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

In accordance with the requirements of the Privacy Act of 1974, CMS is proposing to make minor amendments to an existing system of records (SOR) titled, ``Performance Measurement and Reporting System (PMRS),'' System No. 09-70-0584, published at 72 FR 52133 (September 12, 2007). PMRS serves as a master system of records to assist in projects that provide transparency in health care on a broad scale enabling consumers to compare the quality and price of health care services so that they can make informed choices among individual physicians, practitioners, and other providers of services. We are making minor amendments to PMRS to include two additional legal authorities: The Medicare, Medicaid, and SCHIP Extension Act of 2007 (MMSEA) (Pub. L. 110-173) and the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (Pub. L. 110-275). Section 101(b) of the MMSEA amended section 1848(k)(2)(B) of the Social Security Act (the Act) (42 U.S.C. 1395w-4) and section 101(c) of division B of the Tax Relief and Health Care Act of 2006 to extend the Physician Quality Reporting Initiative (PQRI). MIPPA, effective July 15, 2008, extended the PQRI for 2010 and subsequent years and authorized a new incentive program for successful electronic prescribers under section 1848(m)(2) of the Act. In addition, the MIPPA requires the Secretary to post on the CMS Web site the names of eligible professionals or group practices who satisfactorily submit data on quality measures through PQRI and the names of those eligible professionals or group practices who are successful electronic prescribers. This requirement is codified at section 1848(m)(5)(G) of the Act. Accordingly, CMS is adding Sec. Sec. 131 and 132 of MIPPA, Sec. 101 of MMSEA, Sec. 1848(k) of the Act, and Sec. 1848(m) of the Act to the PMRS' legal authority section. In addition, we are clarifying in this notice that the term, ``performance measurement results'' used in the PMRS includes, but is not limited to, submission of data on measures, e-prescribing usage, frequency of reporting or performance, as well as rates or scores based on application of specific measures. We consider all of these types of information to be valid indicators of a physician's, practitioner's, or other provider's commitment to and delivery of high quality, high value health care. The primary purpose of this system is to support the collection, maintenance, and processing of information to promote the delivery of high quality, efficient, effective, and economical health care services, and promoting the quality and efficiency of services of the type for which payment may be made under title XVIII by allowing for the establishment and implementation of performance measures, the provision of feedback to physicians, and public reporting of performance information. Information in this system will also be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed for the Agency or by a contractor, consultant, or a CMS grantee; (2) assist another Federal and/or state agency, agency of a state government, or an agency established by state law; (3) promote more informed choices by Medicare beneficiaries among their Medicare group options by making physician performance measurement information available to Medicare beneficiaries through a Web site and other forms of data dissemination; (4) provide CVEs and data aggregators with information that will assist in generating single or multi-payer performance measurement results to promote transparency in health care to members of their community; (5) assist individual physicians, practitioners, providers of services, suppliers, laboratories, and other health care professionals who are participating in health care transparency projects; (6) assist individuals or organizations with projects that provide transparency in health care on a broad scale enabling consumers to compare the quality and price of health care services; or for research, evaluation, and epidemiological projects related to the prevention of disease or disability; restoration or maintenance of health or for payment purposes; (7) assist Quality Improvement Organizations; (8) support litigation involving the agency; and (9) and (10) combat fraud, waste, and abuse in certain health benefits programs. We have provided background information about this modified system in the Supplementary Information section below

This document corrects several technical and typographical errors in the final rule with comment period that appeared in the November 19, 2008 Federal Register entitled ``Medicare Program; Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2009; E-Prescribing Exemption for Computer-Generated Facsimile Transmissions; and Payment for Certain Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS); Final Rule'' (73 FR 69726).

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: ``The AHRQ Data Inventory.'' 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. This proposed information collection was previously published in the Federal Register on October 24th, 2008 and allowed 60 days for public comment. One comment was received. The purpose of this notice is to allow an additional 30 days for public comment.

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. Due to an administrative error, this document is being republished.

