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Code · REGISTER · 2006-03-31 · Office of the Secretary, HHS · Notices

Notices. Notice

2,921 words·~13 min read·/register/2006/03/31/06-3123·

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BILLING CODE 6715-01-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary Findings of Scientific Misconduct AGENCY: Office of the Secretary, HHS. ACTION: Notice. SUMMARY: 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 α 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 α 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 α 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 α 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. FOR FURTHER INFORMATION CONTACT: Director, Division of Investigative Oversight, Office of Research Integrity, 1101 Wootton Parkway, Suite 750, Rockville, MD 20852.
(240)453-8800. Chris B. Pascal, Director, Office of Research Integrity. [FR Doc. E6-4688 Filed 3-30-06; 8:45 am] BILLING CODE 4160-17-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration on Aging Agency Information Collection Activities; Proposed Collection; Comment Request; Semi-Annual and Final Reporting Requirements for the Older Americans Act Title IV Discretionary Grant Program AGENCY: Administration on Aging, HHS. ACTION: Notice. SUMMARY: 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. DATES: Submit written or electronic comments on the collection of information by May 30, 2006. ADDRESSES: Submit electronic comments on the collection of information to: *greg.case@aoa.hhs.gov.* Submit written comments on the collection of information to Greg Case, Administration on Aging, Washington, DC 20201 or by fax to
(202)357-3469. FOR FURTHER INFORMATION CONTACT: Greg Case at
(202)357-3442 or *greg.case@aoa.hhs.gov.* SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget
(OMB)for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency request or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the **Federal Register** concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, AoA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, AoA invites comments on:
(1)Whether the proposed collection of information is necessary for the proper performance of AoA's functions, including whether the information will have practical utility;
(2)the accuracy of AoA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(3)ways to enhance the quality, utility, and clarity of the information to be collected; and
(4)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques when appropriate, and other forms of information technology. AoA plans to submit to the Office of Management and Budget for approval *Guidelines for Preparing Performance Reports for Grants Supported by Title IV of the Older Americans Act.* These guidelines provide instructions for semi-annual and final performance reporting pursuant to requirements in Title IV of the Older Americans Act. Through its Title IV Program, the Administration on Aging
(AoA)supports projects for the purpose of developing and testing new knowledge and program innovations with the potential for contributing to the well- being of older Americans. Deliverables required by the AoA of all Title IV grantees are the semi-annual and final reports, as provided for in Department of Health and Human Services regulations, 45 CFR Part 74, Section 74.51. The proposed guidelines may be found on the Administration on Aging Web site at *http://www.aoa.gov/doingbus/grantrep/grantrep.asp.* AoA estimates the burden of this collection of information as follows: Semi-annual submission with the final report taking the place of the semi-annual report at the end of the final year of the grant. *Respondents:* States, public agencies, private nonprofit agencies, institutions of higher education, and organizations including tribal organizations. *Estimated Number of Responses:* 600. *Total Estimated Burden Hours:* 12,000. Dated: March 28, 2006. Josefina G. Carbonell, Assistant Secretary for Aging. [FR Doc. E6-4696 Filed 3-30-06; 8:45 am] BILLING CODE 4154-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Disease, Disability, and Injury Prevention and Control Special Emphasis Panels (SEP): Member Conflict: Safety and Occupational Health, Program Announcements PA-04-038, PA-04-021, PA-04-030, and PAR-04-105 In accordance with Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention
(CDC)announces the following meeting: *Name:* Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Member Conflict: Safety and Occupational Health, Program Announcements PA-04-038, PA-04-021, PA-04-030, and PAR-04-105. *Time and Date:* 2 p.m.-5 p.m., April 20, 2006 (Closed). *Place:* National Institute for Occupational Safety and Health, CDC, 24 Executive Park Drive NE, MS E-74, Room 1429, Atlanta, GA 30329; Telephone Number 404.498.2582. *Status:* The meeting will be closed to the public in accordance with provisions set forth in Section 552b(c)(4) and (6), Title 5 U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Public Law 92-463. *Matters To Be Discussed:* The meeting will include the review, discussion, and evaluation of applications received in response to: Member Conflict: Safety and Occupational Health, Program Announcements PA-04-038, PA-04-021, PA-04-030, and PAR-04-105. *For Further Information Contact:* Charles N. Rafferty, PhD, Designated Federal Official, National Institute for Occupational Safety and Health, CDC, 1600 Clifton Road, NE., Mailstop E-74, Atlanta, GA 30333; Telephone Number 404.498.2582. The Director, Management Analysis and Services Office, has been delegated the authority to sign **Federal Register** notices pertaining to announcements of meetings and other committee management activities, for both CDC and the Agency for Toxic Substances and Disease Registry. Dated: March 27, 2006. Alvin Hall, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E6-4708 Filed 3-30-06; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Statement of Organization, Functions, and Delegations of Authority Part C (Centers for Disease Control and Prevention) of the Statement of Organization, Functions, and Delegations of Authority of the Department of Health and Human Services (45 FR 67772-76, dated October 14, 1980, and corrected at 45 FR 69296, October 20, 1980, as amended most recently at 71 FR 6777, dated February 9, 2006) is amended to reflect the reorganization of the Division of Birth Defects and Developmental Disabilities, within the National Center on Birth Defects and Developmental Disabilities. Section C-B, Organization and Functions, is hereby amended as follows: After the mission statement for the *Division of Birth Defects and Developmental Disabilities (CUBB),* insert the following: *Office of the Director (CUBB1).*
(1)Manages, directs, and coordinates the research agenda and activities of the division;
(2)provides leadership and guidance on strategic planning, policy, program and project priority planning and setting, program management, and operations;
(3)establishes division goals, objectives, and priorities;
