E7-14610. Assuring Radiation Protection; Cooperative Agreement; Request for Applications: RFA-FDA-CDRH-07-004; Catalog of Federal Domestic Assistance Number: 93.103

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

I. Funding Opportunity Description

The Food and Drug Administration (FDA) is announcing its intention to receive and consider applications for the award of a cooperative agreement in fiscal year 2007 (FY07) to provide support in furtherance of FDA's responsibilities, under section 532 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360ii), to establish and carry out a comprehensive radiation control program. An estimated amount of support in FY07 will be for up to $400,000, with an additional 5 years of support, subject to the condition that in addition to FDA funds, augmenting funds are transferred to FDA from other Federal agencies to fully support this program. Funds may not be used to fund or conduct international activities or initiatives. As the lead Federal agency, FDA intends to collect funds from all other contributing Federal agencies through Interagency Agreements and fund one award for up to $400,000 in total costs (including both direct and indirect costs). After the first year, additional years of noncompetitive support are predicated upon acceptable performance during the preceding year and the availability of Federal funds.

The cooperative agreement will allow FDA to continue to work with the Nuclear Regulatory Commission and its predecessor organizations, the Environmental Protection Agency and the Federal Emergency Management Agency, to provide financial support for a forum established to foster the exchange of ideas and information among the States and the Federal Government concerning radiation control. This forum has made it possible for State and Federal agencies to work together to study existing and potential radiological health problems of mutual interest and to apply their increasingly limited resources with maximum efficiency in seeking ways to address these problems, fostering coordination, and providing original views.

II. Award Information

The objective of this cooperative agreement is to coordinate Federal, State, and Tribal activities to achieve effective solutions to present and future radiation control problems. The recipient of this cooperative agreement award will be expected to obtain the States' cooperation and participation on committees and working groups established to deal with individual problems. The recipient will also plan and facilitate an annual meeting, and develop and offer educational activities to demonstrate mutually beneficial techniques, procedures, and systems relevant to the mission of assuring radiation protection. The recipient will establish committees to address, evaluate, and offer solutions for a wide range of radiation health and protection issues. Examples of relevant areas of interest include, but are not limited to: (1) The application of x-rays to the healing arts, (2) the application of medical/nonmedical ionizing radiation, and (3) the control and mitigation of radiation exposure from all sources.

Copyright Material: Applicants and applicants' subgrantees and subcontractors must ensure that any projects developed in whole or in part with Federal funds will be made available to other State, territorial, local, and tribal agencies by FDA or its agents. Any copyrighted or copyrightable works shall be subject to a royalty-free, nonexclusive, and irrevocable license to the Federal Government to reproduce, publish, or otherwise use them, and to authorize others to do so for Federal Government purposes.

III. Eligibility Information

This cooperative agreement is available to any domestic private or public nonprofit organization (including State and local units of government) and to any domestic for-profit organization. For-profit organizations must exclude fees or profit from their requested support. Organizations described in section 501(c)(4) of the Internal Revenue Code of 1968 that engage in lobbying are not eligible to receive awards.

IV. Submission Information/Requirements

Applications for this program must be made electronically. To apply, applicants should visit http://www.grants.gov^[1] and follow the instructions under “Apply for Grants.” The required application, SF424 (Research & Related) (also referred to as the “SF424 (R&R)”), can be completed and submitted online. The package should be labeled “Response to FDA RFA number is FD07-004”. If you experience technical difficulties with your online submission, you should contact the Grants.gov Customer Response Center. Information about submitting an application electronically can be found at http://www.grants.gov. In order to apply electronically, the applicant must have a DUNS number and register in the Central Contractor Registration (CCR) database. In addition, applicants will be required to register with the Credential Provider. Information about this is available at http://apply.grants.gov/​OrcRegister,¹ or by calling ORC's help desk at 800-816-5548.

Dun and Bradstreet Number (DUNS): As of October 1, 2003, applicants are required to have a DUNS number to apply for a grant or cooperative agreement from the Federal Government. The DUNS number is a 9-digit identification number that uniquely identifies business entities. Obtaining a DUNS number is easy and there is no charge. To obtain a DUNS number, call Dun and Bradstreet at 1-866-705-5711 and identify yourself as a Federal grant applicant.

Central Contractor Registration: Applicants must also register in the Central Contractor Registration (CCR) database. Applicants must have a DUNS number to begin registration in the CCR database. The CCR is a database is a government wide repository of commercial and financial information for all organizations conducting business with the Federal Government. Registration with CCR will eventually become a requirement for grant applicants and is consistent with the government wide management reform to create a citizen-centered Web presence and build e-gov infrastructures in and across agencies to establish a “single face to industry.” The preferred method for completing registration is on the Internet at http://www.ccr.gov.¹ This Web site provides a CCR handbook with detailed information on data that applicants will need prior to beginning the online registration, as well as steps to walk applicants through the registration process.

Additional information concerning the application process for this cooperative agreement can be found on FDA's Web site (http://www.fda.gov/​cdrh) and also through the Grants.gov Web site (http://www.grants.gov).

Submission Date: The application receipt date August 14, 2007. No supplemental or addendum material will be accepted after the receipt date.

V. Agency Contacts

For additional information regarding the administrative and financial management aspects of this notice, contact Gladys M. Bohler, Food and Drug Administration (HFA-500), 5630 Fishers Lane, Rm. 2105, Rockville, MD 20857; 301-827-7168, FAX: [phone]; e-mail: [e-mail].

For additional information regarding the programmatic aspects of this notice, contact Sara Sutphin, Center for Devices and Radiological Health (HFZ-205), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850; 240-276-3225, FAX: [phone]; e-mail: [e-mail].

Dated: July 23, 2007.

Jeffrey Shuren,

Assistant Commissioner for Policy.

Footnotes

1.  (FDA has verified the Web site address, but FDA is not responsible for any subsequent changes to the Web site after this document publishes in the Federal Register.)