Health Resources and Services Administration 2007 – Federal Register Recent Federal Regulation Documents
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Announcement of Potential Eligibility for Compensation Under Public Readiness and Emergency Preparedness Act Declaration and Filing Deadlines
This Notice provides notification that individuals who have been injured by pandemic, epidemic, or security countermeasures identified in a declaration issued by the Secretary pursuant to section 319F-3(b) of the Public Health Service Act (PHS Act) (42 U.S.C. 247d- 6d) have one (1) year from the time they receive the covered countermeasure to file requests for compensation for injuries directly resulting from administration or use of covered countermeasures under the Public Readiness and Emergency Preparedness Act (PREP Act).
Part C HIV Early Intervention Services Grant
HRSA will be providing temporary critical HIV medical care and treatment services through Chase Brexton Health Services to avoid a disruption of HIV clinical care to homeless populations in the Baltimore, Maryland, area.
HIV/AIDS Bureau; Ryan White HIV/AIDS Program Core Medical Services Waiver Application Requirements
This notice solicits comments on the HRSA proposed uniform waiver standards for Ryan White HIV/AIDS Program grantees requesting a core medical services waiver for Fiscal Year 2008 and beyond. Title XXVI of the Public Health Service Act (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, effective Fiscal Year (FY) 2007. HRSA has issued guidance for obtaining a waiver for FY 2007 and seeks to issue waiver requirements for grantees under Parts A, B, and C of Title XXVI of the PHS Act for FY 2008 and future years.
Cooperative Agreement for Poison Prevention Education; CFDA #93.253
HRSA will be enhancing the partnership with the Home Safety Council (HSC) to collaborate on reaching America's low literacy population. Through this project, additional poison prevention training materials targeting the low literacy population will be developed and distributed to the public, poison centers, safety and injury prevention professionals, health educators, and first responders. HRSA first announced the partnership with the HSC in the Federal Register, Vol. 71, No. 146, July 31, 2006.
Advisory Committee on Interdisciplinary, Community-Based Linkages; Notice of Request for Nominations
The Health Resources and Services Administration (HRSA) is requesting nominations to fill seven (7) 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.
Revisions to the Program Guidance for the Training in Primary Care Medicine and Dentistry Program
HRSA announces a revision to the program guidance for the Training in Primary Care Medicine and Dentistry Program posted on August 23, 2007 on Grants.gov, https://www.grants.gov. The guidance includes information for the following competitive funding opportunities: HRSA-08-032 Academic Administrative Units; HRSA-08-035 Physician Faculty Development; HRSA-08-037 Predoctoral Training; HRSA-08-039 Physician Assistant Training; HRSA-08-042 Residency Training; and HRSA- 08-044 Residency Training in General and Pediatric Dentistry. This revision only affects the Physician Faculty Development program, HRSA- 08-035. A revised guidance has been posted on Grants.gov. Specifically, the additional language included in the guidance is presented below: Primary Care Clinician Research FellowshipThis track provides fellowships that focus on development of primary care research investigators. DurationFellowships will last 2 to 3 years. FeaturesApplications should include a rigorous research/training track which is offered at an academic health science center. Advanced degrees (e.g., M.P.H., M.P.A.) are a desirable option. Desirable candidates include multidisciplinary physician faculty and fellows. Research areas should be consistent with the scope and content of primary care practice and education, and may include such areas as the linkage between Healthy People 2010 and health disparities, community and practice-based research, patient safety, quality improvement, professionalism, health literacy, and cultural competency. Stipend LevelEnhanced stipend level is equivalent to National Research Service Award (NRSA) stipends, which range from $36,996 for individuals entering immediately following receipt of their doctoral degree to $51,036 for individuals with 7 years or more of relevant experience and/or training. A table of stipend levels is provided in this guidance. Supplementation of the stipends is allowable and encouraged; however, the combination of stipend and supplementation may not exceed the full-time salary of comparable multidisciplinary physician faculty at the applicant's institution. Time RequirementPro-rated stipends are not available. For applicants requesting full stipends, 60 percent of a Fellow's time for 24- to 36 months of fellowship must be devoted to formal research training. The remaining 40 percent of time for a 24 to 36-month fellowship must be spent in activities consistent with the roles of academic faculty (clinical practice, teaching, and/or administration).
