Federal register
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The Food and Drug Administration (FDA) is adopting as a final rule, without change, the provisions of the interim final rule that amended the regulation authorizing a health claim on the relationship between beta-glucan soluble fiber from whole oat sources and reduced risk of coronary heart disease (CHD) by adding barley as an additional source of beta-glucan soluble fiber eligible for the health claim. FDA is taking this action to complete the rulemaking initiated with the interim final rule.
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The Secretary of Health and Human Services is adopting rules for the imposition of civil money penalties on entities that violate rules adopted by the Secretary to implement the Administrative Simplification provisions of the Health Insurance Portability and Accountability Act of 1996, Public Law 104-191 (HIPAA). The final rule amends the existing rules relating to the investigation of noncompliance to make them apply to all of the HIPAA Administrative Simplification rules, rather than exclusively to the privacy standards. It also amends the existing rules relating to the process for imposition of civil money penalties. Among other matters, the final rule clarifies and elaborates upon the investigation process, bases for liability, determination of the penalty amount, grounds for waiver, conduct of the hearing, and the appeal process.
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Eligibility for health care benefits for certain Filipino veterans in the United States. Final rule.
Department of Veterans Affairs (VA) medical regulations describe veterans who are eligible to receive health care from VA in the United States. This document amends VA medical regulations to provide eligibility for VA hospital care, nursing home care, and outpatient services for any Filipino Commonwealth Army veteran, including those recognized by authority of the U. S. ⋯ S. or is lawfully admitted to the United States for permanent residence. Under this regulatory provision, these certain veterans are eligible for VA hospital care, nursing home care, and outpatient medical services in the United States in the same manner and subject to the same terms and conditions as apply to U. S. veterans.
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The Food and Drug Administration (FDA) is amending its current good manufacturing practice (CGMP) regulations for human drugs, including biological products, to exempt most investigational "Phase 1" drugs from complying with the requirements in FDA's regulations. FDA will instead exercise oversight of production of these drugs under the agency's general statutory CGMP authority and investigational new drug application (IND) authority. ⋯ The companion proposed rule and direct final rule are substantively identical. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a draft guidance for industry entitled "INDs--Approaches to Complying With CGMP During Phase 1" to provide further guidance on the subject.
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The Food and Drug Administration (FDA) is amending its regulations on the exportation of investigational new drugs, including biological products. The final rule describes four different mechanisms for exporting an investigational new drug product. These provisions implement changes in FDA's export authority resulting from the FDA Export Reform and Enhancement Act of 1996 and also simplify the existing requirements for exports of investigational new drugs.