This document corrects errors that appeared in the correction notice published in the October 3, 2008 Federal Register entitled ``Medicare Program; Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2009 Rates; Payments for Graduate Medical Education in Certain Emergency Situations; Changes to Disclosure of Physician Ownership in Hospitals and Physician Self- Referral Rules; Updates to the Long-Term Care Prospective Payment System; Updates to Certain IPPS-Excluded Hospitals; and Collection of Information Regarding Financial Relationships Between Hospitals; Correction.''

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: The Women's Health Initiative (WHI) Observational Study. Type of Information Collection Request: Revision OMB 0925-0414. Need and Use of Information Collection: This study will be used by the NIH to evaluate risk factors for chronic disease among older women by developing and following a large cohort of postmenopausal women and relating subsequent disease development to baseline assessments of historical, physical, psychosocial, and physiologic characteristics. In addition, the observational study will complement the clinical trial (which has received clinical exemption) and provide additional information on the common causes of frailty, disability and death for postmenopausal women, namely, coronary heart disease, breast and colorectal cancer, and osteoporotic fractures. Continuation of follow-up for ascertainment of medical history update forms will provide essential data for outcomes assessment for this population of aging women. Frequency of Response: Annually. Affected Public: Individuals or households and health care providers. Type of Respondents: Individuals or households; health care providers. The annual reporting burden is as follows:

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 reporting requirements for filing a notice of participation with FDA.

This notice announces an administrative hearing to be held on January 27, 2009, at the CMS Denver Regional Office, 1600 Broadway, Suite 700, Denver, Colorado 80202 to reconsider CMS' decision to disapprove Montana SPA 08-003. Closing Date: Requests to participate in the hearing as a party must be received by the presiding officer by January 13, 2009.

The Office of Global Health Affairs within the U.S. Department of Health and Human Services (``HHS'') is issuing this final rule to clarify that recipients of HHS funds to implement HIV/AIDS programs and activities under the United States Leadership Against HIV/AIDS, Tuberculosis and Malaria Act of 2003 (the ``Leadership Act''), Public Law 108-25 (May 27, 2003), that are required to have a policy opposing prostitution and sex trafficking, and must submit certification of this policy with the grant or contract application, may, consistent with this policy requirement, maintain an affiliation with organizations that do not have such a policy, provided such affiliations do not threaten the integrity of the government's programs and its message opposing prostitution and sex trafficking. The rule describes the separation that must exist between a recipient of HHS HIV/AIDS funds that has a policy opposing prostitution and sex trafficking, as required under section 301(f) of the Leadership Act, 22 U.S.C. 7631(f), and another organization that engages in activities that are not consistent with a policy opposing prostitution and sex trafficking.

The Food and Drug Administration's (FDA's) Center for Biologics Evaluation and Research (CBER) is reannouncing the invitation for participation in its Regulatory Site Visit Training Program (RSVP). This training program is intended to give CBER regulatory review, compliance, and other relevant staff an opportunity to visit biologics facilities. These visits are intended to allow CBER staff to directly observe routine manufacturing practices and to give CBER staff a better understanding of the biologics industry, including its challenges and operations. The purpose of this notice is to invite biologics facilities to contact CBER for more information if they are interested in participating in this program.

The Administration for Native Americans (ANA) herein issues final interpretive rules, general statements of policy and rules of agency organization, procedure or practice relating to the Social and Economic Development Strategies (hereinafter referred to as SEDS), Social and Economic Development Strategies for Alaska (hereinafter referred to as SEDS-AK), Native Language Preservation and Maintenance Assessment (hereinafter referred to as Native Language Assessment), Native Language Preservation and Maintenance Planning (hereinafter referred to as Native Language Planning), Native Language Preservation and Maintenance Implementation (hereinafter referred to as Native Language Implementation), Native Language Preservation and Maintenance Immersion (hereinafter referred to as Native Language Immersion), Family PreservationImproving the Well-Being of Children Project Planning (hereinafter referred to as Family Preservation Planning), Family PreservationImproving the Well-Being of Children Project Implementation (hereinafter referred to as Family Preservation Implementation) and Environmental Regulatory Enhancement (hereinafter referred to as ERE).

