Department of Health and Human Services July 2013 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Environmental Impact Considerations'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Health Resources and Services Administration's (HRSA) Office of Women's Health, located within the Department of Health and Human Services (HHS), and in collaboration with the HHS Office on Women's Health, announces the launch of the Care Counts: Educating Women and Families Challenge. Women are often at the center of healthy and resilient families; they make approximately 80 percent of all family health care decisions and are more likely to be the primary caregivers for children and elderly parents. To help make women aware of the important benefits available to them and their families through the Affordable Care Act, HHS is initiating this Challenge. The Affordable Care Act is already making a difference in the lives of millions of Americans. Starting October 1, 2013, millions of uninsured Americans will be able to find affordable health insurance that meets their needs at the new Health Insurance Marketplace (Marketplace). The Marketplace is a one stop shop where people can learn about health insurance, get accurate information on different plans, and make apples-to-apples comparisons of private insurance plans. For the first time, comprehensive information about benefits and quality, side-by-side with facts about price, will help each consumer make the best coverage decision. For more information about how the Marketplace will work, including important deadlines and milestones, visit HealthCare.gov (English) or CuidadoDeSalud.gov (Spanish). This Challenge will allow teams (the ``Contestants'') to create innovative, educational tools (``Tools'') to inform women consumers, particularly women living in medically underserved communities, about enrollment in new health plans, as well as key provisions of the Affordable Care Act to improve their own health and that of their families. For purposes of this Challenge, the key provision of the Affordable Care Act is coverage of 22 preventive services for women without copayment. See https://www.healthcare.gov/what-are-my-preventive-care- benefits#part=2. The Tool must refer to two or more of the 22 covered preventive services for women. The Tool must also direct consumers to HealthCare.gov (English) or CuidadoDeSalud.gov (Spanish), and the toll- free Centers for Medicare and Medicaid (CMS) call centers (1-800-318- 2596) (English and Spanish) to promote enrollment in the Marketplace. The Tool must also include the TTY/TTD call center number (1-888-871- 6594). The Tool may be designed to be used within systems of health care. For purposes of this Challenge, a system of health care is defined as the organization of people, institutions, and resources to deliver comprehensive culturally competent, quality, services to meet the health needs of the target audience. Examples include HRSA's Community Health Centers, Healthy Start programs, Ryan White Care service sites, National Health Service Corps sites, and HHS-supported Title X service sites. The Tool may also be designed to be used in community-based settings where women live, work, and purchase goods and services, such as schools, faith-based settings, recreation centers, and shopping centers. ``Tools'' are defined as print, web, or other social media (including Facebook, Twitter, Google+, Apps, and/or other innovative resources) used to educate the target audience to improve knowledge and abilities leading to action. The target audience for the Tools is adult women in the United States and its territories, particularly women living in medically underserved communities or who experience difficulty accessing health care. The Tools shall focus on communicating complex information in understandable, culturally competent, and relevant ways. Reading level, common language, and health literacy of the target audiences should be considered in development of the Tools. Contestants must also submit a Promotion/Outreach Plan for the tools. The Promotion/Outreach Plan shall: (1) Be no more than two pages in length; (2) demonstrate the Contestants' understanding of the target audience; and (3) demonstrate how they will use the Tools to reach the target audience.

