Department of Health and Human Services 2006 – Federal Register Recent Federal Regulation Documents

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) allow the proposed information collection project: ``Pilot Study of Proposed Nursing Home Survey on Resident Safety''. In accordance with the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)), AHRQ invites the public to comment on this proposed information collection.

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.

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

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Office for Human Research Protections (OHRP), Office of Public Health and Science, is announcing the availability of a draft guidance document entitled, ``OHRP Guidance on Engagement of Institutions in Human Subjects Research.'' The draft guidance document would revise and replace two existing OHRP guidance documents on the engagement of institutions in human subjects research: (1) The January 26, 1999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 To facilitate public review of the draft guidance document, OHRP has developed a table presenting a side-by-side comparison of OHRP's draft revised guidance document and the current guidance documents on the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.

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).

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:

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:

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.

The Food and Drug Administration (FDA) is amending an interim final rule (IFR) that was published in the Federal Register of March 29, 2005 (70 FR 15755). The IFR amended the color additive regulations by increasing the fees for certification services. The IFR was published with one typographical error regarding fees for repacks of certified color additives and color additive mixtures. FDA also inadvertently omitted the color certification fee study referenced in the IFR from the docket at the time of publication. This document corrects the typographical error in the fees for repacks of certified color additives and color additive mixtures, announces the availability of the referenced color certification fee study, and provides for additional time to submit comments.

The Food and Drug Administration (FDA) is publishing this companion proposed rule to the direct final rule, published elsewhere in this issue of the Federal Register, that is intended to amend our regulation on the use of ozone-depleting substances (ODSs) in pressurized containers to remove the essential use designations for beclomethasone, dexamethasone, fluticasone, bitolterol, salmeterol, ergotamine tartrate, and ipratropium bromide used in oral pressurized metered-dose inhalers (MDIs). Under the Clean Air Act, FDA, in consultation with the Environmental Protection Agency (EPA), is required to determine whether an FDA-regulated product that releases an ODS is essential. None of these products is currently being marketed, which provides grounds for removing their essential use designation.

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: Jennifer Blaisdell, University of Pennsylvania and Retinal Consultants of Arizona, Ltd.: Based on the report of an investigation conducted by the University of Pennsylvania (UP) and additional analysis conducted by ORI in its oversight review, the U.S. Public Health Service (PHS) found that Ms. Jennifer Blaisdell, former Clinical Coordinator for Retinal Consultants of Arizona, Ltd. (RCA), committed research misconduct in a study sponsored by two cooperative agreements funded by the National Eye Institute (NEI), National Institutes of Health (NIH): U10 EY012261, ``Age-related Macular Degeneration Prevention Trial,'' Dr. Stuart Fine, Principal Investigator (P.I.), and U10 EY012279, ``Coordinating Center for AMD, Complications of Age- Related Macular Degeneration Prevention Trial'' (CAPT), Dr. Maureen McGuire, P.I. Specifically, PHS found that Ms. Blaisdell knowingly and intentionally committed research misconduct by: 1. Fabricating a CAPT data form dated 5/29/02 reporting a 30-month telephone follow-up visit with patient 01-026; this patient died on 5/ 3/02; 2. Fabricating a CAPT data form dated 2/20/03 reporting a 43-month telephone follow-up visit with patient 01-019; this patient died on 2/ 10/03; 3. Falsifying a CAPT data form dated 2/13/01 reporting a visit to the clinic on that date for patient 01-049; this patient's visit was 2/ 20/01; 4. Falsifying the CAPT form for patient 01-055 dated 4/11/01, when no clinic visit took place, by substituting information purportedly obtained at a non-study visit on 2/28/01. Ms. Blaisdell has entered into a Voluntary Exclusion Agreement in which she has voluntarily agreed, for a period of two (2) years, beginning on November 14, 2006: (1) 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; and (2) That any institution that submits an application for PHS support for a research project on which Ms. Blaisdell's participation is proposed or which uses her in any capacity on PHS supported research, or that submits a report of PHS-funded research in which she is involved, must concurrently submit a plan for supervision of Ms. Blaisdell's duties to the funding agency for approval. The supervisory plan must be designed to ensure the scientific integrity of her research contribution. Ms. Blaisdell also agrees to ensure that the institution submits a copy of the supervisory plan to ORI. She further agrees that she will not participate in any PHS- supported research until such a supervisory plan is submitted to ORI.

