R -- Radiologic Systems Consultant

The Food and Drug Administration (FDA) intends to award a purchase order on a sole source, non-competitive basis for consulting services to: Charles Gunzburg 24237 Clematis Drive Gaithersburg, MD 20882-3821 The proposed action is to meet the continued demand for expertise for the compliance program for diagnostic x-ray products which evolved from an inspection based program to a surveillance program based on field testing of newly installed units. The basic needs of this program have changed along with the complexity and risk of the products regulated under this program. In order to implement the current Radiological Health Program Plan, a change to a factory inspection based plan is indicated along with the realization that this plan must continue to be reviewed to ensure it sufficiently deals with current generation products. Knowledge of factory inspections along with current product knowledge is needed to produce a compliance plan adapted to the new risk based enforcement strategy in the current plan. Diagnostic x-ray equipment is regulated under both Subchapter C Electronic Product Radiation Control(formerly the Radiation Control for Health and Safety Act of 1968) and Subchapter A Drugs and Devices of Chapter V of the Federal Food, Drug, and Cosmetic Act (FFDCA). Subchapter C provides authority to require product recalls for noncompliant or defective radiation emitting electronic products. In addition, Subchapter A (as amended by the Safe Medical Devices Act) provides authority to require product recalls for medical devices that may cause a serious risk to health. (All diagnostic (medical) x-ray products are medical devices.) When there is a choice, regulatory/administrative action is preferred under Subchapter C, but both portions of the FDCA may be used in conjunction for maximum effectiveness. In this capacity, there is a need for an individual that can 1) recognize basic medical physics principles associated with radiation protection, x-ray production, x-ray circuitry, and x-ray equipment performance; 2) identify key requirements of Subchapter C - Electronic Product Radiation Control of Chapter V of the Federal Food, Drug and Cosmetic Act (FFDCA) and the associated regulations of not only Subchapter A but also Subchapter J ? Radiological Health of Title 21 Code of Federal Regulations as they relate to Diagnostic X-Ray Systems; 3) can address testing procedures of radiographic and fluoroscopic x-ray systems; and 4) recognize the process used by the Food and Drug Administration in the regulation of the manufacturer, assembler, and user of Diagnostic X-Ray Systems. This expertise will ensure CDRHs ability to develop guidance and training that will address the needs of State officials and FDA investigators who perform testing of diagnostic x-ray systems for compliance with Federal Performance Standard 21 CFR 1020.30-1020.32. Mr. Gunzburg has over 30 years experience with the x-ray area including first hand knowledge of factory inspections, field measurements and the compliance program. He is uniquely qualified to analyze the needs of a new factory inspection program due to his experience in performing these in the past and his ability to incorporate the 30 years of knowledge of the evolving industry and products coupled with his knowledge of radiation risk. He is ideally suited to generate the plan for inspection along with the training needed to educate ORA field personnel to successfully perform the inspections. Additionally, he has been active with the mammography program since its inception. He is an expert on the facility inspection function and is ideally suited to instruct, counsel and test student inspectors. He is also an expert in both the x-ray compliance and mammography inspection programs. Mr. Gunzburg brings an in-depth knowledge of the CDRH Programs and regulatory requirements as well as established relationships with the Division of Mamography Quality Radiation Program (DMQRP), other supporting OCER organizations and Industry. In addition, the consultant has an expert working knowledge of the Model 204 computer application, which is a database management system in which access structures, programs and data are stored together. This system has its own user language, and has relationships that are based solely on the value of data; relating two or more records requiring the existence of common data values within the records thus allowing hierarchical and network relationships to be supported by the commonality of data characteristic. Mr. Gunzburg's education, experience and existing relationships with Industry and the Center for Devices and Radiological Health, and expert knowledge of the regulations to be addressed and M204 system provides unique expertise and allows for a continuity necessary to efficiently achieve program objectives. This is a substantial advantage and efficiency, and it can be reasonably asserted that not only to identify, but to award, to any other source will unnecessarily retard efforts to effectively and efficiently accomplish the goals and requirements of the program and its initiatives. Because of this experience and knowledge, Mr. Gunzburg will need no training thus, only Mr. Gunzburg will be able to perform the identified work and will be able to complete the identified tasks in the time allotted. NO REQUEST FOR QUOTE (RFQ) IS AVAILABLE. Notwithstanding, any firm that believes it is capable of providing the required service as stated herein may submit a capability statement to document its ability to provide the required services, which will be considered if received by the fifteenth (15th) calendar day following the appearance of this announcement. A determination to compete this procurement based on a response to this notice is solely within the discretion of the Government. All responses or questions regarding this posting must be in writing and can be sent via email to darren.jansen@fda.gov. No phone calls will be accepted. An award will be made in fifteen (15) calendar days from the date of this notice. This sole source procurement will be awarded as a simplified acquisition for commercial items in accordance with FAR Subpart 13.5.