Department of Health and Human Services January 23, 2008 – Federal Register Recent Federal Regulation Documents
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Interstate Shipment of Etiologic Agents
HHS is removing Part 72 of Title 42, Code of Federal Regulations, which governs the interstate shipment of etiologic agents, because the U.S. Department of Transportation (DOT) already has in effect a more comprehensive set of regulations applicable to the transport in commerce of infectious substances. DOT harmonizes its transport requirements with international standards adopted by the United Nations (UN) Committee of Experts on the Transport of Dangerous Goods for the classification, packaging, and transport of infectious substances. Rescinding the rule eliminates duplication of the more current DOT regulations that cover intrastate and international, as well as interstate, transport. HHS replaced those sections of Part 72 that deal with select biological agents and toxins with a new set of regulations found in Part 73 of Title 42. Removal of Part 72 alleviates confusion and reduces the regulatory burden with no anticipated adverse impact on public health and safety.
National Institute for Occupational Safety and Health; Determination Concerning a Petition To Add a Class of Employees to the Special Exposure Cohort
The Department of Health and Human Services (HHS) gives notice of a determination concerning a petition to add a class of employees at the Y-12 Plant, Oak Ridge, Tennessee, to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA), 42 U.S.C. 7384q. On December 14, 2007, the Secretary of HHS determined that the following employees do not meet the statutory criteria for addition to the SEC as authorized under EEOICPA:
National Institute for Occupational Safety and Health; Decision To Evaluate a Petition To Designate a Class of Employees at Spencer Chemical Co., Jayhawks Works, Pittsburg, KS, To Be Included in the Special Exposure Cohort
The Department of Health and Human Services (HHS) gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees at Spencer Chemical Co., Jayhawks Works, Pittsburg, Kansas, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: Spencer Chemical Co., Jayhawks Works. Location: Pittsburg, Kansas. Job Titles and/or Job Duties: All employees. Period of Employment: January 1, 1958 through December 31, 1963.
Findings of Scientific Misconduct
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: Scott E. Monte, Huntington Memorial Hospital: Based on the findings of an investigation conducted by Huntington Memorial Hospital (HMH) and information obtained by the Office of Research Integrity (ORI) during its oversight review, the U.S. Public Health Service (PHS) found that Scott E. Monte, L.V.N., former Clinical Research Associate, HMH, engaged in scientific misconduct by knowingly and intentionally falsifying and fabricating clinical research records in HMH cancer prevention and treatment protocols supported by National Cancer Institute (NCI), National Institutes of Health (NIH), awards U10 CA69651, U10 CA12027, U10 CA32012, and U10 CA86004. Specifically, Mr. Monte knowingly and intentionally: (1) Entered falsified and fabricated laboratory data or physical examination results on five (5) research protocol case report forms (CRFs); (2) Falsified a gynecological examination report in a physician's progress note and entered the falsified document in the patient's research chart; and (3) Fabricated progress notes for four patients and a case report form for one of these patients. ORI has implemented the following administrative actions for a period of three (3) years, beginning on January 7, 2008: (1) Dr. Monte is 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 pursuant to HHS' implementation of the OMB Guidelines to Agencies on Governmentwide Debarment and Suspension at 2 CFR Part 376; and (2) Dr. Monte 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.
Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort
The Department of Health and Human Services (HHS) gives notice concerning the final effect of the HHS decision to designate a class of employees at Nuclear Materials and Equipment Corporation (NUMEC) in Apollo, Pennsylvania, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On November 29, 2007, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:
Annual Update of the HHS Poverty Guidelines
This notice provides an update of the HHS poverty guidelines to account for last calendar year's increase in prices as measured by the Consumer Price Index.
Notice of Availability: Secretarial Recognition of Certain Healthcare Information Technology Standards Panel (HITSP) Interoperability Specifications as Interoperability Standards for Health Information Technology
By publication of this document, we are informing the public of the Secretary's recognition of certain Healthcare Information Technology Standards Panel (HITSP) ``Interoperability Specifications'' as interoperability standards for health information technology. The Secretary accepted these HITSP ``Interoperability Specifications'', Version 1.2, in December of 2006, and hereby recognizes them as interoperability standards in updated versions in January of 2008. The list of recognized interoperability standards is provided below and is available at https://www.hitsp.org; click on ``HITSP Interoperability Specifications HERE'' box.
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