Health Resources and Services Administration 2007 – Federal Register Recent Federal Regulation Documents

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).

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.

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).

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 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.

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).

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.

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).

The Health Resources and Services Administration published a document in the Federal Register of June 20, 2007. The document pertaining to the HRSA Information Center (IC) entitled ``Privacy Act of 1974: New System of Record'' Integrated Clearinghouse System (ICS), HHS/HRSA/OC No. 09-15-0067, was inadvertently omitted as the attachment for the notice.

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.

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 final rule establishes the new method of calculating the average cost of a health insurance policy and determines the amount of the average cost of a health insurance policy to be deducted from the compensation award.

In accordance with the requirements of the Privacy Act, the Health Resources and Services Administration (HRSA) is publishing notice of a proposal to add a new system of records titled, ``Information Center (IC) Integrated Clearinghouse System (IC/ICS),'' System No. 09-15-0067. The HRSA IC/ICS will facilitate the delivery of publications and requested information by members of the general public. The HRSA IC/ICS will also enable HRSA to deliver information efficiently through physical mailings or broadcast e-mail messages to HRSA Grantee organizations and other interested parties.

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), as enacted by Public Law (Pub. L.) 99-660 and as subsequently amended, 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 (FR) on December 6, 2006, (Vol. 71, No. 234, pp. 70780-70781), describing a funding priority to be included in the fiscal year (FY) 2007 New Access Points in High Poverty Counties grant opportunity. The notice requested public comments on the proposed funding priority to be sent to HRSA no later than January 5, 2007. Comments were received from over 30 organizations and/or individuals in response to the notice of the proposed funding priority. The majority of comments received did not pertain specifically to the proposed funding priority, but rather the President's High Poverty Counties Initiative (``the Initiative'') and grant opportunity; therefore this notice presents a summary of the general comments received with HRSA's corresponding responses including references to the FY 2007 New Access Points in High Poverty Counties (HRSA-07-069) funding opportunity, as well as a summary of the final funding priority.

Public Law 109-129 requires the Secretary of Health and Human Services to establish a 3-year demonstration project for qualified cord blood banks to collect and store at no charge to families, umbilical cord blood units for families where a first-degree relative has been diagnosed with a condition that may benefit from blood stem cell transplantation. Umbilical cord blood units collected through the demonstration project do not count toward the current National Cord Blood Inventory (NCBI) goal of 150,000 cord blood units to be made available through the C.W. Bill Young Cell Transplantation Program. Qualified umbilical cord blood banks participating in the demonstration project must provide assurances that the cord blood units will be available for directed transplantation until such time as the cord blood unit is needed. Within 90 days of the termination of the demonstration project, the Secretary will submit to Congress a report on the outcomes of the project including recommendations with respect to the continuation of such a project. HRSA's Healthcare Systems Bureau (HSB), Division of Transplantation (DoT) is in the process of information-gathering to assist in implementation of the related cord blood demonstration project. The purpose of this solicitation is to receive public input on the following: (1) The key questions that should be studied through this project; (2) the mechanism for funding this project; and, (3) umbilical cord blood bank liability. HRSA has identified the following key study questions to be considered in the design of this demonstration project: (1) What is the value and feasibility of implementing a long-term program modeled after this demonstration project; (2) how often and for what clinical indications are cord blood units banked through this project used for transplantation; (3) what is the breakdown of cord blood units collected, stored, and transplanted by race, ethnicity, and disease; (4) do those cord blood units, especially those released for transplant, represent rare Human Leukocyte Antigen (HLA) types such that the recipient would otherwise have been unable to find a matched unrelated donor; (5) how do transplant outcomes using these cord blood units compare to unrelated allogeneic umbilical cord blood transplants and unrelated allogeneic transplants using blood stem cells from adult donors; and, (6) what are the general physical characteristics of these units (e.g., total nucleated count, CD34+ content) and how does their quality compare to that of the general public inventory. HRSA proposes to invite the first cohort of umbilical cord blood banks receiving NCBI contracts to submit competitive proposals for participation in this demonstration project with an emphasis on: (1) Establishment of nationwide collections; and, (2) encouraging banks to subcontract with other experienced, high-quality cord blood banks to assist in their education, collection, processing, and storing efforts. HRSA has approximately $200,000 available for this demonstration project this fiscal year and anticipates selecting 2 or 3 banks to participate in this demonstration project to be funded through modification of their existing NCBI contracts with HRSA. HRSA recognizes the need for this service is likely greater than what can be satisfied in a limited demonstration project. Because of the great diversity in HLA types among African-Americans, HRSA recognizes that patients from this population are significantly less likely to find a suitably matched unrelated blood stem cell donor than patients from other racial or ethnic groups. Therefore, HRSA invites comments on the desirability of limiting participation to African- American families in which a first-degree relative has been diagnosed with a condition that may benefit from blood stem cell transplantation. HRSA understands that there may be special considerations associated with liability for those umbilical cord blood banks participating in this project. HRSA invites comment on how umbilical cord blood banks participating in this project may best address these concerns. Interested parties are invited to submit written comments on the key study questions, the funding approach, and umbilical cord blood bank liability for this demonstration project to the address below.

