Submission for OMB Review; 30-Day Comment Request; NIMH Database of Cognitive Training and Remediation Studies (DCTRS) (NIMH), 60478-60479 [2014-23938]

Download as PDF 60478 Federal Register / Vol. 79, No. 194 / Tuesday, October 7, 2014 / Notices knowledge of product analyses used by tobacco product manufacturers to ensure product consistency. Dated: September 30, 2014. Leslie Kux, Assistant Commissioner for Policy. II. Description of Site Tours Program [FR Doc. 2014–23844 Filed 10–6–14; 8:45 am] plans and instruments or request more information on the proposed project contact: Keisha Shropshire, NIMH Project Clearance Liaison, Science Policy and Evaluation Branch, OSPPC, NIMH, NIH, Neuroscience Center, 6001 Executive Boulevard, MSC 9667, Rockville Pike, Bethesda, MD 20892, or call 301–443–4335 or Email your request, including your address to: nimhprapubliccomments@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing. BILLING CODE 4164–01–P In the Laboratory Site Tours Program, small groups of CTP staff plan to observe the operations of laboratories that perform testing and analyses of tobacco products and tobacco smoke relative to analytical chemistry, microbiology, toxicology, biomarkers of exposure or risk, and analytical method development. Please note that the Laboratory Site Tours Program is not intended to include official FDA inspections of facilities to determine compliance with the FD&C Act or for the purposes of developing Tobacco Product Manufacturing Practice regulations; rather, the program is meant to educate CTP staff and improve their understanding of laboratory testing and analyses used by the tobacco industry. III. Site Selection CTP plans to select a wide variety of laboratories that include academic, private, and those affiliated with tobacco manufacturers. All travel expenses associated with the site tours will be the responsibility of CTP. Final site selections will be based on the availability of CTP funds and resources for the relevant fiscal year, as well as the following factors, if applicable: (1) Compliance status of the requesting facility and affiliated firm, (2) whether the requesting facility is in arrears for user fees, and (3) whether the requesting facility or affiliated firm has a significant request or marketing application or submission pending with FDA. IV. Requests for Participation Identify requests for participation with the docket number found in brackets in the heading of this document. Received requests are available for public examination in the Division of Dockets Management (see ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday. DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Review; 30-Day Comment Request; NIMH Database of Cognitive Training and Remediation Studies (DCTRS) (NIMH) Proposed Collection Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) 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 April 15, 2014, pages 21250–21252 and allowed 60days 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 Institute of Mental Health (NIMH), 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 SUMMARY: NIMH Database of Cognitive Training and Remediation Studies (DCTRS)— New—National Institute of Mental Health (NIMH), National Institute of Health (NIH). Need and Use of Information Collection: The NIMH Database of Cognitive Training and Remediation Studies (DCTRS) is an integrated database that includes study- and subject-level data from studies of cognitive remediation (CR) in schizophrenia. DCTRS will allow NIMH staff and interested investigators to examine the ways in which various patient characteristics, intervention approaches and features, and treatment combinations affect responses to remediation. The DCTRS Study Information Form and Data Submission Agreement are necessary for the ‘‘Submitter’’ to request permission to submit study data to the NIMH DCTRS for general research purposes. The primary use of this information is to collect submitter information and study information for inclusion in the NIMH DCTRS database. The DCTRS data submission agreement includes two forms: (1) The data submission form that includes the terms, agreement, submitter information and certifications, and (2) the study information form which collects de-identified data for each study. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 60. asabaliauskas on DSK5VPTVN1PROD with NOTICES ESTIMATED ANNUALIZED BURDEN HOURS Form Type of respondent Number of respondents Frequency of response Average time per response (in hours) Annual hour burden Data Submission Agreement ............ Principal Investigators/Physicians .... 12 1 5 60 VerDate Sep<11>2014 17:15 Oct 06, 2014 Jkt 235001 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 E:\FR\FM\07OCN1.SGM 07OCN1 60479 Federal Register / Vol. 79, No. 194 / Tuesday, October 7, 2014 / Notices Dated: September 29, 2014. Keisha Shropshire, NIMH Project Clearance Officer, NIMH, NIH. [FR Doc. 2014–23938 Filed 10–6–14; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Proposed Collection; 60-Day Comment Request; NIMH Data Repositories Data Submission Request; NIMH Data Repositories Data Access and Use Certification 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 Institute of Mental Health (NIMH), 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 on 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 SUMMARY: Mental Health (NIMH) Data Repositories are a group of Federal data repositories based on an informatics platform for human-subjects research domains related to mental health, initially established as the National Database for Autism Research (NDAR) to support autism-related research. In 2013, NIMH received approval from OMB for use of the NIMH Data Access Request and Use Certification (DUC) Form to meet the unique data access needs of all existing NIMH data repositories, which at the time consisted of NDAR, Pediatric MRI (PedsMRI), and the NIMH Clinical Research Datasets (NCRD)—OMB# 0925–0667 (Expiration: 09/30/2016). Now in 2014, two new databases have been added and integrated into the NDAR infrastructure, NDCT and RDoCdb. At this time, NIMH is seeking OMB approval to add an all-purpose NIMH Data Repositories Data Submission Request Form and to add a revised all-purpose NIMH Data Repositories Data Access and Use Certification Form. As the data repositories have matured, and with the introduction of the new databases— namely NDCT and RDoCdb—the information being collected for data submission has become more complex, rendering an OMB-approved submission form a new necessity. OMB approval is requested for three years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 221. methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to 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: NIMH Project Clearance Liaison, Science Policy and Evaluation Branch, OSPPC, NIMH, NIH, Neuroscience Center, 6001 Executive Boulevard, MSC 9667, Rockville Pike, Bethesda, MD 20892, or call 301–443– 4335 or Email your request, including your address to: nimhprapubliccomments@mail.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: NIMH Data Repositories (NDR) Data Submission Request, the NIMH Data Repositories Data Access and Use Certification, 0925–0667 Revision; National Institute of Mental Health (NIMH), National Institutes of Health (NIH). Need and Use of Information Collection: The National Institutes of ESTIMATED ANNUALIZED BURDEN HOURS A. Estimates annual burden hours Number of respondents Form NIMH Data Repositories Data Submission Request Form ............................. NIMH Data Repositories Data Access and Use Certification Form ................ Dated: September 29, 2014. Keisha L Shropshire, Project Clearance Liaison, NIMH, NIH. [FR Doc. 2014–23959 Filed 10–6–14; 8:45 am] asabaliauskas on DSK5VPTVN1PROD with NOTICES 40 100 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings BILLING CODE 4140–01–P 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 VerDate Sep<11>2014 17:15 Oct 06, 2014 Jkt 235001 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 Frequency of response 1 1 Average time per response (in hours) 95/60 95/60 Annual burden hour 63 158 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 Fellowships: Synthetic and Biological Chemistry. Date: November 4–5, 2014. Time: 8:00 a.m. to 3:00 p.m. Agenda: To review and evaluate grant applications. E:\FR\FM\07OCN1.SGM 07OCN1

