81_FR_33784 81 FR 33681 - Submission for OMB Review; 30-Day Comment Request; The Clinical Trials Reporting Program (CTRP) Database (NCI) [email protected] 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."> [email protected] 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." /> [email protected] 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." />

81 FR 33681 - Submission for OMB Review; 30-Day Comment Request; The Clinical Trials Reporting Program (CTRP) Database (NCI)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 81, Issue 103 (May 27, 2016)

Page Range33681-33682
FR Document2016-12504

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, [email protected] 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.

Federal Register, Volume 81 Issue 103 (Friday, May 27, 2016) 
[Federal Register Volume 81, Number 103 (Friday, May 27, 2016)]
[Notices]
[Pages 33681-33682]
From the Federal Register Online  [www.thefederalregister.org]
[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, [email protected] 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: [email protected]. 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

Federal Register / Vol. 81, No. 103 / Friday, May 27, 2016 / Notices 33681 passive), and novel adjuvants, including Please limit responses to <1500 information collection that has been the coordinated role that mucosal and characters. Responses to this RFI Notice extended, revised, or implemented on or systemic immunity play in protection are voluntary. The submitted after October 1, 1995, unless it displays from viral acquisition and infection. information will be reviewed by NIH a currently valid OMB control number. 2. Emerging topics related to the staff and may be made available to the Direct Comments to OMB: Written development, testing, and formulation public. Submitted information will not comments and/or suggestions regarding of microbicides, pre-exposure be considered confidential. This request the item(s) contained in this notice, prophylaxis candidates, long acting/ is for information and planning especially regarding the estimated and/or injectable formulations of purposes and should not be construed public burden and associated response antiretroviral treatment candidates (and as a solicitation or as an obligation of time, should be directed to the: Office related methods of delivery for HIV the federal government or the NIH. No of Management and Budget, Office of treatments) that are less toxic, longer awards will be made based on responses Regulatory Affairs, OIRA_submission@ acting, have fewer side effects and to this Request for Information. The omb.eop.gov or by fax to 202–395–6974, complications, and easier to take and information submitted will be analyzed Attention: NIH Desk Officer. adhere to than current regimens. and may be used in reports or 3. Emerging topics that relate to the Comment Due Date: Comments presentations. Those who respond are research toward a cure, including the regarding this information collection are advised that the NIH is under no development of novel approaches and obligation to acknowledge receipt of best assured of having their full effect if strategies that could lead to sustained your comments, or provide comments received within 30 days of the date of HIV remission or viral eradication on your submission. No proprietary, this publication. without the continuing need for classified, confidential and/or sensitive FOR FURTHER INFORMATION CONTACT: To combination antiretroviral therapy, information should be included in your obtain a copy of the data collection including studies of HIV persistence, response. The NIH and the government plans and instruments, or request more latency, and reservoir formation. reserve the right to use any non- information on the proposed project, 4. Emerging topics that relate to the proprietary technical information in any contact: Jose Galvez, MD, Office of the HIV cascade of care, including the future solicitation(s). Director, National Cancer Institute, 9609 development, testing, and Medical Center Drive, Rockville, MD Dated: May 20, 2016. implementation of integrated 20852 or call non-toll-free number 240– biomedical, behavioral, and social Lawrence A. Tabak, 276–5206 or Email your request, science strategies to improve HIV testing Deputy Director, National Institutes of Health. including your address to: jose.galvez@ and entry into prevention and treatment [FR Doc. 2016–12578 Filed 5–26–16; 8:45 am] nih.gov. Formal requests for additional services, including linkage, engagement, BILLING CODE 4140–01–P plans and instruments must be and retention in these services for requested in writing. optimal treatment response. Proposed Collection: The Clinical 5. Emerging topics that relate to basic DEPARTMENT OF HEALTH AND HUMAN SERVICES Trials Reporting Program (CTRP) research underlying the basic biology of Database (NCI), 0925–0600, Expiration HIV, (e.g., acquisition, transmission and National Institutes of Health Date 05/31/2016—Revision, National pathogenesis; viral persistence; immune Cancer Institute (NCI), National dysfunction and chronic inflammation; Submission for OMB Review; 30-Day Institutes of Health (NIH). host microbiome and genetic Comment Request; The Clinical Trials determinants; and pathogenesis of Need and Use of Information Reporting Program (CTRP) Database Collection: The Clinical Trials Reporting opportunistic infections, coinfections, (NCI) comorbidities, and HIV-related Program (CTRP) is an electronic mortalities. SUMMARY: Under the provisions of resource that serves as a single, 6. Emerging topics that relate to Section 3507(a)(1)(D) of the Paperwork definitive source of information about reducing health disparities in the Reduction Act of 1995, the National all NCI-supported clinical research. This incidence of new HIV infections or in Cancer Institute (NCI), the National resource allows the NCI to consolidate treatment outcomes of those living with Institutes of Health, has submitted to the reporting, aggregate information and HIV/AIDS, with a specific focus on Office of Management and Budget reduce redundant submissions. structural, environmental, and (OMB) a request for review and Information is submitted by clinical community-level determinants of health approval of the information collection research administrators as designees of and the interplay of these determinants listed below. This proposed information clinical investigators who conduct NCI- in developing strategies to mitigate the collection was previously published in supported clinical research. The disparities in HIV incidence and access the Federal Register on March 11, 2016 designees can electronically access the to HIV preventive and treatment (Vol. 81, P. 12914) and allowed 60-days CTRP Web site to complete the initial services, for public comment. No public trial registration. Subsequent to 7. Emerging topics that relate to the comments were received. The purpose registration, four amendments and four challenges and opportunities that of this notice is to allow an additional study subject accrual updates occur per should be considered for research 30 days for public comment. The trial annually. training and career development National Cancer Institute (NCI), OMB approval is requested for 3 programs targeting researchers National Institutes of Health, may not years. There are no costs to respondents conducting high priority HIV/AIDS conduct or sponsor, and the respondent other than their time. The estimated sradovich on DSK3TPTVN1PROD with NOTICES research. is not required to respond to, an annualized burden hours are 18,000. VerDate Sep<11>2014 18:00 May 26, 2016 Jkt 238001 PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 E:\FR\FM\27MYN1.SGM 27MYN1

