Bioterrorism Training and Curriculum Development Program; Notification of Exception to Competition
The Health Resources and Services Administration's (HRSA) Healthcare Systems Bureau, Division of Healthcare Preparedness Bioterrorism Training and Curriculum Development Program (BTCDP) will provide supplemental funding to approximately five fiscal year (FY) 2006 BTCDP awardees to plan, test and evaluate the expansion of regional healthcare preparedness training efforts to a nationwide focus. A limited competition within the existing 19 awardees will be used to identify the recipients. Authority: This activity is under that authority of the Public Health Service Act, Title III, Section 319F(g), 42 U.S.C. 247d-6(g). Purpose: The purpose of supplemental awards is to expand the reach of the originally approved BTCDP awards from the currently approved geographic region to include the entire Nation. The intended recipients of this limited eligibility program expansion will be the successfully competed and objectively reviewed applicants from the already supported 19 regional BTCDP awardees. The program expansion will enhance consistency in preparedness training by providing proven training through a nationwide focus. Previous efforts have consisted of a more limited approach focusing training at a local/regional level. Amount: The anticipated award amount of $1.8 million will be distributed among the 4 or 5 most highly ranked (by objective review) applicants from the existing 19 BTCDP awardees. Awards will average $360,000. Project Period: The period of support is from September 30, 2006, to August 31, 2007, and will align with the existing budget period. Justification for the Exception to Competition: Open competition applications for the BTCDP program were received and reviewed by an objective review panel in the summer of FY 2005, at which time BTCDP's local and regional training plans, curriculum and evaluation strategies were reviewed and approved. A total of 74 Continuing Education applications were reviewed and 50 applications were approved. Nineteen projects were funded after careful review from a strongly competitive pool of applicants, emerging as the strongest entities with proven experience and track records to expand their accomplishments to a nationwide target of healthcare providers. Since that time, the awardees have continued to use Federal funds to align their training with the National Preparedness Goal and to deliver training consistent with HRSA's goals. BTCDP funded programs are uniquely suited to participate in this geographic expansion based upon their authorship and mastery of tested curriculum. BTCDP awardees have been awarded funds specifically to develop training strategies for all healthcare professionals. Their experiences have made them uniquely aware of potential pitfalls to be overcome in developing and testing a national training plan and have the expertise to respond to such barriers as they arise. Since the inception of the program in FY 2003, BTCDP awardees have been responsible for the training of 225,000 healthcare providers on a locality-by-locality basis and stand ultimately poised to deploy and evaluate national training strategies. BTCDP awardees are highly regarded academic institutions which have dedicated staff and infrastructure to create quality training opportunities for healthcare providers. Curriculum created with BTCDP dollars has already been approved by the academic institutions from which they emanate and has already secured the approval of healthcare professional continuing education accreditation bodies. Awardees possess the building blocks of the infrastructure necessary to efficiently test a national training system, and they have the knowledge and experience necessary to ensure the efficient use of funds for healthcare preparedness training. The BTCDP is the only Federal program solely committed to the preparedness training of healthcare providers. As such, BTCDP awardees share curriculum, accomplishments and lessons learned through an established network on a regular basis, a network vital to the development of a national plan. Awardees stand uniquely prepared to respond to congressional demand for an efficient and effective national training strategy within the fiscal and time constraints of this supplement. This supplement is the first step in meeting this demand through the efficient use of proven curriculum by experienced trainers on a national basis.
Cooperative Agreement for Poison Prevention Education
HRSA will be forming a partnership with the Home Safety Council (HSC) to collaborate on reaching America's low literacy population. Through this project, easy to read and comprehend poison prevention material will be developed and distributed to the public, poison centers, safety and injury prevention professionals, health educators, and first responders.
Advisory Commission on Childhood Vaccines; Request for Nominations for Voting Members
The Health Resources and Services Administration (HRSA) is requesting nominations to fill three vacancies on the Advisory Commission on Childhood Vaccines (ACCV). The ACCV was established by Title XXI of the Public Health Service Act (the Act), 42 U.S.C. 300aa-1 et seq., and advises the Secretary of Health and Human Services (the Secretary) on issues related to implementation of the National Vaccine Injury Compensation Program (VICP).
``Low Income Levels'' Used for Various Health Professions and Nursing Programs Included in Titles III, VII and VIII of the Public Health Service Act
The Health Resources and Services Administration (HRSA) is updating income levels used to identify a ``low income family'' for the purpose of determining eligibility for programs that provide health professions and nursing training for individuals from disadvantaged backgrounds. These various programs are included in Titles III, VII and VIII of the Public Health Service (PHS) Act. The Department periodically publishes in the Federal Register low income levels used to determine eligibility for grants and cooperative agreements to institutions providing training for (1) disadvantaged individuals, (2) individuals from disadvantaged backgrounds, or (3) individuals from ``low income families.''
