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

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.