Reimbursement of Travel and Subsistence Expenses Toward Living Organ Donation Proposed Eligibility Guidelines and Publication of Final Program Eligibility Guidelines
The Health Resources and Services Administration published a notice in the Federal Register of October 5, 2007 (FR Doc. E7-19747), on pages 57049-57052, regarding response to solicitation of comments and publication of final program eligibility guidelines.
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 a notice of a proposal to add a new system of records. The Campus Based Branch (CBB) of the Division of Health Careers Diversity and Development in the Bureau of Health Professions is currently utilizing a document management system (DMS) that dynamically manages its flow of documents produced and received. the DMS is an intra-office system in which documents contained within the system are only shared among CBB staff. The DMS contains names and other personally identifiable information of borrowers.
HRSA's Bureau of Primary Health Care (BPHC) Awards Unsolicited Proposal for Cooperative Agreement to the National Network for Oral Health Access
HRSA's BPHC has performed a formal review of an unsolicited proposal from NNOHA to establish a cooperative agreement with HRSA to provide services and resources to support the Health Center Program's oral health providers serving the oral health needs of underserved populations. BPHC has reviewed the proposal and has determined that it has merit. This request is of strategic importance to the Department of Health and Human Services (HHS) and is time critical. Funding for the proposed activities will promote access to oral health services as an integral component of primary health care, improve the quality of those services provided, and sustain the forward motion of departmental priorities in this area. The Cooperative Agreement with NNOHA will have a project period of 1 year with funding at $200,000. The funds will support selected activities described in the application to develop a national infrastructure to support improved access to oral health care, and improved quality and workforce development for the growing number of health center oral health programs. The key anticipated outcomes of the proposed cooperative agreement are as follows: The development of oral health clinical quality infrastructure to support HRSA in achieving its goal of improved quality of care; The development of a recruitment and retention strategy to address dentist and dental hygienist vacancies, including National Health Service Corps dentist and dental hygiene openings; and NNOHA will work in collaboration with HRSA to implement a strategy to integrate oral health as it moves all of its programs forward in Health Information Technology to assure that oral health strategies are included. There is a strategic importance of access to oral health as part of the primary care services supported by BPHC's Health Center Program. The Health Center Program has had significant growth as part of the President's Health Center Initiative. The number of patients seen by the Health Center Program has increased by 90 percent. Health centers have reported significant challenges recruiting and retaining oral health providers. Consequently, HRSA has determined that the scope of this proposal is immediate and necessary. The proposed outcomes will contribute to the success and quality of oral health programs and are essential for long term sustainability and viability of health centers funded by HRSA. This award is being made non-competitively because there is no current, pending, or planned funding opportunity announcement under which this proposal could be competed. HRSA/BPHC has identified three key reasons to support rationale for not awarding competitively: 1. NNOHA is uniquely positioned to provide oral health program support services on a national basis to community health centers. As the only organization of health center dental providers, NNOHA is dedicated to increasing the effectiveness of dental programs in reaching all underserved populations by supporting efforts to strengthen existing health center dental programs; manage the growth of new health center dental programs; and manage the quality improvement in health center dental programs. 2. With this experience, and its nationwide membership of health center dentists, NNOHA has a proven track record of effective collaborations with health center dental programs. Increased access to quality oral health is enhanced through NNOHA's partnerships with organizations and governmental agencies at the local, State and national levels. 3. No other organization has the national scope of respected experience in the area of health center oral health leadership and can perform immediately, especially given the complexity of activities that are critical to HRSA.
Advisory Committee on Heritable Disorders and Genetic Diseases in Newborns and Children (ACHDGDNC)
The ACHDGDNC will be conducting a two hour conference call to hear a presentation from the ACHDGDNC's Evidence Review Workgroup and discuss the Committee's Report on long-term followup.
Notice of Availability of Draft Policy Documents for Comment
The Health Resources and Services Administration published a notice in the Federal Register of August 29, 2007, requesting comments on draft Agency Guidance (Policy Information Notices (PINS)) to describe the policy and processes pertaining to requests from federally-funded health centers to change the scope of their Federal project. The PINS, ``Defining Scope of Project and Policy for Requesting Changes,'' ``Changes in Scope Requests: Policy for Adding a New Target Population,'' and ``Specialty Services and Health Centers' Scope of Project,'' are available on the Internet at https:// bphc.hrsa.gov. Correction: In the Federal Register of August 29, 2007, FR Doc. E7- 17092, on page 49724, in the first column, under DATES, the deadline for comments has been extended to October 19, 2007.
