Department of Health and Human Services October 2008 – Federal Register Recent Federal Regulation Documents

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, and to allow 60 days for public comment in response to the notice. This notice solicits comments on a voluntary consumer survey of fishing and fish consumption habits in the Mississippi Delta.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute on Drug Abuse (NIDA), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on June 26, 2008, (Vol. 73 No. 124, page 36337) 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 November 15, 2008, unless it displays a currently valid OMB control number. Proposed Collection: Title: Simulations for Drug Related Science Education. Type of Information Collection Request: NEW. Need and Use of Information Collection: This is a request for a one-time clearance to evaluate an interactive multimedia module developed by ArchieMD. This evaluation seeks to determine whether the multimedia module ArchieMD: The Science of Drugs (1) Increases students' knowledge in brain and heart biology and the effects drugs have on the body (2) Increases positive attitudes towards science education for high school students (3) Reinforces or instills negative attitudes towards substance abuse. In order to test the effectiveness of the interactive multimedia module, data will be collected in the form of pre and post test surveys from 10th and 11th grade high school students utilizing the developed module. The findings will provide valuable information regarding information pertaining to the use of interactive multimedia educational modules in high school science classrooms and their ability to increase knowledge and change attitudes and perceptions. Frequency of Response: 4. Affected Public: High school students engaged with the ArchieMD: The Science of Drugs program. Type of Respondent: Participants will include high school students enrolled in the tenth and eleventh grade. Estimated Total Annual Number of Respondents: 360. Estimated Number of Responses per Respondent: 4. Average Burden Hours per Response: One high school period lasting 50 minutes. Estimated Total Annual Burden Hours Requested: 1,199.95. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. The estimated annualized burden is summarized below.

This notice announces our decision to conditionally approve, with a probationary period, the Joint Commission's request for continued recognition as a national accreditation program for critical access hospitals (CAHs) seeking to participate in the Medicare or Medicaid programs.

This notice announces a listening session being conducted as part of the development of a plan for the transition to a value-based purchasing program for physician and other professional services as required by section 131(d) of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA). The purpose of the listening session is to solicit comments on an issues paper that will present the range of issues being considered for plan development. Physicians, physician associations, and all others interested in the pursuit of new payment approaches to enhance the quality and efficiency of physician and other professional services are invited to participate, in person or by calling in to the teleconference. The issues paper will be posted on the CMS Web site Physician Center Spotlights at https://www.cms.hhs.gov/ center/physician.asp no later than November 28, 2008. The issues identified and discussed during this meeting will assist us in developing options for the plan. The meeting is open to the public, but attendance is limited to space and teleconference lines available.

The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of April 25, 2008 (73 FR 22720). The document amended the agency's regulations to prohibit the use of certain cattle origin materials in the food or feed of all animals to further strengthen existing safeguards against bovine spongiform encephalopathy (BSE). The document was inadvertently published with incorrect dollar amounts in two separate areas: The summary of economic impacts and the paperwork burden table. This document corrects those errors.

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 record retention requirement of the soy protein/coronary heart disease health claim.

NICEATM announces the availability of the ``Biennial Progress Report: Interagency Coordinating Committee on the Validation of Alternative Methods: 2006-2007.'' In accordance with requirements of the ICCVAM Authorization Act of 2000 (42 U.S.C. 285l-3), this report describes progress and activities during 2006-2007 by ICCVAM and NICEATM. The report is available on the NICEATM-ICCVAM Web site at https://iccvam.niehs.nih.gov/about/ICCVAMrpts.htm. Copies can also be requested from NICEATM at the address given below.

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 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 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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on the use of MedWatch\Plus\ Portal and Rational Questionnaire to collect electronically all adverse event, consumer complaint/product problem and medication use error data submitted to FDA.

The Office for Human Research Protections (OHRP), Office of Public Health and Science, is announcing the availability of a guidance document entitled, ``OHRP Guidance on Engagement of Institutions in Human Subjects Research.'' The guidance document describes: (1) Scenarios that, in general, would result in an institution being considered engaged in a human subjects research project; (2) scenarios that would result in an institution being considered not engaged in a human subjects research project; and (3) IRB review considerations for cooperative research in which multiple institutions are engaged in the same non-exempt human subjects research project. The guidance document is intended primarily for institutional review boards (IRBs), research administrators and other relevant institutional officials, investigators, and funding agencies that may be responsible for the conduct, review and oversight of human subject research that is conducted or supported by the Department of Health and Human Services (HHS). The guidance document announced in this notice finalizes the draft guidance with the same title that was made available for public comment in the Federal Register on December 8, 2006 (71 FR 71169). OHRP received twenty-four comments on the draft guidance document, and those comments were considered as the guidance was finalized. The final guidance document replaces two existing OHRP guidance documents on the engagement of institutions in human subjects research: (1) The January 26, 1999, document on ``Engagement of Institutions in Research,'' and (2) the December 23, 1999, document on ``Engagement of Pharmaceutical Companies in HHS Supported Research.''

This notice announces an administrative hearing to be held on December 9, 2008, at the CMS Dallas Regional Office, 1301 Young Street, Suite 833, Room 1196, Dallas, Texas 75202, to reconsider CMS' decision to disapprove Arkansas SPA 07-024.