Recruitment of Sites for Assignment of Corps Personnel
The Health Resources and Services Administration (HRSA) announces that the listing of entities, and their Health Professional Shortage Area (HPSA) scores, that will receive priority for the assignment of National Health Service Corps (NHSC) personnel (Corps Personnel, Corps members) for the period July 1, 2006 through June 30, 2007 is posted on the NHSC Web site at http://nhsc.bhpr.hrsa.gov/ resources/fedreg-hpol/. This list specifies which entities are eligible to receive assignment of Corps members who are participating in the NHSC Scholarship Program, the NHSC Loan Repayment Program, and Corps members who have become Corps members other than pursuant to contractual obligations under the Scholarship or Loan Repayment Programs. Please note that not all vacancies associated with sites on this list will be for Corps members, but could be for individuals serving an obligation to the NHSC through the Private Practice Option.
Response to Solicitation on Organ Procurement and Transplantation Network (OPTN) Living Donor Guidelines
A notice was published in the Federal Register on January 23, 2006 (Vol. 71, No. 14, pages 3519-3520). The purpose of this notice was to solicit comments to assist HRSA in determining whether criteria developed by the Organ Procurement and Transplantation Network (OPTN) concerning organs procured from living donors, including those concerning the allocation of organs from living donors, should be given the same status, and be subject to the same enforcement actions, as other OPTN policies.
National Vaccine Injury Compensation Program: Calculation of Average Cost of a Health Insurance Policy
Subtitle 2 of Title XXI of the Public Health Service Act, as enacted by the National Childhood Vaccine Injury Act of 1986, as amended (the Act), governs the National Vaccine Injury Compensation Program (VICP). The VICP, administered by the Secretary of Health and Human Services (the Secretary), provides that a proceeding for compensation for a vaccine-related injury or death shall be initiated by service upon the Secretary, and the filing of a petition with the United States Court of Federal Claims (the Court). In some cases, the injured individual may receive compensation for future lost earnings, less appropriate taxes and the ``average cost of a health insurance policy, as determined by the Secretary.'' The Secretary now proposes a new method of calculating the average cost of a health insurance policy.
Smallpox Vaccine Injury Compensation Program: Administrative Implementation
This document adopts the Smallpox Vaccine Injury Compensation Program (the Program) Administrative Implementation Interim Final Rule as the Final Rule with amendments, as follows: explains how the term ``child'' survivor is defined; updates the effective period of the Secretary's Declaration Regarding Administration of Smallpox Countermeasures (the Declaration); corrects an error in Sec. 102.20(d) to clarify that one of the Smallpox (Vaccinia) Vaccine Injury Table requirements to establish a covered Table injury is the first symptom or manifestation of onset of the injury in the Table time period specified; reflects the change in name from the Special Programs Bureau to the Healthcare Systems Bureau; provides the new address of the Bureau's Associate Administrator, and the new address of the Program Office; clarifies that no payments are authorized for fees or costs of personal representatives, including those of attorneys; and corrects a typographical error in Sec. 102.83(c) to make clear that the Secretary determines the timeframe for submission of required documentation.
Smallpox Vaccine Injury Compensation Program: Smallpox (Vaccinia) Vaccine Injury Table
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.
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.
Blood Vessels Recovered With Organs and Intended for Use in Organ Transplantation; Companion Document to Direct Final Rule
The Health Resources and Services Administration (HRSA) and the Food and Drug Administration (FDA) are proposing to amend their regulations to consider as part of an organ those blood vessels recovered with the organ that are intended for use in organ transplantation (HRSA regulation); and to exclude such blood vessels from the definition of human cells, tissues, and cellular and tissue- based products (HCT/Ps) (FDA regulation). We (HRSA and FDA) are taking this action to provide that blood vessels recovered with organs and intended for use in organ transplantation will be governed by the regulations pertaining to organs. The regulation of other recovered blood vessels would remain unchanged. We believe that this change will eliminate the unnecessary burden resulting from an organ procurement organization's efforts to comply with both FDA and HRSA rules with respect to blood vessels (FDA jurisdiction) and organs (HRSA jurisdiction). This proposed rule is a companion document to the direct final rule published elsewhere in this issue of the Federal Register. We are taking this action because the proposed changes are noncontroversial, and we do not anticipate any significant adverse comments. If we receive any significant adverse comments that warrant terminating the direct final rule, we will consider such comments on the proposed rule in developing the final rule.
