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

The Presidential Commission for the Study of Bioethical Issues is requesting public comment on the report of the International Research Panel titled, Research Across Borders: Proceedings of the International Research Panel of the Presidential Commission for the Study of Bioethical Issues, available for review at https:// www.bioethics.gov.

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 Clinical Center, 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: The SSA-NIH Collaboration to Improve the Disability Determination Process: Validation of IRT-CAT tools. Type of Information Collection Request: NEW. Need and Use of Information Collection: The Epidemiology and Biostatistics section in RMD will be collecting information through a contractor (Boston UniversityHealth and Disability Research Institute (BU-HDR)) and subcontractor for validation of the Computer Adaptive Tests which are being developed to assist in the SSA disability determination process. The utilization of CAT technology could potentially allow the SSA to collect more relevant and precise data about human functioning in a faster, more efficient fashion. To validate the CAT assessments that have been developed, the contractor will administer both the BU-HDR CAT and established legacy instruments in a small sample of adults who report their current employment status as ``permanently disabled''. Individuals will complete the CAT tools for the functional domains of Physical Demands and Interpersonal Interactions along with established legacy instruments. For the domain of physical function, individuals will complete the BU-HDR CAT; the PROMIS Item Bank v 1.0Physical Functioning (copyright) PROMIS Health Organization and PROMIS Cooperative Group; and The Short Form (36) Health SurveyTM (SF-36). For the domain of interpersonal interactions, individuals will complete the BU-HDR CAT, the SF-36 and the BASIS- 24(copyright) (Behavior and Symptom Identification Scale). Data collected will be used to validate the BU-HDR CAT tools. Without this information, completion of the BU-HDR CAT tools will not be possible. Frequency of Response: Once. Affected Public: Individuals who have opted in to participate in web surveys through a survey research firm. Type of Respondents: Adults who indicate ``permanently disabled'' as a working status. There are no Capital Costs, Operating Costs and/or Maintenance Costs to report. The annual reporting burden is as follows:

This document contains the final Administration for Children and Families (ACF) Tribal Consultation Policy outlining the policy to engage in meaningful consultation with federally recognized tribes and the procedures and processes to be followed by tribes and the ACF bureaus and offices when the need for consultation is requested or required.

The Office for Human Research Protections (OHRP), Office of the Assistant Secretary for Health and the Food and Drug Administration (FDA), are announcing the availability of a draft guidance entitled, ``Guidance on Exculpatory Language in Informed Consent.'' The draft guidance, when finalized, will represent OHRP's and FDA's current thinking on this topic and will supersede OHRP's November 15, 1996 guidance document entitled ```Exculpatory Language' in Informed Consent'' and question number 52 in FDA's January 1998 guidance entitled, ``Institutional Review Boards Frequently Asked Questions Information Sheet Guidance for Institutional Review Boards and Clinical Investigators.'' The draft guidance is intended primarily for institutional review boards (IRBs), investigators, sponsors, and funding agencies that may be responsible for the review, conduct, or oversight of human subject research conducted or supported by HHS or regulated by FDA.

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 reporting requirements contained in existing FDA regulations regarding the general administrative procedures for a person to petition the Commissioner of Food and Drugs (the Commissioner) to issue, amend, or revoke a rule; to file a petition for an administrative reconsideration or an administrative stay of action; and to request an advisory opinion from the Commissioner.

The NTP is postponing the release of the Draft NTP Monograph on Potential Developmental Effects of Cancer Chemotherapy during Pregnancy and the peer review panel meeting. Release of the draft monograph was scheduled for September 9, 2011, and the meeting for October 19-20, 2011; both were announced on August 17, 2011 (76 FR 51034). Information about rescheduling the release of the draft monograph and the peer review will be announced in the Federal Register and posted on the NTP Web site at https://ntp.niehs.nih.gov/go/36639.

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 correcting a notice that appeared in the Federal Register of Friday, August 12, 2011 (76 FR 50231). The document announced a public workshop entitled ``Mobile Medical Applications Draft Guidance.'' The document was published with an outdated address in the section entitled ``Will there be transcripts of the meeting?'' This document corrects that error.

A notice was published in the Federal Register on Tuesday, July 5, 2011, Vol. 76, No. 128, to announce that a meeting of the Advisory Committee on Minority Health (ACMH) was scheduled to be held on Monday, August 29, 2011 from 9 a.m. to 5 p.m., and Tuesday, August 30, 2011, from 9 a.m. to 1 p.m. This meeting has been cancelled in its entirety. The meeting was cancelled because of the weather projections that the Washington, DC metropolitan area would be affected by a significant hurricane. The meeting was cancelled to ensure the safety of the Committee members, Federal staff, and all other interested parties. Information about this meeting being rescheduled will be posted on the Committee's Web site, which can be accessed at https:// minorityhealth.hhs.gov.

The Health Resources and Services Administration published a notice in the Federal Register, (76 FR 50442, Doc. 2011-20690), on August 15, 2011, announcing the meeting of the Negotiated Rulemaking Committee on Designation of Medically Underserved Populations and Health Professional Shortage Areas on September 20, 21, and 22, 2011. The dates of the meeting and contact information were incorrect.