Department of Health and Human Services May 16, 2013 – Federal Register Recent Federal Regulation Documents

Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarket Surveillance
Document Number: 2013-11697
Type: Notice
Date: 2013-05-16
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 information collection requirements for postmarket surveillance of medical devices.
Announcement of Requirements and Registration for “Propose New Ideas For Prescription Drugs Oral Overdose Protection”
Document Number: 2013-11689
Type: Notice
Date: 2013-05-16
Agency: Department of Health and Human Services, National Institutes of Health
Prescription drug abuse is a growing drug problem for America. The ``Propose New Ideas For Prescription Drugs Oral Overdose Protection'' is a Challenge to find new and creative ways that diminish or eliminate overconsumption of intact opioid pills. This notice provides information about the requirements and registration for the Challenge.
Announcement of Requirements and Registration for: “Data Rx: Prescription Drug Abuse Infographic Challenge”
Document Number: 2013-11688
Type: Notice
Date: 2013-05-16
Agency: Department of Health and Human Services, National Institutes of Health
The ``Data Rx: Prescription Drug Abuse Infographic Challenge Concept'' challenges the general public to create an infographic that presents information, rooted in the current research, concerning the growing trend of prescription drug abuse. The infographic should be designed to inform and educate the general public in interesting, novel, and creative ways about the dangers involved with the abuse of prescription drugs.
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2013-11672
Type: Notice
Date: 2013-05-16
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Request for Comment on the Federal Guidelines for Opioid Treatment
Document Number: 2013-11637
Type: Notice
Date: 2013-05-16
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
This document is a request for comment on the revised draft of the Federal Guidelines for Opioid Treatment. These guidelines elaborate upon the Federal opioid treatment standards set forth under 42 CFR part 8.
Agency Information Collection Activities; Proposed Collection; Comment Request; Substances Prohibited From Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed; Extension
Document Number: 2013-11633
Type: Notice
Date: 2013-05-16
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 extending OMB approval on the existing recordkeeping requirements for this information collection, regarding animal proteins prohibited in ruminant feed.
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on How To Submit Information in Electronic Format to Center for Veterinary Medicine Using the Food and Drug Administration's Electronic Submission Gateway
Document Number: 2013-11632
Type: Notice
Date: 2013-05-16
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 the existing reporting requests in CVM Guidance 108, ``How to Register with the CVM Electronic Submission System to Submit Information in Electronic Format using the FDA Electronic Submissions Gateway.''
Agency Information Collection Activities; Proposed Collection; Comment Request; Infant Formula Requirements
Document Number: 2013-11631
Type: Notice
Date: 2013-05-16
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 our proposed collection of certain information. 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 infant formula regulations, including infant formula labeling, quality control procedures, notification requirements, and recordkeeping.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Bar Code Label Requirement for Human Drug and Biological Products
Document Number: 2013-11630
Type: Notice
Date: 2013-05-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing 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.
Medical Devices; General Hospital and Personal Use Monitoring Devices; Classification of the Ingestible Event Marker
Document Number: 2013-11628
Type: Rule
Date: 2013-05-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is classifying the ingestible event marker into class II (special controls). The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
Prospective Grant of Start-Up Exclusive Evaluation Option License Agreement: In Vitro Diagnostics for Prediction of Therapeutic Efficacy in Cancer and Other Angiogenesis-Mediated Diseases
Document Number: 2013-11609
Type: Notice
Date: 2013-05-16
Agency: Department of Health and Human Services, National Institutes of Health
This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR Part 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of a Start-Up Exclusive Evaluation Option License Agreement to Advanced Personalized Diagnostics, LLC, a company having a place of business in Alexandria, Virginia, to practice the inventions embodied in U.S. Provisional Patent Application No. 60/976,732, entitled ``Stably Transfected Multicolored Fluorescent Cells'', filed October 1, 2007 (HHS Ref. No. E-281-2007/0-US-01); U.S. Patent Application No. 12/ 060,752, entitled ``Multiplex Assay Method for Mixed Cell Populations'', filed April 1, 2008, (HHS Ref. No. E-281-2007/0-US-02); and U.S. Patent Application No. 12/802,666, entitled ``Methods of Monitoring Angiogenesis and Metastasis in Three Dimensional Co- Cultures'', filed June 10, 2010 (HHS Ref. No. E-281-2007/1-US-01). The patent rights in these inventions have been assigned to the Government of the United States of America. The territory of the prospective Start-Up Exclusive Evaluation Option License Agreement may be worldwide, and the field of use may be limited to ``The use of the Licensed Patent Rights limited to an FDA-approved Class III in vitro diagnostic device for prediction of therapeutic efficacy in cancer and other angiogenesis-mediated diseases.'' Upon the expiration or termination of the Start-up Exclusive Evaluation Option License Agreement, Advanced Personalized Diagnostics, LLC will have the exclusive right to execute a Start-Up Exclusive Patent License Agreement which will supersede and replace the Start-up Exclusive Evaluation Option License Agreement, with no greater field of use and territory than granted in the Start-up Exclusive Evaluation Option License Agreement.
Government-Owned Inventions; Availability for Licensing
Document Number: 2013-11602
Type: Notice
Date: 2013-05-16
Agency: Department of Health and Human Services, National Institutes of Health
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
National Institute of Diabetes and Digestive and Kidney Diseases Notice of Closed Meetings
Document Number: 2013-11600
Type: Notice
Date: 2013-05-16
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases Notice of Meetings
Document Number: 2013-11599
Type: Notice
Date: 2013-05-16
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases Notice of Closed Meetings
Document Number: 2013-11598
Type: Notice
Date: 2013-05-16
Agency: Department of Health and Human Services, National Institutes of Health
Meeting of the Advisory Committee on Blood and Tissue Safety and Availability
Document Number: 2013-11582
Type: Notice
Date: 2013-05-16
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA) will hold a meeting. The meeting will be open to the public.
Information Collection Activities; Proposed Collection; Comment Request
Document Number: 2013-11340
Type: Notice
Date: 2013-05-16
Agency: Department of Health and Human Services, Agency for Healthcare Research and Quality Agency Information Collection Activities
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Collection of Information for Agency for Healthcare Research and Quality's (AHRQ) Hospital Survey on Patient Safety Culture Comparative Database.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection.