Department of Health and Human Services October 2007 – Federal Register Recent Federal Regulation Documents

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.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``The Use of Mechanical Calibration of Dissolution Apparatus 1 and 2 - Current Good Manufacturing Practice (CGMP).'' The draft guidance is intended to aid drug manufacturers and ancillary testing laboratories in using mechanical calibration as an alternate approach to the use of calibrator tablets in calibrating an apparatus used for dissolution testing. The guidance provides references to information on critical tolerances that should be achieved with mechanical calibration.

The Food and Drug Administration (FDA) is classifying the remote medication management systems into class II (special controls). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled, ``Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Remote Medication Management System,'' which will serve as the special control for this device type. The agency is classifying this device type into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of these devices.

The Food and Drug Administration (FDA) is amending the biologics regulations by providing options to the existing requirement for the processing of live vaccines. FDA is amending the regulations due to advances in technology that will allow processing of live vaccines to be performed in multiproduct manufacturing areas. We are publishing this rule because the existing requirement regarding facilities and equipment for live vaccine processing is too prescriptive and is no longer necessary. We are taking this action as part of our continuing effort to reduce the burden of unnecessary regulations on industry and to revise outdated regulations without diminishing public health protection. Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule under our usual procedures for notice and comment in the event that we receive any significant adverse comments on the direct final rule. If we receive any significant adverse comments that warrant terminating the direct final rule, we will consider such comments on the proposed rule in developing the final rule.

The National Health and Nutrition Examination Survey (NHANES) is a program of periodic surveys conducted by the National Center for Health Statistics (NCHS) of the Centers for Disease Control and Prevention (CDC). Examination surveys conducted since 1960 by NCHS have provided national estimates of the health and nutritional status of the U.S. civilian noninstitutionalized population. To add to the extensive amount of information collected for the purpose of describing the health of the population, DNA specimens were collected during two NHANES surveys. DNA is available in the form of crude lysates of cell lines derived from approximately 7,157 participants enrolled in Phase II of NHANES III (1991-1994). In addition, DNA purified from whole blood is also available from approximately 7,900 participants enrolled in the 1999-2002 NHANES survey years. All specimens (NHANES III and NHANES 1999-2002 were sent to the Division of Laboratory Sciences (DLS) at the National Center for Environmental Health (NCEH) for processing. DNA samples from these specimens are being made available to the research community for genetic analyses. No funding is provided as part of this solicitation. NCHS will begin to accept proposals after the publication of this notice and will continue to accept proposals on an on-going basis. Proposals received within 60 days of the notice will complete review approximately 180 days after the notice is published. After this initial review of proposals, all proposal categories will be reviewed twice a year beginning January 1 and July 1 of each year. Unforeseen circumstances could result in a change to this schedule. Proposals will be reviewed by a technical panel and by an internal Secondary Review Committee of senior CDC scientists. The Secondary Review Committee will perform a programmatic review based on the results of the technical review panel and consider the scientific and technical results from the first level of review, important programmatic considerations such as program priorities, program relevance, and other criteria germane to this announcement and to CDC. Projects approved by both reviews will be submitted to the NCHS Ethics Review Board for final approval. Approved projects that do not obtain funding on their own will be canceled. A more complete description of this program follows.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guidance for Industry on Special Protocol Assessment'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The President's Council on Bioethics (Edmund D. Pellegrino, MD, Chairman) will hold its thirty-first meeting, at which it will continue (1) its inquiry into the ``crisis'' of the healing professions with expert presentations and Council discussions; and (2) its inquiry into the moral foundations of health care. Subjects discussed at past Council meetings (although not on the agenda for the November 2007 meeting) include: Therapeutic and reproductive cloning, assisted reproduction, reproductive genetics, neuroscience, aging retardation, organ transplantation, newborn screening, human dignity, personalized medicine, and lifespan-extension. Publications issued by the Council to date include: Human Cloning and Human Dignity: An Ethical Inquiry (July 2002); Beyond Therapy: Biotechnology and the Pursuit of Happiness (October 2003); Being Human: Readings from the President's Council on Bioethics (December 2003); Monitoring Stem Cell Research (January 2004), Reproduction and ResponsibilityL: The Regulation of New Biotechnologies (March 2004), Alternative Sources of Human Pluripotent Stem Cells: A White Paper (May 2005), and Taking Care: Ethical Caregiving in Our Aging Society (September 2005). Reports on (a) the bioethical significance of the concept of human dignity, (b) controversies in the determination of death, and (c) organ procurement, transplantation, and allocation are forthcoming.

Pursuant to Public Law 92-463, notice is hereby given of a meeting of the NTP Board of Scientific Counselors (NTP BSC). The NTP BSC is composed of scientists from the public and private sectors and provides primary scientific oversight to the NTP Director and evaluates the scientific merit of the NTP's intramural and collaborative programs.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

This notice announces the first demonstration site for the Medicare Clinical Laboratory Services Competitive Bidding Demonstration project and the date for the Bidder's Conference. The Medicare Clinical Laboratory Competitive Bidding Demonstration was mandated by the Congress. Section 302(b) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173) requires the Centers for Medicare & Medicaid Services (CMS) to conduct a demonstration project on the application of competitive acquisition for clinical laboratory services that would otherwise be paid under the Medicare Part B fee schedule. The objective of the demonstration is to determine whether competitive bidding can be used to provide Part B clinical laboratory services at fees below current Medicare payment rates while maintaining quality and access to care. The MMA specifically requires that the demonstration: (1) Includes tests paid under the Medicare Part B Clinical Laboratory Fee Schedule; (2) excludes entities that have a ``face-to-face encounter'' with the patient; (3) excludes Pap smears and colorectal cancer screening tests; and, (4) includes requirements under the Clinical Laboratory Improvement Amendments (CLIA) program. An initial Report to the Congress was submitted April 2006. Site(S): The fundamental criteria for selecting demonstration sites require that each Metropolitan Statistical Area (MSA) allows for potential Medicare program savings from the demonstration, is administratively feasible, represents the laboratory market, and will yield demonstration results that can be generalized to other MSAs. The first demonstration site will be the San Diego-Carlsbad-San Marcos, California MSA. A Bidders Conference is planned for October 31, 2007 in the San Diego-Carlsbad-San Marcos, California MSA. The demonstration covers tests provided to beneficiaries enrolled in the traditional fee-for-service (FFS) Medicare program who reside in the area of the demonstration site or competitive bid area (CBA) during the 3 year demonstration period. Beneficiaries who travel outside the CBA during the demonstration period and require laboratory services will be able to access services from most laboratories in the United States. We will not directly pay, however, for services furnished by a required bidder that did not bid or bid and did not win or a non- required bidder that bid and did not win. (The terms ``required bidder'' and ``non-required bidder'' are explained in section II below.) Laboratories may not bill beneficiaries for laboratory services covered under the Medicare program.