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

The Administration on Aging (AoA) 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 the information collection requirements relating to Performance Progress Reports for Title IV grantees.

The Health Resources and Services Administration (HRSA) announces the cancellation of the following grant opportunities that were initially published on Grants.gov Find, in the HRSA Preview, and on the HRSA Web site (https://www.hrsa.gov/grants/preview/).

Notice is hereby given that on February 28, 2006, the Department of Health and Human Services (HHS) Debarring Official, on behalf of the Secretary of HHS, issued a final notice of debarment based on the scientific misconduct findings of the U.S. Public Health Service (PHS) in the following case: Susan M. Aronica, PhD, Indiana University Purdue University Indianapolis: Based on the evidence and findings of an investigation report by Indiana University Purdue University Indianapolis (IUPUI) and additional analysis conducted by the Office of Research Integrity (ORI) in its oversight review, ORI found that Susan M. Aronica, Ph.D., former Postdoctoral Student/Fellow, IUPUI, committed 21 acts of scientific misconduct by knowingly and intentionally falsifying and fabricating data in her notebooks, in 17 figures and figure panels, in two tables published in the Journal of Biological Chemistry (J. Biol. Chem. 270:21998-22007, 1995) and Blood (Blood 89:3582-3595, 1997), and in two figures in a manuscript submitted for publication to Blood in August 1997. ORI issued a charge letter enumerating the above findings of scientific misconduct. However, Dr. Aronica requested a hearing to dispute these findings to the Departmental Appeals Board. Based upon the insufficiency of Dr. Aronica's hearing request, ORI filed a Motion to Dismiss. On February 10, 2006, the Administrative Law Judge (ALJ) ruled in ORI's favor by dismissing Dr. Aronica's request for a hearing. ORI's research misconduct regulation specifically delineates the requisite content for an acceptable hearing request. A sustainable hearing request must admit or deny each finding of research misconduct, and each denial must be detailed and substantive. 42 CFR 93.501(c). Dr. Aronica's hearing request contained only a general denial of the proposed findings. The regulation states that a general denial is not sufficient to establish a genuine dispute. 42 CFR 93.503. The regulation also states that the ALJ must dismiss a hearing request if the respondent does not raise a genuine dispute over facts or law material to the research misconduct findings. 42 CFR 93.504(a)(2). The ALJ concluded that the determination of whether the hearing request raises a genuine dispute is a threshold jurisdictional determination. Thus, the ALJ decided that Dr. Aronica's request did not show a genuine dispute, because it did not specifically deny any allegation. As a result, the ALJ concluded that Dr. Aronica's hearing request could not be granted, but was required to be dismissed pursuant to 42 CFR 93.504(a)(2). Specifically, ORI found that Dr. Aronica falsified and fabricated data in: Figures 1, 2, 3, 4, 5A, 5B, 5C, 6A, and 6B, and Tables III and IV in: Aronica, S.M., Mantel, C., Gonin, R., Marshall, M.S., Sarris, A., Cooper, S., Hague, N., Zhang, X., & Broxmeyer, H.E. ``Interferon-inducible Protein 10 and Macrophage Inflammatory Protein-1 [alpha] Inhibit Growth Factor Stimulation of Raf-1 Kinase Activity and Protein Synthesis in a Human Growth Factor-dependent Hematopoietic Cell Line.'' JBC 270:21998-22007, 1995 (September 15) (``JBC paper''). Figures 1 (both panels), 3A, 3B, 3D, 3E, 4A, and 8A in: Aronica, S.M., Gingras, A.C., Sonenberg, N., Cooper, S., Hague, N., & Broxmeyer, H.E. ``Macrophage Inflammatory Protein-1 [alpha] and Interferon-inducible Protein 10 Inhibit Synergistically Induced Growth Factor Stimulation of MAP Kinase Activity and Suppress Phosphorylation of Eukaryotic Initiation Factor 4E and 4E Binding Protein 1.'' Blood 89:3582-3595, 1997 (May 15) (``Blood paper''). Figures 1B and 2B in: Aronica, S.M., Reid, S.L., & Broxmeyer, H.E. ``Chemokine Inhibition of Stress-Activated Kinase Activity in a Human Hematopoietic Cell