Department of Health and Human Services May 2006 – Federal Register Recent Federal Regulation Documents

The Office of Global Health Affairs (OGHA) announces that up to $335,916 in fiscal year (FY) 2006 funds is available for a cooperative agreement to the California Department of Health Services, who will work through the California Outreach Office of the U.S.-Mexico Border Health Commission, to strengthen the binational public health projects and programs along the California-Baja California border. This initiative addresses outreach and health promotion activities, evaluation and assessments, health data analysis and surveillance, Healthy Border/Healthy Gente activities, and programmatic and administrative support to the members and staff of the U.S.-Mexico Border Health Commission. The budget period will be one year with a project period of five years for a total of $335,916 (including indirect costs). Funding for the cooperative agreement is contingent upon the availability of funds.

Under the National Childhood Vaccine Injury Act (NCVIA) (42 U.S.C. Sec. 300aa-26), the CDC must develop vaccine information materials that all health care providers are required to give to patients/parents prior to administration of specific vaccines. On July 28, 2005, CDC published a notice in the Federal Register (70 FR 43694) seeking public comments on proposed new vaccine information materials for hepatitis A vaccine. Following review of the comments submitted and consultation as required under the law, CDC has finalized the hepatitis A vaccine information materials. The final hepatitis A materials are contained in this notice. Also noted are edits to the instructions for use of vaccine information materials.

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 the information collection provisions of FDA's regulations requiring that the agency receive prior notice before food is imported or offered for import into the United States.

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 Schering-Plough Animal Health Corp. The supplemental NADA provides for revised food safety labeling for trimethoprim and sulfadiazine oral paste, administered to horses as a systemic antibacterial.

This rule finalizes the February 4, 2005 proposed rule entitled ``Medicare and Medicaid Programs; Conditions for Coverage for Organ Procurement Organizations (OPOs).'' It establishes new conditions for coverage for organ procurement organizations (OPOs) that include multiple new outcome and process performance measures based on organ donor potential and other related factors in each service area of qualified OPOs. Our goal is to improve OPO performance and increase organ donation. In addition, this final rule re-certifies these 58 OPOs from August 1, 2006 through July 31, 2010 and provides an opportunity for them to sign agreements with the Secretary that will begin on August 1, 2006 and end on January 31, 2011. New agreements are needed so that the Medicare and Medicaid Programs can continue to pay them for their organ procurement activities after July 31, 2006.

This notice of proposed rulemaking authorizes approval of annual waivers, under certain circumstances, from two provisions in the current Head Start transportation regulation (45 CFR part 1310): The requirement that each child be seated in a child restraint system while the vehicle is in motion, and the requirement that each bus have at least one bus monitor on board at all times. Waivers would be granted when the Head Start or Early Head Start grantee demonstrates that compliance with the requirement(s) for which the waiver is being sought will result in a significant disruption to the Head Start program or the Early Head Start program and that waiving the requirement(s) is in the best interest of the children involved. The proposed rules also would revise the definition of child restraint system in the regulation. The proposed change in the definition would remove the reference to weight which now conflicts with Federal Motor Vehicle Safety Standards. The regulation also is being amended to reflect new effective dates for Sec. Sec. 1310.12(a) and 1310.22(a) on the required use of school buses or allowable alternate vehicles and the required availability of such vehicles adapted for use of children with disabilities, as the result of enactment of Section 224 of Public Law 109-149.

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 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.

This final notice announces the approval of URAC for deeming authority as a national accreditation organization for health maintenance organizations and local preferred provider organizations participating in the Medicare Advantage program, for a term of 6 years upon publication of this notice in the Federal Register. This notice describes the processes and criteria used in evaluating the application. We did not receive any public comments during the public comment period, which ended on April 28, 2006.

