Department of Health and Human Services March 22, 2010 – Federal Register Recent Federal Regulation Documents
Results 1 - 29 of 29
Decision To Evaluate a Petition To Designate a Class of Employees for the De Soto Facility in Los Angeles County, CA, 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 for the De Soto Facility in Los Angeles County, California, 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:
Decision To Evaluate a Petition To Designate a Class of Employees for the Downey Facility in Los Angeles County, CA, 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 for the Downey Facility in Los Angeles County, California, 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:
Decision To Evaluate a Petition To Designate a Class of Employees for the Simonds Saw and Steel Co., Lockport, New York, 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 for Simonds Saw and Steel Co., Lockport, New York, 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:
Impact of Dissolvable Tobacco Use on Public Health; Request for Comments
The Food and Drug Administration (FDA) is establishing a public docket to provide an opportunity for interested parties to share information, research, and ideas on how use of dissolvable tobacco products may impact public health, including such use among children. This information will be used to support the work of the Tobacco Products Scientific Advisory Committee, which is charged with evaluating this issue.
Compliance Policy Guide Sec. 540.375 Canned Salmon - Adulteration Involving Decomposition (CPG 7108.10); Withdrawal of Guidance
The Food and Drug Administration (FDA) is announcing the withdrawal of Compliance Policy Guide Sec. 540.375 Canned Salmon Adulteration Involving Decomposition (CPG 7108.10) (CPG Sec. 540.375). CPG Sec. 540.375 is included in FDA's Compliance Policy Guides Manual, which was listed in the Annual Comprehensive List of Guidance Documents that published on March 28, 2006.
Biocompatibles UK Ltd.; Filing of Color Additive Petition
The Food and Drug Administration (FDA) is announcing that Biocompatibles UK Ltd., has filed a petition proposing that the color additive regulations be amended to provide for the safe use of C.I. Reactive Blue No. 4 [2-anthracenesulfonic acid, 1-amino-4-(3-((4,6- dichloro-s-triazin-2-yl)amino)-4-sulfoanilino)-9,10-dihydro-9 ,10-dioxo, disodium salt] (CAS Reg. No. 4499-01-8) reacted with polyvinyl alcohol as a color additive in vascular embolization devices.
Agency Information Collection Activities; Proposed Collection: Comment Request: Guidance for Industry Entitled Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims
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 the information collection associated with the guidance ``Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims,'' which is intended to assist applicants in developing labeling for outcome claims for drugs that are indicated to treat hypertension.
Agency Information Collection Activities; Proposed Collection; Comment Request; Focus Groups About Drug Products, as Used by the Food and Drug Administration
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 focus groups about drug products used by FDA to gauge informally public opinion, on a variety of subjects related to consumer, patient, or healthcare professional perceptions and use of drug products and related materials, including but not limited to, direct-to-consumer (DTC) prescription drug promotion, physician labeling of prescription drugs, Medication Guides, over-the- counter (OTC) drug labeling, emerging risk communications, patient labeling, online sales of medical products, and consumer and professional education.
Revised Draft Guidance for Industry on Pharmacokinetics in Patients With Impaired Renal Function-Study Design, Data Analysis, and Impact on Dosing and Labeling; Availability
The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry entitled ``Pharmacokinetics in Patients With Impaired Renal FunctionStudy Design, Data Analysis, and Impact on Dosing and Labeling.'' The draft guidance is intended to assist sponsors planning to conduct studies to assess the influence of renal impairment on the pharmacokinetics of an investigational drug. It provides recommendations on when studies should be conducted to assess the influence of renal impairment on the pharmacokinetics of an investigational drug, the design of such studies, and how such studies should be carried out.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
