Department of Health and Human Services September 15, 2017 – Federal Register Recent Federal Regulation Documents

The subcommittees listed below are part of AHRQ's Health Services Research Initial Review Group Committee. Grant applications are to be reviewed and discussed at these meetings. Each subcommittee meeting will commence in open session before closing to the public for the duration of the meeting.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Voluntary Customer Survey Generic Clearance for the Agency for Healthcare Research and Quality.'' This proposed information collection was previously published in the Federal Register on May 30, 2017 and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Utilizing Animal Studies to Evaluate Organ Preservation Devices.'' The intent of this draft guidance is to provide recommendations regarding best practices for utilizing animal studies for the evaluation of organ preservation devices. This draft guidance is not final nor is it in effect at this time.

The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.

The Food and Drug Administration (FDA or Agency) is announcing the availability of draft guidance for industry (GIF) #210 entitled ``The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species.'' This draft guidance describes the process for adding a new animal drug to the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species (the Index). The Index consists of a list of legally marketed unapproved new animal drugs for minor species that meet the requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act).

The Food and Drug Administration (FDA or Agency) is publishing a list of premarket approval applications (PMAs) that have been approved by the Center for Biologics Evaluation and Research (CBER). This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the internet and the Agency's Dockets Management Staff.

Government owned intellectual property covering imaging agents with improved renal clearance available for licensing and commercialization.

The Administration for Community Living (ACL) is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget (OMB) for review and clearance as required under the Paperwork Reduction Act of 1995 (the PRA). This 30-day notice requests comments on the information collection requirements related to a proposed Extension Without Changes of a Currently Approved Information Collection (ICR Ext) (OMB approval number 0985-0023). The extension would allow ACL to continue to collect information necessary to determine grantee compliance with Title VII of the Rehabilitation Act of 1973, as Amended by the Workforce Innovation and Opportunity Act of 2014. ACL received a large number of public comments resulting from a 60- day Federal Register notice for the 704 Part II report. In response to the comments, ACL is proposing to extend the currently approved forms for one year while we work on a revision that addresses all the comments from the 60-day notice regarding the updated form.