82 FR 57284 - National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 82, Issue 231 (December 4, 2017)

Page Range		57284-57285
FR Document		2017-25985

Federal Register, Volume 82 Issue 231 (Monday, December 4, 2017)

[Federal Register Volume 82, Number 231 (Monday, December 4, 2017)]
[Notices]
[Pages 57284-57285]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-25985]


-----------------------------------------------------------------------

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, [email protected].

    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, [email protected].

(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

57284 Federal Register / Vol. 82, No. 231 / Monday, December 4, 2017 / Notices

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Guidance recommendations responses per burden per Total hours
respondents responses
respondent response

New written requests to be placed on the lists ................... 370 1 370 1 370
Third-party certification ........................................................ 370 1 370 21 7,770
Biennial update .................................................................... 555 1 555 1 555
Third-party certification biennial update ............................... 555 1 555 21 11,655
Occasional updates ............................................................. 100 1 100 0.5 50

Total .............................................................................. ........................ ........................ ........................ ........................ 20,400
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

This is a newly established FDA, including time reviewing the individuals associated with the grant
information collection. Based on our information and corresponding with applications, the disclosure of which
experience maintaining other export FDA, for a total of 555 hours. would constitute a clearly unwarranted
lists, we estimate that, annually, an During the biennial update, invasion of personal privacy.
average of 370 new manufacturers/ manufacturers/processors also need to Name of Committee: National Center for
processors will submit written requests be recertified by a third-party certifier to Advancing Translational Sciences Special
to be placed on the China lists. The remain on the lists. FDA estimates that Emphasis Panel; CTSA.
estimate of the number of hours that it each year approximately half of the Date: February 21, 2018.
will take a manufacturer/processor to manufacturers/processors on the lists, Time: 8:00 a.m. to 5:00 p.m.
gather the information needed to be 555 manufacturers/processors (1110 Agenda: To review and evaluate grant
manufacturers/processors × 0.5 = 555), applications.
placed on a list or update its
Place: Bethesda Marriott Suites,
information is based on FDA’s will get recertified. We estimate that it
Independence Ballrooms 1 & 2, 6711
experience with manufacturers/ will take each manufacturer/processor Democracy Blvd., Bethesda, MD 20817.
processors submitting similar requests. about 21 hours to complete the Contact Person: Carol Lambert, Ph.D.,
FDA believes that the information to be certification process for a total of 11,655 Acting Director, Office of Scientific Review,
submitted will be readily available to burden hours (555 manufacturers/ National Center for Advancing Translational
manufacturers/processors. We estimate processors × 21 hours). Sciences (NCATS), National Institutes of
that a firm will require 1 hour to read FDA expects that, each year, Health, 6701 Democracy Blvd., Democracy 1,
approximately 100 manufacturers/ Room 1076, Bethesda, MD 20892, 301–435–
the guidance, to gather the information
processors will need to submit an 0814, lambert@mail.nih.gov.
needed, and to prepare a
occasional update and each (Catalogue of Federal Domestic Assistance
communication to FDA that contains
manufacturer/processor will require 0.5 Program Nos. 93.859, Pharmacology,
the information needed to request that Physiology, and Biological Chemistry
the manufacturer/processor be placed hours to prepare a communication to Research; 93.350, B—Cooperative
on a list. FDA reporting the change, for a total of Agreements; 93.859, Biomedical Research
To be placed on a list, manufacturers/ 50 hours. and Research Training, National Institutes of
processors should provide FDA with Dated: November 29, 2017. Health, HHS)
evidence that they have obtained third- Leslie Kux, Dated: November 28, 2017.
party certification from a CNCA- Associate Commissioner for Policy. David Clary,
acknowledged certifier that the [FR Doc. 2017–26042 Filed 12–1–17; 8:45 am] Program Analyst, Office of Federal Advisory
manufacturer/processor complies with BILLING CODE 4164–01–P Committee Policy.
the standards, laws and regulations of [FR Doc. 2017–25982 Filed 12–1–17; 8:45 am]
China according to relevant BILLING CODE 4140–01–P
requirements specified in AQSIQ Decree DEPARTMENT OF HEALTH AND
145. Based on our experience with other HUMAN SERVICES
certification programs, FDA estimates DEPARTMENT OF HEALTH AND
that it will take each new manufacturer/ National Institutes of Health HUMAN SERVICES
processor about 21 hours to complete
the third-party certification process for National Center for Advancing National Institutes of Health
a total of 7,770 burden hours (370 Translational Sciences; Notice of
manufacturers/processors × 21 hours). Closed Meeting National Institute of Diabetes and
Under the guidance, every 2 years Digestive and Kidney Diseases; Notice
Pursuant to section 10(d) of the
each manufacturer/processor on the lists of Closed Meetings
Federal Advisory Committee Act, as
must provide updated information to amended, notice is hereby given of the Pursuant to section 10(d) of the
remain on the lists. FDA estimates that following meeting. Federal Advisory Committee Act, as
each year approximately half of the The meeting will be closed to the amended, notice is hereby given of the
manufacturers/processors on the lists, or public in accordance with the
sradovich on DSK3GMQ082PROD with NOTICES

