Energia i regulacje · 27.06.2001
Agency Information Collection Activities: Proposed Collection; Comment Request
The NRC is preparing a submittal to OMB for review of continued approval of information collections under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). Information pertaining to the requirement to be submitted: 1. The title of the information collection: 10 CFR 35.32 and 35.33 "Quality Management Program and Misadministrations". 2. Current OMB approval number: 3150-0171. 3. How often the collection is required: For quality management program (QMP): Reporting: New applicants for medical use licenses, who plan to use byproduct material in limited diagnostic and therapy quantities under Part 35, must develop a written QMP and submit a copy of it to NRC. When a new modality involving therapeutic quantities of byproduct material is added to an existing license, current licensees must submit QMP modifications. This ICR burden estimate is inflated by the one-time cost for the development and submission of QMPs for approximately 2000 Agreement States licensees in the ten Agreement States who have not adopted the rule and are not required to. Recordkeeping: Records of written directives, administered dose or dosage, annual review, and recordable events, for 3