Federal Register / Vol. 86, No. 169 / Friday, September 3, 2021 / Notices 49537 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10637] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, Health and Human 

Services (HHS). 

ACTION: Notice. 

SUMMARY: The Centers for Medicare & 

Medicaid Services (CMS) is announcing 

an opportunity for the public to 

comment on CMS’ intention to collect 

information from the public. 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 or reinstatement of an existing 

collection of information, and to allow 

a second opportunity for public 

comment on the notice. Interested 

persons are invited to send comments 

regarding the burden estimate or any 

other aspect of this collection of 

information, including the necessity and 

utility of the proposed information 

collection for the proper performance of 

the agency’s functions, the accuracy of 

the estimated burden, ways to enhance 

the quality, utility, and clarity of the 

information to be collected, and the use 

of automated collection techniques or 

other forms of information technology to 

minimize the information collection 

burden. 

DATES: Comments on the collection(s) of 

information must be received by the 

OMB desk officer by October 4, 2021. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice to www.reginfo.gov/public/do/ 

PRAMain . Find this particular 

information collection by selecting 

‘‘Currently under 30-day Review—Open 

for Public Comments’’ or by using the 

search function. 

To obtain copies of a supporting 

statement and any related forms for the 

proposed collection(s) summarized in 

this notice, you may make your request 

using one of following: 

1. Access CMS’ website address at 

website address at: https://

www.cms.gov/Regulations-andGuidance/Legislation/Paperwork

ReductionActof1995/PRA-Listing.html. 

FOR FURTHER INFORMATION CONTACT: 

William Parham at (410) 786–4669. 

SUPPLEMENTARY INFORMATION: Under the 

Paperwork Reduction Act of 1995 (PRA) 

(44 U.S.C. 3501–3520), federal agencies 

must obtain approval from the Office of 

Management and Budget (OMB) for each 

collection of information they conduct 

or sponsor. The term ‘‘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 publish a 30-day notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension or 

reinstatement of an existing collection 

of information, before submitting the 

collection to OMB for approval. To 

comply with this requirement, CMS is 

publishing this notice that summarizes 

the following proposed collection(s) of 

information for public comment: 

1. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Marketplace 

Operations; Use: The data collections 

and third-party disclosure requirements 

will assist HHS in determining 

Exchange compliance with Federal 

standards and monitoring QHP issuers 

in FFEs for compliance with Federal 

QHP issuer standards. The data 

collection will also assist HHS in 

monitoring Web-brokers for compliance 

with Federal Web-broker standards. The 

data collected by health insurance 

issuers and Exchanges will help to 

inform HHS, Exchanges, and health 

insurance issuers as to the participation 

of individuals, employers, and 

employees in the individual Exchange, 

the SHOP, and the premium 

stabilization programs. Form Number: 

CMS–10637 (OMB control number 

0938–1353); Frequency: Annually; 

Affected Public: Private sector (Business 

or other for-profits); Number of 

Respondents: 3,902; Total Annual 

Responses: 3,902; Total Annual Hours: 

2,336,190. (For policy questions 

regarding this collection contact: 

Nikolas Berkobien at 301–492–4400.) 

Dated: August 31, 2021. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2021–19142 Filed 9–2–21; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2019–N–3402] 

Advisory Committee; National 

Mammography Quality Assurance 

Advisory Committee; Renewal 

AGENCY: Food and Drug Administration, 

Health and Human Services (HHS). 

ACTION: Notice; renewal of advisory 

committee. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

renewal of the National Mammography 

Quality Assurance Advisory Committee 

by the Commissioner of Food and Drugs 

(the Commissioner). The Commissioner 

has determined that it is in the public 

interest to renew the National 

Mammography Quality Assurance 

Advisory Committee for an additional 2 

years beyond the charter expiration 

date. The new charter will be in effect 

until July 7, 2023, expiration date. 

DATES: Authority for the National 

Mammography Quality Assurance 

Advisory Committee will expire on July 

7, 2023, unless the Commissioner 

formally determines that renewal is in 

the public interest. 