following meetings.
555 manufacturers/processors (1110 provisions set forth in sections The meetings will be closed to the
manufacturers/processors × 0.5 = 555), 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., public in accordance with the
will resubmit the information to remain as amended. The grant applications and provisions set forth in sections
on the lists. We estimate that a the discussions could disclose 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
manufacturer/processor already on the confidential trade secrets or commercial as amended. The grant applications and
lists will require 1 hour to biennially property such as patentable material, the discussions could disclose
update and resubmit the information to and personal information concerning confidential trade secrets or commercial

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Federal Register / Vol. 82, No. 231 / Monday, December 4, 2017 / Notices 57285

property such as patentable material, as amended. The grant applications and Agenda: To review and evaluate grant
and personal information concerning the discussions could disclose applications.
individuals associated with the grant confidential trade secrets or commercial Place: National Institutes of Health, Two
applications, the disclosure of which property such as patentable material, Democracy Plaza, 6707 Democracy
Boulevard, Bethesda, MD 20892 (Telephone
would constitute a clearly unwarranted and personal information concerning Conference Call).
invasion of personal privacy. individuals associated with the grant Contact Person: Michele L. Barnard, Ph.D.,
Name of Committee: National Institute of applications, the disclosure of which Scientific Review Officer, Review Branch,
Diabetes and Digestive and Kidney Diseases would constitute a clearly unwarranted DEA, NIDDK, National Institutes of Health,
Special Emphasis Panel; Pragmatic Research invasion of personal privacy. Room 7353, 6707 Democracy Boulevard,
and Natural Experiments. Name of Committee: Center for Scientific Bethesda, MD 20892–2542, (301) 594–8898,
Date: February 23, 2018. Review Special Emphasis Panel; Fellowship: barnardm@extra.niddk.nih.gov.
Time: 9:00 a.m. to 5:00 p.m. Infectious Diseases and Microbiology. This notice is being published less than 15
Agenda: To review and evaluate grant Date: December 18, 2017. days prior to the meeting due to the timing
applications. Time: 1:00 p.m. to 3:00 p.m. limitations imposed by the review and
Place: Bethesda Marriott Suites, 6711 Agenda: To review and evaluate grant funding cycle.
Democracy Boulevard, Bethesda, MD 20817. applications. Name of Committee: National Institute of
Contact Person: Michele L. Barnard, Ph.D., Place: National Institutes of Health, 6701 Diabetes and Digestive and Kidney Diseases
Scientific Review Officer, Review Branch, Rockledge Drive, Bethesda, MD 20892 Special Emphasis Panel; PAR–17–270:
DEA, NIDDK, National Institutes Of Health, (Telephone Conference Call). NIDDK Central Repositories Sample Access
Room 7353, 6707 Democracy Boulevard, Contact Person: Tamara Lyn McNealy, (X01): Diabetes, Liver and Kidney Diseases.
Bethesda, MD 20892–2542, (301) 594–8898, Ph.D., Scientific Review Officer, Center for Date: January 29, 2018.
barnardm@extra.niddk.nih.gov. Scientific Review, National Institutes of Time: 12:00 p.m. to 3:00 p.m.
Name of Committee: National Institute of Health, 6701 Rockledge Drive, Room 3188, Agenda: To review and evaluate grant
Diabetes and Digestive and Kidney Diseases Bethesda, MD 20747, tamara.mcnealy@ applications.
Special Emphasis Panel; PAR–13–266: nih.gov. Place: National Institutes of Health, Two
NIDDK Program Projects (P01) in Digestive (Catalogue of Federal Domestic Assistance Democracy Plaza, 6707 Democracy
Sciences. Program Nos. 93.306, Comparative Medicine; Boulevard, Bethesda, MD 20892 (Telephone
Date: March 14, 2018. 93.333, Clinical Research, 93.306, 93.333, Conference Call).
Time: 11:00 a.m. to 3:00 p.m. 93.337, 93.393–93.396, 93.837–93.844, Contact Person: Najma S. Begum, Ph.D.,
Agenda: To review and evaluate grant 93.846–93.878, 93.892, 93.893, National Scientific Review Officer, Review Branch,
applications. Institutes of Health, HHS) DEA, NIDDK, National Institutes of Health,
