[Federal Register Volume 67, Number 124 (Thursday, June 27, 2002)]
[Notices]
[Pages 43326-43330]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-16293]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA), Center for Devices and 
Radiological Health (CDRH), is announcing the availability of 
approximately $500,000 in total fiscal year (FY) 2002 funds. These 
funds will be used to support one cooperative agreement for the 
coordination of Federal and State actions to assure radiation 
protection of the American public.

DATES: Submit applications by July 29, 2002.

ADDRESSES: Completed applications should be submitted to: Maura C. 
Stephanos, Grants Management Specialist, Grants Management Staff (HFS-
520), Division of Contracts and Procurement Management, Food and Drug 
Administration, 5600 Fishers Lane, rm. 2129, Rockville, MD 20857, 301-
827-7183, FAX 301-827-7101, e-mail: [email protected]. Application 
forms are available either from Maura C. Stephanos or on the Internet 
at http://grants.nih.gov/grants/funding/pjs398/phs398.html/. Note: Do 
not send applications to the Center for Scientific Research (CSR), 
National Institutes of Health (NIH).

FOR FURTHER INFORMATION CONTACT:
    Regarding the administrative and financial management aspects of 
this notice, contact Maura C. Stephanos (see ADDRESSES).
    Regarding the programmatic aspects of this notice, contact Penny R. 
Boyce, Center for Devices and Radiological Health (HFZ-240), Food and 
Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, 301-594-
3650, FAX 301-594-3306; e-mail: [email protected].

SUPPLEMENTARY INFORMATION: FDA is announcing its intention to accept 
and consider applications for a cooperative agreement in support of 
coordination of Federal and State action to protect the American public 
from exposure to radiation. The cooperative agreement covered by this 
notice will be 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. 
FDA's authority to enter into grants and cooperative agreements is set 
out in section 301 of the Public Health Service Act (42 U.S.C. 241). 
FDA's research program is described in the Catalog of Federal Domestic 
Assistance No. 93.103. Before entering into cooperative agreements, FDA 
carefully considers the benefits such agreements will provide to the 
public.

[[Page 43327]]

    The Public Health Service (PHS) strongly encourages all award 
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.
    FDA is committed to achieving the health promotion and disease 
prevention objectives of ``Healthy People 2010,'' a national effort 
designed to reduce morbidity and mortality and to improve quality of 
life. Applicants may obtain a paper copy of the ``Healthy People 2010'' 
objectives, vols. I and II, for $70 ($87.50 foreign) S/N 017-000-00550-
9 by writing to the Superintendent of Documents, P.O. Box 371954, 
Pittsburgh, PA 15250-7954. Telephone orders can be placed to 202-512-
2250. The document is also available in CD-ROM format, S/N 017-001-
00549-5 for $19 ($23.50 foreign) as well as on the Internet at http://health.gov/healthypeople. Internet viewers should proceed to 
``Publications.''

I. Background

    Since 1968, FDA has taken the lead in working with the Nuclear 
Regulatory Commission (NRC) and its predecessor organizations, the 
Environmental Protection Agency (EPA), the Federal Emergency Management 
Agency (FEMA), and the Department of Energy (DOE), 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.
    Three major mechanisms traditionally have been used to achieve this 
coordination between State and Federal agencies:
    1. When certain radiation control issues warrant specific 
consideration, committees and other working groups comprised of 
representatives of State radiation control programs and liaison members 
from the concerned Federal agencies have been formed to evaluate these 
issues and recommend ways to address them. 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. The annual meeting lasts approximately 4 days, 
with an average attendance of 350 participants.
    3. Additional educational activities have been provided for the 
benefit of members of State programs having radiation control 
responsibilities and 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 coordinate 
Federal and State 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 already identified to be 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; (3) the development of a system for managing the disposition 
of unwanted radioactive materials (orphan sources); and (4) the control 
and mitigation of radiation exposure from all sources. These areas are 
explained more fully in the following paragraphs.

