Federal register
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The Food and Drug Administration (FDA) is amending its regulation governing notice-and-comment (informal) rulemaking by removing from the regulation the requirement that the agency issue interpretative rules and rules of agency practice and procedure by informal rulemaking. As amended, the regulation provides that informal rulemaking procedures by followed to the extent required by the Administrative Procedure Act.
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This final rule amends the existing regulations governing the National Practitioner Data Bank for Adverse Information on Physicians and Other Health Care Practitioners (the Data Bank), codified at 45 CFR part 60, authorizing the reporting and release of information concerning: (1) Payments made for the benefit of physicians, dentists, and other health care practitioners as a result of medical malpractice actions or claims; and (2) certain adverse actions taken regarding the licenses and clinical privileges of physicians and dentists. This final rule revises section 60.12 to change the process for collecting user fees from eligible individuals and entities requesting disclosure of information from the Data Bank.