Department of Health and Human Services July 5, 2011 – Federal Register Recent Federal Regulation Documents
Results 1 - 14 of 14
Tobacco Products, Exemptions From Substantial Equivalence Requirements
The Food and Drug Administration (FDA) is issuing this final rule to establish procedures for requesting an exemption from the substantial equivalence requirements of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). The final rule describes the process and statutory criteria for requesting an exemption and explains how FDA reviews requests for exemptions. This regulation satisfies the requirement in the Tobacco Control Act that FDA issue regulations implementing the exemption provision.
Medicare Program; Hospital Inpatient Value-Based Purchasing Program; Correction
This document corrects technical errors that appeared in the final rule published in the Federal Register on May 6, 2011 (76 FR 26490) entitled ``Medicare Program; Hospital Inpatient Value-Based Purchasing Program.''
Meeting of the Advisory Committee on Minority Health
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (DHHS) is hereby giving notice that the Advisory Committee on Minority Health (ACMH) will hold a meeting. This meeting is open to the public. Preregistration is required for both public attendance and comment. Any individual who wishes to attend the meeting and/or participate in the public comment session should e-mail acmh@osophs.dhhs.gov.
Medicare Program; Section 3113: The Treatment of Certain Complex Diagnostic Laboratory Tests Demonstration
This notice informs interested parties of an opportunity to participate in the Treatment of Certain Complex Diagnostic Laboratory Tests Demonstration. The Demonstration is mandated by section 3113 of the Affordable Care Act. This notice also serves to notify interested parties that they must obtain a temporary code from CMS for tests currently billed using a ``not otherwise classified (NOC)'' code but that would otherwise meet the criteria set forth in section 3113 for being a complex diagnostic laboratory test under the Demonstration. The statute requires a Report to Congress that includes an assessment of the impact of the Demonstration on access to care, quality of care, health outcomes, and expenditures.
Negotiated Rulemaking Committee on Designation of Medically Underserved Populations and Health Professional Shortage Areas; Notice of Meeting
In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), notice is hereby given of the following meeting of the Negotiated Rulemaking Committee on Designation of Medically Underserved Populations and Health Professional Shortage Areas.
Draft Guidance for Industry; Dietary Supplements: New Dietary Ingredient Notifications and Related Issues; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.'' The draft guidance, when finalized, will assist industry in deciding when a premarket safety notification for a dietary supplement containing a new dietary ingredient (NDI) is necessary and in preparing premarket safety notifications (also referred to as ``NDI notifications'').
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