The Office of Public Health and Science (OPHS) announces the availability of Fiscal Year (FY) 2006 funds to support a total of three to four new cooperative agreement grant projects, with the goal of increasing public awareness of embryo donation and/or adoption. Approximately $1,000,000 in funding is available on a competitive basis for cooperative agreements each in the range of $250,000 to $350,000 per year. Projects will be funded in annual increments (budget periods) and for a project period of two years. Funding for all budget periods beyond the first year of the cooperative agreement is contingent upon the availability of funds, satisfactory progress of the project, and adequate stewardship of Federal funds. The OPHS intends to fund at least one project in each of three distinct categories (professional meeting(s); training for professionals to equip them with the skills necessary to provide information and education; and an evidence-based assessment of the emerging field of embryo donation and/or adoption) with the goal of increasing public awareness regarding embryo donation and/or adoption. Entities may apply for more than one category; however, a separate application is required for each category identified in this announcement. Applicants must demonstrate experience with embryo donation and/or adoption programs that conform with professionally recognized standards governing embryo donation and/or adoption and other applicable Federal or State requirements. For the purposes of this announcement, embryo donation and/or adoption is defined as the donation of frozen embryo(s) from one party to a recipient who wishes to bear and raise a child or children.

This notice announces a public meeting to discuss payment determinations for specific new Physicians' Current Procedural Terminology (CPT) codes for clinical laboratory tests. The meeting provides a forum for interested parties to make oral presentations and submit written comments on the new codes that will be included in Medicare's Clinical Laboratory Fee Schedule for calendar year 2007, which will be effective on January 1, 2007. Discussion is directed toward technical issues relating to payment determinations for a specified list of new clinical laboratory codes. The development of the codes for clinical laboratory tests is performed by the CPT Editorial Panel and will not be discussed at the public meeting.

The Department of Health and Human Services proposes to amend its acquisition regulations (HHSAR) to make administrative and editorial changes to reflect organizational title changes resulting from Office of the Secretary (OS) and Operating Division (OPDIV) reorganizations and to update or remove outdated text and references. The intent of the proposal is to bring the HHSAR up to date and to make the HHSAR consistent with the latest amendments to the Federal Acquisition Regulations (FAR).

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 User Fee Cover Sheet; Form FDA 3397 that must be submitted along with certain drug and biologic product applications and supplements.

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 the collection of information contained in a guidance for industry entitled ``Submitting and Reviewing Complete Responses to Clinical Holds.'' The guidance describes how to submit a complete response if an investigational new drug (IND) application is placed on clinical hold by FDA.

This document adopts the Smallpox (Vaccinia) Vaccine Injury Table (the Table) Interim Final Rule as the Final Rule with an amendment, as follows: the Final Rule clarifies that, in order for the presumption of causation to apply, the time intervals listed on the Table refer specifically to the period in which the first symptom or manifestation of onset of injury must appear following administration of the smallpox vaccine or exposure to vaccinia, and that the time intervals listed have no relevance to time of diagnosis of the injury.

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials.'' This draft guidance provides FDA's recommendations on the use of Bayesian statistical methods in the design and analysis of medical device clinical trials. This draft guidance is neither final nor is it in effect at this time.

This program is authorized by 42 U.S.C. 300u-2(a). The Office on Women's Health (OWH) is the focal point for women's health within the Department of Health and Human Services (DHHS). Under the direction of the Deputy Assistant Secretary for Women's Health, OWH provides leadership to promote health equity for women and girls through gender-specific approaches. To that end, OWH has established activities to address critical women's health issues nationwide. These include: developing and implementing model public/private partnerships that address the health issues of incarcerated and newly released women, largely women of color, living with HIV/AIDS/STDs or at increased risk for sexually transmitted infections. These may include piloting a comprehensive system of health related support services, such as ensuring access to health care and most current therapies, pre- release discharge planning, case managing transition processes, and establishing linkages to various community based support and prevention services. The OWH HIV/AIDS program began in 1999 with funding from the Minority AIDS Fund (formerly Minority AIDS Initiative) to address the gaps in services provided to women who are at risk or living with HIV. Since the inception of the HIV/AIDS programs, the program focus has expanded from two to seven. These programs include: (1) HIV Prevention for Women Living in the Rural South, (2) Prevention and Support for Incarcerated/ Newly Released Women, (3) Model Mentorship for Strengthening Organizational Capacity, (4) HIV Prevention for Young Women Attending Minority Institutions (e.g. Historically Black Colleges and Universities, Hispanic Serving Institutions, and Tribal Colleges and Universities), (5) HIV Prevention for Women Living in the U.S. Virgin Islands, (6) Prevention and Support for HIV Positive Women Living in Puerto Rico, and (7) Inter- generational Approaches to HIV/AIDS Prevention Education with Women across the Lifespan. Funding will be directed at activities designed to improve the delivery of services to women disproportionately impacted by HIV/AIDS.

