Department of Health and Human Services February 2005 – Federal Register Recent Federal Regulation Documents

Currently, application scores for New Access Point (NAP) applications under the President's Health Centers Initiative (Program) cluster at the high end of the scoring range, providing little distinction among applicants. Since the intent of the Program is to provide grants to the neediest communities, HRSA is considering placing more emphasis on assessing the need for comprehensive primary and preventive health care services in the service area or for the population for which the applicant is seeking support, by revising the Need for Assistance Criteria and changing the relative weights of the review criteria used in evaluating such applications. This notice offers public and private nonprofit entities an opportunity to comment on the proposed changes in the Need for Assistance Criteria (NFA), and on the degree to which need should be weighted relative to other criteria used in evaluating future applications. In order to solicit comments from the public on these proposed changes, HRSA is delaying the due date (May 23, 2005) for the second round of fiscal year (FY) 2005 New Access Point applications. Authorizing Legislation: Section 330(e)(1)(A) of the Public Health Service Act, as amended, authorizes support for the operation of public and nonprofit private health centers that provide health services to medically underserved populations. Reference: For the current Need for Assistance (NFA) criteria and other application review criteria, including weights used most recently, see Program Information Notice (PIN) 2005-01, titled ARequirements of Fiscal Year 2005 Funding Opportunity for Health Center New Access Point Grant Applications,'' are available on HRSA's Bureau of Primary Health Care (BPHC) Web site at https://bphc.hrsa.gov/ pinspals/pins.htm. That PIN detailed the eligibility requirements, review criteria, and awarding factors for applicants seeking support for the operation of New Access Points in FY 2005. Background: The goal of the President's Health Centers Initiative, which began in FY 2002, is to increase access to comprehensive primary and preventive health care services to 1,200 of the Nation's neediest communities through new and/or significantly expanded health center access points over five years. These health center access points are to provide comprehensive primary and preventive health care services in areas of high need that will improve the health status of the medically underserved populations to be served and decrease health disparities. Services at these new access points may be targeted toward an entire community or service area or toward a specific population group in the service area that has been identified as having unique and significant barriers to affordable and accessible health care services. While it is extremely important that NAP grant awards be made to entities that will successfully implement a viable and compliant program for the delivery of comprehensive primary health services to the populations or communities they propose to serve, HRSA also needs to assure that all applicants seeking support for a NAP applicant can demonstrate the need for such services in the community (area or population group) to be served and be evaluated on that need. Under the current guidance, NFA criteria are used to quantify barriers to access and identify health disparities. The NFA process also establishes a threshold which applicants must meet in order for their applications to be reviewed by the Objective Review Committee (ORC). Description of Current NFA process. The current NFA process (as described in Form 9-Part A of PIN 2005-01) involves two major groups of indicators. First, from eight (8) ``Barriers and Access to Care'' measures, the applicant must select five (5). These measures are: Shortage of primary care physicians, as measured by whether the target service area has been designated as a geographic or population group Health Professions Shortage Area (HPSA); Percent of the population with incomes below 200% of the Federal poverty level; Life expectancy of target population (in years); percentage of target population uninsured; unemployment rate of target population; average travel time or distance to nearest source of primary care for target population; percentage of target population age 5 or older who speak a language other than English at home; and length of waiting time for public housing and Section 8 certificates for target population. For the first of these measures, the applicant receives 14 points if HPSA-designated and zero otherwise; for each of the other measures, the NFA criteria define a 6-level scale from 0 to 14 points. The applicant provides data for its service area or target population for each of the 5 measures selected, and identifies the source of data used. Given 5 indicators and a maximum of 14 points for each, there are a possible 70 points for the ``Barriers and Access to Care'' indicators. Second, from 28 ``Health Disparity Factors'', the applicant selects 10 and provides data on each for its service areas or target populations. For each factor selected, the applicant can receive 3 points if the value for the target population exceeds the benchmark used. The applicant defines the benchmark, and gives a source for that benchmark as well as a source for the target population data provided. The guidance lists 27 specific factors, plus an ``other'' category allowing the applicant to select one additional locally-relevant factor not anticipated by the guidance. This approach produces a possible 30 points for the ``Health Disparities Factors'' section; combined with the possible 70 for ``Barriers and Access to Care'' section, allowing a possible 100 total points are possible. In current guidance, the threshold for having the application reviewed has been set at an NFA score of 70 out of the possible 100 total points.

