Department of Health and Human Services April 2006 – Federal Register Recent Federal Regulation Documents

In accordance with the Federal Advisory Committee Act, 5 U.S.C. Appendix 2, section 10(a) (Pub. L. 92-463), this notice announces a meeting of the Advisory Panel on Medicare Education (the Panel) on May 25, 2006. The Panel advises and makes recommendations to the Secretary of Health and Human Services and the Administrator of the Centers for Medicare & Medicaid Services on opportunities to enhance the effectiveness of consumer education strategies concerning the Medicare program. This meeting is open to the public.

The NCI is establishing common guidelines for the collection of biospecimens and their accompanying data by NCI-sponsored biorepositories. These guidelines are intended to standardize and enhance the quality of research material and data used in cancer research.

This proposed rule would establish regulations required by section 506 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), (Pub. L. 108-173). Section 506 of the MMA amended section 1866(a)(1) of the Social Security Act to add subparagraph (U) which requires hospitals that furnish inpatient hospital services payable under Medicare to participate in the contract health services program funded by the Indian Health Service (IHS) whether operated by the IHS, tribes or tribal organizations and any health program operated by Urban Indian organizations that are funded by IHS with respect to any medical care furnished under those programs. Section 506 also requires such participation to be in accordance with the admission practices, payment methodology, and payment rates set forth in regulation established by the Secretary, including acceptance of no more than the payment rate as payment in full.

This document amends the interim final regulation that implements the Mental Health Parity Act of 1996 (MHPA) to conform the sunset date of the regulation to the sunset date of the statute under legislation passed on December 30, 2005.

Public Law 109-129 requires the Secretary of Health and Human Services to recognize one or more cord blood accreditation entities for the accreditation of cord blood banks participating in the collection and maintenance of umbilical cord blood units for the National Cord Blood Inventory. These cord blood units will be made available for unrelated donor blood stem cell transplants through the C.W. Bill Young Cell Transplantation Program. The HRSA, Healthcare Systems Bureau (HSB), Division of Transplantation (DoT) is in the process of information-gathering to assist in the determination of which cord blood bank accreditation program(s) to recognize on an interim basis for the initial cycle of funding for the National Cord Blood Inventory. The purpose of this solicitation is to receive public input on the following: (1) Approaches to accreditation required to ensure quality cord blood bank operations (including collection sites); (2) Utilization of accreditation programs to ensure product quality and best practices; (3) Degree to which accreditation standards are evidence based and supported by published literature; (4) Extent to which accreditation standards allow for variations in cord blood bank practices; (5) Criteria for the Secretary to consider in recognizing cord blood bank accrediting programs for the National Cord Blood Inventory, C.W. Bill Young Cell Transplantation Program. The HRSA intends for this interim process to be followed by a formal, more comprehensive recognition process that will include input from both the Advisory Council, once it is established, and the interested public as required in the legislation. The purpose of this Notice is to invite interested parties to register for and participate in either of two conference calls, described below, that HRSA is scheduling to obtain comment on factors relevant to determining which accrediting organization(s) to recognize for the initial cycle of funding under the National Cord Blood Inventory.

The Office for Human Research Protections (OHRP), a program office in the Office of Public Health and Science, Department of Health and Human Services (HHS), is seeking nominations of qualified candidates to be considered for appointment as members of the Secretary's Advisory Committee on Human Research Protections (SACHRP). SACHRP provides advice and recommendations to the Secretary, HHS, and the Assistant Secretary for Health on matters pertaining to the continuance and improvement of functions within the authority of HHS directed toward protections for human subjects in research. SACHRP was established by the Secretary, HHS, on October 1, 2002. OHRP is seeking nominations of qualified candidates to fill four positions on the Committee membership that will become vacant on January 3, 2007.

