30-day FRN

30-day FRN2016-02447.pdf

Investigator Registration and Financial Disclosure for Investigational Trials in Cancer Treatment (NCI)

30-day FRN

OMB: 0925-0613

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6876

Federal Register / Vol. 81, No. 26 / Tuesday, February 9, 2016 / Notices

associated with the grant applications,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.

Dated: February 3, 2016.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory
Committee Policy.

Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel;
Transcatheter Cavopulmonary Bypass
Endograft.
Date: March 2, 2016.
Time: 9:30 a.m. to 12:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institutes of Health, 6701
Rockledge Drive, Room 7182, Bethesda, MD
20892, (Telephone Conference Call).
Contact Person: Susan Wohler Sunnarborg,
Ph.D., Scientific Review Officer, Office of
Scientific Review/DERA, National, Heart,
Lung, and Blood Institute, 6701 Rockledge
Drive, Room 7182, Bethesda, MD 20892,
[email protected].
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel;
Career Development Program to Promote
Diversity in Health Research.
Date: March 4, 2016.
Time: 8:30 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: The River Inn, 924 25th Street NW.,
Washington, DC 20037.
Contact Person: Stephanie L. Constant,
Ph.D., Scientific Review Officer, Office of
Scientific Review/DERA, National Heart,
Lung, and Blood Institute, 6701 Rockledge
Drive, Room 7189, Bethesda, MD 20892, 301–
443–8784, [email protected].
(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung
Diseases Research; 93.839, Blood Diseases
and Resources Research, National Institutes
of Health, HHS)

[FR Doc. 2016–02455 Filed 2–8–16; 8:45 am]

Dated: February 3, 2016.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–02458 Filed 2–8–16; 8:45 am]
BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health

mstockstill on DSK4VPTVN1PROD with NOTICES

Center for Scientific Review; Amended
Notice of Meeting
Notice is hereby given of a change in
the meeting of the Neurogenesis and
Cell Fate Study Section, February 18,
2016, 08:00 a.m. to February 19, 2016,
02:00 p.m., Hotel Kabuki, 1625 Post
Street, San Francisco, CA, 94115 which
was published in the Federal Register
on January 26, 2016, 81 FR 4316–4317.
The meeting will be held on February
18, 2016 from 8:00 a.m.–8:00 p.m. The
meeting location remains the same. The
meeting is closed to the public.

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BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), 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: Center for Scientific
Review Special Emphasis Panel; BD2K RFAs:
Courses for Skills Development and Open
Educational Resources for Biomedical Big
Data (R25).
Date: March 2, 2016.
Time: 12:00 p.m. to 5:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Kee Hyang Pyon, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5148,
MSC 7806, Bethesda, MD 20892,
[email protected].
Name of Committee: Center for Scientific
Review Special Emphasis Panel;
Fellowships: Oncology.
Date: March 3–4, 2016.
Time: 10:00 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Juraj Bies, Ph.D., Scientific
Review Officer, Center for Scientific Review,
National Institutes of Health, 6701 Rockledge
Dr., Rm. 4158, MSC 7806, Bethesda, MD
20892, 301–435–1256, [email protected].
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR 12–
251: Behavioral Science Track Award for
Rapid Transition Review.
Date: March 3, 2016.
Time: 11:30 a.m. to 1:00 p.m.

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Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Serena Chu, Ph.D.,
Scientific Review Officer, BBBP IRG, Center
for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3178,
MSC 7848, Bethesda, MD 20892, 301–500–
5829, [email protected].
(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: February 3, 2016.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–02454 Filed 2–8–16; 8:45 am]
BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request; Drug
Accountability Report Form and
Investigator Registration Procedure in
the Conduct of Investigational Trials
for the Treatment of Cancer (NCI)
Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Cancer Institute, the National Institutes
of Health, has submitted to the Office of
Management and Budget (OMB) a
request for review and approval of the
information collection listed below.
This proposed information collection
was previously published in the Federal
Register on November 17, 2015 page
71815 and allowed 60 days for public
comment. No public comments were
received. The purpose of this notice is
to allow an additional 30 days for public
comment. The National Cancer Institute,
National Institutes of Health, may not
conduct or sponsor, and the respondent
is not required to respond to, an
information collection that has been
extended, revised, or implemented on or
after October 1, 1995, unless it displays
a currently valid OMB control number.
Direct Comments to OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the: Office
of Management and Budget, Office of
Regulatory Affairs,
[email protected] or by
fax to 202–395–6974, Attention: NIH
Desk Officer.

