Document ID: FDA-2013-N-0012-0001
Agency: fda
Document Type: Notice
Title: 2013 Assuring Radiation Protection
Posted Date: 2013-01-28T05:00Z

[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]

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

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.

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

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

[[Page 5814]]

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

[[Page 5815]]

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]
BILLING CODE 4160-01-P