Department of Health and Human Services July 5, 2013 – Federal Register Recent Federal Regulation Documents
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National Biodefense Science Board; Call for Nominees
The deadline for all application submissions to the National Biodefense Science Board (NBSB) is extended from July 7, 2013, to August 4, 2013 at 11:59 p.m. The Office of the Secretary is accepting application submissions from qualified individuals who wish to be considered for membership on the NBSB; six members have membership expiration dates of December 31, 2013, therefore, six new voting members will be selected for the Board. Nominees are being accepted in the following categories: Industry, Academia, Healthcare Consumer Organizations, and Organizations Representing Other Appropriate Stakeholders. Please visit the NBSB Web site at www.phe.gov/nbsb for all application submission information and instructions. All members of the public are encouraged to apply.
Declaration That Circumstances Exist Justifying Authorization of 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 anthracispursuant to section 564(b)(1)(A) of the Federal Food, Drug, and Cosmetic (FD&C) Act.\1\ On the basis of that determination, and pursuant to section 564(b) of the FD&C Act, the Secretary of Health and Human Services (HHS) is declaring that circumstances exist 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 section 564(a) of the FD&C Act. This notice is being issued in accordance with section 564(b)(4) of the FD&C Act.
Lung Cancer Patient-Focused Drug Development; Extension of Comment Period
The Food and Drug Administration (FDA) is extending the comment period for the public docket on lung cancer patient-focused drug development. In the Federal Register of June 5, 2013 (78 FR 33581), FDA announced an opportunity for public comment on this topic and explained that the comment period would close on July 29, 2013. The Agency is taking this action to allow interested persons additional time to submit comments.
Determination That METADATE ER (Methylphenidate Hydrochloride) Extended-Release Tablet, 10 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that METADATE ER (methylphenidate hydrochloride (HCl)) extended-release tablet, 10 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for methylphenidate HCl extended-release tablet, 10 mg, if all other legal and regulatory requirements are met.
Agency Information Collection Activities: Proposed Collection; Comment Request
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including any of the following subjects: (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.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including any of the following subjects: (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.
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