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300.'' This guidance document describes a means by which male condoms made of natural rubber latex (latex condoms) may comply with the requirement of special controls for class II devices. FDA believes that the labeling recommendations contained in this guidance, in addition to general controls, will provide reasonable assurance of the safety and effectiveness of latex condoms without spermicidal lubricant. In the Federal Register of November 10, 2008 (73 FR 66522), FDA published a final rule that amended the classification regulation for condoms from class II (performance standards) to class II (special controls) and designated this guidance document as the special control for male condoms made of natural rubber latex classified under that regulation.

Declaration pursuant to section 319F-3 of the Public Health Service Act (42 U.S.C. 247d-6d) to provide targeted liability protections for pandemic influenza diagnostics, personal respiratory protection devices, and respiratory support devices based on a credible risk that an avian influenza virus spreads and evolves into a strain capable of causing a pandemic of human influenza.

This document corrects technical errors that appeared in the update notice published in the Federal Register on November 3, 2008, entitled ``Medicare Program; Home Health Prospective Payment System Rate Update for Calendar Year 2009.''

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Class II Special Controls Guidance Document: Tissue Expander.'' This draft guidance document describes a means by which the tissue expander device type may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a proposed rule to classify this device type into class II (special controls). This draft guidance is not final nor is it in effect at this time.

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the availability of the following draft document available for public comment entitled ``Preventing Deaths and Injuries of Fire Fighters When Fighting Fires in Unoccupied Structures.'' The draft document and instructions for submitting comments can be found at https://www.cdc.gov/niosh/review/public/141/. Comments may be provided to the NIOSH Docket Number above.

In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 which requires 30 days for public comment on proposed information collection projects, the Indian Health Service (IHS) 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 project was previously published in the Federal Register (73 FR 23254) on August 25, 2008 and allowed 60 days for public comment. No public comment was received in response to the notice. The purpose of this notice is to allow 30 days for public comment to be submitted directly to OMB. Proposed Collection: Title: 0917-NEW, ``Indian Health Service HIV Knowledge/Attitudes/Practice Customer Survey.'' Type of Information Collection Request: This is a one time survey to deliver the mission of the IRS and Centers for Disease Control (CDC) national guidelines collection, 0917-NEW, ``Indian Health Service HIV Knowledge/Attitudes/ Practice Customer Survey.'' Form Number(s): None. Need and Use of Information Collection: The IHS goal is to raise the health status of the American Indian and Alaska Native (AI/AN) people to the highest possible level by providing comprehensive health care and preventive health services. To support the IHS mission, the Division of Epidemiology and Disease Prevention (DEDP) and the Human Immunodeficiency Virus (HIV) Program collaborate to provide programmatic, technical, and financial assistance to IRS Areas and Service Units for improving prevention, detection, and treatment of infectious and chronic disease, specifically in this case, HIV and Sexually Transmitted Disease (STD). The ``HIV Knowledge/Attitudes/Practice Customer Survey'' (hereafter referred to as Customer Survey), will provide the information needed to understand the most effective and appropriate methods to complete these goals. With the information collected from patients, the DEDP and HIV programs will be able to offer recommendations to Service Units on how to best scale up screening for sensitive topics such as HIV and STDs in AllAN communities. Also, the information will give lETS the tools to assist the IHS Service Units with implementation of current national recommendations by CDC. At the moment, the DEDP and HIV programs are encouraging uptake of current CDC national recommendations; however, without this information, the DEDP and HIV programs are unable to maximize effectiveness, dispel myths, and identify misinformation. Voluntary customer surveys will be conducted through self- administered questionnaires, face-to-face interviews, and potentially electronic media. The information gathered will be used by DEDP and the HIV Program to identify how patients would prefer to be offered expanded testing in a way that is respectful, confidential, and effective. Affected Public: Individuals. Type of Respondents: IHS customers. The table below provides: Types of data collection instruments, estimated number of respondents, responses per respondent, average burden hour per response, and total annual burden hour(s).

