Department of Health and Human Services April 2010 – Federal Register Recent Federal Regulation Documents
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Total Inward Leakage Requirements for Respirators
The Centers for Disease Control and Prevention (CDC) is reopening the comment period for the notice of proposed rulemaking by the National Institute for Occupational Safety and Health (NIOSH) of CDC, entitled ``Total Inward Leakage Requirements for Respirators,'' published in the Federal Register on October 30, 2009 (74 FR 56141). The comment period on this proposed regulation closed on March 29, 2010 (74 FR 66935) and is being reopened until September 30, 2010.
Announcement of the Sixth and Final Dietary Guidelines Advisory Committee Meeting and Solicitation of Written Comments
The Department of Agriculture (USDA) and the Department of Health and Human Services (HHS) (a) provide notice of the sixth and final meeting of the Dietary Guidelines Advisory Committee, and (b) solicit written comments pertinent to the Dietary Guidelines for Americans.
New Animal Drugs; Change of Sponsor's Name and Address
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor's name from Parnell Laboratories (Aust) Pty. Ltd. to Parnell Technologies Pty. Ltd. In
New Animal Drugs; Change of Sponsor's Name and Address
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor's name from Minrad,
Risk Profile: Pathogens and Filth in Spices: Request for Comments and for Scientific Data and Information
The Food and Drug Administration (FDA) is requesting comments and scientific data and information that would assist the agency in its plans to conduct a risk profile for pathogens and filth in spices. The purpose of the risk profile is to ascertain the current state of knowledge about spices contaminated with microbiological pathogens and/ or filth, and the effectiveness of current and potential new interventions to reduce or prevent illnesses from contaminated spices.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Postmarket Surveillance
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 (the PRA).
Agency Information Collection Activities; Proposed Collection; Comment Request; Tobacco Health Document Submission
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 proposed extension of an existing collection of information pertaining to the submission of tobacco health documents under the Family Smoking Prevention and Tobacco Control Act (the Tobacco Control Act).
Notice of Re-Designation of the Service Delivery Area for the Cowlitz Indian Tribe
This Notice advises the public that the Indian Health Service (IHS) proposes to expand the geographic boundaries of the Service Delivery Area (SDA) for the Cowlitz Indian Tribe. The Cowlitz SDA currently is comprised of Clark, Cowlitz, King, Lewis, Pierce, Skamania, and Thurston in the State of Washington. These counties were designated as the Tribe's SDA in 67 FR 46329. It is proposed that Columbia County, Oregon, and Wahkiakum and Kittitas Counties, Washington be added to the existing SDA.
Implantation or Injectable Dosage Form New Animal Drugs; Change of Sponsor; Propofol
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for a new animal drug application (NADA) from Intervet, Inc., to Teva Animal Health, Inc.
Request for Public Comment: 30-Day Proposed Information Collection: Application for Participation in the IHS Scholarship Program
In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 which requires a 30-day advance opportunity for public comment on the proposed information collection project, the Indian Health Service (IHS) has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection project was previously published in the Federal Register (74 FR 36714) on July 24, 2009 and allowed 60 days for public comment. No public comment was received in response to the notice. The purpose of this notice is to allow 30 days for public comment to be submitted directly to OMB.
Authorization of Emergency Use of Certain In Vitro Diagnostic Devices; Availability
The Food and Drug Administration (FDA) is announcing the issuance of 10 Emergency Use Authorizations (EUAs) (the Authorizations) several of which were amended after initial issuance, for certain in vitro diagnostic devices. FDA also is announcing an amendment to the EUA for the Centers for Disease Control and Prevention (CDC) Swine Influenza Virus Real-time RT-PCR Detection Panel authorized on April 27, 2009. 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 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 Federal Food, Drug, and Cosmetic Act (the act). The Authorizations, which include explanations of the reasons for their issuance or reissuance, are reprinted in this document.
Amended Authorization of Emergency Use of the Antiviral Product Peramivir Accompanied by Emergency Use Information; Availability
The Food and Drug Administration (FDA) is announcing an amendment to the Emergency Use Authorization (EUA) (the Authorization) for peramivir injection 200 milligrams (mg)/20 milliliter (mL) (10 mg/ mL) single use vial manufactured for BioCryst Pharmaceuticals, Inc. (BioCryst) for intravenous (IV) administration in certain adult and pediatric patients issued on October 23, 2009, under the Federal Food, Drug, and Cosmetic Act (the act), as requested by the Centers for Disease Control and Prevention (CDC). FDA received inquiries related to the recommended dosing for patients with renal impairment. On November 19, 2009, FDA amended the Authorization letter and reissued the Authorization letter in its entirety to provide additional clarification. The Authorization letter, as amended and reissued, which includes explanations for its reissuance, is reprinted in this notice.
Amended Authorizations of Emergency Use of Certain Antiviral Drugs Zanamivir and Oseltamivir Phosphate; Availability
The Food and Drug Administration (FDA) is announcing amendments to the two Emergency Use Authorizations (EUAs) (the Authorizations) for certain products from the neuraminidase class of antivirals, zanamivir and oseltamivir phosphate, issued on April 27, 2009, under the Federal Food, Drug, and Cosmetic Act (the act), as requested by the Centers for Disease Control and Prevention (CDC). On July 14, 2009, in response to a request from CDC, FDA amended and reissued in its entirety the Authorization for certain oseltamivir phosphate products. On October 30, 2009, in response to a request from CDC, among other reasons, FDA amended and reissued in their entirety the Authorization letters for certain zanamivir and oseltamivir phosphate products. Finally, on November 4, 2009, FDA amended and reissued in its entirety the Authorization letter for certain zanamivir inhalation powder. The Authorization letter for certain oseltamivir phosphate products, as amended on October 30, 2009, and the Authorization letter for certain zanamivir inhalation powder, as amended on November 4, 2009, including explanations for their reissuance, are reprinted in this document.
National Center for Complementary and Alternative Medicine Announcement of Workshop on the Deconstruction of Back Pain
The National Center for Complementary and Alternative Medicine (NCCAM) invites the public to observe at a Workshop on the Deconstruction of Back Pain. The purpose of this workshop is to identify what types of studies are needed to better understand chronic back pain, to assess new interventions and management strategies for back pain as a chronic condition, to evaluate the utility of existing datasets and ongoing cohort studies for future studies of chronic back pain, and to determine what study designs should be utilized to look at the natural history of back pain. This information will help inform future research directions for NIH and the biomedical scientific field. This workshop will be divided into five sessions that will feature presentations and discussions focusing on the current understanding and complexity of chronic back pain, characterization of research, and the epidemiology and psychological components of chronic back pain.
Proposed Collection; Comment Request; Web Based Training for Pain Management Providers
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute on Drug Abuse, the National Institutes of Health has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register in Vol. 75, No. 25 on Monday, February 8 and allowed 60 days for public comment. No public comments were received on the planned study or any of the specific topics outlined in the 60 day notice. Three comments were received requesting information on the educational program rather than the study. We responded to requests for additional information from interested parties. The purpose of this notice is to allow an additional 30 days for public comment.
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