The Federal Register

Submission for OMB Review; Comment Request

Fri, Nov 6 2009 11:00:00 GMT

Title: Native Employment Works (NEW) Program Plan Guidance and Report Requirements.

OMB No.: 09700174.

Description: The Native Employment Works (NEW) program plan is the application for NEW program funding. As approved by the Department of Health and Human Services (HHS), it documents how the grantee will carry out its NEW program. The NEW program plan guidance provides instructions for preparing a NEW program plan and explains the process for plan submission every third year. The NEW program report provides information on the activities and accomplishments of grantees' NEW programs. The NEW program report and instructions specify the program data that NEW grantees report annually.

Respondents: Federally recognized Indian Tribes and Tribal organizations that are NEW program grantees.
Annual Burden Estimates Number of Average

Draft Guidance on Institutional Review Board Continuing Review of Research

Fri, Nov 6 2009 11:00:00 GMT

The Office for Human Research Protections (OHRP), Office of Public Health and Science, is announcing the availability of a draft guidance document entitled, ``Guidance on IRB Continuing Review of Research,'' and is seeking comment on the draft guidance. The draft guidance document, when finalized, will represent OHRP's current thinking on this topic and will supersede OHRP's January 15, 2007 guidance document entitled ``Guidance on Continuing Review,'' available at http://www.hhs.gov/ohrp/humansubjects/guidance/contrev0107.htm. The draft document, which is available on the OHRP Web site at http:// www.hhs.gov/ohrp/requests/, is intended primarily for institutional review boards (IRBs), investigators, Departm

Agency Information Collection Activities: Proposed Collection; Comment Request; Requirements for Submission of

Fri, Nov 6 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995, 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 reporting requirements contained in the requirements for submission of labeling for human prescription drugs and biologics in electronic format.
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Agency Information Collection Activities: Proposed Collection; Comment Request

Fri, Nov 6 2009 11:00:00 GMT

Agency Information Collection Activities: Proposed Collection; Comment Request

Fri, Nov 6 2009 11:00:00 GMT

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Collection of Information for Agency for Healthcare Research and Quality's (AHRQ) Hospital Survey on Patient Safety Culture Comparative Database.'' In accordance with the Paperwork Reduction Act of 1995, 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 September 2nd, 2009 and allowed 60 days for public comment. One comment was received. The purpose of this notice is to allow an additional 30 days for public comment.

Agency Information Collection Activities; Proposed Collection; Comment Request; Bar Code Label Requirement for Human

Fri, Nov 6 2009 11:00:00 GMT

The Food and Drug Administration (FDA) 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 bar code label requirements for human drug and biological products.

Agency Information Collection Activities: Submission for OMB Review; Comment Request

Fri, Nov 6 2009 11:00:00 GMT

Periodically, the Substance Abuse and Mental Health Services Administration (SAMHSA) will publish a summary of information collection requests under OMB review, in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these documents, call the SAMHSA Reports Clearance Officer on (240) 2761243. Project: Recovery Services for Adolescents and FamiliesNew

The Substance Abuse and Mental Health Services Administration's (SAMHSA) Center for Substance Abuse Treatment will conduct a data collection on the helpfulness of recovery support services for whether young people and their families after leaving substance abuse treatment. Specifically, the Recovery Services for Adolescents and Families (RSAF) project is evaluating a pilot test of the following recovery support services for whether young people and their families find the following recovery support services helpful: (1) Telephone/ text message support; (2) a recoveryoriented social networking site; and (3)

Proposed Collection; Comment Request; Next Series of Tobacco Use Supplements to the Current Population Survey

Fri, Nov 6 2009 11:00:00 GMT

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 Cancer Institute (NCI), 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.

Proposed Collection: Title: Next Series of Tobacco Use Supplements to the Current Population Survey (TUSCPS). Type of information request: REINSTATEMENT WITH CHANGE of OMB 09250368, Expiration 4/30/2009. Need and Use of Information Collection: The 2010 2011 Tobacco Use Supplement to the Current Population Survey conducted by the Census Bureau will collect data from the U.S. civilian non institutionalized population on smoking, other tobacco use, and attempts at cessation; policy information such as home and workplace smoking policies; health professional advice to stop smoking; and changes in smoking no

Agency Information Collection Activities: Submission for OMB Review; Comment Request

Fri, Nov 6 2009 11:00:00 GMT

Draft Guidance on Institutional Review Board Approval of Research With Conditions

Fri, Nov 6 2009 11:00:00 GMT

The Office for Human Research Protections (OHRP), Office of Public Health and Science, is announcing the availability of a draft guidance document entitled ``Guidance on IRB Approval of Research with Conditions,'' and is seeking comment on the draft guidance. The draft guidance document, when finalized, would provide OHRP's first formal guidance on this topic. The draft document, which is available on the OHRP Web site at http://www.hhs.gov/ohrp/requests/, is intended primarily for institutional review boards (IRBs), investigators, Department of Health and Human Services (HHS) funding agencies, and others that may be responsible for the review, conduct, or oversight of human subject research conducted or supported by HHS. OHRP will consider comments received before issuing the final guidance document.

Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies

Fri, Nov 6 2009 11:00:00 GMT

The Department of Health and Human Services (HHS) notifies Federal agencies of the laboratories currently certified to meet the standards of Subpart C of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908), on September 30, 1997 (62 FR 51118), and on April 13, 2004 (69 FR 19644).

A notice listing all currently certified laboratories is published in the Federal Register during the first week of each month. If any laboratory's certification is suspended or revoked, the laboratory will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines.

If any laboratory has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end, and will be omitted fro