Blood Vessels Recovered With Organs and Intended for Use in Organ Transplantation
The Health Resources and Services Administration (HRSA) and the Food and Drug Administration (FDA) are amending their regulations to consider as part of an organ those blood vessels recovered with the organ that are intended for use in organ transplantation (HRSA regulation); and to exclude such blood vessels from the definition of human cells, tissues, and cellular and tissue- based products (HCT/Ps) (FDA regulation). We (HRSA and FDA) are taking this action to provide that blood vessels recovered with organs and intended for use in organ transplantation are governed by the regulations pertaining to organs. The regulation of other recovered blood vessels remains unchanged. We believe that this change will eliminate the unnecessary burden resulting from an organ procurement organization's efforts to comply with both FDA and HRSA rules with respect to blood vessels (FDA jurisdiction) and organs (HRSA jurisdiction). We are issuing these amendments directly as a final rule because they are noncontroversial, and there is little likelihood that we will receive any significant adverse comments. Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule under our usual procedures for notice and comment in the event that we receive any significant adverse comments on the direct final rule. If we receive any significant adverse comments that warrant terminating the direct final rule, we will consider such comments on the proposed rule in developing the final rule.
C.W. Bill Young Cell Transplantation Program: National Cord Blood Inventory; Recognition of Cord Blood Bank Accreditation Program(s)
Public Law 109-129 requires the Secretary of Health and Human Services to recognize one or more cord blood accreditation entities for the accreditation of cord blood banks participating in the collection and maintenance of umbilical cord blood units for the National Cord Blood Inventory. These cord blood units will be made available for unrelated donor blood stem cell transplants through the C.W. Bill Young Cell Transplantation Program. The HRSA, Healthcare Systems Bureau (HSB), Division of Transplantation (DoT) is in the process of information-gathering to assist in the determination of which cord blood bank accreditation program(s) to recognize on an interim basis for the initial cycle of funding for the National Cord Blood Inventory. The purpose of this solicitation is to receive public input on the following: (1) Approaches to accreditation required to ensure quality cord blood bank operations (including collection sites); (2) Utilization of accreditation programs to ensure product quality and best practices; (3) Degree to which accreditation standards are evidence based and supported by published literature; (4) Extent to which accreditation standards allow for variations in cord blood bank practices; (5) Criteria for the Secretary to consider in recognizing cord blood bank accrediting programs for the National Cord Blood Inventory, C.W. Bill Young Cell Transplantation Program. The HRSA intends for this interim process to be followed by a formal, more comprehensive recognition process that will include input from both the Advisory Council, once it is established, and the interested public as required in the legislation. The purpose of this Notice is to invite interested parties to register for and participate in either of two conference calls, described below, that HRSA is scheduling to obtain comment on factors relevant to determining which accrediting organization(s) to recognize for the initial cycle of funding under the National Cord Blood Inventory.
Response to Solicitation of Comments on Proposed Changes to Criteria and Process for Assessing Community Need Under the President's Health Centers Initiative
A notice was published in the Federal Register (FRN) on February 4, 2005 (Vol. 70, No. 23, pp. 6016-6023), detailing proposed changes to the Need for Assistance (NFA) Worksheet criteria being considered for use in future Consolidated Health Center New Access Point (NAP) grant cycles. The FRN requested public comments on these proposed changes and on the degree to which Need should be weighted relative to the other criteria used in the NAP application scoring process. Comments were to be provided to HRSA by March 7, 2005. The proposed changes to the NFA Worksheet criteria and the solicitation of comments were motivated by HRSA's continuous efforts to improve its grant processes. To that end, HRSA sought comment on how to improve its measure of need for comprehensive primary and preventive health care services in the service area or population to be served by a NAP applicant, and whether the weighting of need relative to other application review criteria should be increased. Comments were received from over 50 organizations and/or individuals regarding the proposed changes. These comments were thoroughly evaluated. This FRN presents a summary of the comments received by topic, with HRSA's corresponding responses, and a summary of the final changes HRSA has decided to make to the NFA Worksheet and the weighting of Need in the application review process. Authorizing Legislation: Section 330(e)(1)(A) of the Public Health Service (PHS) Act, as amended, authorizes support for the operation of public and nonprofit private health centers that provide health services to medically underserved populations. Similarly, section 330(g) authorizes grants for delivery of services to Migratory and Seasonal Agricultural Workers; section 330(h) to Homeless populations; and section 330(i) to residents of Public Housing. Reference: For the previous NFA Worksheet criteria and previously used application weights, see Program Information Notice (PIN) 2005-01, entitled (Requirements of Fiscal Year 2005 Funding Opportunity for Health Center New Access Point Grant Applications.'' Background: The goal of the President's Health Centers Initiative, which began in fiscal year (FY) 2002, is to increase access to comprehensive primary and preventive health care services through development of new and/or significantly expanded health center access points in 1,200 of the Nation's neediest communities. Funded health centers are expected 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. It is important that NAP grant awards be made to entities that will successfully implement a viable and legislatively compliant program for the delivery of comprehensive primary health services. It is also essential that all NAP applicants demonstrate the need for such services in the community/population to be served and be evaluated on that need. As part of its efforts to improve the needs assessment process, HRSA arranged for an external evaluation of the NFA Worksheet criteria and the use of need factors in the overall application review process. The evaluation was conducted by a team consisting of HSR, Inc. and the University of North Carolina's Cecil G. Sheps Center for Health Services Research. Key results of the evaluation analyses were presented in the FRN, as well as recommendations for proposed changes. Comments were solicited for the proposed changes. A summary of the comments received from the public and HRSA's response to these comments are presented below.
