National Vaccine Injury Compensation Program: Addition of Trivalent Influenza Vaccines to the Vaccine Injury Table
Through this notice, the Secretary announces that trivalent influenza vaccines are covered vaccines under the National Vaccine Injury Compensation Program (VICP), which provides a system of no-fault compensation for certain individuals who have been injured by covered childhood vaccines. This notice serves to include trivalent influenza vaccines as covered vaccines under Category XIV (new vaccines) of the Vaccine Injury Table (Table), which lists the vaccines covered under the VICP. This notice ensures that petitioners may file petitions relating to trivalent influenza vaccines with the VICP even before such vaccines are added as a separate and distinct category to the Table through rulemaking.
Notice of Meeting of the Advisory Committee on Organ Transplantation
Pursuant to Pub. L. 92-463, the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the eighth meeting of the Advisory Committee on Organ Transplantation (ACOT), Department of Health and Human Services (HHS). The meeting will be held from approximately 9 a.m. to 5:30 p.m. on May 9, 2005, and from 9 a.m. to 3 p.m. on May 10, 2005, at the Rockville DoubleTree Hotel, 1750 Rockville Pike, Rockville, Maryland 20852. The meeting will be open to the public; however, seating is limited and pre-registration is encouraged (see below).
HHS Approval of Professional Organizations and States' Standards for Certification
The Health Resources and Services Administration's (HRSA) Healthcare Systems Bureau, Division of Healthcare Preparedness Poison Control Program, provides supplemental funding to Poison Control Centers (PCCs) across the United States, promotes universal access to PCC services, and encourages the enhancement and improvement of poison education, prevention, and treatment. To receive funding from HRSA, PCCs must meet certain certification requirements. The purpose of this solicitation of comments is to assist HRSA in establishing criteria/ guidelines to approve professional organizations and State governments' certification standards for PCCs.
Following the Senate Committee's recommendation, the Health Resources and Services Administration (HRSA) will give funding preference during the FY 2005 competition to current and former Healthy Start grantees, including those whose Healthy Start grant application was approved but not funded in FY 2004. Senate Report 108-345 at 54 (2004) accompanying the Consolidated Appropriations Act, 2005 (Pub. L. 108-447) states ``The Committee urges HRSA to give preference to current and former grantees with expiring or recently expired project periods. This should include grantees whose grant applications were approved but not funded during fiscal year 2004.''
Health Resources and Services Administration (HRSA); Request for Public Comment on a HRSA Commissioned Report: Newborn Screening: Toward a Uniform Screening Panel and System
The changing dynamics of emerging technology, and the complexity of genetics require an assessment of the state of the art in newborn screening and a perspective on the future directions such programs should take. In 1999, the American Academy of Pediatrics Newborn Screening Task Force recommended that ``HRSA should engage in a national process involving government, professionals, and consumers to advance the recommendations of this Task Force and assist in the development and implementation of nationally recognized newborn screening system standards and policies.'' In response to this need, pursuant to 42 U.S.C. 701(a)(2), the Maternal and Child Health Bureau (MCHB) of HRSA commissioned the American College of Medical Genetics (ACMG) to conduct an analysis of the scientific literature on the effectiveness of newborn screening and gather expert opinion to delineate the best evidence for screening specified conditions and develop recommendations focused on newborn screening, including but not limited to the development of a uniform condition panel. It was expected that the analytical endeavor and subsequent recommendations be based on the best scientific evidence and analysis of that evidence. ACMG was specifically asked to develop recommendations to address: A uniform condition panel (including implementation methodology); Model policies and procedures for State newborn screening programs (with consideration of a national model); Model minimum standards for State newborn screening programs (with consideration of national oversight); A model decision matrix for consideration of State newborn screening program expansion; and The value of a national process for quality assurance and oversight. The ACMG report is a response to the HRSA/MCHB request. The ACMG report, Newborn Screening: Toward a Uniform Screening Panel and System is available at http://mchb.hrsa.gov/screening. In the report, 29 conditions were identified as primary targets or core panel conditions for screening; an additional 25 conditions were listed as conditions that could be identified in the course of screening for core panel conditions. Many of these 25 additional conditions are included in the differential diagnosis of the conditions including in the primary target list. With additional screening, an improvement in the infrastructure for appropriate follow-up and management throughout the lives of children who have been identified as having one of these rare conditions will be needed. A cost analysis for the State of California indicates newborn screening is beneficial to patients and may have some net costs or net savings over time depending on assumptions of expected lifetime costs of medical care. HRSA is now seeking public comments on the report and its recommendations.
