Department of Health and Human Services December 11, 2014 – Federal Register Recent Federal Regulation Documents

Agency Information Collection Activities; Proposed Collection; Comment Request; Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Restaurant Facility Types
Document Number: 2014-29065
Type: Notice
Date: 2014-12-11
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 a survey entitled, ``Occurrence of Foodborne Illness Risk Factors in Selected Restaurant Facility Types (2013-2022).''
Agency Information Collection Activities; Proposed Collection; Comment Request; MedWatch: The Food and Drug Administration Medical Products Reporting Program
Document Number: 2014-29064
Type: Notice
Date: 2014-12-11
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 revisions to Forms FDA 3500, 3500A, and 3500B used in the FDA Medical Products Reporting Program.
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2014-29047
Type: Notice
Date: 2014-12-11
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance on Consultation Procedures: Foods Derived From New Plant Varieties
Document Number: 2014-29046
Type: Notice
Date: 2014-12-11
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. This notice solicits comments on the information collection provisions of FDA's consultation procedures for foods derived from new plant varieties, including the information collection provisions in the guidance entitled, ``Guidance on Consultation Procedures: Foods Derived From New Plant Varieties,'' and in Form FDA 3665 entitled, ``Final Consultation For Food Derived From a New Plant Variety (Biotechnology Final Consultation),'' which developers may use to prepare the final consultation in a standard format.
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2014-29036
Type: Notice
Date: 2014-12-11
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Bioequivalence Recommendations for Budesonide Extended-Release Tablets; Draft Guidance for Industry; Availability
Document Number: 2014-29035
Type: Notice
Date: 2014-12-11
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Bioequivalence Recommendations for Budesonide Extended-Release Tablets.'' The guidance provides specific recommendations on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for budesonide extended-release tablets.
Determination That PFIZERPEN (Penicillin G Potassium) Injection, 1 Million Units/Vial, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2014-29034
Type: Notice
Date: 2014-12-11
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined that PFIZERPEN (penicillin G potassium) Injection, 1 million units/vial, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for penicillin G potassium injection, 1 million units/vial, if all other legal and regulatory requirements are met.
National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings
Document Number: 2014-29021
Type: Notice
Date: 2014-12-11
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: 2014-29020
Type: Notice
Date: 2014-12-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2014-29019
Type: Notice
Date: 2014-12-11
Agency: Department of Health and Human Services, National Institutes of Health
Interagency Coordinating Committee on the Validation of Alternative Methods Communities of Practice Webinar on Reverse Toxicokinetics; Notice of Public Webinar and Registration Information
Document Number: 2014-29018
Type: Notice
Date: 2014-12-11
Agency: Department of Health and Human Services, National Institutes of Health
The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) announces a public webinar ``Reverse Toxicokinetics: Using In Vitro Data to Estimate Exposures that Could Be Associated with Adverse Effects In Vivo.'' The webinar is organized on behalf of ICCVAM by the National Toxicology Program Interagency Center for the Evaluation Alternative Toxicological Methods (NICEATM) and hosted by the Environmental Protection Agency's National Center for Computational Toxicology (NCCT). Interested persons may participate via Adobe[supreg] ConnectTM. Time is allotted for questions from participants.
Prospective Grant of a Start-Up Exclusive Patent License Agreement: Use of Compounds Covered by Patent Rights for Diagnosis of Human Thyroid Cancer Requiring FDA Premarket Approval or an Equivalent Authority Outside of the United States, and Treatment of Human Thyroid Cancer
Document Number: 2014-29017
Type: Notice
Date: 2014-12-11
Agency: Department of Health and Human Services, National Institutes of Health
This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of a Start-Up Exclusive Patent License to Nova Therapeutics LLC, a company having a place of business in Delaware, to practice the inventions embodied in the following patent applications: