[Federal Register Volume 62, Number 118 (Thursday, June 19, 1997)]
[Notices]
[Pages 33424-33426]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-16124]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Assuring Radiation Protection; Availability of Cooperative 
Agreement; Request for Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA), Center for Devices and 
Radiological Health (CDRH), Office of Health and Industry Programs 
(OHIP), is announcing the availability of up to $1,500,000 in total 
costs (including both direct and indirect costs) per year, for a period 
of 5 years, for the establishment of a cooperative agreement to support 
efforts to coordinate Federal and State actions to assure radiation 
protection of the American public. Federal funds are currently 
available for this program, but an award is subject to the condition 
that funds are transferred to FDA from other Federal agencies to 
support this program.

DATES: Applications must be received by close of business on July 25, 
1997.

ADDRESSES: Application kits are available from, and completed 
applications should be submitted to: Robert L. Robins, Grants 
Management Officer, Division of Contracts and Procurement Management 
(HFA-520), Food and Drug Administration, Park Bldg., 5600 Fishers Lane, 
rm. 3-40, Rockville, MD 20857, 301-443-6170.
    NOTE: Applications hand-carried or commercially delivered should be 
addressed to Park Bldg., 12420 Parklawn Dr., rm. 3-40, Rockville, MD 
20857. Please do NOT send applications to the Division of Research 
Grants, National Institutes of Health (NIH).

FOR FURTHER INFORMATION CONTACT:
    Regarding the administrative and financial management aspects of 
this notice: Robert L. Robins (address above).
    Regarding the programmatic aspects of this notice: Richard E. 
Gross, Center for Devices and Radiological Health (HFZ-200), Food and 
Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, 301-443-
2845.

SUPPLEMENTARY INFORMATION: FDA will support the efforts covered by this 
notice under section 532 of the Federal Food, Drug, and Cosmetic Act 
(the act) (21 U.S.C. 360ii). FDA's research program is described in the 
Catalog of Federal Domestic Assistance, No. 93.103.
    The Public Health Service (PHS) is committed to achieving the 
health promotion and disease prevention objectives of ``Healthy People 
2000,'' a PHS-led national activity for setting priority areas. This 
request for application (RFA), Assuring Radiation Protection, is 
related to the priority area of ``Healthy People 2000'' Cancer 
Objectives (chapter 16). Potential applicants may obtain a copy of 
``Healthy People 2000'' (Full Report, Stock No. 017-001-00474-0) 
through the Superintendent of Documents, Government Printing Office, 
Washington, DC 20402-9325, 202-512-1800.
    PHS strongly encourages all grant recipients to provide a smoke-
free workplace and to discourage the use of all tobacco products. This 
is consistent with the PHS mission to protect and advance the physical 
and mental health of the American people.

I. Background

    Since 1968, FDA, the Nuclear Regulatory Commission and its 
predecessor organizations, the Environmental Protection Agency and more 
recently, the Federal Emergency Management Agency and the Department of 
Energy have provided financial support for a forum for the exchange of 
ideas and information among the States and the Federal Government and 
to study existing and potential problems of radiation control. Other 
Federal agencies, notably the National Institute of Standards and 
Technology and the Centers for Disease Control and Prevention, have 
provided additional support for specific activities associated with the 
exchange of ideas and approaches for improving radiation control 
techniques. This forum has made it possible for State and Federal 
agencies to work together to study radiological health problems of 
mutual interest and to apply their increasingly limited resources with 
maximum effectiveness in seeking ways to control these public health 
problems.
    Three major mechanisms have been used to achieve this coordination:
    (1) When certain radiation control subjects warrant specific 
consideration, committees and other working groups composed of 
representatives of State radiation control programs and liaison members 
from the concerned Federal agencies have been formed to evaluate and 
offer solutions to the problems. The recommendations of the committees 
are evaluated by a central management board and final recommended 
actions are relayed to the appropriate Federal and State agencies.
    (2) Annual meetings of Federal and State officials are convened to 
present and discuss the results of the studies conducted. The annual 
meetings also include workshops to more carefully define new problems 
and areas of mutual concern in radiation control, and clinics to 
demonstrate mutually beneficial radiological health techniques, 
procedures, and systems.
    (3) Additional educational activities have been provided to members 
of State programs having radiation control responsibilities and to the 
general public to acquaint them with radiation exposure problems and 
the proposed solutions.
    Methods used have included videotapes, publications, and training 
courses.

