Department of Health and Human Services January 2011 – Federal Register Recent Federal Regulation Documents

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Cancer Institute (NCI), 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 15, 2010 (75 FR 69681) 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. Proposed Collection: Title: California Health Interview Survey Cancer Control Module (CHIS-CCM) 2011. Type of Information Collection Request: Revision. Need and Use of Information Collection: The NCI has sponsored four Cancer Control Modules in the California Health Interview Survey (CHIS), and will be sponsoring a sixth to be administered in 2011. CHIS is a telephone survey that collects population-based, standardized health-related data to assess California's progress in meeting Healthy People 2010 objectives for the nation and the State. The CHIS sample is designed to provide statistically reliable estimates statewide, for California counties, and for California's ethnically and racially diverse population. Initiated by the UCLA Center for Health Policy Research, the California Department of Health Services, and the California Public Health Institute, the survey is funded by a number of public and private sources. It was first administered in 2001 to 55,428 adults and subsequently in 2003 to 42,043 adults, in 2005 to 43,020 adults, and in 2007 to 48,150 adults. These adults are a representative sample of California's non-institutionalized population living in households. CHIS 2011 is planned for continual administration to 48,000 adult Californians. This study will allow NCI to examine patterns and trends in cancer screening and follow-up, as well as to study other cancer- related topics such as tobacco control, diet, physical activity, obesity, and human papillomavirus. Additionally, CHIS is designed to be comparable to the National Health Interview Survey (NHIS) data in order to conduct comparative analyses. CHIS provides enhanced estimates for cancer risk factors and screening among racial/ethnic minority populations. Frequency of Response: Once. Affected public: Individuals. Types of Respondents: U.S. adults and adolescents (persons 12 years of age and older). The total annual burden hours requested are 2,177 (see Table 1). There are no Capital Costs, Operating Costs, and/or Maintenance Costs to report.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection provisions of FDA's recordkeeping and records access requirements for food facilities.

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in U.S. Provisional Patent Application No. 61/083,000, filed July 23, 2008 [HHS Ref. No. E-202-2008/0-US-01], now expired and PCT Patent Application No. PCT/US09/50637 [HHS Ref. No. E-202-2008/0-PCT-02] filed July 15, 2009, which published as WO/2010/011537 on January 28, 2010, both applications entitled ``Inhibitors of the Plasmodial Surface Anion Channel As Antimalarials,'' and all continuing applications and foreign counterparts to Microbiotix, Inc., having a place of business in Worcester, Massachusetts. The patent rights in these inventions have been assigned to the United States of America. The prospective exclusive license territory may be ``worldwide'', and the field of use may be limited to ``prevention and treatment of malaria in humans.''

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 Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Current Good Manufacturing Practice Quality System Regulation'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

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: ``Questionnaire and Data Collection Testing, Evaluation, and Research for the Agency for Healthcare Research and Quality.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3520, AHIRQ invites the public to comment on this proposed information collection.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute on Drug Abuse, the National Institutes of Health 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 in Vol. 75 No. 144, pages 44265-44266, on July 28, 2010 and allowed 60 days for public comment. One public comment was received on the instruments outlined in the 60- day notice. A response to this request was sent to the interested party. The purpose of this notice is to allow an additional 30 days for public comment. 5 CFR 1320.5 (General requirements) Reporting and Recordkeeping Requirements: Final Rule requires that the agency inform the potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number. Proposed Collection: Title: Online Skills Training for PCPs on Substance Abuse. Type of Information Collection Request: New. Need and Use of Information Collection: This research will evaluate the effectiveness of the Online Skills Training for PCPs on Substance Abuse, via the Web site SBIRTTraining.com, to positively impact the knowledge, attitudes, intended behaviors and clinical skills of primary care physicians in the U.S. who treat substance abuse patients. The Online Skills Training for PCPs on Substance Abuse is a new program developed with funding from the National Institute on Drug Abuse. The primary goal is to assess the impact of the training program on knowledge, attitude, intended behavior, and clinical skills. A secondary goal is to assess learner satisfaction with the program. If the program is a success, there will be a new, proven resource available to primary care physicians to improve their ability to assess and treat substance use disorders. In order to evaluate the effectiveness of the program, information will be collected from primary care physicians before exposure to the Web based materials (pre-test), after exposure to the Web based materials (post-test), and 4-6 weeks after the program has been completed (follow-up). Frequency of Response: On occasion. Affected Public: Primary care physicians who treat patients who have substance abuse. Type of Respondents: Physicians. The annual reporting burden is as follows: Estimated Number of Respondents: 80. Estimated Number of Responses per Respondent: 3. Average Burden Hours per Response: 0.75. Estimated Total Annual Burden Hours Requested: 180. The annualized cost to respondents is estimated at: $13,500. There are no Capital Costs, Operating Costs, and/or Maintenance Costs to report.

