Department of Health and Human Services 2008 – Federal Register Recent Federal Regulation Documents

This notice sets forth the Secretary's proposal to require Hospital Preparedness Program (HPP) cooperative agreement recipients to contribute non-federal matching funds starting with the FY 2009 funding cycle and each year thereafter. The amount of the cost sharing requirement in FY 2009 will be five percent of the award amount and in FY 2010 and each year thereafter the amount of match will be ten percent of the award amount.

The Food and Drug Administration (FDA) has determined the regulatory review period for TYZEKA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submissions of applications to the Director of Patents and Trademarks, Department of Commerce, for the extension of patents which claim that human drug product.

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the following public meeting: ``Partnerships to Advance the National Occupational Research Agenda (NORA)''. Public Meeting Time and Date: 9 a.m.-3 p.m. EDT, June 19, 2008. Place: Patriots Plaza, 395 E Street, SW., Conference Room 9000, Washington, DC 20201. Purpose of Meeting: The National Occupational Research Agenda (NORA) has been structured to engage partners with each other and/or with NIOSH to advance NORA priorities. The NORA Liaison Committee continues to be an opportunity for representatives from organizations with national scope to learn about NORA progress and to suggest possible partnerships based on their organization's mission and contacts. This opportunity is now structured as a public meeting via the Internet to attract participation by a larger number of organizations and to further enhance the success of NORA. Some of the types of organizations of national scope that are especially encouraged to participate are employers, unions, trade associations, labor associations, professional associations, and foundations. Others are welcome. This meeting will include updates from NIOSH leadership on NORA as well as updates from approximately half of the Sector Councils on their progress, priorities, and implementation plans to date, including the Construction Sector, Manufacturing Sector, Services Sector, Public Safety Sub-Sector, and Wholesale and Retail Trade Sector. After each update, there will be time to discuss partnership opportunities. Status: The meeting is open to the public, limited only by the capacities of the conference call and conference room facilities. There is limited space available in the meeting room (capacity 34). Therefore, information to allow participation in the meeting through the Internet (to see the slides) and a teleconference call (capacity 50) will be provided to registered participants. Participants are encouraged to consider attending by this method. Each participant is requested to register for the free meeting by sending an e-mail to noracoordinator@cdc.gov containing the participant's name, organization name, contact phone number on the day of the meeting, and preference for participation by Web meeting (requirements include: computer, Internet connection, and phone, preferably with ``mute'' capability) or in person. An e-mail confirming registration will include the details needed to participate in the web meeting. Non-US citizens are encouraged to participate in the web meeting. Non-US citizens registering to attend in person after June 2 will not have time to comply with security procedures. Background: NORA is a partnership program to stimulate innovative research in occupational safety and health leading to improved workplace practices. Unveiled in 1996, NORA has become a research framework for the nation. Diverse parties collaborate to identify the most critical issues in workplace safety and health. Partners then work together to develop goals and objectives for addressing those needs and to move the research results into practice. The NIOSH role is facilitator of the process. For more information about NORA, see http:/ /www.cdc.gov/niosh/nora/about.html. Since 2006, NORA has been structured by industrial sectors. Eight sector groups have been defined using the North American Industrial Classification System (NAICS). After receiving public input through the web and town hall meetings, NORA Sector Councils have been working to define sector-specific strategic plans for conducting research and moving the results into widespread practice. During 2008, most of these Councils will post draft strategic plans for public comment. For more information, see the link above and choose ``Sector-based Approach,'' ``NORA Sector Councils'' and ``Comment on Draft Sector Agendas'' from the right-side menu. Contact Person for Technical Information: Sidney C. Soderholm, PhD, NORA Coordinator, e-mail noracoordinator@cdc.gov, telephone (202) 245- 0665.

The Food and Drug Administration (FDA) has determined the regulatory review period for AVASTIN and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human biological product.

The Food and Drug Administration (FDA) has determined the regulatory review period for INVEGA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.

This notice announces the meeting date for the 22nd meeting of the American Health Information Community in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.) The American Health Information Community will advise the Secretary and recommend specific actions to achieve a common interoperability framework for health information technology (IT). Meeting Date: June 3, 2008, from 8:30 a.m. to 2 p.m. (Eastern).

The Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) of the Food and Drug Administration (FDA) are announcing a public technical meeting in preparation for a pilot program to enable pharmaceutical firms to evaluate proposed propriety names and submit the data generated from those evaluations to FDA for review. The purpose of the public technical meeting is to discuss a concept paper that describes the logistics of the pilot program, proposed recommendations for carrying out a proprietary name review, and the way FDA intends to review submissions made under the pilot program. FDA plans to formally issue the concept paper by the end of fiscal year (FY) 2008 and expects to begin enrollment in the pilot program in FY 2009.

