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

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 to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on May 29, 2008, pages 30951-30952 and allowed 60 days for public comment. 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 current valid OMB control number. Proposed Collection: Title: The Prevalence and Incidence of HIV Molecular Variants and Their Correlation With Risk Behaviors and HIV Treatment in Brazilian Blood Donors. Type of Information Collection Request: New. Need and Use of Information Collection: Establishing and monitoring viral prevalence and incidence rates, and identifying risk behaviors for HIV incidence among blood donors, are critical to assessing and reducing risk of HIV transmission through blood transfusion. Identifying donation samples from donors with recent HIV infection is particularly critical as it enables characterization of the viral subtypes currently transmitted within the screened population and hence most likely to ``break-through'' routine screening measures (i.e., peri-seroconversion window period donations). Molecular surveillance of incident HIV infections in blood donors not only characterizes genotypes of recently infected donors for purposes of blood safety, but also enables documentation of the rates of primary transmission of anti-viral drug resistant strains in the community, serving a public health role in identifying new HIV infections for anti-retroviral treatment. Both a prospective surveillance and a case- control design are proposed to enroll all eligible HIV seropositives detected at three blood centers in Brazil (Sao Paulo, Belo Horizante, and Rec[iacute]fe) plus a satellite center in Rio de Janeiro. A comparison of epidemiological risk profiles will be made between the seropositive donors and a group of randomly selected seronegative donors. There are three study aims. Laboratory studies (LS-EIA testing and sequencing of pol region) on linked specimens from all enrolled HIV cases, will allow for estimation of HIV prevalence and incidence relative to genotype and putative route of infection. Data derived from molecular genotyping, including drug resistant genotypes, will be provided, along with counseling, to all enrolled HIV positive donors to facilitate their clinical care via referral to the Brazilian national HIV treatment system. Our findings will be compared to trends in prevalence, incidence and molecular variants from studies of the general population and high risk populations in Brazil, thus allowing for broad monitoring of the HIV epidemic in Brazil and assessment of the impact of donor selection criteria on these parameters. Finally, HIV cases and a group of controls, through responses to a questionnaire, will provide data on HIV risk behaviors among prospective blood donors. This HIV risk behavior data will be used as covariates in the molecular surveillance analyses described above, as well as aid in assessing whether modifications may be needed to Brazil's routine blood center operational donor screening questionnaire. The study participants will return to their local blood center for the administration of an informed consent form, explaining the confidential nature of the research study as well as the risks and benefits to their participation. Once enrolled, they will be asked to complete the self-administered risk factor questionnaire. In addition, a small blood sample will be collected from each HIV seropositive participant to be used for the genotyping and drug resistance testing. The results of the drug resistance testing will be communicated back to the seropositive participants during an in-person counseling session at the blood center. Defining prevalence and incidence in blood donors and residual risk of HIV transmission by transfusions may lead to new regulations and blood safety initiatives in Brazil. The data can be used to project the yield, safety impact and cost effectiveness of implementing enhanced testing strategies such as combination antigen-antibody assays and/or NAT. Determination of HIV risk factors in donors (first time versus repeat donor status; volunteer versus replacement status; demographics and risk behaviors) will support policy discussions over strategies to recruit the safest possible donors in Brazil. The findings from this project will also complement similar monitoring of HIV prevalence, incidence, transfusion risk and molecular variants in the U.S. and other funded international REDS-II sites, thus allowing direct comparisons of these parameters on a global level. Frequency of Response: Once. Affected Public: Individuals. Type of Respondents: Adult Blood Donors. The annual reporting burden is as follows: Estimated Number of Respondents: 2,000; Estimated Number of Responses per Respondent: 1; Average Burden of Hours per Response: 0.40 (including administration of the informed consent form and questionnaire completion instructions); and Estimated Total Annual Burden Hours Requested: 800. The annualized cost to respondents is estimated at: $5,200 (based on $6.50 per hour). There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.