A notice was published in the Federal Register (FRN) on February 4, 2005 (Vol. 70, No. 23, pp. 6016-6023), detailing proposed changes to the Need for Assistance (NFA) Worksheet criteria being considered for use in future Consolidated Health Center New Access Point (NAP) grant cycles. The FRN requested public comments on these proposed changes and on the degree to which Need should be weighted relative to the other criteria used in the NAP application scoring process. Comments were to be provided to HRSA by March 7, 2005. The proposed changes to the NFA Worksheet criteria and the solicitation of comments were motivated by HRSA's continuous efforts to improve its grant processes. To that end, HRSA sought comment on how to improve its measure of need for comprehensive primary and preventive health care services in the service area or population to be served by a NAP applicant, and whether the weighting of need relative to other application review criteria should be increased. Comments were received from over 50 organizations and/or individuals regarding the proposed changes. These comments were thoroughly evaluated. This FRN presents a summary of the comments received by topic, with HRSA's corresponding responses, and a summary of the final changes HRSA has decided to make to the NFA Worksheet and the weighting of Need in the application review process. Authorizing Legislation: Section 330(e)(1)(A) of the Public Health Service (PHS) Act, as amended, authorizes support for the operation of public and nonprofit private health centers that provide health services to medically underserved populations. Similarly, section 330(g) authorizes grants for delivery of services to Migratory and Seasonal Agricultural Workers; section 330(h) to Homeless populations; and section 330(i) to residents of Public Housing. Reference: For the previous NFA Worksheet criteria and previously used application weights, see Program Information Notice (PIN) 2005-01, entitled (Requirements of Fiscal Year 2005 Funding Opportunity for Health Center New Access Point Grant Applications.'' Background: The goal of the President's Health Centers Initiative, which began in fiscal year (FY) 2002, is to increase access to comprehensive primary and preventive health care services through development of new and/or significantly expanded health center access points in 1,200 of the Nation's neediest communities. Funded health centers are expected 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. It is important that NAP grant awards be made to entities that will successfully implement a viable and legislatively compliant program for the delivery of comprehensive primary health services. It is also essential that all NAP applicants demonstrate the need for such services in the community/population to be served and be evaluated on that need. As part of its efforts to improve the needs assessment process, HRSA arranged for an external evaluation of the NFA Worksheet criteria and the use of need factors in the overall application review process. The evaluation was conducted by a team consisting of HSR, Inc. and the University of North Carolina's Cecil G. Sheps Center for Health Services Research. Key results of the evaluation analyses were presented in the FRN, as well as recommendations for proposed changes. Comments were solicited for the proposed changes. A summary of the comments received from the public and HRSA's response to these comments are presented below.

This notice announces the fifth of the American Health Information Community Biosurveillance Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).

This notice announces the fifth meeting of the American Health Information Community Chronic Care Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).

The National Institutes of Health (NIH) is providing notice of the ``List of Drugs for Which Pediatric Studies Are Needed.'' The NIH developed the list in consultation with the Food and Drug Administration (FDA) and pediatric experts, as mandated by the Best Pharmaceuticals for Children Act. This list prioritizes certain drugs most in need of study for use by children to ensure their safety and efficacy. The NIH will update the list at least annually until the Act expires on October 1, 2007.

The Food and Drug Administration is correcting a notice that appeared in the Federal Register of April 11, 2006. The document reannounced the invitation for participation in its Regulatory Site Visit Training Program. The document was published with an incorrect e- mail address. This document corrects that error.

We are proposing to revise the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs to implement changes arising from our continuing experience with these systems, and to implement a number of changes made by the Deficit Reduction Act of 2005 (Pub. L. 109-171). In addition, in the Addendum to this proposed rule, we describe the proposed changes to the amounts and factors used to determine the rates for Medicare hospital inpatient services for operating costs and capital-related costs. We also are setting forth proposed rate-of-increase limits as well as proposed policy changes for hospitals and hospital units excluded from the IPPS that are paid in full or in part on a reasonable cost basis subject to these limits. These proposed changes would be applicable to discharges occurring on or after October 1, 2006. In this proposed rule, we discuss our proposals to refine the diagnosis-related group (DRG) system under the IPPS to better recognize severity of illness among patientsfor FY 2007, we are proposing to use a hospital-specific relative value cost center weighting methodology to adjust DRG relative weights and in FY 2008 (if not earlier), to implement consolidated severity-adjusted DRGs or alternative severity adjustment methods. Among the other policy changes that we are proposing to make are changes related to: limited revisions of the reclassification of cases to DRGs; the long-term care (LTC)-DRGs and relative weights; the wage data, including the occupational mix data, used to compute the wage index; applications for new technologies and medical services add-on payments; payments to hospitals for the direct and indirect costs of graduate medical education; submission of hospital quality data; payments to sole community hospitals and Medicare-dependent, small rural hospitals; and provisions governing emergency services under the Emergency Medical Treatment and Labor Act of 1986 (EMTALA). We are also inviting comments on a number of issues including performance-based hospital payments for services and health information technology, as well as how to improve data transparency for consumers.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Ivy Laboratories, Division of Ivy Animal Health, Inc. The ANADA provides for use of single-ingredient Type A medicated articles containing melengestrol and monensin to make two-way combination drug Type C medicated feeds for heifers fed in confinement for slaughter.