Pursuant to Public Law 92-463, notice is hereby given of a meeting of the NTP Board of Scientific Counselors (NTP BSC). The NTP BSC is a federally chartered, external advisory group composed of scientists from the public and private sectors that provides primary scientific oversight to the NTP and evaluates the scientific merit of the NTP's intramural and collaborative programs.

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 requirements for medical device recall authority.

This notice announces the final Federal share disproportionate share hospital (DSH) allotments for Federal fiscal year (FFY) 2007 and the preliminary Federal share DSH allotments for FFY 2009. This notice also announces the final FFY 2007 and the preliminary FFY 2009 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' FFY DSH allotments.

The Food and Drug Administration (FDA) has determined that the eleven drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to the drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.

The Department of Health and Human Services (HHS) is announcing the availability of a new Web-based system, MedicalCountermeasures.gov. MedicalCountermeasures.gov will enable external stakeholders to request meetings with personnel from the organizations that comprise the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) regarding medical countermeasures to threats to public health, either naturally occurring or manmade. The goal of these meetings is to provide an opportunity for stakeholders to share information regarding medical countermeasures. The system can be accessed from the Web site https://www.medicalcountermeasures.gov/ RequestMeeting.aspx. During the BioShield Stakeholders Workshop, HHS Secretary Michael O. Leavitt announced that HHS would develop a Web based system ``through which those in industry and the research and development community can reach the people they need in the federal government, whether they're looking at a basic level of research or are focused on end-stage development.'' In fulfillment of this promise, HHS has developed MedicalCountermeasures.gov. MedicalCountermeasures.gov enables external stakeholders to request a meeting with federal representatives from participating PHEMCE agencies regarding medical countermeasures they are developing for use in response to a public health emergency. The information will then be routed to personnel within the relevant PHEMCE agencies, which currently include: The National Institutes of Health (NIH), the Office of the Biomedical Advanced Research and Development Authority (BARDA), the Food and Drug Administration (FDA), and the Department of Veterans Affairs (VA). MedicalCountermeasures.gov also provides information on upcoming and past conferences; procurements and grants; regulatory information; and strategic plans from throughout the PHEMCE agencies.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Diabetes Mellitus Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes.'' This guidance makes recommendations about how to demonstrate that a new antidiabetic therapy to treat type 2 diabetes is not associated with an unacceptable increase in cardiovascular risk. We are issuing this guidance for immediate implementation to ensure that relevant issues related to minimizing cardiovascular risk are considered by all sponsors who have ongoing drug development programs for type 2 diabetes.

This final rule sets forth the data elements necessary to comply with the requirements of Section 1923(j) of the Social Security Act (Act) related to auditing and reporting of disproportionate share hospital payments under State Medicaid programs. These requirements were added by Section 1001(d) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA).

The American Society for Histocompatibility and Immunogenetics (ASHI) was granted deeming authority as an accrediting organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program on March 25, 2005. The deeming authority was granted for the CLIA specialty of Histocompatibility and the subspecialty ABO/Rh. In this notice, we approve and grant ASHI deeming authority for the additional CLIA subspecialty of General Immunology.

This final rule sets forth reporting requirements for private insurers that issue qualified long-term care insurance policies in States participating in the State Long-Term Care Partnership Program established under the Deficit Reduction Act of 2005 (DRA) (Pub. L. 109- 171). Section 6021 of the DRA requires that the Secretary of Health and Human Services (the Secretary) specify a set of reporting requirements and collect data from insurers on qualified long-term care insurance policies issued under the program and the subsequent use of the benefits under these policies. Under a State Long-Term Care Partnership Program, an amount equal to the benefits received under the long-term care insurance policy is disregarded in determining the assets of an individual for purposes of Medicaid eligibility and estate recovery.

