Federal register
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The Food and Drug Administration (FDA) is issuing regulations to provide protection for human subjects of clinical investigations conducted pursuant to requirements for prior submission to FDA or conducted in support of applications for permission to conduct further research or to market regulated products. The regulations clarify existing FDA requirements governing informed consent and provide protection of the rights and welfare of human subjects involved in research activities that fall within FDA's jurisdiction.
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The Food and Drug Administration(FDA) is amending its patient package insert regulations to make the distribution requirements for patient package inserts for drug products in unit-of-use containers the same as the requirements for products in bulk containers. The agency is also amending its antibiotic drug regulations to permit manufacturers and distributors of antibiotics to make changes in labeling to comply with the patient package insert regulations without advance approval by FDA. This action will conform the requirements for implementing FDA's patient package insert regulations for antibiotics to the requirements currently applicable to the other drugs in the program.
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These regulations define "radiological services" for which the Medicare program provides for payment at 100 percent of reasonable charges. Section 1833(2)(1)(B) of the Act provides for the 100 percent reimbursement for "radiological services" when furnished to hospital inpatients by physicians in the field of radiology. ⋯ On the basis of information acquired through public comments on the proposed regulations, we have concluded that there is not sufficient reason at this time to extend the 100 percent reimbursement to services not already so reimbursed. Accordingly, these regulations follow current operating instructions and define "radiological services" as those in which ionizing radiation is used for diagnostic or therapeutic purposes.
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This rule establishes requirements for grants and applications for grants under the Community Mental Helath Centers Act (42 U. S. C. 2689 et seq.), excluding Part D thereof ("Rape Prevention and Control"), as amended by the Community Mental Health Centers Amendments of 1975 (Title III of the Act of July 29, 1975; Pub L. 94-63), section 308 of the Health Services Extension Act of 1977 (in Title III of the Act of August 1, 1977; Pub. ⋯ L 95-622), and section 8 of the Act of July 10, 1979 (Pub. L. 96-32). Also included are requirements for the development, submission, and approval of State plans.