33682 Federal Register / Vol. 81, No. 103 / Friday, May 27, 2016 / Notices ESTIMATED ANNUALIZED BURDEN HOURS Average Number of Total annual Number of time per Type of respondents Form responses per burden respondents response respondent hours (in hours) Clinical Trials ..................................... Initial Registration ............................. 3,000 1 1 3,000 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. Dated: May 23, 2016. 166: Early Phase Clinical Trials in Imaging Karla Bailey, Michelle Trout, and Image-Guided Interventions. Date: June 17, 2016. Project Clearance Liaison, National Cancer Program Analyst, Office of Federal Advisory Time: 11:00 a.m. to 5:00 p.m. Institute, NIH. Committee Policy. Agenda: To review and evaluate grant [FR Doc. 2016–12504 Filed 5–26–16; 8:45 am] [FR Doc. 2016–12502 Filed 5–26–16; 8:45 am] applications. BILLING CODE 4140–01–P BILLING CODE 4140–01–P Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892. Contact Person: Chiayeng Wang, Ph.D., DEPARTMENT OF HEALTH AND DEPARTMENT OF HEALTH AND Scientific Review Officer, Center for HUMAN SERVICES HUMAN SERVICES Scientific Review, 6701 Rockledge Drive, Room 5213, MSC 7852, Bethesda, MD 20892, National Institutes of Health 301–435–2397, chiayeng.wang@nih.gov. National Institutes of Health Name of Committee: Center for Scientific National Heart, Lung, and Blood Center for Scientific Review; Notice of Review Special Emphasis Panel; Small Closed Meetings Business: HIV/AIDS Innovative Research Institute; Notice of Closed Meeting Applications. Pursuant to section 10(d) of the Date: June 21–22, 2016. Pursuant to section 10(d) of the Time: 10:00 a.m. to 4:00 p.m. Federal Advisory Committee Act, as Federal Advisory Committee Act, as Agenda: To review and evaluate grant amended (5 U.S.C. App.), notice is amended (5 U.S.C. App.), notice is applications. hereby given of the following meeting. hereby given of the following meetings. Place: National Institutes of Health, 6701 The meetings will be closed to the Rockledge Drive, Bethesda, MD 20892, The meeting will be closed to the public in accordance with the (Virtual Meeting). public in accordance with the Contact Person: Jingsheng Tuo, Ph.D., provisions set forth in sections provisions set forth in sections Scientific Review Officer, Center for 552b(c)(4) and 552b(c)(6), title 5 U.S.C., 552b(c)(4) and 552b(c)(6), title 5 U.S.C., Scientific Review, National Institutes of as amended. The grant applications and as amended. The grant applications and Health, 6701 Rockledge Drive, Room 5207, the discussions could disclose the discussions could disclose Bethesda, MD 20892, 301–451–8754, tuoj@ confidential trade secrets or commercial confidential trade secrets or commercial nei.nih.gov. property such as patentable material, property such as patentable material, Name of Committee: Center for Scientific and personal information concerning and personal information concerning Review Special Emphasis Panel; Clinical and individuals associated with the grant individuals associated with the grant Translational Imaging Applications. applications, the disclosure of which applications, the disclosure of which Date: June 22, 2016. would