In accordance with section 205 of the Health Insurance Portability and Accountability Act (HIPAA) of 1996, this annual notice solicits proposals and recommendations for developing new and modifying existing safe harbor provisions under the Federal anti-kickback statute (section 1128B(b) of the Social Security Act), as well as developing new OIG Special Fraud Alerts.

The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between the Office of the Assistant Secretary of Defense (Health Affairs), the Veterans Health Administration, and the U.S. Food and Drug Administration. The purpose of the MOU is to enhance knowledge and efficiency by providing for the sharing of information and expertise between the Federal partners. The goals of the collaboration are to explore ways to: Further enhance information sharing efforts through more efficient and robust interagency activities; promote efficient utilization of tools and expertise for product risk identification, validation and analysis; and build infrastructure and processes that meet the common needs for evaluating the safety, efficacy, and utilization of drugs, biologics, and medical devices, as well as the safety and utilization of foods. The MOU is available on FDA's Web site at www.fda.gov/oc/mous/domestic/ domesticmous.htm.

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 requirements imposed on firms that intend to export to countries that require an export certificate as a condition of entry for FDA regulated products, pharmaceuticals, biologics, and devices as indicated in the Federal Food, Drug, and Cosmetic Act (the act) as amended.

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 the Federal Government Response Stages of an influenza pandemic. The agency makes recommendations to industry for focusing limited resources on reports related to influenza-related products and other specific types of reports indicated in the draft guidance.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Bioequivalence Recommendation for Vancomycin HCl.'' The recommendation provides specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for vancomycin HCl capsules.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Orally Disintegrating Tablets.'' The guidance provides pharmaceutical manufacturers of new and generic products with an agency perspective on the definition of an orally disintegrating tablet (ODT) and also provides recommendations to applicants who would like to designate proposed products as ODTs.

The Food and Drug Administration (FDA) is announcing that, as required by the Federal Advisory Committee Act, the agency has filed with the Library of Congress the annual reports of those FDA advisory committees that held closed meetings during fiscal year 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 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 postmarketing adverse drug experience reporting and recordkeeping requirements.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval the information collection listed below. This proposed information collection was previously published in the Federal Register on October 3, 2008, page 57634, and allowed 60 days for public comment. One 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: Hispanic Community Health Study (HCHS)/ Study of Latinos (SOL). Type of Information Collection Request: New Collection. Need and Use of Information Collection: The Hispanic Community Health Study (HCHS)/ Study of Latinos (SOL) will identify risk factors for cardiovascular and lung disease in Hispanic populations and determine the role of acculturation in the prevalence and development of these diseases. Hispanics, now the largest minority population in the US, are influenced by factors associated with immigration from different cultural settings and environments, including changes in diet, activity, community support, working conditions, and health care access. This project is a multicenter, six- and-a-half year epidemiologic study and will recruit 16,000 Hispanic men and women aged 18-74 in four community-based cohorts in Chicago, Miami, San Diego, and the Bronx. The study will examine measures of obesity, physical activity, nutritional habits, diabetes, lung and sleep function, cognitive function, hearing, and dental conditions. Closely integrated with the research component will be a community and professional education component, with the goals of bringing the research results back to the community, improving recognition and control of risk factors, and attracting and training Hispanic researchers in epidemiology and population-based research. Frequency of Response: The participants will be contacted annually. Affected Public: Individuals or households; Businesses or other for profit; Small businesses or organizations. Type of Respondents: Individuals or households; physicians. The annual reporting burden is as follows: Estimated Number of Respondents: 30,401; Estimated Number of Responses per Respondent: 2.234; Average Burden Hours Per Response: 0.7178; and Estimated Total Annual Burden Hours Requested: 48,755. The annualized cost to respondents is estimated at $756,412, assuming respondents time at the rate of $15 per hour and physician time at the rate of $55 per hour. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.

