2011-12722. Submission for OMB review; Comment Request; Process Evaluation of the NIH Roadmap Epigenomics Program

SUMMARY:

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute on Drug Abuse (NIDA), the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register in Vol. 76, No. 49, pages 13648-13649 on March 14, 2011, and allowed 60 days for public comment. No public comments were received on the planned study or any of the specific topics outlined in the 60-day notice. The purpose of this notice is to allow an additional 30 days for public comment. 5 CFR 1320.5 (General requirements) Reporting and Recordkeeping Requirements: Final Rule requires that the agency inform the potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.

Proposed Collection

Title: Process Evaluation of the NIH Roadmap Epigenomics Program.

Type of Information Collection Request: New.

Need and Use of Information Collection: The proposed information collection is essential to the process evaluation of the NIH Roadmap Epigenomics Program. The process evaluation is a requirement of each of the relevant RFAs funded under the NIH Roadmap Epigenomics Program which require participating in evaluation research activities.

This evaluation study, a mixed-methods study which uses secondary source documentation and information from tracking and monitoring systems along with primary data to assess program process and progress, is non-experimental. The assessment is based on secondary source information, with primary source information collection added to augment the reliability and internal validity. The primary data collection uses information categories that genuinely tap added distinctions and opinions that relate to it to build the weight of evidence from first-hand sources that substantiate the initial hypotheses about the program phenomenon and its differences from a typical research portfolio of individual and insular projects.

The synthesized results across primary and secondary data sources will provide critical insights on transformativeness of high-impact, trans-NIH programs and contribute important information about the synergies and collaborations in multi-component scientific research. It will also identify areas for program improvement and lessons learned that might be useful to other research programs of the Agency.

To reduce response bias and to make the survey as accessible as possible to busy principal investigators, the survey will be web-based.

Frequency of Response: Once.

Affected Public: Principal Investigators of the program at not-for-profit institutions.

Type of Respondents: Principle Investigators.

The annual reporting burden is as follows:

Estimated Number of Respondents: 53.

Estimated Number of Responses per Respondent: 1.

Average Burden Hours per Response: .33.

Estimated Total Annual Burden Hours Requested: 17.49.

The annualized cost to respondents is estimated at: $891.99.

There are no Capital Costs, Operating Costs and/or Maintenance Costs to report.

Estimated Annualized Burden Hours and Costs

Type of respondent	Number of respondents	Number of responses per respondent	Total number of responses	Avg. burden hours per response	Annual burden hours requested	Avg. hourly wage rate	Total annual respondent cost
Principal Investigators	53	1	1	1 33	17.49	51	891.99
1 20 minutes.

Request for Comments: 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 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.

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, [e-mail] or by fax to 202-395-6974, Attention: Desk Officer for NIH. To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact Genevieve deAlmeida-Morris, PhD, M.P.H., Project Officer, Office of Science Policy and Communications, NIH/NIDA, NSC—Neuroscience Center, 5229, 6001 Executive Blvd., Rockville, MD, 20852, or call non-toll-free number 301-594-6802 or e-mail your request including your address to: [e-mail].

Comments 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.

Dated: May 18, 2011.

Mary Affeldt,

Executive Officer, (OM Director, NIDA).