To improve emergency preparedness, response and recovery efforts, HHS invites public comment on the availability or feasibility of private sector services through which individuals could voluntarily submit their personal information for storage so that they, their family members, or other designated individuals could access the information in an emergency. HHS invites all comments, suggestions, recommendations, and creative ideas on the establishment of voluntary nationwide services that can best offer this capability. This Request for Information (RFI) is intended to provide a synthesis of ideas for consideration, and it is not intended to be part of any procurement process.

The Food and Drug Administration (FDA) is announcing the availability of a draft compliance policy guide (CPG) entitled ``Sec. 500.500 Guidance Levels for 3-MCPD (3-chloro-1,2-propanediol) in Acid- Hydrolyzed Protein and Asian-Style Sauces.'' The draft CPG establishes regulatory action guidance for FDA personnel for 3-MCPD in acid- hydrolyzed protein (acid-HP) and Asian-style sauces.

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 February 1, 2006, pages 5344-5355 and allowed 60 days for public comment. No comments were received in response to this notice. 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 Leukocyte Antibodies Prevalence (LAP) Study. Type of Information Collection Request: NEW. Need and Use of Information Collection: The two current hypotheses for pathogenesis of transfusion-related acute lung injury (TRALI) include the development of acute pulmonary insufficiency from immune and non-immune causes. The immune mediated mechanism postulates that passively transferred anti-leukocyte antibodies from blood donors are responsible for TRALI. The donor antibodies implicated in TRALI include antibodies directed towards HLA class I and class II antigens, and anti-neutrophil antibodies. The LAP Study is a cross-sectional multi-center study to measure the prevalence of HLA and neutrophil antibodies in blood donors with or without a history of blood transfusion or pregnancy, and the development of a repository of blood samples obtained from these donors. Specifically, 7,900 adult blood donors across six blood centers participating in the Retrovirus Epidemiology Donor Study II (REDS-II) will be enrolled in the study. Eligible donors will be asked to complete a short questionnaire on their transfusion history (ever, and date of last transfusion) and, for female donors, questions on pregnancy history (ever, number and outcome of pregnancies, last pregnancy). Each donor will also be asked to provide a sample of blood which will be tested for the presence of HLA class I and Class II antibodies. This data will help us evaluate variations in HLA antibody prevalence based on blood transfusion and pregnancy history and time since the last immunizing event. Further, neutrophil specific antibodies will be measured in those blood donors who have HLA antibodies. Also, donors with neutrophil antibodies will be tested to determine their neutrophil phenotype using routine serologic and DNA methods, since individuals homozygous for certain neutrophil antigens are more prone to develop certain neutrophil antibodies. The results from testing HLA positive donors for neutrophil antibodies in this primary study could be used to develop an optimal testing strategy for large number of donors using the stored repository samples. These dat will provide the basis for calculating donor loss in the event that a TRALI prevention strategy is implemented that includes deferring donors with a history of transfusion or pregnancy or those with HLA or neutrophil antibodies. The second major goal of this study is to develop a repository of blood samples from well characterized blood donors whose detailed transfusion and pregnancy histories are known. Repository samples will be stored indefinitely. Although future research on repository samples is yet to be determined, they may be tested for studies designed to help transfusion safety and transfusion biology. Frequency of Response: Once. Affected Public: Individuals. Type of Respondents: Adult Blood Donors. The annual reporting burden is as follows: Estimated Number of Respondents: 7,900; Estimated Number of Responses per Respondent: 1; Average Burden of Hours per Response: 0.17; and Estimated Total Annual Burden Hours Requested: 1343. The annualized cost to respondents is estimated at: $24,174 (based on $18 per hour). There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.