Line.'' Blood, submitted August 4, 1997 (``Blood manuscript''). The research was supported by or reported in the following U.S. Public Health Service (PHS) grants from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health: RO1 HL49202, ``Myeloid Regulation by Growth-Suppressing Cytokines.'' R01 HL54037, ``Stem Cell Transduction of SLF/FLT-3-Ligand Genes by AAV.'' R01 HL56416, ``Mechanisms of Synergistic Regulation of Stem/Progenitors.'' T32 DK07519, ``Regulation of Hematopoietic Cell Production.'' The following administrative actions have been implemented: (1) Dr. Aronica has been debarred from any contracting or subcontracting with any agency of the United States Government and from eligibility or involvement in nonprocurement programs of the United States Government referred to as ``covered transactions'' as defined in the debarment regulations at 45 CFR part 76 for a period of five (5) years, beginning on February 10, 2006; (2) Dr. Aronica is prohibited from serving in any advisory capacity to PHS including but not limited to service on any PHS advisory committee, board, and/or peer review committee, or as consultant for a period of five (5) years, beginning on February 10, 2006; and (3) Within 60 days of February 10, 2006, the authors of the following papers will be requested to submit a letter to the editors of Journal of Biological Chemistry and Blood, requesting their retraction of: Aronica, S.M., Mantel, C., Gonin, R., Marshall, M., Sarris, A., Cooper, S., Hague, N., Zhang, X-f., & Broxmeyer, H.E. ``Interferon-Inducible Protein 10 and Macrophage Inflammatory Protein-1 [alpha] inhibit Growth Factor Stimulation of Raf-1 Kinase Activity and Protein Synthesis in a Human Growth Factor-Dependent Hematopoietic Cell Line.'' J. Biol. Chem. 270:21998-22007, 1995. Aronica, S.M., Gingras, A.-C., Sonenberg, N., Cooper, S., Hague, N., and Broxmeyer, H.E. ``Macrophage Inflammatory Protein-1 [alpha] and Interferon-Inducible Protein 10 Inhibit Synergistically Induced Growth Factor Stimulation of MAP Kinase Activity and Suppress Phosphorylation of Eukaryotic Initiation Factor 4E and 4 Binding Protein 1.'' Blood 89:3582-3595, 1997.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of three supplemental new animal drug applications (NADAs) filed by Alpharma, Inc. Two of the supplemental NADAs provide for the use of approved, single-ingredient Type A medicated articles containing bacitracin methylene disalicylate and zoalene, with or without roxarsone, to formulate two-way or three- way combination drug Type C medicated feeds for replacement chickens. The third NADA provides for the use of bacitracin zinc and nitarsone single-ingredient Type A medicated articles for two-way combination Type C medicated feeds for growing turkeys. These approvals reflect FDA's effectiveness conclusions, which relied on the National Academy of Sciences/National Research Council (NAS/NRC) Drug Efficacy Study Group's evaluation of the effectiveness of these drugs when used in animal feed as single ingredients.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of four supplemental new animal drug applications (NADAs) filed by Phibro Animal Health. One supplemental NADA provides for the use of fixed-combination Type A medicated articles containing oxytetracycline and neomycin sulfate to formulate two-way fixed-combination drug Type B and Type C medicated feeds for chickens, turkeys, swine, cattle, and sheep. Two of the supplemental NADAs provide for the use of approved, single-ingredient Type A medicated articles containing nicarbazin and penicillin, with or without roxarsone, to formulate two-way or three-way combination drug Type C medicated feeds for broiler chickens. The fourth supplemental NADA provides for the use of approved, single-ingredient Type A medicated articles nicarbazin, bacitracin methylene disalicylate, and roxarsone to formulate three-way combination drug Type C medicated feeds for broiler chickens. These approvals reflect FDA's effectiveness conclusions which relied on the National Academy of Sciences/National Research Council (NAS/NRC) Drug Efficacy Study Group's evaluation of the effectiveness of these drugs when used in animal feed as single ingredients.

In accordance with the requirements of the Privacy Act of 1974, the Indian Health Service (IHS) is proposing to modify or alter an SOR, ``Medical Staff Credentials and Privileges Records,'' System No. 09-17-0003. We propose to modify the SOR to reflect current program changes, technology changes, statutory and implementation changes. Under the system name, we propose to change to the current program office name. We are proposing to update the categories of individuals covered by the system with minor edits to the Active, Temporary and Courtesy or Associate. We are proposing to update the Authority for maintenance by including the Federal Records Act and the Privacy Act. We are proposing to update the Purposes to reflect the new program title of the National Practitioner Data Bank to include the Healthcare Integrity and Protection Data Bank and the inclusion of authorizing statute. We are proposing to update the Routine Uses to reflect the new program title of the National Practitioner Data Bank to include the Healthcare Integrity and Protection Data Bank and the inclusion of authorizing statute for routine use numbers 2 and 3. We will also take the opportunity to update any sections of the system notice to provide clarity on the changing environment to include for digital records and the initiative of transitioning from a paper-based record to a computerized-based or electronic medical record.

The Indian Health Service (IHS), as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre- clearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA95) (44 U.S.C. 3506(c)(2)(A)). This program helps to ensure that the requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. As required by section 3507(a)(1)(D) of the Act, the proposed information collection has been submitted to the Office of Management and Budget (OMB) for review and approval. The IHS received no comments in response to the 60-day Federal Register notice (71 FR 3098) published on January 19, 2006. The purpose of this notice is to allow an additional 30 days for public comments to be submitted directly to OMB. Proposed Collection: Title: 0917-NEW, ``Indian Health Service Chief Executive Officer Retention Survey''. Type of Information Collection Request: New Collection. Form Number: None. Forms: Retention Survey. Need and Use of Information Collection: The National Council of Chief Executive Officers (NCCEOs) was established to ensure that the IHS Service Unit Chief Executive Officers (CEOs) effectively participate in the establishment and implementation of strategies to achieve the IHS mission. Part of their responsibility (as stated in their Charter) includes: Ongoing recruitment, development, and retention of professional CEOs. The NCCEOs' purpose is to ensure that the IHS Service Unit CEO and their Tribal CEO counterparts effectively participate in the establishment and implementation of an agency strategy to achieve the IHS mission. The current Executive Committee is actively addressing recruitment, retention and succession planning for their constituents, the IHS CEOs. To enhance their ability to be effective in this challenging tasks, the NCCEOs need to know more about IHS CEOs and the issues that affect retention and recruitment including the competitive influences of private sector health care delivery systems. The chosen method to obtain this critical information from the CEOs of IHS, Tribal and urban facilities is by electronic survey. The goal of the IHS is to raise the health status of American Indians and Alaska Natives to the highest possible level. The meet this goal, the IHS is committed to providing high quality health services to he eligible service population. An important factor in improving the quality of services is ensuring that our clinics and hospitals recruit and retain the best possible CEO reasonably available. The proposed survey is designed to as certain current demographics: Age, gender, years of experience, education, pay compared to complexity of facilities, job satisfaction and retirement eligibility. Affected Public: Individuals. Type of Respondents: Individuals. The table below provide the estimated burden hours for this information collection:

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; and Israel on March 20, 2006. On March 15, 2006, OIE reported confirmation of highly pathogenic avian influenza H5N1 in poultry in Afghanistan. At this time, HHS/CDC is adding Afghanistan to its current embargo. This action is effective on March 21, 2006, and will remain in effect until further notice.

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 the information collection contained in FDA regulations entitled ``Environmental Impact Considerations.''

The Food and Drug Administration (FDA) is announcing its decision to authorize the use of a health claim regarding the association between sucralose and the nonpromotion of dental caries. Based on its review of evidence described in the proposed rule and comments submitted on the proposed rule, the agency has concluded that sucralose does not promote dental caries. Therefore, the agency has decided to amend the regulation that authorizes a health claim regarding noncariogenic carbohydrate sweeteners to include sucralose.

