Department of Health and Human Services July 23, 2014 – Federal Register Recent Federal Regulation Documents
Results 1 - 12 of 12
Availability of Interpretive Rule: Implementation of the Exclusion of Orphan Drugs for Certain Covered Entities Under the 340B Program
HHS is announcing the availability of an interpretive rule providing HHS's interpretation of section 340B(e) of the Public Health Service Act (PHSA), entitled ``Implementation of the Exclusion of Orphan Drugs for Certain Covered Entities Under the 340B Program.'' The interpretive rule states that section 340B(e) of the PHSA excludes drugs with an orphan designation only when those drugs are transferred, prescribed, sold, or otherwise used for the rare condition or disease for which the drug was designated under section 526 of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Announcement of Requirements and Registration for “Stories of Basic Science to Medical Advances” Challenge
The National Institute of General Medical Sciences (NIGMS), one of the components of the National Institutes of Health (NIH), announces a challenge titled ``Stories of Basic Science to Medical Advances.'' This Challenge aims to track medical advances stemming from NIGMS-supported basic science.
Designation of a Class of Employees for Addition to the Special Exposure Cohort
HHS gives notice of a decision to designate a class of employees from the Nuclear Metals, Inc. facility in West Concord, Massachusetts, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On July 11, 2014, the Secretary of HHS designated the following class of employees as an addition to the SEC:
Agency Information Collection Activities; Proposed Collection; Comment Request; Information Request Regarding pH of Smokeless Tobacco Products
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on the collection of information regarding pH of smokeless tobacco products.
Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations; Availability
The Food and Drug Administration (FDA) is announcing the availability of additional draft and revised draft product-specific bioequivalence (BE) recommendations. The recommendations provide product-specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled ``Bioequivalence Recommendations for Specific Products,'' which explained the process that would be used to make product-specific BE recommendations available to the public on FDA's Web site. The BE recommendations identified in this notice were developed using the process described in that guidance.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Generic Food and Drug Administration Rapid Response Surveys
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Generic FDA Rapid Response Surveys'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Meeting of the Presidential Advisory Council on HIV/AIDS
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Service (DHHS) is hereby giving notice that the Presidential Advisory Council on HIV/AIDS (PACHA) will hold a meeting to discuss HIV/AIDS in the Southern United States, HIV related workforce issues, and Hepatitis C and the impact of the Affordable Care Act. The meeting will be open to the public.
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