Advisory Committee on Organ Transplantation; Notice of Meeting
Pursuant to Public Law 92-463, the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the tenth 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 4, 2006, and from 9 a.m. to 3 p.m. on May 5, 2006, 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).
Cancellation of Previously Announced Grant Opportunities
The Health Resources and Services Administration (HRSA) announces the cancellation of the following grant opportunities that were initially published on Grants.gov Find, in the HRSA Preview, and on the HRSA Web site (http://www.hrsa.gov/grants/preview/).
National Practitioner Data Bank for Adverse Information on Physicians and Other Health Care Practitioners: Reporting on Adverse and Negative Actions
This proposed rule would revise existing regulations under sections 401-432 of the Health Care Quality Improvement Act of 1986, governing the National Practitioner Data Bank for Adverse Information on Physicians and Other Health Care Practitioners, to incorporate statutory requirements under section 1921 of the Social Security Act, as amended by section 5(b) of the Medicare and Medicaid Patient and Program Protection Act of 1987, and as amended by the Omnibus Budget Reconciliation Act of 1990. The Medicare and Medicaid Patient and Program Protection Act of 1987, along with certain additional provisions in the Omnibus Budget Reconciliation Act of 1990, was designed to protect program beneficiaries from unfit health care practitioners, and otherwise improve the anti-fraud provisions of the Medicare and State health care programs. Section 1921, the statutory authority upon which this regulatory action is based, requires each State to adopt a system of reporting to the Secretary of Health and Human Services (the Secretary) certain adverse licensure actions taken against health care practitioners and health care entities licensed or otherwise authorized by a State (or a political subdivision thereof) to provide health care services. It also requires each State to report any negative actions or findings that a State licensing authority, peer review organization, or private accreditation entity has concluded against a health care practitioner or health care entity.
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.
Organ Procurement and Transplantation Network Status of Living Donor Guidelines
Federal Register Notice (volume 71, number 14, pp 3519-3520) published on January 23, 2006, inadvertently omitted information on the review and access of the material received in response to the solicitation of comments to assist HRSA in determining whether criteria developed by the Organ Procurement and Transplantation Network (OPTN) concerning organs procured from living donors, including those concerning the allocation of organs from living donors, should be given the same status, and be subject to the same enforcement actions, as other OPTN policies. Docket: For access to the docket to read background documents or comments received, go to the Division of Transplantation, Healthcare Systems Bureau, Health Resources and Services Administration (HRSA), 5600 Fishers Lane, Room 12C-06, Rockville, Maryland 20857 weekdays (Federal holidays excepted) between the hours of 8:30 a.m. and 5 p.m. To schedule an appointment to view public comments, phone (301) 443- 7757.
National Practitioner Data Bank: Change in User Fees
The Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS), is announcing a fifty cent increase in the fee charged to entities authorized to request information from the National Practitioner Data Bank (NPDB) for all queries. The new fee will be $4.75. There will be no change to the $8.00 self-query fee.
Healthy Start Program
The Conference Report (H.R. Rep. No. 109-337) accompanying the Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2006, indicates concurrence with the Senate report language regarding the recompetition of Healthy Start programs. Following the Senate Committee's recommendation in Senate Report 109-103, the Health Resources and Services Administration (HRSA) will give preference during the FY 2006 competition ``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 2005.''