1508 Federal Register / Vol. 86, No. 5 / Friday, January 8, 2021 / Notices 

CONTACT). All nominations for 

nonvoting industry representatives 

should be submitted electronically by 

accessing the FDA Advisory Committee 

Membership Nomination Portal: https:// 

www.accessdata.fda.gov/scripts/ 

FACTRSPortal/FACTRS/index.cfm or by 

mail to Advisory Committee Oversight 

and Management Staff, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, Rm. 5103, Silver Spring, 

MD 20993–0002. Information about 

becoming a member of an FDA advisory 

committee can also be obtained by 

visiting FDA’s website at https://

www.fda.gov/AdvisoryCommittees/ 

default.htm. 

FOR FURTHER INFORMATION CONTACT: 

Margaret Ames, Division of 

Management Services, Center for 

Devices and Radiological Health, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 66, Rm. 5213, 

Silver Spring, MD 20993, 301–796– 

5960, email: margaret.ames@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

Agency is requesting nominations for 

nonvoting industry representative on 

the National Mammography Quality 

Assurance Advisory Committee: 

I. General Description of the Committee 

Duties 

The Committee shall advise FDA on: 

(1) Developing appropriate quality 

standards and regulations for 

mammography facilities; (2) developing 

appropriate standards and regulations 

for bodies accrediting mammography 

facilities under this program; (3) 

developing regulations with respect to 

sanctions; (4) developing procedures for 

monitoring compliance with standards; 

(5) establishing a mechanism to 

investigate consumer complaints; (6) 

reporting new developments concerning 

breast imaging that should be 

considered in the oversight of 

mammography facilities; (7) 

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 these areas; (8) 

determining whether there will exist a 

sufficient number of medical physicists 

after October 1, 1999; and (9) 

determining the costs and benefits of 

compliance with these requirements. 

II. Selection Procedure 

Any industry organization interested 

in participating in the selection of an 

appropriate nonvoting member to 

represent industry interests should send 

a letter stating that interest to the FDA 

contact (see FOR FURTHER INFORMATION

CONTACT) within 30 days of publication 

of this document (see DATES). Within the 

subsequent 30 days, FDA will send a 

letter to each organization that has 

expressed an interest, attaching a 

complete list of all such organizations; 

and a list of all nominees along with 

their current re ́sume ́s. The letter will 

also state that it is the responsibility of 

the interested organizations to confer 

with one another and to select a 

candidate, within 60 days after the 

receipt of the FDA letter, to serve as the 

nonvoting member to represent industry 

interests for the committee. The 

interested organizations are not bound 

by the list of nominees in selecting a 

candidate. However, if no individual is 

selected within 60 days, the 

Commissioner will select the nonvoting 

member to represent industry interests. 

III. Nomination Procedure 

Individuals may self-nominate and/or 

an organization may nominate one or 

more individuals to serve as a nonvoting 

industry representative. Nominations 

must include a current, complete 

re ́sume ́ or curriculum vitae for each 

nominee including current business 

address and telephone number, email 

address if available, and a signed copy 

of the Acknowledgement and Consent 

form available at the FDA Advisory 

Nomination Portal (see ADDRESSES). 

Nominations must also specify the 

advisory committee for which the 

nominee is recommended. Nominations 

must also acknowledge that the 

nominee is aware of the nomination 

unless self-nominated. FDA will 

forward all nominations to the 

organizations expressing interest in 

participating in the selection process for 

the committee. (Persons who nominate 

themselves as nonvoting industry 

representatives will not participate in 

the selection process.) 

FDA seeks to include the views of 

women and men, members of all racial 

and ethnic groups, and individuals with 

and without disabilities on its advisory 

committees and therefore encourages 

nominations of appropriately qualified 

candidates from these groups. 

Specifically, in this document, 

nominations for a nonvoting 

representative of industry interests are 

encouraged from the mammography 

manufacturing industry. 

This notice is issued under the 

Federal Advisory Committee Act (5 

U.S.C. app. 2) and 21 CFR part 14, 

relating to advisory committees. 

Dated: January 4, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–00122 Filed 1–7–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–1031] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Food and Drug 

Administration Recall Regulations 

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 provisions associated with 

FDA recalls for products regulated by 

the Agency. 

DATES: Submit either electronic or 

written comments on the collection of 

information by March 9, 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 March 9, 

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

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of March 9, 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 


tkelley on DSKBCP9HB2PROD with NOTICES
Federal Register / Vol. 86, No. 5 / Friday, January 8, 2021 / Notices 1509 

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–N–1031 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; FDA 

Recall Regulations.’’ 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. 

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. 

FDA Recall Regulations—21 CFR Part 7 

OMB Control Number 0910–0249— 

Extension 

This information collection helps 

support implementation of section 701 

of the Federal Food, Drug, and Cosmetic 

Act (21 U.S.C. 371) pertaining to 

product recalls, and regulations in part 

7 (21 CFR part 7), subpart C 

promulgated to clarify and explain 

associated practices and procedures. 