The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees'' dated March 2006. The guidance is intended to assist sponsors of clinical trials in determining when a data monitoring committee (DMC) is needed for study monitoring, and how such committees should operate. The guidance announced in this notice finalizes the draft guidance entitled ``Guidance for Clinical Trial Sponsors on the Establishment and Operation of Clinical Trial Data Monitoring Committees'' dated November 2001.

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 ``Guidance for Industry on Formal Meetings With Sponsors and Applicants for Prescription Drug User Fee Act Product'' 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 twenty-fourth meeting, at which, among other things, it will hear presentations on and discuss issues in two broad areas: (1) Children and clinical research and (2) organ procurement and transplantation. Subjects discussed at past Council meetings (though not on the agenda for the present one) include: Cloning, assisted reproduction, reproductive genetics, IVF, ICSI, PGD, sex selection, inheritable genetic modification, patentability of human organisms, neuroscience, aging retardation, 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 Responsibility: 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).

The National Institute for Occupational Safety and Health (NIOSH) has changed a guideline for determining the probability of causation under the Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA) for energy employees with cancers of the lung, trachea, or bronchus. The change affects only the NIOSH- Interactive RadioEpidemiological Program (IREP) cancer risk model termed ``Lung (162).'' The new guideline, which became effective on February 28, 2006, with the introduction of NIOSH-IREP Version 5.5, requires the use of both a National Institutes of Health (NIH)-IREP lung model implemented by NIH in 2003 and the original NIOSH-IREP lung model implemented by NIOSH in 2002. NIOSH-IREP Version 5.5 calculates separately the probability of causation produced under each model for each cancer of the lung, trachea, or bronchus. The result from the model that produces the higher probability of causation at the upper 99th percentile credibility limit is reported as the probability of causation result of record for the claim. NIOSH-IREP Version 5.5 also incorporates a bias correction factor for random errors in dosimetry for those energy workers who had not smoked cigarettes (``never smokers'') and who were exposed to radon. This correction was previously applied to smokers, but had been inadvertently omitted for never smokers. These changes may result in the Department of Labor (DOL) calculating higher probability of causation determinations for select cases of cancer of the lung, trachea, or bronchus among previously decided and current EEOICPA cancer claims. The changes cannot result in any lower probability of causation determinations. Although this change to the NIOSH-IREP lung cancer risk model took effect February 28, 2006, NIOSH will fully consider all comments received regarding this change and may reconsider this change or consider further revisions to the lung cancer risk model based on public comment.

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 Mine Safety and Health Administration (MSHA) and the National Institute for Occupational Safety and Health (NIOSH) are hosting a workshop to identify the major issues and concerns related to mine escape planning and emergency shelters in the mining industry, and share information with the mining community. The workshop will provide for an exchange of information among all segments of the mining community involved with mine emergency preparedness and will generate an agenda for research to improve technology for mine safety in these areas.

The Food and Drug Administration (FDA) is correcting a final rule that published in the Federal Register of May 25, 2004 (69 FR 29786). The final rule required human cell, tissue, and cellular and tissue-based product (HCT/P) establishments to screen and test cell and tissue donors for risk factors for, and clinical evidence of, relevant communicable disease agents and diseases. The document was published with an error in the codified section. This document corrects that error.

This notice announces the selection of a new member 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.

This proposed notice announces URAC's submission of an application for deeming authority as a national accreditation organization for health maintenance organizations and local preferred provider organizations participating in the Medicare Advantage program. This announcement describes the criteria to be used in evaluating the application and provides information for submitting comments during a public comment period that will span at least 30 days.

The National Centers of Excellence in Women's Health and the National Community Centers of Excellence in Women's Health programs provide funding to academic health centers and community-based organizations to enhance their women's health programs through the integration of these components: (1) Leadership development for women, (2) training for lay, allied health, and professional health care providers, (3) public education and outreach with special emphasis on outreach to minority women, (4) comprehensive health service delivery that includes gender and age-appropriate preventive services and allied health professionals as members of the comprehensive care team, and (5) basic science, clinical and community-based research. In addition, the community centers must replicate their National Community Center of Excellence in Women's Health (CCOE) model in another organization or community.

