Department of Health and Human Services December 7, 2006 – Federal Register Recent Federal Regulation Documents

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.