Agencies

[Federal Register Volume 79, Number 194 (Tuesday, October 7, 2014)]
[Notices]
[Pages 60478-60479]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-23938]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; 30-Day Comment Request; NIMH Database 
of Cognitive Training and Remediation Studies (DCTRS) (NIMH)

SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork 
Reduction Act of 1995, the National Institutes of Health (NIH) 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 April 15, 2014, pages 21250-21252 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 Institute of Mental Health (NIMH), 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: Keisha Shropshire, NIMH Project Clearance 
Liaison, Science Policy and Evaluation Branch, OSPPC, NIMH, NIH, 
Neuroscience Center, 6001 Executive Boulevard, MSC 9667, Rockville 
Pike, Bethesda, MD 20892, or call 301-443-4335 or Email your request, 
including your address to: nimhprapubliccomments@mail.nih.gov. Formal 
requests for additional plans and instruments must be requested in 
writing.

Proposed Collection

    NIMH Database of Cognitive Training and Remediation Studies 
(DCTRS)--New--National Institute of Mental Health (NIMH), National 
Institute of Health (NIH).
    Need and Use of Information Collection: The NIMH Database of 
Cognitive Training and Remediation Studies (DCTRS) is an integrated 
database that includes study- and subject-level data from studies of 
cognitive remediation (CR) in schizophrenia. DCTRS will allow NIMH 
staff and interested investigators to examine the ways in which various 
patient characteristics, intervention approaches and features, and 
treatment combinations affect responses to remediation. The DCTRS Study 
Information Form and Data Submission Agreement are necessary for the 
``Submitter'' to request permission to submit study data to the NIMH 
DCTRS for general research purposes. The primary use of this 
information is to collect submitter information and study information 
for inclusion in the NIMH DCTRS database. The DCTRS data submission 
agreement includes two forms: (1) The data submission form that 
includes the terms, agreement, submitter information and 
certifications, and (2) the study information form which collects de-
identified data for each study.
    OMB approval is requested for 3 years. There are no costs to 
respondents other than their time. The total estimated annualized 
burden hours are 60.

                                                            Estimated Annualized Burden Hours
 
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                          Average time
                      Form                                Type of  respondent            Number of       Frequency of     per response     Annual hour
                                                                                        respondents        response        (in hours)         burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
Data Submission Agreement.......................  Principal Investigators/Physicians              12                1                5               60
--------------------------------------------------------------------------------------------------------------------------------------------------------



[[Page 60479]]

    Dated: September 29, 2014.
Keisha Shropshire,
NIMH Project Clearance Officer, NIMH, NIH.
[FR Doc. 2014-23938 Filed 10-6-14; 8:45 am]
BILLING CODE 4140-01-P