The Food and Drug Administration (FDA) has determined the regulatory review period for MYCAMINE 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 that claims that human drug product.

The Food and Drug Administration (FDA) has determined the regulatory review period for ALAMAST 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 that claims that human drug product.

Briefly provide a statement of the proposed demonstration project indicating that this is a CARE demonstration project and whether it is for a local or statewide project; Type of organization applying (school, state agency, voluntary agency, etc.); Geographic area to be served (urban, rural, suburban); Description of target population to be served; Statement of the program intervention; Brief description of the proposed project. Description of Applicant Organization: Describe the decision-making authority and structure (e.g. relationship to the Board of Directors), its resources, experience, existing program units and/or those to be established if funding is obtained. This description should cover personnel, time and facilities and contain evidence of the organization's capacity to provide the rapid and effective use of resources needed to conduct the project, collect necessary data and evaluate it. Rationale: Describe the rationale for use of the proposed approach based upon previous practice and review of the literature and/ or evaluation findings. Geographic Area: Describe the geographic area to be served. Document the incidence of adolescent pregnancy, and describe economic conditions, income levels, existing services and unmet needs in the proposed service area. Program Outcome Objectives: Provide a clear statement of results or benefits expected that are consistent with the OAPP performance measures. Objectives should be specific, measurable, achievable, realistic, and time-framed. Care Services Demonstration Model: Describe the program, including how services will continue to be provided to clients after the birth of the child to enable parents to acquire good parenting skills and to ensure that their children are developing normally physically, intellectually and emotionally. Describe how the applicant will add care services to supplement existing adolescent health services in a school, hospital or other community setting. Describe how the applicant will provide directly, or by referral, each of the required ten core services and any supplemental services as appropriate. As appropriate, state how the project will be coordinated, integrated and linked to existing services within the service area. Describe case management and follow-up procedures. Describe the population, recruitment methods and selection criteria. Describe how the applicant will as appropriate, involve families, voluntary associations, religious and charitable organizations and other groups in the private sector. Workplan and Timetable: Provide a year long work plan and timetable, which spans at least three years of program implementation. Numbers and Types of Clients: Provide estimates of clients expected to be served during the first year (e.g. adolescent mothers, extended family members, fathers of their children, husbands, and/or male partners with whom they are in a long-term relationship). Documentation of Support: Provide a summary of the views of public agencies, providers of services and the general public in the geographical area to be served. Provide documentation of the support from other community agencies. Continuation Funding: Describe the plan regarding continuation of services at the termination of this Federal funding. Evaluation Plan: The evaluation plan must clearly articulate the program interventions and/or processes to be tested; theory upon which the program intervention is based; proposed questions/hypotheses the evaluation will address; instruments, including information regarding reliability and validity of instruments; sampling plan and data collection schedule; data analysis plan, including statistical tests. Describe how the evaluation is consistent with the program, particularly how data will be used for mid-course corrections and ongoing program improvements. Discuss how the evaluator will ensure confidentiality of the data. Describe the qualitative methodology planned and how it will be integrated with the required quantitative design. Describe how the data will be collected. Appendices: Include articles of incorporation and mission statement for private nonprofit organizations. Resumes of key staff and detailed position descriptions. How the project will obtain parental consent. Letters of commitment and support from other providers. Provide evidence of a working agreements with an evaluator affiliated with a college or university located in the applicant's State. The entities to be involved in the evaluation must be identified, their willingness to participate documented, their role (s) described and their capability documented by an attached curriculum vitae. Provide a copy of the table of contents of the proposed curriculum, plus a list of any other instructional materials that will be an integral part of the proposed project. Applicants must be familiar with Title XX in its entirety to ensure that they have complied with all applicable requirements. A copy of the legislation is included in the application kit. A Dun and Bradstreet Universal Numbering System (DUNS) number is required for all applications for Federal assistance. Organizations should verify that they have a DUNS number or take the steps necessary to obtain one. Instructions for obtaining a DUNS number are included in the application package, and may be downloaded from the OPA Web site.

