Health Resources and Services Administration 2008 – Federal Register Recent Federal Regulation Documents

The Health Resources and Services Administration (HRSA) is requesting nominations to fill four upcoming vacancies on the Advisory Committee on Interdisciplinary, Community-Based Linkages (ACICBL).

Through this interim final rule, the Secretary removes the category of vaccines containing live, oral, rhesus-based rotavirus, Category XII, from the Vaccine Injury Table (Table). The Table includes a list of covered vaccines under the National Vaccine Injury Compensation Program (VICP). The VICP provides a system of no-fault compensation for certain individuals who have been injured by covered childhood vaccines. This interim final rule is technical in nature. Even prior to the publication of this final rule, Category XII, the category that is being removed from the Table, only applied to vaccines that were administered on or before August 26, 2002. Given the applicable statute of limitations and the fact that Category XII limited its application to vaccines administered on or before August 26, 2002, the Secretary believes that no persons have claims that could be pursued under that category. Petitioners may still be able to file petitions relating to rotavirus vaccines under Category XI of the Table, the category of ``rotavirus vaccines,'' which does not include any associated injuries. Although the Secretary believes that the changes made in this interim final rule are noncontroversial as they do not affect the rights of any potential petitioners with the VICP, the Department is seeking public comment on this interim final rule. Written comments must be submitted on or before November 10, 2008. The Department will consider the comments received and will decide whether to amend the Table based on such comments.

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 National Center for Hearing Assessment and Management (NCHAM) at Utah State University is the national resource center for the Universal Newborn Hearing Screening and Intervention Program. Funds will be used to provide technical assistance and training for physiologic hearing screening services in Early Head Start and Head Start programs in 17 States with plans to expand to 3 additional States.

This notice finalizes an amendment to the eligibility guidelines proposed on March 5, 2008, in the Federal Register (73 FR 11930). The purpose of this notice was to solicit comments on the amendment to the Program Eligibility Guidelines proposed by HRSA concerning the Reimbursement of Travel and Subsistence Expenses Program.

The Health Resources and Services Administration (HRSA) is amending the uniform waiver standards for Ryan White HIV/AIDS Program grantees requesting a core medical services waiver for fiscal year (FY) 2009 and beyond. Title XXVI of the Public Health Service (PHS) Act, as amended by the Ryan White HIV/AIDS Treatment Modernization Act of 2006 (Ryan White HIV/AIDS Program), requires that grantees expend 75 percent of Parts A, B, and C funds on core medical services, including antiretroviral drugs, for individuals with HIV/AIDS identified and eligible under the legislation. HRSA has issued waiver standards for grantees under Parts A, B, and C of Title XXVI of the PHS Act. This Federal Register notice seeks to make public the final notice of Uniform Standard for Waiver of Core Medical Services Requirements for Grantees Under Parts A, B, and C effective FY 2009.

The Health Resources and Services Administration (HRSA) is requesting nominations to fill five (5) upcoming vacancies on the Advisory Committee on Interdisciplinary, Community-Based Linkages (ACICBL).

The Conference Report (H.R. Rep. No. 110-107) accompanying the Consolidated Appropriations Act 2008 (Pub. L. 110-161), Division G Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2008, indicates concurrence with the Senate report language regarding the recompetition of Healthy Start programs. Following the Senate Committee's recommendation, the Health Resources and Services Administration (HRSA) will give funding preference during the FY 2008 competition to current Healthy Start grantees. Senate Report 110-107 urges ``HRSA to give preference to current and former grantees with expiring or recently expired project periods.''

HRSA is announcing the reissuance of Fiscal Year 2009 Service Area CompetitionNew and Competing Continuation Funding (HRSA Announcement Numbers HRSA-09-095, HRSA-09-096, HRSA-09-097, and HRSA- 09-098). The HRSA Electronic Handbook (EHB) application deadline for project periods beginning in November and December 2008 has been changed and the list of available service areas has been updated. The new EHB application deadline for HRSA-09-095 is May 9, 2008. (The grants.gov application deadline of April 7, 2008 remains the same.) All other requirements of HRSA-09-095 remain the same. Please see the chart on pages 6 and 7 of the guidance for a complete listing of all application deadlines. In addition, corrections to two service areas listed in the Service Area Competition guidance have been made. In Appendix F of the guidance, Bismarck, ND, is incorrectly listed as an available service area in fiscal year (FY) 2009. The correct service area that is currently available in FY 2009 is Beulah, ND. Also, Clay, WV, is incorrectly listed as an available service area in FY 2009. The correct service area that is currently available in FY 2009 is Blacksville, WV. Bismarck, ND and Clay, WV, are not available service areas for the FY 2009 Service Area Competition. For a complete listing of all available service areas for the FY 2009 Service Area Competition funding opportunity, please see Appendix F of the guidance.