In fiscal year 2009, the Substance Abuse and Mental Health Services Administration (SAMHSA) plans to require matching funds for some discretionary grant funding opportunities within the Programs of Regional and National Significance as described in the President's Fiscal Year (FY) 2009 Budget Request. This notice describes the specific FY 2009 funding opportunities for which matching is proposed. We understand that some grantees could experience initial difficulty with the matching requirements. The goal of this solicitation is to seek comment so that we can design these activities to assist grantees in lessening these challenges over time.

The Office of Disease Prevention and Health Promotion (ODPHP), Office of Public Health and Science (OPHS), U.S. Department of Health and Human Services (HHS), is soliciting written comments on key elements of Healthy People 2020, including the vision, mission, overarching goals and framework. Every 10 years, through the Healthy People initiative, HHS leverages scientific insights and lessons from the past decade, along with the new knowledge of current data, trends, and innovations to develop the next iteration of national health promotion and disease prevention objectives. Healthy People provides science-based, 10-year national objectives for promoting health and preventing disease. Since 1979, Healthy People has set and monitored national health objectives to meet a broad range of health needs, encourage collaborations across sectors, guide individuals toward making informed health decisions, and measure the impact of our prevention and health promotion activities. Healthy People 2020 will reflect assessments of major risks to health and wellness, changing public health priorities, and emerging issues related to our nation's health preparedness and prevention. Background: The Healthy People process is inclusive: its strength is directly tied to collaboration. The development process strives to maximize transparency, public input and stakeholder dialogue to ensure that Healthy People 2020 is relevant to diverse public health needs and seizes opportunities to achieve its goals. Since its inception, Healthy People has become a broad-based, public engagement initiative with thousands of citizens helping to shape it at every step along the way. Drawing on the expertise of a Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2020 and public input, Healthy People will organize and establish a framework to address risk factors and determinants of health and the diseases and disorders that are affecting our communities. Public participation will shape Healthy People 2020, its purpose, goals, organization, and action plans. HHS has sought input from communities and stakeholders across the nation through six regional meetings and is soliciting written public comments on the development of Healthy People 2020 through an online public comment database. As a national initiative, Healthy People's success depends on a coordinated commitment to improve the health of the nation. Individuals may subscribe to the listserv at: https://www.healthypeople.gov/Contact for the latest information on Healthy People 2020 and to receive email notices of related Healthy People 2020. Healthy People 2020 will be released in two-phases. The vision, mission, overarching goals, and organizing framework will be released in late 2008-early 2009. A year later, in January 2010, the specific Healthy People 2020 objectives with baselines and targets will be released.

The Administration for Children and Families proposes to revise the TANF regulations to eliminate the provision that allows a State to receive additional caseload reduction credit for maintenance- of-effort (MOE) expenditures in excess of its required MOE spending. This provision is no longer necessary and not consistent with Congressional direction in the Deficit Reduction Act of 2005.

This final rule updates the payment rates used under the prospective payment system (PPS) for skilled nursing facilities (SNFs), for fiscal year (FY) 2009. 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, this final rule makes 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 final rule sets forth the hospice wage index for fiscal year 2009. In addition, this final rule finalizes the policy to phase out the Medicare hospice budget neutrality adjustment factor, and clarifies two wage index issues pertaining to the definition of rural and urban areas and multi-campus hospital facilities.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Phibro Animal Health. The supplemental NADA provides for use of oxytetracycline dihydrate in Type C medicated feeds for the control of mortality in freshwater-reared salmonids due to coldwater disease and for the control of mortality in freshwater-reared Oncorhynchus mykiss due to columnaris disease.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Control of Residual Solvents in Drug Products Marketed in the United States.'' On July 1, 2008, the United States Pharmacopeia (USP) published a new test requirement for the control of residual solvents, General Chapter ``Residual Solvents,'' which replaced USP General Chapter ``Organic Volatile Impurities.'' The change affects all compendial drug products marketed in the United States. This draft guidance reflects FDA's recommendations on how to comply with those USP changes.

The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved by the Center for Biologics Evaluation and Research (CBER). This list is intended to inform the public of the availability through the Internet and FDA's Division of Dockets Management of summaries of safety and effectiveness data of approved PMAs.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Phibro Animal Health. The supplemental NADA provides for label revisions associated with a previous change of sponsorship and other minor changes for amprolium concentrate solution to make medicated drinking water for chickens and turkeys for the treatment of coccidiosis. The product approval is being codified for the first time.

