Federal Register / Vol. 87, No. 118 / Tuesday, June 21, 2022 / Notices 36859 

information collection, OMB Control 

No. 9000–0114 will be discontinued. 

The burden requirements previously 

approved under the discontinued 

number will be covered under OMB 

Control No. 9000–0082. 

This clearance covers the information 

that offerors or contractors must submit 

to comply with the following FAR 

requirements: 

FAR clause 52.207–3, Right of First 

Refusal of Employment, requires 

contractors to provide the contracting 

officer, within 120 days of beginning 

contract performance, the names of 

personnel who were: Adversely affected 

or separated from Government 

employment as a result of the contract 

award; and subsequently hired by the 

contractor to perform under the contract 

within 90 days after contract 

performance began. The information 

provided under this clause is used by 

the Government to ensure: Contractor 

compliance with providing the right of 

first refusal to such affected personnel; 

and certain obligations to displaced 

employees are met by the Government. 

FAR provision 52.207–4, Economic 

Purchase Quantity—Supplies, permits 

offerors, who believe that acquisition of 

supplies in quantity different from what 

is being solicited would be more 

advantageous to the Government, to 

recommend with their offer a more 

economic purchase quantity for the 

required supplies. The information 

provided under this provision is used 

by the Government to acquire supplies 

at the total and unit costs most 

advantageous to the Government and to 

develop a database for future 

acquisitions of such items of supply. 

C. Annual Burden 

Respondents: 14,510. 

Total Annual Responses: 14,510. 

Total Burden Hours: 14,530. 

D. Public Comment 

A 60-day notice was published in the 

Federal Register at 87 FR 19515, on 

April 4, 2022. No comments were 

received. 

Obtaining Copies: Requesters may 

obtain a copy of the information 

collection documents from the GSA 

Regulatory Secretariat Division, by 

calling 202–501–4755 or emailing 

GSARegSec@gsa.gov. Please cite OMB 

Control No. 9000–0082, Federal 

Acquisition Regulation Part 7 

Requirements. 

Janet Fry, 

Director, Federal Acquisition Policy Division, 

Office of Governmentwide Acquisition Policy, 

Office of Acquisition Policy, Office of 

Governmentwide Policy. 

[FR Doc. 2022–13218 Filed 6–17–22; 8:45 am] 

BILLING CODE 6820–EP–P 

GENERAL SERVICES 

ADMINISTRATION 

[Notice–MRB–2022–02; Docket No. 2022– 

0002; Sequence No. 6] 

Notice of Establishment of a Federal 

Advisory Committee 

AGENCY: Office of Government-wide 

Policy (OGP), General Services 

Administration (GSA). 

ACTION: Notice. 

SUMMARY: The U.S. General Services 

Administration (GSA) is announcing the 

establishment of the GSA Acquisition 

Policy Federal Advisory Committee 

(hereinafter ‘‘the Committee’’ or ‘‘the 

GAP FAC’’) in accordance with the 

provisions of the Federal Advisory 

Committee Act (FACA). 

DATES: June 21, 2022. 

FOR FURTHER INFORMATION CONTACT: 

Boris Arratia, OGP, 703–795–0816, or 

Stephanie Hardison, OGP, 202–258– 

6823, or email: gapfac@gsa.gov. 

SUPPLEMENTARY INFORMATION: The 

Administrator of GSA established the 

GSA Acquisition Policy Federal 

Advisory Committee (GAP FAC) as a 

discretionary advisory committee under 

agency authority in accordance with the 

provisions of FACA (5 U.S.C. App 2). 

GSA has determined that the 

establishment of GAP FAC is necessary 

and in the public interest. 

As America’s buyer, GSA is uniquely 

positioned to enable a modern, 

accessible, and streamlined acquisition 

ecosystem and a robust marketplace 

connecting buyers to the suppliers and 

businesses that meet their mission 

needs. The GAP FAC will assist GSA in 

this endeavor through expert advice on 

a broad range of innovative solutions to 

acquisition policy, workforce and 

industry partnership challenges. 

The GAP FAC will serve as an 

advisory body to GSA’s Administrator 

on how GSA can use its acquisition 

tools and authorities to target the 

highest priority Federal acquisition 

challenges. The GAP FAC will advise 

GSA’s Administrator on emerging 

acquisition issues, challenges, and 

opportunities to support its role as 

America’s buyer. The initial focus for 

the GAP FAC will be on driving 

regulatory, policy, and process changes 

required to embed climate and 

sustainability considerations in Federal 

acquisition. This includes examining 

and recommending steps GSA can take 

to support its workforce and industry 

partners in ensuring climate and 

sustainability issues are fully 

considered in the acquisition process. In 

accordance with FACA, the charter for 

the Committee will be filed with the 

appropriate entities no earlier than 15 

calendar days following the date of 

publication of this notice. 

Krystal Brumfield, 

Associate Administrator, Office of 

Government-wide Policy, General Services 

Administration. 

