Request for Nominations on the National Mammography Quality Assurance Advisory Committee, 1507-1508 [2021-00122]
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Federal Register / Vol. 86, No. 5 / Friday, January 8, 2021 / Notices
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
Number of
respondents
Activity
Number of
responses per
respondent
Total annual
responses
(15
(15
(15
(15
minutes)
minutes)
minutes)
minutes)
Total hours
New Non-Employee Data Form ...............................
Proof of Health Insurance ........................................
Emergency Contact Information ..............................
UFMS Supplier and Site Information for Stipend
Payments, Financial Information.
CONCUR GOV New Traveler Profile ......................
Absence Recording Form ........................................
Personal Custody Property Record .........................
FDA Health Summary ..............................................
Discovery and Invention Form .................................
Training Development Plan .....................................
Final Project Report .................................................
Training Request ......................................................
Travel Request .........................................................
LMS Access .............................................................
SOP Verification .......................................................
Program Evaluation .................................................
Exit Checklist ...........................................................
1,220
600
1,220
600
1
1
1
1
1
1
1
1
0.25
0.25
0.25
0.25
......
......
......
......
305
150
305
150
620
1,220
1,220
1,220
1,220
1,220
1,220
610
610
1,220
1,220
1,220
1,220
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
0.25 (15 minutes) ......
0.25 (15 minutes) ......
0.25 (15 minutes) ......
1 ................................
1 ................................
1 ................................
1 ................................
0.5 (30 minutes) ........
0.5 (30 minutes) ........
0.25 (15 minutes) ......
0.25 (15 minutes) ......
0.5 (30 minutes) ........
1 ................................
155
305
305
1,220
1,220
1,220
1,220
305
305
305
305
610
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]
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.
BILLING CODE 4164–01–P
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
SUMMARY:
tkelley on DSKBCP9HB2PROD with NOTICES
Average burden per
response
VerDate Sep<11>2014
21:23 Jan 07, 2021
Jkt 253001
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
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.
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.
DATES:
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
ADDRESSES:
E:\FR\FM\08JAN1.SGM
08JAN1
1508
Federal Register / Vol. 86, No. 5 / Friday, January 8, 2021 / Notices
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:
tkelley on DSKBCP9HB2PROD with NOTICES
CONTACT).
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
VerDate Sep<11>2014
21:23 Jan 07, 2021
Jkt 253001
contact (see FOR FURTHER INFORMATION
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.
CONTACT)
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.
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
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.
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.
SUMMARY:
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
E:\FR\FM\08JAN1.SGM
08JAN1
Agencies
[Federal Register Volume 86, Number 5 (Friday, January 8, 2021)]
[Notices]
[Pages 1507-1508]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-00122]
-----------------------------------------------------------------------
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
[[Page 1508]]
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: [email protected].
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 r[eacute]sum[eacute]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
r[eacute]sum[eacute] 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