A. Areas of Interest

1. Application of X-Rays to the Healing Arts
    The recipient's activities related to x-rays in the healing arts 
should include issues related to general diagnostic radiology and 
mammography.
a. General Diagnostic Radiology
    Issues related to radiography, fluoroscopy, and computed tomography 
should be considered in terms of practice guidelines, quality assurance 
procedures, and patient exposure evaluation. In the area of patient 
exposure, the recipient will be responsible for conducting an annual 
survey of a representative sample of medical x-ray facilities 
conducting one specific diagnostic x-ray procedure (from a set of 
predefined procedures that will be the subject of the survey over 
time).
b. Mammography
    The recipient will be responsible for providing advice and 
recommendations to FDA on issues related to the implementation of the 
Mammography Quality Standards Act (MQSA). Consideration should be given 
to issues related to: The training of those conducting MQSA 
inspections; the results of the ongoing FDA Inspection Demonstration 
Program under MQSA; and informing mammography facilities about the 
results of MQSA inspections nationwide and steps that they can take to 
improve their performance under MQSA.
2. Application of Medical/Nonmedical Ionizing Radiation
    The recipient will also address issues in the nonmedical 
applications of ionizing radiation as well as the medical and 
nonmedical applications of nonionizing radiation, particularly 
ultraviolet radiation.
3. Managing the Disposition of Unwanted Radioactive Materials (Orphan 
Sources)
    The recipient will develop, implement, and manage a national 
program to identify, handle, and dispose of unwanted radioactive 
materials (orphan sources). The responsibilities for this task include: 
(1) Clarifying the State and Federal jurisdictional and regulatory 
responsibilities; (2) establishing agreements with interested NRC 
Agreement and non-Agreement States to identify and dispose of discrete 
orphan sources; (3) establishing cost guidelines for disposal of 
discrete orphan sources; and (4) reimbursing States for recovery, 
recycling, arrangements for reuse, and disposal costs of these sources. 
Additionally, the recipient will study, evaluate, and develop actions 
on issues related to radioactive waste disposal, radioactive 
contamination, contaminated sites, and international radiation 
protection as recommended by working groups and subcommittees 
established by the recipient.

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4. Control and Mitigation of Radiation Exposure
    The recipient will be responsible for developing criteria relevant 
to the control and mitigation of radiation exposure from all sources. 
Specific areas to be addressed include: Responding to radiation 
accidents or incidents; evaluating the adequacy of State radiation 
control programs, controlling residual radioactivity levels from 
decontamination and decommissioning of nuclear facilities, determining 
the propriety of delegating implementation authority for Federal 
standards for control of radionuclides as hazardous air pollutants, and 
implementing the Indoor Radon Abatement Act. The recipient will also be 
required to review and provide comments on issues related to 
radiological emergency preparedness.

B. Suggested State Regulations for the Control of Radiation (SSRCR)

    Updating and maintaining the SSRCR will be an integral aspect of 
this cooperative agreement. These regulations will be disseminated to 
the States for the purpose of promoting uniformity between the States. 
The regulations will address issues relevant to controlling radiation 
exposure from all sources such as low-level waste, radioactive 
contamination, radioactive materials, radon, and x-rays in the healing 
arts.

C. Committee Oversight and Management

    The recipient should anticipate oversight and management 
responsibilities for approximately 45 committees. In some instances, 
the recipient will be required to provide representatives to certain 
Federal radiation committees, such as the Federal Radiological 
Preparedness Coordinating Committee (FRPCC) and its subcommittees 
(overseen by FEMA).
    Federal representatives will be appointed to these committees and 
other working groups dealing with problems related to the agency 
mission. These representatives 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 Federal representatives will also act as investigators, 
collaborators, or resource personnel, as appropriate.

D. Special Projects

    The recipient will also 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.

E. Annual Meeting

    The recipient will be required to plan, conduct, and handle all 
administrative functions for an annual meeting. This meeting will offer 
an opportunity for member States and other interested parties to 
convene to exchange concerns and ideas for problem solving. The 
recipient should consult with stakeholders to determine priority agenda 
items and topics of interest. General sessions of this annual meeting 
should include workshops to define new problems, and discussions and 
lectures on mutually beneficial radiological health techniques, 
procedures, and systems. Identified areas of mutual concern in 
radiation control should be considered for assignment to a task force 
or committee comprised of experts. The recipient will be expected to 
publish the meeting proceedings in hardcopy and on the recipient's web 
site for limited dissemination to member States and relevant Federal 
personnel.
    In conjunction with the annual meeting, the recipient will be 
required to hold training sessions. These sessions should demonstrate 
mutually beneficial techniques, procedures, and systems that have been 
developed by the sponsoring agencies or the recipient. The recipient 
may also be requested by FDA to provide instructors for Federal 
training courses with a radiological component held outside of the 
annual meeting.
    Additionally, the recipient of this cooperative agreement award 
will be expected to provide the leadership to refresh and update 
previously-developed consensus guidance documents and SSRCR to provide 
States with up-to-date assistance in effective management of 
radiological hazards.
    A Web site will be maintained by the recipient for the benefit of 
the States and other interested parties; the FDA Project Officer and 
other designated Federal personnel will be given complete and full 
access to all information posted on the site that is relevant to the 
work supported by FDA and other supporting agencies. The information 
and materials posted on the site should be reviewed and updated at 
regular intervals. Expertise in Web site maintenance and security is 
required to fulfill this task.

