81 FR 12914 - Proposed Collection; 60-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 48 (March 11, 2016)
National Institutes of Health
Federal Register Volume 81, Issue 48 (March 11, 2016)
| Page Range | 12914-12915 | |
| FR Document | 2016-05425 |
[Federal Register Volume 81, Number 48 (Friday, March 11, 2016)] [Notices] [Pages 12914-12915] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-05425] ----------------------------------------------------------------------- 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: [email protected]. 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
![12914 Federal Register / Vol. 81, No. 48 / Friday, March 11, 2016 / Notices
received within 60 days of the date of methodological studies in support of Control Act. The methodological studies
this publication. improvements in the Study’s under this extension will continue to
Proposed Collection: Methodological approaches for data and biospecimen enhance the approaches used by the
Studies for the Population Assessment collection. The PATH Study is a PATH Study for data and biospecimen
of Tobacco and Health (PATH) Study national longitudinal cohort study of collections to obtain high quality and
(NIDA), 0925–0675, expiration date 5/ tobacco use behavior and health among useful data; minimize respondent
31/2016—EXTENSION—NIDA, NIH, in the U.S. household population of adults burden; and achieve and maintain high
partnership with the Food and Drug age 18 and older and youth ages 12 to response, retention, and follow-up rates.
Administration (FDA). 17; the Study conducts annual or
Need and Use of Information biannual interviews and collects OMB approval is requested for 3
Collection: This is a request to continue biospecimens from adults and youth to years. There are no costs to respondents
the Population Assessment of Tobacco inform FDA’s regulatory actions under other than their time. The total
and Health (PATH) Study’s conduct of the Family Smoking Prevention and annualized burden hours are 29,750.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per Total annual
Data collection activity Type of respondent responses per
respondents response burden hours
respondent (in hours)
In-person surveys ......................................... Adults .................................... 5,000 1 90/60 7,500
Youth .................................... 3,500 1 90/60 5,250
Web surveys ................................................. Adults .................................... 5,000 1 90/60 7,500
Youth .................................... 3,500 1 90/60 5,250
Focus groups and individual in-depth quali- Adults .................................... 1,000 1 2 2,000
tative interviews.
Youth .................................... 1,000 1 2 2,000
Biospecimen collection ................................. Adults .................................... 1,000 1 15/60 250
Total ....................................................... 20,000 20,000 ........................ 29,750
Dated: March 7, 2016. the function of the agency, including best assured of having their full effect if
Genevieve deAlmeida-Morris, whether the information will have received within 60 days of the date of
Project Clearance Liaison. NIDA, NIH. practical utility; (2) The accuracy of the this publication.
[FR Doc. 2016–05431 Filed 3–10–16; 8:45 am] agency’s estimate of the burden of the Proposed Collection: The Clinical
BILLING CODE 4140–01–P
proposed collection of information, Trials Reporting Program (CTRP)
including the validity of the Database, 0925–0600, Expiration Date
methodology and assumptions used; (3) 05/31/2016—EXTENSION, National
DEPARTMENT OF HEALTH AND The quality, utility, and clarity of the Cancer Institute (NCI), National
HUMAN SERVICES information to be collected; and (4) Institutes of Health (NIH).
Minimize the burden of the collection of Need and Use of Information
National Institutes of Health information on those who are to Collection: The Clinical Trials Reporting
respond, including the use of Program (CTRP) Database is an
Proposed Collection; 60-Day Comment appropriate automated, electronic, electronic resource that serves as a
Request; The Clinical Trials Reporting mechanical, or other technological single, definitive source of information
Program (CTRP) Database (NCI) collection techniques or other forms of about all NCI-supported clinical
Summary: In compliance with the information technology. research. This resource allows the NCI
requirement of Section 3506(c)(2)(A) of To Submit Comments and For Further to consolidate reporting, aggregate
the Paperwork Reduction Act of 1995, Information: To obtain a copy of the information and reduce redundant
for opportunity for public comment on data collection plans and instruments, submissions. Information is submitted
proposed data collection projects, the submit comments in writing, or request by clinical research administrators as
National Cancer Institute, the National more information on the proposed designees of clinical investigators who
Institutes of Health (NIH) will publish project, contact: Jose Galvez, MD, Office conduct NCI-supported clinical
periodic summaries of proposed of the Director, National Cancer research. The designees can
projects to be submitted to the Office of Institute, 9609 Medical Center Drive, electronically access the CTRP Web site
Management and Budget (OMB) for 1W468, Rockville, MD 20852 or call to complete the initial trial registration.
review and approval. non-toll-free number 240–276–5206 or Subsequent to registration, four
Written comments and/or suggestions Email your request, including your amendments and four study subject
address to: jose.galvez@nih.gov. Formal
asabaliauskas on DSK3SPTVN1PROD with NOTICES
from the public and affected agencies accrual updates occur per trial annually.
are invited to address one or more of the requests for additional plans and OMB approval is requested for 3
following points: (1) Whether the instruments must be requested in years. There are no costs to respondents
proposed collection of information is writing. other than their time. The estimated
necessary for the proper performance of Comment Due Date: Comments annualized burden hours are 18,000.
regarding this information collection are
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![Federal Register / Vol. 81, No. 48 / Friday, March 11, 2016 / Notices 12915
ESTIMATED ANNUALIZED BURDEN HOURS
Number of Average time
Number of Total annual
Type of respondents Forms responses per per response
respondents burden hours
respondent (in hours)
Clinical Research Administrators .......................... Initial Registration ......... 3,000 1 1 3,000
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. Dated: March 4, 2016. children of depressed parents; youth
Karla Bailey, Natasha M. Copeland, and young adults who identify as a
Project Clearance Liaison, National Cancer Program Analyst, Office of Federal Advisory sexual and gender minority) are at
Institute, NIH. Committee Policy. increased risk for suicidal behaviors.
