Submission for OMB Review; Emergency Processing; Rapid Access to Interventional Development, 1899-1900 [05-466]

Agencies

• DEPARTMENT OF HEALTH AND HUMAN SERVICES
• National Institutes of Health

[Federal Register Volume 70, Number 7 (Tuesday, January 11, 2005)]
[Notices]
[Pages 1899-1900]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-466]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


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 (https://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 (https://dtp.nci.nih.gov/docs/raid/
raid_index.html); NCI R*A*N*D (https://dtp.nci.nih.gov/docs/rand/rand_
index.html); NCI-NIAID Inter-Institute Program for the Development of 
AIDS-Related Therapeutics (https://dtp.nci.nih.gov/docs/dart/dart/html); 
NCI RAPID (https://www3.cancer.gov/prevention/rapid/); NCI DECIDE 
(https://dtp.nci.nih.gov/docs/ddg/ddg_descript.html); NIDDKT1D-RAID 
(https://www.niddk.nih.gov/fund/diabetesspecailfunds/t1d-raid/raid.htm); 
NIH Roadmap RAID program (https://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.

[[Page 1900]]

    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 (301) 435-0935, or e-mail your request, 
including your address to: ellisj@od.nih.gov.
    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.
[FR Doc. 05-466 Filed 1-10-04; 8:45 am]
BILLING CODE 4140-01-M