Proposed Collection; 60-Day Comment Request; The Clinical Trials Reporting Program (CTRP) Database (NCI), 12914-12915 [2016-05425]

Download as PDF 12914 Federal Register / Vol. 81, No. 48 / Friday, March 11, 2016 / Notices received within 60 days of the date of this publication. Proposed Collection: Methodological Studies for the Population Assessment of Tobacco and Health (PATH) Study (NIDA), 0925–0675, expiration date 5/ 31/2016—EXTENSION—NIDA, NIH, in partnership with the Food and Drug Administration (FDA). Need and Use of Information Collection: This is a request to continue the Population Assessment of Tobacco and Health (PATH) Study’s conduct of Control Act. The methodological studies under this extension will continue to enhance the approaches used by the PATH Study for data and biospecimen collections to obtain high quality and useful data; minimize respondent burden; and achieve and maintain high response, retention, and follow-up rates. methodological studies in support of improvements in the Study’s approaches for data and biospecimen collection. The PATH Study is a national longitudinal cohort study of tobacco use behavior and health among the U.S. household population of adults age 18 and older and youth ages 12 to 17; the Study conducts annual or biannual interviews and collects biospecimens from adults and youth to inform FDA’s regulatory actions under the Family Smoking Prevention and OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total annualized burden hours are 29,750. ESTIMATED ANNUALIZED BURDEN HOURS Data collection activity Number of respondents Type of respondent In-person surveys ......................................... Web surveys ................................................. Focus groups and individual in-depth qualitative interviews. Biospecimen collection ................................. Adults Youth Adults Youth Adults [FR Doc. 2016–05431 Filed 3–10–16; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health asabaliauskas on DSK3SPTVN1PROD with NOTICES Proposed Collection; 60-Day Comment Request; The Clinical Trials Reporting Program (CTRP) Database (NCI) Summary: In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Cancer Institute, the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Written comments and/or suggestions from the public and affected agencies are invited to address one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of VerDate Sep<11>2014 17:56 Mar 10, 2016 Jkt 238001 Total annual burden hours .................................... .................................... .................................... .................................... .................................... 5,000 3,500 5,000 3,500 1,000 1 1 1 1 1 90/60 90/60 90/60 90/60 2 7,500 5,250 7,500 5,250 2,000 Youth .................................... Adults .................................... 1,000 1,000 1 1 2 15/60 2,000 250 20,000 20,000 ........................ 29,750 Total ....................................................... Dated: March 7, 2016. Genevieve deAlmeida-Morris, Project Clearance Liaison. NIDA, NIH. Average burden per response (in hours) Number of responses per respondent the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) The quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To Submit Comments and For Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Jose Galvez, MD, Office of the Director, National Cancer Institute, 9609 Medical Center Drive, 1W468, 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. Comment Due Date: Comments regarding this information collection are PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 best assured of having their full effect if received within 60 days of the date of this publication. Proposed Collection: The Clinical Trials Reporting Program (CTRP) Database, 0925–0600, Expiration Date 05/31/2016—EXTENSION, National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: The Clinical Trials Reporting Program (CTRP) Database 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. E:\FR\FM\11MRN1.SGM 11MRN1 12915 Federal Register / Vol. 81, No. 48 / Friday, March 11, 2016 / Notices ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Number of responses per respondent Average time per response (in hours) Total annual burden hours Type of respondents Forms Clinical Research Administrators .......................... Initial Registration ......... Amendment .................. Accrual Updates ........... 3,000 3,000 3,000 1 4 4 1 1 15/60 3,000 12,000 3,000 Totals ............................................................. ....................................... 9,000 27,000 ........................ 18,000 Dated: March 2, 2016. Karla Bailey, Project Clearance Liaison, National Cancer Institute, NIH. Dated: March 4, 2016. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2016–05425 Filed 3–10–16; 8:45 am] [FR Doc. 2016–05430 Filed 3–10–16; 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 Institute of Allergy and Infectious Diseases; Notice of Closed Meeting NIH Pathways to Prevention Workshop: Advancing Research To Prevent Youth Suicide asabaliauskas on DSK3SPTVN1PROD with NOTICES 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. Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel; Nonhuman Primate Reagent Resource (U24). Date: April 8, 2016. Time: 10:30 a.m. to 1:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 5601 Fishers Lane, Rockville, MD 20892 (Telephone Conference Call). Contact Person: Nancy VazquezMaldonado, Ph.D., Scientific Review Officer, Scientific Review Program, Division of Extramural Activities, Room 3F52B, National Institutes of Health/NIAID, 5601 Fishers Lane, MSC 9834, Bethesda, MD 20892–9834, (240) 669–5044, nvazquez@niaid.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.855, Allergy, Immunology, and Transplantation Research; 93.856, Microbiology and Infectious Diseases Research, National Institutes of Health, HHS) VerDate Sep<11>2014 17:56 Mar 10, 2016 Jkt 238001 The National Institutes of Health (NIH) will host a workshop on Advancing Research To Prevent Youth Suicide on March 29–30, 2016. The workshop is free and open to the public. DATES: March 29, 2016, from 8:30 a.m.– 4:50 p.m. and March 30, 2016, from 8:30 a.m.–1:00 p.m. ADDRESSES: The workshop will be held at the NIH, Masur Auditorium, Building 10 (Clinical Center), 9000 Rockville Pike, Bethesda, Maryland 20892. Registration and workshop information are available on the NIH Office of Disease Prevention (ODP) Web site at <https://prevention.nih.gov/p2psp>. FOR FURTHER INFORMATION CONTACT: For further information concerning this workshop, contact the ODP at <NIHP2P@mail.nih.gov>, 6100 Executive Blvd., Room 2B03, MSC 7523, Bethesda, MD 20892–7523; Telephone: 301–496–1508; FAX: 301–480–7660. SUPPLEMENTARY INFORMATION: Suicide was the second leading cause of death for youth (10- to 24-year-olds) in 2014, resulting in 5,504 deaths in the United States. This mortality has not decreased compared to other external causes of death, and youth suicide attempts have remained at consistent rates for decades. According to the 2011 Youth Risk Behavior Surveillance System, 2.4% of high school students received medical treatment for attempted suicide, and 7.8% attempted suicide one or more times within the year. Some groups (e.g., American Indian youth; young adults with substance use problems; SUMMARY: PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 children of depressed parents; youth and young adults who identify as a sexual and gender minority) are at increased risk for suicidal behaviors. One of the challenges in suicide prevention research is that the primary outcome of interest is multidetermined and, depending on the target population, suicide can be a low base rate occurrence. Many studies examining risk in important subgroups (e.g., racial, ethnic, sexual and gender minorities) often lack sufficient power to accurately determine the effectiveness of the intervention. Because suicidal behavior is often multidetermined, it may be that interventions addressing suicide risk factors have benefits for suicide reduction, but these benefits are not obvious in research findings, nor can the larger community know of these benefits. Pooling studies and being able to link data from individual studies to multiple data surveillance systems would be important to better understand the effectiveness of prevention strategies on outcomes such as suicide, suicide attempts, and suicide ideation. Preventing attempts and self-harm ideation would likely result in a reduction in deaths, as well as reductions in health care and social burden associated with suicidal behavior. Closing the research gaps related to youth suicide could lead to improved prevention strategies. The NIH is engaging in a rigorous assessment of the available scientific evidence to better understand the importance of identifying efforts that could be effective in preventing suicidal thoughts and behaviors as early as possible. The National Institute of Mental Health, the National Institute on Drug Abuse, the National Center for Complementary and Integrative Health, and the NIH Office of Disease Prevention (ODP) are sponsoring the Pathways to Prevention Workshop: Advancing Research To Prevent Youth Suicide on March 29–30, 2016, in Bethesda, Maryland. The workshop will evaluate the current state of knowledge on youth suicide and identify opportunities for future E:\FR\FM\11MRN1.SGM 11MRN1

