Department of Health and Human Services April 25, 2011 – Federal Register Recent Federal Regulation Documents
Results 1 - 10 of 10
Request for Information (RFI) To Identify and Obtain Relevant Information From Public or Private Entities With an Interest in Biovigilance
This Request for Information (RFI) seeks to identify and obtain relevant information regarding the possible development of a public-private partnership (PPP) designed to facilitate the identification of risks and strategies to assure safety of the U.S. supply of blood and blood components, tissues, cells, and organs. This RFI is intended to inform the Department of Health and Human Services (HHS) regarding stakeholders, mechanisms, and approaches on issues related to developing and managing a PPP and scope of PPP activities. Replies are invited from (1) public or private entities with an interest in biovigilance, and (2) entities with experience and capabilities managing public-private partnerships (PPPs) in the biological sciences and public health domains. This RFI is for information and planning purposes only and is not a solicitation for applications or an obligation on the part of the U.S. Government to provide support for any ideas identified in response to it. Please note that the U.S. Government will not pay for the preparation of any information submitted or for its use of that information.
Federal Health IT Strategic Plan: 2011-2015 Open Comment Period Extended Until Friday, May 6
The Federal Health IT Strategic Plan: 2011-2015 (``the Plan'') was posted on the ONC Web site on March 25, 2011 and originally open for public comment through Friday, April 22 at 11:59 p.m. (Eastern). This notice serves to announce that the public comment period for the Plan has been extended through Friday, May 6 at 11:59 p.m. (Eastern). In order for your comments to be read and considered, you must submit your comment via the Federal Health IT Buzz Blog: https:// www.healthit.gov/buzz-blog/from-the-onc-desk/hit-strat-plan/.
Draft Guidance for Industry and Food and Drug Administration Staff; Establishing That a Tobacco Product Was Commercially Marketed in the United States as of February 15, 2007; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Establishing That a Tobacco Product Was Commercially Marketed in the United States as of February 15, 2007.'' This draft guidance provides information on how a manufacturer may demonstrate that a tobacco product was commercially marketed in the United States as of February 15, 2007. In this draft guidance, FDA provides recommendations on the evidence that a manufacturer may use to demonstrate that a tobacco product was commercially marketed in the United States as of February 15, 2007. This draft guidance is not final nor is it in effect at this time.
Guidance for Food and Drug Administration Staff and Tobacco Retailers on Civil Money Penalties and No-Tobacco-Sale Orders for Tobacco Retailers; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Civil Money Penalties and No- Tobacco-Sale Orders for Tobacco Retailers.'' This guidance document describes FDA's current policies with respect to civil money penalties and no-tobacco-sale orders for retailers who violate requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) relating to tobacco products, including the FD&C Act requirement that tobacco products may not be sold or distributed in violation of FDA's ``Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents.'' With the release of this final guidance document, several provisions in the Family Smoking Prevention and Tobacco Control Act (the Tobacco Control Act) that relate to civil money penalties and no-tobacco-sale orders become effective.
Decision To Evaluate a Petition To Designate a Class of Employees From Ames Laboratory in Ames, IA, To Be Included in the Special Exposure Cohort
HHS gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees from Ames Laboratory in Ames, Iowa, 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: Ames Laboratory. Location: Ames, Iowa. Job Titles and/or Job Duties: All Department of Energy (DOE) employees, its predecessor agencies, and its contractors and subcontractors who worked in any area of the DOE facility. Period of Employment: January 1, 1942 through December 31, 1970.
Ferm Solutions, Inc.; Filing of Food Additive Petition (Animal Use); Erythromycin Thiocyanate
The Food and Drug Administration (FDA) is announcing that Ferm Solutions, Inc., has filed a petition proposing that the food additive regulations be amended to provide for the safe use of erythromycin thiocyanate as an antimicrobial processing aid in fuel-ethanol fermentations with respect to its consequent presence in byproduct distiller grains used as an animal feed or feed ingredient.
Medical Devices; Reclassification of the Topical Oxygen Chamber for Extremities
The Food and Drug Administration (FDA) is reclassifying the topical oxygen chamber for extremities (TOCE) from class III to class II. This device is intended to surround a patient's limb and apply humidified oxygen topically at a pressure slightly greater than atmospheric pressure to aid healing of chronic skin ulcers, such as bedsores. This reclassification is on the Secretary of Health and Human Services's own initiative based on new information. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) as amended by the Medical Device Amendments of 1976 (the 1976 Amendments), the Safe Medical Devices Act of 1990 (the SMDA), and the Food and Drug Administration Modernization Act of 1997 (FDAMA). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document entitled ``Class II Special Controls Guidance Document: Topical Oxygen Chamber for Extremities,'' which will serve as the special control for this device.
Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Topical Oxygen Chamber for Extremities; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled, ``Class II Special Controls Guidance Document: Topical Oxygen Chamber for Extremities.'' This guidance document was developed as a special control to support the reclassification of the topical oxygen chamber for extremities (TOCE) from class III (premarket approval) into class II (special controls). This guidance document describes a means by which manufacturers of TOCE may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule reclassifying these devices from class III into class II (special controls).
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