In accordance with section 10(a) of the Federal Advisory Committee Act, this notice announces a meeting of the Practicing Physicians Advisory Council (the Council). The Council will be meeting to discuss certain proposed changes in regulations and carrier manual instructions related to physicians' services, as identified by the Secretary of the Department of Health and Human Services (the Secretary). This meeting is open to the public.

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of a an exclusive license to practice the invention embodied in: (1) U.S. Patent No. 4,968,690, issued Nov. 6, 1990, entitled ``3- DEAZANEPLANOCIN A AND METHOD OF PREPARATION'' (E-493-1985/0-US-02) (Inventors: Victor E. Marquez, John S. Driscoll, Mu-III Lim, Christopher K Tseng, Alberto Haces and Robert Glazer) (NCI), a continuation of prior application 867,583, filed May 27, 1986, now abandoned. (2) U.S. Patent No. 4,975,434, issued Dec. 4, 1990, entitled ``ANTIVIRAL AND ANTICANCER CYCLOPENTENYL CYTOSINE'' (E-493-1985/1-US- 01) (Inventors: Victor E. Marquez, John S. Driscoll, Mu-III Lim, Christopher K Tseng, Alberto Haces and Robert Glazer) (NCI), a continuation of prior application 867,583, filed May 27, 1986, now abandoned to GRX Pharmaceuticals (hereafter GRX), having a place of business in Marlboro, New Jersey. The patent rights in these inventions have been assigned to the United States of America.

This notice, in accordance with Section 1153(i) of the Social Security Act, gives at least 6-months' advance notice of the expiration dates of contracts with out-of-State Utilization and Quality Control Peer Review Organizations. It also specifies the period of time in which in-State organizations may submit a statement of interest so that they may be eligible to compete for these contracts.

This proposed rule would set forth the requirements that heart, heart-lung, intestine, kidney, lung, and pancreas transplant centers must meet to participate as Medicare-approved transplant centers. These proposed revised requirements focus on an organ transplant center's ability to perform successful transplants and deliver quality patient care as evidenced by good outcomes and sound policies and procedures. We are proposing that approval, as determined by a center's compliance with the proposed data submission, outcome, and process requirements would be granted for 3 years. Every 3 years, approvals would be renewed for transplant centers that continue to meet these requirements. We are proposing these revised requirements to ensure that transplant centers continually provide high-quality transplantation services in a safe and efficient manner.

This proposed rule would revise the requirements that end stage renal disease (ESRD) dialysis facilities must meet to be certified under the Medicare program. The revised requirements focus on the patient and the results of the care provided to the patient, establish performance expectations for facilities, encourage patients to participate in their care plan and treatment, eliminate many procedural requirements from the current conditions for coverage, and preserve strong process measures when necessary to promote patient well being and continuous quality improvement. These changes are necessary to reflect the advances in dialysis technology and standard care practices since the requirements were last revised in their entirety in 1976.

The Department of Health and Human Services (HHS) notifies Federal agencies of the laboratories currently certified to meet the standards of Subpart C of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908), on September 30, 1997 (62 FR 51118), and on April 13, 2004 (69 FR 19644). A notice listing all currently certified laboratories is published in the Federal Register during the first week of each month. If any laboratory's certification is suspended or revoked, the laboratory will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end, and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at https:// workplace.samhsa.gov and https://www.drugfreeworkplace.gov.

The Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER), in collaboration with FDA's Office of Regulatory Affairs (ORA), Southwest Regional Office (SWRO), is announcing a public workshop entitled ``FDA Drug Educational Forum.'' This public workshop is intended to provide information about FDA's premarket requirements to the drug industry, particularly small businesses, startups, and entrepreneurs. Date and Time: The public workshop will be held on May 11, 2005, from 8 a.m. to 5 p.m. Location: The public workshop will be held at the Kansas City Health Department Auditorium, 2400 Troost Ave., Kansas City, MO 64108- 2666. For directions to the facility, please call 816-513-6008, e-mail: health@kcmo.org, or visit https://www.kcmo.org/health.nsf/web/ healthmap?opendocument. (FDA has verified the Web site address, but FDA is not responsible for any subsequent changes to the Web site after this document publishes in the Federal Register.) Contact: David Arvelo or Cassandra Davis, Food and Drug Administration, 4040 N. Central Expressway, suite 900, Dallas, TX 75204-3128, 214-253-4952 or 214-253-4951, FAX: 214-253-4970, e-mail: oraswrsbr@ora.fda.gov. Registration: Registration begins on April 6, 2005, and ends May 6, 2005. Registration is free. Seats are limited, please register as soon as possible. Space will be filled in order of receipt of registration. Those registered will receive confirmation. Registration will close after available space fills. Registration at the site will be based on space availability on the day of the event starting at 8 a.m. If you need special accommodations due to disability, please contact David Arvelo or Cassandra Davis (see CONTACT) at least 7 days in advance. Registration Form Instructions: To register, complete the following registration form and submit via: E-mail: oraswrsbr@ora. fda.gov, FAX: 214-253-4970, or Mail to: Food and Drug Administration, Southwest Regional Office, Small Business Representative, 4040 N. Central Expressway, suite 900, Dallas, TX 75204-3128. Name: Company Name: Mailing Address: City: State: Zip Code: Phone: ( ) Fax: ( ) E-mail: ( ) Transcripts: Transcripts of the public workshop will not be available due to the format of this workshop. Course handouts may be requested in writing from the Freedom of Information Office (HFI-35), Food and Drug Administration, 5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857, approximately 15 working days after the public workshop at cost of 10 cents per page.