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 the availability of a guidance document for FDA advisory committee members and FDA staff entitled ``Voting Procedures for Advisory Committee Meetings.'' This document is intended to provide guidance on advisory committee voting procedures that should be used when votes are taken during advisory committee meetings. It does not define when votes should be taken. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of three additional guidances and one draft guidance, intended to improve FDA's advisory committee procedures.

The Food and Drug Administration (FDA) is announcing the availability of a guidance document for the public, FDA advisory committee members, and FDA staff entitled ``Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees'' dated August 2008. This guidance describes the factors and analyses that should be used in considering whether an advisory committee member has a potential conflict of interest and whether participation in a meeting is appropriate. This guidance is intended to help the public, FDA advisory committee members, and FDA staff to understand and implement FDA policy in applying the applicable statutory and regulatory requirements. This guidance finalizes the draft guidance of the same title dated March 2007 and replaces the guidance document entitled ``FDA Waiver Criteria 2000.'' Elsewhere in this issue of the Federal Register, FDA is announcing the availability of three additional guidances, and one draft guidance, intended to improve FDA's advisory committee procedures.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 4C: Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance provides the results of the ICH Q4B evaluation of the Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter harmonized text from each of the three pharmacopoeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The draft guidance conveys recognition of the three pharmacopoeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The draft guidance is intended to recognize the interchangeability between the local regional pharmacopoeias, thus avoiding redundant testing in favor of a common testing strategy in each regulatory region. This draft guidance is part C of the fourth annex to the core Q4B guidance, which was made available in the Federal Register of February 21, 2008 (73 FR 9575).

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 4B: Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-organisms General Chapter.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance provides the results of the ICH Q4B evaluation of the Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-organisms General Chapter harmonized text from each of the three pharmacopoeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The draft guidance conveys recognition of the three pharmacopoeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The draft guidance is intended to recognize the interchangeability between the local regional pharmacopoeias, thus avoiding redundant testing in favor of a common testing strategy in each regulatory region. This draft guidance is part B of the fourth annex to the core Q4B guidance, which was made available in the Federal Register of February 21, 2008 (73 FR 9575).

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``E2F Development Safety Update Report.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance describes the format, content, and timing of a development safety update report (DSUR) for an investigational drug. The DSUR would serve as a harmonized, annual clinical trial safety report that would be standard among the three ICH regions. The DSUR could be submitted in the United States in place of an annual report for an investigational new drug application (IND). The harmonized DSUR is intended to promote a consistent approach to annual clinical safety reporting among the ICH regions and enhance efficiency by reducing the number of reports generated for submission to the regulatory authorities.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Labeling OTC Skin Protectant Drug Products.'' This guidance provides recommendations on how to label over-the-counter (OTC) skin protectant drug products. An OTC skin protectant active ingredient can be combined with another OTC skin protectant active ingredient or OTC external analgesic, first aid antiseptic, or sunscreen active ingredients. Each of these combinations has specific labeling requirements, and therefore labeling of OTC skin protectant drug products is complex. This guidance is designed to clarify the permitted combinations of active ingredients along with the corresponding required labeling.

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.

Pursuant to the Improving Head Start for School Readiness Act of 2007, Public Law 110-134, notice is hereby given of a one-day Tribal Consultation Session to be held between the Department of Health and Human Services, Administration for Children and Families, Office of Head Start leadership and the leadership of Tribal governments operating Head Start (including Early Head Start) programs. The purpose of the Consultation Session is to discuss ways to better meet the needs of Indian, including Alaska Native, children and their families, taking into consideration funding allocations, distribution formulas, and other issues affecting the delivery of Head Start services in their geographic locations [42 U.S.C. 9835, Section 640(l)(4)].