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: ``Evaluation of the Children's Health Insurance Program Reauthorization Act of 2009 (CHIPRA) Quality Demonstration Grant Program: Qualitative Data Collection.'' 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 Food and Drug Administration's (FDA's) Center for Drug Evaluation and Research in cosponsorship with the American Association for the Study of Liver Diseases (AASLD) is announcing a 2-day public workshop entitled ``Trial Designs and Endpoints for Liver Disease Secondary to Nonalcoholic fatty liver disease (NAFLD).'' There are no approved treatments for NAFLD and its complications of nonalcoholic steatohepatitis (NASH) and liver fibrosis and cirrhosis. This workshop will provide a forum to discuss trial design, including endpoints for clinical trials in NAFLD, to promote efficient drug development in this area and thus improved treatments for patients. Date and Time: The public workshop will be held on September 5 and 6, 2013, from 8 a.m. to 5 p.m. Location: The meeting will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, in the Great Room (room 1503), Silver Spring, MD 20993. Entrance for the public meeting 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.htm. Contact Person: Anissa Davis, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-5016, FAX: 301-796-9904, email: Anissa.Davis@fda.hhs.gov. Registration: There is no fee to attend the public workshop, but attendees must register online at https://www.aasld.org/ additionalmeetings/Pages/aasldfdanash.aspx before September 1, 2013. (FDA has verified this Web site address but is not responsible for subsequent changes to the Web site after this document publishes in the Federal Register.) Space is limited, and registration will be on a first-come, first-served basis. Those without Internet access should contact Anissa Davis (see Contact Person) to register. Onsite registration will not be available. If you need special accommodations due to a disability, please contact Anissa Davis (see Contact Person) at least 7 days in advance. Transcripts: Please be advised that as soon as a transcript is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD. A transcript will also be available in either hardcopy or on CD-ROM, after submission of a Freedom of Information request. Written requests are to be sent to the Division of Freedom of Information (ELEM-1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing 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.

In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate below, or any other aspect of the ICR.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Safety Labeling ChangesImplementation of Section 505(o)(4) of the FD&C Act.'' The Food and Drug Administration Amendments Act of 2007 (FDAAA) added new provisions to the Federal Food, Drug, and Cosmetic Act (the FD&C Act) authorizing FDA to require certain drug and biological product application holders to make safety-related labeling changes based upon new safety information that becomes available after the drug or biological product is approved under the FD&C Act or the Public Health Service Act (the PHS Act). This final guidance provides information on the implementation of section 505(o)(4) of the FD&C Act, including a description of the types of safety labeling changes that ordinarily might be required under this section; how FDA plans to determine what constitutes new safety information; the procedures involved in requiring safety labeling changes; and enforcement of the requirements for safety labeling changes.

NIDCR is developing a new strategic plan to guide the Institute's research efforts and priorities over the next six years (2014-2019). The purpose of this time-sensitive Request for Information (RFI) is to seek input from a broad range of stakeholders about prospective activities, areas of research emphasis, future research approaches, needs, and opportunities.

The Food and Drug Administration (FDA) is proposing to adopt regulations on foreign supplier verification programs (FSVPs) for importers of food for humans and animals. The proposed regulations would require importers to help ensure that food imported into the United States is produced in compliance with processes and procedures, including reasonably appropriate risk-based preventive controls, that provide the same level of public health protection as those required under the hazard analysis and risk-based preventive controls and standards for produce safety sections of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), is not adulterated, and is not misbranded with respect to food allergen labeling. We are proposing these regulations in accordance with the FDA Food Safety Modernization Act (FSMA). The proposed regulations would help ensure that imported food is produced in a manner consistent with U.S. standards.

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 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.

This notice sets forth the final allotments of federal funding available to each State, the District of Columbia, and each U.S. Territory and Commonwealth for fiscal year 2013. Title XXI of the Social Security Act (the Act) authorizes payment of federal matching funds to States, the District of Columbia, and the U.S. Territories and Commonwealths to initiate and expand health insurance coverage to uninsured, low-income children under the Children's Health Insurance Program (CHIP). The fiscal year allotments contained in this notice were determined in accordance with the funding provisions and final regulations published in the February 17, 2011 Federal Register (76 FR 9233).

This notice sets forth the States' final allotments available to pay the Medicare Part B premiums for Qualifying Individuals (QIs) for the Federal fiscal year (FY) 2012 and the preliminary QI allotments for FY 2013. The amounts of these QI allotments were determined in accordance with the methodology set forth in regulations and reflect funding for the QI program made available under recent legislation.

This notice announces a meeting of the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM). SACATM advises the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), the National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), and the Director of the National Institute of Environmental Health Sciences (NIEHS) and NTP regarding statutorily mandated duties of ICCVAM and activities of NICEATM. Information about the meeting and registration are available at https://ntp.niehs.nih.gov/go/32822.