National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings, 57284-57285 [2017-25985]
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57284
Federal Register / Vol. 82, No. 231 / Monday, December 4, 2017 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Guidance recommendations
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
New written requests to be placed on the lists ...................
Third-party certification ........................................................
Biennial update ....................................................................
Third-party certification biennial update ...............................
Occasional updates .............................................................
370
370
555
555
100
1
1
1
1
1
370
370
555
555
100
1
21
1
21
0.5
370
7,770
555
11,655
50
Total ..............................................................................
........................
........................
........................
........................
20,400
sradovich on DSK3GMQ082PROD with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
This is a newly established
information collection. Based on our
experience maintaining other export
lists, we estimate that, annually, an
average of 370 new manufacturers/
processors will submit written requests
to be placed on the China lists. The
estimate of the number of hours that it
will take a manufacturer/processor to
gather the information needed to be
placed on a list or update its
information is based on FDA’s
experience with manufacturers/
processors submitting similar requests.
FDA believes that the information to be
submitted will be readily available to
manufacturers/processors. We estimate
that a firm will require 1 hour to read
the guidance, to gather the information
needed, and to prepare a
communication to FDA that contains
the information needed to request that
the manufacturer/processor be placed
on a list.
To be placed on a list, manufacturers/
processors should provide FDA with
evidence that they have obtained thirdparty certification from a CNCAacknowledged certifier that the
manufacturer/processor complies with
the standards, laws and regulations of
China according to relevant
requirements specified in AQSIQ Decree
145. Based on our experience with other
certification programs, FDA estimates
that it will take each new manufacturer/
processor about 21 hours to complete
the third-party certification process for
a total of 7,770 burden hours (370
manufacturers/processors × 21 hours).
Under the guidance, every 2 years
each manufacturer/processor on the lists
must provide updated information to
remain on the lists. FDA estimates that
each year approximately half of the
manufacturers/processors on the lists, or
555 manufacturers/processors (1110
manufacturers/processors × 0.5 = 555),
will resubmit the information to remain
on the lists. We estimate that a
manufacturer/processor already on the
lists will require 1 hour to biennially
update and resubmit the information to
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FDA, including time reviewing the
information and corresponding with
FDA, for a total of 555 hours.
During the biennial update,
manufacturers/processors also need to
be recertified by a third-party certifier to
remain on the lists. FDA estimates that
each year approximately half of the
manufacturers/processors on the lists,
555 manufacturers/processors (1110
manufacturers/processors × 0.5 = 555),
will get recertified. We estimate that it
will take each manufacturer/processor
about 21 hours to complete the
certification process for a total of 11,655
burden hours (555 manufacturers/
processors × 21 hours).
FDA expects that, each year,
approximately 100 manufacturers/
processors will need to submit an
occasional update and each
manufacturer/processor will require 0.5
hours to prepare a communication to
FDA reporting the change, for a total of
50 hours.
Dated: November 29, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–26042 Filed 12–1–17; 8:45 am]
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individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Center for
Advancing Translational Sciences Special
Emphasis Panel; CTSA.
Date: February 21, 2018.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda Marriott Suites,
Independence Ballrooms 1 & 2, 6711
Democracy Blvd., Bethesda, MD 20817.
Contact Person: Carol Lambert, Ph.D.,
Acting Director, Office of Scientific Review,
National Center for Advancing Translational
Sciences (NCATS), National Institutes of
Health, 6701 Democracy Blvd., Democracy 1,
Room 1076, Bethesda, MD 20892, 301–435–
0814, lambert@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.859, Pharmacology,
Physiology, and Biological Chemistry
Research; 93.350, B—Cooperative
Agreements; 93.859, Biomedical Research
and Research Training, National Institutes of
Health, HHS)
Dated: November 28, 2017.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2017–25982 Filed 12–1–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Center for Advancing
Translational Sciences; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
PO 00000
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National Institutes of Health
National Institute of Diabetes and
Digestive and Kidney Diseases; Notice
of Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
E:\FR\FM\04DEN1.SGM
04DEN1
Federal Register / Vol. 82, No. 231 / Monday, December 4, 2017 / Notices
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel; Pragmatic Research
and Natural Experiments.
Date: February 23, 2018.
Time: 9:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda Marriott Suites, 6711
Democracy Boulevard, Bethesda, MD 20817.
Contact Person: Michele L. Barnard, Ph.D.,
Scientific Review Officer, Review Branch,
DEA, NIDDK, National Institutes Of Health,
Room 7353, 6707 Democracy Boulevard,
Bethesda, MD 20892–2542, (301) 594–8898,
barnardm@extra.niddk.nih.gov.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel; PAR–13–266:
NIDDK Program Projects (P01) in Digestive
Sciences.
Date: March 14, 2018.
Time: 11:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Two
Democracy Plaza, 6707 Democracy
Boulevard, Bethesda, MD 20892 (Telephone
Conference Call).
Contact Person: Najma S. Begum, Ph.D.,
Scientific Review Officer, Review Branch,
DEA, NIDDK, National Institutes of Health,
Room 7349, 6707 Democracy Boulevard,
Bethesda, MD 20892–5452, (301) 594–8894,
begumn@niddk.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.847, Diabetes,
Endocrinology and Metabolic Research;
93.848, Digestive Diseases and Nutrition
Research; 93.849, Kidney Diseases, Urology
and Hematology Research, National Institutes
of Health, HHS)
Dated: November 28, 2017.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2017–25985 Filed 12–1–17; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
sradovich on DSK3GMQ082PROD with NOTICES
Center for Scientific Review; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
VerDate Sep<11>2014
18:22 Dec 01, 2017
Jkt 244001
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Fellowship:
Infectious Diseases and Microbiology.