The Department of Health and Human Services (HHS) gives notice of a decision to designate a class of employees at the Connecticut Aircraft Nuclear Engine Laboratory in Middletown, Connecticut, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On October 24, 2008, the Secretary of HHS designated the following class of employees as an addition to the SEC: All employees of the Department of Energy (DOE), its predecessor agencies, and DOE contractors or subcontractors who worked at the Connecticut Aircraft Nuclear Engine Laboratory in Middletown, CT, from January 1, 1958 through December 31, 1965 for a number of work days aggregating at least 250 work days occurring either solely under this employment or in combination with work days within the parameters established for one or more other classes of employees in the Special Exposure Cohort. This designation will become effective on November 23, 2008, unless Congress provides otherwise prior to the effective date. After this effective date, HHS will publish a notice in the Federal Register reporting the addition of this class to the SEC or the result of any provision by Congress regarding the decision by HHS to add the class to the SEC.

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Modifications to Devices Subject to Premarket Approval (PMA)the PMA Supplement Decision-Making Process.'' The purpose of this guidance is to help industry determine the type of regulatory submission that may be required when a device subject to PMA is modified.

The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance entitled ``Questions and Answers Regarding the Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Revision 1.'' This revised draft guidance is intended to assist industry in complying with the labeling requirements for nonprescription (over-the-counter (OTC)) human drugs marketed without an approved application established by the Dietary Supplement and Nonprescription Drug Consumer Protection Act. The revision of the draft guidance changes the date on which FDA intends to begin enforcing these labeling requirements. Separate guidance, issued by the Center for Food Safety and Applied Nutrition on complying with the labeling requirements for dietary supplements, is announced elsewhere in this issue of the Federal Register.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (ANADA) filed by Ivy Laboratories, Division of Ivy Animal Health, Inc. The supplemental ANADA provides for an increased level of monensin in four-way combination Type C medicated feeds containing ractopamine, melengestrol, monensin, and tylosin for heifers fed in confinement for slaughter; and a revision to bacterial pathogen nomenclature.

The Department of Health and Human Services (HHS) gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees at the Mallinckrodt Chemical Co., Destrehan Street Plant in St. Louis, Missouri, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: Mallinckrodt Chemical Co., Destrehan Street Plant. Location: St. Louis, Missouri. Job Titles and/or Job Duties: All employees who worked with uranium. Period of Employment: January 1, 1958 to December 31, 1958.

The Department of Health and Human Services (HHS) gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees at the Metallurgical Laboratory in Chicago, Illinois, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: Metallurgical Laboratory. Location: Chicago, Illinois. Job Titles and/or Job Duties: All Atomic Weapons Employer employees. Period of Employment: August 13, 1942 through June 30, 1946.

The Department of Health and Human Services (HHS) proposes to update existing quality assurance requirements under 42 CFR Part 84 for the manufacture of all respirators approved by the National Institute for Occupational Safety and Health (``NIOSH'') of Centers for Disease Control and Prevetion (CDC), HHS. The proposed new requirements would require respirator manufacturers to be compliant with a widely adopted voluntary consensus standard for quality management systems, would update technical requirements particular to quality assurance for manufacturing of NIOSH-approved respirators, and would establish requirements governing the related quality assurance oversight activities of NIOSH.

