Rules and Regulations. Notice
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/register/2007/06/20/07-3052A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
BILLING CODE 4150-37-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary Findings of Research Misconduct 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: *Carlos A. Murillo, M.D., University of Texas Medical Branch at Galveston:* Based on the report of an inquiry conducted by the University of Texas Medical Branch at Galveston
(UTMB)and additional analysis and information obtained by the Office of Research Integrity during its oversight review, the U.S. Public Health Service
(PHS)found that Carlos A. Murillo, M.D., former Surgical Resident, Department of Surgery, UTMB, engaged in research misconduct in research supported by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH), grants R01 DK48498 and T32 DK07639. Specifically, Dr. Murillo falsified research on the amelioration by antisense RNA (siRNA) of dextran-induced colonic toxicity in mice. He altered the concentrations of dextran solution fed to mice to induce colonic inflammation, by intentionally including little or no dextran in the drinking water of siRNA treated mice, so that the animals that received siRNA would have few or no colonic lesions. Dr. Murillo has entered into a Voluntary Exclusion Agreement (Agreement) in which he has voluntarily agreed, for a period of three
(3)years, beginning on May 30, 2007:
(1)That any institution that submits an application for PHS support for a research project on which Dr. Murillo's participation is proposed or that uses him in any capacity on PHS support research, or that submits a report of PHS-funded research in which he is involved, must concurrently submit a plan for supervision of his duties to the funding agency for approval; the supervisory plan must be designed to ensure the scientific integrity of Dr. Murillo's research contribution; Dr. Murillo agrees to ensure that a copy of the supervisory plan is also submitted to ORI by the institution and agrees that he will not participate in any PHS-supported research until such a supervision plan is submitted to ORI;
(2)to exclude himself 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
(3)to request retraction of the abstract entitled “Inhibition of Phosphoinositol 3-kinase Using Anti-p85 siRNA Attenuates Dextran-Sulfate-Induced Inflammatory Bowel Disease” ( *Gastroenterology* 126:A49, 2004), by signing the letter of retraction prepared by ORI attached as Attachment 2 and made part of the Agreement. FOR FURTHER INFORMATION CONTACT: Director, Division of Investigative Oversight, Office of Research Integrity, 1101 Wootton Parkway, Suite 750, Rockville, MD 20852,
(240)453-8800. John Dahlberg, Acting Director,Office of Research Integrity. [FR Doc. E7-11908 Filed 6-19-07; 8:45 am] BILLING CODE 4150-31-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-07-06BF] Agency Forms Undergoing Paperwork Reduction Act Review The Centers for Disease Control and Prevention
(CDC)publishes a list of information collection requests under review by the Office of Management and Budget
(OMB)in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at
(404)639-5960 or send an e-mail to *omb@cdc.gov.* Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC or by fax to
(202)395-6974. Written comments should be received within 30 days of this notice. Proposed Project Assessment and Evaluation of the Role of Care Coordination (Case Management) in Improving Access and Care within the Spina Bifida Clinic System—New—National Center for Birth Defects and Developmental Disabilities (NCBDDD), Centers for Disease Control and Prevention (CDC). Background and Brief Description CDC is requesting a one-year approval from the Office of Management and Budget to collect information about the effectiveness of care coordination for patients with spina bifida. Studies have shown that care coordination is beneficial for individuals with complex health conditions such as cystic fibrosis and sickle cell anemia, however, the extent to which care coordination is effective for assisting individuals with spina bifida is unknown. Spina bifida is one of the most common birth defects, affecting approximately 3 per 10,000 live births in the United States annually. The proposed activity is part of the National Spina Bifida Program mandated in Section 317C of the Public Health Service Act (42 U.S.C. 247b-4). Researchers will visit 10 spina bifida clinics nationwide. At each clinic, one focus group will be conducted with approximately eight caregivers of children with spina bifida. Each focus group will last about two hours. In addition, interviews will be conducted with approximately five staff members at each clinic; each interview will take approximately 45 minutes. Focus group and interview respondents will be asked a variety of questions related to care coordination for individuals with spina bifida including how care is coordinated in the clinic, barriers and facilitators to the provision of care coordination, the effectiveness of care coordination, and recommendations for improving care coordination. There will be no costs to the respondents other than their time. The total estimated annualized burden hours are 244. *Estimated Annualized Burden Hours:* Type of respondents Form name Number of respondents Number of reponses per respondent Average burden per response (in hours) Caregivers for Spina Bifida Patients Focus Group Response Form 100 1 5/60 Focus Group Telephone Script 100 1 15/60 Focus Group Moderator's Guide 80 1 2 Spina Bifida Clinic Staff Clinic Recruitment Script 14 1 15/60 Clinic Staff Telephone Interview Script 55 1 10/60 Clinic Staff Interview Guide 50 1 45/60 Dated: June 14, 2007. Catina Conner, Acting Assistant Reports Clearance Officer,Centers for Disease Control and Prevention. [FR Doc. E7-11934 Filed 6-19-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-07-05AT] Proposed Data Collections Submitted for Public Comment and Recommendations The Centers for Disease Control and Prevention
(CDC)publishes a list of information collection requests under review by the Office of Management and Budget
