Department of Health and Human Services October 2017 – Federal Register Recent Federal Regulation Documents

In accordance with section 10(a) of the Federal Advisory Committee Act, this notice announces a meeting of the National Advisory Council for Healthcare Research and Quality.

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected; and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

The Indian Health Service published a notice in the Federal Register (FR) on August 14, 2017, for the Fiscal Year 2017 Behavioral Health Integration Initiative (BH2I), Funding Announcement Number: HHS- 2017-IHS-BH2I-0001. Several Key Dates have been modified.

The Secretary of the Department of Health and Human Services hereby issues this final notice to re-designate the Purchased/Referred Care Delivery Area (PRCDA) for the Tolowa Dee-ni' Nation (Tribe) (previously known as the Smith River Rancheria of Smith River, California), to provide Purchased/Referred Care (PRC) services to their Tribal members residing in Curry County, Oregon, which is in the Portland Area Indian Health Service (IHS). The Tolowa Dee-ni's Tribal Headquarters is located 3 miles south of the California-Oregon border in Northern California. The entire State of California, excluding the counties of Alameda, Contra Costa, Los Angeles, Marin, Orange, Sacramento, San Francisco, San Mateo, Santa Clara, Kern, Merced, Monterey, Napa, San Benito, San Joaquin, San Luis Obispo, Santa Cruz, Solano, Stanislaus, and Ventura, was designated by the IHS as a PRCDA, formerly known as a Contract Health Service Delivery Area, in accordance with statute. The current PRCDA for Tolowa Dee-ni' Tribal members is the statutorily specified California PRCDA. The expanded PRCDA for the Tolowa Dee-ni' Tribe includes the statutorily specified California PRCDA and Curry County in the State of Oregon.

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery. In order to work continuously to ensure that our programs are effective and meet our customers' needs, the National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention (CDC) seeks to obtain Office of Management and Budget approval of a generic information collection request to collect qualitative feedback on our service delivery.

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort 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 study titled ``Understanding Decisions and Barriers about PrEP Use and Uptake among Men Who Have Sex with Men.'' This study will provide insight on individual and community level PrEP-related decision-making, and identify barriers and facilitators to successful PrEP initiation and PrEP acceptability.

The Department of Health and Human Services, National Institutes of Health published a document in the Federal Register on October 2, 2017, contemplating the modification of grant of an Exclusive Patent License to EncepHeal Therapeutics, Inc., located in Winston-Salem, North Carolina, to practice the inventions embodied in the patent applications listed in the Supplementary Information section of this notice. The document contained an incorrect date of signature.

The Food and Drug Administration (FDA) is correcting a final order entitled ``Medical Devices; Cardiovascular Devices; Classification of the Adjunctive Cardiovascular Status Indicator'' that appeared in the Federal Register of July 28, 2017. The final order was published with an incorrect statement in the preamble about whether FDA planned to exempt the device from premarket notification requirements. This document corrects that error.

The Department of Health and Human Services (HHS), Office of Minority Health (OMH), is seeking nominations of qualified candidates to be considered for appointment as a member of the Advisory Committee on Minority Health (hereafter referred to as the ``Committee or ACMH''). In accordance with Public Law 105-392, the Committee provides advice to the Deputy Assistant Secretary for Minority Health on improving the health of racial and ethnic minority groups, and on the development of goals and specific program activities of OMH designed to improve the health status and outcomes of racial and ethnic minorities. Nominations of qualified candidates are being sought to fill vacancies on the Committee.

In compliance with the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Science Advisory Board (SAB) to the National Center for Toxicological Research (NCTR). The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. At least one portion of the meeting will be closed to the public.

The Food and Drug Administration (FDA, the Agency, or we) is announcing the forthcoming public meeting entitled ``Animal Generic Drug User Fee Act.'' The topic to be discussed is proposed recommendations for the reauthorization of the Animal Generic Drug User Fee Act (AGDUFA III). The meeting will be open to the public.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for IMPELLA 2.5 SYSTEM 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 medical device.

In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC), National Institute for Occupational Safety and Health (NIOSH), announces the following meeting for the Mine Safety and Health Research Advisory Committee (MSHRAC). This meeting is open to the public, limited only by the limited only by the space available. The meeting room accommodates approximately 50 people. If you wish to attend in person or by phone, please contact Marie Chovanec by email at MChovanec@cdc.gov or by phone at least 5 business days in advance of the meeting.