[Federal Register Volume 78, Number 18 (Monday, January 28, 2013)]
[Notices]
[Pages 5813-5815]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-01639]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0012]
2013 Assuring Radiation Protection
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of grant funds for the support of the Center for Devices
and Radiological Health (CDRH) radiation protection program. The goal
of the 2013 Assuring Radiation Protection will be 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, in accordance with Federal
statutes and regulations, to address, evaluate, and propose 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 non-medical ionizing radiation and medical/non-
medical non-ionizing radiation; and (3) the control and mitigation of
radiation exposure from all sources.
DATES: Important dates are as follows:
1. The application due date is April 1, 2013.
2. The anticipated start date is May 1, 2013.
3. The opening date is January 28, 2013.
4. The expiration date is April 2, 2013.
ADDRESSES: Submit electronic applications to: http://www.grants.gov/.
For more information, see section III of the SUPPLEMENTARY INFORMATION
section of this notice.
FOR FURTHER INFORMATION CONTACT:
R. Matt Erbe, Food and Drug Administration, Center for Devices and
Radiological Health, 301-796-5744, FAX: 301-847-8142,
Matthew.Erbe@fda.hhs.gov;
or
Gladys Melendez Bohler, Food and Drug Administration, Office of
Acquisition and Grant Services, 301-827-7175, FAX: 301-827-0505,
gladys.bohler@fda.hhs.gov.
For more information on this funding opportunity announcement (FOA)
and to obtain detailed requirements, please refer to the full FOA
located at http://www.grants.gov/.
SUPPLEMENTARY INFORMATION:
I. Funding Opportunity Description
RFA-FD-13-002
93.103
A. 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), and the
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Federal Emergency Management Agency (FEMA), 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, foster coordination, and provide original
views.
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 and Tribal organizations.
2. Annual meetings of Federal and State officials are convened to
present and discuss the results of the recommended actions. 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 developed and
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.
B. Research Objectives
The objective of this cooperative agreement will be 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, in accordance with
Federal statutes and regulations, to address, evaluate, and propose
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 non-medical ionizing radiation and
medical/non-medical non-ionizing radiation; and (3) the control and
mitigation of radiation exposure from all sources. These areas are
explained more fully in the following paragraphs.
1. Areas of Interest
a. Application of x-rays to the healing arts. The recipient will
address issues related to x-rays in the healing arts including issues
related to general diagnostic and therapeutic radiology. Issues related
to medical imaging (fluoroscopy and computed tomography) and therapy
radiography (linear accelerator or source based therapy) 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 a 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. Application of non-medical ionizing radiation and medical/non-
medical non-ionizing radiation. The recipient will address issues in
the non-medical applications of ionizing radiation as well as the
medical and non-medical applications of non-ionizing radiation.
c. 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: (1) Responding to radiation accidents or incidents;
(2) evaluating the adequacy of State radiation control programs;
overseeing radiation laboratory capabilities; (3) controlling residual
radioactivity levels from decontamination and decommissioning of
nuclear facilities; (4) determining the propriety of delegating
implementation authority for Federal standards for control of
radionuclides as hazardous air pollutants; and (5) implementing the
Indoor Radon Abatement Act (15 U.S.C. 53, Subchapter III). The
recipient will also be required to review and provide comments on
issues related to radiological emergency preparedness and homeland
security.
2. Suggested State Regulations for the Control of Radiation (SSRCR)
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.
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.
The recipient will be required to develop a process to determine
the need, priority, and timing for regulation updates and development
of new SSRCRs. This shall include collaboration with the Federal
Agencies, in accordance with Federal statutes and regulations that are
providing access to rules that are still under development to enable
the recipient to initiate timely development or revisions in parallel.
3. 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 and its subcommittees (overseen by
FEMA).
While official committee members are limited to State members, non-
State and Federal representatives may be appointed as advisors 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 statutes,
regulations, and policy. The representatives will also act
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as investigators, collaborators, or resource personnel, as appropriate.
4. Special Projects
The recipient will 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. Deliverables may
include studies, reports, or recommendations.
5. Annual Meeting/Training
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 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.
6. Information Access
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.
7. Reports and Publications
Reports generated by the task forces, committees, and workshops
should include recommendations for the resolution of problem areas as
well as cost/benefit evaluations and should be delivered within the
time frame determined at the time of assignment. These reports will be
reviewed, in accordance with Federal statutes and regulations, 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 Agencies.
The recipient will 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 Federal
Agencies supporting this Agreement will be provided access to secured
information on the Web site via passwords.
The recipient will also maintain a directory of personnel
responsible for radiological health programs in the member States and
Federal Agencies. This directory will be updated annually and published
for distribution by the recipient. At least two paper copies of the
directory and a non-copyright electronic version will be provided to
all contributing Federal Agencies.
C. Eligibility Information
Nonprofits Other Than Institutions of Higher Education:
Nonprofits with 501(c)(3) IRS status (other than
institutions of higher education).
For-Profit Organizations:
Small businesses; and
For-profit organizations (other than small businesses).
Governments:
State Governments,
County Governments,
Indian/Native American Tribal Governments (Federally
recognized), and
U.S. Territory or Possession.
Foreign Institutions:
Non-domestic (non-U.S.) entities (foreign institutions)
are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. organizations
are not eligible to apply.
II. Award Information/Funds Available
A. Award Amount
FDA in collaboration with the NRC, the EPA, and FEMA, intends to
commit $400,000 in FY 2013. Only one award will be made.
B. 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.
III. Electronic Application, Registration, and Submission
Only electronic applications will be accepted. To submit an
electronic application in response to this FOA, applicants should first
review the full announcement located at http://www.grants.gov/ (FDA has
verified the Web site addresses throughout this document, but FDA is
not responsible for any subsequent changes to the Web sites after this
document publishes in the Federal Register.) For all electronically
submitted applications, the following steps are required.
Step 1: Obtain a Dun and Bradstreet (DUNS) Number
Step 2: Register With System for Award Management at
https://www.sam.gov/portal/public/SAM
Step 3: Obtain Username & Password
Step 4: Authorized Organization Representative (AOR)
Authorization
Step 5: Track AOR Status
Step 6: Register With Electronic Research Administration
(eRA) Commons
Steps 1 through 5, in detail, can be found at http://www07.grants.gov/applicants/organization_registration.jsp. Step 6, in
detail, can be found at https://commons.era.nih.gov/commons/registration/registrationInstructions.jsp. After you have followed
these steps, submit electronic applications to: http://www.grants.gov/.
Dated: January 22, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-01639 Filed 1-25-13; 8:45 am]
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