Department of Health and Human Services November 14, 2013 – Federal Register Recent Federal Regulation Documents

Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2013-27275
Type: Notice
Date: 2013-11-14
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2013-27274
Type: Notice
Date: 2013-11-14
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities; Proposed Collection; Public Comment Request
Document Number: 2013-27244
Type: Notice
Date: 2013-11-14
Agency: Department of Health and Human Services, Office of the Secretary
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit a new Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting that ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Medical Device Development Tools; Draft Guidance for Industry, Tool Developers, and Food and Drug Administration Staff; Availability
Document Number: 2013-27233
Type: Notice
Date: 2013-11-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Medical Device Development Tools.'' This document provides guidance to FDA staff, industry, healthcare providers, researchers, and patient and consumer groups on a new voluntary process within the Center for Devices and Radiological Health (CDRH) for qualification of medical device development tools (MDDT) for use in device development and evaluation programs. This draft guidance is not final nor is it in effect at this time.
Agency Information Collection Activities; Proposed Collection; Comment Request; Patent Term Restoration, Due Diligence Petitions, Filing, Format, and Content of Petitions
Document Number: 2013-27226
Type: Notice
Date: 2013-11-14
Agency: Food and Drug Administration, Department of Health and Human Services
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, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on FDA's patent term restoration regulations on due diligence petitions for regulatory review period revision. Where a patented product must receive FDA approval before marketing is permitted, the Office of Patents and Trademarks may add a portion of the FDA review time to the term of a patent. Petitioners may request reductions in the regulatory review time if FDA marketing approval was not pursued with ``due diligence.''
Agency Information Collection Activities; Proposed Collection; Comment Request; Petition to Request an Exemption From 100 Percent Identity Testing of Dietary Ingredients: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements
Document Number: 2013-27222
Type: Notice
Date: 2013-11-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) 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, including each proposed extension of an existing collection of information and to allow 60 days for public comment in response to the notice. This notice invites comments on the information collection provisions of our existing regulations governing petitions to request an exemption from 100 percent identity testing of dietary ingredients.
Proposed Information Collection Activity; Comment Request
Document Number: 2013-27221
Type: Notice
Date: 2013-11-14
Agency: Department of Health and Human Services, Administration for Children and Families
Draft Guidance for Industry on Frequently Asked Questions About Medical Foods; Second Edition; Reopening of the Comment Period
Document Number: 2013-27213
Type: Notice
Date: 2013-11-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is reopening the comment period for the draft guidance for industry entitled ``Frequently Asked Questions About Medical Foods; Second Edition.'' We are reopening the comment period in response to requests for an extension to allow interested persons additional time to submit comments.
Guidance for Industry: Studies To Evaluate the Utility of Anti-Salmonella Chemical Food Additives in Feeds; Request for Comments
Document Number: 2013-27194
Type: Notice
Date: 2013-11-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is considering revising the guidance entitled ``Guidance for Industry: Studies to Evaluate the Utility of Anti-Salmonella Chemical Food Additives in Feeds,'' and is seeking comments on this guidance before revisions are made.
Bruce I. Diamond; Denial of Hearing; Final Debarment Order
Document Number: 2013-27186
Type: Notice
Date: 2013-11-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is denying Dr. Bruce I. Diamond's request for a hearing and is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Dr. Diamond for 10 years from providing services in any capacity to a person who has an approved or pending drug product application. FDA bases this order on findings that Dr. Diamond was convicted of felonies under State law for conduct relating to the development or approval of a drug product or otherwise relating to the regulation of a drug product under the FD&C Act, was convicted of felonies involving fraud, and was a material participant in acts forming the basis of a conviction that subjects another person to debarment. In determining the appropriateness and length of Dr. Diamond's debarment period, FDA has evaluated the relevant considerations listed in the FD&C Act. Dr. Diamond has failed to file with the Agency information and analysis sufficient to create a basis for a hearing concerning this action.
Notice of Meeting
Document Number: 2013-27174
Type: Notice
Date: 2013-11-14
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
In accordance with section 10(a)(2) of the Federal Advisory Committee Act (5 U.S.C. App. 2), announcement is made of an Agency for Healthcare Research and Quality (AHRQ) Special Emphasis Panel (SEP) meeting on ``AHRQ RFA-HS14-002, Addressing Methodological Challenges in Research for Patients With Multiple Chronic Conditions (R21)''. Each SEP meeting will commence in open session before closing to the public for the duration of the meeting.
Notice of Meeting
Document Number: 2013-27173
Type: Notice
Date: 2013-11-14
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
In accordance with section 10(a)(2) of the Federal Advisory Committee Act (5 U.S.C. App. 2), announcement is made of an Agency for Healthcare Research and Quality (AHRQ) Special Emphasis Panel (SEP) meeting on ``AHRQ RFA-HS14-001, Rapid Secondary Analysis to Optimize Care for Patients with Multiple Chronic Conditions (R01)''. Each SEP meeting will commence in open session before closing to the public for the duration of the meeting.
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2013-27172
Type: Notice
Date: 2013-11-14
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meeting
Document Number: 2013-27171
Type: Notice
Date: 2013-11-14
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-27170
Type: Notice
Date: 2013-11-14
Agency: Department of Health and Human Services, National Institutes of Health
Notice of Senior Executive Service Performance Review Board Membership
Document Number: 2013-27169
Type: Notice
Date: 2013-11-14
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services