Department of Health and Human Services November 16, 2011 – Federal Register Recent Federal Regulation Documents
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Proposed National Toxicology Program (NTP) Review Process for the Report on Carcinogens: Request for Public Comment and Listening Session: Amended Notice
The NTP announces that the public listening session on the proposed review process for the Report on Carcinogens on November 29, 2011, has been extended from 1-5 p.m. (EST) to 1-7 p.m. (EST). Registration to present oral remarks is increased from the first 15 to the first 23 registrants who wish to speak, with one time slot per organization. However, the total number of connections available for all registrants (including speakers plus observers) remains at 50. Presenters will speak in the order that they are registered. The agenda, including the list of speakers, will be posted on the NTP Web site (https://ntp.niehs.nih.gov/go/rocprocess) prior to the November 29, 2011, listening session. Information regarding the listening session was published on October 31, 2011, in the Federal Register (76 FR 67200) and is available on the NTP Web site (https://ntp.niehs.nih.gov/go/rocprocess). The guidelines and deadlines published in the Federal Register notice still apply except as noted above. Any updates or additional information will be posted on the NTP Web site.
Sixth Annual Philip S. Chen, Jr. Distinguished Lecture on Innovation and Technology Transfer
The Office of the Director, NIH, invites you to the sixth annual Philip S. Chen, Jr., Ph.D. Distinguished Lecture on Innovation and Technology Transfer.
Scott S. Reuben: Debarment Order
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act permanently debarring Scott S. Reuben, M.D. from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Dr. Reuben was convicted of a felony under Federal law for conduct relating to the regulation of a drug product under the Federal Food, Drug, and Cosmetic Act. Dr. Reuben was given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Dr. Reuben failed to respond. Dr. Reuben's failure to respond constitutes a waiver of his right to a hearing concerning this action.
Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Recall Authority
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 information collection requirements for medical device recall authority.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; State Petitions for Exemption for Preemption
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``State Petitions for Exemption for Preemption'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
International Conference on Harmonisation; E2B(R3) Electronic Transmission of Individual Case Safety Reports; Draft Guidance on Implementation; Data Elements and Message Specification; Appendix on Backwards and Forwards Compatibility; Availability; Correction
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of Thursday, October 20, 2011 (76 FR 65199). The document announced the availability of a draft guidance entitled ``E2B(R3) Electronic Transmission of Individual Case Safety Reports (ICSRs): Implementation GuideData Elements and Message Specification'' (the draft E2B(R3) implementation guidance) and an appendix to the draft guidance entitled ``ICSRs: Appendix to the Implementation GuideBackwards and Forwards Compatibility'' (the draft BFC appendix). The document was published with an incorrect date in the DATES section. This document corrects that error.
Determination That TRAVATAN (Travoprost Ophthalmic Solution), 0.004%, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that TRAVATAN (travoprost ophthalmic solution), 0.004%, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for travoprost ophthalmic solution, 0.004%, if all other legal and regulatory requirements are met.
Center for Biologics Evaluation and Research Report of Scientific and Medical Literature and Information on Non-Standardized Allergenic Extracts in the Diagnosis and Treatment of Allergic Disease; Extension of Comment Period
The Food and Drug Administration (FDA) is extending to April 25, 2012, the comment period for the notice on its report of scientific and medical literature and information concerning the use of non- standardized allergenic extracts in the diagnosis and treatment of allergic disease that appeared in the Federal Register of September 26, 2011 (76 FR 59407). In the notice, FDA requested comments from public and private stakeholders on the report it provided in a data file entitled ``Center for Biologics Evaluation and Research Report of Scientific and Medical Literature and Information on Non-Standardized Allergenic Extracts in the Diagnosis and Treatment of Allergic Disease.'' The Agency is taking this action in response to input it received from the Allergenic Products Advisory Committee (APAC) at a meeting held on October 25, 2011, to allow interested persons additional time to submit comments.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Infant Formula Recall Regulations
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Infant Formula Recall Regulations'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Proposed Collection; Comment Request; Record Retention Requirements for the Soy Protein and Risk of Coronary Heart Disease Health Claim
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 requirements for the soy protein and coronary heart disease health claim.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Extralabel Drug Use in Animals
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.
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