Department of Health and Human Services June 2012 – Federal Register Recent Federal Regulation Documents

This document corrects technical and typographical errors in the proposed rule that appeared in the May 11, 2012 Federal Register entitled ``Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Fiscal Year 2013 Rates; Hospitals' Resident Caps for Graduate Medical Education Payment Purposes; Quality Reporting Requirements for Specific Providers and for Ambulatory Surgical Centers.''

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Library of Medicine (NLM), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on April 2, 2012 (Vol. 77, No. 63, p. 19673) and allowed 60-days for public comment. A single public comment was 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. Proposed Collection: Title: Generic Clearance to Conduct Voluntary Customer/Partner Surveys; Type of Information Collection Request: Extension of currently approved collection [OMB No. 0925-0476, expiration date 06/30/2012] Form Number: NA; Need and Use of Information Collection: Executive Order 12962 directed agencies that provide significant services directly to the public to survey customers to determine the kind and quality of services they want and their level of satisfaction with existing services. Additionally, since 1994, the NLM has been a ``Federal Reinvention Laboratory'' with a goal of improving its methods of delivering information to the public. An essential strategy in accomplishing reinvention goals is the ability to periodically receive input and feedback from customers about the design and quality of the services they receive. The NLM provides significant services directly to the public including health providers, researchers, universities, other federal agencies, state and local governments, and to others through a range of mechanisms, including publications, technical assistance, and Web sites. These services are primarily focused on health and medical information dissemination activities. The purpose of this submission is to obtain OMB's generic approval to continue to conduct satisfaction surveys of NLM's customers. The NLM will use the information provided by individuals and institutions to identify strengths and weaknesses in current services and to make improvements where feasible. The ability to periodically survey NLM's customers is essential to continually update and upgrade methods of providing high quality service. Frequency of Response: Annually or biennially. Affected Public: Individuals or households; businesses or other for profit; state or local governments; Federal agencies; non-profit institutions; small businesses or organizations. Type of Respondents: Organizations, medical researchers, physicians and other health care providers, librarians, students, and the general public. The annual reporting burden is as follows:

The National Health and Nutrition Examination Survey (NHANES) will not be receiving DNA proposals in the near future. NHANES is changing its plan for making DNA available for genetic research and its proposal guidelines. NHANES will announce when it will reopen its repository for use of DNA specimens for research protocols once it has developed its new plan of operation.

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. 207 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.

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Amendment (revisions to labeling recommendations for potential risk of vCJD) to `Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products' '' dated June 2012. The draft guidance document proposes amendments to the labeling recommendations for plasma-derived products, including albumin and products containing plasma-derived albumin, in the guidance document entitled ``Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products'' dated May 2010 (2010 CJD/vCJD guidance). When finalized, the revised labeling recommendations will be incorporated into the 2010 CJD/vCJD guidance, but FDA will otherwise continue with its recommendations in the 2010 CJD/vCJD guidance as currently provided.

This notice describes the standards, criteria, and procedures we will use to evaluate an End-Stage Renal Disease (ESRD) Network Organization's capabilities to perform, and actual performance of, the duties and functions under the ESRD Network Statement of Work (SOW).

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of May 2, 2012 (77 FR 26017). The document concerned FDA's determination of the regulatory review period for KALBITOR. The document published with an incorrect patent number for KALBITOR. This document corrects that error.

Environmental and public health are closely related and complementary fieldsand their future depends on a closer understanding of those connections. New portable sensors have the potential to transform the way we measure and interpret the influence of pollution on health. These technologies can provide a picture that is more detailed and more personal, with dramatic implications for health care, air quality oversight, and individuals' control over their own environments and health. The U.S. Environmental Protection Agency (EPA) and U.S. Department of Health and Human Service (HHS) [National Institute of Environmental Health Sciences (NIEHS) and Office of the National Coordinator for Health Information Technology (ONC)] envision a future in which powerful, affordable, and portable sensors provide a rich awareness of environmental quality, moment-to-moment physiological changes, and long-term health outcomes. Health care will be connected to the whole environment, improving diagnosis, treatment, and prevention at all levels. Many of the first steps toward this future have already been taken. Prototype projects have developed portable air quality and physiologic sensors, and experimental analysis tools for handling data that is higher quantity, but often lower quality, than more traditional monitoring techniques. The ``My Air, My Health Challenge'' aims to build on this foundation. We are seeking solutions that integrate data from portable physiological and air quality monitors, producing a combined picture that is meaningful and usable. The statutory authority for this challenge competition is Section 105 of the America COMPETES Reauthorization Act of 2010 (Pub. L. 111-358) and section 103 of the Clean Air Act, 42 U.S.C. 7403. This challenge addresses the mission of the NIEHS to conduct and support programs with respect to factors in the environment that affect human health, directly or indirectly. 42 U.S.C. 285.

The Health Resources and Services Administration (HRSA) will be issuing a non-competitive supplement and a 7-month extension of the period of support to the Frontier Extended Stay Clinic (FESC) Cooperative Agreement recipient of record, SouthEast Alaska Regional Health Consortium (Grant Number U17RH23237). The FESC Cooperative Agreement helps to examine the effectiveness and appropriateness of a new type of provider, FESC, in providing health care services in remote areas. The 7-month extension with funds will align with the related three-year Centers for Medicare and Medicaid Services (CMS) demonstration, which will run until March 2013.