Federal Register / Vol. 86, No. 5 / Friday, January 8, 2021 / Notices 1507 

the SOPs for said program. The form 

collects the following: (1) Name; (2) 

signature; (3) date; and (4) center. 

(G) Program evaluation—Participants 

in FDA fellowship and traineeship 

programs will be asked to complete an 

evaluation providing program data that 

will be synthesized into program reports 

on the overall effectiveness of the 

program. The evaluation collects the 

following information: (1) Demographic 

data; (2) expectations of fellowship or 

training program; (3) administration 

processes and support to fellow or 

trainee; (4) FDA retention and plans of 

fellow or trainee; (5) training and 

education completed; and (6) 

professional/research goals. The 

purpose of this evaluation is to assess 

the effectiveness of the program and 

feedback from participants to improve 

the quality of the experience. 

4. To end the program, a nonemployee must submit the exit 

checklist—Participants in FDA 

fellowship and traineeship programs 

may be asked to complete the exit 

checklist to manage the exit process and 

return of FDA property. The exit 

checklist guides the exit process for the 

following operational components: (1) 

Access key/pass; (2) accountable 

property; (3) system applications 

inactive; (4) library materials; (5) 

government-issued documents (i.e., 

passports); (6) personal identity 

verification card/badge; (7) borrowed 

records; (8) employee records; and (9) 

information technology accounts. 

All exit information will be entered to 

terminate access to any FDA 

information. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden per 

response Total hours 

New Non-Employee Data Form ............................... 1,220 1 1 0.25 (15 minutes) ...... 305 

Proof of Health Insurance ........................................ 600 1 1 0.25 (15 minutes) ...... 150 

Emergency Contact Information .............................. 1,220 1 1 0.25 (15 minutes) ...... 305 

UFMS Supplier and Site Information for Stipend 

Payments, Financial Information.

600 1 1 0.25 (15 minutes) ...... 150 

CONCUR GOV New Traveler Profile ...................... 620 1 1 0.25 (15 minutes) ...... 155 

Absence Recording Form ........................................ 1,220 1 1 0.25 (15 minutes) ...... 305 

Personal Custody Property Record ......................... 1,220 1 1 0.25 (15 minutes) ...... 305 

FDA Health Summary .............................................. 1,220 1 1 1 ................................ 1,220 

Discovery and Invention Form ................................. 1,220 1 1 1 ................................ 1,220 

Training Development Plan ..................................... 1,220 1 1 1 ................................ 1,220 

Final Project Report ................................................. 1,220 1 1 1 ................................ 1,220 

Training Request ...................................................... 610 1 1 0.5 (30 minutes) ........ 305 

Travel Request ......................................................... 610 1 1 0.5 (30 minutes) ........ 305 

LMS Access ............................................................. 1,220 1 1 0.25 (15 minutes) ...... 305 

SOP Verification ....................................................... 1,220 1 1 0.25 (15 minutes) ...... 305 

Program Evaluation ................................................. 1,220 1 1 0.5 (30 minutes) ........ 610 

Exit Checklist ........................................................... 1,220 1 1 1 ................................ 1,220 

Total .................................................................. 9,605 

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

FDA published a 60-day notice for 

this information collection on 

November 22, 2019 (84 FR 64536). FDA 

is reopening the 60-day comment period 

in order to satisfy PRA requirements. No 

changes have been made to the 

information collection. 

Dated: January 4, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–00120 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–2018–N–0417] 

Request for Nominations on the 

National Mammography Quality 

Assurance Advisory Committee 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is requesting that 

any industry organizations interested in 

participating in the selection of 

nonvoting industry representatives to 

serve on the National Mammography 

Quality Assurance Advisory Committee 

in the Center for Devices and 

Radiological Health notify FDA in 

writing. FDA is also requesting 

nominations for nonvoting industry 

representatives to serve on the National 

Mammography Quality Assurance 

Advisory Committee. A nominee may 

either be self-nominated or nominated 

by an organization to serve as a 

nonvoting industry representative. 

Nominations will be accepted for 

current vacancies effective with this 

notice. 

DATES: Any industry organization 

interested in participating in the 

selection of appropriate nonvoting 

members to represent industry interests 

must send a letter stating that interest to 

FDA by February 8, 2021 (see sections 

I and II of this document for further 

details). Concurrently, nomination 

materials for prospective candidates 

should be sent to FDA by February 8, 

2021. 

ADDRESSES: All statements of interest 

from industry organizations interested 

in participating in the selection process 

of nonvoting industry representative 

nominations should be sent to Margaret 

Ames (see FOR FURTHER INFORMATION


tkelley on DSKBCP9HB2PROD with NOTICES
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