Findings of Misconduct in Science, 45056-45057 [E6-12857]

Download as PDF jlentini on PROD1PC65 with NOTICES 45056 Federal Register / Vol. 71, No. 152 / Tuesday, August 8, 2006 / Notices scope of the proposed project and funding level that conforms to the project’s stated goals and objectives. The evaluation plan should include both a process evaluation to track the implementation of project activities and an outcome evaluation to measure changes in knowledge and skills that can be attributed to the project. Project funds may be used to support evaluation activities. In addition to conducting their own evaluation of projects, the successful applicant must be prepared to participate in an external evaluation, to be supported by ODPHP/ HHS and conducted by an independent entity, to assess efficiency and effectiveness for the project funded under this announcement. Within 30 days following the end of each of quarter, a performance report no more than ten pages in length must be submitted to ODPHP/HHS. A sample monthly performance report will be provided at the time of notification of award. At a minimum, monthly performance reports should include: • Concise summary of the most significant achievements and problems encountered during the reporting period, e.g. number of training courses held and number of trainees. • A comparison of work progress with objectives established for the quarter using the grantee’s implementation schedule, and where such objectives were not met, a statement of why they were not met. • Specific action(s) that the grantee would like the ODPHP/HHS to undertake to alleviate a problem. • Other pertinent information that will permit monitoring and overview of project operations. • A quarterly financial report describing the current financial status of the funds used under this award. The awardee and ODPHP will agree at the time of award for the format of this portion of the report. Within 90 days following the end of the project period a final report containing information and data of interest to HHS must be submitted to ODPHP/HHS. The specifics as to the format and content of the final report and the summary will be sent to the successful applicant. At minimum, the report should contain: • A summary of the major activities supported under the agreement and the major accomplishments resulting from activities with the potential for improving the health of children in Arkansas and its potential for generalizability to other States and communities. • An analysis of the project based on the problem(s) described in the VerDate Aug<31>2005 20:06 Aug 07, 2006 Jkt 208001 application and needs assessments, performed prior to or during the project period, including a description of the specific objectives stated in the grant application and the accomplishments and failures resulting from activities during the grant period. Quarterly performance reports and the final report may be submitted to: Office of Disease Prevention and Health Promotion, Office of Public Health and Science, Office of the Secretary Department of Health and Human Services, 1101 Wootton Parkway, Suite LL100, Rockville, Maryland 20852. A Financial Status Report (FSR) SF– 269 is due 90 days after the close of each 12-month budget period and submitted to the OPHS-Office of Grants Management. VII. Agency Contacts For programmatic requirements, please contact: Woodie Kessel, MD, MPH; Cecilia Penn, MD, MPH; Kathryn McMurry, MS, Office of Disease Prevention and Health Promotion, Department of Health and Human Services, 1101 Wootton Parkway, Suite LL100, Rockville, Maryland 20852, telephone: (240) 453–8256. For administrative requirements, please contact: Office of Grants Management, Office of Public Health and Science, Department of Health and Human Services, 1101 Wootton Parkway, Suite 550, Rockville, Maryland 20852, telephone: (240) 453– 8822. VIII. Tips for Writing a Strong Application Include DUNS Number. You must include a DUNS Number to have your application reviewed. To obtain a DUNS number, access www.dunandbradstreet.com or call 1– 866–705–5711. Please include the DUNS number next to the OMB Approval Number on the application face page. Keep your audience in mind. Reviewers will use only the information contained in the application to assess the application. Be sure the application and responses to the program requirements and expectations are complete and clearly written. Do not assume that reviewers are familiar with the applicant organization. Keep the review criteria in mind when writing the application. Start preparing the application early. Allow plenty of time to gather required information from various sources. Follow the instructions in this guidance carefully. Place all information in the order requested in the guidance. If the information is not placed in the PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 requested order, you may receive a lower score. Be brief, concise, and clear. Make your points understandable. Provide accurate and honest information, including candid accounts of problems and realistic plans to address them. If any required information or data is omitted, explain why. Make sure the information provided in each table, chart, attachment, etc., is consistent with the proposal narrative and information in other tables. Be organized and logical. Many applications fail to receive a high score because the reviewers cannot follow the thought process of the applicant or because parts of the application do not fit together. Be careful in the use of appendices. Do not use the appendices for information that is required in the body of the application. Be sure to crossreference all tables and attachments located in the appendices to the appropriate text in the application. Carefully proofread the application. Misspellings and grammatical errors will impede reviewers in understanding the application. Be sure pages are numbered (including appendices) and that page limits are followed. Limit the use of abbreviations and acronyms, and define each one at its first use and periodically throughout application. Dated: July 31, 2006. Woodie Kessel, Deputy Director for Medicine and Health Science, Office of Disease Prevention and Health Promotion. [FR