Department of Health and Human Services July 21, 2016 – Federal Register Recent Federal Regulation Documents

General Principles for Evaluating the Human Food Safety of New Animal Drugs Used in Food-Producing Animals; Draft Guidance for Industry; Availability
Document Number: 2016-17188
Type: Notice
Date: 2016-07-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft revised guidance for industry #3 entitled ``General Principles for Evaluating the Human Food Safety of New Animal Drugs Used in Food-Producing Animals.'' This draft revised guidance describes the type of information that FDA's Center for Veterinary Medicine (CVM) recommends sponsors provide to address the human food safety of new animal drugs used in food-producing animals.
Determination of Regulatory Review Period for Purposes of Patent Extension; QUTENZA
Document Number: 2016-17187
Type: Notice
Date: 2016-07-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for QUTENZA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Administrative Actions for Noncompliance; Lesser Administrative Actions; Confirmation of Effective Date
Document Number: 2016-17186
Type: Rule
Date: 2016-07-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is confirming the effective date of August 17, 2016, for the direct final rule that appeared in the Federal Register of April 4, 2016. The direct final rule amends the regulations describing lesser administrative actions that may be imposed on an Institutional Review Board (IRB) that has failed to comply with applicable regulations. We are taking this action to ensure clarity and improve the accuracy of the regulations. This document confirms the effective date of the direct final rule.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Evaluation of the Program for Enhanced Review Transparency and Communication for New Molecular Entity New Drug Applications and Original Biologics License Applications in Prescription Drug User Fee Acts
Document Number: 2016-17185
Type: Notice
Date: 2016-07-21
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 (the PRA).
Advisory Committee; Science Board to the Food and Drug Administration, Renewal
Document Number: 2016-17182
Type: Notice
Date: 2016-07-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the renewal of the Science Board to the Food and Drug Administration by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Science Board to the Food and Drug Administration for an additional 2 years beyond the charter expiration date. The new charter will be in effect until June 26, 2018.
Center for Scientific Review Amended; Notice of Meeting
Document Number: 2016-17176
Type: Notice
Date: 2016-07-21
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2016-17175
Type: Notice
Date: 2016-07-21
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2016-17170
Type: Notice
Date: 2016-07-21
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the proposed revision of the National Death Index (NDI). The NDI is a national data base containing identifying death record information submitted annually to NCHS by all the state vital statistics offices, beginning with deaths in 1979. Searches against the NDI file provide the states and dates of death, and the death certificate numbers of deceased study subjects. Using the NDI Plus service, researchers have the option of also receiving cause of death information for deceased subjects.