Department of Health and Human Services June 12, 2012 – Federal Register Recent Federal Regulation Documents
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Draft Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Considerations When Transferring Clinical Investigation Oversight to Another Institutional Review Board; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Considerations When Transferring Clinical Investigation Oversight to Another IRB.'' The draft guidance discusses regulatory responsibilities of institutional review boards (IRBs), clinical investigators, and sponsors when oversight of a previously approved clinical investigation under FDA's jurisdiction is transferred from one IRB to another IRB. The draft guidance also addresses questions that have been previously raised concerning procedures and processes that are required and/or recommended by FDA when such oversight is transferred.
Draft Guidance on Considerations in Transferring a Previously-Approved Research Project to a New IRB or Research Institution
The Office for Human Research Protections (OHRP), Office of the Assistant Secretary for Health, is announcing the availability of a draft guidance document entitled ``Draft Guidance on Considerations in Transferring a Previously-Approved Research Project to a New IRB or Research Institution,'' and is seeking comment on the draft guidance. The draft guidance document, when finalized, would provide OHRP's first formal guidance on this topic.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 https://www.hhs.gov/ohrp/newsroom/rfc/ index.html, is intended primarily for institutional review boards (IRB), institutions, and investigators that are responsible for the review, conduct, or oversight of human subjects research conducted or supported by HHS. OHRP will consider comments received before issuing the final guidance document.
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are Not Individually Identifiable
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 guidance on informed consent for in vitro diagnostic device studies using leftover human specimens that are not individually identifiable.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Contact Substance Notification Program
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.
Decision To Evaluate a Petition To Designate a Class of Employees From the Medina Facility in San Antonio, TX, To Be Included in the Special Exposure Cohort
NIOSH gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees from the Medina Facility in San Antonio, Texas, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: Medina Facility. Location: San Antonio, Texas. Job Titles and/or Job Duties: Workers potentially exposed to radioactive materials while working at the Medina facility. Period of Employment: January 1, 1958 to December 31, 1966.
Decision To Evaluate a Petition To Designate a Class of Employees From the Clarksville Facility in Clarksville, TN, To Be Included in the Special Exposure Cohort
NIOSH gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees from the Clarksville Facility in Clarksville, Tennessee, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: Clarksville Facility. Location: Clarksville, Tennessee. Job Titles and/or Job Duties: Workers potentially exposed to radioactive materials while working at the Clarksville facility. Period of Employment: January 1, 1949 to December 31, 1967.
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