The Food and Drug Administration (FDA) has determined the regulatory review period for OMNARIS and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.

This final rule updates the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs). We are also consolidating the annual July 1 update for payment rates and the October 1 update for Medicare severity long-term care diagnosis-related group (MS-LTC-DRG) weights to a single rulemaking cycle that coincides with the Federal fiscal year (FFY). In addition, we are clarifying various policy issues. This final rule also finalizes the provisions from the Electronic Submission of Cost Reports: Revision to Effective Date of Cost Reporting Period interim final rule with comment period that was published in the May 27, 2005 Federal Register which revises the existing effective date by which all organ procurement organizations (OPOs), rural health clinics (RHCs), Federally qualified health centers (FQHCs), and community mental health centers (CMHCs) are required to submit their Medicare cost reports in a standardized electronic format from cost reporting periods ending on or after December 31, 2004 to cost reporting periods ending on or after March 31, 2005. This final rule does not affect the current cost reporting requirement for hospices and end-stage renal disease (ESRD) facilities. Hospices and ESRD facilities are required to continue to submit cost reports under the Medicare regulations in a standardized electronic format for cost reporting periods ending on or after December 31, 2004.

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 emergency processing under the Paperwork Reduction Act of 1995 (the PRA). The proposed collection of information concerns the requirement established by the Food and Drug Administration Amendments Act of 2007 (FDAAA), that device establishments must submit registration and listing information by electronic means using FDA Form 3673, unless the Secretary of Health and Human Services (the Secretary) grants them a waiver from the electronic submission requirement.

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Administrative Procedures for CLIA Categorization.'' The guidance describes FDA's current practices concerning the administrative aspects of categorizing commercially available in vitro diagnostic tests under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). The guidance discusses what manufacturers should submit to help expedite CLIA categorization by FDA.

This proposed rule would update the payment rates used under the prospective payment system (PPS) for skilled nursing facilities (SNFs), for fiscal year (FY) 2009. In addition, it would recalibrate the case-mix indexes so that they more accurately reflect parity in expenditures related to the implementation of case-mix refinements in January 2006. It also discusses our ongoing analysis of nursing home staff time measurement data collected in the Staff Time and Resource Intensity Verification (STRIVE) project. Finally, the proposed rule would make technical corrections in the regulations text with respect to Medicare bad debt payments to SNFs and the reference to the definition of urban and rural as applied to SNFs.

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 invention embodied in U.S. Patent Application Number 11/895,326, filed August 24, 2007, entitled ``Tumor Markers in Ovarian Cancer'' [E-138-2000/0-US-05]; to Morphotek, Incorporated, having a place of business at Exton, PA. 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 antibodies developed by Licensee's proprietary Human MORPHODOMA[supreg] antibody technology or via humanization for anti-claudin-3 antibody therapeutics for ovarian cancer.

Notice is hereby given that the Office of Research Integrity (ORI) and the Assistant Secretary for Health have taken final action in the following case: Lois Bartsch, Ph.D., University of Nebraska Medical Center: Based on the report of an investigation conducted by the University of Nebraska Medical Center (UNMC) and additional analysis conducted by the Office of Research Integrity (ORI) during its oversight review, the U.S. Public Health Service (PHS) found that Lois Bartsch, Ph.D., former postdoctoral research trainee, Department of Genetics, Cell Biology, and Anatomy, UNMC, engaged in scientific misconduct in research supported by National Cancer Institute (NCI), National Institutes of Health (NIH), grants P30 CA36727 and R01 CA77876 and National Center for Research Resources (NCRR), NIH, grant P20 RR016469. Specifically, PHS found that Dr. Bartsch: Falsified DNA sequence files by deleting a nucleotide and changing nucleotide designations and reported the altered file as the ACI rat p16Cdkn2a sequence with a CpG dinucleotide polymorphism in the upstream region to GenBank, in grant application CA118151, and in the poster presented to Cold Spring Harbor Laboratory (CSHL); Fabricated the claim in grant application CA118151 that GenBank entries for the human p16Cdkn2a gene had a CpG polymorphism near the transcription start site; Falsified the differential methylation of CpG dinucleotides near the transcription start site of p16Cdkn2a DNA and reported that tumor tissue was more methylated than normal tissue in ACI rats treated with estrogen and that the ACI allele was more methylated than the BN allele in tumor tissue from (BN x ACI)F1 animals treated with estrogen in grant application CA118151. Dr. Bartsch has entered into a Voluntary Exclusion Agreement (Agreement) in which she neither admits nor denies ORI's finding of scientific misconduct; the settlement is not an admission of liability on the part of the respondent. In accordance with the terms of the Agreement, she has voluntarily agreed, beginning on April 15, 2008: (1) To exclude herself from any contracting or subcontracting with any agency of the United States Government and from eligibility or involvement in nonprocurement programs of the United States Government referred to as ``covered transactions'' pursuant to HHS' Implementation (2 CFR Part 376 et seq.) of OMB Guidelines to Agencies on Government- wide Debarment and Suspension (2 CFR Part 180) for a period of two (2) years; and (2) To exclude herself permanently from serving in any advisory capacity to PHS, including but not limited to service on any PHS advisory committee, board, and/or peer review committee, or as a consultant or contractor to PHS for a period of three (3) years.