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: Homer D. Venters, Jr., M.D., University of Illinois at Urbana- Champaign: Based on the report of an investigation conducted by the University of Illinois at Urbana-Champaign (UIUC) and extensive additional image analysis conducted by the Office of Research Integrity (ORI), the U.S. Public Health Service (PHS) found that Dr. Homer D. Venters, former graduate student, Neuroscience Program, UIUC, engaged in scientific misconduct in research supported by National Institute of Mental Health (NIMH), National Institutes of Health (NIH), awards R01 MH051569 and F30 MH12558 and National Institute on Aging (NIA), NIH, award R01 AG06246. Specifically, PHS found that the Respondent committed misconduct in science: By intentionally and knowingly preparing and including duplicate image data in Figures 5 and 10 of PHS fellowship application F31 MH12558, ``Neurodegeneration via TNF-alpha inhibition of IGF-1,'' submitted in 1999, which was funded as F30 MH12558 from June 1, 2000, to May 31, 2003. Because the duplicate data were labeled as having been obtained from different experiments, the results for at least one of the two figures were intentionally falsified and constitute an act of scientific misconduct. By intentionally and knowingly preparing and including duplicate image data in Figure 3 and/or 4 of a manuscript submitted and published as: Venters, H.D., et al. ``A New Mechanism of Neurodegeneration: A Proinflammatory Cytokine Inhibits Receptor Signaling by a Survival Peptide.'' Proceedings of the National Academy of Sciences U.S.A. 96:9879-9884, 1999. By preparing and providing to his dissertation committee in March 2000 a thesis proposal entitled ``An Alternate Mechanism of Neurodegeneration: Silencing of Insulin-like Growth Factor-I survival signals by Tumor Necrosis Factor-[alpha],'' which contained five falsified figures: Figures 1.3, 1.4a, 2.1b, 2.3e, and 2.5b. In each figure, he reused data within the same figure or in another thesis proposal figure as representing differently treated samples or as data obtained with different immunoblotting antisera. In March and April 2001, Respondent included several of the same falsified figures as in the thesis proposal and multiple additional falsified figures in his dissertation ``Silencing of Insulin-like Growth Factor I Neuronal Survival Signals by Tumor Necrosis Factor-[alpha].'' In all, Figures 3.3, 3.4a, 3.4b, 4.1b, 4.3a, 4.5b, 5.1a, 5.2, 5.4a, 5.5a, 5.6a, 5.7a, and 5.8a were falsified. In each instance, he assembled figures by reusing significant data, on some occasions after manipulating the orientation of the data, either within the same figure or in other figures related to his thesis and represented the data falsely as coming from different samples or different experiments. Dr. Venters has entered into a Voluntary Settlement Agreement (Agreement) in which he has voluntarily agreed, for a period of three (3) years, beginning on November 19, 2008: (1) That any institution that submits an application for PHS support for a research project on which the Respondent's participation is proposed or that uses the Respondent in any capacity on PHS- supported research, or that submits a report of PHS-funded research in which the Respondent is involved, must concurrently submit a plan for monitoring of the Respondent's research to the funding agency and ORI for approval; the monitoring plan must be designed to ensure the scientific integrity of the Respondent's research contribution; Respondent agreed that he will not participate in any PHS-supported research until such a monitoring plan is submitted to ORI and the funding agency; (2) That Respondent will ensure that any institution employing him will submit to ORI, in conjunction with each application for PHS funds or report, manuscript, or abstract of PHS-funded research in which the Respondent is involved, a certification that the data provided by the Respondent are based on actual experiments or are otherwise legitimately derived, and that the data analyses, procedures, and methodology are accurately reported in the application or report; Respondent must ensure that the institution sends a copy of each certification to ORI; and (3) To exclude himself 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. Respondent also voluntarily agreed that within 30 days of the effective date of this Agreement: (4) He will submit a letter to the journal editor, with copies to his coauthors, identifying his falsification of Figures 3 and/or 4 in the following article: Venters et al. ``A New Mechanism of Neurodegeneration: A Proinflammatory Cytokine Inhibits Receptor Signaling by a Survival Peptide.'' Proceedings of the National Academy of Sciences 96:9879-9884, 1999.

