Department of Health and Human Services May 2011 – Federal Register Recent Federal Regulation Documents

The NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), on behalf of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), convened an independent international scientific peer review panel (hereafter, Panel) on March 29-30, 2011, to evaluate the validation status of the LUMI-CELL[supreg] (BG1Luc ER TA) test method, an in vitro transcriptional activation (TA) assay used to identify chemicals that can interact with human estrogen receptors (ERs). The Panel report is now available on the NICEATM-ICCVAM Web site at: http:/ / iccvam.niehs.nih.gov/docs/endodocs/EDPRPRept2011.pdf or by contacting NICEATM (see ADDRESSES). The report contains (1) the Panel's evaluation of the validation status of the test method and (2) the Panel's comments on the draft ICCVAM test method recommendations. NICEATM invites public comment on the Panel report.

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), announces the availability of a draft Alert entitled ``Preventing Occupational Respiratory Disease from Dampness in Office Buildings, Schools, and other Nonindustrial Buildings'' now available for public comment. The draft document and instructions for submitting comments can be found at: https://nioshdev.cdc.gov/niosh/docket/review/docket238/ default.html. The purpose of this Alert is to provide workers and employers with information necessary for prevention of respiratory disease and proper response to damp building conditions. This guidance does not have the force and effect of the law. Public Comment Period: Comments must be received by July 12, 2011.

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Class II Special Controls Guidance Document: In Vitro Diagnostic Devices for Bacillus spp. Detection.'' This draft guidance document describes means by which in vitro diagnostic devices for Bacillus species (spp.) detection may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a proposed rule to classify in vitro diagnostic devices for Bacillus spp. detection into class II, subject to special controls. This draft guidance is not final nor is it in effect at this time.

HHS gives notice of a decision to designate a class of employees from the Grand Junction Operations Office in Grand Junction, Colorado, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On April 29, 2011, the Secretary of HHS designated the following class of employees as an addition to the SEC:

HHS gives notice of a decision to designate a class of employees from the Wah Chang facility in Albany, Oregon, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On April 29, 2011, the Secretary of HHS designated the following class of employees as an addition to the SEC:

HHS gives notice of a decision to designate a class of employees from the Norton Co. (or any subsequent owner) in Worcester, Massachusetts, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On April 29, 2011, the Secretary of HHS designated the following class of employees as an addition to the SEC:

HHS gives notice of a decision to designate a class of employees from the Vitro Manufacturing facility in Canonsburg, Pennsylvania, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On April 29, 2011, the Secretary of HHS designated the following class of employees as an addition to the SEC:

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Cancer Institute (NCI), and the National Institutes of Health (NIH), have 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 March 15, 2011 (76 FR 14034) 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 National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Proposed Collection: Title: NCI Cancer Genetics Services Directory Web-based Application Form and Update Mailer. Type of Information Collection Request: Existing Collection in Use Without an OMB Number. Need and Use of Information Collection: The purpose of the online application form and the Web-based update mailer is to collect information about genetics professionals to be included in the NCI Cancer Genetics Services Directory on NCI's Cancer.gov Web site. The information collected includes name, practice locations, professional qualifications, and areas of specialization. Frequency of Response: Information is collected once via the online application form, and then updated annually via the Web-based mailer. Affected Public: Individuals. Type of Respondents: Genetics professionals including nurses, physicians, genetic counselors, and other professionals who provide services related to cancer genetics. The annual reporting burden is estimated at 180 hours (see Table below). There are no Capital Costs, Operating Costs, and/or Maintenance Costs to report.