This rule finalizes without change the provisions of the Interim Final Rule published on December 28, 2004 and responds to public comments received as a result of the interim final rule. The rule permits States to use a reasonable quantitative standard to determine whether or not to proceed with an adjustment of an existing child support award amount after conducting a review of the order, regardless of the method of review used.

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

In accordance with the requirements of the Privacy Act of 1974, we are proposing to establish a new SOR titled, ``Organ Procurement Organizations System (OPOS), System No. 09-70-0575.'' The Organ Procurement Organization (OPO) Certification Act of 2000 (Sec. 701 of Pub. L. 106-505) directs the Secretary of HHS to establish regulations that provide the statutory qualifications and requirements that an OPO must meet in order for organ procurement costs to be reimbursed under the Medicare and Medicaid programs. As part of the efficient administration of this program, CMS is charged with the responsibility to conduct investigations, analysis, and reporting of adverse events that are described as an untoward, undesirable, and unanticipated event that causes death or serious injury. At this time, individually-identifiable data is only requested from OPOs under two circumstances: (1) Due to the suspicion that an infectious disease has been transmitted to a recipient; and (2) when there has been a complaint alleged against an OPO. CMS regional office survey and certification staff would request individually-identifiable data to complete the investigation. Due to certain investigatory activities related to this system, CMS proposes to exempt this system from the notification, access, correction and amendment provisions of the Privacy Act of 1974. The purpose of this system is to collect and maintain individually identifiable information pertaining to complaint allegations filed by a complainant, beneficiary, or providers of services made against OPOs, information gathered during the complaint investigation, findings and results of the investigation, and correspondence relating to the outcome of the investigation. Information retrieved from this system will also be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the agency, or by a contractor, consultant or grantee; (2) assist another Federal or state agency in the enforcement of OPO regulations where sharing the information is necessary to complete the processing of a complaint, contribute to the accuracy of CMS's proper payment of Medicare benefits, and/or enable such agency to administer a Federal health benefits program; (3) support constituent requests made to a Congressional representative; and (4) support litigation involving the agency. We have provided background information about the modified system in the ``Supplementary Information'' section below. Although the Privacy Act requires only that CMS provide an opportunity for interested persons to comment on the proposed routine uses, CMS invites comments on all portions of this notice. See ``Effective Dates'' section for comment period.

The Health Resources and Services Administration (HRSA) is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (``the Program''), as required by section 2112(b)(2) of the Public Health Service (PHS) Act, as amended. While the Secretary of Health and Human Services is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Neurological Disorders and Stroke (NINDS) Office of Science Policy and Planning, the National Institute of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on December 21, 2005, pages 75823-75824, and allowed 60-days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Proposed Collection: Title: A Process/Outcome Evaluation of Parkinson's Disease Research Centers Type of Information Collection Request: NEW. Need and Use of Information Collection: This study is primarily an outcome evaluation, designed to assess the extent to which the NINDS-funded Morris K. Udall Centers for Excellence in Parkinson's Disease Research have achieved the program's short-term and long-term goals. The study also includes elements of a process evaluation in its examination of the major activities conducted by the Udall Centers, the relationship between Center activities and the achievement of program goals, and the NINDS management of the program. The results of the full-scale evaluation should be very helpful to NINDS in identifying the most relevant measures for tracking the future progress of the Centers, developing strategies to enhance the program's effectiveness, and improving program management. NINDS will also use the findings to inform its National Advisory Neurological Disorders and Stroke Council, and to address inquiries from the public regarding the impact of the Udall Centers Program. Lastly, Udall Center awardees will be able to use the evaluation results to improve the performance of their Centers; and other NIH Institutes and Centers may use the methodology and results of this evaluation to guide their own centers assessments. Frequency of Response: Once or twice. Affected Public: Researchers, Not-for-profit institutions; Federal Government; individuals or households. Type of Respondents: Adult professionals. The annual reporting burden is provided in the following table:

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 requirements for recordkeeping and reports concerning experience with approved new animal drugs. The information contained in the reports required by this regulation enables FDA to monitor the use of new animal drugs after approval and to ensure their continued safety and efficacy.