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Class II Special Controls Guidance Document: Reagents for Detection of Specific Novel Influenza A Viruses''. This guidance document describes a means by which Reagents for detection of specific novel influenza A viruses may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule to classify Reagents for detection of specific novel influenza A viruses into class II (special controls). This guidance document is immediately in effect as a special control for Reagents for detection of specific novel influenza A viruses, but it remains subject to comment in accordance with the agency's good guidance practices (GGPs).

The Food and Drug Administration (FDA) is issuing an order prohibiting the extralabel use of anti-influenza adamantane and neuraminidase inhibitor drugs in chickens, turkeys, and ducks. We are issuing this order based on evidence that extralabel use of these anti- influenza drugs in chickens, turkeys, and ducks will likely cause an adverse event in humans.

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 is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR Part 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is contemplating the grant of an exclusive patent license to practice the inventions embodied in U.S. Patent No. 6,040,334 issued March 21, 2000, entitled ``Use of Inhibitors of 3-Hydroxy-3-Methylglutaryl Coenzyme A reductase as a Modality in Cancer Therapy'' [HHS Reference E-146-1992/0-US-23] and related foreign applications to Nascent Oncology, Inc., which has offices in Chapel Hill, North Carolina. The patent rights in these inventions have been assigned and/or exclusively licensed to the Government of the United States of America. The prospective exclusive license territory may be worldwide, and the field of use may be limited to the treatment of adenocarcinoma and Ewing's sarcoma with HMG-CoA inhibitors.

This proposed rule would revise existing regulations under sections 401-432 of the Health Care Quality Improvement Act of 1986, governing the National Practitioner Data Bank for Adverse Information on Physicians and Other Health Care Practitioners, to incorporate statutory requirements under section 1921 of the Social Security Act, as amended by section 5(b) of the Medicare and Medicaid Patient and Program Protection Act of 1987, and as amended by the Omnibus Budget Reconciliation Act of 1990. The Medicare and Medicaid Patient and Program Protection Act of 1987, along with certain additional provisions in the Omnibus Budget Reconciliation Act of 1990, was designed to protect program beneficiaries from unfit health care practitioners, and otherwise improve the anti-fraud provisions of the Medicare and State health care programs. Section 1921, the statutory authority upon which this regulatory action is based, requires each State to adopt a system of reporting to the Secretary of Health and Human Services (the Secretary) certain adverse licensure actions taken against health care practitioners and health care entities licensed or otherwise authorized by a State (or a political subdivision thereof) to provide health care services. It also requires each State to report any negative actions or findings that a State licensing authority, peer review organization, or private accreditation entity has concluded against a health care practitioner or health care entity.

The purpose of this Memorandum of Understanding (MOU) is to set forth an agreement between the Food and Drug Administration (FDA), the National Cancer Institute (NCI), and the Centers for Medicare and Medicaid Services (CMS) to develop strategic plans, set priorities, and leverage resources and expertise from multiple sources, including the private sector, toward the goal of improving the clinical utility of biomarker technologies as diagnostic and assessment tools that facilitate the development of safer and more effective cancer therapies. This collaboration among FDA, NCI, and CMS shall be known as the Oncology Biomarker Qualification Initiative.

The Food and Drug Administration (FDA) is canceling the meeting of the Manufacturing Subcommittee of the Advisory Committee for Pharmaceutical Science scheduled for April 18 and 19, 2006. This meeting was announced in the Federal Register of February 16, 2006 (71 FR 8307).

This document corrects an incorrect date that appeared in the notice [Document Identifier: CMS-10185] titled ``Emergency Clearance: Public Information Collection Requirements Submitted to the Office of Management and Budget (OMB)'' that was published in the Federal Register on March 3, 2006 (71 FR 10976).

The Department of Health and Human Services (HHS) gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees at the Nevada Test Site, Mercury, Nevada, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: Nevada Test Site. Location: Mercury, Nevada. Job Titles and/or Job Duties: Workers potentially exposed to above- ground weapons testing. Period of Employment: 1951 to 1963.

