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

This final rule implements provisions of the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act of 2010 (collectively referred to as the Affordable Care Act). Specifically, this final rule outlines Exchange standards with respect to eligibility appeals, agents and brokers, privacy and security, issuer direct enrollment, and the handling of consumer cases. It also sets forth standards with respect to a State's operation of the Exchange and Small Business Health Options Program (SHOP). It generally is finalizing previously proposed policies without change.

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.

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 Secretary of Education and the Secretary of Health and Human Services (hereafter ``the Secretaries'') announce priorities, requirements, definitions, and selection criteria for the Race to the TopEarly Learning Challenge (RTT-ELC) program. The Secretaries may use one or more of these priorities, requirements, definitions, and selection criteria for competitions in fiscal year (FY) 2013 and later years. The U.S. Department of Education (ED) and the U.S. Department of Health and Human Services (HHS) (collectively, ``the Departments'') conducted the first competition under the RTT-ELC program in FY 2011 and awarded grants to nine States. In FY 2012, the Departments funded the five next highest-rated applicants on the slate of high-scoring applications from the FY 2011 competition. In order to maintain the overall purpose and structure of the FY 2011 RTT-ELC competition in future competitions, these final priorities, requirements, definitions, and selection criteria are almost identical to the ones used in the FY 2011 competition, with the exception of small language clarifications and eight substantive changes from the prior competition.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Nursing Research (NINR), 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 June, 14, 2013, page 35942 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 National Institutes of Health 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. 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. To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Ms. Adrienne Burroughs, Health Communications Specialist, Office of Communications and Public Liaison, NINR, NIH, Building 31, Room 5B10, 31 Center Drive, Bethesda, MD 20892, or call non-toll-free number (301) 496-0256, or Email your request, including your address to: adrienne.burroughs@nih.gov. Formal requests for additional plans and instruments must be requested in writing. Proposed Collection: Palliative Care: Conversations Matter Evaluation, -0925-NewNational Institute of Nursing Research (NINR), National Institutes of Health (NIH). Need and Use of Information Collection: NINR developed Palliative Care: Conversations Matter, a pediatric palliative care campaign to address the communications challenges faced by health care providers who recommend and provide palliative care to pediatric populations. NINR is launching this effort to increase the use of palliative care for children living with serious illness or life-limiting conditions. The Palliative Care: Conversations Matter evaluation will assess the information and materials being disseminated as part of the official campaign. Survey findings will help (1) Determine if the campaign is effective, relevant, and useful to health care providers who recommend and provide palliative care to pediatric populations; (2) to better understand the information needs of health care providers to inform future campaign efforts; and (3) examine how effective the campaign materials are in starting and continuing a pediatric palliative care conversation and addressing the communications needs of health care providers around this topic. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 200.

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). The ICR is for extending the use of the approved information collection assigned OMB control number 0990-0317, which expires on October 31, 2013. Prior to submitting ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

This is notice, in accordance with 35 U.S.C. 209 and 37 CFR Part 404, that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to Peptron, Inc., a company having a place of business in Daejeon, South Korea, to practice the inventions embodied in U.S. Provisional Patent Application No. 60/309,076, filed July 31, 2001, entitled ``Long-Acting Insulinotropic Peptides and Uses Thereof'' (HHS Ref. No. E-049-2001/0-US-01); U.S. Patent No. 7,576,050, issued August 18, 2009, entitled ``GLP-1 Exendin-4 Peptide Analogs and Uses Thereof'' (HHS Ref. No. E-049-2001/0-US-03); U.S. Patent No. 8,278,272, issued October 2, 2012, entitled ``GLP-1, Exendin-4, Peptide Analogs and Uses Thereof'' (HHS Ref. No. E-049-2001/0-US-14); U.S. Patent Application No. 13/594,313, filed August 24, 2012, entitled ``GLP-1, Exendin-4, Peptide Analogs and Uses Thereof'' (HHS Ref. No. E-049-2001/0-US-21); PCT Patent Application No. PCT/US2002/024141, filed July 30, 2002, entitled ``GLP-1, Exendin-4, Peptide Analogs and Uses Thereof'' (HHS Ref. No. E-049-2001/0-PCT-02); Australian Patent No. 2002317599, issued July 17, 2008, entitled ``GLP-1, Exendin-4, Peptide Analogs and Uses Thereof'' (HHS Ref. No. E-049-2001/0-AU-04); Australian Patent No. 2008202893, issued April 26, 2012, entitled ``GLP-1, Exendin-4, Peptide Analogs and Uses Thereof'' (HHS Ref. No. E-049-2001/0-AU-10); Australian Patent Application No. 2012202081, filed April 11, 2012, entitled ``GLP-1, Exendin-4, Peptide Analogs and Uses Thereof'' (HHS Ref. No. E-049-2001/0-AU-20); Canadian Patent Application No. 2455963, filed January 29, 2004, entitled ``GLP-1, Exendin-4, Peptide Analogs and Uses Thereof'' (HHS Ref. No. E-049-2001/0-CA-05); European Patent No. 1411968, issued September 17, 2008, entitled ``GLP-1, Exendin-4, Peptide Analogs and Uses Thereof'' (HHS Ref. No. E-049-2001/0-EP-06) and validated in Germany (HHS Ref. No. E-049-2001/0-DE-11), France (HHS Ref. No. E-049-2001/0-FR-12), and Great Britain (HHS Ref. No. E-049- 2001/0-GB-13); European Patent No. 2022505, issued December 14, 2011, entitled ``GLP-1, Exendin-4, Peptide Analogs and Uses Thereof'' (HHS Ref. No. E-049-2001/0-EP-09) and validated in Germany (HHS Ref. No. E- 049-2001/0-DE-17), France (HHS Ref. No. E-049-2001/0-FR-18), and Great Britain (HHS Ref. No. E-049-2001/0-GB-19); European Patent Application No. 10177860.3, filed September 21, 2010, entitled ``GLP-1, Exendin-4, Peptide Analogs and Uses Thereof'' (HHS Ref. No. E-049-2001/0-EP-16); Indian Patent Application No. 0488/DELNP/2004, filed February 27, 2004, entitled ``GLP-1, Exendin-4, Peptide Analogs and Uses Thereof'' (HHS Ref. No. E-049-2001/0-IN-07); Japanese Patent Application No. 2003- 517083, filed February 2, 2004, entitled ``GLP-1, Exendin-4, Peptide Analogs and Uses Thereof'' (HHS Ref. No. E-049-2001/0-JP-08); Japanese Patent Application No. 2009-262568, filed November 18, 2009, entitled ``GLP-1, Exendin-4, Peptide Analogs and Uses Thereof'' (HHS Ref. No. E- 049-2001/0-JP-15; and Japanese Patent Application No. 2013-007743, filed January 18, 2013, entitled ``GLP-1, Exendin-4, Peptide Analogs and Uses Thereof'' (HHS Ref. No. E-049-2001/0-JP-22). The patent rights in these inventions have been assigned to the Government of the United States of America. The territory of the prospective Exclusive Patent License may be worldwide, and the field of use may be limited to ``Methods of using exenatide for the treatment of neurodegenerative disease in humans.''