The Food and Drug Administration (FDA) is announcing the opening of a public docket to provide a forum to facilitate communication regarding the conduct of clinical trials needed to verify and describe the clinical benefit of midodrine hydrochloride (HCl) when used to treat symptomatic orthostatic hypotension.

The Administration for Native Americans (ANA) is issuing final interpretive rules, general statements of policy and rules of agency organization, procedure, or practice relating to the following Funding Opportunity Announcements (FOAs): Social and Economic Development Strategies (SEDS), Social and Economic Development StrategiesTribal Governance (SEDSTG), Social and Economic Development Strategies Assets for Independence (SEDSAFI), Native Language Preservation and Maintenance (Language P&M), Native Language Preservation and MaintenanceEsther Martinez Initiative (LanguageEMI), and Environmental Regulatory Enhancement (ERE). This notice also provides information about how ANA will administer these programs.

This notice announces and informs the public of the revised Head Start Child Outcomes Framework, renamed The Head Start Child Development and Learning Framework: Promoting Positive Outcomes in Early Childhood Programs Serving Children 3-5 Years Old. The Framework was revised to give more prominence to the information part of the initial document. The revisions do not create new requirements on Head Start and delegate agencies. The revised Framework continues to identify the developmental outcomes that Head Start and delegate agencies have been responsible for addressing in their Head Start preschool programs serving 3 to 5 year old children since the original was published in 2000.

This amendment rescinds the addition and definition of voluntary advance care planning as a specified element of the annual wellness visit that was finalized in the ``Medicare Program; Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2011'' that appeared in the November 29, 2010 Federal Register.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic.'' The draft guidance discusses FDA's intended approach to enforcement of adverse event reporting requirements for drugs, biologics, medical devices, and dietary supplements during an influenza pandemic. The agency makes recommendations to industry for focusing limited resources on reports related to products indicated for the prevention and treatment of influenza and other specific types of reports indicated in the draft guidance. This draft guidance is a revision of the draft guidance for industry of the same title published on December 16, 2008.

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 Food and Drug Administration (FDA) is announcing a public workshop entitled ``Determination of System Attributes for the Tracking and Tracing of Prescription Drugs.'' This public workshop is intended to provide a forum for discussing potential approaches toward a track and trace system and obtaining input from supply chain partners on attributes and standards for the identification, authentication, and tracking and tracing of prescription drug packages, and to further the Agency's goal of protecting public health by securing the drug supply chain against the introduction of counterfeit and other substandard drugs.

The Food and Drug Administration (FDA) is announcing that all outstanding hearing requests pertaining to Docket Nos. 81N-0391, 82N- 0078, and 82N-0311 have been withdrawn and therefore, shipment in interstate commerce of the products identified in those dockets, or any identical, related, or similar product that is not the subject of an approved new drug application (other than an over-the-counter (OTC) product that complies with an applicable OTC monograph), is unlawful as of the effective date of this notice. FDA is also offering an opportunity to affirm outstanding hearing requests in Docket Nos. 81N- 0393, 81N-0396, 82N-0095, 82N-0096, and 83N-0095. FDA will assume that companies with outstanding hearing requests that do not respond to this notice are no longer interested in pursuing their requests, and will deem the requests withdrawn.

This final rule establishes a permanent certification program for the purpose of certifying health information technology (HIT). This final rule is issued pursuant to the authority granted to the National Coordinator for Health Information Technology (the National Coordinator) by section 3001(c)(5) of the Public Health Service Act (PHSA), as added by the Health Information Technology for Economic and Clinical Health (HITECH) Act. The permanent certification program will eventually replace the temporary certification program that was previously established by a final rule. The National Coordinator will use the permanent certification program to authorize organizations to certify electronic health record (EHR) technology, such as Complete EHRs and/or EHR Modules. The permanent certification program could also be expanded to include the certification of other types of HIT.

The Food and Drug Administration (FDA) is issuing this proposed rule to establish procedures for requesting an exemption from the substantial equivalence requirements of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). The proposed rule would describe the process and statutory criteria for requesting an exemption and explain how FDA would review requests for exemptions. Once finalized, this regulation will satisfy the requirement in the Tobacco Control Act that FDA issue regulations implementing the exemption provision.

