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.