Department of Health and Human Services February 13, 2015 – Federal Register Recent Federal Regulation Documents
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Announcement of Ruling: Implementing United States v. Windsor for Purposes of Entitlement and Enrollment in Medicare Hospital Insurance and Supplementary Medical Insurance
This document announces a CMS Ruling that states the CMS policies for implementing United States v. Windsor (``Windsor''), in which the Supreme Court held that section 3 of the Defense of Marriage Act (DOMA), enacted in 1996, is unconstitutional. Section 3 of DOMA defined ``marriage'' and ``spouse'' as excluding same-sex marriages and same-sex spouses, and effectively precluded the Federal government from recognizing same-sex marriages and spouses.
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Export of Food and Drug Administration Regulated Products: Export Certificates; Correction
The Food and Drug Administration is correcting a notice entitled ``Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Export of Food and Drug Administration Regulated Products: Export Certificates '' that appeared in the Federal Register of February 6, 2015 (80 FR 6728). The document announced that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. The document was published with three errors. This document corrects those errors.
Determination That SUBUTEX (Buprenorphine Hydrochloride) Sublingual Tablets, Equivalent 2 Milligrams Base and Equivalent 8 Milligrams Base, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that SUBUTEX (buprenorphine hydrochloride (HCl)) Sublingual Tablets, Equivalent (Eq) 2 milligrams (mg) base and Eq 8 mg base, were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to SUBUTEX, and it will allow FDA to continue to approve ANDAs that refer to SUBUTEX as long as they meet relevant legal and regulatory requirements.
Announcement of a Draft NIH Policy on Dissemination of NIH-Funded Clinical Trial Information
On November 19, 2014, the National Institutes of Health (NIH) published a request for public comments in the NIH Guide for Grants and Contracts on a draft policy to promote broad and responsible dissemination of information on clinical trials funded by the NIH through registration and submission of summary results information to ClinicalTrials.gov. See Guide notice NOT-OD-15-019 at https:// grants.nih.gov/grants/guide/notice-files/NOT-OD-15-019.html. NIH is publishing this notice in order to inform readers of the Federal Register about the draft policy and the opportunity to comment.
Bethesda Campus Master Plan Record of Decision
The Department of Health and Human Services, the National Institutes of Health (NIH), has decided, after completion of a Final Environmental Impact Statement (FEIS) and a thorough consideration of the public comments on the Draft EIS, to implement the Proposed Action, referred to as the Proposed Action in the Final EIS. This action is for a long-range physical Master Plan for National Institutes of Health Bethesda Campus (NIH) located in Bethesda, Maryland. This alternative accounts for potential growth in NIH personnel, new construction, additions, renovations, demolitions, and upgrades in site utilities. Responsible Official: Daniel G. Wheeland, Director, Office of Research Facilities (ORF) Development and Operations, NIH.
Clinical Trials Registration and Results Submission
The Department of Health and Human Services (HHS) is extending the public comment period for the Notice of Proposed Rulemaking (NPRM) on Clinical Trials Registration and Results Submission. The proposed rule was published on November 21, 2014 (79 FR 69566) with a deadline for public comments of February 19, 2015. The comment period is being extended to provide additional time for commenters to prepare their responses. The comment period will close at 5 p.m. Eastern Standard Time (EST) on March 23, 2015.
Identifying Potential Biomarkers for Qualification and Describing Contexts of Use To Address Areas Important to Drug Development; Request for Comments
The Food and Drug Administration (FDA or Agency) is seeking information to facilitate development and qualification of biomarkers in areas related to human drug therapeutics. Towards this goal, FDA is encouraging interested groups and individuals to submit information on specific medical and biological areas where novel biomarkers can be identified that would meaningfully advance drug development. FDA encourages respondents to describe evidentiary considerations that are important to qualify these biomarkers for a specific context of use. Details of information that should be provided to the Agency are described in the survey.
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