constitute a clearly unwarranted Time: 10:00 a.m. to 5:00 p.m. would constitute a clearly unwarranted Agenda: To review and evaluate grant invasion of personal privacy. invasion of personal privacy. applications. Name of Committee: National Heart, Lung, Name of Committee: Center for Scientific Place: National Institutes of Health, 6701 and Blood Institute Special Emphasis Panel; Review Special Emphasis Panel; Member Rockledge Drive, Bethesda, MD 20892. Grant Review for NHLBI K Award Recipients. Conflict: Neuroimaging, Neuroinformatics Contact Person: Eileen W. Bradley, DSC, and Neurogenetics. Chief, SBIB IRG, Center for Scientific Review, Date: June 21, 2016. Date: June 10, 2016. National Institutes of Health, 6701 Rockledge Time: 8:00 a.m. to 4:00 p.m. Time: 2:00 p.m. to 6:00 p.m. Drive, Room 5100, MSC 7854, Bethesda, MD Agenda: To review and evaluate grant Agenda: To review and evaluate grant applications. 20892, (301) 435–1179, bradleye@csr.nih.gov. applications. Name of Committee: Infectious Diseases Place: Bethesda Marriott Suites, 6711 Place: National Institutes of Health, 6701 Democracy Boulevard, Bethesda, MD 20817. and Microbiology Integrated Review Group; Rockledge Drive, Bethesda, MD 20892 Drug Discovery and Mechanisms of Contact Person: Melissa E Nagelin, Ph.D., (Telephone Conference Call). Scientific Review Officer, Office of Scientific Antimicrobial Resistance Study Section. Contact Person: Vilen A. Movsesyan, Date: June 23–24, 2016. Review/DERA, National Heart, Lung, and Ph.D., Scientific Review Officer, Center for Time: 8:00 p.m. to 6:00 p.m. Blood Institute, 6701 Rockledge Drive, Room Scientific Review, National Institutes of Agenda: To review and evaluate grant 7202, Bethesda, MD 20892, 301–435–0297, Health, 6701 Rockledge Drive, Room 4040M, applications. sradovich on DSK3TPTVN1PROD with NOTICES nagelinmh2@nhlbi.nih.gov. MSC 7806, Bethesda, MD 20892, 301–402– Place: American Inn of Bethesda, 8130 (Catalogue of Federal Domestic Assistance 7278, movsesyanv@csr.nih.gov. Wisconsin Avenue, Bethesda, MD 20814. Program Nos. 93.233, National Center for This notice is being published less than 15 Contact Person: Guangyong Ji, Ph.D., Sleep Disorders Research; 93.837, Heart and days prior to the meeting due to the timing Scientific Review Officer, Center for Vascular Diseases Research; 93.838, Lung limitations imposed by the review and Scientific Review, National Institutes of Diseases Research; 93.839, Blood Diseases funding cycle. Health, 6701 Rockledge Drive, Room 3188, and Resources Research, National Institutes Name of Committee: Center for Scientific MSC 7808, Bethesda, MD 20892, 301–435– of Health, HHS) Review Special Emphasis Panel; PAR–14– 1146, jig@csr.nih.gov. VerDate Sep<11>2014 18:00 May 26, 2016 Jkt 238001 PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 E:\FR\FM\27MYN1.SGM 27MYN1


Document Created: 2018-02-07 15:10:17
Document Modified: 2018-02-07 15:10:17
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
DatesComments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication.
ContactTo 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,
FR Citation81 FR 33681 
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