Department of Health and Human Services 2009 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the Anti-Infective Drugs Advisory Committee. This meeting was announced in the Federal Register of October 26, 2009 (74 FR 55057). The amendment is being made to reflect a change in the Location portion of the document. There are no other changes.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on Wednesday, July 29, 2009, Volume 74, Number 144 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.

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 inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

The Food and Drug Administration (FDA) is announcing that Sauflon Pharmaceuticals Ltd. has filed a petition proposing that the color additive regulations be amended to provide for the safe use of disodium 1-amino-4-[[4-[(2-bromo-1-oxoallyl)amino]-2- sulfonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-su lfonate (CAS Reg. No. 70209-99-3) as a color additive in contact lenses.

In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 which requires 60 day advance opportunity for public comment on proposed information collection projects, the Indian Health Service (IHS) is publishing for comment a summary of a proposed information collection to be submitted to the Office of Management and Budget (OMB) for review.

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), will hold a public meeting concerning the proposed rule that was published in the Federal Register on Friday, October 30, 2009. The proposed rule proposes to establish total inward leakage (TIL) requirements for half- mask air-purifying particulate respirators approved by NIOSH. The proposed new requirements specify TIL minimum performance requirements and testing to be conducted by NIOSH and respirator manufacturers to demonstrate that these respirators, when selected and used correctly, provide effective respiratory protection to intended users against toxic dusts, mists, fumes, fibers, and biological and infectious aerosols (e.g. influenza A(H5N1), severe acute respiratory syndrome (SARS) coronavirus, and Mycobacterium tuberculosis).

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.

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the National Biodefense Science Board (NBSB) will hold a teleconference meeting. The meeting is open to the public. Pre- registration is NOT required, however, individuals who wish to participate in the public comment session should e-mail NBSB@HHS.GOV to RSVP.

The Department of Health and Human Services (HHS) establishes the standards for Federal workplace drug testing programs under authority of Section 503 of Public Law 100-71, 5 U.S.C. Section 7301 and Executive Order No. 12564. As required, HHS published the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Guidelines) in the Federal Register on April 11, 1988 (53 FR 11979). The Substance Abuse and Mental Health Services Administration (SAMHSA) subsequently revised the Guidelines on June 9, 1994 (59 FR 29908), on September 30, 1997 (62 FR 51118), on November 13, 1998 (63 FR 63483), on April 13, 2004 (69 FR 19644) and on November 25, 2008 (73 FR 71858) with an effective date of May 1, 2010 (correct effective date published on December 10, 2008; 73 FR 75122). The Guidelines establish comprehensive standards for all aspects of the Federal workplace drug testing program, including the requirement for all urine specimens to be collected using chain of custody procedures to document specimen integrity and security from the time of collection until receipt by the ``test facility.'' To ensure uniformity among all Federal agency workplace drug testing programs and procedures, the Guidelines require agencies to use an Office of Management and Budget (OMB) approved Federal Custody and Control Form (Federal CCF) for their programs. Additionally, the Department of Transportation (DOT) requires its regulated industries to use the Federal CCF.

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) is conducting an evaluation of source capture ventilation systems (SCVS) units for use in nail salons, including downdraft vented nail tables and portable SCVS. This notice invites developers, manufacturers, distributors, and vendors of downdraft vented nail tables and portable nail salon SCVS that feature local exhaust recirculation to submit new, unused units for evaluation. A supply of filters sufficient to provide ventilation during 6 months of daily operation (as recommended by the developer or manufacturer), should be submitted to the NIOSH laboratory in Cincinnati, OH, together with the table or portable SCVS.

The Food and Drug Administration (FDA) is announcing the reopening until November 15, 2010 of a public docket to receive information and comments on laser-assisted in situ keratomileusis (LASIK) devices.