FOR FURTHER INFORMATION CONTACT: 

Aden Asefa, Office of Management, 

Center for Devices and Radiological 

Health, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 66, 

Rm. 5214, Silver Spring, MD 20993– 

0002, 301–796–0400, email: 

aden.asefa@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Pursuant 

to 41 CFR 102–3.65 and approval by the 

Department of Health and Human 

Services pursuant to 45 CFR part 11 and 

by the General Services Administration, 

FDA is announcing the renewal of the 

National Mammography Quality 

Assurance Advisory Committee (the 

Committee). The committee is a nondiscretionary Federal advisory 

committee established to provide advice 

to the Commissioner. 

The Commissioner is charged with 

the administration of the Federal Food, 

Drug and Cosmetic Act and various 

provisions of the Public Health Service 

Act. The Mammography Quality 

Standards Act of 1992 amends the 

Public Health Service Act to establish 

national uniform quality and safety 

standards for mammography facilities. 

The National Mammography Quality 

Assurance Advisory Committee advises 

the Secretary and, by delegation, the 

Commissioner or designee in 

discharging their responsibilities with 


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49538 Federal Register / Vol. 86, No. 169 / Friday, September 3, 2021 / Notices 

respect to establishing a mammography 

facilities certification program. The 

Committee shall advise the HHS 

Secretary and the Commissioner or 

designee on: 

(A) Developing appropriate quality 

standards and regulations for 

mammography facilities; 

(B) Developing appropriate standards 

and regulations for bodies accrediting 

mammography facilities under this 

program; 

(C) Developing regulations with 

respect to sanctions; 

(D) Developing procedures for 

monitoring compliance with standards; 

(E) Establishing a mechanism to 

investigate consumer complaints; 

(F) Reporting new developments 

concerning breast imaging which should 

be considered in the oversight of 

mammography facilities; 

(G) Determining whether there exists 

a shortage of mammography facilities in 

rural and health professional shortage 

areas and determining the effects of 

personnel on access to the services of 

such facilities in such areas; 

(H) Determining whether there will 

exist a sufficient number of medical 

physicists after October 1, 1999; and 

(I) Determining the costs and benefits 

of compliance with these requirements. 

The Committee shall consist of a core 

of 15 members, including the Chair. 

Members and the Chair are selected by 

the Commissioner or designee from 

among physicians, practitioners, and 

other health professionals, whose 

clinical practice, research 

specialization, or professional expertise 

includes a significant focus on 

mammography. Members will be invited 

to serve for overlapping terms of up to 

4 years. Almost all members of this 

committee serve as Special Government 

Employees. The core of voting members 

shall include at least four individuals 

from among national breast cancer or 

consumer health organizations with 

expertise in mammography, and at least 

two practicing physicians who provide 

mammography services. In addition to 

the voting members, the Committee 

shall include two nonvoting industry 

representative members who have 

expertise in mammography equipment. 

The Committee may include one 

technically qualified member, selected 

by the Commissioner or designee, who 

is identified with consumer interests. 

Further information regarding the 

most recent charter and other 

information can be found at https://

www.fda.gov/AdvisoryCommittees/ 

CommitteesMeetingMaterials/RadiationEmittingProducts/ 

NationalMammography

QualityAssuranceAdvisoryCommittee/ 

ucm520365.htm or by contacting the 

Designated Federal Officer (see FOR

FURTHER INFORMATION CONTACT). In light 

of the fact that no change has been made 

to the committee name or description of 

duties, no amendment will be made to 

21 CFR 14.100. 

This notice is issued under the 

Federal Advisory Committee Act (5 

U.S.C. app.). For general information 

related to FDA advisory committees, 

please visit us at https://www.fda.gov/ 

AdvisoryCommittees/default.htm. 

Dated: August 31, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–19108 Filed 9–2–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–D–0609] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Drug Supply Chain 

Security Act Implementation 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) 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 information 

collection associated with the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act). 

DATES: Submit either electronic or 

written comments on the collection of 

information by November 2, 2021. 

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 November 2, 

2021. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of November 2, 2021. 

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– 

2014–D–0609 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; Drug 

Supply Chain Security Act 

Implementation.’’ 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 


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