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (DHHS) is hereby giving notice that the Presidential Advisory Council on HIV/AIDS (PACHA) will hold a meeting. This meeting is open to the public. A description of the Council's functions is included also with this notice.

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (DHHS) is hereby giving notice that the Advisory Committee on Minority Health (ACMH) will hold a meeting. This meeting is open to the public. Preregistration is required for both public attendance and comment. Any individual who wishes to attend the meeting and/or participate in the public comment session should e-mail acmh@osophs.dhhs.gov.

CERHR announces the availability of the genistein and soy formula expert panel reports on the CERHR Web site (https:// cerhr.niehs.nih.gov) or in print from CERHR (see ADDRESSES below). These expert panel reports are evaluations of the reproductive and developmental toxicity of genistein and soy formula conducted by a 14- member expert panel composed of scientists from the federal government, universities, and private organizations. CERHR invites the submission of public comments on these expert panel reports.

On Monday, October 7, 2002, CDC published final criteria for consideration of chemicals or categories of chemicals for possible inclusion in future releases of CDC's ``National Report on Human Exposure to Environmental Chemicals (the ``Report'') and also solicited chemicals for possible inclusion in future editions of the ``Report'' (See Federal Register, 67 FR 62477). The final selection criteria have remained the same since the issuance of the 2002 notice. They are as follows: (1) Independent scientific data which suggest that the potential for exposure of the U.S. population to a particular chemical is changing (i.e., increasing or decreasing) or persisting; (2) seriousness of health effects known or suspected to result from exposure to the chemical (for example, cancer, birth defects, or other serious health effects); (3) proportion of the U.S. population likely to be exposed to levels of chemicals of known or potential health significance; (4) need to assess the efficacy of public health actions to reduce exposure to a chemical in the U.S. population or a large component of the U.S. population (for example, among children, women of childbearing age, the elderly); (5) existence of an analytical method that can measure the chemical or its metabolite in blood or urine with adequate accuracy, precision, sensitivity, and speed; and (6) incremental analytical cost (in dollars and personnel) to perform the analyses (preference is given to chemicals that can be added readily to existing analytical methods). On Tuesday, September 30, 2003, CDC published a record of the nominated chemicals of interest that were scored by a panel of experts in accordance with the published selection criteria. (See Federal Register, 68 FR 56296.) All of this information is available on CDC's Web site at https://www.cdc.gov/exposurereport/chemical nominations.htm. Past and future nominations do not result in obligatory laboratory analysis or inclusion of nominated chemicals in the ``Report,'' but rather serve to better inform CDC about which chemicals are of concern to the public. CDC now requests public comment on proposed criteria for removing chemicals from future editions of the ``Report.'' These removal criteria (given below) will become part of a combined process of nominating chemicals for inclusion in or removal from the ``Report.'' This process will include (a) nominations from the public of chemicals to include or remove from the ``Report,''(b) an external scoring of nominations in accord with the published nomination and removal criteria, and (c) assistance from the Board of Scientific Counselors of CDC's National Center for Environmental Health/Agency for Toxic Substances and Disease Registry in reviewing plans for including or removing chemicals and identifying alternatives for monitoring specific at-risk population subgroups. This combined process for nomination and removal would occur periodically (e.g., every six years). The criteria for selecting and removing chemicals apply only to those chemicals published in the ``Report,'' not those merely nominated. The proposed removal criteria are as follows: A chemical may be removed from the ``Report'': (1) If a new replacement chemical (i.e., a metabolite) is more representative of exposure than the chemical currently being measured or; (2) if after three survey periods (or not less than six years), detection rates for all chemicals within a methodological and chemically-related group* are less than 5 percent for all population subgroups (two sexes, three race/ethnicity, and three age groups) or; (3) if after three survey periods (or not less than six years), levels of chemicals within a methodological and chemically- related group are unchanged or declining in all the specific subgroups as documented in the ``Report.'' A chemical would continue to be measured and not be removed from the ``Report'' if it met either of two proposed exceptions to these criteria: (a) It is a chemical for which there is an established biomonitoring health threshold (e.g., CDC's level of concern for blood lead levels in children) or any chemical for which there is widespread public health concern (e.g., mercury) or (b) three survey periods (or not less than six years) have passed, which constitute the minimum time before a chemical could be removed; a longer period may be necessary to account for the half-life of a particular chemical or to account for a recent change (e.g., the removal of a chemical from commerce) that would necessitate monitoring of the population. Note that the criteria for removing a chemical from the ``Report'' are not the corollaries of the criteria for adding chemicals to the ``Report.'' After reviewing and incorporating public comments from this announcement, CDC will publish the criteria in their final form in the Federal Register.

