Submission for OMB Review; 30-Day Comment Request; The Clinical Trials Reporting Program (CTRP) Database (NCI), 33681-33682 [2016-12504]

Download as PDF sradovich on DSK3TPTVN1PROD with NOTICES Federal Register / Vol. 81, No. 103 / Friday, May 27, 2016 / Notices passive), and novel adjuvants, including the coordinated role that mucosal and systemic immunity play in protection from viral acquisition and infection. 2. Emerging topics related to the development, testing, and formulation of microbicides, pre-exposure prophylaxis candidates, long acting/ and/or injectable formulations of antiretroviral treatment candidates (and related methods of delivery for HIV treatments) that are less toxic, longer acting, have fewer side effects and complications, and easier to take and adhere to than current regimens. 3. Emerging topics that relate to the research toward a cure, including the development of novel approaches and strategies that could lead to sustained HIV remission or viral eradication without the continuing need for combination antiretroviral therapy, including studies of HIV persistence, latency, and reservoir formation. 4. Emerging topics that relate to the HIV cascade of care, including the development, testing, and implementation of integrated biomedical, behavioral, and social science strategies to improve HIV testing and entry into prevention and treatment services, including linkage, engagement, and retention in these services for optimal treatment response. 5. Emerging topics that relate to basic research underlying the basic biology of HIV, (e.g., acquisition, transmission and pathogenesis; viral persistence; immune dysfunction and chronic inflammation; host microbiome and genetic determinants; and pathogenesis of opportunistic infections, coinfections, comorbidities, and HIV-related mortalities. 6. Emerging topics that relate to reducing health disparities in the incidence of new HIV infections or in treatment outcomes of those living with HIV/AIDS, with a specific focus on structural, environmental, and community-level determinants of health and the interplay of these determinants in developing strategies to mitigate the disparities in HIV incidence and access to HIV preventive and treatment services, 7. Emerging topics that relate to the challenges and opportunities that should be considered for research training and career development programs targeting researchers conducting high priority HIV/AIDS research. VerDate Sep<11>2014 18:00 May 26, 2016 Jkt 238001 Please limit responses to <1500 characters. Responses to this RFI Notice are voluntary. The submitted information will be reviewed by NIH staff and may be made available to the public. Submitted information will not be considered confidential. This request is for information and planning purposes and should not be construed as a solicitation or as an obligation of the federal government or the NIH. No awards will be made based on responses to this Request for Information. The information submitted will be analyzed and may be used in reports or presentations. Those who respond are advised that the NIH is under no obligation to acknowledge receipt of your comments, or provide comments on your submission. No proprietary, classified, confidential and/or sensitive information should be included in your response. The NIH and the government reserve the right to use any nonproprietary technical information in any future solicitation(s). Dated: May 20, 2016. Lawrence A. Tabak, Deputy Director, National Institutes of Health. [FR Doc. 2016–12578 Filed 5–26–16; 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; The Clinical Trials Reporting Program (CTRP) Database (NCI) Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Cancer Institute (NCI), 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 March 11, 2016 (Vol. 81, P. 12914) 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 (NCI), National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an SUMMARY: PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 33681 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. 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. To obtain a copy of the data collection plans and instruments, or request more information on the proposed project, contact: Jose Galvez, MD, Office of the Director, National Cancer Institute, 9609 Medical Center Drive, Rockville, MD 20852 or call non-toll-free number 240– 276–5206 or Email your request, including your address to: jose.galvez@ nih.gov. Formal requests for additional plans and instruments must be requested in writing. Proposed Collection: The Clinical Trials Reporting Program (CTRP) Database (NCI), 0925–0600, Expiration Date 05/31/2016—Revision, National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: The Clinical Trials Reporting Program (CTRP) is an electronic resource that serves as a single, definitive source of information about all NCI-supported clinical research. This resource allows the NCI to consolidate reporting, aggregate information and reduce redundant submissions. Information is submitted by clinical research administrators as designees of clinical investigators who conduct NCIsupported clinical research. The designees can electronically access the CTRP Web site to complete the initial trial registration. Subsequent to registration, four amendments and four study subject accrual updates occur per trial annually. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The estimated annualized burden hours are 18,000. FOR FURTHER INFORMATION CONTACT: E:\FR\FM\27MYN1.SGM 27MYN1 33682 Federal Register / Vol. 81, No. 103 / Friday, May 27, 2016 / Notices ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Average time per response (in hours) Number of responses per respondent Total annual burden hours Type of respondents Form Clinical Trials ..................................... Initial Registration ............................. Amendment ...................................... Update .............................................. Accrual Updates ............................... 3,000 1,500 1,500 3,000 1 4 4 4 1 1 1 15/60 3,000 6,000 6,000 3000 Total ........................................... ........................................................... 9,000 27,000 ........................ 18,000 Dated: May 23, 2016. Michelle Trout, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2016–12504 Filed 5–26–16; 8:45 am] [FR Doc. 2016–12502 Filed 5–26–16; 8:45 am] BILLING CODE 4140–01–P BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institutes of Health National Heart, Lung, and Blood Institute; Notice of Closed Meeting 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 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. sradovich on DSK3TPTVN1PROD with NOTICES Dated: May 20, 2016. Karla Bailey, Project Clearance Liaison, National Cancer Institute, NIH. 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: National Heart, Lung, and Blood Institute Special Emphasis Panel; Grant Review for NHLBI K Award Recipients. Date: June 21, 2016. Time: 8:00 a.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: Bethesda Marriott Suites, 6711 Democracy Boulevard, Bethesda, MD 20817. Contact Person: Melissa E Nagelin, Ph.D., Scientific Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, 6701 Rockledge Drive, Room 7202, Bethesda, MD 20892, 301–435–0297, nagelinmh2@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) Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Neuroimaging, Neuroinformatics and Neurogenetics. Date: June 10, 2016. Time: 2:00 p.m. to 6:00 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: Vilen A. Movsesyan, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4040M, MSC 7806, Bethesda, MD 20892, 301–402– 7278, movsesyanv@csr.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: Center for Scientific Review Special Emphasis Panel; PAR–14– VerDate Sep<11>2014 18:00 May 26, 2016 Jkt 238001 PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 166: Early Phase Clinical Trials in Imaging and Image-Guided Interventions. Date: June 17, 2016. Time: 11:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892. Contact Person: Chiayeng Wang, Ph.D., Scientific Review Officer, Center for Scientific Review, 6701 Rockledge Drive, Room 5213, MSC 7852, Bethesda, MD 20892, 301–435–2397, chiayeng.wang@nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Small Business: HIV/AIDS Innovative Research Applications. Date: June 21–22, 2016. Time: 10:00 a.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Virtual Meeting). Contact Person: Jingsheng Tuo, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5207, Bethesda, MD 20892, 301–451–8754, tuoj@ nei.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Clinical and Translational Imaging Applications. Date: June 22, 2016. Time: 10:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892. Contact Person: Eileen W. Bradley, DSC, Chief, SBIB IRG, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5100, MSC 7854, Bethesda, MD 20892, (301) 435–1179, bradleye@csr.nih.gov. Name of Committee: Infectious Diseases and Microbiology Integrated Review Group; Drug Discovery and Mechanisms of Antimicrobial Resistance Study Section. Date: June 23–24, 2016. Time: 8:00 p.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: American Inn of Bethesda, 8130 Wisconsin Avenue, Bethesda, MD 20814. Contact Person: Guangyong Ji, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3188, MSC 7808, Bethesda, MD 20892, 301–435– 1146, jig@csr.nih.gov. E:\FR\FM\27MYN1.SGM 27MYN1

