2017-14451. Proposed Collection; 60-Day Comment Request; The National Institute of Mental Health Data Archive (NDA), (NIMH)

AGENCY:

National Institutes of Health, HHS.

ACTION:

Notice.

SUMMARY:

In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, 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.

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.

FOR FURTHER INFORMATION CONTACT:

To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Melba Rojas, NIMH Project Clearance Liaison, Science Policy and Evaluation Branch, Office of Science Policy, Planning and Communications, NIMH, Neuroscience Center, 6001 Executive Boulevard, MSC 9667, Bethesda, Maryland 20892, call 301-443-4335, or email your request, including your mailing address, to [e-mail]. Formal requests for additional plans and instruments must be requested in writing.

SUPPLEMENTARY INFORMATION:

Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 requires: 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) 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.

Proposed Collection Title: The National Institute of Mental Health Data Archive (NDA), REVISION, OMB Control Number 0925-0667, National Institute of Mental Health (NIMH), National Institutes of Health (NIH).

Need and Use of Information Collection: This REVISION request seeks approval of updates to the previously approved National Database for Autism Research Data Access Request and Data Use Certification documents. The NIMH Data Archive (NDA), formerly known as the National Database for Autism Research (NDAR), is an infrastructure that allows for the submission and storage of human subjects data from researchers conducting studies related to many scientific domains, regardless of the source of funding. The NIH and NIMH developed this resource to allow for the public collection of information from: (1) Individuals who seek permission to access data from the NDA for the purpose of scientific investigation, scholarship or teaching, or other forms of research and research development, via the Data Use Certification (DUC), and (2) individuals who request permission to submit data to the NDA for the purpose of scientific investigation, scholarship or teaching, or other forms of research and research development, via the Data Submission Agreement (DSA). The extensive information stored in the NDA continues to provide a rare and valuable scientific resource to the field, and plays an integral part in fulfilling research objectives in multiple scientific domains. The NIH and the NIMH seek to encourage use of the NDA by investigators in the field of multiple scientific research domains to achieve rapid scientific progress. In order to take full advantage of this resource and maximize its research value, it is important that data are made broadly available, on appropriate terms and conditions, to the largest possible number of investigators.

OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 1000.

Estimated Annualized Burden Hours

Form name	Type of respondents	Number of respondents	Number of responses per respondent	Average burden per response (in hours)	Total annual burden hours
NDA Data Submission Agreement (DSA)	Researchers submitting data	250	1	1 hour	250
NDA Data Use Certification (DUC)	Researchers requesting access to data	750	1	1 hour	750
Total		1000	1000		1000

Melba Rojas,

Project Clearance Liaison, National Institute of Mental Health, National Institutes of Health.