The Food and Drug Administration (FDA) is seeking volunteers to participate in a pilot project involving the testing of a Health Level 7 (HL7) data interchange standard for the submission of product stability data to FDA to facilitate the review of this data. Using the data interchange standards and the analytical tools will allow consistent data presentation to the agency and allow a reviewer to more efficiently and consistently display and evaluate product stability data submitted in electronic format.

The Agency for Healthcare Research and Quality (AHRQ) is seeking nominations for members of an AHRQ-convened Workgroup on risk adjustment specifically aimed at the AHRQ Quality Indicators (QIS). This Workgroup is being formed as part of a structured approach for evaluating risk-adjustment and the appropriateness of hierarchical modeling methodology for the AHRQ Quality Indicators at the area and/or provider levels. The Workgroup will evaluate appropriate technical and methodological approaches currently available, and will also discuss and suggest strategies as to what risk adjustment approach(s), if any, would best fit AHRQ QI user needs. As part of this effort and using the AHRQ QIs, the Workgroup member will be addressing several key issues for the development of a risk adjustment methodology, including but not limited to: Statistical and methodological issues related to the development and validation of risk adjusted models that predict patient outcomes using administrative data, and are suitable for assessing quality at different levels (individual hospital, State, region). Methods for comparing the performance of hierarchical methods with previously employed methods based on administrative data to improve predictive and discriminant ability, and overall fit. Appropriate use of sub-sampling techniques for model validation. Computation of confidence intervals for assessing provider-specific and State-level performance in comparison to national summary statistics (means or percentiles). For additional information about the AHRQ QIs, please visit the AHRQ Web site at https://www.qualityindicators.ahrq.gov. Specifically, the AHRQ QIs Risk Adjustment Workgroup will consist of up to 9 individuals who are familiar with different risk adjustment methodologies including hierarchical modeling approaches. The Workgroup will have a series of conference calls to discuss the technical and policy issues surrounding risk adjustment for the AHRQ QIs and will then assist AHRQ in developing a report that will aim to summarize the discussions and suggestions of the workgroup, which will be made available for public comment.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for a new animal drug application (NADA) for fomepizole solution for injection from Orphan Medical, Inc., to Jazz Pharmaceuticals, Inc. The regulations are also being amended to reflect approval of a supplemental NADA to remove a vial of saline diluent from this product.

This is a project to enhance the surveillance, epidemiological investigation, and laboratory diagnostic capabilities in Panama and other selected countries in Latin America that are at risk for an avian influenza (H5N1) outbreak. Such enhancements will help establish an early-warning system that could prevent and contain the spread of a highly pathogenic avian influenza to the United States and enhance our nation's preparedness for a possible human influenza pandemic.

