Description
Food and Drug Administration/ Center for Devices and Radiological (CDRH) is announcing its intention to accept and consider a single source application for the award of a cooperative agreement in fiscal year 2018 to Conference of Radiation Control Program Directors, Inc. (CRCPD) in support of coordination of Federal and State actions to assure radiation protection of the American public. 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. 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. The document is available 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), and other agencies 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 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. Program Goals and 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. CRCPD will be expected to obtain the States' cooperation and participation on committees and working groups established to deal with individual problems and 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. CRCPD will be expected to 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/non-medical ionizing radiation; and (3) 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 activities related to x-rays in the healing arts should include issues related to 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 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). 2. Application of Medical/Non-medical Ionizing Radiation CRCPD will address issues in the non-medical applications of ionizing radiation as well as the medical and non-medical applications of non-ionizing radiation. 3. Control and Mitigation of Radiation Exposure CRCPD 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, overseeing radiation laboratory capabilities, 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. Also be required to review and provide comments on issues related to radiological emergency preparedness and homeland security. B. Suggested State Regulations for the Control of Radiation (SSRCR) CRCPD 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. Be required to develop a process to determine the need, priority and timing for regulation updates and development of new SSRCRs. C. Committee Oversight and Management CRCPD 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. 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 policy and regulations. The representatives will also act as investigators, collaborators, or resource personnel, as appropriate. D. Special Projects CRCPD will 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/Training CRCPD 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. 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. Be expected to publish the meeting proceedings on the 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. May also be requested by FDA to provide instructors for Federal training courses with a radiological component held outside of the annual meeting. F. 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.