Department of Health and Human Services December 8, 2006 – Federal Register Recent Federal Regulation Documents
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Oral Dosage Form New Animal Drugs; Lincomycin and Spectinomycin Powder
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 Agri Laboratories, Ltd. The ANADA provides for the oral use of lincomycin and spectinomycin soluble powder to create a solution administered in the drinking water of chickens as an aid in the control of airsacculitis.
Oral Dosage Form New Animal Drugs; Oxytetracycline Powder
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application (ANADA) filed by IVX Animal Health, Inc. The supplemental ANADA revises labeling of generic oxytetracycline soluble powder with the current scientific names of the causative bacteria of foulbrood of honeybees.
Findings of Research 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: Nicholas McMaster, University of Chicago: Based on a College Discipline Hearing report and on additional analysis conducted by ORI in its oversight review, the U.S. Public Health Service (PHS) found that Mr. Nicholas McMaster, undergraduate student, Biological Sciences Collegiate Division in the Departments of Psychology and Comparative Human Development at the University of Chicago (UC), engaged in research misconduct supported by National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH), grant P50 ES12382 and National Institute on Aging (NIA), NIH, grant P01 AG018911. Specifically, PHS found that Mr. McMaster fabricated data in recording the score for the lordosis reflex and in recording the cell types present in vaginal epithelium from rats in two experimental psychology protocols. Mr. McMaster has entered into a Voluntary Exclusion Agreement in which he has voluntarily agreed, for a period of three (3) years, beginning on November 14, 2006: (1) 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 (2) that any institution which submits an application for PHS support for a research project on which Mr. McMaster's participation is proposed or which uses him in any capacity on PHS supported 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 his research contribution. Mr. McMaster also agrees to ensure that the institution submits a copy of the supervisory plan to ORI. He further agrees that he will not participate in any PHS-supported research until such a supervisory plan is submitted to ORI.
Agency Information Collection Activities; Proposed Collection; Comment Request; Alzheimer's Disease Demonstration Grants to States Program Standardized Data Collection
The Administration on Aging (AoA) 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 information collection requirements relating to Alzheimer's Disease Demonstration Grants to States Program
Draft Guidance on Engagement of Institutions in Human Subjects Research
The Office for Human Research Protections (OHRP), Office of Public Health and Science, is announcing the availability of a draft guidance document entitled, ``OHRP Guidance on Engagement of Institutions in Human Subjects Research.'' The draft guidance document would revise and replace two existing OHRP guidance documents on the engagement of institutions in human subjects research: (1) The January 26, 1999 document on ``Engagement of Institutions in Research, and (2) the December 23, 1999 document on ``Engagement of Pharmaceutical Companies in HHS Supported Research.'' To facilitate public review of the draft guidance document, OHRP has developed a table presenting a side-by-side comparison of OHRP's draft revised guidance document and the current guidance documents on the engagement of institution in human subjects research, which is available on the OHRP Web site at https://www.hhs.gov/ohrp/requests/. OHRP's current engagement guidance documents and the proposed draft guidance document provide examples of when institutions generally would be considered to be engaged or not engaged in human subjects research. The draft document is intended primarily for institutional review boards (IRB), research administrators and other relevant institutional officials, investigators, and funding agencies that may be responsible for the conduct, review and oversight of human subject research that is conducted or supported by HHS. OHRP will consider comments received before issuing the final guidance document.
Privacy Act of 1974; Revisions to OIG's Privacy Act System of Records-Criminal Investigative Files
The Office of Inspector General (OIG) is revising the existing system of records, entitled ``Criminal Investigative Files'' (09-90- 0003), by updating the ``Systems Location'' section of that document, and republishing the revised system of records in its entirety. This notice is in accordance with the Privacy Act requirement that agencies publish their amended systems of records in the Federal Register when there is a revision, change, or addition. This system of records, maintained by OIG, was last revised and updated on June 19, 2003 (68 FR 36828).
Medicare and Medicaid Programs; Programs of All-Inclusive Care for the Elderly (PACE); Program Revisions
This rule finalizes the interim final rule with comment period published in the Federal Register November 24, 1999 (64 FR 66234) and the interim final rule with comment period published in the Federal Register on October 1, 2002 (67 FR 61496). The November 1999 interim final rule implemented sections 4801 through 4803 of the Balanced Budget Act of 1997 (Pub. L. 105-33) and established requirements for Programs of All-inclusive Care for the Elderly (PACE) under the Medicare and Medicaid programs. The interim final rule with comment period published on October 1, 2002 (67 FR 61496) implemented section 903 of the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA) (Pub. L. 106-554).
Designation of a Class of Employees for Addition to the Special Exposure Cohort
The Department of Health and Human Services (HHS) gives notice of a decision to designate a class of employees at the Oak Ridge Thermal Diffusion Plant (S-50), Oak Ridge, Tennessee, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On November 9, 2006, the Secretary of HHS designated the following class of employees as an addition to the SEC:
Designation of a Class of Employees for Addition to the Special Exposure Cohort
The Department of Health and Human Services (HHS) gives notice of a decision to designate a class of employees at the Los Alamos National Laboratory, Los Alamos, New Mexico, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On November 9, 2006, the Secretary of HHS designated the following class of employees as an addition to the SEC:
Designation of a Class of Employees for Addition to the Special Exposure Cohort
The Department of Health and Human Services (HHS) gives notice of a decision to designate a class of employees at the Oak Ridge Institute of Nuclear Studies Cancer Research Hospital, Oak Ridge, Tennessee, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On November 9, 2006, the Secretary of HHS designated the following class of employees as an addition to the SEC:
Decision To Evaluate a Petition to Designate a Class of Employees at Hanford Nuclear Reservation, Richland, WA, To Be Included in the Special Exposure Cohort
The Department of Health and Human Services (HHS) gives notice as required by 42 CFR Sec. 83.12(e) of a decision to evaluate a petition to designate a class of employees at the Hanford Nuclear Reservation, Richland, Washington, 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: Hanford Nuclear Reservation. Location: Richland, Washington. Job Titles and/or Job Duties: All employees. Period of Employment: January 2, 1942 through December 31, 1990.
Medicare and Medicaid Programs; Hospital Conditions of Participation: Patients' Rights
This final rule finalizes the Patients' Rights Condition of Participation (CoP) which is applicable to all Medicare- and Medicaid- participating hospitals and contains standards that ensure minimum protections of each patient's physical and emotional health and safety. It responds to comments on the following standards presented in the July 2, 1999 interim final rule: Notice of rights; exercise of rights; privacy and safety; confidentiality of patient records; restraint for acute medical and surgical care; and seclusion and restraints for behavior management. As a result of comments received, we have revised the standards regarding restraint and seclusion and set forth standards regarding staff training and death reporting.
Medicare Program; Revisions to Payment Policies, Five-Year Review of Work Relative Value Units, and Changes to the Practice Expense Methodology Under the Physician Fee Schedule, and Other Changes to Payment Under Part B; Corrections
This correction document corrects a limited number of technical and typographical errors in the final rule with comment period that appeared in the December 1, 2006 Federal Register (71 FR 69624). The final rule with comment period addressed Medicare Part B payment policy, including the physician fee schedule (PFS) that is applicable for calendar year (CY) 2007, finalized the CY 2006 interim relative value units (RVUs), and established interim RVUs for new and revised procedure codes for CY 2007.
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