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

The Administration for Children and Families (ACF), Office of Community Services (OCS) announces that applications will be accepted for new grants pursuant to the U.S. Department of Health and Human Services (HHS) Secretary's Compassion Capital Fund (CCF) authorized under section 1110 of the Social Security Act governing Social Services Research and Demonstration activities and the Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2005, Public Law 108-447. Pursuant to this announcement, OCS will award funds to help build the capacity of faith-based and community organizations that address the needs of distressed communities. A ``distressed community'' is defined as a neighborhood or geographic community with an unemployment rate and/or poverty rate equal to or greater than the state or national rate. Priority areas of need include at-risk youth; the homeless; marriage education and preparation services to help couples who choose marriage for themselves develop the skills and knowledge to form and sustain healthy marriages; or social services to those living in rural communities.

The Food and Drug Administration (FDA) has determined the regulatory review period for GEODON and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.

In accordance with section 10(a) of the Federal Advisory Committee Act, this notice announces the first meeting of the Citizens' Health Care Working Group mandated by section 1014 of the Medicare Modernization Act.

This proposed rule would set forth the hospice wage index for fiscal year 2006 and identifies the revised labor market and metropolitan statistical areas. This proposed rule would also codify provisions of sections 408 and 946 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003.

This notice announces that laboratories located in the State of Washington that possess a valid license under the Medical Test Site Licensure Law, Chapter 70.42 of the Revised Code of Washington (RCW), continue to be exempt from the requirements of the Clinical Laboratory Improvement Amendments of 1988 (CLIA) until April 30, 2007.

An influenza pandemic has greater potential than any other naturally occurring infectious disease event to cause large and rapid global and domestic increases in deaths and serious illnesses. Preparedness is the key to substantially reducing the health, social, and economic impacts of an influenza pandemic and other public health emergencies. One component of preparedness involves understanding the impact that annual epidemics of influenza have on the population. These data regarding impact are critical to the development of prevention and control measures such as vaccination policies. Vaccination efforts are the cornerstone of influenza prevention and will be the primary means of mitigating the impact of an influenza pandemic. The systematic collection of influenza surveillance data over time is necessary to monitor and track influenza virus and disease activity and is essential to understanding the impact influenza has on a country's population. Improving surveillance systems by developing influenza surveillance networks is critical for the rapid detection of new variants, including those with pandemic potential, to contribute to the global surveillance system. Global collaboration, under the coordination of the World Health Organization (WHO), is a key feature of influenza surveillance. WHO established an international laboratory- based surveillance network for influenza in 1948. The network currently consists of 112 National Influenza Center (NIC) laboratories in 83 countries, and four WHO Collaborating Centers for Reference and Research of Influenza (including one located at the Centers for Disease Control and Prevention). The primary purposes of the WHO network are to detect the emergence and spread of new antigenic variants of influenza, to use this information to update the formulation of influenza vaccine, and to provide as much warning as possible about the next pandemic. This system provides the foundation of worldwide influenza prevention and control. Monitoring of influenza viruses and providing contributions to the global surveillance system will assure that data used in annual WHO vaccine recommendations are relevant to each country that participates. Increased participation in the global surveillance system for influenza viruses will enhance each country's ability to monitor severe respiratory illness, to develop vaccine policy, and to help build global and regional strategies for the prevention and control of influenza. Monitoring influenza disease activity is important to facilitate resource planning, communication, intervention, and investigation. This announcement seeks to support foreign governments through their Ministries of Health or other responsible Ministries for human health in the development or improvement of epidemiologic and virologic influenza surveillance networks. These networks will focus on the systematic collection of virological and epidemiological information for influenza. This support is meant to enhance, and not to supplant, current influenza surveillance activities. Proposals should build upon infrastructure already in place. Preference will be given to countries where resources are currently limited and influenza surveillance is not well established due to lack of resources.

The Indian Health Service published a document in the Federal Register on April 14, 2005. The document contained one error.