This notice announces a forthcoming meeting of a public advisory committee of the Administration for Children and Families (ACF). The meeting will be open to the public. Name of Committee: Advisory Committee for Head Start Research and Evaluation. General Function of Committee: The Advisory Committee for Head Start Research and Evaluation will provide feedback on the published final report for the Head Start Impact Study, offering interpretations of the findings, discussing implications for practice and policy, and providing recommendations on follow-up research, including additional analysis of the Head Start Impact Study data. The Committee will also be asked to provide recommendations to the Secretary regarding how to improve Head Start and other early childhood programs by enhancing the use of research-informed practices in early childhood. Finally, the Committee will be asked to provide recommendations on the overall Head Start research agenda, includingbut not limited tohow the Head Start Impact Study fits within this agenda. The Committee will provide advice regarding future research efforts to inform HHS about how to guide the development and implementation of best practices in Head Start and other early childhood programs around the country.

This notice announces public meetings of the Technical Advisory Panel on Medicare Trustee Reports (Panel). Notice of these meetings is given under the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)(1) and (a)(2)). The Panel will discuss the long- term rate of change in health spending and may make recommendations to the Medicare Trustees on how the Trustees might more accurately estimate health spending in the long run. The Panel's discussion is expected to be very technical in nature and will focus on the actuarial and economic assumptions and methods by which Trustees might more accurately measure health spending. Although panelists are not limited in the topics they may discuss, the Panel is not expected to discuss or recommend changes in current or future Medicare provider payment rates or coverage policy. Meeting Dates: January 10, 2011, 9 a.m. to 6 p.m. and January 28, 2011, 9:30 a.m.-5 p.m. e.t.

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Antibodies to Borrelia burgdorferi.'' FDA is issuing this draft guidance to provide industry and agency staff with recommendations for studies to establish the analytical and clinical performance of in vitro diagnostic devices (IVDs) intended for the detection of antibodies to Borrelia burgdorferi. These devices are used to aid in the diagnosis of Lyme disease. This draft guidance is not final nor is it in effect at this time.

This final rule will implement a quality incentive program (QIP) for Medicare outpatient end-stage renal disease (ESRD) dialysis providers and facilities with payment consequences beginning January 1, 2012, in accordance with section 1881(h) of the Act (added on July 15, 2008 by section 153(c) of the Medicare Improvements for Patients and Providers Act (MIPPA)). Under the ESRD QIP, ESRD payments made to dialysis providers and facilities under section 1881(b)(14) of the Social Security Act will be reduced by up to two percent if the providers/facilities fail to meet or exceed a total performance score with respect to performance standards established with respect to certain specified measures.

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

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Petition to Request an Exemption From 100 Percent Identity Testing of Dietary Ingredients; Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

HRSA will be issuing non-competitive supplemental grant funding to the University of Wisconsin, Laboratory of Hygiene, Madison, Wisconsin, under the Maternal Child and Health Bureau's Blood Lead Proficiency Testing Program. The University of Wisconsin will use these funds to initiate an orderly closeout of HRSA-funded activities which clearly fall within the purview of the Centers for Disease Control and Prevention's ``Preventing Lead Poisoning in Young Children'' initiative at their National Center for Environmental Health. This action will also accord the University of Wisconsin and the Center additional time to solicit recommendations from the CDC's Advisory Committee on Childhood Lead Poisoning Prevention with respect to future funding for this activity. The Maternal and Child Health Bureau (MCHB) has continuously supported the National Blood Lead and Erythrocyte Protoprophyrin (EP) Proficiency Testing Program through the University of Wisconsin since 1988. Childhood lead poisoning is a well-characterized public health problem in the U.S., and is unfortunately over-represented in minority, immigrant, and low socio-economic populations. The proper detection and treatment of lead poisoning relies entirely on the accurate and precise measurement of blood lead concentration. EP is utilized as an adjunct test to indicate the extent and duration of lead exposure, as well as the detection of iron deficiency, another pediatric health issue. Proficiency testing (PT) is a proven method for assuring and improving laboratory test accuracy. This program has cost-effectively provided monthly PT and other lab quality improvement tools to nearly 600 laboratories across the U.S. and beyond. Of note, the primary focus of the program over the last few years has been the integration of new and usually inexperienced participants into the program. An enrollment boom has been fueled by proliferation of the CLIA-waived LeadCare II point of care testing instrument. In the three years since its introduction, LeadCare II enrollment has grown from zero to 300 laboratories, comprising approximately 40 percent of all participants. Continued participation increases, and the fact that those increases are nearly totally comprised of LeadCare II users, represent both a public health success and a challenge for this program. Since its introduction in early 2007, over 300 of these laboratories have enrolled for PT, swelling program participation to 800 laboratories.

This notice announces the final Federal share disproportionate share hospital (DSH) allotments for Federal FY (FY) 2009 and the preliminary Federal share DSH allotments for FY 2011. This notice also announces the final FY 2009 and the preliminary FY 2011 limitations on aggregate DSH payments that States may make to institutions for mental disease and other mental health facilities. In addition, this notice includes background information describing the methodology for determining the amounts of States' FY DSH allotments.