Department of Health and Human Services February 18, 2014 – Federal Register Recent Federal Regulation Documents

As authorized by the Secretary of HHS, AHRQ coordinates the development of common definitions and reporting formats (Common Formats) for reporting patient safety events to Patient Safety Organizations (PSOs) and other entities. The purpose of this notice is to announce the availability of a new type of Common Formats for public review and commentCommon Formats for SurveillanceHospital.

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: ``Pharmacy 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 December 6th, 2013 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.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Animal Feed Regulatory Program Standards'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA or the Agency) has determined that STAVZOR (valproic acid) delayed-release capsules, 125 milligrams (mg), 250 mg, and 500 mg, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for valproic acid, delayed-release capsules, 125 mg, 250 mg, and 500 mg, if all other legal and regulatory requirements are met.

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with FDA Staff.'' The purpose of this guidance is to provide an overview of the mechanisms available to application sponsors through which to obtain FDA feedback regarding potential or planned medical device submissions reviewed in the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER), including the Pre-Submission program (formerly the pre-Investigational Device Exemption (pre-IDE) program). In addition, the guidance provides recommendations regarding information that should be included in a Pre- Submission Package. This guidance also describes the procedures that CDRH and CBER intend to follow when manufacturers, their representatives, or application sponsors request a meeting with review staff.

This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive evaluation option license to practice the inventions covered under the scope of the following patents and patent applications: United States Patent No. 8,207,142 issued Jun 26, 2012 entitled ``Inhibitor of DNA Methylation'' (HHS Ref. No. E-081-2001/2- US-06); EP Patent No. 1418949 issued June 19, 2013, entitled ``Inhibitor of DNA Methylation'' (HHS Ref. No. E-081-2001/2-EP-02) and validated in Great Britain, Germany and France; Australia Patent No. 2002322805 issued February 21, 2008 entitled ``Inhibitor of DNA Methylation'' (HHS Ref. No. E-081-2001/2- AU-03); Australia Patent No. 2008200601 issued November 25, 2010 entitled ``Inhibitor of DNA Methylation'' (HHS Ref. No. E-081-2001/2- AU-07); Canada Patent No. 2,454,147 issued May 21, 2013 entitled ``Inhibitor of DNA Methylation'' (HHS Ref. No. E-081-2001/2-CA-04); Japan Patent Application No. 2003-517229 filed July 30, 2002 entitled ``Inhibitor of DNA Methylation'' (HHS Ref. No. E-081- 2001/2-JP-05); and Japan Patent No. 5416660 issued November 22, 2013 entitled ``Inhibitor of DNA Methylation'' (HHS Ref. No. E-081-2001/2-JP-08)

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 research entitled ``Disclosure Regarding Additional Risks in Direct-to-Consumer (DTC) Prescription Drug Television (TV) Advertisements (Ads).'' This study will investigate the impact of limiting the risks presented in DTC prescription drug television ads to those that are serious and actionable, and including a disclosure to alert consumers that there are other product risks not disclosed in the ad.

The Food and Drug Administration (FDA) is classifying the neuropsychiatric interpretive electroencephalograph (EEG) assessment aid into class II (special controls). The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

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 collection of information contained in FDA's Tobacco Product Violations Reporting Form.

Under the Food and Drug Administration Modernization Act of 1997 (FDAMA), the Food and Drug Administration (FDA) is required to report annually in the Federal Register on the status of postmarketing requirements and commitments required of, or agreed upon by, holders of approved drug and biological products. This notice is the Agency's report on the status of the studies and clinical trials that applicants have agreed to, or are required to, conduct.

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 focus groups as used by FDA to gauge public opinion on all FDA-regulated products.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Over-the-Counter Human Drugs; Labeling Requirements'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.