National Vaccine Injury Compensation Program: Addition of Meningococcal and Human Papillomavirus (HPV) Vaccines to the Vaccine Injury Table
Through this notice, the Secretary announces that meningococcal (conjugate and polysaccharide) and human papillomavirus (HPV) vaccines are covered vaccines under the National Vaccine Injury Compensation Program (VICP), which provides a system of no-fault compensation for certain individuals who have been injured by covered childhood vaccines. This notice serves to include meningococcal and HPV vaccines as covered vaccines under Category XIV (new vaccines) of the Vaccine Injury Table (Table), which lists the vaccines covered under the VICP. This notice ensures that petitioners may file petitions relating to meningococcal and HPV vaccines with the VICP even before such vaccines are added as separate and distinct categories to the Table through rulemaking.
National Vaccine Injury Compensation Program; List of Petitions Received
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.
Reimbursement of Travel and Subsistence Expenses Toward Living Organ Donation Proposed Eligibility Guidelines
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, http://www.livingdonorassistance.org.
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 primary health care programs, including the Health Center 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.
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 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).
Notice of Availability of Final Policy Guidance
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 http://bphc.hrsa.gov/chc/sao.htm.
Blood Vessels Recovered With Organs and Intended for Use in Organ Transplantation
The Food and Drug Administration (FDA) and the Health Resources and Services Administration (HRSA) are amending their regulations to include 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, or cellular or tissue- based products (HCT/Ps) (FDA regulation). The purpose of this final rule is to amend the regulations so that blood vessels recovered with organs and intended for use in organ transplantation, and labeled as such, are governed by the regulations pertaining to organs. The regulation of other recovered blood vessels remains unchanged. We (HRSA and FDA) believe that this change will eliminate the 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).
Organ Procurement and Transplantation Network
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.
National Practitioner Data Bank; Announcement of Proactive Disclosure Service (PDS) Opening Date and User Fees
The Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS), is announcing the implementation of a Proactive Disclosure Service (PDS) Prototype. The PDS is being offered as an alternative to the periodic querying of the National Practitioner Data Bank (NPDB). It was developed in response to the growing interest of healthcare entities in on-going monitoring of practitioner credentials. Authorized Data Bank entities can choose to enroll all of their practitioners in PDS or enroll some practitioners while continuing to periodically query on others using the regular query methods. The query fee for periodic queries remains $4.75 per name. Entities with PDS enrolled practitioners will be notified within one business day of the NPDB's receipt of a report on any of their enrollees. While entities can expect to receive reports sooner with PDS, the format of and the information contained in a report, as well as the information required to be reported will remain the same. Initially, the PDS is being offered as a prototype. The annual subscription fee, during the prototype period, is $3.25 per practitioner. This rate is subject to change after the prototype period is complete.
Notice of Availability of Draft Policy Document for Comment
This is a Notice of Availability and request for comments on the draft policy document, ``Emergency Management Program Expectations,'' prepared by HRSA. This document is currently posted on the Internet at http://bphc.hrsa.gov. Comments will be reviewed and analyzed, and a summary and general response will be published as soon as possible after the deadline for receipt of comments.
HIV/AIDS Bureau Policy Notice 99-02; Correction
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.
Poison Control Centers Stabilization and Enhancement 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), the agency believes, in the case of its Poison Control Program, that full recovery of overhead expenditures would be detrimental to the poison control centers (PCCs) funded under the program because of the financial instability of PCCs. The purpose of the HRSA Poison Control Centers Stabilization and Enhancement Grant Program is to assist PCCs in achieving financial stability, preventing poisonings and providing treatment recommendations for poisonings. Limiting indirect costs is necessary because many PCCs are located within institutions such as universities and hospitals that have established indirect cost rates in the range of 30 to 50 percent. It is in the best interest of PCCs to limit the indirect cost recovery to 10 percent, leaving 90 percent of the grant funds to achieve the objectives of the grant program. This limitation would be applicable to all awardees of the Poison Control Center Stabilization and Enhancement Grant Programs.
Advisory Committee on Heritable Disorders and Genetic Diseases in Newborns and Children
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.
Healthy Tomorrows Partnership for Children Program (HTPC)
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.
Establishment of Advisory Council on Blood Stem Cell Transplantation and Solicitation of Nominations for Membership
Pursuant to Public Law 109-129, 42 U.S.C. 274k (section 379 of the Public Health Service Act, as amended) and the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), the Administrator, HRSA, announces the establishment of the Advisory Council on Blood Stem Cell Transplantation by the Secretary, HHS. The Council will advise the Secretary on proposed C.W. Bill Young Cell Transplantation Program policies and other such matters as the Secretary determines. Duration of this Council is for two years unless renewed by the Secretary, HHS. This notice also requests nominations for membership on the Council.
Notice Regarding Section 602 of the Veterans Health Care Act of 1992 Definition of “Patient”
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.
Notice Regarding 340B Drug Pricing Program-Contract Pharmacy Services
Section 340B of the Public Health Service Act implements a drug pricing program in which manufacturers who sell covered outpatient drugs to covered entities must agree to charge a price that will not exceed an amount determined under a statutory formula. The purpose of this notice is to inform interested parties of proposed guidelines regarding contract pharmacy services that will allow covered entities to utilize contract pharmacy services arrangements previously limited to the Alternative Methods Demonstration Project program.