[FR Doc. 2016–05425 Filed 3–10–16; 8:45 am] [FR Doc. 2016–05430 Filed 3–10–16; 8:45 am] One of the challenges in suicide
BILLING CODE 4140–01–P BILLING CODE 4140–01–P prevention research is that the primary
outcome of interest is multidetermined
and, depending on the target
DEPARTMENT OF HEALTH AND DEPARTMENT OF HEALTH AND population, suicide can be a low base
HUMAN SERVICES HUMAN SERVICES rate occurrence. Many studies
examining risk in important subgroups
National Institutes of Health National Institutes of Health (e.g., racial, ethnic, sexual and gender
minorities) often lack sufficient power
National Institute of Allergy and NIH Pathways to Prevention to accurately determine the
Infectious Diseases; Notice of Closed Workshop: Advancing Research To effectiveness of the intervention.
Meeting Prevent Youth Suicide Because suicidal behavior is often
SUMMARY: The National Institutes of multidetermined, it may be that
Pursuant to section 10(d) of the interventions addressing suicide risk
Health (NIH) will host a workshop on
Federal Advisory Committee Act, as factors have benefits for suicide
Advancing Research To Prevent Youth
amended (5 U.S.C. App.), notice is reduction, but these benefits are not
Suicide on March 29–30, 2016. The
hereby given of the following meeting. obvious in research findings, nor can
workshop is free and open to the public.
The meeting will be closed to the DATES: March 29, 2016, from 8:30 a.m.–
the larger community know of these
public in accordance with the 4:50 p.m. and March 30, 2016, from 8:30 benefits. Pooling studies and being able
provisions set forth in sections a.m.–1:00 p.m. to link data from individual studies to
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., multiple data surveillance systems
ADDRESSES: The workshop will be held
as amended. The grant applications and would be important to better understand
the discussions could disclose at the NIH, Masur Auditorium, Building the effectiveness of prevention strategies
confidential trade secrets or commercial 10 (Clinical Center), 9000 Rockville on outcomes such as suicide, suicide
property such as patentable material, Pike, Bethesda, Maryland 20892. attempts, and suicide ideation.
and personal information concerning Registration and workshop information Preventing attempts and self-harm
individuals associated with the grant are available on the NIH Office of ideation would likely result in a
applications, the disclosure of which Disease Prevention (ODP) Web site at reduction in deaths, as well as
would constitute a clearly unwarranted <https://prevention.nih.gov/p2psp>. reductions in health care and social
invasion of personal privacy. FOR FURTHER INFORMATION CONTACT: For burden associated with suicidal
further information concerning this behavior.
Name of Committee: National Institute of
workshop, contact the ODP at Closing the research gaps related to
Allergy and Infectious Diseases Special
Emphasis Panel; Nonhuman Primate Reagent
<NIHP2P@mail.nih.gov>, 6100 youth suicide could lead to improved
Resource (U24). Executive Blvd., Room 2B03, MSC 7523, prevention strategies. The NIH is
Date: April 8, 2016. Bethesda, MD 20892–7523; Telephone: engaging in a rigorous assessment of the
Time: 10:30 a.m. to 1:00 p.m. 301–496–1508; FAX: 301–480–7660. available scientific evidence to better
Agenda: To review and evaluate grant SUPPLEMENTARY INFORMATION: Suicide understand the importance of
applications. was the second leading cause of death identifying efforts that could be effective
Place: National Institutes of Health, 5601 for youth (10- to 24-year-olds) in 2014, in preventing suicidal thoughts and
Fishers Lane, Rockville, MD 20892 resulting in 5,504 deaths in the United behaviors as early as possible. The
(Telephone Conference Call). States. This mortality has not decreased National Institute of Mental Health, the
Contact Person: Nancy Vazquez-
compared to other external causes of National Institute on Drug Abuse, the
Maldonado, Ph.D., Scientific Review Officer,
Scientific Review Program, Division of
death, and youth suicide attempts have National Center for Complementary and
remained at consistent rates for decades. Integrative Health, and the NIH Office of
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Extramural Activities, Room 3F52B, National
Institutes of Health/NIAID, 5601 Fishers According to the 2011 Youth Risk Disease Prevention (ODP) are
Lane, MSC 9834, Bethesda, MD 20892–9834, Behavior Surveillance System, 2.4% of sponsoring the Pathways to Prevention
(240) 669–5044, nvazquez@niaid.nih.gov. high school students received medical Workshop: Advancing Research To
(Catalogue of Federal Domestic Assistance treatment for attempted suicide, and Prevent Youth Suicide on March 29–30,
Program Nos. 93.855, Allergy, Immunology, 7.8% attempted suicide one or more 2016, in Bethesda, Maryland. The
and Transplantation Research; 93.856, times within the year. Some groups workshop will evaluate the current state
Microbiology and Infectious Diseases (e.g., American Indian youth; young of knowledge on youth suicide and
Research, National Institutes of Health, HHS) adults with substance use problems; identify opportunities for future
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Document Created: 2016-03-11 01:50:44
Document Modified: 2016-03-11 01:50:44
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Dates | Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. | |
| FR Citation | 81 FR 12914 |
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