SUMMARY:

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6877

Federal Register / Vol. 81, No. 26 / Tuesday, February 9, 2016 / Notices
Comment Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30 days of the date of
this publication.
FOR FURTHER INFORMATION CONTACT: To
obtain a copy of the data collection
plans and instruments, or request more
information on the proposed project,
contact: Charles Hall, RPh, M.S., Chief,
Pharmaceutical Management Branch,
Cancer Therapy Evaluation Program,
National Cancer Institute, 9609 Medical
Center Drive, RM 5W240, MSC 9725,
Bethesda, Maryland 20892. Or call nontoll-free number (240) 276–6575, or
email your request, include your
address to: [email protected].
Formal requests for additional plans
and instruments must be requested in
writing.
Proposed Collection: Drug
Accountability Report Form and

the patient to that drug. Investigators are
physicians who specialize in the
treatment of patients with cancer. Data
obtained from the Drug Accountability
Record is used to track the dispensing
of investigational anticancer agents from
receipt from the NCI to dispensing or
administration to patients. NCI and/or
its auditors use this information for
compliance purposes. The frequency of
Response is up to 16 times per year. The
affected public is private sector
including businesses, other for-profit
organizations, and non-profit
institutions. The type of respondents are
investigators, pharmacists, nurses,
pharmacy technicians, and data
managers.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
14,649 hours.

Investigator Registration Procedure in
the Conduct of Investigational Trials for
the Treatment of Cancer, 0925–0613,
Expiration Date 03/31/2016, Revision,
National Cancer Institute (NCI),
National Institutes of Health (NIH).
Need and Use of Information
Collection: The U.S. Food and Drug
Administration (FDA) holds the
National Cancer Institute (NCI)
responsible, as a sponsor of
investigational drug trials, for the
collection of information about the
clinical investigators who participate in
these trials and to assure the FDA that
systems for accountability are being
maintained by investigators in its
clinical trials program. The information
collected is used to identify qualified
investigators and to facilitate the
submission and distribution of
important information relative to the
investigational drug and the response of

TABLE 1—ESTIMATES OF ANNUAL BURDEN
Estimated annualized burden hours
Form

Investigators and Designee for Investigator Registration and DARF.

Statement of Investigator .................

22,283

1

15/60

5,571

NCI/DCTD/CTEP Supplemental Investigator.
Financial Disclosure Forms ..............
NCI/DCTD/CTEP Drug Accountability Record Form (DARF and
DARF-Oral).

22,283

1

10/60

3,714

22,283
3,288

1
16

5/60
4/60

1,857
3,507

...........................................................

25,571

119,457

........................

14,649

Total ...........................................

Dated: February 3, 2016.
Karla Bailey,
Project Clearance Liaison, National Cancer
Institute, NIH.

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.

[FR Doc. 2016–02447 Filed 2–8–16; 8:45 am]
BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health

mstockstill on DSK4VPTVN1PROD with NOTICES

National Institute of Neurological
Disorders and Stroke; Notice of Closed
Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), 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

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17:54 Feb 08, 2016

Jkt 238001

Number of
respondents

Average time
per response
(in hours)

Type of
respondents

Name of Committee: National Institute of
Neurological Disorders and Stroke Special
Emphasis Panel; NST1 Member Conflict SEP.
Date: March 8, 2016.
Time: 9:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hyatt Arlington, 1325 Wilson
Boulevard, Arlington, VA 22209.
Contact Person: William C Benzing, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, Division of Extramural Research,
NINDS/NIH/DHHS/Neuroscience Center,
6001 Executive Boulevard, Suite 3208, MSC
9529, Bethesda, MD 20892–9529, 301–496–
0660, [email protected].
Name of Committee: National Institute of
Neurological Disorders and Stroke Special
Emphasis Panel; NINDS R 35 Review.
Date: March 17–18, 2016.
Time: 8:00 a.m. to 6:00 p.m.

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Number of
responses

Total hour
burden

Agenda: To review and evaluate grant
applications.
Place: Hyatt Regency Bethesda, One
Bethesda Metro Center, 7400 Wisconsin
Avenue, Bethesda, MD 20814.
Contact Person: Natalia Strunnikova,
Ph.D., Scientific Review Officer, Scientific
Review Branch, Division of Extramural
Research, NINDS/NIH/DHHS/Neuroscience
Center, 6001 Executive Boulevard, Suite
3208, MSC 9529, Bethesda, MD 20892–9529,
301–402–0288, [email protected].
Name of Committee: National Institute of
Neurological Disorders and Stroke Special
Emphasis Panel; NINDS R35 Review.
Date: March 17–18, 2016.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hyatt Regency Bethesda, One
Bethesda Metro Center, 7400 Wisconsin
Avenue, Bethesda, MD 20814.
Contact Person: Ernest W Lyons, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, Division of Extramural Research,
NINDS/NIH/DHHS/Neuroscience Center,
6001 Executive Boulevard, Suite 3208, MSC
9529, Bethesda, MD 20892–9529, 301–496–
4056, [email protected].

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