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

This interim final rule with comment establishes provisions that alter the parameters of select special enrollment periods and that revise certain rules governing consumer operated and oriented plans (CO-OPs).

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 on November 10, 2015, page 69685 and allowed 60-days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The Office of the Director (OD), 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.

In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for a new collection. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period. Proposed Project: Million Hearts Social Network Analysis: Network SurveyOMB No. 0990-NewOffice of the Assistant Secretary for Planning and Evaluation (ASPE). Abstract: The Office of the Assistant Secretary for Planning and Evaluation (ASPE) is requesting approval on a new information collection request from the Office of Management and Budget (OMB) for purposes of conducting a study about the Million Hearts Initiative and its subsequent public-private partner network. Million Hearts focuses on aligning the efforts of federal agencies, states, regions, health systems, communities and individuals towards this common goal, ensuring the coordination of public health, clinical care, and policy approaches to this complex problem. Previous research has shown that collaborative efforts among organizations with a variety of programming, resources and skill sets result in higher levels of community impact. Integrated efforts to address public health issues by involving multiple stakeholders are predicted to result in better health outcomes than programs that do not use a collaborative approach. ASPE is requesting comment on the burden for this study that is examining the Million Hearts public-private partnership network. The goal of developing this activity is to examine the network to identify facilitators and barriers to effective communication and collaboration in addressing large and complex public health problems like cardiovascular disease. This project wants to take the lessons learned from this unique and massive collaboration and apply them to other efforts to improve the health and well-being of Americans.

The Food and Drug Administration (FDA) is announcing a public workshop regarding clinical trial design considerations for malaria drug development. FDA is interested in discussing the scientific challenges pertaining to malaria drug development and malaria parasite detection methods used as endpoints in clinical trials. This public workshop is intended to provide information for and gain perspective from health care providers, other U.S. government agencies, public health organizations, academic experts, and industry on various aspects of the design of clinical trials evaluating new drugs to treat malaria. The input from this public workshop will also help in developing topics for future discussion. Dates and Times: The public workshop will be held on June 30, 2016, from 8:30 a.m. to 4 p.m. Location: The public workshop will be held at FDA's White Oak campus, 10903 New Hampshire Ave., Bldg. 31 Great Rm., Silver Spring, MD 20993. Entrance for the public workshop participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/ BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.ht m. Seating is limited and available only on a first-come, first-served basis. Contact Persons: Ms. Lori Benner and/or Ms. Jessica Barnes, Center for Drug Evaluation and Research, Food and Drug Administration, Bldg. 22, Rm. 6221, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-1300. Registration: Registration is free for the public workshop. Interested parties are encouraged to register early. Seating will be available on a first-come, first-served basis. To register electronically, email registration information (including name, title, firm name, address, telephone, and fax number) to Malariaworkshop2016@fda.hhs.gov. Persons without access to the Internet can call 301-796-1300 to register. Persons needing a sign language interpreter or other special accommodations should notify Ms. Jessica Barnes or Ms. Lori Benner (see Contact Persons) at least 7 days in advance.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Tobacco Product Master Files.'' This guidance provides recommendations to industry on tobacco product master files (TPMFs). TPMFs are voluntary submissions used to permit the person that owns the TPMF to authorize other parties to rely on information in the TPMF to support a submission to FDA without the TPMF owner having to disclose that information to the authorized parties. Parties that obtain a right of reference from a TPMF owner may reference information in a TPMF that the TPMF owner does not want to make public, but that the other party would otherwise need to develop on its own to make a complete submission to FDA.

The Food and Drug Administration (FDA or we) is issuing a final rule that requires domestic manufacturers and importers of cigars and pipe tobacco to submit information needed to calculate the amount of user fees assessed under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). FDA recently expanded its authority by issuing a final rule, ``Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products'' (Deeming rule), deeming all products that meet the statutory definition of ``tobacco product,'' except accessories of the newly deemed tobacco products, to be subject to the FD&C Act. The Deeming rule, among other things, subjected domestic manufacturers and importers of cigars and pipe tobacco to the FD&C Act's user fee requirements. Consistent with the Deeming rule and the requirements of the FD&C Act, this final rule requires the submission of the information needed to calculate user fee assessments for each manufacturer and importer of cigars and pipe tobacco to FDA.

The Food and Drug Administration (FDA) is issuing this final rule to deem products meeting the statutory definition of ``tobacco product,'' except accessories of the newly deemed tobacco products, to be subject to the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). The Tobacco Control Act provides FDA authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless tobacco, and any other tobacco products that the Agency by regulation deems to be subject to the law. With this final rule, FDA is extending the Agency's ``tobacco product'' authorities in the FD&C Act to all other categories of products that meet the statutory definition of ``tobacco product'' in the FD&C Act, except accessories of such newly deemed tobacco products. This final rule also prohibits the sale of ``covered tobacco products'' to individuals under the age of 18 and requires the display of health warnings on cigarette tobacco, roll-your own tobacco, and covered tobacco product packages and in advertisements. FDA is taking this action to reduce the death and disease from tobacco products. In accordance with the Tobacco Control Act, we consider and intend the extension of our authorities over tobacco products and the various requirements and prohibitions established by this rule to be severable.

This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from January through March 2016, relating to the Medicare and Medicaid programs and other programs administered by CMS.

The Food and Drug Administration (FDA or we) is extending the comment period for the document entitled ``Streamlining Regulations for Good Manufacturing Practices for Hearing Aids; Public Workshop'' that appeared in the Federal Register of January 7, 2016. In the document, FDA requested comments on the appropriate level of good manufacturing practices (GMPs) regulation to ensure the safety and effectiveness of air-conduction hearing aid devices. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.

The invention listed below is owned by an agency of the U.S. Government and is available for licensing and/or co-development in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing and/or co-development.

In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting that ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) repeals the Medicare sustainable growth rate (SGR) methodology for updates to the physician fee schedule (PFS) and replaces it with a new Merit-based Incentive Payment System (MIPS) for MIPS eligible clinicians or groups under the PFS. This proposed rule would establish the MIPS, a new program for certain Medicare-enrolled practitioners. MIPS would consolidate components of three existing programs, the Physician Quality Reporting System (PQRS), the Physician Value-based Payment Modifier (VM), and the Medicare Electronic Health Record (EHR) Incentive Program for Eligible Professionals (EPs), and would continue the focus on quality, resource use, and use of certified EHR technology (CEHRT) in a cohesive program that avoids redundancies. This proposed rule also would establish incentives for participation in certain alternative payment models (APMs) and includes proposed criteria for use by the Physician-Focused Payment Model Technical Advisory Committee (PTAC) in making comments and recommendations on physician-focused payment models. In this proposed rule we have rebranded key terminology based on feedback from stakeholders, with the goal of selecting terms that would be more easily identified and understood by our stakeholders.

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 require; 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.