The Food and Drug Administration (FDA) is reissuing the notice announcing an opportunity to request a hearing on the agency's proposal to withdraw approval of 13 new drug applications (NDAs) from multiple sponsors. The basis for the proposal is that the sponsors have repeatedly failed to file required annual reports for these applications. In the Federal Register of January 28, 2005 (70 FR 4134), FDA published a notice announcing an opportunity for a hearing on the agency's proposal to withdraw approval of 13 NDAs from multiple sponsors. That notice published with an inadvertent error; in a document published elsewhere in this issue of the Federal Register, the agency is withdrawing that notice.

The Food and Drug Administration (FDA) is reclassifying tricalcium phosphate (TCP) granules for dental bone repair from class III to class II (special controls), classifying into class II (special controls) other bone grafting material for dental indications, and revising the classification name and identification of the device type. Bone grafting materials that contain a drug that is a therapeutic biologic will remain in class III and continue to require a premarket approval application. The classification identification includes materials such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen. This action is being taken to establish sufficient regulatory controls that will provide reasonable assurance of the safety and effectiveness of these devices. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for the class II devices.

The Department of Health and Human Services (HHS) seeks nominations of public and private sector organizations to receive the 2005 Secretary's Innovation in Prevention Awards Initiative. This activity is part of a broader Departmental initiative called Steps to a Healthier U.S. that advances President George W. Bush's HealthierUS goal of helping Americans live longer, better and healthier lives. The statutory authority for this health promotion activity is Section 1703 [42 U.S.C. 300u-2] from Title XVII of the Public Health Service Act. The Secretary's Innovation in Prevention Awards Initiative will identify and celebrate outstanding organizations that have implemented innovative and creative chronic disease prevention and health promotion programs. To be nominated, a program must address at least one of the following risk factors:

The Food and Drug Administration (FDA) is responding to objections and is denying requests that it has received for a hearing on the final rule that amended the food additive regulations authorizing the use of neotame as a nonnutritive sweetener in food. After reviewing the objections to the final rule and the requests for a hearing, the agency has concluded that the objections do not raise issues of material fact that justify a hearing or otherwise provide a basis for revoking the amendment to the regulation.

The Department of Health and Human Service (DHHS), Office of Public Health and Science (OPHS), is seeking nominations of qualified candidates to be considered for appointment as a member of the Advisory Committee on Minority Health (ACMH or Committee). In accordance with Public Law 105-392, the Committee provides advice to the Deputy Assistant Secretary for Minority Health (DASMH), on the development of goals and specific program activities of the Office of Minority Health (OMH) designed to improve the health of racial and ethnic minority groups. Nominations of qualified candidates are being sought to fill vacant positions on the Committee.

Funds are provided for Graduate Student Research Grants to Support field-initiated research activities. This grant program is part of a larger set of Head Start research announcements. Three other grant funding mechanisms are being offered concurrently with the one described in this announcement. They include: (1) Head Start Graduate Student Research Partnership Development Grants, (2) Head Start-University Partnership Research Grants: Curriculum Development and Enhancement for Head Start and Early Head Start Programs, and (3) American Indian-Alaska Native Head Start- University Partnerships. For more information, please see these other Head Start Research announcements listed in the Federal Register or listed on https://www.Grants.Gov, or send an inquiry to the e-mail address listed above. Funding for this grant program is shared with the Head Start Graduate Student Research Partnership Development Grants. Relative funding for the two sets of Head Start Graduate Student Research Grants is contingent upon the results of the review process.

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of March 4, 2005 (70 FR 10651). The document announced the withdrawal of approval of 76 new drug applications (NDAs) and 60 abbreviated new drug applications (ANDAs). The document inadvertently withdrew approval of ANDA 76-214 for Sotalol Hydrochloride Tablets, 80 milligrams (mg), 120 mg, and 160 mg, held by TorPharm, c/o Apotex Corp., 616 Heathrow Dr., Lincolnshire, IL 60069. FDA confirms that approval of ANDA 76-214 is still in effect.

This notice requests nominations for individuals to serve on the Advisory Panel on Medicare Education (the Panel). The Panel advises and makes recommendations to the Secretary of the Department of Health and Human Services (HHS) (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) (the Administrator) on opportunities for CMS to optimize the effectiveness of the National Medicare Education Program and other CMS programs that help Medicare beneficiaries understand the Medicare program and the range of health plan options available. Nominees must be knowledgeable in the field of managing a drug benefit.