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 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 the reporting and recordkeeping requirements contained in the regulations implementing the Prescription Drug Marketing Act of 1987 (PDMA).

The Health Resources and Services Administration (HRSA) is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (``the Program''), as required by Section 2112(b)(2) of the Public Health Service (PHS) Act, as amended. While the Secretary of Health and Human Services is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.

The Food and Drug Administration (FDA) has determined the regulatory review period for TYSABRI 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 biological product.

The National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) announces the availability of an addendum to the report entitled, ``Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) Evaluation of In Vitro Test Methods for Detecting Potential Endocrine Disruptors: Estrogen Receptor and Androgen Receptor Binding and Transcriptional Activation Assays'' [NIH Publication 03-4503]. The addendum describes the rationale for proposed revisions to the original list of recommended reference substances for validation of in vitro estrogen receptor (ER) and androgen receptor (AR) binding and transcriptional activation (TA) assays. The original list was made publicly available in June 2003 (Federal Register, Vol. 68, No. 106, pp. 33171-33172, June 3, 2003). NICEATM requests public comments on the substances proposed as substitutes for six of the 78 substances in the original list. Data are also requested from in vitro and in vivo studies evaluating the estrogenic and androgenic activity of the 78 substances in the revised list of reference substances.

The Food and Drug Administration (FDA) is providing notice of a confidentiality arrangement between the United States Food and Drug Administration and the French Health Products Safety Agency. The purpose of this confidentiality arrangement is to establish mutual commitments to retain the confidentiality of non-public information shared between the agencies.

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the following: Availability of opportunity for the public to enter into a Cooperative Research and Development Agreement (CRADA) to reduce noise emissions from powered hand tools. Notice: This notice invites manufacturers of electric and pneumatic-powered hand tools to enter into a cooperative research and development agreement (CRADA) with NIOSH and some of the leading technical experts on noise control engineering in the United States to reduce noise emissions from powered hand tools. By reducing the noise emissions of electric and pneumatic powered hand tools, the risk of noise-induced hearing loss among construction workers may be lowered. Additional efficiency in tool performance may also be realized as tool designs are optimized to reduce vibration and noise emissions. This effort will identify sources of noise emissions in powered hand tools and will investigate ways to reduce the noise emissions through engineering noise control. NIOSH has successfully worked with university partners to analyze several classes of tools (e.g. table saws, pneumatic nail guns, and air compressors) and demonstrated that significant reductions in noise levels can be achieved through application of noise control engineering. Furthermore, NIOSH expects to partner with academic programs that have advanced technical expertise, acoustic test facilities and specialized equipment, software and data analysis necessary for such an effort. NIOSH is seeking an industrial partner in a CRADA so that particular problems of interest can be targeted for investigation. The industry partners will provide power tools for investigation of noise source identification, product life cycle testing of new designs, and nominal funding of $50,000 to defray expenses in the effort. NIOSH expects to provide up to $50,000 per year over a three-year CRADA agreement. The CRADA defines the role of the various partners regarding intellectual rights, publications, and the material and financial resources that are exchanged during the period of the agreement. At this time, this announcement seeks to identify potential partners in the effort. Detailed development of the CRADA will occur over the next eight months, with the partnership beginning in October 2006. This announcement does not obligate NIOSH to enter into an agreement with any respondent. NIOSH reserves the right to establish a partnership based on engineering analysis and capabilities found by way of this announcement or other searches, if determined to be in the best interest of the government.

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

Pursuant to Section 10(a) of the Federal Advisory Committee Act as amended (5 U.S.C. Appendix 2) notice is hereby given that the President's Committee for People with Intellectual Disabilities will hold its first quarterly meeting of 2006 by telephone conference call. The conference call will be open to the public to listen, with call-ins limited to the number of telephone lines available. Individuals who plan to call in and need special assistance, such as TTY, assistive listening devices, or materials in alternative format, should inform Ericka Alston, Executive Assistant, PCPID, Telephone202-619-0634, Fax202-205-9519, E-mail: ealston@acf.hhs.gov, no later than March 10, 2006. Efforts will be made to meet special requests received after that date, but availability of special needs accommodations to respond to these requests cannot be guaranteed.