In accordance with the requirements of the Privacy Act, the Health Resources and Services Administration (HRSA) is publishing notice of a proposal to alter the system of records for Organ Procurement and Transplantation Network (OPTN)/Scientific Registry of Transplant Recipients (SRTR) Data System. This system of records is required to comply with the implementation directives of Public Law 109-129. HRSA published in the Federal Register of September 8, 2003, a document concerning notice of a new system of records, 09-15-0055, Organ Procurement and Transplantation Network (OPTN)/Scientific Registry of Transplant Recipients (SRTR) Data System, 68 FR 52950. This document more fully explains the routine uses of records maintained in the system and amends the records' purpose and routine uses of records maintained in the system. Accordingly, the notice is published below in its entirety, as amended.

The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs),'' dated April 2008. The guidance document provides to sponsors recommendations on the CMC information to include in an original IND for human gene therapy. In addition, the guidance provides instructions to FDA reviewers about the information to record and assess as part of the IND review. The guidance document announced in this notice finalizes the draft guidance of the same title dated November 2004.

The Health Resources and Services Administration published a Statement of Organization, Functions and Delegations of Authority document in the Federal Register of March 10, 2008 (73 FR 12742), regarding the Bureau of Health Professions. In section heading RP, Office of the Administrator, the title was incorrect. Correction

The Health Resources Services Administration (HRSA) published a notice in the Federal Register of March 3, 2008 (FR Doc. E8-3994), pages 11420-11421, requesting comments to assist in determining whether it should engage in rulemaking with respect to vascularized composite allografts, and also to announce a meeting for discussion and recommendations regarding that issue. The notice is to extend HRSA's deadline for receiving written comments to July 2, 2008, and to change the zip code of the address where the meeting will be held. Correction: In the Federal Register of March 3, 2008, in FR Doc. E8-3994, on page 11421, 1st column under the heading DATES: 1st line, change to read: Written comments must be received at HRSA by July 2, 2008. 10th line, change to read: The meeting will be held on Friday, April 4, 2008, from 10 a.m. to 4 p.m., at the Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857.

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 fourteenth 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 5, 2008, and from 9 a.m. to 3 p.m. on May 6, 2008, at the Hilton Washington D.C./ Rockville Executive Meeting Center, 1750 Rockville Pike, Rockville, MD 20852. The meeting will be open to the public; however, seating is limited and pre-registration is encouraged (see below).

HRSA, Healthcare Systems Bureau, Division of Transplantation (DoT) is in the process of information- gathering to assist in determining whether it should engage in rulemaking with respect to vascularized composite allografts, described more fully below. The purpose of this solicitation is to receive feedback from stakeholders and the public on the following questions: (1) Whether vascularized composite allografts should be included within the definition of organs covered by the regulations governing the operation of the Organ Procurement and Transplantation Network (OPTN) (referred to here as the ``final rule''), and regulated as such, and the likely impact of such an amendment; (2) whether vascularized composite allografts should be added to the definition of human organs covered by section 301 of the National Organ Transplant Act of 1984, as amended, (NOTA) and the likely impact of such an addition; and (3) if either of these changes are pursued, the optimal way to define vascularized composite allografts for the above-described purposes. This Request for Information is limited to information-gathering and is not a proposal to make any determinations regarding Federal oversight of vascularized composite allografts.

The Health Resources and Services Administration (HRSA) is requesting nominations to fill five (5) upcoming vacancies on the Advisory Committee on Interdisciplinary, Community-Based Linkages (ACICBL). Authority: 42 U.S.C. 294f, section 756 of the PHS Act, as amended. The Advisory Committee is governed by provisions of Public Law (Pub. L.) 92-463, as amended (5 U.S.C. Appendix 2) which sets forth standards for the formation and use of advisory committees.

The Health Resources and Services Administration (HRSA) is requesting nominations to fill 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 Public Law 92-463, was chartered on September 1, 2000.

The Health Resources and Services Administration (HRSA) is issuing a non-competitive program expansion supplement to the National Health Care for the Homeless Council (NHCHC) to provide expanded training and technical assistance to HRSA-funded grantees serving individuals who are homeless. Authority: This activity is under the authority of the Public Health Service Act, section 330(l). Catalog of Federal Domestic Assistance Number: 93.224. Background: The National Health Care for the Homeless Council (NHCHC) is a cooperative agreement grantee that provides training and technical assistance support to health centers that serve homeless individuals and families. The NHCHC requires supplemental funding to provide, through expanded regional and national training activities, a broader and enriched menu of support for HRSA grantees, including Health Care for the Homeless (HCH) administrators, clinicians, and members of HCH Boards of Directors and consumer advisory groups. Amount: The amount of the award is $225,000. Project Period: July 1, 2006, to June 30, 2008. Budget Period Supplemented: July 1, 2007, to June 30, 2008. Justification for The Exception to Competition: Given the recent growth of the HCH component of HRSA's Health Center program, it is critical that expanded regional and national training be provided in as timely a manner as possible. This supplemental request is being awarded noncompetitively because, at this time, there are no other organizations with the expertise to complete these activities, and no other organization is prepared to provide these services within the timeframe in which they are needed. Due to the emerging and urgent needs of the HCH program, this supplemental request and the activities proposed are essential to ensuring successful delivery of health care to the target population.