II. Goals and Objectives

    The objective of this cooperative agreement will be to continue the 
Federal and State coordination activities with the goal of achieving 
effective solutions to present and future radiation control problems. 
The recipient of this cooperative agreement award will be expected to 
continue the annual meetings and to obtain the cooperation of the 
individual States in maintaining the system of committees and working 
groups established to deal with individual problems. Additionally, the 
recipient of this cooperative agreement award will be expected to 
continue to provide the leadership to refresh and update previously 
developed consensus

[[Page 33425]]

guidance documents and suggested regulations to provide States with up-
to-date assistance in effective management of radiological hazards and 
occasionally implement special projects as determined by the 
participating State and Federal agencies. Areas for which groups may be 
needed include, but are not limited to, radioactive materials and 
radiation exposure problems in the environment, in the healing arts, in 
industry, and in or related to consumer products.

III. Reporting Requirements

    A program progress report and an annual Financial Status Report 
(FSR) (SF-269) are required. An original and two copies of these 
reports shall be submitted to FDA's Grants Management Officer within 90 
days of the budget expiration date of the cooperative agreement. 
Failure to file the FSR in a timely fashion will be grounds to withhold 
continued support of the cooperative agreement. A final program 
progress report and FSR must be submitted within 90 days after the 
expiration of the project period as noted on the Notice of Grant Award.
    Program monitoring of the recipient will be conducted on an ongoing 
basis through telephone conversations between the project officer and/
or the grants management staff and the other participating Federal 
agencies and the principal investigator. Periodic site visits with 
appropriate officials of the grantee organization may also be 
conducted. The results of these communications and visits will be 
recorded in the official cooperative agreement file and may be 
available to the recipient upon request consistent with FDA disclosure 
regulations.

IV. Mechanism of Support

A. Award Instrument

    Support for this program will be in the form of a cooperative 
agreement award. This award will be subject to all policies and 
requirements that govern the research grant programs of PHS, including 
the provisions of 42 CFR part 52 and the appropriate provisions of 45 
CFR parts 74 and 92. The regulations issued under Executive Order 12372 
do not apply to this program.

B. Eligibility

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

C. Length of Support

    This agreement is planned for 5 years. However, noncompetitive 
continuation of support beyond the first year will depend on: (1) 
Acceptable programmatic performance during the preceding year, and (2) 
the availability of Federal fiscal year appropriations.

D. Funding Plan

    Federal funds are currently available for this program, but an 
award is subject to the condition that funds are transferred to FDA 
from other Federal agencies to support this program. FDA intends to 
fund an agreement up to $1,500,000 in total costs (including both 
direct and indirect costs) 1 year for a period of up to 5 years 
conditional upon the availability of Federal funds in subsequent fiscal 
years.

V. Delineation of Substantive Involvement

    Inherent in the cooperative agreement award is substantive 
involvement by the awarding agency and the other agencies providing 
additional support. Accordingly, FDA and the other supporting agencies 
will have a substantive involvement in the programmatic activities of 
the project funded under this program.
    Substantive involvement includes, but is not limited to, the 
following:
     (1) FDA will appoint a project officer who will actively monitor 
the FDA-supported program under this award. Priorities on issues to be 
addressed will be jointly agreed to by the recipient and FDA. The FDA 
project officer is to be invited to all planning meetings of the 
central management board or committee of the recipient of the award. 
The project officer will participate in the making of the decisions 
with respect to the annual meeting (including the topics to be 
discussed), committee organization and mission, and other activities 
under this award.
    (2) FDA liaisons will be appointed to all committees and other 
working groups dealing with problems related to the agency mission. The 
liaison members will participate in the discussions leading to any 
recommendations developed by the committees and working groups. They 
will be primarily responsible for assuring that such recommendations 
are in accordance with Federal policy and regulations. The liaison 
members will also act as investigators, collaborators, or resource 
personnel, as appropriate.
    (3) FDA personnel will collaborate with the recipient on data 
analysis, interpretation of findings, and, where appropriate, co-author 
publications.
    (4) Other Federal agencies providing financial support under this 
agreement will similarly provide representatives to attend the planning 
meetings of the central management board and liaisons to appropriate 
task forces, committees and other working groups. These representatives 
will participate in the decisionmaking and discussions in a way similar 
to the participation of FDA personnel.