The Food and Drug Administration (FDA) is publishing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2009. The Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), the Medical Device User Fee Stabilization Act of 2005 (MDUFSA), and the Medical Device User Fee Amendments of 2007 (Title II of the Food and Drug Administration Amendments Act of 2007 (FDAAA)), authorizes FDA to collect user fees for certain medical device submissions, and annual fees both for certain periodic reports and for certain establishments subject to registration. The FY 2009 fee rates are provided in this notice. These fees apply from October 1, 2008, through September 30, 2009. To avoid delay in the review of your application, you should pay the fee before or at the time you submit your application to FDA. The fee you must pay is the fee that is in effect on the later of the date that your application is received by FDA or the date your fee payment is received. If you want to pay a reduced small business fee, you must qualify as a small business before you make your submission to FDA; if you do not qualify as a small business before you make your submission to FDA, you will have to pay the higher standard fee. This notice provides information on how the fees for FY 2009 were determined, the payment procedures you should follow, and how you may qualify for reduced small business fees.

This document corrects several technical and typographical errors in the proposed rule that was issued on June 30, 2008 and appeared in the July 7, 2008 Federal Register (73 FR 38502). The proposed rule addressed Medicare Part B payment policy, including the physician fee schedule (PFS) that is applicable for calendar year (CY) 2009. The proposed rule also addressed refinements to relative value units (RVUs) and physician self-referral issues. Specifically, the errors pertain to the following provisions: Practice expense, telehealth services, competitive acquisition program (CAP), anti-markup provisions, and the Physician Quality Reporting Initiative.

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) is announcing that a collection of information entitled ``Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protection Agency Pursuant to Dietary Risk Considerations'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

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.

In compliance with the provisions of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comments on proposed data collection projects, the National Institutes of Health (NIH), National Cancer Institute (NCI) 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 National Survey of Physician Attitudes Regarding the Care of Cancer Survivors (SPARCCS); Type of Information Collection Request: NEW; Need and Use of Information Collection: The purpose of SPARCCS is to identify the beliefs, knowledge, attitudes, and practices of primary care physicians and cancer specialists regarding the components described by the Institute of Medicine's (IOM) 2005 report that described the essential components of cancer survivorship care within a health care delivery system. These data will inform the process of standardization of survivorship care practices; augment the data collected in other cancer survivorship studies such as the Cancer Care Outcomes Research and Surveillance Consortium (CanCORS), and the Cancer Research Network; and monitor the progress made toward achieving NCI strategic goals of improving the quality of cancer care across the cancer control continuum. Two questionnaires, one sent to primary care physicians and one sent to medical oncologists, will be administered by mail to a randomly selected national sample of 2,200 physicians. Study participants will be 1,100 practicing physicians who are family practitioners, general internists, and obstetrician/gynecologists and 1,100 medical oncologists. Frequency of Response: Once. Affected Public: Individuals and Businesses. Type of Respondents: Primary care and medical oncology physicians practicing in a non-federal facility. The annual reporting burden is estimated at 903 hours as shown in Table 1. The total burden hours is estimated at 1,808 hours over the two year field period of the study. There are no capital, operating or maintenance costs to report.

This notice announces the 29th meeting of the American Health Information Community Population Health and Clinical Care Connections Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).

The Food and Drug Administration (FDA) is announcing the availability of a draft information sheet guidance entitled ``Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs; Frequently Asked QuestionsStatement of Investigator (Form FDA 1572).'' This guidance is intended to assist institutional review boards (IRBs), clinical investigators, and sponsors involved in clinical investigations of investigational drugs and biologics in completing the Statement of Investigator form (Form FDA 1572). FDA developed this draft information sheet guidance in response to numerous questions from the research community regarding Form FDA 1572. This draft information sheet guidance provides FDA's responses to the most frequently asked questions.

The Food and Drug Administration is correcting a notice that appeared in the Federal Register of July 15, 2008 (73 FR 40582). The document announced the determination that SANOREX (mazindol) Tablets, 1 and 2 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness. The document was published with an incorrect docket number. This document corrects that error.

This notice announces the 28th meeting of the American Health Information Community Consumer Empowerment Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.).

This notice announces the opportunity for an administrative hearing to be held on September 26, 2008 at the CMS Dallas Regional Office, 1301 Young Street, Room 1196, Dallas, Texas 75202, to consider whether Texas State plan provisions concerning payments for birthing center facility services comply with the requirements of the Social Security Act as discussed in the July 28, 2008 letter sent to the State and published herein.