(OMB)in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at
(404)639-4604 or send an e-mail to *omb@cdc.gov.* Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC or by fax to
(202)395-6974. Written comments should be received within 30 days of this notice. Proposed Project A Site Specific Modular Evaluation Instrument for Behavior Outcome Measurement—New—Agency for Toxic Substances and Disease Registry (ATSDR), Centers for Disease Control and Prevention (CDC). Background and Brief Description ATSDR considers evaluation to be a critical component for enhancing program effectiveness and improving resource management. ATSDR's mandate under the Comprehensive Environmental Response, Compensation, and Liability Act (CERLCA), as amended, is to help prevent or reduce further exposures at hazardous waste sites and the illnesses that result from such exposures. A standardized methodology to monitor outcomes associated with agency intervention will provide the data needed for demonstrating effectiveness and efficiency as well as identifying areas for improvement. ATSDR, in cooperation with our cooperative agreement partners, is developing a series of survey modules designed to measure individual attitudes, knowledge and behaviors, as well as mental and physical health self-assessments, that may be influenced by health education and health promotion efforts conducted by the agency at hazardous waste sites. These modules will be used to determine knowledge improvements, attitude shifts, and behavior change following specific ATSDR program efforts and activities. The particular module or combination of modules(s) used at a site will vary depending on the contaminant(s) of concern and education/health promotion actions undertaken. In addition, the timing of the data collection will vary depending on whether this is a new site or one that has been underway for some time. In general, for new sites or existing sites with new intervention efforts, we would aim for two data collections, baseline and post-intervention. At existing sites where ATSDR interventions have been completed, we would collect data once, post-intervention. Health education and promotion activities are conducted at approximately 250 sites annually. We estimate that 90% will have total exposed or potentially exposed populations of 10,000 or less, and we expect to survey up to 150 respondents at each site. At sites with exposed or potentially exposed populations of more than 10,000, we expect to survey up to 500 respondents at each site. Using a standardized methodology and survey instrument to assess outcomes related to targeted intervention activities at hazardous waste sites will provide the agency with important feedback for program improvement. There will be no costs to respondents except for their time to participate in the survey. The total estimated annualized burden hours are 27,250. *Estimated Annualized Burden Hours:* Type of respondents Number of sites Number of respondents Number of responses per respondent Average burden per response (in hours) General Public at Existing Sites with Exposed Populations of 10,000 or Less 55 150 1 20/60 General Public at Existing Sites with New Interventions or New Sites with Exposed Populations of 10,000 or Less 170 150 2 20/60 General Public at Existing Sites with Exposed Populations of 10,000 or More 5 500 1 20/60 General Public at Existing Sites with New Interventions or New Sites with Exposed Populations of 10,000 or More 20 500 2 20/60 Dated: June 14, 2007. Catina Conner, Acting Assistant Reports Clearance Officer,Centers for Disease Control and Prevention. [FR Doc. E7-11936 Filed 6-19-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Privacy Act of 1974: New System of Records AGENCY: Health Resources and Services Administration (HRSA), HHS. ACTION: Notification of new system of records. SUMMARY: In accordance with the requirements of the Privacy Act, the Health Resources and Services Administration
(HRSA)is publishing notice of a proposal to add a new system of records titled, “Information Center
(IC)Integrated Clearinghouse System (IC/ICS),” System No. 09-15-0067. The HRSA IC/ICS will facilitate the delivery of publications and requested information by members of the general public. The HRSA IC/ICS will also enable HRSA to deliver information efficiently through physical mailings or broadcast e-mail messages to HRSA Grantee organizations and other interested parties. DATES: HRSA invites interested parties to submit comments on the proposed New System of Records on or before July 30, 2007. HRSA has sent a Report of New Systems of Records to Congress and to the Office of Management and Budget (OMB). The New System of Records will be effective 40 days from the date submitted to OMB unless HRSA receives comments which would result in a contrary determination. ADDRESSES: Please address comments to Donn Taylor, Health Resources and Services Administration, Division of Management Services, 5600 Fishers Lane, Room 14A-20, Rockville, Maryland 20857; Telephone
(301)443-0204. Comments received will be available for inspection at this same address from 9 a.m. to 3 p.m., Monday through Friday. This is not a toll-free number. FOR FURTHER INFORMATION CONTACT: Tina Cheatham, Acting Director, Office of Communications, Health Resources and Services Administration, 5600 Fishers Lane, Room 14-27, Rockville, Maryland 20857, Telephone: 301-443-3376. Please note this is not a toll free telephone number. SUPPLEMENTARY INFORMATION: The Health Resources and Services Administration proposes to establish a new system of records: “The HRSA Information Center
(IC)Integrated Clearinghouse System (ICS),” HHS/HRSA/Office of Communications. The HRSA Information Center provides easy access to a diversity of resources and a broad range of health information from over 70 Agency programs. The HRSA Information Center makes this information available to the public, health care professionals, policy makers and researchers to enhance their access to vital knowledge generated by HRSA supported public health programs. Dated: May 31, 2007. Elizabeth M. Duke, Administrator. [FR Doc. 07-3052 Filed 6-19-07; 8:45 am]
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