Department of Health and Human Services June 2005 – Federal Register Recent Federal Regulation Documents
Results 1 - 50 of 314
Medicare Program; Changes to the Medicare Claims Appeal Procedures: Correcting Amendment to an Interim Final Rule
This amendment corrects technical errors in the interim final rule with comment period that appeared in the Federal Register, entitled ``Medicare Program: Changes to the Medicare Claims Appeal Procedures.''
``Guidance for Industry: Discontinuation of Donor Deferral Related to Recent Fever with Headache as a Symptom of West Nile Virus Infection''; Withdrawal of Guidance
The Food and Drug Administration (FDA) is announcing the withdrawal of a guidance entitled ``Guidance for Industry: Discontinuation of Donor Deferral Related to Recent Fever with Headache as a Symptom of West Nile Virus Infection'' (May 2005 guidance) that was issued on May 6, 2005. A guidance entitled `` Guidance for Industry: Assessing Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection,'' dated June 2005, is being announced elsewhere in this issue of the Federal Register, and supersedes the May 2003 guidance entitled ``Guidance for Industry: Revised Recommendations for the Assessment of Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection'' (May 2003 guidance) (68 FR 25897).
``Guidance for Industry: Assessing Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection;'' Availability
The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Assessing Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection'' dated June 2005. This guidance document provides revisions to the previously published recommendations for assessing donor suitability and product safety when donors are diagnosed with or suspected of West Nile Virus (WNV) infection based on symptoms and laboratory tests. This guidance revises recommended deferral periods for such donors, and updates information on component retrieval and quarantine. This guidance finalizes the draft ``Guidance for Industry: Assessing Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection'' dated April 2005 and supersedes the final ``Guidance for Industry: Revised Recommendations for the Assessment of Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection'' dated May 2003. Elsewhere in this issue of the Federal Register, FDA is withdrawing the guidance entitled ``Guidance for Industry: Discontinuation of Donor Deferral Related to Recent Fever with Headache as a Symptom of West Nile Virus Infection,'' dated May 2005.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Performance Standard for Diagnostic X-Ray Systems and Their Major Components
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Performance Standard for Diagnostic X-Ray Systems and Their Major Components'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Evaluating the Safety of Antimicrobial New Animal Drugs With Regard to Their Microbiological Effects on Bacteria of Human Health Concerns
The Food and Drug Administration (FDA) is announcing that the 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.
Determination That ZYVOX (Linezolid) Tablets, 400 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that ZYVOX (linezolid) tablets, 400 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for linezolid tablets, 400 mg.
International Conference on Harmonisation; Guidance on Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The purpose of the guidance is to provide principles for assessing the comparability of biotechnological/biological products before and after changes are made in the manufacturing process for the drug substance or drug product. The guidance is intended to assist in the collection of relevant technical information that serves as evidence that the manufacturing process changes will not have an adverse impact on the quality, safety, and efficacy of the drug product.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Medical Device Labeling Regulations
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Medical Device Labeling Regulations'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Decision To Evaluate a Petition To Designate a Class of Employees at the Rocky Flats Plant, Golden, CO, To Be Included in the Special Exposure Cohort
The Department of Health and Human Services (HHS) gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees at the Rocky Flats Plant, in Golden, Colorado, 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: Rocky Flats Plant. Location: Golden, Colorado. Job Titles and/or Job Duties: All represented members, past, present, and current, of USWA Local 8031 and its predecessors. Period of Employment: April 1952 to February 15, 2005.
Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort
The Department of Health and Human Services (HHS) gives notice concerning the final effect of the HHS decision to designate a class of employees at the Iowa Army Ammunition Plant (IAAP), in Burlington, Iowa as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On May 20, 2005, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:
Vessel Sanitation Program; Notice of Revision and Implementation of the Vessel Sanitation Program Operations Manual
This notice announces the revision and implementation of the Vessel Sanitation Program Operations Manual. The manual will become effective on August 1, 2005.
Public Health Assessments Completed
This notice announces those sites for which ATSDR has completed public health assessments during the period from January through March 2005. This list includes sites that are on or proposed for inclusion on the National Priorities List (NPL) and includes sites for which assessments were prepared in response to requests from the public.
Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D3
The Food and Drug Administration (FDA) is amending the food additive regulations to provide for the safe use of vitamin D3 as a nutrient supplement in meal replacement bars, other- type bars, and soy-protein based meal replacement beverages represented for special dietary use in reducing or maintaining body weight. This action is in response to a petition filed by Unilever United States, Inc. (Unilever).
Draft Guidance for Industry on Gingivitis: Development and Evaluation of Drugs for Treatment or Prevention; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Gingivitis: Development and Evaluation of Drugs for Treatment or Prevention.'' The draft guidance is intended to assist sponsors in developing clinical trials for drug products that treat or prevent gingivitis. It addresses specific protocol design elements as well as general concerns about drugs for this indication.
Draft “Guidance for Food and Drug Administration Reviewers: Premarket Notification Submissions for Automated Testing Instruments Used in Blood Establishments;” Withdrawal of Guidance
The Food and Drug Administration (FDA) is announcing the withdrawal of a draft guidance that was issued on August 3, 2001.
Supplemental Financial Disclosure Requirements for Employees of the Department of Health and Human Services
This interim final rule extends the due date for NIH employees to file a report of prohibited financial interests held on or acquired after February 3, 2005. The reports are now due no earlier than October 3, 2005.
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