This final rule requires that all providers and suppliers (other than physicians or practitioners who have elected to ``opt-out'' of the Medicare program) complete an enrollment form and submit specific information to us. This final rule also requires that all providers and suppliers periodically update and certify the accuracy of their enrollment information to receive and maintain billing privileges in the Medicare program. In addition, this final rule implements provisions in the statute that require us to ensure that all Medicare providers and suppliers are qualified to provide the appropriate health care services. These statutory provisions include requirements meant to protect beneficiaries and the Medicare Trust Funds by preventing unqualified, fraudulent, or excluded providers and suppliers from providing items or services to Medicare beneficiaries or billing the Medicare program or its beneficiaries.

This notice announces a public meeting on the subject of the importation, sale, and distribution of exotic animals. The purpose of the meeting is to gather information and discuss issues and concerns related to infectious disease threats associated with the importation, sale, and distribution of exotic animals.

The proposed information collection described below will be submitted to the Office of Management and Budget (OMB) for review and approval, as required by the Paperwork Reduction Act of 1995. In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act, for opportunity for public comment on proposed data collection projects, the Office of Dietary Supplements (ODS), at the National Institutes of Health (NIH) is soliciting public comments on the subject proposal.

The Food and Drug Administration (FDA) is announcing a public meeting entitled ``Preparation for ICH meetings in Yokohama, Japan'' to provide information and receive comments on the International Conference on Harmonization (ICH) as well as the upcoming meetings in Yokohama, Japan. The topics to be discussed are the topics for discussion at the forthcoming ICH Steering Committee Meeting. The purpose of the meeting is to solicit public input prior to the next Steering Committee and Expert Working Groups meetings in Yokohama, Japan on June 5 through 8, 2006, at which discussion of the topics underway and the future of ICH will continue. Date and Time: The meeting will be held on Monday, May 8, 2006, from 9:30 a.m. to 12:30 p.m. Location: The meeting will be held at 5600 Fishers Lane, 3rd floor, Maryland Conference Room, Rockville, MD 20857. For security reasons, all attendees are asked to arrive no later than 9:25 a.m., as you will be escorted from the front entrance of 5600 Fishers Lane to the Maryland Conference Room. Contact Person: All participants must register with Sema Hashemi, Office of the Commissioner, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, e-mail: Sema.Hashemi@fda.hhs.gov or FAX: 301-480-0716. Registration and Requests for Oral Presentations: Send registration information (including name, title, firm name, address, telephone, and fax number), written material and requests to make oral presentations, to the contact person by May 1, 2006. If you need special accommodations due to a disability, please contact Sema Hashemi at least 7 days in advance. Transcripts: Transcripts of the meeting 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 meeting at a cost of 10 cents per page.

Pursuant to the requirements of 42 CFR 83.15(a), the Department of Health and Human Services (HHS) gives notice of petitions to add classes of employees to the Special Exposure Cohort (SEC) and the findings of the National Institute for Occupational Safety and Health (NIOSH) from evaluating these petitions that are to be considered by the Advisory Board on Radiation and Worker Health April 25-27, 2006 (see notice: Federal Register/Vol. 71, No. 66/Thursday, April 6, 2006/Notices, p. 17470). Summary of petitions and NIOSH findings:

On February 4, 2004, the Centers for Disease Control and Prevention (CDC) within the U.S. Department of Health and Human Services issued an order to ban immediately the import of all birds (Class: Aves) from specified countries, subject to limited exemptions for returning pet birds of U.S. origin and certain processed bird- derived products. HHS/CDC took this step because birds from these countries potentially can infect humans with avian influenza (influenza A/ [H5N1]). The February 4, 2004, order complemented a similar action taken at the same time by the Animal and Plant Health Inspection Service (APHIS) within the U.S. Department of Agriculture (USDA). On March 10, 2004, HHS/CDC lifted the embargo of birds and bird products from the Hong Kong Special Administrative Region (HKSAR) because of the documented public-health and animal health measures taken by Hong Kong officials to prevent spread of the outbreak within the HKSAR, and the absence of highly pathogenic avian influenza H5N1 cases in Hong Kong's domestic and wild bird populations. USDA/APHIS took a similar action. On September 28, 2004, HHS/CDC extended the embargo on birds and bird products to include Malaysia because of the documented cases of highly pathogenic avian influenza A H5N1 in poultry in Malaysia. On July 20, 2005, USDA/APHIS adopted as a final rule the interim rule that became effective on February 4, 2004, which amended its regulations to prohibit or restrict the importation of birds, poultry, and unprocessed birds and poultry products from regions that have reported the presence of highly pathogenic avian influenza H5N1 in poultry. (See 70 FR 41608 [July 20, 2005].) As the United Nations Food and Agriculture Organization and the World Organization for Animal Health (OIE) have confirmed additional cases of highly pathogenic avian influenza (H5N1), USDA/APHIS has added additional countries to its ban. Because of the documentation of highly pathogenic avian influenza H5N1 in poultry, HHS/CDC added the following countries to its embargo: Kazakhstan, Romania, Russia, Turkey, and Ukraine on December 29, 2005; Nigeria on February 8, 2006; India on February 22, 2006; Egypt on February 27, 2006; Niger on March 2, 2006; Albania, Azerbaijan, Cameroon, and Burma (Myanmar) on March 15, 2006; Israel on March 20, 2006; Afghanistan on March 21, 2006; Jordan on March 29, 2006; and Burkina Faso on April 10, 2006. On April 4, 2006, OIE reported confirmation of highly pathogenic avian influenza H5N1 in poultry in Pakistan. At this time, HHS/CDC is adding Pakistan to its current embargo. This action is effective on April 10, 2006, and will remain in effect until further notice.

As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that a meeting has been scheduled for the Advisory Committee on Blood Safety and Availability (ACBSA).

Under the provisions of section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH), National Cancer Institute (NCI), has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on January 20, 2006, page 3309 and allowed 60-days for public comment. No public comments 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. Proposed Collection: Title: National Survey of Primary Care Physicians' Recommendations and Practice for Breast, Cervical, Colorectal, and Lung Cancer Screening. Type of Information Collection Request: New. Need and Use of Information Collection: This study will obtain current, national data on primary care physicians' knowledge, attitudes, recommendations, and practices related to screening for breast, cervical, colorectal, and lung cancer. There have been substantial changes in guidelines and/or technologies for these types of cancer screening in recent years. The data collected in this study will support and further NCI work in monitoring and evaluating providers' cancer control knowledge, attitudes, and practices and their impact on population health, as well as enable monitoring of progress toward major cancer control goals. Two questionnaires, one covering breast and cervical cancer screening and the other colorectal and lung cancer screening, will be administered by mail or telephone to a randomly-selected national sample of primary care physicians. Frequency of Response: One Time. Affected Public: Medical practices, clinics, or other health care organizations. Type of Respondents: Primary Care Physicians. Burden estimates are as follows:

This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 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-177- 1990/2-US-01, ``Activity-dependent Neurotrophic Factor'' by Douglas E. Brenneman and Illana Gozes, patent number 5,767,240 (issue date June 16, 1998); 2. E-177-1990/3-US-01, ``Activity-dependent Neurotrophic Factor'' by Douglas E. Brenneman and Illana Gozes, patent number 6,174,862 (issue date January 16, 2001); 3. E-177-1990/1-PCT-01, ``Activity-dependent Neurotrophic Factor'' by Douglas E. Brenneman and Illana Gozes, patent application number PCT/US92/03109 (filing date April 22, 1992) and all related foreign patent applications; 4. E-177- 1990/3-PCT-02, ``Activity-dependent Neurotrophic Factor'' by Douglas E. Brenneman and Illana Gozes, patent application number PCT/US95/12929 (issue date October 16, 1995) and all related foreign patent applications; 5. E-209-2001/0-US-01, ``Neurotrophic Components of the ADNF I Complex'' by Brenneman et al., patent application number 60/ 322,760 (filing date September 12, 2001); 6. E-209-2001/2-US-01, ``Neurotrophic Components of the ADNF I Complex'' by Brenneman et al., patent application number 60/371,961 (filing date April 10, 2002); 7. E-209-2001/1-PCT-01, ``Neurotrophic Components of the ADNF I Complex'' by Brenneman et al., patent application number PCT/US02/29146 (filing date September 12, 2002); 8. E-209-2001/1-US-02, ``Neurotrophic Components of the ADNF I Complex'' by Brenneman et al., patent application number 10/489,515 (filing date March 11, 2004); to Allon Therapeutics, having a place of business in Vancouver, BC, Canada. 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 human neurodegenerative diseases.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry (178) entitled ``Recommended Study Design and Evaluation of Effectiveness Studies for Swine Respiratory Disease Claims.'' This draft guidance provides recommendations to industry relating to study design and describes the criteria that the Center for Veterinary Medicine (CVM) intends to use to evaluate effectiveness studies for swine respiratory disease (SRD) claims.