Advisory Committee on Organ Transplantation; Request for Nominations for Voting Members
The Health Resources and Services Administration (HRSA) is requesting nominations to fill up to 13 vacancies on the Advisory Committee on Organ Transplantation (ACOT). The ACOT was established by the Amended Final Rule of the Organ Procurement and Transplantation Network (OPTN) (42 CFR Part 121) and, in accordance with Pub. L. 92- 463, was chartered on September 1, 2000.
Final Nurse Practitioner and Nurse-Midwifery Education Program Guidelines
On November 3, 2003, the Health Resources and Services Administration (HRSA) published for comment proposed revisions to the Nurse Practitioner and Nurse-Midwifery Education Program Guidelines (Guidelines) for use in the Advanced Education Nursing Grant Program. HRSA has considered the comments received and is publishing the final Guidelines with responses to the comments.
National Vaccine Injury Compensation Program; List of Petitions Received
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.
New Methodology and Increase in Low Income Levels for Various Health Professions and Nursing Training and Assistance Programs
HRSA uses ``low-income'' levels to determine whether an individual is from an economically disadvantaged background in making eligibility and funding determinations for participants in various health professions and nursing grant and cooperative agreement programs authorized by Titles III, VII and VIII of the Public Health Service (PHS) Act. In the past, an individual's economically disadvantaged background status, as a basis for participation in certain programs, was based on the income level of the individual's parents. However, many potential program participants are well above the age of majority. Accordingly, questions have been raised by potential program participants and program officials regarding the feasibility and fairness in determining economically disadvantaged status based solely on the parent's income. This notice updates the low-income levels published by HRSA on August 5, 2003 (68 FR 46199-46200), and changes the methodology used to determine low income for use in these programs beginning in Fiscal Year (FY) 2005.
Chiropractor Loan Repayment Demonstration Project
The authority for the Demonstration Project has been extended with respect to chiropractors (see legislative authority below). The Health Resources and Services Administration (HRSA) announces that applications from qualified chiropractors who agree to serve underserved populations in Primary Care Health Professional Shortage Areas (HPSAs) throughout the Nation will be accepted by the National Health Service Corps (NHSC) for loan repayment awards. A two-year service commitment is required. There is no guarantee that participants in this demonstration project will have an opportunity to continue their service and loan repayments beyond the initial two-year service period. Chiropractors, with qualifying educational loans, must serve at organized primary health care sites in Primary Care HPSAs that have another NHSC clinician on staff who will be concurrently fulfilling an NHSC service commitment through the scholarship or loan repayment program and who is licensed to prescribe medications. This demonstration project will include an evaluation component to determine whether adding chiropractors as permanent NHSC members would enhance the effectiveness of the NHSC. A maximum of 40 individuals will be awarded loan repayment contracts under this demonstration project. Purpose: Eligible chiropractors will participate in the Loan Repayment Demonstration Project to determine whether their services will enhance the effectiveness of the NHSC. Legislative Authority: These applications are solicited under section 338L of the Public Health Service (PHS) Act, as amended by Public Law. 107-251 and Public Law 108-447. See also H.R. Conf. Rep. No. 108-792, at 1113, 1155 (2004); S. Rep. No. 108-345, at 41-42 (2004). Eligible Applicants: Eligible applicants must (1) be citizens or nationals of the United States, (2) possess a current unrestricted license to practice as a chiropractor in the State in which they intend to practice, (3) be negotiating or have secured employment at an eligible community site, and (4) meet the additional eligibility requirements outlined in the application materials. Chiropractors must also have a doctor of chiropractic degree from a four-year chiropractic college that is currently fully accredited by the Commission on Accreditation of the Council on Chiropractic Education, and successfully passed the entire examination by the National Board of Chiropractic Examiners. Funding Priorities or Preferences: Priority will be given to (A) applicants who have characteristics that increase the