Department of Health and Human Services December 13, 2016 – Federal Register Recent Federal Regulation Documents

Proposed Collection; 60-Day Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery (National Cancer Institute)
Document Number: 2016-29890
Type: Notice
Date: 2016-12-13
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI) will publish periodic summaries of propose projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Animal Feed Regulatory Program Standards
Document Number: 2016-29839
Type: Notice
Date: 2016-12-13
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.
Determination of Regulatory Review Period for Purposes of Patent Extension; NUCALA
Document Number: 2016-29838
Type: Notice
Date: 2016-12-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for NUCALA 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 biological product.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Donor Risk Assessment Questionnaire for the Food and Drug Administration/National Heart, Lung, and Blood Institute-Sponsored Transfusion-Transmissible Infections Monitoring System-Risk Factor Elicitation
Document Number: 2016-29814
Type: Notice
Date: 2016-12-13
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.
Agency Information Collection Activities; Proposed Collection; Public Comment Request
Document Number: 2016-29810
Type: Notice
Date: 2016-12-13
Agency: Department of Health and Human Services, Office of the Secretary
In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for renewal of the approved information collection assigned OMB control number 0990-0001, scheduled to expire on December 31, 2016. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.
Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishment; Guidance for Industry; Availability
Document Number: 2016-29776
Type: Notice
Date: 2016-12-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a revised guidance for industry entitled ``Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments.'' This guidance is intended to assist persons making tobacco product establishment registration and product listing submissions to FDA.
Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs; Correction
Document Number: 2016-29774
Type: Rule
Date: 2016-12-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is correcting a final rule entitled ``Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs'' that appeared in the Federal Register of August 31, 2016 (81 FR 60169). That final rule amended current regulations concerning who must register establishments and list human drugs, human drugs that are also biological products, and animal drugs. The final rule was published with an incorrect statement in the preamble about the rule's effect on establishments at which investigational drugs are manufactured. This document corrects that error.
Proposed Collection; 60-Day Comment Request; CTEP Support Contracts Forms and Surveys (National Cancer Institute)
Document Number: 2016-29767
Type: Notice
Date: 2016-12-13
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI) will publish periodic summaries of propose projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
National Institute of General Medical Sciences; Notice of Meeting
Document Number: 2016-29766
Type: Notice
Date: 2016-12-13
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2016-29765
Type: Notice
Date: 2016-12-13
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2016-29764
Type: Notice
Date: 2016-12-13
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 2016-29763
Type: Notice
Date: 2016-12-13
Agency: Department of Health and Human Services
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD); Notice of Meeting
Document Number: 2016-29762
Type: Notice
Date: 2016-12-13
Agency: Department of Health and Human Services, National Institutes of Health
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