Department of Health and Human Services June 2007 – Federal Register Recent Federal Regulation Documents

In accordance with the requirements of the Privacy Act of 1974, we are proposing to establish a new system titled, ``The National Disaster Medical System (NDMS) Patient Treatment and Tracking Records System,'' System Number 09-90-0040. The primary purpose of the NDMS Patient Treatment and Tracking Records System is to collect data from individuals using the medical care capabilities provided by NDMS.

The National Institutes of Health (NIH) proposes to amend the existing regulations governing grants for research projects by revising the definition of Principal Investigator to mean one or more individuals designated by the grantee in the grant application and approved by the Secretary, who is or are responsible for the scientific and technical direction of the project, rather than limiting the role of principal investigator to one single individual, and the conditions for multiple or concurrent awards permitting the Secretary to evaluate, approve and make one or more awards pursuant to one or more applications.

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the Graduate Partnerships Program/OITE/OIR/OD, the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

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: Joy Bryant, University of Oklahoma Health Sciences Center: Based on the report of an investigation conducted by the University of Oklahoma Health Sciences Center (OUHSC) and additional analysis conducted by the Office of Research Integrity during its oversight review, the U.S. Public Health Service (PHS) found that Ms. Joy Bryant, Tribal Efforts Against Lead (TEAL) phlebotomist, OUHSC, engaged in scientific misconduct in research supported by National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH), grant R01 ES008755. Specifically, Ms. Bryant falsified research in the TEAL study by substituting or conspiring with another phlebotomist to substitute her blood or blood of another phlebotomist for blood samples of 10-15 child participants in the TEAL study. Ms. Bryant has entered into a Voluntary Exclusion Agreement (Agreement) in which she has voluntarily agreed, for a period of three (3) years, beginning on May 30, 2007: (1) To exclude herself 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 as defined in HHS' implementation of OMB Guidelines to Agencies on Governmentwide Debarment and Suspension at 2 CFR part 376, et seq.; and (2) to exclude herself 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.

The Food and Drug Administration (FDA) is issuing an interim final rule (IFR) that sets forth a procedure for requesting an exemption from the requirement in the final rule ``Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements,'' published elsewhere in this issue of the Federal Register, that the manufacturer conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient. This IFR allows for submission to, and review by, FDA of an alternative to the required 100 percent identity testing of components that are dietary ingredients, provided certain conditions are met and establishes a requirement for retention of records relating to the FDA's response to an exemption request.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Infant Formula Requirements'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

This notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from January 2007 through March 2007, relating to the Medicare and Medicaid programs. This notice provides information on national coverage determinations (NCDs) affecting specific medical and health care services under Medicare. Additionally, this notice identifies certain devices with investigational device exemption (IDE) numbers approved by the Food and Drug Administration (FDA) that potentially may be covered under Medicare. This notice also includes listings of all approval numbers from the Office of Management and Budget for collections of information in CMS regulations and a list of Medicare-approved carotid stent facilities. Included in this notice is a list of the American College of Cardiology's National Cardiovascular Data registry sites, active CMS coverage-related guidance documents, and special one-time notices regarding national coverage provisions. Also included in this notice is a list of National Oncologic Positron Emissions Tomography Registry sites, a list of Medicare-approved ventricular assist device (destination therapy) facilities, a list of Medicare-approved lung volume reduction surgery facilities, a list of Medicare-approved clinical trials for fluorodeoxyglucose positron emissions tomography for dementia, and a list of Medicare-approved bariatric surgery facilities. Section 1871(c) of the Social Security Act requires that we publish a list of Medicare issuances in the Federal Register at least every 3 months. Although we are not mandated to do so by statute, for the sake of completeness of the listing, and to foster more open and transparent collaboration efforts, we are also including all Medicaid issuances and Medicare and Medicaid substantive and interpretive regulations (proposed and final) published during this 3-month time frame.

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.