Regulations in part 7, subpart C §§ 7.49, 

7.50, and 7.59 (21 CFR 7.49, 7.50, and 

7.59) apply specifically to product 

recalls, which may be undertaken 

voluntarily and at any time by 

manufacturers and distributors, or at the 

request of the Agency. Recalls are 

terminated when all reasonable efforts 

have been made to remove or correct the 

product in accordance with the recall 

strategy. The regulations also provide 

for corrective actions to be taken 

regarding violative products and 

establish specific requirements that 

enable us to monitor and assess the 

adequacy of a firm’s efforts in this 

regard. The provisions include reporting 

to FDA on the initiation and termination 

of a recall, as well as submitting recall 

status reports and making required 

communication disclosures. Specific 

guidance regarding recalls is set forth in 

§ 7.59, although product-specific 

guidance documents may also be 

developed to assist respondents to the 

information collection. Agency 

guidance documents are issued in 

accordance with our good guidance 

regulations in 21 CFR 10.115, which 

provide for public comment at any time. 

Consistent with § 7.50, all recalls 

monitored by FDA are included in an 

‘‘Enforcement Report’’ once they are 

classified and may be listed prior to 

classification when FDA determines the 

firm’s removal or correction of a 

marketed product(s) meets the 

definition of a recall. Recall data in the 

Enforcement Report can be accessed 

through the weekly report publication, 

the quick and advanced search 

functionalities, and an Application 


tkelley on DSKBCP9HB2PROD with NOTICES
1510 Federal Register / Vol. 86, No. 5 / Friday, January 8, 2021 / Notices 

Programming Interface (API). 

Instructions for navigating the report, 

accessing and using the API, and 

definitions of the report contents are 

found at https://www.fda.gov/safety/ 

enforcement-reports/enforcementreport-information-and-definitions.com. 

We estimate the burden of the 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity; 21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total 

annual 

responses 

Average 

burden per 

response 

Total hours 

Firm initiated recall; § 7.46 ................................................... 2,779 1 2,779 25 69,475 

Termination of recall; § 7.55 ................................................ 2,095 1 2,095 10 20,950 

Recall status reports; § 7.53 ................................................ 2,779 13 36,127 10 361,270 

Total .............................................................................. ........................ ........................ 41,001 ........................ 451,695 

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

A review of Agency data shows that 

8,337 recalls were conducted during 

fiscal years 2017 through 2019, for an 

average of 2,779 recalls annually. We 

assume an average of 25 hours is needed 

to submit the requisite notification to 

FDA, for a total annual burden of 69,475 

hours. Similarly, during the same 

period, 6,287 recalls were terminated, 

for an average of 2,095 recall 

terminations annually, and we assume 

an average of 10 hours is needed for the 

corresponding information collection 

activity. To determine burden 

associated with recall status reports we 

divided the average number of annual 

submissions (36,127) by the average 

number of annual respondents (2,779) 

and assume 10 hours is necessary for 

the corresponding information 

collection, resulting in 361,270 hours 

annually. 

TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

Activity; 21 CFR part Number of 

respondents 

Number of 

disclosures 

per 

respondent 

Total 

annual 

disclosures 

Average burden per 

disclosure Total hours 

Recall communications; 

§ 7.49.

2,779 ........................... 445 1,236,655 .................... 0.05 (3 minutes) .......... 61,832.75 

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

To determine burden associated with 

recall communication disclosures 

described in § 7.49, we calculated an 

average of 445 disclosures per recall and 

attribute 3 minutes for each disclosure, 

resulting in 61,832.75 burden hours 

annually. 

These estimates reflect an overall 

decrease in the average number of 

annual responses by 245,846 and a 

decrease in the average number of 

annual burden hours by 70,949.25 since 

our last submission for OMB review and 

approval of the information collection. 

Dated: January 4, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–00125 Filed 1–7–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–N–0008] 

Request for Nominations for 

Individuals and Consumer 

Organizations for Advisory 

Committees 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is requesting that 

any consumer organizations interested 

in participating in the selection of 

voting and/or nonvoting consumer 

representatives to serve on its advisory 

committees or panels notify FDA in 

writing. FDA is also requesting 

nominations for voting and/or 

nonvoting consumer representatives to 

serve on advisory committees and/or 

panels for which vacancies currently 

exist or are expected to occur in the near 

future. Nominees recommended to serve 

as a voting or nonvoting consumer 

representative may be self-nominated or 

may be nominated by a consumer 

organization. FDA seeks to include the 

views of women and men, members of 

all racial and ethnic groups, and 

individuals with and without 

disabilities on its advisory committees 

and, therefore, encourages nominations 

of appropriately qualified candidates 

from these groups. 

DATES: Any consumer organization 

interested in participating in the 

selection of an appropriate voting or 

nonvoting member to represent 

consumer interests on an FDA advisory 

committee or panel may send a letter or 

email stating that interest to FDA (see 

ADDRESSES) by January 29, 2021, for 

vacancies listed in this notice. 

Concurrently, nomination materials for 

prospective candidates should be sent to 

FDA (see ADDRESSES) by February 8, 

2021. Nominations will be accepted for 

current vacancies and for those that will 

or may occur through December 31, 

2021. 

ADDRESSES: All statements of interest 

from consumer organizations interested 

in participating in the selection process 

should be submitted electronically to 

ACOMSSubmissions@fda.hhs.gov, by 


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