[Federal Register: June 27, 2002 (Volume 67, Number 124)]
[Notices]
[Page 43326-43330]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27jn02-94]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: mstepha1@oc.fda.gov. 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: pzb@cdrh.fda.gov.
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.
[[Page 43328]]
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