Request for Nominations of Voting Members on a Public Advisory Committee; National Mammography Quality Assurance Advisory Committee, 66680-66681 [2019-26279]
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66680
Federal Register / Vol. 84, No. 234 / Thursday, December 5, 2019 / Notices
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued
Number of
recordkeepers
21 CFR section; activity
111.180; records associated with components, packaging, labels, and
product received for packaging and labeling as a dietary supplement.
111.210; requirements for what the master manufacturing record must
include.
111.260; requirements for what the batch record must include .............
111.325; records that quality control personnel must make and keep
for laboratory operations.
111.375; records of the written procedures established for manufacturing operations.
111.430; records of the written procedures for packaging and labeling
operations.
111.475; records of product distribution and procedures for holding
and distributing operations.
111.535; records for returned dietary supplements ................................
111.570; records regarding product complaints .....................................
Total .................................................................................................
1 There
Number of
records per
recordkeeper
Total annual
records
Average burden
per recordkeeping
Total hours
240
1,163
279,120
1 ...................................
279,120
240
1
240
2.5 ................................
600
145
120
1,408
1
204,160
120
1 ...................................
15 .................................
204,160
1,800
260
1
260
2 ...................................
520
50
1
50
12.6 ..............................
630
15,000
1
15,000
0.4 (24 minutes) ..........
6,000
110
240
4
600
440
144,000
13.5 ..............................
0.5 (30 minutes) ..........
5,940
72,000
........................
........................
........................
......................................
929,140
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR section; activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average burden
per response
Total hours
111.75; petition for exemption from 100 percent identity testing .................................................................
1
1
1
8
8
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: November 26, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
Quality Assurance Advisory Committee
in the Center for Devices and
Radiological Health. Nominations will
be accepted for upcoming vacancies
effective with this notice.
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.
[FR Doc. 2019–26250 Filed 12–4–19; 8:45 am]
DATES:
We have made no changes to our
estimate of the information collection
based on our most recent review.
However, in consolidating burden from
information collection previously
accounted for under OMB control
number 0910–0608, the information
collection reflects an increase of 8 hours
and one response annually.
Nominations received on or
before February 3, 2020, will be given
first consideration for membership on
the National Mammography Quality
Assurance Advisory Committee.
Nominations received after February 3,
2020, will be considered for nomination
to the committee as later vacancies
occur.
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–3207]
jbell on DSKJLSW7X2PROD with NOTICES
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is requesting
nominations for voting members to
serve on the National Mammography
SUMMARY:
VerDate Sep<11>2014
17:38 Dec 04, 2019
Jkt 250001
All nominations for
membership should be submitted
electronically by logging into the FDA
Advisory Nomination Portal at 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 on an FDA advisory
committee can also be obtained by
visiting FDA’s website at https://
ADDRESSES:
Request for Nominations of Voting
Members on a Public Advisory
Committee; National Mammography
Quality Assurance Advisory
Committee
PO 00000
Frm 00032
Fmt 4703
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www.fda.gov/AdvisoryCommittees/
default.htm.
FOR FURTHER INFORMATION CONTACT:
Regarding all nomination questions for
membership: Sara Anderson, Center for
Devices and Radiological Health, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5210,
Silver Spring, MD 20993, 301–796–
7047, email: Sara.Anderson@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is
requesting nominations for voting
members to fill upcoming vacancies on
the National Mammography Quality
Assurance Advisory Committee.
I. General Description of the Committee
Duties
The National Mammography Quality
Assurance Advisory Committee advises
the Commissioner of Food and Drugs
(the Commissioner) or designee 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
E:\FR\FM\05DEN1.SGM
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Federal Register / Vol. 84, No. 234 / Thursday, December 5, 2019 / Notices
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 such 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. Criteria for Voting Members
III. Nomination Procedures
jbell on DSKJLSW7X2PROD with NOTICES
Any interested person may nominate
one or more qualified persons for
membership on the advisory committee.
Self-nominations are also accepted.
Nominations must include a current,
complete re´sume´ or curriculum vitae for
each nominee, including current
business address, telephone number,
and 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 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 ask
potential candidates to provide detailed
information concerning such matters
related to financial holdings,
employment, and research grants and/or
contracts to permit evaluation of
possible sources of conflict of interest.
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: December 2, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
BILLING CODE 4164–01–P
VerDate Sep<11>2014
17:38 Dec 04, 2019
Jkt 250001
Food and Drug Administration
[Docket No. FDA–2019–D–4656]
Interstitial Cystitis/Bladder Pain
Syndrome: Establishing Effectiveness
of Drugs for Treatment; Draft Guidance
for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled
‘‘Interstitial Cystitis/Bladder Pain
Syndrome (IC/BPS): Establishing
Effectiveness of Drugs for Treatment.’’
There is pharmaceutical and
stakeholder interest in the development
of new drugs for patients with IC/BPS.
This draft guidance provides FDA’s
recommendations for clinical trials
intended to establish clinical
effectiveness and safety for drugs
intended to treat IC/BPS.
DATES: Submit either electronic or
written comments on the draft guidance
by February 3, 2020 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:
SUMMARY:
The committee consists 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.
Almost all non-Federal members of this
committee serve as Special Government
Employees. Members will be invited to
serve for terms of up to 4 years.
[FR Doc. 2019–26279 Filed 12–4–19; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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
PO 00000
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66681
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–
2019–D–4656 for ‘‘Interstitial Cystitis/
Bladder Pain Syndrome (IC/BPS):
Establishing Effectiveness of Drugs for
Treatment.’’ 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.
• 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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
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]]>Agencies
[Federal Register Volume 84, Number 234 (Thursday, December 5, 2019)]
[Notices]
[Pages 66680-66681]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-26279]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-3207]
Request for Nominations of Voting Members on a Public Advisory
Committee; National Mammography Quality Assurance Advisory Committee
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is requesting
nominations for voting members to serve on the National Mammography
Quality Assurance Advisory Committee in the Center for Devices and
Radiological Health. Nominations will be accepted for upcoming
vacancies effective with this notice.
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: Nominations received on or before February 3, 2020, will be
given first consideration for membership on the National Mammography
Quality Assurance Advisory Committee. Nominations received after
February 3, 2020, will be considered for nomination to the committee as
later vacancies occur.
ADDRESSES: All nominations for membership should be submitted
electronically by logging into the FDA Advisory Nomination Portal at
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 on 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: Regarding all nomination questions for
membership: Sara Anderson, Center for Devices and Radiological Health,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm.
5210, Silver Spring, MD 20993, 301-796-7047, email:
[email protected].
SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting
members to fill upcoming vacancies on the National Mammography Quality
Assurance Advisory Committee.
I. General Description of the Committee Duties
The National Mammography Quality Assurance Advisory Committee
advises the Commissioner of Food and Drugs (the Commissioner) or
designee 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
[[Page 66681]]
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 such 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. Criteria for Voting Members
The committee consists 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.
Almost all non-Federal members of this committee serve as Special
Government Employees. Members will be invited to serve for terms of up
to 4 years.
III. Nomination Procedures
Any interested person may nominate one or more qualified persons
for membership on the advisory committee. Self-nominations are also
accepted. Nominations must include a current, complete
r[eacute]sum[eacute] or curriculum vitae for each nominee, including
current business address, telephone number, and 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 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 ask potential
candidates to provide detailed information concerning such matters
related to financial holdings, employment, and research grants and/or
contracts to permit evaluation of possible sources of conflict of
interest.
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: December 2, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-26279 Filed 12-4-19; 8:45 am]
BILLING CODE 4164-01-P