This final rule prohibits Medicare Advantage (MA) organizations, including organizations offering MA plans to employer and union group health plan sponsors, from making midyear changes to non-prescription drug benefits, premiums, and cost-sharing submitted in their approved bids for a given contract year. This final rule also clarifies that MA organizations offering certain kinds of plans restricted to employer and union group health plan sponsors and not open to general enrollment may continue to offer benefit enhancements as they do currently, through means other than midyear benefit enhancements (MYBEs). Programs of all-inclusive care for elderly (PACE) are not subject to the provisions of this final rule and may continue to offer enhanced benefits as specified in our guidance for PACE plans.

This notice invites all organizations representing physicians to submit nominations for consideration to fill two seats on the Practicing Physicians Advisory Council (the Council) that will be vacated by current Council members in 2009. This notice also announces a quarterly meeting of the Council. The Council will meet to discuss certain proposed changes in regulations and manual instructions related to physicians' services, as identified by the Secretary of Health and Human Services (the Secretary). This meeting is open to the public.

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 National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the following revised draft document available for public comment entitled ``Asbestos Fibers and Other Elongated Mineral Particles: State of the Science and Roadmap for Research.'' The document and instructions for submitting comments can be found at https://www.cdc.gov/niosh/review/public/099-A/. Public Comment Period: July 24, 2008 through September 30, 2008. Status: Written comments may be mailed to the attention of Diane Miller, NIOSH Docket Office, Robert A. Taft Laboratories, 4676 Columbia Parkway, MS-C34, Cincinnati, Ohio 45226, telephone (513) 533-8450, facsimile (513) 533-8285. Comments may also be submitted by e-mail to nioshdocket@cdc.gov. All material submitted to the Agency should reference the NIOSH Docket number 099-A. All electronic comments should be formatted as Microsoft Word. All information received in response to this notice will be available for public examination and copying at the NIOSH Docket Office, 4676 Columbia Parkway, Cincinnati, Ohio 45226. Purpose: To obtain comments from the public on the revised draft document entitled, ``Asbestos Fibers and Other Elongated Mineral Particles: State of the Science and Roadmap for Research,'' referred to as Roadmap. Asbestos has been a highly visible issue in public health for over three decades. Many advances have been made in the scientific understanding of worker health effects from exposure to asbestos and other elongated mineral particles (EMPs), and it is now well documented that fibers of asbestos minerals, when inhaled, can cause serious diseases in exposed workers. Yet, many questions and areas of scientific uncertainty remain. Background: As the Federal agency responsible for conducting research and making recommendations for the prevention of worker injury and illness, NIOSH is undertaking a reappraisal of how to ensure appropriate protection of workers from exposure to asbestos fibers and other EMPs. NIOSH prepared a first draft of the document ``Asbestos and Other Mineral Fibers: A Roadmap for Scientific Research,'' and invited comments at a public meeting, from the Internet, and from selected expert peer reviewers on the occupational health issues identified and the framework for research. As a result of comments received during the public and expert peer review process, NIOSH has substantially revised the earlier draft and is now inviting comments on a revised draft of the document with the new title ``Asbestos Fibers and Other Elongated Mineral Particles: State of the Science and Roadmap for Research.'' The previous draft, public comments, peer review comments, and the responses to peer reviewers' comments on the previous draft can be found at https://www.cdc.gov/niosh/docket/NIOSHdocket0099.html. The purpose of the revised draft Roadmap is to outline major areas of controversy and to recommend a research agenda that can serve as a guide for the development of specific research programs within and across disciplines. The intended goal is to provide answers to current scientific questions, reduce scientific uncertainties, and provide a sound scientific foundation for future policy development so that optimal health protection can be assured. NIOSH is seeking comments on the scope and information used to support the development of a research framework for asbestos fibers and other EMPs. Of special interest are comments on the following revisions to the draft document: 1. A discussion of particle characteristics (e.g., dimension, chemistry) and their potential influence on biological responses (Sections 1.6.1, 1.6.2, 1.6.3, and 1.6.4). 2. Toxicological research with EMPs (Section 2.2). 3. Epidemiological studies of workers exposed to EMPs (Section 2.3.3). 4. Capabilities and limitations of analytical instruments used to identify EMPs (Section 2.4.2). Also of special interest are comments on the entirely new content in the document: 1. A rephrasing of the NIOSH recommended exposure limit (REL) for asbestos and related EMPs (Section 1.8.2). 2. The inclusion of ``How the proposed research could lead to the development of improved public health policies for asbestos and other EMPs'' (Section 2.5). 3. Clinical issues (Section 1.4). 4. Recommendations for clinical research (Section 2.3.4). NIOSH continues to be interested in available and forthcoming research results that can help answer the questions set forth in the Roadmap, as well as information on existing workplace exposure data, health effects, and control technologies. Submitted comments on the revised draft Roadmap should indicate the pertinent page(s) and line(s) in the draft document being addressed. Contact Person for Technical Information: Paul Middendorf, Office of the Director, NIOSH, CDC, telephone (513) 533-8606, e-mail pmiddendorf@cdc.gov.