Place: National Institutes of Health, Two Room 7349, 6707 Democracy Boulevard,
Democracy Plaza, 6707 Democracy Dated: November 28, 2017.
Bethesda, MD 20892–5452, (301) 594–8894,
Boulevard, Bethesda, MD 20892 (Telephone Natasha M. Copeland, begumn@niddk.nih.gov.
Conference Call). Program Analyst, Office of Federal Advisory
Contact Person: Najma S. Begum, Ph.D., Name of Committee: National Institute of
Committee Policy. Diabetes and Digestive and Kidney Diseases
Scientific Review Officer, Review Branch, [FR Doc. 2017–25981 Filed 12–1–17; 8:45 am]
DEA, NIDDK, National Institutes of Health, Special Emphasis Panel; Biomarker for
Room 7349, 6707 Democracy Boulevard, BILLING CODE 4140–01–P Diabetes, Liver and Kidney Diseases using
Bethesda, MD 20892–5452, (301) 594–8894, NIDDK Repository Samples–R01 (PAR–17–
begumn@niddk.nih.gov. 123).
DEPARTMENT OF HEALTH AND Date: February 5, 2018.
(Catalogue of Federal Domestic Assistance Time: 1:00 p.m. to 3:00 p.m.
HUMAN SERVICES
Program Nos. 93.847, Diabetes, Agenda: To review and evaluate grant
Endocrinology and Metabolic Research; applications.
National Institutes of Health
93.848, Digestive Diseases and Nutrition Place: National Institutes of Health, Two
Research; 93.849, Kidney Diseases, Urology Democracy Plaza, 6707 Democracy
National Institute of Diabetes and
and Hematology Research, National Institutes Boulevard, Bethesda, MD 20892 (Telephone
of Health, HHS) Digestive and Kidney Diseases; Notice
Conference Call).
of Closed Meetings
Contact Person: Najma S. Begum, Ph.D.,
Dated: November 28, 2017. Scientific Review Officer, Review Branch,
Pursuant to section 10(d) of the
David Clary, Federal Advisory Committee Act, as DEA, NIDDK, National Institutes of Health,
Program Analyst, Office of Federal Advisory amended, notice is hereby given of the Room 7349, 6707 Democracy Boulevard,
Committee Policy. Bethesda, MD 20892–5452, (301) 594–8894,
following meetings.
[FR Doc. 2017–25985 Filed 12–1–17; 8:45 am] begumn@niddk.nih.gov.
The meetings will be closed to the
BILLING CODE 4140–01–P public in accordance with the Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
provisions set forth in sections Special Emphasis Panel; PAR–16–126: High
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Impact, Interdisciplinary Science in NIDDK
DEPARTMENT OF HEALTH AND as amended. The grant applications and Research Areas (RC2)—Diabetes,
HUMAN SERVICES the discussions could disclose Endocrinology and Metabolic Diseases.
confidential trade secrets or commercial Date: February 16, 2018.
National Institutes of Health
property such as patentable material, Time: 3:00 p.m. to 4:30 p.m.
and personal information concerning Agenda: To review and evaluate grant
Center for Scientific Review; Notice of applications.
Closed Meeting individuals associated with the grant
applications, the disclosure of which Place: National Institutes of Health, Two
Democracy Plaza, 6707 Democracy
sradovich on DSK3GMQ082PROD with NOTICES

Pursuant to section 10(d) of the would constitute a clearly unwarranted
Federal Advisory Committee Act, as Boulevard, Bethesda, MD 20892 (Telephone
invasion of personal privacy. Conference Call).
amended, notice is hereby given of the Contact Person: Dianne Camp, Ph.D.,
Name of Committee: National Institute of
following meeting. Diabetes and Digestive and Kidney Diseases Scientific Review Officer, Review Branch,
The meeting will be closed to the Special Emphasis Panel; Time-Sensitive DEA, NIDDK, National Institutes of Health,
public in accordance with the Obesity PAR. Room 7013, 6707 Democracy Boulevard,
provisions set forth in sections Date: December 18, 2017. Bethesda, MD 20892–2542, 301–594–7682,
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Time: 2:30 p.m. to 4:30 p.m. campd@extra.niddk.nih.gov.

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Document Created: 2017-12-02 00:40:13
Document Modified: 2017-12-02 00:40:13

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Dates		February 23, 2018.
FR Citation		82 FR 57284

82 FR 57284 - National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 82, Issue 231 (December 4, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health