Submission for OMB Review; 30-Day Comment Request; HIV Study in Blood Donors From Five Chinese Regions (NHLBI)
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register in Volume 79, June 12, 2014 on page 33764 and allowed 60-days for public comment. One public comment was received that was a personal opinion regarding conducting research about the Chinese blood donation system. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health (NIH) may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication.
The National Institute of Mental Health (NIMH) Draft Strategic Plan; Request for Comments
NIMH is revising its 2008 Strategic Plan to guide the Institute's research efforts and priorities over the next five years (2015-2020). The purpose of this Notice is to seek input from the public about the draft NIMH 2015 Strategic Plan. The draft plan will be publicly available through the NIMH Draft Strategic Plan Web page (https://www.nimh.nih.gov/about/strategic-planning-reports/rev iew-the- draft-2015-nimh-strategic-plan.shtml) for a 30-day period beginning on the publication date of this Notice. The public is invited to provide comments via the email address or postal address provided in this Notice and on the NIMH Draft Strategic Plan Web page.
Orthopedic Devices; Reclassification of Thoracolumbosacral Rigid Pedicle Screw Systems; Classification and Effective Date of Requirement for Premarket Approval for Dynamic Stabilization Systems
The Food and Drug Administration (FDA) is proposing in this administrative order to reclassify rigid pedicle screw systems, a preamendments class III device, into class II (special controls); require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the dynamic stabilization systems, currently a subtype of pedicle screws, regardless of the indication for use; and clarify the device identification of pedicle screw spinal systems, to more clearly delineate between rigid pedicle screw systems and dynamic stabilization systems. FDA is proposing this action based on new information pertaining to the device type. This proposed action implements certain statutory requirements.
Nominations to the Presidential Advisory Council on HIV/AIDS
The Office of the Assistant Secretary for Health (OASH) is seeking nominations of qualified individuals to be considered for appointment as members of the Presidential Advisory Council on HIV/AIDS (PACHA). The PACHA is a federal advisory committee within the Department of Health and Human Services (HHS). Management support for the activities of this Council is the responsibility of the OASH. The qualified individuals will be nominated to the Secretary of Health and Human Services for consideration for appointment as members of the PACHA. Members of the Council, including the Chair, are appointed by the Secretary. Members are invited to serve on the Council for up to four-year terms. The Council was established to provide advice, information, and recommendations to the Secretary regarding programs and policies intended to promote effective prevention and care of HIV disease and AIDS. The functions of the Council are solely advisory in nature.
DSM Nutritional Products; Food Additive Petition (Animal Use); Ethoxyquin; Environmental Assessment
The Food and Drug Administration (FDA) is announcing the availability of an environmental assessment filed by DSM Nutritional Products in support of their petition proposing that the food additive regulations be amended to provide for the safe use of ethoxyquin in vitamin D formulations, including 25-hydroxyvitamin D3, used in animal food.
Agency Information Collection Activities; Proposed Collection; Comment Request; Impact of Ad Exposure Frequency on Perception and Mental Processing of Risk and Benefit Information in Direct-to-Consumer Prescription Drug Ads
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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on research entitled, ``Impact of Ad Exposure Frequency on Perception and Mental Processing of Risk and Benefit Information in DTC Prescription Drug Ads.'' This project will examine the effects of variation in ad exposure frequency on perception and mental processing of risk and benefit information in direct-to-consumer (DTC) prescription drug ads.
Combined Functionality for Molecular Diagnostic Instruments; Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Molecular Diagnostic Instruments with Combined Functions.'' This guidance document provides industry and Agency staff with FDA's current thinking on regulation of molecular diagnostic instruments that combine in a single instrument both approved/cleared device functions and device functions for which approval/clearance is not required, and on the type of information that FDA recommends that applicants include in a submission for a molecular diagnostic instrument that measures or characterizes nucleic acid analytes and has combined functions.