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: ``National Study of the Hospital Adverse Event Reporting Follow-Up Survey.'' In accordance with the Paperwork Reduction Act of 1995, 44 U.S.C. 3506(c)(2)(A), AHRQ invites the public to comment on this proposed information collection.

The Health Resources and Services Administration (HRSA) received many substantive comments on the proposed rule and will consider these comments carefully. Based on a preliminary review of the comments, it appears that HRSA will need to make a number of changes in the proposed rule. Instead of issuing a final regulation as the next step, HHS will issue a new Notice of Proposed Rulemaking for further review and public comment prior to issuing a final rule.

The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Division of Federal-State Relations (DFSR) is announcing the availability of a Sole Source to the Association of Food and Drug Officials (AFDO) to provide funding for a 3-year cooperative agreement award to support a Special Project Cooperative Agreement program. No other applications are solicited. This cooperative agreement is intended to have AFDO update and maintain the FDA Directory of State and Local Officials and to update the AFDO document ``State Food Safety Resource Survey (2000)'' by providing funding for additional personnel, equipment, and supplies to support activities related to these projects.

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: Roxana Gonzalez, Carnegie Mellon University: Based on reports submitted by Carnegie Mellon University's (CMU) inquiry and investigation committees, the Respondent's own admission in sworn testimony, and additional analysis conducted by the Office of Research Integrity (ORI) during its oversight review, the U.S. Public Health Service (PHS) found that Roxana Gonzalez, graduate student, Department of Social and Decision Sciences and Psychology, CMU, engaged in scientific misconduct in research supported by National Institute of Mental Health (NIMH), National Institutes of Health (NIH), grants R01 MH56880, R03 MH62376, and R24 MH67346. Specifically, PHS found that Ms. Gonzalez engaged in the following acts of scientific misconduct: 1. Respondent altered the main dependent variable (life events; life expectation) in the electronic file and the manipulation check variables for ease-of-thought generation so that the reported study results are largely unsupported in: (a) Publication: Lerner, J.S., & Gonzalez, R.M. ``Forecasting one's future based on fleeting subjective experiences.'' Personality and Social Psychology Bulletin 31:454-466, 2005; (b) 2005 Manuscript: Lerner, J. S., & Gonzalez, R. M. ``On perceiving the self as triumphant when happy or angry''; (c) Review Article: Lerner J. S., Tiedens, L.Z., & Gonzalez, R. M. ``Portrait of the angry decision maker: How appraisal tendencies shape anger's influence on cognition.'' Journal of Behavioral Decision Making: Special Issue on Emotion and Decision Making. 2. Respondent falsified cortisol values, and possibly cardiovascular measures and optimistic appraisals (as measured by LOT), so that a large portion of the mediation analyses of Table 3 does not reflect the data actually collected and analyzed for the study reported in a publication (Lerner, J.S., Gonzalez, R.M., Dahl, R.E., Hariri, A.R., & Taylor, S.E. ``Facial expressions of emotion reveal neuroendocrine and cardiovascular stress responses.'' Biological Psychiatry 58:743-750, 2005). Respondent further allowed one of her collaborators to report the results from this study at the Annual Meeting of the American Psychological Society held in Los Angeles, California in May 2005, although Respondent's collaborator did not know at the time that the results were tainted by Respondent's acts of research misconduct. 3. Respondent falsified the analyses based on participants' responses to the manipulation check items (including the data for self reported fear) in a study reported in a publication (Fischhoff, B., Gonzalez, R.M., Lerner, J.S., & Small, D.A. ``Evolving judgments of terrorism's risks: Foresight, hindsight, and emotion.'' Journal of Experimental Psychology: Applied 11:124-139, 2005. 