Notice of 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 thirteenth 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 November 15, 2007, and from 9 a.m. to 3 p.m. on November 16, 2007, at the Crowne Plaza Hotel Washington, DCSilver Spring, 8777 Georgia Avenue, Silver Spring, MD 20910. The meeting will be open to the public; however, seating is limited and pre-registration is encouraged (see below).
Reimbursement of Travel and Subsistence Expenses Toward Living Organ Donation Proposed Eligibility Guidelines and Publication of Final Program Eligibility Guidelines
A notice was published in the Federal Register on April 9, 2007 (72 FR 17564). The purpose of this notice was to solicit comments on the eligibility criteria that were proposed by HRSA concerning the Reimbursement of Travel and Subsistence Expenses Grant Program.
Notice of Availability of Draft Policy Document for Comment
HRSA believes that community input is valuable to the development of policies and policy documents related to the implementation of BPHC programs, including the FQHC Look-Alike Program. Therefore, we are requesting comments on the PIN referenced above. After review and consideration of all comments received, the PIN may be amended to incorporate certain recommendations from the public. Once the PIN is finalized, it will be made available on HRSA's Web site, along with the Agency's ``Response to Public Comments.'' That document will summarize the major comments received and describe the Agency's response, including any corresponding changes made to the PIN. Where comments do not result in a revision to the PIN, explanations will be provided. Background: HRSA has received numerous requests for clarification regarding the program guidelines, requirements, and application process for the FQHC Look-Alike program. The purpose of the FQHC Look-Alike PIN is to respond to these requests for clarification and to make the application process more consistent with section 330 grant programs. The Omnibus Budget Reconciliation Acts of 1989, 1990, and 1993 amended section 1905 of the Social Security Act to create a new category of facility under Medicaid and Medicare known as Federally Qualified Health Centers (FQHCs). The Social Security Act Sec. 1905(l)(2)(B) definition of an FQHC included an entity which, based on the recommendation of HRSA, is determined to meet the requirements of the section 330 grant program but does not receive the grant. This category of health centers has been labeled FQHC Look-Alikes. To ensure that there are appropriate numbers of health centers to serve the millions of uninsured and underinsured populations throughout the country, FQHC Look-Alike status was made available to those entities that do not receive funding under section 330 but operate and provide services similar to grant-funded programs. As such, FQHC Look- Alikes are expected to demonstrate a commitment to serve all populations residing in their respective medically underserved communities regardless of their ability to pay and to satisfy all of the administrative, management, governance and service-related requirements that apply to section 330 funded health centers. Benefits of obtaining FQHC Look-Alike status include eligibility for enhanced Medicaid and Medicare reimbursement, participation in the 340(b) Federal Drug Pricing Program, and automatic Health Professional Shortage Area designation. HRSA is responsible for managing the FQHC Look-Alike program and submitting recommendations to the Centers for Medicare and Medicaid Services (CMS) for designation as FQHCs; however, CMS has the final authority to designate applicants as FQHCs. The organizations are recertified annually to assure they are in compliance with these regulations.
Notice of Availability of Final Policy Guidance
The Health Resources and Services Administration (HRSA) is publishing a final Agency Guidance (``Policy Information Notice'' (PIN) 2007-16) to describe and clarify the circumstances under which Federal Tort Claims Act (FTCA)deemed Health Center Program grantees are covered under the FTCA as they respond to emergencies. The PIN, ``Federal Tort Claims Act Coverage for Health Center Program Grantees Responding to Emergencies,'' and the Agency's ``Response to Public Comments'' are available on the Internet at https://bphc.hrsa.gov/ policy/pin0716.