The revised Federal Medical Assistance Percentages and Enhanced Federal Medical Assistance Percentages for Alaska for Fiscal Years 2006 and 2007 have been calculated pursuant to section 6053(a) of the Deficit Reduction Act. These percentages will be effective from October 1, 2005 through September 30, 2006 and October 1, 2006 through September 30, 2007. These revised Federal Medical Assistance Percentages for Alaska replace the percentages previously published for Fiscal Year 2006 (published November 24, 2004) and Fiscal Year 2007 (published November 30, 2005). This notice announces the revised ``Federal Medical Assistance Percentages'' and ``Enhanced Federal Medical Assistance Percentages'' that we will use in determining the amount of Federal matching for State medical assistance (Medicaid) and State Children's Health Insurance Program (SCHIP) expenditures for Alaska. The table gives the figure for Alaska, which is the only state affected by section 6053(a) of the Deficit Reduction Act. Section 6053(a) of the Deficit Reduction Act of 2005 provides for a modification of Alaska's Medicaid FMAP for Fiscal Years 2006 and 2007. The provision permits a maintenance of the Fiscal Year 2005 FMAP for Fiscal Year 2006 and Fiscal Year 2007 if the 2006 or 2007 FMAPs as calculated pursuant to section 1905(b) of the Act are less than the 2005 FMAP. Since the calculated Fiscal Year 2006 and 2007 FMAPs for Alaska are less than the 2005 FMAP, Alaska's 2005 FMAP will apply for Fiscal Years 2006 and 2007. Section 6053(a) applies to expenditures under Title XIX and Title XXI. Therefore, the Enhanced Federal Medical Assistance Percentages for Alaska for 2006 and 2007 will be calculated from Alaska's revised Federal Medical Assistance Percentages for 2006 and 2007. Federal Medical Assistance Percentages are used to determine the amount of Federal matching for State expenditures for assistance payments for certain social services such as Temporary Assistance for Needy Families (TANF) Contingency Funds, Child Care Mandatory and Matching Funds for the Child Care and Development Fund, Title IV-E Foster Care Maintenance payments, Adoption Assistance payments, and State medical and medical insurance expenditures for Medicaid and the State Children's Health Insurance Program (SCHIP). However, the modification of the Federal Medical Assistance Percentages and the Enhanced Federal Medical Assistance Percentages under the Deficit Reduction Act of 2005 affect only medical expenditure payments under Title XIX and all expenditure payments for the State Children's Health Insurance Program under Title XXI. The Department believes that the percentages in this notice do not apply to payments under Title IV of the Act. In addition, the Title XIX statute provides separately for Federal matching of administrative costs, which is not affected by the Deficit Reduction Act of 2005. The Deficit Reduction Act of 2005, section 6053(b) also instructs the Secretary of HHS to disregard Katrina evacuees and income attributable to them in calculating the FMAPs for states with a significant number of evacuees. This provision would affect the calculation of the Federal Medical Assistance Percentages for Fiscal Year 2008, which HHS will publish in Fall 2006.

In accordance with section 10(a) of the Federal Advisory Committee Act, this notice announces a meeting of the Citizens' Health Care Working Group (the Working Group) mandated by section 1014 of the Medicare Modernization Act.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for 25 approved new animal drug applications (NADAs) and 16 approved abbreviated new animal drug applications (ANADAs) for Type A medicated articles and feed use combinations from Intervet, Inc., to Huvepharma AD.

This proposed rule would update the prospective payment rates for inpatient rehabilitation facilities (IRFs) for Federal fiscal year (FY) 2007 (for discharges occurring on or after October 1, 2006 and on or before September 30, 2007) as required under section 1886(j)(3)(C) of the Social Security Act (the Act). Section 1886(j)(5) of the Act requires the Secretary to publish in the Federal Register on or before the August 1 that precedes the start of each fiscal year, the classification and weighting factors for the inpatient rehabilitation facility prospective payment system's case-mix groups and a description of the methodology and data used in computing the prospective payment rates for that fiscal year. We are proposing to revise existing policies regarding the prospective payment system within the authority granted under section 1886(j) of the Act. In addition, we are proposing to revise the current regulation text at 42 CFR 412.23(b)(2)(i) and (b)(2)(ii) to reflect the changes enacted under section 5005 of the Deficit Reduction Act of 2005.

Pursuant to Section 10(a) of the Federal Advisory Committee Act as amended (5 U.S.C. Appendix 2), notice is hereby given of the ninth Policy Committee meeting concerning adoption of the final report. The meeting will be open to the public, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should inform the contact person listed below in advance of the meeting. This notice is being published less than 15 days prior to the meeting due to scheduling problems.