National Center for Advancing Translational Sciences; Notice of Closed Meeting, 57284 [2017-25982]
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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]
BILLING CODE 4164–01–P
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]
BILLING CODE 4140–01–P
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
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]]>Agencies
[Federal Register Volume 82, Number 231 (Monday, December 4, 2017)]
[Notices]
[Page 57284]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-25982]
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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 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]
BILLING CODE 4140-01-P