probability of their continuing to practice in HPSAs after they have completed service, and (B) subject to paragraph (A), applicants from disadvantaged backgrounds. A funding preference will also be given to applicants serving Primary Care HPSAs of greatest shortage (based on the HPSA scores). Statutory Matching or Cost Sharing Requirement: None. Review Criteria: Loan repayment applications will be evaluated to determine (1) the eligibility of the applicant, and (2) the applicant's priority for funding. Estimated Amount of this Competition: $2,000,000. Estimated Number of Awards: 40. Estimated or Average Size of Each Award: $50,000. Estimated Project Period: 2 years. Application Requests, Availability, Dates and Addresses: Application materials are available for downloading via the Web at http://nhsc.bhpr.hrsa.gov. Applicants may also request a hard copy of the application materials by contacting the National Health Service Corps at 1-800-638-0824. All application materials must be submitted in hard copy format. In order to be considered for an award, applications from chiropractors must be postmarked or delivered to the HRSA National Health Service Corps by no later than June 17, 2005 at 5 p.m. ET. Completed applications must be mailed or delivered to: Division of National Health Service Corps, NHSC Loan Repayment Program, c/o I.Q. Solutions, 11300 Rockville Pike, Suite 901, Rockville, MD, 20852. Applicants should request a legibly dated U.S. Postal Service postmark or obtain a legibly dated receipt from a commercial carrier or the U.S. Postal Service. Private metered postmarks shall not be acceptable as proof of timely mailing. Applications postmarked or submitted after the deadline date, or sent to any address other than that above, will be returned to the applicant and not processed. The NHSC will acknowledge receipt of the application if the applicant chooses to complete the notification postcard that is included in the application materials. Application Availability Date: February 2005. Application Deadline: June 17, 2005 at 5 p.m. et. Projected Award Date: September 30, 2005.
Development of Revised Need for Assistance Criteria for Assessing Community Need for Comprehensive Primary and Preventive Health Care Services Under the President's Health Centers Initiative
Currently, application scores for New Access Point (NAP) applications under the President's Health Centers Initiative (Program) cluster at the high end of the scoring range, providing little distinction among applicants. Since the intent of the Program is to provide grants to the neediest communities, HRSA is considering placing more emphasis on assessing the need for comprehensive primary and preventive health care services in the service area or for the population for which the applicant is seeking support, by revising the Need for Assistance Criteria and changing the relative weights of the review criteria used in evaluating such applications. This notice offers public and private nonprofit entities an opportunity to comment on the proposed changes in the Need for Assistance Criteria (NFA), and on the degree to which need should be weighted relative to other criteria used in evaluating future applications. In order to solicit comments from the public on these proposed changes, HRSA is delaying the due date (May 23, 2005) for the second round of fiscal year (FY) 2005 New Access Point applications. Authorizing Legislation: Section 330(e)(1)(A) of the Public Health Service Act, as amended, authorizes support for the operation of public and nonprofit private health centers that provide health services to medically underserved populations. Reference: For the current Need for Assistance (NFA) criteria and other application review criteria, including weights used most recently, see Program Information Notice (PIN) 2005-01, titled ARequirements of Fiscal Year 2005 Funding Opportunity for Health Center New Access Point Grant Applications,'' are available on HRSA's Bureau of Primary Health Care (BPHC) Web site at http://bphc.hrsa.gov/ pinspals/pins.htm. That PIN detailed the eligibility requirements, review criteria, and awarding factors for applicants seeking support for the operation of New Access Points in FY 2005. Background: The goal of the President's Health Centers Initiative, which began in FY 2002, is to increase access to comprehensive primary and preventive health care services to 1,200 of the Nation's neediest communities through new and/or significantly expanded health center access points over five years. These health center access points are to provide comprehensive primary and preventive health care services in areas of high need that will improve the health status of the medically underserved populations to be served and decrease health