Department of Health and Human Services June 21, 2010 – Federal Register Recent Federal Regulation Documents
Results 1 - 15 of 15
National Institute of Child Health and Human Development; Revision to Proposed Collection; Comment Request; The National Children's Study (NCS), Vanguard (Pilot) Study
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Child Health and Human Development (NICHD), 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 March 22, 2010, pages 14165-14168, and allowed 60 days for public comment. One comment was received. The comment questioned the value and utility of the proposed data collection, stating that this type of research is not needed. 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 October 1, 1995, unless it displays a currently valid OMB control number.
Authorization of Emergency Use of Certain In Vitro Diagnostic Devices; Availability
The Food and Drug Administration (FDA) is announcing the issuance of seven Emergency Use Authorizations (EUAs) (the Authorizations), two of which were amended after initial issuance, for certain in vitro diagnostic devices. FDA is issuing the Authorizations and amendments thereto under the Federal Food, Drug, and Cosmetic Act (the act). The Authorizations contain, among other things, conditions on the emergency use of the authorized in vitro diagnostics. The Authorizations follow the determination by the then Acting Secretary of the U.S. Department of Health and Human Services Charles E. Johnson (the Acting Secretary) that a public health emergency exists involving Swine Influenza A (now known as 2009 H1N1 Influenza A, or 2009 H1N1 flu) that affects, or has the significant potential to affect, national security. On the basis of such determination, the Acting Secretary declared an emergency justifying the authorization of the emergency use of certain in vitro diagnostics, accompanied by emergency use information subject to the terms of any authorization issued under the act. The Authorizations, which include explanations of the reasons for their issuance or reissuance, are reprinted in this document.
Notice of Approval of a Supplemental New Animal Drug Application; Penicillin G Procaine Suspension
The Food and Drug Administration (FDA) is providing notice that it has approved a supplemental new animal drug application (NADA) filed by Norbrook Laboratories, Ltd. The supplemental NADA provides for a revised formulation of penicillin G procaine injectable suspension that includes lecithin as a surfactant.
Agency Information Collection Activities; Proposed Collection; Comment Request
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: ``Avoiding Readmissions in Hospitals Serving Diverse Patients.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3520, AHRQ invites the public to comment on this proposed information collection.
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