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``The Applicability of Good Laboratory Practice in Premarket Device Submissions: Questions & Answers.'' This draft guidance answers commonly asked questions about the applicability of good laboratory practice (GLP) to nonclinical laboratory studies conducted in support of research and marketing applications for medical devices. This draft guidance is not final nor is it in effect at this time.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers.'' This draft guidance clarifies stability testing recommendations for abbreviated new drug applications (ANDAs) by providing responses to public comments in a questions-and-answers format. This draft guidance addresses public comments regarding FDA's recommendation to generic drug manufacturers to follow International Conference on Hamonisation (ICH) stability guidances Q1A (R2) through Q1E.

The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public on imaging tests for the diagnosis and staging of pancreatic adenocarcinoma. Scientific information is being solicited to inform our review of Imaging Tests for the Diagnosis and Staging of Pancreatic Adenocarcinoma, which is currently being conducted by the Evidence- based Practice Centers for the AHRQ Effective Health Care Program. Access to published and unpublished pertinent scientific information on imaging tests for the diagnosis and staging of pancreatic adenocarcinoma will improve the quality of this review. AHRQ is conducting this comparative effectiveness review pursuant to Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Public Law 108-173, and Section 902(a) of the Public Health Service Act, 42 U.S.C. 299a(a).

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: ``Pilot Test of an Emergency Department Discharge Tool.'' In accordance with the Paperwork Reduction Act of 1995, 44 U.S.C. 3506(c)(2)(A), AHRQ invites the public to comment on this proposed information collection.

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed.'' The guidance announced in this notice is intended to assist institutional review boards (IRBs), clinical investigators, and sponsors involved in clinical investigations of FDA-regulated products in fulfilling responsibilities related to reviewing the qualifications of investigators and adequacy of research sites, and determining whether an investigational new drug (IND) application or investigational device exemption (IDE) is required, to protect the rights and welfare of human subjects involved in biomedical research.

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the National Vaccine Advisory Committee (NVAC) will hold a meeting. The meeting is open to the public. Pre-registration is required for both public attendance and comment. Individuals who wish to attend the meeting and/or participate in the public comment session should register at https://www.hhs.gov/nvpo/nvac, email nvpo@hhs.gov, or call 202-690-5566 and provide name, organization, and email address.

Behavioral health disorders are common in the United States. Approximately 20% of adults and 13% of adolescents suffer from mental disorders each year and 8.7% of Americans aged 12 and older experience substance dependence or abuse each year.1 2 Rates of mental health problems are significantly higher for patients with chronic conditions such as diabetes, asthma, and heart conditions \3\ and failure to treat both physical and mental health conditions results in poorer health outcomes and higher health care costs.\3\ Yet despite the high personal and societal burden of these disorders fewer than half of adults and only one-third of children with mental disorders and only 11 percent of individuals with substance use disorders receive treatment.1 2 For many individuals this results from limited access to care, for others it is a result of reservations about accessing specialty care.