In compliance with the requirement of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of Loan Repayment, the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on December 10, 2004, and allowed 60 days for public comment. No responses to the notice were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. The programs have existing data collections with an OMB control number (OMB No. 0925- 0361, expiration date 12/31/2004). An extension has been granted until March 2005 due to an administrative delay caused by a change in office responsible for the LRPs.

This notice is to inform interested parties of corrections to the Head Start Tribally Controlled Land Grant College and University Partnerships Program Announcement that was published on Wednesday, April 13, 2005. The following corrections should be noted: (1) Under Priority Areas I, Section VII. Agency Contacts, Program Office Contact, please delete the following name, address, phone number, and e-mail address: Katherine Gray, U.S. Department of Health and Human Services, Administration for Children and Families, ACYF Head Start Bureau, 330 C Street, SW., Switzer Room 2211, Washington, DC 20447. Phone: 312-353-2260. E-mail: kgray@acf.hhs.gov. Please replace the deleted name, address, phone number, and e-mail address with the following: Rosalind Dailey, U.S. Department of Health and Human Services, Administration for Children and Families, ACYF Head Start Bureau, 330 C Street, SW., Switzer Room 2211, Washington, DC 20447. Phone: 202-205-8653. E-mail: rdailey@acf.hhs.gov. All information in this notice of correction is accurate and replaces information specified in the April 13 notice. Applications are still due by the deadline date that was published in the April 13 notice (May 13 for Letters of Intent or Preapplications and June 13 for Applications).

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry and FDA staff entitled ``Application User Fees for Combination Products.'' This document provides guidance to industry and FDA staff on marketing application user fees for combination products. The guidance also describes how the ``barrier to innovation'' waiver provision under the prescription drug user fee provisions of the Federal Food, Drug, and Cosmetic Act (the act) may be applied to innovative combination products in the infrequent situation where FDA requires the submission of two marketing applications.

The purpose of the program is to strengthen the nation's capacity to carry out public health activities in the area of asthma education. More specifically, the objective is to provide appropriate resources for health education of patients and others impacted by asthma.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on a survey of customers who should be served by FDA's Center for Devices and Radiological Health (CDRH) Web site, in order to determine the kind and quality of services they want.

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 an exclusive license worldwide to practice the invention embodied in U.S. Patent No. 6,407,079, entitled ``Pharmaceutical compositions containing drugs which are instable or sparingly soluble in water and methods for their preparation,'' to Jurox Pty Ltd., having a place of business in Rutherford, Australia. The field of use may be limited to the development of injectable anesthetic formulations containing Alfaxalone-hydroxypropyl-beta cyclodextrin complex for use in humans. The United States of America has an interest in the patent rights of this invention.

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 Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (the PRA).

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Assessing Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection,'' dated April 2005. The draft guidance document provides revisions to the previously published recommendations for assessing donor suitability and product safety when donors are diagnosed with or suspected of West Nile Virus (WNV) infections based on symptoms and laboratory tests. This draft guidance proposes revised deferral periods for such donors, and updates information on product retrieval and quarantine. When finalized, this guidance will supersede ``Guidance for Industry: Revised Recommendations for the Assessment of Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection,'' dated May 2003.

The Head Start Bureau is announcing the availability of funds and request for applications for professional development and training grants for institutions of higher education with experience and capability in educating and preparing professionals to work effectively with Hispanic young children and families, in partnership with Head Start, Migrant Head Start and Early Head Start programs. The Head StartHigher Education Hispanic Service Institution Partnership (HS-HEHSIPs) program is funded to improve the quality and long-term effectiveness of program services to Hispanic children and their families by developing academic and other training models and forming partnerships between institutions of higher education and Head Start, Migrant Head Start, and Early Head Start programs. Through this announcement, the Administration on Children, Youth and Families (ACYF) is making available up to $1,500,000 annually for each of five years to support Head StartHigher Education Hispanic Service Institution Partnerships (HS-HEHSIPs). These partnerships are designed to improve the quality and long-term effectiveness of Head Start, Migrant Head Start and Early Head Start grantees by developing academic and other training models to increase the number of Head Start teachers with degrees in early childhood education.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``User Fee Waivers for FDC and Co-Packaged HIV Drugs for PEPFAR.'' This draft guidance describes the circumstances under which certain applications for fixed dose combination (FDC) and copackaged versions of previously approved antiretroviral therapies for the treatment of human immunodeficiency virus (HIV) under the President's Emergency Plan for Acquired Immunodeficiency Syndrome Relief (PEPFAR) will not be assessed user fees. The draft guidance also describes circumstances under which some of the applications that will be assessed fees may be eligible for a public health or a barrier-to-innovation waiver.