4. Respondent falsified the main dependent variable (reservation price, BDM) in the electronic file for 48 of the 175 subjects participating in a study reported in a 2005 manuscript (Lerner, J.S., Gonzalez, R.M., Small, D.A., Lowenstein, G., & Dahl, R.E. ``Emotional influence on economic behavior among adolescents.''). Respondent directed the alteration of the paper files for those subjects in order to match the altered electronic file. One of Respondent's collaborators included a qualitative description of the results of the research that is the subject of this study in an NIH grant application, although Respondent's collaborator did not know at the time that the results were tainted by the Respondent's acts of research misconduct. ORI acknowledges Ms. Gonzalez' extensive cooperation with CMU's research misconduct proceedings. Ms. Gonzalez has entered into a Voluntary Exclusion Agreement (Agreement) in which she has voluntarily agreed, beginning on June 26, 2008: (1) To exclude herself 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; (2) That for a period of three (3) years, 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 supervision of the Respondent's duties to the funding agency for approval; the supervisory plan must be designed to ensure the scientific integrity of the respondent's research contribution; Respondent agrees to ensure that a copy of the supervisory plan is also submitted to ORI by the institution; Respondent agrees that she will not participate in any PHS-supported research until such a supervisory plan is submitted to ORI; (3) for a period of three (3) years to ensure that any institution employing her submits, 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, procedures, analyses, and methodology are accurately reported in the application, report, manuscript or abstract; the Respondent must ensure that the institution sends a copy of the certification to ORI; and (4) to write ORI-approved letters to (a) collaborators/coauthors of the manuscripts and published papers cited above, stating what she falsified/fabricated and offering restitution; and (b) editors of the journals in which papers were published (even if they have been retracted/corrected) to state that her falsifications/fabrications were the underlying reason for the retraction/correction.

This notice with comment period describes the general criteria we intend to use to evaluate the efficiency and effectiveness of the Quality Improvement Organizations (QIOs) who will enter into contract with CMS under the 9th SOW on August 1, 2008. The evaluation of the QIOs' performance related to their Statement of Work (SOW) will be based on evaluation criteria specified within the themes, tasks, and subtasks set forth in the QIO's 9th SOW.

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 Brookhaven National Laboratory, Upton, New York, 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: Brookhaven National Laboratory. Location: Upton, New York. Job Titles and/or Job Duties: All workers. Period of Employment: January 1, 1947 through December 31, 2007.

This regulation revises Federal requirements for establishing and enforcing medical support obligations in Child Support Enforcement (CSE) program cases receiving services under title IV-D of the Social Security Act (the Act). The changes: require that all support orders in the IV-D program address medical support; redefine reasonable-cost health insurance; require health insurance to be accessible, as defined by the State; and make conforming changes to the Federal interstate, substantial-compliance audit, and State self-assessment requirements.

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 Nuclear Materials and Equipment Corporation (NUMEC) facility in Parks Township, Pennsylvania, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On May 30, 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:

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 SAM (Special Alloyed or Substitute Alloy Materials) Laboratories of Columbia University in New York City, New York, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On May 30, 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:

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 for the Linde Ceramics Plant, Tonawanda, New York, 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: Linde Ceramics Plant. Location: Tonawanda, New York. Job Titles and/or Job Duties: All employees. Period of Employment: During the applicable covered residual radiation period from January 1, 1954 through July 31, 2006.

The Food and Drug Administration (FDA) is announcing the availability of draft Compliance Policy Guide Sec. 540.370 Fish and Fishery Products Decomposition (the draft CPG). The draft CPG, when final, will provide FDA staff with current regulatory action guidance relating to decomposition in fish and fishery products.