Department of Health and Human Services September 21, 2015 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or we) is announcing the availability of a draft Compliance Policy Guide (CPG) entitled ``Compliance Policy Guide Sec. 100.101 Crotalaria spp. Seeds in Grains'' (the draft CPG). The draft CPG, when finalized, will provide guidance for FDA staff on our regulatory action guidance criteria for Crotalaria species (spp.) seeds in grains.

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: ``Developing a Registry of Registries.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection.

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 information collection request entitled ``A Study of Viral Persistence in Ebola Virus Disease (EVD) Survivors''. The purpose of this information collection is to gather the necessary information for the CDC and the international community to begin the activities necessary to reach the goal of zero new EVD cases throughout West Africa. Once that goal is reached, the 42-day countdown to declare West Africa Ebola-free can begin. ``Persistence of Ebola Virus in Body Fluids of Ebola Virus Disease (EVD) Survivors in Sierra Leone''. This information collection will be the first systematic examination of the post- recovery persistence of Ebola virus and the risks of transmission from a cohort of convalescent Ebola survivors during close or intimate contact.

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 a proposed revision of the information collection entitled ``National Disease Surveillance ProgramICase Reports.''

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Animal Food Labeling; Declaration of Certifiable Color Additives'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is requesting that any consumer organizations interested in participating in the selection of a voting consumer representative to serve on the Patient Engagement Advisory Committee (the Committee) notify FDA in writing. FDA is also requesting nominations for a voting consumer representative to serve on the Committee. Nominees recommended to serve as a voting consumer representative may either be self-nominated or may be nominated by a consumer organization. Nominations will be accepted for the current vacancy effective with this notice. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore encourages nominations of appropriately qualified candidates from these groups.

The Food and Drug Administration (FDA or Agency) is announcing the establishment of the Patient Engagement Advisory Committee (the Committee). The Committee will provide advice to the Commissioner of Food and Drugs (the Commissioner) or designee, on complex issues relating to medical devices, regulation of devices, and their use by patients. The Committee may consider topics such as Agency guidance and policies, clinical trial or registry design, patient preference study design, benefit-risk determinations, device labeling, unmet clinical needs, available alternatives, patient reported outcomes and device- related quality of life or health status issues, and other patient- related topics. The Agency is also announcing the establishment of a public docket for comments on the potential topics.