Department of Health and Human Services March 31, 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.