Health Resources and Services Administration 2006 – Federal Register Recent Federal Regulation Documents

The HRSA HIV/AIDS Bureau (HAB) Policy Notice 99-02 entitled, The Use of Ryan White CARE Act funds for Housing Referral Services and Short-term or Emergency Housing Needs, provides grantees with guidance on the use of Ryan White Comprehensive AIDS Resources Emergency (CARE) Act funds for short-term and emergency housing assistance for persons living with HIV/AIDS. The current policy does not establish a time limit for such assistance under the Ryan White CARE Act. An amendment to Policy Notice 99-02 is proposed, which places a cumulative lifetime period of 24 months on short-term and emergency housing assistance under the Ryan White CARE Act. This proposed amendment results from an Office of Inspector General audit encouraging HRSA to clarify the definition of short-term housing and emergency housing assistance. This amendment will help align the HRSA definition of short-term housing with the widely accepted program standard used by the U.S. Department of Housing and Urban Development, Continuum of Care Homeless Assistance Programs and the Housing Opportunities for Persons with AIDS program. This policy becomes effective March 1, 2007.

In accordance with the Grants Policy Directive Part 1.03, the Office of Health Information Technology (OHIT) has been granted a class deviation from the competition requirements contained in the Grants Policy Directive Part 2.04 to provide an additional year of funding without competition for Health Center Controlled Network (HCCN) Initiatives funded under Section 330 of the Public Health Service Act, as amended.

HRSA is requesting comments on the future direction and strategy regarding investments in health information technology (HIT) for section 330 grantees and other HRSA safety-net providers through its Office of Health Information Technology (OHIT). OHIT will evaluate all comments received during the public comment period to inform OHIT's policy direction.

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.

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).

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.

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.

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 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.

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.

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.

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 (https://www.hrsa.gov/grants/preview/).

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.

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.