III. Reporting Requirements

    An annual program progress report, a report detailing progress made 
under the National Orphan Source Program, 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 these reports in a timely fashion may be 
grounds to withhold continued support of the cooperative agreement and/
or suspend or terminate the agreement. The recipient will be advised of 
the suggested format for the annual Program Progress Report and the 
National Orphan Source Program report at the time an award is made.
    A final program progress report and FSR will be due within 90 days 
after the expiration of the project period as noted on the Notice of 
Grant Award.
    Reports generated by the task forces, committees, and workshops 
should include recommendations for the resolution of problem areas as 
well as cost/benefit evaluations. These reports will be reviewed by the 
recipient's governing body before final dissemination to Federal and/or 
State officials. Any publications supported by Federal funds must 
include a statement acknowledging Federal support, as well as a 
disclaimer that the information presented is not necessarily the view 
of the supporting agency.
    Program monitoring of the recipient will be conducted by FDA on an 
ongoing basis through telephone conversations between the FDA Project 
Officer and/or the FDA Grants Management Specialist and the principal 
investigator. Periodic site visits with appropriate officials of the 
recipient 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.
    The recipient will also provide a periodic newsletter that will be 
made available to member States and relevant Federal personnel on the 
Web site. The newsletter should include updates on projects and 
programs relevant to the mission of, and supported by, the contributing 
Federal agencies. The FDA Project Officer and liaisons from other 
agencies supporting this Agreement will be provided access to secured 
information on the Web site via passwords.
    The recipient will maintain a database of personnel responsible for 
radiological

[[Page 43329]]

health programs in the member States and Federal agencies. This 
database will be updated annually and published for distribution by the 
recipient. Two paper copies of the directory and a noncopyright 
electronic version will be provided to all contributing Federal 
agencies.

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 45 CFR parts 74 and 92. The 
regulations issued under Executive Order 12372 do not apply to this 
program. The National Institutes of Health's (NIH) modular grant 
program does not apply to this FDA program.

B. Eligibility

    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.

C. Length of Support

    The length of support will be for up to 5 years. Funding beyond the 
first year will be noncompetitive and will depend on: (1) Acceptable 
programmatic performance during the preceding year, and (2) the 
availability of Federal fiscal year funds.

D. Funding Plan

    Federal funds are currently available from FDA for this program. 
However, an award is 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. As the lead Federal agency, FDA 
intends to collect funds from all other contributing Federal agencies 
through Interagency Agreements (IAGs) and fund one award for up to 
$500,000 in total costs (including both direct and indirect costs). 
Support of this cooperative agreement may be for up to 5 years in 
duration with the total budget amount not to exceed $500,000 (direct 
plus indirect costs) per year or a total of $2,500,000 for a 5-year 
award. Funds obligated through IAGs will be immediately transferred to 
FDA for use in support of this agreement.
    Any application received that exceeds $500,000 (direct plus 
indirect costs) per year will not be considered responsive and will be 
returned to the applicant without being reviewed. After the first year, 
additional years of noncompetitive support are predicated upon 
acceptable performance during the preceding year and the availability 
of Federal funds.

V. Delineation of Substantive Involvement

    Substantive involvement by the awarding agency is inherent in the 
cooperative agreement award. Accordingly, FDA will have a substantive 
involvement in the programmatic activities of the project funded by the 
cooperative agreement.
    Substantive involvement includes, but is not limited to, the 
following:
    (1) Priorities on issues to be addressed will be jointly agreed to 
by the recipient and FDA in coordination with the Federal liaisons of 
agencies providing funding to FDA under an Interagency Agreement. The 
FDA Project Officer will be invited to all planning meetings of the 
central management board or committee of the recipient of the award. 
These meetings must be held on normal business days during normal 
business hours. The Project Officer will participate in the making of 
decisions with respect to the annual meeting (including the topics to 
be discussed and meeting site selection), committee organization and 
mission, and other activities under this award.
    (2) Senior Federal liaisons from all contributing Federal agencies 
will also be named and will regularly attend the planning meetings of 
the central management board or committee, and will communicate with 
the other liaisons from their agency who are members of the task forces 
and related committees. These Senior Federal Liaisons will also 
regularly attend the annual meeting. Through the FDA Project Officer, 
the recipient will communicate with agencies on major policy and 
regulatory issues relevant to the work of FDA and the supporting 
agencies.
    (3) FDA will collaborate with the recipient on data analysis, 
interpretation of findings, and, where appropriate, coauthor 
publications.