Date: December 18, 2017.
Time: 1:00 p.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Tamara Lyn McNealy,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3188,
Bethesda, MD 20747, tamara.mcnealy@
nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: November 28, 2017.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2017–25981 Filed 12–1–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and
Digestive and Kidney Diseases; Notice
of Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel; Time-Sensitive
Obesity PAR.
Date: December 18, 2017.
Time: 2:30 p.m. to 4:30 p.m.
PO 00000
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57285
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Two
Democracy Plaza, 6707 Democracy
Boulevard, Bethesda, MD 20892 (Telephone
Conference Call).
Contact Person: Michele L. Barnard, Ph.D.,
Scientific Review Officer, Review Branch,
DEA, NIDDK, National Institutes of Health,
Room 7353, 6707 Democracy Boulevard,
Bethesda, MD 20892–2542, (301) 594–8898,
barnardm@extra.niddk.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel; PAR–17–270:
NIDDK Central Repositories Sample Access
(X01): Diabetes, Liver and Kidney Diseases.
Date: January 29, 2018.
Time: 12:00 p.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Two
Democracy Plaza, 6707 Democracy
Boulevard, Bethesda, MD 20892 (Telephone
Conference Call).
Contact Person: Najma S. Begum, Ph.D.,
Scientific Review Officer, Review Branch,
DEA, NIDDK, National Institutes of Health,
Room 7349, 6707 Democracy Boulevard,
Bethesda, MD 20892–5452, (301) 594–8894,
begumn@niddk.nih.gov.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel; Biomarker for
Diabetes, Liver and Kidney Diseases using
NIDDK Repository Samples–R01 (PAR–17–
123).
Date: February 5, 2018.
Time: 1:00 p.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Two
Democracy Plaza, 6707 Democracy
Boulevard, Bethesda, MD 20892 (Telephone
Conference Call).
Contact Person: Najma S. Begum, Ph.D.,
Scientific Review Officer, Review Branch,
DEA, NIDDK, National Institutes of Health,
Room 7349, 6707 Democracy Boulevard,
Bethesda, MD 20892–5452, (301) 594–8894,
begumn@niddk.nih.gov.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel; PAR–16–126: High
Impact, Interdisciplinary Science in NIDDK
Research Areas (RC2)—Diabetes,
Endocrinology and Metabolic Diseases.
Date: February 16, 2018.
Time: 3:00 p.m. to 4:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Two
Democracy Plaza, 6707 Democracy
Boulevard, Bethesda, MD 20892 (Telephone
Conference Call).
Contact Person: Dianne Camp, Ph.D.,
Scientific Review Officer, Review Branch,
DEA, NIDDK, National Institutes of Health,
Room 7013, 6707 Democracy Boulevard,
Bethesda, MD 20892–2542, 301–594–7682,
campd@extra.niddk.nih.gov.
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]]>Agencies
[Federal Register Volume 82, Number 231 (Monday, December 4, 2017)]
[Notices]
[Pages 57284-57285]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-25985]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases;
Notice of Closed Meetings
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended, notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the
provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5
U.S.C., as amended. The grant applications and the discussions could
disclose confidential trade secrets or commercial
[[Page 57285]]
property such as patentable material, and personal information
concerning individuals associated with the grant applications, the
disclosure of which would constitute a clearly unwarranted invasion of
personal privacy.
Name of Committee: National Institute of Diabetes and Digestive
and Kidney Diseases Special Emphasis Panel; Pragmatic Research and
Natural Experiments.
Date: February 23, 2018.
Time: 9:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Bethesda Marriott Suites, 6711 Democracy Boulevard,
Bethesda, MD 20817.
Contact Person: Michele L. Barnard, Ph.D., Scientific Review
Officer, Review Branch, DEA, NIDDK, National Institutes Of Health,
Room 7353, 6707 Democracy Boulevard, Bethesda, MD 20892-2542, (301)
594-8898, barnardm@extra.niddk.nih.gov.
Name of Committee: National Institute of Diabetes and Digestive
and Kidney Diseases Special Emphasis Panel; PAR-13-266: NIDDK
Program Projects (P01) in Digestive Sciences.
Date: March 14, 2018.
Time: 11:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Two Democracy Plaza, 6707
Democracy Boulevard, Bethesda, MD 20892 (Telephone Conference Call).
Contact Person: Najma S. Begum, Ph.D., Scientific Review
Officer, Review Branch, DEA, NIDDK, National Institutes of Health,
Room 7349, 6707 Democracy Boulevard, Bethesda, MD 20892-5452, (301)
594-8894, begumn@niddk.nih.gov.
(Catalogue of Federal Domestic Assistance Program Nos. 93.847,
Diabetes, Endocrinology and Metabolic Research; 93.848, Digestive
Diseases and Nutrition Research; 93.849, Kidney Diseases, Urology
and Hematology Research, National Institutes of Health, HHS)
Dated: November 28, 2017.
David Clary,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2017-25985 Filed 12-1-17; 8:45 am]
BILLING CODE 4140-01-P