disparities. Services at these new access points may be targeted toward an entire community or service area or toward a specific population group in the service area that has been identified as having unique and significant barriers to affordable and accessible health care services. While it is extremely important that NAP grant awards be made to entities that will successfully implement a viable and compliant program for the delivery of comprehensive primary health services to the populations or communities they propose to serve, HRSA also needs to assure that all applicants seeking support for a NAP applicant can demonstrate the need for such services in the community (area or population group) to be served and be evaluated on that need. Under the current guidance, NFA criteria are used to quantify barriers to access and identify health disparities. The NFA process also establishes a threshold which applicants must meet in order for their applications to be reviewed by the Objective Review Committee (ORC). Description of Current NFA process. The current NFA process (as described in Form 9-Part A of PIN 2005-01) involves two major groups of indicators. First, from eight (8) ``Barriers and Access to Care'' measures, the applicant must select five (5). These measures are: Shortage of primary care physicians, as measured by whether the target service area has been designated as a geographic or population group Health Professions Shortage Area (HPSA); Percent of the population with incomes below 200% of the Federal poverty level; Life expectancy of target population (in years); percentage of target population uninsured; unemployment rate of target population; average travel time or distance to nearest source of primary care for target population; percentage of target population age 5 or older who speak a language other than English at home; and length of waiting time for public housing and Section 8 certificates for target population. For the first of these measures, the applicant receives 14 points if HPSA-designated and zero otherwise; for each of the other measures, the NFA criteria define a 6-level scale from 0 to 14 points. The applicant provides data for its service area or target population for each of the 5 measures selected, and identifies the source of data used. Given 5 indicators and a maximum of 14 points for each, there are a possible 70 points for the ``Barriers and Access to Care'' indicators. Second, from 28 ``Health Disparity Factors'', the applicant selects 10 and provides data on each for its service areas or target populations. For each factor selected, the applicant can receive 3 points if the value for the target population exceeds the benchmark used. The applicant defines the benchmark, and gives a source for that benchmark as well as a source for the target population data provided. The guidance lists 27 specific factors, plus an ``other'' category allowing the applicant to select one additional locally-relevant factor not anticipated by the guidance. This approach produces a possible 30 points for the ``Health Disparities Factors'' section; combined with the possible 70 for ``Barriers and Access to Care'' section, allowing a possible 100 total points are possible. In current guidance, the threshold for having the application reviewed has been set at an NFA score of 70 out of the possible 100 total points.
Privacy Act of 1974; New System of Records
In accordance with the requirements of the Privacy Act, the Health Resources and Services Administration (HRSA) is publishing notice of a proposal to add a new system of records. The new system of records, ``State-Provided Physician Records for the Application Submission & Processing System, SDB, BHPr, HRSA,'' will cover health care practitioners who are the subjects of databases collected and maintained by State Primary Care Offices/Associations. Such health care practitioners include physicians (both M.D.s and D.O.s), licensed or otherwise authorized by a State to provide health care services. This system of records is required to comply with the implementation directives of the Act, Public Law 108-20. The records will be used to support the Application Submission and Processing System electronic application for the development, submission, and review of applications for HPSAs and MUPs. The most critical requirement for accurate designation determinations is accurate data on the location of primary care providers relative to the population. To this end, SDB continually tries to obtain the latest data on primary care providers and their practice location(s) at the lowest geographical level possible for use in the designation process, with the objective of minimizing the level of effort required on the part of States and communities seeking designations.