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), 6876-6877 [2016-02447]

Download as PDF 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, sunnarborgsw@nhlbi.nih.gov. 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, constantsl@nhlbi.nih.gov. (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. VerDate Sep<11>2014 17:54 Feb 08, 2016 Jkt 238001 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, pyonkh2@csr.nih.gov. 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, biesj@mail.nih.gov. 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. PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 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, sechu@csr.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: 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, OIRA_submission@omb.eop.gov or by fax to 202–395–6974, Attention: NIH Desk Officer. SUMMARY: E:\FR\FM\09FEN1.SGM 09FEN1 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: hallch@mail.nih.gov. 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 VerDate Sep<11>2014 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, benzingw@mail.nih.gov. 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. PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 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, Natalia.strunnikova@nih.gov. 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, lyonse@ninds.nih.gov. E:\FR\FM\09FEN1.SGM 09FEN1

Agencies

[Federal Register Volume 81, Number 26 (Tuesday, February 9, 2016)]
[Notices]
[Pages 6876-6877]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-02447]

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

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)

SUMMARY: 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, OIRA_submission@omb.eop.gov or by fax to 202-395-6974,
Attention: NIH Desk Officer.

[[Page 6877]]

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 non-toll-free number (240) 276-
6575, or email your request, include your address to:
hallch@mail.nih.gov.
Formal requests for additional plans and instruments must be
requested in writing.
Proposed Collection: Drug Accountability Report Form and
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 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.

Table 1--Estimates of Annual Burden
----------------------------------------------------------------------------------------------------------------
Estimated annualized burden hours
-----------------------------------------------------------------------------------------------------------------
Average time
Type of respondents Form Number of Number of per response Total hour
respondents responses (in hours) burden
----------------------------------------------------------------------------------------------------------------
Investigators and Designee for Statement of 22,283 1 15/60 5,571
Investigator Registration and Investigator.
DARF.
NCI/DCTD/CTEP 22,283 1 10/60 3,714
Supplemental
Investigator.
Financial 22,283 1 5/60 1,857
Disclosure
Forms.
NCI/DCTD/CTEP 3,288 16 4/60 3,507
Drug
Accountability
Record Form
(DARF and DARF-
Oral).
---------------------------------------------------------------------------------
Total..................... ................ 25,571 119,457 .............. 14,649
----------------------------------------------------------------------------------------------------------------

Dated: February 3, 2016.
Karla Bailey,
Project Clearance Liaison, National Cancer Institute, NIH.
[FR Doc. 2016-02447 Filed 2-8-16; 8:45 am]
BILLING CODE 4140-01-P

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