Department of Health and Human Services July 5, 2012 – Federal Register Recent Federal Regulation Documents
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Renewal of Declaration Regarding Emergency Use of All Oral Formulations of Doxycycline Accompanied by Emergency Use Information
The Secretary of Homeland Security determined on September 23, 2008 that there is a significant potential for a domestic emergency involving a heightened risk of attack with a specified biological, chemical, radiological, or nuclear agent or agentsin this case, Bacillus anthracis. On the basis of that determination, and pursuant to section 564(b) of the Federal Food, Drug, and Cosmetic Act (``FD&C Act''), the Secretary of Health and Human Services is renewing her July 20, 2011 declaration of an emergency justifying the authorization of emergency use of all oral formulations of doxycycline accompanied by emergency use information subject to the terms of any authorization issued by the Commissioner of Food and Drugs under 21 U.S.C. 360bbb- 3(a). This notice is being issued in accordance with section 564(b)(4) of the FD&C Act, 21 U.S.C. 360bbb-3(b)(4).
Agency Information Collection Activities; Proposed Collection; Public Comment Request
In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Electronic Government Office (EGOV), Department of Health and Human Services, announces plans to submit a request to extend the use of an approved Information Collection Request (ICR) to the Office of Management and Budget. The approved ICR is assigned OMB control number 4040-0005 and expires on August 31, 2012. Prior to submitting that ICR to OMB, HHS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR. HHS especially requests comments on (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions, (2) the accuracy of the estimated burden, (3) ways to enhance the quality, utility, and clarity of the information to be collected, and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden. Deadline: Comments on the ICR must be received within 60 days of the issuance of this notice.
Draft Guidance for Industry on Organ-Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use-Labeling for Products That Contain Acetaminophen; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Organ-Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human UseLabeling for Products That Contain Acetaminophen.'' The draft guidance is intended to inform manufacturers of certain over-the-counter (OTC) internal analgesic, antipyretic, and antirheumatic (IAAA) drug products that contain acetaminophen of the circumstances in which FDA intends to exercise enforcement discretion with regard to the liver warning required in the labeling.
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