In accordance with the requirements of the Privacy Act of 1974, CMS is proposing to modify or alter existing system of records titled ``Medicare Exclusion Database'' (MED), System No. 09-70-0534,'' established at 67 Federal Register 8810 (February 26, 2002). We propose to modify existing routine use number 1 that permits disclosure to agency contractors and consultants to include disclosure to CMS grantees who perform a task for the agency. CMS grantees, charged with completing projects or activities that require CMS data to carry out that activity, are classified separate from CMS contractors and/or consultants. The modified routine use will remain as routine use number 1. Published routine use number 2 and 3 will be combined as one because both are written to complete the same or similar purpose. Disclosures allowed by published routine uses numbers 2, and 3 will be covered by a new routine use numbered 2 to permit release of information to ``another Federal and/or State agency, agency of a State government, an agency established by State law, or its fiscal agent.'' The scope of this routine use has been broadened to include State Medicaid agencies when disclosure of the information proved compatible with the purpose for which CMS collects the information. We will delete routine use number 5 authorizing disclosure to support constituent requests made to a congressional representative. If an authorization for the disclosure has been obtained from the data subject, then no routine use is needed. The Privacy Act allows for disclosures with the ``prior written consent'' of the data subject. Finally, we will delete the section titled ``Additional Circumstances Affecting Routine Use Disclosures,'' that addresses ``Protected Health Information (PHI)'' and ``small cell size.'' The requirement for compliance with HHS regulation ``Standards for Privacy of Individually Identifiable Health Information'' does not apply because this system does not collect or maintain PHI. In addition, our policy to prohibit release if there is a possibility that an individual can be identified through ``small cell size'' is not applicable to the data maintained in this system. We are modifying the language in the remaining routine uses to provide a proper explanation as to the need for the routine use and to provide clarity to CMS's intention to disclose individual-specific information contained in this system. The routine uses will then be prioritized and reordered according to their usage. We will also take the opportunity to update any sections of the system that were affected by the recent reorganization or because of the impact of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Public Law 108-173) provisions and to update language in the administrative sections to correspond with language used in other CMS SORs. The primary purpose of this system of records is to collect and maintain information on individuals that have been excluded from receiving Medicare payments for any item or service furnished during the period when excluded from participation in the Medicare program. Information maintained in this system will also be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the Agency or by a contractor, consultant or CMS grantee; (2) assist another Federal or State agency, agency of a State government, an agency established by State law, or its fiscal agent; (3) facilitate research on the quality and effectiveness of care provided, as well as epidemiological projects; (4) support litigation involving the Agency; and (5) combat fraud, waste and abuse in certain health benefits programs. We have provided background information about the modified system in the SUPPLEMENTARY INFORMATION section below. Although the Privacy Act requires only that CMS provide an opportunity for interested persons to comment on the proposed routine uses, CMS invites comments on all portions of this notice. See EFFECTIVE DATES section for comment period.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The National Vaccine Program Office (NVPO), a program office within the Office of Public Health and Science, DHHS, is soliciting nominations of qualified candidates to be considered for appointment as members and representatives to the National Vaccine Advisory Committee (NVAC). The activities of this Committee are governed by the Federal Advisory Committee Act (FACA). Consistent with the National Vaccine Plan, the Committee advises and makes recommendations to the Assistant Secretary for Health in his/ her capacity as the Director of the National Vaccine Program, on matters related to the Program's responsibilities. Specifically, the Committee studies and recommends ways to encourage the availability of an adequate supply of safe and effective vaccination products in the United States; recommends research priorities and other measures to enhance the safety and efficacy of vaccines. The Committee also advises the Assistant Secretary for Health in the implementation of Sections 2102 and 2103 of the PHS Act; and identifies annually the most important areas of government and non- government cooperation that should be considered in implementing Sections 2102 and 2103 of the PHS Act.