Department of Health and Human Services July 2016 – Federal Register Recent Federal Regulation Documents

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 accompanies a Notice of Proposed Rulemaking and invites comment on the information collection request Airline and Vessel and Traveler Information Collection. This information collection request pertains to CDC's activities with regard to requirements at proposed Sec. 71.4 and Sec. 71.5 that airlines and vessels arriving to the United States from foreign countries send passenger, crew, and conveyance information (aka manifests) to CDC in the event that a communicable disease of public health concern is suspected or confirmed in a person aboard who poses a potential public health risk to other travelers and their communities after arriving in the United States. This information also pertains to current activities with regard to the collection of manifests from domestic flights within the United States, as well as the collection of traveler information using the Passenger Locator Form (PLF) on both international and domestic flights.

The Food and Drug Administration (FDA or Agency) is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA Recognized Consensus Standards). This publication, entitled Modifications to the List of Recognized Standards, Recognition List Number: 044 (Recognition List Number: 044), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance for industry and FDA staff entitled ``Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI).'' When finalized, this draft document will define the expected content and forms of the unique device identifier (UDI), to assist both labelers and FDA-accredited issuing agencies better ensure the UDIs developed under systems for the issuance of UDIs are in compliance with the unique device identification system rule (UDI Rule). This draft guidance is not the final version of the guidance nor is it in effect at this time.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for 57 approved new animal drug applications (NADAs) and 14 approved abbreviated new animal drug applications (ANADAs) from Elanco Animal Health, A Division of Eli Lilly & Co. to Elanco US, Inc.

The Bureau of Primary Health Care (BPHC) is awarding funds to health centers transitioning to value-based models of care, improving the use of information in decision making, and increasing engagement in delivery system transformation.

In compliance with the Paperwork Reduction Act of 1995 which requires 60 days advance opportunity for public comment on proposed information collection projects, the Indian Health Service (IHS) is publishing for comment a summary of proposed information collection to be submitted to the Office of Management and Budget (OMB) for review. Proposed Collection: Proposed Collection: Title: 0917-NEW, ``Indian Health Service Environmental Health Assessment of Tribal Child Care Centers in the Pacific Northwest.'' Type of Information Collection Request: Three year approval of this new information collection, 0917- NEW, ``Indian Health Service Environmental Health Assessment of Tribal Child Care Centers in the Pacific Northwest.'' Form(s): Child Care Center Director Questionnaire and Pesticide Applicator Questionnaire.

The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908); September 30, 1997 (62 FR 51118); April 13, 2004 (69 FR 19644); November 25, 2008 (73 FR 71858); December 10, 2008 (73 FR 75122); and on April 30, 2010 (75 FR 22809). A notice listing all currently HHS-certified laboratories and IITFs is published in the Federal Register during the first week of each month. If any laboratory or IITF certification is suspended or revoked, the laboratory or IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory or IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at https:// www.samhsa.gov/workplace.

In accordance with Section 10(a) of the Federal Advisory Committee Act, Public Law 92-463, as amended (5 U.S.C. App.), notice is hereby given that a meeting is scheduled for the Advisory Group on Prevention, Health Promotion, and Integrative and Public Health (the ``Advisory Group''). This meeting will be open to the public. Information about the Advisory Group and the agenda for this meeting can be obtained by accessing the following Web site: https:// www.surgeongeneral.gov/priorities/prevention/advisorygrp/advi sory- group-meetings.html.

This document is a request for information on whether there are alternative ways (other than those offered in current regulations) for eligible organizations that object to providing coverage for contraceptive services on religious grounds to obtain an accommodation, while still ensuring that women enrolled in the organizations' health plans have access to seamless coverage of the full range of Food and Drug Administration-approved contraceptives without cost sharing. This information is being solicited in light of the Supreme Court's opinion in Zubik v. Burwell, 136 S. Ct. 1557 (2016). The Departments of Health and Human Services (HHS), Labor, and the Treasury (collectively, the Departments) invite public comments via this request for information.

The Food and Drug Administration (FDA) has determined the regulatory review period for QUTENZA 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 human drug product.

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 (the PRA).

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 revision of the National Death Index (NDI). The NDI is a national data base containing identifying death record information submitted annually to NCHS by all the state vital statistics offices, beginning with deaths in 1979. Searches against the NDI file provide the states and dates of death, and the death certificate numbers of deceased study subjects. Using the NDI Plus service, researchers have the option of also receiving cause of death information for deceased subjects.

The Health Resources and Services Administration, Department of Health and Human Services, is announcing a decrease in user fees charged to individuals and entities authorized to request information from the National Practitioner Data Bank (NPDB). The new fee will be $2.00 for both continuous and one-time queries and $4.00 for self- queries. The reduction in NPDB user fees is intended to encourage new users while ensuring sufficient funds to the full cost of NPDB operations and retain appropriate cash reserves. The goals of the cash reserves are to mitigate risks, cover operational costs should revenue decrease, and cover the cost of reasonable enhancement and maintenance of the NPDB management system. HRSA has the standard operating procedure of reviewing NPDB user fees every 2 years. The biennial review of NPDB user fees offers HRSA the opportunity to evaluate its reserves as well as revenue relative to costs. Further, the review provides essential information on whether the fee rates and authorized activities are aligned with actual program costs and activities, and can help promote greater understanding of the fee by NPDB users.

The Health Resources and Services Administration (HRSA) is requesting nominations to fill vacancies on the Advisory Committee on Training in Primary Care Medicine and Dentistry (ACTPCMD). ACTPCMD is authorized by Section 749 of the Public Health Service (PHS) Act (42 U.S.C. 293l), as amended. The Advisory Committee is governed by provisions of the Federal Advisory Committee Act (FACA) (5 U.S.C. Appendix 2), as amended, which sets forth standards for the formation and use of advisory committees, and applies to the extent that the provisions of FACA do not conflict with the requirements of PHS Act Section 749.

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 (the 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 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.