The Secretary of Health and Human Services is proposing rules for the imposition of civil money penalties on entities that violate rules adopted by the Secretary to implement the Administrative Simplification provisions of the Health Insurance Portability and Accountability Act of 1996, Pub. L. 104-191 (HIPAA). The proposed rule would amend the existing rules relating to the investigation of noncompliance to make them apply to all of the HIPAA Administrative Simplification rules, rather than exclusively to the privacy standards. It would also amend the existing rules relating to the process for imposition of civil money penalties. Among other matters, the proposed rules would clarify and elaborate upon the investigation process, bases for liability, determination of the penalty amount, grounds for waiver, conduct of the hearing, and the appeal process.

The Community Services Block Grant (CSBG) Act, as amended, authorizes the Secretary of Health and Human Services to make funds available under several programs to support program activities that will result in direct benefits targeted to low-income people. This program announcement covers the grant authority found at Section 681 of the Community Services Block Grant Act, (The Act) (Pub. L. 97-35) as amended by the Community Opportunities, Accountability, and Training and Educational Services Act of 1998 (Pub. L. 105-285), Community Food and Nutrition Program. The Act authorizes the Secretary to award grants on a competitive basis to eligible entities for community-based, local, statewide and national programs including programs benefiting Indians (as defined in section 677(e) of the CSBG Act) and migrant farm workers. Grant funds are provided to: (1) Coordinate private and public food assistance resources, wherever the grant recipient involved determines such coordination to be inadequate, to better serve low-income populations; (2) assist low-income communities to identify potential sponsors of child nutrition programs and to initiate such programs in underserved or unserved areas; and (3) develop innovative approaches at the State and local level to meet the nutrition needs of low-income individuals. Office of Community Services views this program as a capacity building program, rather than a food delivery program. OCS encourages eligible applicants with programs addressing obesity to submit applications. Eligible applicants with programs benefiting Native Americans and migrant or seasonal farm workers are also encouraged to submit applications. Public and non-profit agencies, faith-based and community-based organizations reaching underserved populations are encouraged to apply.

This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR Part 404.7(a)(1)(i), announces that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive license to practice the inventions embodied in 1. E-223- 1992/0-US-01, ``SIGNAL TRANSDUCTION INHIBITOR COMPOUNDS'', by Elise Kohn, Lance Liotta, Christian Felder, issued Pat No. 5,359,078 (issue date October 25, 1994); 2. E-223-1992/0-US-02, ``SIGNAL TRANSDUCTION INHIBITOR TRIAZOLE AND DIAZOLE COMPOUNDS'' by Elise Kohn, Lance Liotta, Christian Felder, issued Pat No. 5,482,954 (issue date January 9, 1996); 3. E-223-1992/0-US-03, ``SIGNAL TRANSDUCTION INHIBITOR 1,2,3,- TRIAZOLO COMPOUNDS'' by Elise Kohn, Lance Liotta, Christian Felder, issued Pat No. 5,498,620, (issued date March 12, 1996); 4. E-223-1992/ 0-US-04, ``SIGNAL TRANSDUCTION INHIBITOR COMPOUNDS'' by Elise Kohn, Lance Liotta, Christian Felder, issued Pat No 5,705,514 (issued date January 6, 1998); 5. E-223-1992/0-US-05, ``SIGNAL TRANSDUCTION INHIBITOR COMPOUNDS'' by Elise Kohn, Lance Liotta, Christian Felder, issued Pat No 5,880,129 (issued date March 9, 1999); 6. E-068-1991/1- US-01, ``METHOD FOR INHIBITING METALLOPROTEINASE EXPRESSION'' by Elise Kohn, Lance Liotta, issued Pat No. Pat No. 5,602,156 (issued date February 11, 1997); 7. E-220-1993/1-US-01 ``METHOD FOR INHIBITING ANGIOGENESIS'' by Elise Kohn, Lance Liotta and Riccardo Alessandro issued patent No 5,744,492 (issue date April 28,1998), to RFE Pharma, having a place of business in Framingham, MA. The patent rights in these inventions have been assigned to the United States of America. The prospective exclusive license territory may be worldwide, and the field of use may be limited to therapeutics for the treatment of retinopathy.