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the Office of Extramural Research, the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: Research and Research Training Grant Applications and Related Forms. Type of Information Collection Request: Revision, OMB 0925-0001, Expiration Date 11/30/10. Form Numbers: PHS 398, 2590, 2271, 3734 and HHS 568. Need and Use of Information Collection: The application is used by applicants to request Federal assistance for research and research- related training. The other related forms are used for trainee appointment, final invention reporting, and to relinquish rights to a research grant. Frequency of response: Applicants may submit applications for published receipt dates. If awarded, annual progress is reported and trainees may be appointed or reappointed. Affected Public: Individuals or Households; Business or other for- profit; Not-for-profit institutions; Federal Government; and State, Local or Tribal Government. Type of Respondents: Adult scientific professionals. The annual reporting burden is as follows: Estimated Number of Respondents: 160,135; Estimated Number of Responses per Respondent: 1; Average Burden Hours per Response: 14; and Estimated Total Annual Burden Hours Requested: 2,251,500. The estimated annualized cost to respondents is $78,802,500. Request for Comments: Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 which requires 30 days for public comment on proposed information collection projects, the Indian Health Service (IHS) 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 project was previously published in the Federal Register (73 FR 23254) on August 25, 2008 and allowed 60 days for public comment. No public comment was received in response to the notice. The purpose of this notice is to allow 30 days for public comment to be submitted directly to OMB. Proposed Collection: Title: 0917-NEW, ``Indian Health Service Health Promotion/Disease Prevention Grantee Survey.'' Type of Information Collection Request: This is a one-time survey to fulfill an OMB request for an independent external evaluation collection, 0917-NEW, ``Indian Health Service Health Promotional Disease Prevention (HP/DP) Grantee Survey.'' Form Number(s): None. Need and Use of Information Collection: The IHS goal is to raise the health status of the American Indian and Alaska Native (AI/AN) people to the highest possible level by providing comprehensive health care and preventive health services. HP/DP is one of the three IHS Director's initiatives to reduce health disparities among AI/AN populations through a coordinated and systematic approach to enhance health promotion and chronic disease prevention approaches at the local, regional, and national levels. The HP/DP competitive grant was established in 2005 to encourage Tribal and urban Indian programs to fully engage their local schools, communities, health care providers, health centers, faith-based/ spiritual communities, senior centers, youth programs, local governments, academia, non-profit organizations, and many other community sectors to work together to enhance and promote health and prevent chronic disease in their communities. Thirty-three Tribal/urban Indian organizations and programs were awarded competitive grants to expand and enhance health promotion and disease prevention to address health disparities among AI/AN populations. To conduct a thorough evaluation of the grant program, 29 telephone and four face-to-face interviews will be conducted to collect information to complete a quantitative and qualitative evaluation of the HP/DP grant program. The teleconference interviews may include one staff member per site. Each of the Tribal/urban organization/programs will determine the number of their staff members that will participate in the interview. The evaluation will include an assessment of whether HP/DP grantees achieve measurable health outcomes, synthesize the evaluation findings, and include a written report with recommendations to enhance program effectiveness. The information gathered will be used to prepare a final report for OMB. Affected Public: Individuals. Type of Respondents: Tribal/urban organizations program staff. The table below provides: Types of data collection instruments, estimated number of respondents, number of responses per respondent, average burden hour per response, and total annual burden hour(s).

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request the Office of Management and Budget (OMB) to allow the proposed information collection project: ``Overcoming Barriers to Expanded Health Information Exchange (HIE) Participation in Indiana.'' 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. This proposed information collection was previously published in the Federal Register on June 10th, 2008 and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment.

https:// www.fda.gov/cder/meeting/SummaryPublicHearingMedicationGuides .htm). Finally, PPIs are also required for some drugs and are considered part of the approved product labeling, for example, for estrogens and oral contraceptives. FDA will seek the advice of the advisory committee, and commentary from stakeholders and from the public, for consideration as it considers appropriate next steps to improve the communication of information about prescription drugs to patients. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is or will be available at https://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on the year 2009 and scroll down to the appropriate advisory committee link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before February 19, 2009. Oral presentations from the public will be scheduled between approximately 1 p.m. and 3 p.m. on February 26 and between approximately 10:30 a.m. and 11:30 a.m. on February 27. Those desiring to make formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before February 19, 2009. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by February 20, 2009. Persons attending FDA's advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Lee L. Zwanziger at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at https://www.fda.gov/oc/advisory/ default.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).

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 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.