Agencies

[Federal Register Volume 81, Number 48 (Friday, March 11, 2016)]
[Notices]
[Pages 12914-12915]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-05425]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; 60-Day Comment Request; The Clinical Trials 
Reporting Program (CTRP) Database (NCI)

    Summary: In compliance with the requirement of Section 
3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity 
for public comment on proposed data collection projects, the National 
Cancer Institute, the National Institutes of Health (NIH) will publish 
periodic summaries of proposed projects to be submitted to the Office 
of Management and Budget (OMB) for review and approval.
    Written comments and/or suggestions from the public and affected 
agencies are invited to address one or more of the following points: 
(1) Whether the proposed collection of information is necessary for the 
proper performance of the function of the agency, including whether the 
information will have practical utility; (2) The accuracy of the 
agency's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) The quality, utility, and clarity of the information to be 
collected; and (4) Minimize the burden of the collection of information 
on those who are to respond, including the use of appropriate 
automated, electronic, mechanical, or other technological collection 
techniques or other forms of information technology.
    To Submit Comments and For Further Information: To obtain a copy of 
the data collection plans and instruments, submit comments in writing, 
or request more information on the proposed project, contact: Jose 
Galvez, MD, Office of the Director, National Cancer Institute, 9609 
Medical Center Drive, 1W468, 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.
    Comment Due Date: Comments regarding this information collection 
are best assured of having their full effect if received within 60 days 
of the date of this publication.
    Proposed Collection: The Clinical Trials Reporting Program (CTRP) 
Database, 0925-0600, Expiration Date 05/31/2016--EXTENSION, National 
Cancer Institute (NCI), National Institutes of Health (NIH).
    Need and Use of Information Collection: The Clinical Trials 
Reporting Program (CTRP) Database 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 12915]]



                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of     Average time
      Type of respondents             Forms          Number of     responses per   per response    Total annual
                                                    respondents     respondent      (in hours)     burden hours
----------------------------------------------------------------------------------------------------------------
Clinical Research               Initial                    3,000               1               1           3,000
 Administrators.                 Registration.
                                Amendment.......           3,000               4               1          12,000
                                Accrual Updates.           3,000               4           15/60           3,000
                                                 ---------------------------------------------------------------
    Totals....................  ................           9,000          27,000  ..............          18,000
----------------------------------------------------------------------------------------------------------------


    Dated: March 2, 2016.
Karla Bailey,
Project Clearance Liaison, National Cancer Institute, NIH.
[FR Doc. 2016-05425 Filed 3-10-16; 8:45 am]
 BILLING CODE 4140-01-P