The Food and Drug Administration (FDA) is declaring unlawful the unapproved marketing of certain parenteral multivitamin drug products for which a hearing was requested, but for which the sponsors have withdrawn the hearing requests. FDA is taking this action because the products lack substantial evidence of effectiveness as fixed combination drug products.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Exploratory IND Studies.'' This draft guidance clarifies what preclinical and clinical issues (including chemistry, manufacturing, and controls issues) should be considered when planning exploratory studies in humans, including studies of closely related drugs or biologics, under an investigational new drug (IND) application. This draft guidance emphasizes the concept that limited investigations in humans can be initiated with more limited preclinical support because such studies present fewer potential risks than do traditional phase 1 studies that look for dose-limiting toxicities.

The Food and Drug Administration (FDA) is announcing the availability of a compliance policy guide (CPG) entitled ``Sec. 560.400Imported Milk and CreamFederal Import Milk Act (CPG 7119.05).'' The CPG provides guidance on the applicability of the Federal Import Milk Act (FIMA) to imported milk and cream. This document updates the existing CPG.

The Food and Drug Administration (FDA) is withdrawing approval of a new animal drug application (NADA) for dichlorophene and toluene capsules used in dogs and cats for removal of certain intestinal parasites. In a final rule published elsewhere in this issue of the Federal Register, FDA is amending the animal drug regulations to remove portions reflecting approval of this NADA.

The Head Start Bureau is announcing the availability of funds and requesting applications for professional development and training grants for Tribally Controlled Land Grant Colleges and Universities (TCUs). These grants are provided in partnership with Head Start and Early Head Start programs to improve staff training and to thereby enhance services to Head Start and Early Head Start children and families. Through this announcement, the Administration on Children, Youth and Families (ACYF) is making available up to $1,500,000 annually for each of five years to support Tribally Controlled Land Grant Colleges and Universities (TCUs) partnerships. These partnerships seek to increase the number of Head Start teachers with degrees in early childhood education, in order to improve the quality and long-term effectiveness of Head Start and Early Head Start grantees.

This notice announces those sites for which ATSDR has completed public health assessments during the period from October through December 2004. This list includes sites that are on or proposed for inclusion on the National Priorities List (NPL) and includes sites for which assessments were prepared in response to requests from the public.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry and FDA staff entitled ``Submission and Resolution of Formal Disputes Regarding the Timeliness of Premarket Review of a Combination Product.'' The Medical Device User Fee and Modernization Act of 2002 (MDUFMA) delegates to the Office of Combination Products (OCP) responsibility for resolving disputes about the timeliness of premarket review of combination products. This guidance document provides information about presenting requests for resolution of disputes about the timeliness of premarket review of combination products.

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 an exclusive license to practice the invention embodied in Patent Applications U.S. 60/340,772, filed on 12/12/2001, U.S. 60/342,582, filed on 12/19/2001, PCT/US2002/036829, filed on 11/14/2002, and corresponding EP, CA, AU, and JP filings, as well as U.S. 10/498,416, filed on 06/10/2004; entitled ``Methods for using extracellular adenosine inhibitors and adenosine receptor inhibitors to enhance immune response and inflammation'', all by Michail V. Sitkovsky and Akio Ohta, to Adenosine Therapeutics, LLC, having a place of business in Charlottesville, VA. The patent rights in this invention have been assigned to the United States of America.