The Food and Drug Administration (FDA) has determined the regulatory review period for OVIDREL 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.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Prescription Drug Marketing ActDonation of Prescription Drug Samples to Free Clinics.'' The guidance provides information for free clinics that receive donated prescription drug samples from licensed practitioners or other charitable institutions. The guidance discusses concerns that have been expressed by certain individuals regarding regulatory requirements for drug sample donations. The guidance announces that FDA, after reviewing an independent study report analyzing the potential effects of the regulations on free clinics, has decided to propose revisions to those regulations. In the interim, FDA intends to exercise its enforcement discretion and does not intend to object if a free clinic fails to comply with certain regulatory requirements for drug sample donations.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Alpharma Inc. The NADA provides revised labeling for a soluble powder containing sulfamerazine, sulfamethazine, and sulfaquinoxaline used in drinking water of chickens and turkeys as an aid in the control of coccidiosis and acute fowl cholera.

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 Cancer Institute (NCI), 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 Food and Drug Administration (FDA) is amending the food additive regulations to provide for the safe use of a mixture of glycerides and polyethylene glycol mono- and di-esters of fatty acids of hydrogenated vegetable oils as an excipient in dietary supplement tablets, capsules, and liquid formulations that are intended for ingestion in daily quantities measured in drops or similar small units of measure. This action is in response to a petition filed by Gattefosse Corp.

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 Southeast Asian 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 Federal Register 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. On December 29, 2005, HHS/CDC added the Republic of Kazakhstan, Romania, the Russian Federation, the Republic of Turkey, and Ukraine to its current embargo because of documented cases of highly pathogenic avian influenza H5N1 in poultry in those countries. On February 8, 2006, HHS/CDC added Nigeria to its embargo because of the documentation of highly pathogenic avian influenza H5N1 in poultry. On February 24, 2006, HHS/CDC added India to its embargo because of documentation of highly pathogenic avian influenza H5N1 in poultry. Currently, HHS/CDC and USDA/APHIS bans cover birds and bird products from Cambodia, India, Indonesia, Japan, Kazakhstan, Laos, Malaysia, Nigeria, the People's Republic of China, Romania, Russia, South Korea, Thailand, Turkey, Ukraine, and Vietnam. On February 18, 2006, OIE reported confirmation of highly pathogenic avian influenza H5N1 in poultry in Egypt. USDA added Egypt to their ban on February 23, 2006. At this time, HHS/CDC is adding Egypt to its current embargo. This action is effective on February 27, 2006, and will remain in effect until further notice.

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 Southeast Asian 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 Federal Register 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. On December 29, 2005, HHS/CDC added the Republic of Kazakhstan, Romania, the Russian Federation, the Republic of Turkey, and Ukraine to its current embargo because of documented cases of highly pathogenic avian influenza H5N1 in poultry in those countries. On February 8, 2006, HHS/CDC added Nigeria to its embargo because of the documentation of highly pathogenic avian influenza (H5N1) in poultry. Currently, HHS/CDC and USDA/APHIS bans cover birds and bird products from Cambodia, Indonesia, Japan, Kazakhstan, Laos, Malaysia, Nigeria, the People's Republic of China, Romania, Russia, South Korea, Thailand, Turkey, Ukraine, and Vietnam. On February 18, 2006, OIE reported confirmation of highly pathogenic avian influenza (H5N1) in poultry in India. USDA added India to their ban on February 21, 2006. At this time, HHS/CDC is adding India to its current embargo. This action is effective on February 22, 2006, and will remain in effect until further notice.

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines,'' dated March 2006. The draft document is intended to provide to sponsors of pandemic influenza vaccines guidance on clinical development approaches to facilitate and expedite the licensure of influenza vaccines for the prevention of disease caused by pandemic influenza viruses. The draft guidance provides recommendations for clinical data to support biologics license application (BLA) license approval either as a supplement or as a new BLA using the accelerated approval pathway.