The Food and Drug Administration (FDA) is announcing the availability for public comment of the draft drug safety 5-year plan entitled ``Prescription Drug User Fee Act (PDUFA) IV Drug Safety Five- Year Plan.'' This plan is intended to communicate FDA's strategy for meeting the commitments for enhancing and modernizing the drug safety system within the context of the PDUFA IV program.

The Department of Health and Human Services (HHS) notifies Federal agencies of the laboratories currently certified to meet the standards of Subpart C of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908), on September 30, 1997 (62 FR 51118), and on April 13, 2004 (69 FR 19644). A notice listing all currently certified laboratories is published in the Federal Register during the first week of each month. If any laboratory's certification is suspended or revoked, the laboratory will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end, and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at https:// www.workplace.samhsa.gov and https://www.drugfreeworkplace.gov.

The Food and Drug Administration (FDA) has determined the regulatory review period for TEKTURNA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.

The Food and Drug Administration (FDA) has determined the regulatory review period for AZILECT and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.

The Department of Health and Human Services (HHS) gives notice concerning the final effect of the HHS decision to designate a class of employees at the Lawrence Livermore National Laboratory, Livermore, California, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On March 3, 2008, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Dental and Craniofacial Research (NIDCR), 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 February 26, 2008 (Volume 73, Number 38, Page 10262) and allowed 60- days for public comment. One 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: Brain Power! The NIDA Junior Scientist Program, for grades K-5, and the companion program for Middle School, the Brain Power! Challenge. Type of Information Collection Request: This information collection request is for an extension of a previously approved OMB clearance (OMB Control number 0925-0542 that was obtained in 2005, and is requested until April 30, 2010. Need and Use of Information Collection: This is a request to evaluate the effectiveness of the Brain Power! Program's ability (1) increase children's knowledge about the biology of the brain and the neurobiology of drug addiction, (2) increase positive attitudes toward science, careers in science, science as an enjoyable endeavor, and the use of animals in research; and stimulate interest in scientific careers; and (3) engender more realistic perceptions of scientists as being from many races, ages, and genders. The secondary goals of the evaluation are to determine the Program's impact on attitudes and intentions toward drug use. NIDA's mission is to lead the Nation in bringing the power of science to bear on drug abuse and addiction. There are 2 critical components to this mission: 1. the strategic support and conduct of research across a broad range of disciplines; 2. ensuring the rapid and effective dissemination and use of the results of that research to significantly improve the prevention of drug abuse and addiction, its treatment, and policy. The Brainpower! Challenge project is one of NIDA's many dissemination projects that is anticipated to improve the prevention of drug abuse and addiction among children and youth. These dissemination and diffusion projects complement NIDA's research projects to identify, develop, and refine effective efficient methods, structures, and strategies that test models to disseminate and implement research- tested health behavior change interventions and evidence-based interventions in prevention and treatment. Secondly, from its research NIDA knows that in order for prevention efforts to be effective educational programs must involve teachers, peers, parents, and the entire community. In 1996 NIDA convened a national prevention research conference on preventing drug use among children and adolescents. From it a research-base guide was prepared to provide prevention principles that a school or community can use to implement a prevention program specifically tailored to meet each community's particular needs. And the public response to the guide is evident from the continued requests for the guidean average of about 20,000 per month, and more than 200,000 copies distributed to date. The Brainpower! Challenge project provides a tool for science education that involves teachers, peers, parents and the entire community, and adds to any prevention programs implemented in the community. Thirdly, while education for the prevention of drug abuse may be a worthy function for the Department of Education to conduct, Executive Order 12862 directs federal agencies to provide significant services directly to the public. To provide services from NIDA's research findings, the 1993 the Science Education Abuse Partnership Award Program was conceptualized to ``* * *encourage the development and evaluation of programs that foster an understanding of neuroscience and the biology of drug abuse and addiction among K-12 students * * *.'' NIDA's current Science Education Program to increase scientific literacy and interest in science careers, continues this purpose. The Brainpower! Challenge project will bring a service to the schools and to parents, for laying the foundation for drug prevention among children and youth, and to educate them in the biology and neurobiology of the brain and addiction. Its anticipated achievement will be three- foldprevention of drug abuse among youth, fostering positive attitudes towards science careers, and service provision that translates research findings into practice among a vital population group. The findings will provide valuable information concerning the goals of NIDA's Science Education Program of increasing scientific literacy and stimulating interest in scientific careers. In order to test the effectiveness of the evaluation, information will be collected from students before and after exposure to the curriculum with pre- and post-test self-report measures. Surveys will also be administered to teachers after the completion of the program to examine ease and fidelity of implementation, as well as impact in knowledge and understanding of the neurobiology of addiction. Surveys will be administered to parents to obtain parental reaction and opinion on the materials and the degree to which parents find the curriculum informative and appropriate. Frequency of Response: On occasion. Affected Public: Elementary and middle school students, teachers, and parents. Type of Respondents: Students, Teachers, and Parents. The reporting burden is as follows: Estimated Number of Respondents: 1,337; Estimated Number of Responses per Respondent: 2; Average Burden Hours Per Response: .25; Estimated Total Annual Burden Hours Requested: 640.5. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. The estimated annualized burden is summarized below.