The Health Resources and Services Administration's (HRSA) Office of Rural Health Policy (ORHP) has sought to identify clear, consistent, and data-driven methods of defining rural areas in the Metropolitan counties of the United States. ORHP has funded development of Rural-Urban Commuting Area (RUCA) codes as the latest version of the Goldsmith Modification. HRSA is seeking comments on ORHP's use of RUCAs to better target Rural Health funding and projects. While other agencies of HHS may choose to adopt ORHP's definition of ``rural'' there is no requirement that they do so and they may choose other, alternate definitions that best suit their program requirements.

The Health Resources and Services Administration (HRSA) is requesting nominations to fill 11 vacancies on the Advisory Committee on Interdisciplinary, Community-Based Linkages (ACICBL).

HRSA is soliciting comments on the proposed eligibility criteria for the Reimbursement of Travel and Subsistence Expenses toward Living Organ Donations Program. Eligibility criteria were proposed by the program grantee, the Regents of the University of Michigan, to HRSA. HRSA has determined that the proposed eligibility criteria constitute a proper interpretation of the authorizing statute's requirements, including determinations as to which individuals would otherwise be unable to meet the eligible expenses authorized under this Program. HRSA is soliciting public comment on the criteria outlined in this notice. HRSA will consider the comments in light of the authorizing statute and seek feedback from the Regents of the University of Michigan concerning the comments. HRSA will then approve final criteria. The final program eligibility criteria will be posted on the Reimbursement of Travel and Subsistence Expenses for Living Organ Donation Web site, https://www.livingdonorassistance.org.

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 twelfth 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 15, 2007, and from 9 a.m. to 3 p.m. on May 16, 2007, at the DoubleTree Hotel & 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 is publishing a final Agency Guidance (``Policy Information Notice'' (PIN) 2007-09) to describe and clarify HRSA's current policy and process for resolving issues and conflicts related to health center service area overlap. The PIN, ``Service Area Overlap: Policy and Process,'' and the Agency's ``Response to Public Comments'' are available on the Internet at https://bphc.hrsa.gov/chc/sao.htm.

This Final Rule sets forth the Secretary's decision to include intestines within the definition of organs covered by the regulations governing the operations of the Organ Procurement and Transplantation Network. The Secretary under the authority granted by section 301 of the National Organ Transplant Act, as amended, further effects a corresponding change to the definition of human organs covered in the statute with this Final Rule.

The Health Resources and Services Administration published a notice in the Federal Register of December 6, 2006, soliciting comments on a proposed amendment to Policy Notice 99-02 which places a cumulative lifetime period of 24 months on short-term and emergency housing assistance under Title XXVI of the Public Health Service Act, as amended by the Ryan White HIV/AIDS Treatment Modernization Act of 2006. The amendment also specifies a requirement that the need for such assistance must be certified or documented by a case manager, social worker, or other licensed health care professional(s). HRSA received over 150 substantive comments from consumers and numerous organizations around the country in response to the December 6, 2006, notice.

The Health Resources and Services Administration (HRSA) is requesting nominations to fill eight (8) vacancies on the Advisory Committee on Heritable Disorders and Genetic Diseases in Newborns and Children.

This Final Rule sets forth the Secretary's proposal to require HTPC grant recipients to contribute non-Federal matching funds in years 2 through 5 of the project period equal to two times the amount of the Federal Grant Award or such lesser amount determined by the Secretary for good cause shown.

Section 602 of Public Law 102-585, the ``Veterans Health Care Act of 1992,'' enacted Section 340B of the Public Health Service (PHS) Act ``Limitation on Prices of Drugs Purchased by Covered Entities.'' Section 340B provides that in order to obtain Medicaid reimbursement for its covered outpatient drugs, a manufacturer must sign a pharmaceutical pricing agreement with the Secretary of Health and Human Services in which the manufacturer agrees to charge a price to covered entities for outpatient drugs that will not exceed an amount determined under a statutory formula. Section 340B is administered as the ``340B Drug Pricing Program'' and is commonly referred to as ``the 340B Program.'' Section 340B states that it is illegal for covered entities to sell medications purchased under the 340B Program to persons who are not considered ``patients'' of the covered entity. The purpose of this notice is to inform interested parties of proposed clarifications to the definition of ``patient'' for whom the covered entity can purchase discounted pharmaceuticals under the 340B Program. This clarification is necessary to protect the integrity of the 340B Program and to assist covered entities and other participants in their compliance efforts.

The Advisory Committee on Organ Transplantation (ACOT) will be conducting a conference call to discuss the revision of the Uniform Anatomical Gift Act (UAGA).