[FR Doc. 2022–13223 Filed 6–17–22; 8:45 am] 

BILLING CODE 6820–61–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–D–0737] 

Non-Clinical Performance Assessment 

of Tissue Containment Systems Used 

During Power Morcellation 

Procedures; Draft Guidance for 

Industry and Food and Drug 

Administration Staff; 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 the draft 

guidance entitled ‘‘Non-Clinical 

Performance Assessment of Tissue 

Containment Systems Used During 

Power Morcellation Procedures.’’ This 

draft guidance document provides 

recommendations that may help 

manufacturers comply with the special 

controls related to non-clinical 

performance data for gynecologic and 

general laparoscopic power 

morcellation containment systems. This 

draft guidance is not final nor is it for 

implementation at this time. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by August 22, 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: 


jspears on DSK121TN23PROD with NOTICES1
36860 Federal Register / Vol. 87, No. 118 / Tuesday, June 21, 2022 / Notices 

• 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–0737 for ‘‘Non-Clinical 

Performance Assessment of Tissue 

Containment Systems Used During 

Power Morcellation Procedures.’’ 

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)). 

An electronic copy of the guidance 

document is available for download 

from the internet. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. Submit written requests for a 

single hard copy of the draft guidance 

document entitled ‘‘Non-Clinical 

Performance Assessment of Tissue 

Containment Systems Used During 

Power Morcellation Procedures’’ to the 

Office of Policy, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5431, Silver Spring, 

MD 20993–0002. Send one selfaddressed adhesive label to assist that 

office in processing your request. 

FOR FURTHER INFORMATION CONTACT: 

Prasanna Hariharan, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 62, Rm. 2222, Silver Spring, 

MD 20993–0002, 301–796–2689. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is issuing this draft guidance to 

provide recommendations that may help 

manufacturers comply with the special 

controls related to non-clinical 

performance data for gynecologic and 

general laparoscopic power 

morcellation containment systems. 

These devices are class II (special 

controls) devices and subject to 

premarket notification (510(k)) 

requirements. These tissue containment 

systems are prescription devices 

consisting of an instrument port and 

tissue containment method that create a 

working space allowing for direct 

visualization during a power 

morcellation procedure following a 

laparoscopic procedure for the excision 

of benign tissue that is not suspected to 

contain malignancy. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the current thinking of FDA 

on the topic of the guidance. 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. Electronic Access 

Persons interested in obtaining a copy 

of the draft guidance may do so by 

downloading an electronic copy from 

the internet. A search capability for all 

Center for Devices and Radiological 

Health guidance documents is available 

at https://www.fda.gov/medical-devices/ 

device-advice-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. This 

guidance document is also available at 

https://www.regulations.gov or https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents. 

Persons unable to download an 

electronic copy of ‘‘Non-Clinical 

Performance Assessment of Tissue 

Containment Systems Used During 

Power Morcellation Procedures’’ may 

send an email request to CDRHGuidance@fda.hhs.gov to receive an 

electronic copy of the document. Please 

use the document number 19015 and 

complete title to identify the guidance 

you are requesting. 

III. Paperwork Reduction Act of 1995 

While this guidance contains no new 

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 


jspears on DSK121TN23PROD with NOTICES1
Federal Register / Vol. 87, No. 118 / Tuesday, June 21, 2022 / Notices 36861 

OMB under the PRA. The collections of 

information in the following FDA 

regulation and guidance have been 

approved by OMB as listed in the 

following table: 

21 CFR part or guidance Topic OMB control 

No. 

807, subpart E .............................................................................................................. Premarket notification ............................... 0910–0120 

‘‘Requests for Feedback and Meetings for Medical Device Submissions: The QSubmission Program’’.Q-submissions .......................................... 0910–0756 

Dated: June 14, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–13212 Filed 6–17–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–N–0799] 

Improving 510(k) Submission 

Preparation and Review: Center for 

Biologics Evaluation and Research; 

Voluntary Electronic Submission 

Template and Resource Pilot Program; 

Request for Comments 

AGENCY: Food and Drug Administration, 

Department of Health and Human 

Services (HHS). 

ACTION: Notice; request for comments. 

SUMMARY: The Food and Drug 

Administration’s (FDA or Agency) 

Center for Biologics Evaluation and 

Research (CBER) is announcing a pilot 

program for sponsors of CBER 

premarket notification (510(k)) 

submissions that wish to use the 

voluntary Electronic Submission 

Template and Resource (eSTAR) Pilot 

Program. CBER’s voluntary eSTAR Pilot 

Program is intended to improve 

consistency and efficiency in both 

industry’s preparation and FDA’s 

review of premarket notification (510(k)) 

submissions. During CBER’s voluntary 

eSTAR Pilot Program, participants will 

have the opportunity to provide input to 

FDA on the eSTAR Pilot Program for 

submissions to CBER. 

DATES: FDA is seeking participation in 

CBER’s voluntary eSTAR Pilot Program 

beginning June 21, 2022. See section 

I.A. for instructions on how to submit a 

request to participate. The CBER 

voluntary eSTAR Pilot Program will 

select up to nine participants who best 

match the selection criteria. This pilot 

program will begin June 21, 2022. 

Submit either electronic or written 

comments on the notice by August 22, 

2022. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 

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

August 22, 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– 

2022–N–0799 for ‘‘Improving 510(k) 

Submission Preparation and Review: 

Center for Biologics Evaluation and 

Research; Voluntary Electronic 

Submission Template and Resource 

Pilot Program.’’ 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. 


jspears on DSK121TN23PROD with NOTICES1