VI. Review Procedures and Criteria

A. Review Procedures

    FDA's grants management and program staff will review all 
applications submitted in response to this notice for responsiveness. 
To be responsive, an application must: (1) Be received by the specified 
due date; (2) be submitted in accordance with sections IV.B. 
``Eligibility,'' VII. ``Submission Requirements,'' and VIII.A. 
``Submission Instructions'' of this notice; (3) not exceed the 
recommended funding amount stated in section IV.D of this document; (4) 
address the specific requirements of the project stated in section II. 
``Goals and Objectives'' of this document; and (5) bear the original 
signatures of both the Principal Investigator and the Institution's/
Organization's Authorized Official. 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. This 
review will be competitive. The final funding decision will be made by 
the Commissioner of Food and Drugs.

B. Review Criteria

    The application will be reviewed and evaluated according to the 
following criteria that are of equal value:
    1. The application clearly demonstrates an understanding of the 
purpose and objectives of the cooperative agreement regarding the 
coordination of Federal and State activities to assure radiation 
protection of the American public.
    2. The application clearly describes the steps and a proposed 
schedule for planning, implementing, and accomplishing the activities 
to be carried out under the cooperative agreement. The application 
presents a clear plan and schedule of steps to accomplish the goals of 
the cooperative agreement.
    3. The application establishes the applicant's ability to perform 
the responsibilities under the cooperative agreement, including the 
availability of appropriate staff and the ability to carry out the 
stated goals and objectives of the cooperative agreement within the 
established funding constraints stated in this notice.
    4. The application specifies the manner in which interactions with 
FDA will be maintained throughout the lifetime of the project.
    5. The application specifies how the recipient will monitor the 
progress of the work required under the cooperative agreement, and how 
the progress will be reported to FDA.
    6. The application shall include a detailed and fully-justified 
budget that includes anticipated costs for personnel, travel, 
equipment, and supplies.

[[Page 43330]]

VII. Submission Requirements

    The original and two copies of the completed Grant Application Form 
PHS 398 (Rev. 4/98 or Rev. 5/01) or the original and two copies of PHS 
5161-1 (Rev. 7/00) for State and local governments, with copies of the 
appendices for each of the copies, should be delivered to Maura 
Stephanos (see ADDRESSES). State and local governments may choose to 
use the PHS 398 application form in lieu of PHS 5161-1. The application 
receipt date is July 29, 2002. No supplemental or addendum material 
will be accepted after the receipt date. The outside of the mailing 
package and item 2 of the application face page should be labeled: 
``Response to RFA FDA CDRH-02-1.''

VIII. Method of Application

A. Submission Instructions

    Applications will be accepted during normal business hours, 8 a.m. 
to 4:30 p.m., Monday through Friday, on or before the established 
receipt date. Applications will be considered received on time if sent 
or mailed 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.) Do not send applications to the Center for 
Scientific Research (CSR), NIH. Any application that is sent to NIH, 
and is then forwarded to FDA and not received in time for orderly 
processing will be deemed not responsive and returned to the applicant. 
Applications must be submitted via mail or hand delivered as stated 
above. FDA is unable to receive applications electronically. Applicants 
are advised that FDA does not adhere to the page limitations or the 
type size and line spacing requirements imposed by the NIH on its 
applications.

B. Format for Application

    Submission of the application must be on Grant Application Form PHS 
398 (Rev. 4/98 or Rev. 5/01) or on either form PHS 398 or PHS 5161-1 
(Rev. 7/00) for State and local government applicants. All ``General 
Instructions'' and ``Specific Instructions'' in the application kit 
should be followed with the exception of the receipt dates and the 
mailing label address.
    The face page of the application should reflect the request for 
applications number, RFA-FDA-CDRH-02-1. Data and information included 
in the application, if identified by the applicant as trade secret or 
confidential commercial information. Will be given confidential 
treatment to the extent permitted by the Freedom of Information Act (5 
U.S.C. 552(b)(4)) and FDA's implementing regulations (21 CFR 20.61).
    Information collection requirements requested on Form PHS 398 and 
the instructions have been submitted by PHS to the Office of Management 
and Budget (OMB) and were approved and assigned OMB control number 
0925-0001. The requirements requested on Form PHS 5161-1 were approved 
and assigned OMB control number 0348-0043.

    Dated: June 21, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-16293 Filed 6-26-02; 8:45 am]
BILLING CODE 4160-01-S