This proposed rule would update the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs). The payment amounts and factors used to determine the updated Federal rates that are described in this proposed rule have been determined based on the LTCH PPS rate year July 1, 2005 through June 30, 2006. The annual update of the long-term care diagnosis-related group (LTC-DRG) classifications and relative weights remains linked to the annual adjustments of the acute care hospital inpatient diagnosis-related group system, and would continue to be effective each October 1. The proposed outlier threshold for July 1, 2005 through June 30, 2006 is also derived from the LTCH PPS rate year calculations. We are proposing to adopt new labor market area definitions for the purpose of geographic classification and the wage index. We are also proposing policy changes and clarifications.

The Administration for Native Americans (ANA), within the Administration for Children and Families, announces the availability of fiscal year (FY) 2005 funds for new community-based activities under ANA's Native Language program. Financial assistance is provided utilizing a competitive process in accordance with the Native American Programs Act of 1974, as amended. ANA provides financial assistance to eligible applicants for the purpose of assisting Native Americans in assuring the survival and continuing vitality of their languages. Grants are provided under the following two categories: Category I Assessment Grants are used to conduct the assessment needed to identify the current status of the Native American language(s) to be addressed and to establish community long-range language goals; and, Category II Design and/or Implementation Grants are to design and/or implement a preservation language project that will contribute to the achievement of the community's long-range language goal(s). The Program Areas of Interest are projects that ANA considers supportive to Native American communities. Although eligibility for funding is not restricted to projects of the type listed in this program announcement, these Areas of Interest are ones which ANA sees as particularly beneficial to the development of healthy Native American communities.

The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) for Anthrax Vaccine Adsorbed (AVA) for prevention of inhalation anthrax for individuals between 18 and 65 years of age who are deemed by the Department of Defense (DoD) to be at heightened risk of exposure due to attack with anthrax. FDA is issuing this Authorization under the Federal Food, Drug, and Cosmetic Act (the act), as requested by DoD. The Authorization contains, among other things, conditions on the emergency use of AVA. The Authorization follows the determination by DoD that there is a significant potential for a military emergency involving a heightened risk to U.S. military forces of attack with anthrax. On the basis of such determination, Secretary of Health and Human Services Tommy G. Thompson (the Secretary) declared an emergency justifying the authorization of the emergency use of AVA. The Authorization, which includes an explanation of the reasons for its issuance, is reprinted in this Notice.

Title XX of the Public Health Service Act, 42 U.S.C. 300z. et seq., authorizes the Secretary of Health and Human Services to award grants for demonstration projects to provide services to pregnant and nonpregnant adolescents, adolescent parents, and their families. These grants are for public or private nonprofit organizations or agencies to find effective means of strengthening families by providing an array of services that help prevent repeat pregnancy and provide adolescent mothers, fathers and/or male partners, and their babies with services that enhance their well-being. Faith-based organizations are encouraged to apply. See heading ``Care Services'' for additional information. The Office of Adolescent Pregnancy Programs (OAPP) of the Office of Population Affairs (OPA) requests applications for care demonstration grants under the Adolescent Family Life (AFL) Demonstration Projects Program, as authorized by Title XX of the Public Health Service Act. These Title XX grants should clearly and consistently establish comprehensive and integrated approaches to the delivery of care services to pregnant adolescents, adolescent parents, their children, their extended family members, fathers of their children, and/or male partners to whom they are married or in a long-term relationship.