Department of Health and Human Services January 2008 – Federal Register Recent Federal Regulation Documents

This Federal Register notice seeks the input and recommendations of interested parties as OIG revises the compliance program guidance (CPG) for nursing facilities, especially those serving Medicare, Medicaid, and other Federal health care program beneficiaries. The nursing home industry has experienced a number of changes since OIG first published a CPG in this area (65 FR 14289; March 16, 2000). Additionally, the subsequent years of enforcement and compliance activity in the nursing home industry has allowed OIG to address more fully the various risk areas in nursing home compliance. In evaluating the contents of the nursing facility CPG, OIG is soliciting comments, recommendations, and other suggestions from concerned parties and organizations on how best to revise the nursing facility CPG to address relevant compliance issues. Specifically, OIG seeks comments addressing any changes to existing risk areas and introducing any new risk areas.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Novopharm Ltd. The ANADA provides for the veterinary prescription use of clindamycin hydrochloride oral capsules in dogs for the treatment of various infections due to susceptible bacterial pathogens.

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:

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.

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.

The Food and Drug Administration's (FDA's) Center for Biologics Evaluation and Research (CBER) is reannouncing the invitation for participation in its Regulatory Site Visit Training Program (RSVP). This training program is intended to give CBER regulatory review, compliance, and other relevant staff an opportunity to visit biologics facilities. These visits are intended to allow CBER staff to directly observe routine manufacturing practices and to give CBER staff a better understanding of the biologics industry, including its challenges and operations. The purpose of this notice is to invite biologics facilities to contact CBER for more information if they are interested in participating in this program.

The Food and Drug Administration (FDA) 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 proposed collection of information resulting from the guidance to manufacturers of veterinary and human drugs, including human biological drug products, on how to resolve disputes of scientific and technical issues relating to current good manufacturing practice (CGMP).

This interim final rule with comment period implements the continuation of the revisit user fee program for Medicare Survey and Certification activities, in accordance with the statutory authority in the Continuing Appropriations Resolution entitled, ``Making further continuing appropriations for the fiscal year 2008, and for all other purposes,'' Public Law 110-137 (``Continuing Resolution'') passed by the Congress and signed by the President on December 14, 2007. On September 19, 2007, we published a final rule that established a system of revisit user fees applicable to health care facilities that have been cited for deficiencies during initial certification, recertification or substantiated complaint surveys and require a revisit to confirm that previously-identified deficiencies have been corrected.