VI. Review Procedure and Criteria

A. Review Procedure

    All applications submitted in response to this RFA will first be 
reviewed by grants management and program staff for responsiveness. If 
applications are found to be nonresponsive, they will be returned to 
the applicants without further consideration.
    Responsive applications will be reviewed and evaluated for 
scientific and technical merit by an ad hoc panel of experts in the 
subject field of the specific application. This review will be 
competitive. The final funding decision will be made by the 
Commissioner of Food and Drugs.

B. Review Criteria

    Applications will be reviewed according to the following criteria. 
The points indicated with each criterion represent the maximum score 
achievable in that category.
    (1) Request for financial support is adequately justified and fully 
documented (10 points);
    (2) Experience the applicant's organization has acquired in 
successfully conducting national meetings between personnel 
representing Federal, State, and local regulatory agencies (15 points);
    (3) Experience the applicant's organization has acquired in 
establishing priorities for organizing and maintaining a system of 
committees or working groups of representatives of State governments 
for the purpose of evaluating, recommending solutions to specific 
radiological health or radiation safety problems, and maintaining up-
to-date guidance and suggested regulatory approaches (15 points);
    (4) Extent to which the experience described in response to 
criteria 2 and 3 is directly related to national meetings and 
committees or working groups addressing the major areas of radiation 
control concern. Such areas include, but are not necessarily limited 
to,

[[Page 33426]]

radioactive materials licensure and inspection, the nuclear fuel cycle, 
emergency response, electronic product radiation, environmental 
radiation, the medical use of radiation, and radioactive waste 
disposal. The number of State radiation control programs that 
participate in the activities organized by the applicant's 
organization, the extent of the managerial responsibilities in 
radiation control of the personnel representing these programs, and the 
number of radiation control areas considered will also be taken into 
account in evaluating the applicant's experience (30 points);
    (5) Extent to which the activities of the applicant's organization 
have influenced the practices and policies of the Federal and State 
radiation control programs (15 points); and
    (6) Evidence that demonstrates the applicant's ability to obtain 
the support of the radiation control programs of the 50 States for the 
activities to be conducted under this award, including the 
participation, without compensation except for travel expenses, of 
State personnel in the work of the committees and working groups (15 
points).
    A total of 100 points is available.

VII. Submission Requirements

    The original and five copies of the completed Grant Application 
Form PHS 398 (Rev. 5/95) or the original and two copies of Form PHS 
5161 (Rev. 7/92) for State and local governments, with copies of the 
appendix for each of the copies, should be mailed or hand delivered to 
Robert L. Robins (address above). No supplemental material will be 
accepted after the closing date. The outside of the mailing package and 
item 2 of the application face page should be labeled ``Response to 
RFA-FDA-CDRH 97-1''.
    All General Instructions and Specification Instructions in the 
application kit should be followed with the exception of the receipt 
date and the mailing label address. Do not mail the application to 
NIH's Division of Research Grants.
    This information collection is approved under OMB No. 00925-0001. 
Data included in the application, if restricted with the legend 
specified in section VIII. B of this document, may be entitled to 
confidential treatment as trade secret or confidential commercial 
information within the meaning of the Freedom of Information Act (5 
U.S.C. 552(b)(4)) and FDA's implementing regulations (21 CFR 20.61).

VIII. Method of Application

A. Submission Instructions

    Applications will be accepted by close of business, Monday through 
Friday, on or before July 25, 1997.
    Applications will be considered received on time if sent on or 
before the receipt date as evidenced by a legible U.S. Postal Service 
dated postmark or a legible dated receipt from a commercial carrier, 
unless they arrive too late for orderly processing. Private metered 
postmarks shall not be acceptable as proof of timely mailing. 
Applications not received on time will not be considered for review and 
will be returned to the applicant.
    Applicants should note that the U.S. Postal Service does not 
uniformly provide dated postmarks. Before relying on this method, 
applicants should check with their local post office.

B. Legend

    Unless disclosure is required by the Freedom of Information Act as 
amended (5 U.S.C. 552), as determined by the freedom of information 
officials of the Department of Health and Human Services or by a court, 
data contained in the portions of this application that have been 
specifically identified by page number, paragraph, etc., by the 
applicant as containing trade secret, confidential commercial, or other 
information that is exempt from public disclosure will not be used or 
disclosed except for evaluation purposes.

    Dated: June 10, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-16124 Filed 6-18-97; 8:45 am]
BILLING CODE 4160-01-F