05-466. Submission for OMB Review; Emergency Processing; Rapid Access to Interventional Development

SUMMARY:

Under provisions of section 1320.13 of Regulations Implementing the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) is requesting approval from the Office of Management and Budget (OMB) approval of the information collection involved in the Rapid Access to Intervention Development (RAID) mechanism. Under this program NIH makes NIH resources available to requesting extramural investigators with the goal of speeding the progress of therapeutic, preventive and/or imaging agents to clinical testing.

Since the number of requests from extramural investigators greatly exceeds the available resources of the NIH, the NIH needs to collect scientific background information from the extramural investigators to determine which requests are most meritorious. The instructions on the NIH Web sites identified below explain the procedures for applying.

The initial RAID program was developed in 1998 with authorization by the National Cancer Institute (NCI) Board of Scientific Counselors (BSC) and the National Cancer Advisory Board (NCAB). Subsequently, the RAID type programs were expanded within NCI and adopted also by other NIH components [National Institute of Allergy and Infectious Diseases (NIAID) and National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)]. However, the requirement for clearance of the information collection burden associated with the programs was not recognized. Officials in NCI believed that the support of the research facilitated by the RAID-type programs was already covered under existing OMB authorized information collections (OMB No. 0925-0001/Exp. 9/2007 and OMB NO. 0925-0002/Exp. 6/2005), which provide for regular exchanges of information between NIH program officials and the investigators, who are supported by NIH discretionary investigator-initiated research grants, to assure that NIH remains responsive to new directions in the research, progress in conducting the research and additional budgetary and scientific resources needed to successfully complete the research. As a consequence, the requirement for specific approval of the information collected in the furtherance of the Federal assistance activity was not formally recognized.

At this time, NIH is requesting by emergency clearance procedures that the OMB approve the collection of information under the various existing RAID-type programs and to approve the proposed expansion of the program to accommodate new initiatives under the NIH Director's Roadmap (http://nihroadmap.nih.gov/​), which will employ the RAID model to facilitate advances in research by rapid availability of needed resources. Six Raid-like programs are currently in existence; another is shortly to be announced. NCI RAID (http://dtp.nci.nih.gov/​docs/​raid/​raid_​index.html); NCI R*A*N*D (http://dtp.nci.nih.gov/​docs/​rand/​rand_​index.html); NCI-NIAID Inter-Institute Program for the Development of AIDS-Related Therapeutics (http://dtp.nci.nih.gov/​docs/​dart/​dart/​html); NCI RAPID (http://www3.cancer.gov/​prevention/​rapid/​); NCI DECIDE (http://dtp.nci.nih.gov/​docs/​ddg/​ddg_​descript.html); NIDDKT1D-RAID (http://www.niddk.nih.gov/​fund/​diabetesspecailfunds/​t1d-raid/​raid.htm); NIH Roadmap RAID program (http://nihroadmap.nih.gov/​).

The NIH has determined that the continuing collection of information is essential to the mission of the agency and the agency cannot reasonably comply with the normal clearance procedures because public harm is reasonably likely to result and the use of the normal clearance process is reasonably likely to disrupt the collection of information.

NIH is requesting OMB approval by January 24, 2005, in order to be able to receive applications from scientific investigators that have been in preparation and development for many months in the expectation of support under the announced due dates of the RAID programs. Delay or deferral will create disruption of on going investigations and delay scientific advances.

Proposed Collection: Title: “Rapid Access to Interventional Development.” The NCI RAID program receives between 30-40 applications yearly. R*A*N*D receives 8-10 applications yearly. IIP receives 10-15 applications yearly. Technology transfer information—2 hours per application, completed by technology transfer specialist. Letters of commitment—0.5 hours per application, completed by institutional head of clinical research. Application—30-40 hours per application, completed by Ph.D., or M.D., Ph.D., level scientist. Other RAID type programs accept about 10-12 applications; however, the length of the material requested is somewhat shorter than the NCI Raid programs. The proposed NIH director's Roadmap Initiative anticipates 20-30 applications in the initial round. The total annual burden anticipated for the receipt dates for this emergency clearance request is estimated to be 4000 hours. A subsequent regular request for approval of the continuing collection will address the future estimated annual burden. The cost to the respondents based on the 4000 hour burden will be approximately $250,000.

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, New Executive Office Building, Room 10235, Washington, DC 20503, 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 Mr. Joe Ellis, Division of Grants Policy, Office of Policy for Extramural Research Administration, NIH, Rockledge 1 Building, Room 3513, 6705 Rockledge Drive, Bethesda, MD 20892-7974, or call non-toll-free number [phone], 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: January 4, 2005.

Joe Ellis,

Acting Director, OPERA, OER, National Institutes of Health.