The Health Resources and Services Administration (HRSA) is seeking comments from the public on its plan to institute a permanent deviation from a policy in the Department of Health and Human Services (HHS), Grants Policy Directive (GPD) 3.01 governing indirect cost recovery for one of its grant programs. The GPD states ``HHS considers activities conducted by grantees that result in indirect charges a necessary and appropriate part of HHS grants, and HHS awarding offices must reimburse their share of these costs.'' Although HRSA typically reimburses grantees for their full share of administrative overhead represented in approved indirect cost rates, the agency believes, in the case of its State Offices of Rural Health (SORH) Grant Program, that full recovery of overhead expenditures would be detrimental to the SORH grantees' ability to adequately conduct all the activities mandated in the authorizing legislation. Limiting indirect cost recovery is necessary because eleven of fifty SORH grantees are located in academic settings that have established indirect cost rates in the range of 30 to 50 percent or even higher. It is in the best interest of the program to limit the indirect cost recovery to not more than 15 percent of allowable total direct costs, thus leaving 85 percent of the grant funds to conduct the activities required by the grant program. This limitation would be applicable to all awardees of the State Offices of Rural Health Grant Program.

The Health Resources and Services Administration (HRSA) is seeking comments from the public on its plan to institute a permanent deviation from a policy in the Department of Health and Human Services (HHS), Grants Policy Directive (GPD) 3.01 governing indirect cost recovery for one of its grant programs. The GPD states ``HHS considers activities conducted by grantees that result in indirect charges a necessary and appropriate part of HHS grants, and HHS awarding offices must reimburse their share of these costs.'' Although HRSA typically reimburses grantees for their full share of administrative overhead represented in approved indirect cost rates (which can be up to 50 percent or higher), the Agency believes, in the case of its Small Rural Hospital Improvement Grant Program (SHIP), that full recovery of overhead expenditures would be detrimental to the ability to adequately conduct the activities mandated in the authorizing legislation. The purpose of the SHIP grant program is to assist eligible small rural hospitals in implementing Prospective Payments Systems (PPS), compliance with the Health Insurance Portability and Accountability Act (HIPAA) regulations, and to reduce medical errors and to support quality improvement. Funding for the SHIP grant program is routed first through the State Offices of Rural Health (SORH); they are then distributed evenly by the SORH to the individual hospitals. This process creates efficiencies because of the large number of eligible hospitals and relatively small size of each award. In fiscal year 2007, $14,508,691 was awarded to 1,622 hospitals (approximately $8,945 each) in 46 States. Thus, the SORH is the official grantee of record for the State, as the recipient of the award and fiscal intermediary for the Federal government in distributing the funds. It is in the best interest of the SHIP grant program to limit the total administrative cost recovery to 5 percent of the Federal award, thereby allowing 95 percent of available grant funds to be used to carry out the required program activities. Since the SHIP grant program began in FY 02, through FY 07, the administrative costs have been restricted. Indirect costs were not allowed and there was a five percent maximum of other costs, for administrative costs, within the grant guidance. The SORHs voluntarily decided to limit these cost categories. For FY 07, the average administrative charge was only 3.64 percent. Thus, the cap on administrative costs has worked well. Limiting administrative costs is necessary because 20 percent of SHIP grantees are located in academic settings that have established indirect cost rates in the range of 30 to 50 percent. Without a limitation on the amount of grant funds allocated for administrative costs, the SORH grantee could potentially charge its full indirect cost rate and the grant awards would be significantly less for each small rural hospital. As much as 50 percent of the grant award could be consumed by indirect costs, depending upon the host institution's indirect cost rate. This would significantly reduce the amount of funds available to initiate and maintain the activities of the grant. A limitation on administrative costs will ensure that each hospital, not an unintended source, receives the maximum amount of funding. The limitations placed on these cost categories will ensure that the majority of funding is routed to the small rural hospitals, to be used for the prescribed intents and purposes of the grant program. A continued limitation on administrative costs for future SHIP grant cycles will help to assure that small rural hospitals receive the appropriated support, necessary to carry out the objectives of the grant program. The limitation would be applicable to all grantees of the Small Rural Hospital Improvement Grant Program.