Agencies

[Federal Register Volume 81, Number 103 (Friday, May 27, 2016)]
[Notices]
[Pages 33681-33682]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-12504]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health

Submission for OMB Review; 30-Day Comment Request; The Clinical
Trials Reporting Program (CTRP) Database (NCI)

SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National Cancer Institute (NCI), 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 March
11, 2016 (Vol. 81, P. 12914) 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
(NCI), 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.
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: Jose Galvez, MD, Office of the Director,
National Cancer Institute, 9609 Medical Center Drive, Rockville, MD
20852 or call non-toll-free number 240-276-5206 or Email your request,
including your address to: jose.galvez@nih.gov. Formal requests for
additional plans and instruments must be requested in writing.
Proposed Collection: The Clinical Trials Reporting Program (CTRP)
Database (NCI), 0925-0600, Expiration Date 05/31/2016--Revision,
National Cancer Institute (NCI), National Institutes of Health (NIH).
Need and Use of Information Collection: The Clinical Trials
Reporting Program (CTRP) is an electronic resource that serves as a
single, definitive source of information about all NCI-supported
clinical research. This resource allows the NCI to consolidate
reporting, aggregate information and reduce redundant submissions.
Information is submitted by clinical research administrators as
designees of clinical investigators who conduct NCI-supported clinical
research. The designees can electronically access the CTRP Web site to
complete the initial trial registration. Subsequent to registration,
four amendments and four study subject accrual updates occur per trial
annually.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The estimated annualized burden
hours are 18,000.

[[Page 33682]]

Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average time
Type of respondents Form Number of responses per per response Total annual
respondents respondent (in hours) burden hours
----------------------------------------------------------------------------------------------------------------
Clinical Trials............... Initial 3,000 1 1 3,000
Registration.
Amendment....... 1,500 4 1 6,000
Update.......... 1,500 4 1 6,000
Accrual Updates. 3,000 4 15/60 3000
---------------------------------------------------------------
Total..................... ................ 9,000 27,000 .............. 18,000
----------------------------------------------------------------------------------------------------------------

Dated: May 20, 2016.
Karla Bailey,
Project Clearance Liaison, National Cancer Institute, NIH.
[FR Doc. 2016-12504 Filed 5-26-16; 8:45 am]
BILLING CODE 4140-01-P

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