(4)monitors progress in implementation of projects and achievement of objectives;
(5)plans, allocates, and monitors resources;
(6)provides management, administrative, and support services, and coordinates with appropriate NCBDDD offices on program and administrative matters;
(7)provides liaison with other CDC organizations, other governmental agencies, international organizations, and other outside groups;
(8)provides support for internal scientific advisory groups;
(9)provides scientific leadership and guidance to the division to assure highest scientific quality and professional standards; and
(10)provides coordinative support for CDC's efforts to reduce adverse consequences from birth defects, developmental disabilities, and pediatric genetic conditions. *Birth Defects Branch (CUBBB).*
(1)Designs and conducts epidemiologic and genetic research to identify causes and risk factors of birth defects;
(2)conducts evaluates interventions to improve infant and child health by preventing or reducing the adverse consequences of birth defects;
(3)designs and conducts surveillance of selected birth defects to identify rates, trends, and patterns of occurrence, and to evaluate the effectiveness of prevention programs;
(4)disseminates findings of studies to the scientific and public health communities, and to the general public;
(5)provides technical assistance to state and local agencies on surveillance of birth defects, epidemiologic research, prevention program design and evaluation, and prevention effectiveness research;
(6)funds and coordinates grant and cooperative agreement programs and other extramural activities to improve the knowledge base for the prevention of birth defects through surveillance, epidemiologic research, and applies research of preventive interventions;
(7)coordinates activities with other CDC functional units, HHS, other federal agencies,and appropriate private organizations regarding research and prevention programs for birth defects;
(8)works with international organizations in developing strategies for the prevention of birth defects; and
(9)disseminates findings of research through direct contact with health authorities, publication and distribution of special reports, publication in scientific and technical journals, conference presentations, and other appropriate means. *Prevention Research Branch (CUBBC).*
(1)Modifies the impact of prenatal exposures leading to adverse physical and developmental impairments in infants, children, and adults including integrating successful prevention programs into social and medical environments, and evaluating innovative, effective, and strategic health promotion programs;
(2)develops, implements, evaluates, and disseminates education and communication interventions that lead to the prevention of birth defects and developmental disabilities;
(3)designs and conducts surveillance of preventable birth defects and developmental disabilities to identify rates, trends, and patterns of occurrence, and to evaluate the effectiveness of prevention programs;
(4)disseminates findings of epidemiologic studies to the scientific and public health communities, and to the general public;
(5)conducts prevention effectiveness research to evaluate interventions strategies for the prevention of birth defects and developmental disabilities;
(6)identifies and monitors major preconception, prenatal and perinatal risks, and protective factors for fetal alcohol spectrum disorders
(FASD)and other prenatal alcohol-attributable conditions;
(7)provides technical assistance to state and local agencies on surveillance, epidemiologic research, prevention program design and evaluation, and prevention effectiveness research;
(8)funds and coordinates grant and cooperative agreement programs and other extramural activities to improve the knowledge base for the prevention of birth defects and developmental disabilities through surveillance, epidemiologic research, and applies research of preventive interventions;
(9)coordinates activities with other CDC functional units, HHS, other federal agencies and appropriate private organizations regarding research and prevention programs for birth defects and developmental disabilities;
(10)works with international organizations in developing strategies for the prevention of birth defects and developmental disabilities; and
(11)disseminates finding of research through direct contact with health authorities, publication and distribution of special reports, publication in scientific and technical journals, conference presentations, and other appropriate means. *Developmental Disabilities Branch (CUBBD).*
(1)Designs and conducts surveillance of developmental disabilities to identify rates, trends, and patterns of occurrence, and to evaluate the effectiveness of prevention programs;
(2)conducts epidemiologic studies of developmental disabilities to identify causes and risk factors for these conditions;
(3)disseminates findings of epidemiologic studies to the scientific and public health communities and to the general public;
(4)conducts prevention effectiveness research to evaluate interventions strategies for the prevention of developmental disabilities;
(5)conducts epidemiologic studies to identify and describe specific conditions and long-term outcomes of developmental disabilities;
(6)provides technical assistance to state and local agencies on surveillance of developmental disabilities, epidemiologic research, prevention program design and evaluation, and prevention effectiveness research;
(7)funds and coordinates grant and cooperative agreement programs and other extramural activities to improve the knowledge base for the prevention of developmental disabilities through surveillance, epidemiologic research, and applies research of preventive interventions;
(8)coordinates activities with other CDC functional units, HHS, other Federal agencies and appropriate private organizations regarding research and prevention programs for developmental disabilities;
(9)collaborates with international organizations in developing strategies for the prevention of developmental disabilities;
(10)disseminates findings of research through direct contact with health authorities, publication and distribution of special reports, publication in scientific and technical journals, conference presentations, and other appropriate means; and
(11)provides training in the epidemiology of developmental disabilities to professionals throughout the United States and abroad. Dated: March 22, 2006. William H. Gimson, Chief Operating Officer, Centers for Disease Control and Prevention (CDC). [FR Doc. 06-3123 Filed 3-30-06; 8:45 am]
Connectionstraces to 2
8 references not yet in our index
  • 42 CFR 93.501(c)
  • 42 CFR 93.503
  • 42 CFR 93.504(a)(2)
  • 45 CFR 76
  • 44 USC 3501-3520
  • 5 CFR 1320.3(c)
  • 45 CFR 74
  • Pub. L. 92-463
Citation graph
cites case law
Notices
Notice
Cite42 CFR 93.501(c)
Cite42 CFR 93.503
Cite42 CFR 93.504(a)(2)
Cite45 CFR 76
Cite44 USC 3501-3520
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