Notice of Availability of Final Policy Guidance
The Health Resources and Services Administration (HRSA) is publishing a final Agency Guidance (``Policy Information Notice'' (PIN) 2007-15) to provide guidance on emergency management expectations for health centers to assist them in planning and preparing for future emergencies through the development and maintenance of an effective and appropriate emergency management strategy. The PIN, ``Health Center Emergency Management Program Expectations,'' and the Agency's ``Response to Public Comments'' are available on the Internet at http:/ /bphc.hrsa.gov/policy/pin0715. Background: HRSA administers the Health Center Program, which supports more than 3,800 health care delivery sites, including community health centers, migrant health centers, health care for the homeless centers, and public housing primary care centers. Health centers serve clients that are primarily low-income and minorities, and deliver comprehensive, culturally competent, quality primary health care services to patients regardless of their ability to pay. Charges for health care services are set according to income. On February 27, 2007, HRSA made the draft PIN available for public comment on HRSA's Web site. The purpose of the PIN was to provide guidance on emergency management expectations for health centers to assist them in planning and preparing for future emergencies. Comments were due to HRSA by April 13, 2007. Comments were received from 31 organizations and/or individuals. After review and careful consideration of all comments received, HRSA amended the PIN to incorporate certain recommendations from the public. The final PIN reflects these changes. In addition to making the final PIN available on HRSA's Web site, HRSA is also posting the Agency's ``Response to Public Comments.'' The purpose of the document is to summarize the major comments received and describe the Agency's response, including any corresponding changes made to the PIN. Where comments did not result in a revision to the PIN, explanations are provided.
Advisory Committee on Interdisciplinary, Community-Based Linkages; Notice of Request for Nominations
The Health Resources and Services Administration (HRSA) is requesting nominations to fill two (2) vacancies on the Advisory Committee on Interdisciplinary, Community-Based Linkages (ACICBL).
Notice of Availability of Draft Policy Documents for Comment
HRSA believes that community input is valuable to the development of policies and policy documents related to the implementation of HRSA programs, including the Health Center Program. Therefore, we are requesting comments on the PINs referenced above. After review and consideration of all comments received, the PINs may be amended to incorporate recommendations from the public. Once the PINs are finalized, they will be made available on HRSA's Web site, along with the Agency's ``Response to Public Comments.'' The ``Response to Public Comments'' will summarize the major comments received and describe the Agency's response, including any corresponding changes made to the PINs. Where comments do not result in a revision to the PINs, explanations will be provided. Background: HRSA administers the Health Center Program, which supports more than 3,800 health care delivery sites, including community health centers, migrant health centers, health care for the homeless centers, and public housing primary care centers. Health centers serve clients that are primarily low-income and minorities, and deliver preventive and primary care services to patients regardless of their ability to pay. Charges for health care services are set according to income. The purpose of the recently published draft PINs is to describe the policy and processes pertaining to requests from federally-funded health centers to change the scope of their Federal project, including requests to include new specialty services and/or a new target population within the scope of the Federal project.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
The Health Resources and Services Administration published an Agency Information Collection document in the Federal Register of July 31, 2007 (FR Doc. E7-14680), on page 41759, regarding Bureau of Primary Health Care (BPHC) Uniform Data System (OMB No. 0915-0193). In the burden table, the total burden hours published are incorrect.
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 establish a new system of records. The Stem Cell Therapeutic and Research Act of 2005 (the Act) authorizes the C.W. Bill Young Cell Transplantation Program (the Program) and provides for the collection, maintenance, and distribution of human blood stem cells for the treatment of patients and for research. The Program consists of four interrelated components each operated under a separate contract. The four components are: The Bone Marrow Coordinating Center; the Cord Blood Coordinating Center; the Office of Patient Advocacy/Single Point of Access; and the Stem Cell Therapeutic Outcomes Database. The contracts for operation of the Bone Marrow Coordinating Center, Cord Blood Coordinating Center, and Office of Patient Advocacy/Single Point of Access were awarded to the National Marrow Donor Program in September, 2006. A single contract for the Stem Cell Therapeutic Outcomes Database was awarded to the Center for International Blood and Marrow Transplant Research (CIBMTR) at the Medical College of Wisconsin in September, 2006 as well. As identified by the Act, the Program is charged with: Operating a system for identifying, matching, and facilitating the distribution of bone marrow that is suitably matched to candidate patients; operating a system for identifying, matching, and facilitating the distribution of donated umbilical cord blood units that are suitably matched to candidate patients; providing a means by which transplant physicians, other healthcare professionals, and patients can electronically search for and access all available adult marrow donors available through the Program; recruiting potential adult volunteer marrow donors; coordinating with other Federal programs to maintain and expand medical contingency response capabilities; carrying out informational and educational activities; providing patient advocacy services; providing case management services for potential donors; and collecting, analyzing, and publishing blood stem cell transplantation related data in a standardized electronic format. This system of records is required to comply with the implementation directives of the Act, Public Law 109-129. The records will be used for the C.W. Bill Young Cell Transplantation Program's planning, implementation, evaluation, monitoring, and document storage purposes.
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