Health Resources and Services Administration 2008 – Federal Register Recent Federal Regulation Documents
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Reimbursement of Travel and Subsistence Expenses Toward Living Organ Donation Eligibility Guidelines
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.
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, 2008, through June 30, 2009, is posted on the NHSC Web site at https://nhsc.bhpr.hrsa.gov/jobs/ index.asp. 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.
HIV/AIDS Bureau; Ryan White HIV/AIDS Program Core Medical Services Waiver Application Requirements
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.
Advisory Committee on Interdisciplinary, Community-Based Linkages; Notice of Request for Nominations
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).
Preference for Healthy Start Grantees
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.''
National Advisory Council on Migrant Health
The Health Resources and Services Administration published a meeting notice for the National Advisory Council on Migrant in the Federal Register of April 2, 2008 (73 FR 17991). The meeting place has changed. Correction
Amendment to the Fiscal Year 2009 Service Area Competition-New and Competing Continuation Funding
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.
Guidance for Industry on Blue Bird Medicated Feed Labels; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry (181) entitled ``Blue Bird Medicated Feed Labels.'' This guidance provides new animal drug application (NADA) sponsors with the Center for Veterinary Medicine's current thinking on what constitutes recommended content and format of representative labels for new animal drugs intended for use in the manufacture of medicated feeds.
Privacy Act of 1974; 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 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.
Agency Information Collection Activities: Proposed Collection: Comment Request
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.
Guidance for Food and Drug Administration Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control Information for Human Gene Therapy Investigational New Drug Applications; Availability
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.
Statement of Organization, Functions and Delegations of Authority
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
''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 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.
Guidance for Industry on Blue Bird Medicated Feed Labels; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry (181) entitled ``Blue Bird Medicated Feed Labels.'' This guidance provides new animal drug application (NADA) sponsors with the Center for Veterinary Medicine's current thinking on what constitutes recommended content and format of representative labels for new animal drugs intended for use in the manufacture of medicated feeds.
Organ Procurement and Transplantation Network
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.
Meeting of the Advisory Council on Blood Stem Cell Transplantation
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 second meeting of the Advisory Council on Blood Stem Cell Transplantation (ACBSCT), Department of Health and Human Services (HHS). The meeting will be held from approximately 9 a.m. to 5:30 p.m. on April 28, 2008, and from 9 a.m. to 3 p.m. on April 29, 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).
Meeting of the Advisory Committee on Organ Transplantation
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).
Privacy Act of 1974; Revision to Existing System of Records; Revised
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 the C.W. Bill Young Cell Transplantation Program. This system of records is required to comply with the implementation directives of Public Law 109-129. Records are used for the C.W. Bill Young Cell Transplantation Program's planning, implementation, evaluation, monitoring, and document storage purposes. HRSA published in the Federal Register of August 17, 2007, a document concerning notice of a new system of records, 09-15-0068, C.W. Bill Young Cell Transplantation Program (FR. Doc. 07-4019). This document more fully explains the routine uses of records maintained in the system and amends the record retention and disposal policy. Accordingly, the notice is published below in its entirety, as amended.
Reimbursement of Travel and Subsistence Expenses Toward Living Organ Donation Eligibility Guidelines
The Health Resources and Services Administration (HRSA) published the final eligibility guidelines for the Reimbursement of Travel and Subsistence Expense Program in the Federal Register on October 5, 2007 (72 FR 57049). The purpose of this notice was to inform the public of the eligibility requirements for participation in the Reimbursement of Travel and Subsistence Expenses toward Living Organ Donation Program. HRSA is requesting public comments concerning recommended change to a specific section of the reimbursement program eligibility guidelines.
Organ Procurement and Transplantation Network
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.
HIV/AIDS Bureau; Policy Notice 99-02 Amendment #1
The HRSA HIV/AIDS Bureau (HAB) Policy Notice 99-02 entitled, The Use of Ryan White HIV/AIDS Program Funds for Housing Referral Services and Short-term or Emergency Housing Needs, provides grantees with guidance on the use of Title XXVI of the Public Health Service Act (Ryan White HIV/AIDS Program) funds for short-term and emergency housing assistance for persons living with HIV/AIDS. This Federal Register notice seeks to make public the final policy notice 99-02 Amendment 1 which places a cumulative period of 24 months on short-term and emergency housing assistance under the Ryan White HIV/AIDS Program, and clarifies and updates certain nomenclature found in the original housing policy 99-02. This policy becomes effective March 27, 2008.
Advisory Committee on Interdisciplinary, Community-Based Linkages; Notice of Request for Nominations
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.
Advisory Committee on Organ Transplantation Request for Nominations for Voting Members
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.
National Advisory Council on the National Health Service Corps
The Health Resources and Services Administration published a meeting notice for the National Advisory Council on the National Health Service Corps in the Federal Register of January 15, 2008 (FR Doc. E8- 581), on page 2510. The beginning date of the meeting has changed.
Strategy To Support Health Information Technology Among HRSA's Safety Net Providers
The following represents a series of respondents' comments and the Health Resources and Services Administration's (HRSA) responses to the comments regarding the Federal Register notice (FRN): September 19, 2006 (71 FR 54829). The FRN proposed strategies to support health information technology (HIT) among safety net providers, and requested comments on HIT topic areas addressing quality improvement, collaboration, general network-related issues, specific health center controlled network (HCCN) related issues, sustainability and building HIT capacity. HRSA received a total of 53 comments from a broad range of stakeholders, including State health departments, non-profit organizations, individual healthcare providers and the health information technology industry. HRSA's responses reflect activities within the Office of Health Information Technology (OHIT) that include, but are not limited to, the development of an HRSA HIT strategic plan, technical assistance resources including the establishment of the HRSA HIT virtual community, the development of HIT online toolboxes tailored to the needs of various HRSA programs, a TA resource center, and the development of funding opportunities. The comments have helped, in part, to shape the direction and activities of OHIT.
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