Department of Health and Human Services September 7, 2016 – Federal Register Recent Federal Regulation Documents

Notice of Office of Urban Indian Health Programs Strategic Plan
Document Number: 2016-21485
Type: Notice
Date: 2016-09-07
Agency: Department of Health and Human Services, Indian Health Service
Indian Health Service (IHS) has entered into a contract with the National Academy of Public Administration (the Academy) to assist in the development of a five-year strategic plan. Funding for this project was provided by Congress in the 2016 Consolidated Appropriations Act, which directs IHS to develop the plan in consultation with urban Indians and the Academy. As part of this project, the Academy project team is in the process of conducting extensive outreach to IHS/Office of Urban Indian Health Programs (OUIHP) leadership and employees, as well as conferring with urban Indian organizations and other key external stakeholder groups. The final product will be a strategic plan to guide the work of the headquarters office of OUIHP, area urban coordinators, and urban Indian organizations participating in IHS programs. The strategic plan will be completed by the end of December 2016. IHS is requesting input on the strategic planning process, the strengths and weaknesses of OUIHP, and the opportunities and threats facing the program. Comments will be used to help develop the mission, goals, objectives, and strategies to be included in the strategic plan.
Board of Scientific Counselors, Office of Infectious Diseases (BSC, OID)
Document Number: 2016-21400
Type: Notice
Date: 2016-09-07
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Board of Scientific Counselors, National Institute for Occupational Safety and Health (BSC, NIOSH)
Document Number: 2016-21399
Type: Notice
Date: 2016-09-07
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2016-21395
Type: Notice
Date: 2016-09-07
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Prospective Grant of Exclusive Patent License: The Development of an Anti-CD19 Chimeric Antigen Receptor (CAR) for the Treatment of Human Cancers
Document Number: 2016-21366
Type: Notice
Date: 2016-09-07
Agency: Department of Health and Human Services, National Institutes of Health
This 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 an exclusive patent license to practice the inventions embodied in the following Patents and Patent Applications and all continuing U.S. and foreign patents/ patent applications to Sangamo BioSciences, Inc. located in Richmond, California, USA:
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2016-21365
Type: Notice
Date: 2016-09-07
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meetings
Document Number: 2016-21364
Type: Notice
Date: 2016-09-07
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meetings
Document Number: 2016-21363
Type: Notice
Date: 2016-09-07
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Proposed Collection; Public Comment Request
Document Number: 2016-21360
Type: Notice
Date: 2016-09-07
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 the ICR to OMB, OS seeks comments from the public regarding the burden estimate below or any other aspect of the ICR. Prior to submitting the ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Compliance With Title X Requirements by Project Recipients in Selecting Subrecipients
Document Number: 2016-21359
Type: Proposed Rule
Date: 2016-09-07
Agency: Department of Health and Human Services
This document seeks comment on the proposed amendment of Title X regulations specifying the requirements Title X projects must meet to be eligible for awards. The amendment precludes project recipients from using criteria in their selection of subrecipients that are unrelated to the ability to deliver services to program beneficiaries in an effective manner.
Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Zika Virus; Availability
Document Number: 2016-21353
Type: Notice
Date: 2016-09-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) for an in vitro diagnostic device for detection of the Zika virus in response to the Zika virus outbreak in the Americas. FDA issued this Authorization under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) as requested by Viracor-IBT Laboratories, Inc. The Authorization contains, among other things, conditions on the emergency use of the authorized in vitro diagnostic device. The Authorization follows the February 26, 2016, determination by the Secretary of Health and Human Services (HHS) that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves Zika virus. On the basis of such determination, the Secretary of HHS declared on February 26, 2016, that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection, subject to the terms of any authorization issued under the FD&C Act. The Authorization, which includes an explanation of the reasons for issuance, is reprinted in this document.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Requests for Clinical Laboratory Improvement Amendments Categorization
Document Number: 2016-21352
Type: Notice
Date: 2016-09-07
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; Comment Request; Human Cells, Tissues, and Cellular and Tissue-Based Products: Establishment Registration and Listing; Eligibility Determination for Donors; and Current Good Tissue Practice
Document Number: 2016-21351
Type: Notice
Date: 2016-09-07
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 information collection requirements for FDA regulations related to human cells, tissues, and cellular and tissue-based products (HCT/Ps) involving establishment registration and listing using Form FDA 3356; eligibility determination for donors; and current good tissue practice (CGTP).
Request for Comment on the Status of Vinpocetine
Document Number: 2016-21350
Type: Notice
Date: 2016-09-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is requesting comments related to the regulatory status of vinpocetine. Specifically, we request comments on our tentative conclusion that vinpocetine is not a dietary ingredient and is excluded from the definition of dietary supplement in the Federal Food, Drug, and Cosmetic Act (FD&C Act). This action is being taken as part of an administrative proceeding to determine the regulatory status of vinpocetine. All comments submitted by the comment deadline (see DATES) will be accepted as part of the official record for this proceeding.