Department of Health and Human Services April 24, 2007 – Federal Register Recent Federal Regulation Documents

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (DHHS) is hereby giving notice that the Advisory Committee on Minority Health (ACMH) will hold a meeting. This meeting is open to the public. Preregistration is required for both public attendance and comment. Any individual who wishes to attend the meeting and/or participate in the public comment session should e-mail acmh@osophs.dhhs.gov.

The Food and Drug Administration (FDA) is announcing the availability of summaries of medical and clinical pharmacology reviews of pediatric studies submitted in supplements for CELEBREX (celecoxib), COLAZAL (balsalazide), ELOXATIN (oxaliplatin), EMTRIVA (emtricitabine), SUPRANE (desflurane), and TOPROL-XL (metoprolol). These summaries are being made available consistent with the Best Pharmaceuticals for Children Act (the BPCA). For all pediatric supplements submitted under the BPCA, the BPCA requires FDA to make available to the public a summary of the medical and clinical pharmacology reviews of the pediatric studies conducted for the supplement.

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Computerized Labor Monitoring Systems.'' This guidance document describes a means by which computerized labor monitoring systems may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule to classify computerized labor monitoring systems into class II (special controls). This guidance document is being immediately implemented as the special control for computerized labor monitoring systems, but it remains subject to comment in accordance with the agency's good guidance practices (GGPs).

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: ``Improving Quality of Care in Long Term Care.'' 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. This proposed information collection was previously published in the Federal Register on January 16, 2007 and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment.

This notice announces the 10th meeting of the American Health Information Community Confidentiality, Privacy, and Security Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92- 463, 5 U.S.C., App.).

This notice announces the fifth meeting of the American Health Information Community Personalized Healthcare Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.).

This notice announces the 16th meeting of the American Health Information Community Electronic Health Records Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).

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 the Nevada Test Site, Mercury, Nevada, 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: Nevada Test Site. Location: Mercury, Nevada. Job Titles and/or Job Duties: All workers at the Rainier Mesa, including areas 12, 16, and 20. Period of Employment: March 1, 1966 through December 31, 1990.