eastern 

Time. 

ADDRESSES: Please note that due to the 

impact of the COVID–19 pandemic, all 

meeting participants will be joining this 

advisory committee meeting via an 

online teleconferencing platform. 

Answers to commonly asked questions, 

including information regarding special 

accommodations due to a disability, 

may be accessed at: https://

www.fda.gov/AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 

ucm408555.htm. 

FDA is establishing a docket for 

public comment on this meeting. The 

docket number is FDA–2022–N–0589. 

The docket will close on August 29, 

2022. Submit either electronic or 

written comments on this public 

meeting by August 29, 2022. Please note 

that late, untimely filed comments will 

not be considered. Electronic comments 

must be submitted on or before August 

29, 2022. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

August 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. 

Comments received on or before July 

11, 2022, will be provided to the 

committee. Comments received after 

that date will be taken into 

consideration by FDA. In the event that 

the meeting is cancelled, FDA will 

continue to evaluate any relevant 

applications or information, and 

consider any comments submitted to the 

docket, as appropriate. 

You may submit comments 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 


jspears on DSK121TN23PROD with NOTICES1