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.

This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR Part 404.7(a)(1)(i), announces that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive license to practice the inventions embodied in 1. E-073- 1999/0-US-02, patent 6,737,511, issued May 15, 2004, entitled Receptor- Mediated Uptake of an Extracellular BCL-XL Fusion Protein Inhibits Apoptosis and 2. E-073-1999/0-US-05, patent application number 11/ 692,112 filed March 27, 2007, entitled Receptor-Mediated Uptake of an Extracellular BCL-XL Fusion Protein Inhibits Apoptosis, to Protox Therapeutics Incorporated (Protox), having a place of business in Vancouver and Victoria, Canada. 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 therapeutics for the treatment of spinal cord injury, traumatic brain injury and leukemia.

The Food and Drug Administration (FDA), in collaboration with the National Institutes of Health (NIH) and the Juvenile Diabetes Research Foundation (JDRF), is holding a public workshop focused upon the state of the art in the research and development of an artificial pancreas. The public workshop entitled ``Towards an Artificial Pancreas: A Food and Drug Administration, National Institutes of Health, and Juvenile Diabetes Research Foundation Workshop'' will provide a public forum for discussing the progress and remaining challenges in the development of closed-loop systems designed to regulate glycemic control, as an aid in the management of diabetes mellitus. It is intended to provide stakeholders with information that will accelerate the development of an artificial pancreas.

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 for public comment in response to the notice. This notice solicits comments on FDA's Pet Food Labeling Survey.

The Health Resources and Services Administration published a meeting notice for the National Advisory Council on Migrant in the Federal Register of April 2, 2008 (73 FR 17991). The meeting place has changed. Correction

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 PCT Application Serial No. PCT/US07/083027 and foreign equivalents thereof, entitled ``Smoothened Polypeptides and Methods of Use'' [HHS Ref. No. E-014-2007/0]; PCT Application Serial No. PCT/US07/083772 and foreign equivalents thereof, entitled ``Self-Assembling Nanoparticles Composed of Transmembrane Peptides and Their Application for Specific Intra- Tumor Delivery of Anti-Cancer Drugs'' [HHS Ref. No: E-256-2006/0]; and U.S. Patent No. 7,105,488, and foreign equivalents thereof, entitled ``G Protein-Coupled Receptor Antagonists'' [HHS Ref. No: E-290-1997/0] to Calidris Therapeutics which is registered in Japan. The patent rights in these inventions have been assigned to the United States of America. The prospective exclusive licensed territory may be worldwide and the field of use may be limited to peptidomimetic drugs for the treatment of cancer as claimed in the Licensed Patent Rights. These cancers may be limited to multiple myeloma, colon, lung, melanoma, liver, breast, prostate, ovarian, pancreatic cancers, ALL, AML, NHL, rhabdomyosarcoma, neuroblastoma, osteosarcoma and medulloblastoma. With respect to the GPCR technology, the exclusive license field of use may be limited to antagonists of the GPCR CXCR4.

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 Indian Health Service published a document in the Federal Register (FR) on March 31, 2008. The document contained three errors.

As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the Advisory Committee on Blood Safety and Availability (ACBSA) will hold a meeting. The meeting will be open to the public on both Thursday, May 29 and Friday, May 30, 2008.

The Food and Drug Administration (FDA) is amending its regulations on acceptance of foreign clinical studies not conducted under an investigational new drug application (IND) (non-IND foreign clinical studies) as support for an IND or application for marketing approval for a drug or biological product. The final rule replaces the requirement that these studies be conducted in accordance with ethical principles stated in the Declaration of Helsinki (Declaration) issued by the World Medical Association (WMA), specifically the 1989 version (1989 Declaration), with a requirement that the studies be conducted in accordance with good clinical practice (GCP), including review and approval by an independent ethics committee (IEC). The final rule updates the standards for the acceptance of foreign clinical studies not conducted under an IND and helps ensure the protection of human subjects and the quality and integrity of data obtained from these studies.