The Food and Drug Administration (FDA) is announcing the availability for comment of a draft revised guidance for industry (73) entitled ``Stability Testing of New Veterinary Drug Substances and Medicinal Products (Revision)'' VICH GL3(R). This draft revised guidance, which updates a guidance on the same topic for which a notice of availability was published in the Federal Register of October 12, 1999 (64 FR 55293) (the 1999 guidance), has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This draft revised document is intended to provide guidance regarding the development of stability testing data new animal drug applications (referred to as registration applications in the guidance) submitted to the European Union (EU), Japan, and United States.

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institute on Drug Abuse (NIDA), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. The proposed information collection was previously published in the Federal Register on December 8, 2004, page 71060 and allowed 60 days for public comment. No public comments 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 Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``S8 Immunotoxicity Studies for Human Pharmaceuticals.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance provides recommendations on nonclinical testing approaches to identify compounds that have the potential to be immunotoxic and guidance on a weight-of-evidence decisionmaking approach for immunotoxicity testing. The guidance is intended to provide recommendations on nonclinical testing for immunotoxicity induced by human pharmaceuticals. The guidance applies to unintended immunosuppression and immunoenhancement, excluding allergenicity or drug-specific autoimmunity.

The Substance Abuse and Mental Health Services Administration (SAMHSA) published a notice regarding changes to the National Registry of Evidence-based Programs and Practices (NREPP) in the March 14, 2006 Federal Register. This document contained several comments from the American Psychological Association's Division 50 Committee on Evidence- based Practice that were incorrectly attributed to the full American Psychological Association.

This notice announces the fourth meeting of the American Health Information Community Consumer Empowerment workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92463, 5 U.S.C., App.).

This notice announces the fourth meeting of the American Health Information Community Electronic Health Records Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).

This notice announces the fifth meeting of the American Health Information Community in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.) The American Health Information Community will advise the Secretary and recommend specific actions to achieve a common interoperability framework for health information technology (IT). The April 25, 2006 meeting has been canceled.

This announcement seeks applications from public and nonprofit private entities to establish and operate one general training and technical assistance project in Public Health Service (PHS) Region VI (Arkansas, Louisiana, Oklahoma, Texas, and New Mexico). The purpose of the family planning general training program is to ensure that all levels of personnel working in Title X family planning service projects have the knowledge, skills, and abilities necessary for the effective delivery of high quality family planning services. General training also includes specialized technical assistance which consists of specific, specialized or highly skilled family planning training that is usually provided to a single organization based on identified need. The successful applicant will be responsible for the development and overall management of the general training program that provides training for Title X service grantee personnel in PHS Region VI.

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, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on Form FDA 3038, Interstate Shellfish Dealers Certificate.

The Food and Drug Administration (FDA) is announcing the withdrawal of a draft guidance that was issued on July 11, 2001.

The NTP continuously solicits and accepts nominations for toxicological studies to be undertaken by the program. Nominations of substances of potential human health concern are received from federal agencies, the public, and other interested parties. These nominations are subject to several levels of review before selections for testing are made and toxicological studies are designed and implemented. This notice (1) provides brief background information and study recommendations regarding 10 nominations for study by the NTP (Table 1), (2) solicits public comment on the nominations and study recommendations, and (3) requests the submission of additional relevant information for consideration by the NTP in its continued review of these nominations. An electronic copy of this announcement, supporting documents for each nomination, and further information on the NTP and the NTP Study Nomination and Review Process can be accessed through the NTP Web site (https://ntp.niehs.nih.gov/; select ``Nominations to the Testing Program'').

The Food and Drug Administration (FDA) is announcing the withdrawal of a guidance that was issued on March 15, 2000.