Doc. E6–12819 Filed 8–7–06; 8:45 am] BILLING CODE 4150–32–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary Findings of Misconduct in Science Office of the Secretary, HHS. Notice. AGENCY: ACTION: SUMMARY: Notice is hereby given that the Office of Research Integrity (ORI) and the Assistant Secretary for Health have taken final action in the following case: Ms. Sylvia Okoro, University of Maryland at Baltimore: Based on the University of Maryland at Baltimore (UMAB) investigation committee report and additional analysis and information obtained by ORI during its oversight review, the U.S. Public Health Service (PHS) found that Ms. Okoro, former Research Assistant, UMAB, engaged in misconduct in science by fabricating E:\FR\FM\08AUN1.SGM 08AUN1 Federal Register / Vol. 71, No. 152 / Tuesday, August 8, 2006 / Notices and falsifying patient data in research supported by National Institute on Aging (NIA), National Institutes of Health (NIH), grant R01 AG18461. Specifically, Ms. Okoro intentionally and knowingly fabricated and falsified data for six visit dates on one patient data form and falsified and fabricated patient condition information on two additional study subjects by failing to note that each patient had experienced a fall as documented in their medical charts. ORI has implemented the following administrative actions for a period of three (3) years, beginning July 17, 2006: (1) Ms. Okoro 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 a consultant; and (2) Any institution that submits an application for PHS support for a research project on which Ms. Okoro’s participation is proposed or which uses her services in any capacity on PHS supported research must concurrently submit a plan for supervision of her duties. The supervisory plan must be designed to ensure the scientific integrity of Ms. Okoro’s research contribution and must be submitted to ORI by the institution. 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, J.D., Director, Office of Research Integrity. [FR Doc. E6–12857 Filed 8–7–06; 8:45 am] BILLING CODE 4150–31–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Science Advisory Board to the National Center for Toxicological Research; Notice of Meeting AGENCY: Food and Drug Administration, HHS. jlentini on PROD1PC65 with NOTICES ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). At least one portion of the meeting will be closed to the public. Name of Committee: Science Advisory Board (SAB) to the National Center for Toxicological Research (NCTR). General Function of the Committee: The Board advises the Director, NCTR, VerDate Aug<31>2005 20:06 Aug 07, 2006 Jkt 208001 in establishing, implementing, and evaluating the research programs that assist the Commissioner of Food and Drugs in fulfilling his regulatory responsibilities. The Board provides an extra-agency review in ensuring that the research programs at NCTR are scientifically sound and pertinent. Date and Time: The meeting will be held on August 29, 2006 from 8:30 a.m. to 4:30 p.m. and on August 30, 2006, from 8 a.m. to 12 noon. Location: August 29, 2006: NCTR SAB Conference Room B–12, 3900 NCTR Dr., Jefferson, AR 72079. August 30, 2006: University of Arkansas for Medical Sciences, Stephens Spine Center, Hamlin Board Room, 501 Jack Stephens Dr., Little Rock, AR 72205. Contact Person: Leonard Schechtman, Executive Secretary, National Center for Toxicological Research, Food and Drug Administration, 5600 Fishers Lane, rm. 16–85, Rockville, MD 20857, 301–827– 6696, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area), code 3014512559. Please call the Information Line for up-to-date information on this meeting. Agenda: On August 29, 2006, the SAB will hear presentations from the NCTR Divisions that will update them on ongoing research activities. The SAB will be presented with a response to the evaluation of the Division of Neurotoxicology. The evaluation was the product of a site visit team that conducted an on-site review of the Division in January 2004. The response will address the issues raised and recommendations made by the site visit team. On August 30, 2006, the NCTR Director will provide a Center-wide update on scientific endeavors and will discuss the NCTR realignment and strategic focus. Procedure: On August 29, 2006, from 8:30 a.m. to 4:30 p.m., and August 30, 2006, from 8 a.m. to 10:30 a.m., the meeting is open to the public. Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before August 14, 2006. Oral presentations from the public will be scheduled on August 29, 2006, between approximately 12:30 p.m. to 1:30 p.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should likewise notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 45057 requested to make their presentation on or before August 14, 2006. Closed Committee Deliberations: On August 29, 2006, from approximately 11 a.m. to 12:30 p.m., the meeting will be closed to permit discussion where disclosure would constitute a clearly unwarranted invasion of personal privacy (5 U.S.C. 552b(c)(6)). This portion of the meeting will be closed to permit discussion of information concerning individuals associated with the research programs at NCTR. Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact the office of the Executive Secretary at least 7 days in advance of the meeting. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: August 2, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6–12863 Filed 8–7–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 1992S–0251] (formerly 92S– 0251) Food and Drug Administration Electronic Submissions Gateway AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the FDA Electronic Submissions Gateway (ESG) for the receipt and processing of electronic submissions provided so that the Center for Biologics Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER), and the Center for Devices and Radiological Health (CDRH) can receive regulatory submissions electronically. The FDA ESG enables applicants to send applications and other submissions for review using the Internet, provides a single point of entry for these submissions, and fulfills goals identified in the Prescription Drug User Fee Act (PDUFA III). E:\FR\FM\08AUN1.SGM 08AUN1

Agencies

[Federal Register Volume 71, Number 152 (Tuesday, August 8, 2006)]
[Notices]
[Pages 45056-45057]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-12857]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary


Findings of Misconduct in Science

AGENCY: Office of the Secretary, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: Notice is hereby given that the Office of Research Integrity 
(ORI) and the Assistant Secretary for Health have taken final action in 
the following case:
    Ms. Sylvia Okoro, University of Maryland at Baltimore: Based on the 
University of Maryland at Baltimore (UMAB) investigation committee 
report and additional analysis and information obtained by ORI during 
its oversight review, the U.S. Public Health Service (PHS) found that 
Ms. Okoro, former Research Assistant, UMAB, engaged in misconduct in 
science by fabricating

[[Page 45057]]

and falsifying patient data in research supported by National Institute 
on Aging (NIA), National Institutes of Health (NIH), grant R01 AG18461.
    Specifically, Ms. Okoro intentionally and knowingly fabricated and 
falsified data for six visit dates on one patient data form and 
falsified and fabricated patient condition information on two 
additional study subjects by failing to note that each patient had 
experienced a fall as documented in their medical charts.
    ORI has implemented the following administrative actions for a 
period of three (3) years, beginning July 17, 2006:
    (1) Ms. Okoro 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 a consultant; and
    (2) Any institution that submits an application for PHS support for 
a research project on which Ms. Okoro's participation is proposed or 
which uses her services in any capacity on PHS supported research must 
concurrently submit a plan for supervision of her duties. The 
supervisory plan must be designed to ensure the scientific integrity of 
Ms. Okoro's research contribution and must be submitted to ORI by the 
institution.

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, J.D.,
Director, Office of Research Integrity.
 [FR Doc. E6-12857 Filed 8-7-06; 8:45 am]
BILLING CODE 4150-31-P
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