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 Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Export Certificates for FDA- Regulated Products'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Voluntary Hazard Analysis and Critical Control Point Manuals for Operators and Regulators of Retail and Food Service Establishments'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is proposing to amend its current good manufacturing practice (CGMP) regulations to include new requirements for the label, color, dedication, and design of medical gas containers and closures. These requirements are intended to do the following: Make the contents of medical gas containers more readily identifiable, reduce the likelihood that containers of industrial or other gases would be inappropriately connected to medical oxygen supply systems, and reduce the risk of contamination of medical gases. FDA is also proposing to include medical air, oxygen, and nitrogen among, and exclude cyclopropane and ethylene from, those gases intended for drug use that are exempt from certain labeling requirements.

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 Office of Global Health Affairs (OGHA) announces that up to $345,600 in fiscal year (FY) 2006 funds is available for a cooperative agreement to the New Mexico Department of Health, New Mexico Outreach Office of the U.S.-Mexico Border Health Commission (USMBHC) to strengthen the binational public health projects and programs along the New Mexico-Chihuahua border. This initiative addresses outreach and health promotion activities, evaluation and assessments, health data analysis and surveillance, Healthy Border/Healthy Gente activities, and administrative support to the members and staff of the U.S.-Mexico Border Health Commission. The project will be approved for up to a one-year period for a total of $345,600 (including indirect costs). Funding for the cooperative agreement is contingent upon the availability of funds.

In accordance with section 10(a) of the Federal Advisory Committee Act (FACA) (5 U.S.C. Appendix 2), this notice announces the fourth meeting of the Emergency Medical Treatment and Labor Act (EMTALA) Technical Advisory Group (TAG). The purpose of the EMTALA TAG is to review regulations affecting hospital and physician responsibilities under EMTALA to individuals who come to a hospital seeking examination or treatment for medical conditions. The primary purpose of the fourth meeting is to enable the EMTALA TAG to hear additional testimony and further consider written responses from medical societies and other organizations on specific issues considered by the TAG at previous meetings. However, the public is permitted to attend this meeting and, to the extent that time permits and at the discretion of the Chairperson, the EMTALA TAG may hear comments from the floor.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Pennfield Oil Co. that provides for a 0-day preslaughter withdrawal time following use of chlortetracycline in cattle feed.

On February 4, 2004, the Centers for Disease Control and Prevention (CDC) within the U.S. Department of Health and Human Services issued an order to ban immediately the import of all birds (Class: Aves) from specified countries, subject to limited exemptions for returning pet birds of U.S. origin and certain processed bird- derived products. HHS/CDC took this step because birds from these countries potentially can infect humans with avian influenza (influenza A/ [H5N1]). The February 4, 2004, order complemented a similar action taken at the same time by the Animal and Plant Health Inspection Service (APHIS) within the U.S. Department of Agriculture (USDA). On March 10, 2004, HHS/CDC lifted the embargo of birds and bird products from the Hong Kong Special Administrative Region (HKSAR) because of the documented public-health and animal health measures taken by Hong Kong officials to prevent spread of the outbreak within the HKSAR, and the absence of highly pathogenic avian influenza H5N1 cases in Hong Kong's domestic and wild bird populations. USDA/APHIS took a similar action. On September 28, 2004, HHS/CDC extended the embargo on birds and bird products to include Malaysia because of the documented cases of highly pathogenic avian influenza A H5N1 in poultry in Malaysia. On July 20, 2005, USDA/APHIS adopted as a final rule the interim rule that became effective on February 4, 2004, which amended its regulations to prohibit or restrict the importation of birds, poultry, and unprocessed birds and poultry products from regions that have reported the presence of highly pathogenic avian influenza H5N1 in poultry. (See 70 FR 41608 [July 20, 2005].) As the United Nations Food and Agriculture Organization and the World Organization for Animal Health (OIE) have confirmed additional cases of highly pathogenic avian influenza (H5N1), USDA/APHIS has added additional countries to its ban. Because of the documentation of highly pathogenic avian influenza H5N1 in poultry, HHS/CDC added the following countries to its embargo: Kazakhstan, Romania, Russia, Turkey, and Ukraine on December 29, 2005; Nigeria on February 8, 2006; Indian on February 22, 2006; Egypt on February 27, 2006; Niger on March 2, 2006; Albania, Azerbaijan, Cameroon, and Burma (Myanmar) on March 15, 2006; Israel on March 20, 2006; and Afghanistan on March 21, 2006. On March 23, 2006, OIE reported confirmation of highly pathogenic avian influenza H5N1 in poultry in Jordan. At this time, HHS/CDC is adding Jordan to its current embargo. This action is effective on March 29, 2006, and will remain in effect until further notice.