Department of Health and Human Services August 2010 – Federal Register Recent Federal Regulation Documents
Results 51 - 100 of 334
New Animal Drugs; Change of Sponsor; Withdrawal of Approval of New Animal Drug Applications; Deslorelin Acetate; Dichlorophene and Toluene Capsules; Pyrantel Pamoate Suspension
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 Peptech Animal Health Pty, Ltd. to Dechra, Ltd. and for an abbreviated new animal drug application (ANADA) from Church & Dwight Co., Inc., to Pegasus Laboratories, Inc. In addition, FDA is removing those portions of the regulations that reflect approval of two other NADAs transferred from Church & Dwight Co., Inc., to Pegasus Laboratories, Inc., for which voluntary withdrawal of approval was requested after the change of sponsorship. In a notice published elsewhere in this issue of the Federal Register, FDA is withdrawing approval of these two NADAs.
Withdrawal of Approval of New Animal Drug Applications; Dichlorophene and Toluene Capsules
The Food and Drug Administration (FDA) is withdrawing approval of two new animal drug applications (NADAs) for use of dichlorophene and toluene deworming capsules for cats and dogs. In a final rule published elsewhere in this issue of the Federal Register, FDA is amending the regulations to remove portions reflecting approval of these NADAs.
Availability of Draft Toxicological Profile
This notice announces, for review and comment, the availability of one new draft toxicological profile on unregulated hazardous substances that was prepared for the Department of Defense (DOD). All toxicological profiles issued as ``Drafts for Public Comment'' represent ATSDR's best efforts to provide important toxicological information on priority hazardous substances. We are seeking public comments and additional information or reports on studies about the health effects of royal demolition explosive (RDX), chemical name hexahydro-1,3,5-trinitro-1,3,5-triazine, also known as cyclonite, for review and potential inclusion in the profile. ATSDR remains committed to providing a public comment period for these documents as a means to best serve public health and our stakeholders.
Public Meeting of the Presidential Commission for the Study of Bioethical Issues
The Presidential Commission for the Study of Bioethical Issues will conduct a meeting in September. At this meeting, the Commission will continue discussing the emerging science of synthetic biology, including its potential benefits and risks, and appropriate ethical boundaries and principles.
Meeting of the National Vaccine Advisory Committee
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the National Vaccine Advisory Committee (NVAC) will hold a meeting. The meeting is open to the public. Pre-registration is required for both public attendance and comment. Individuals who wish to attend the meeting and/or participate in the public comment session should either e-mail nvpo@hhs.gov or call 202-690-5566 to register.
Su Van Ho: Debarment Order
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the act) debarring Su Van Ho for a period of 15 years from importing articles of food or offering such articles for importation into the United States. FDA bases this order on a finding that Mr. Ho was convicted of three felonies under Federal law for conduct relating to the importation into the United States of an article of food. Mr. Ho was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. As of July 15, 2010, Mr. Ho failed to respond. Mr. Ho's failure to respond constitutes a waiver of his right to a hearing concerning this action.
Medicare Program; Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2011; Corrections
This document corrects technical and typographical errors in the proposed rule entitled ``Medicare Program; Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2011'' that appeared in the July 13, 2010 Federal Register. The proposed rule
Food Labeling; Labeling of Food Made From AquAdvantage Salmon; Public Hearing; Request for Comments
The Food and Drug Administration (FDA) is announcing a public hearing regarding the labeling of food derived from AquAdvantage Salmon, a genetically engineered Atlantic salmon. The purpose of the hearing is for FDA to explain the relevant legal principles for food labeling and to solicit information and views from interested persons on the application of these principles to the labeling of food derived from AquAdvantage Salmon. In a separate notice published elsewhere in this issue of the Federal Register, FDA is announcing that it will hold a public Veterinary Medicine Advisory Committee (VMAC) meeting.
Implementation of Section 5001 of the American Recovery and Reinvestment Act of 2009 (Pub. L. 111-5) for Adjustments to the Third Quarter of Fiscal Year 2010 Federal Medical Assistance Percentage Rates for Federal Matching Shares for Medicaid and Title IV-E Foster Care, Adoption Assistance and Guardianship Assistance Programs
This notice provides the adjusted Federal Medical Assistance Percentage (FMAP) rate for the third quarter of Fiscal Year 2010 (FY10) as required under Section 5001 of the American Recovery and Reinvestment Act of 2009 (ARRA). Section 5001 of the ARRA provides for temporary increases in the FMAP rates to provide fiscal relief to States and to protect and maintain State Medicaid and certain other assistance programs in a period of economic downturn. The increased FMAP rates apply during a recession adjustment period that is defined in ARRA as the period beginning October 1, 2008 and ending December 31, 2010. This notice does not account for changes as a result of Public Law 111-226. However, future FMAP notices will account for these changes.
Availability of Interim Procedures for Federal External Review and Model Notices Relating to Internal Claims and Appeals and External Review Under the Patient Protection and Affordable Care Act; Notice
This document announces the availability of guidance detailing interim procedures for the Federal external review process and model notices both for internal claims and appeals and for external review processes under the Patient Protection and Affordable Care Act.
A Review of Information Published Since 1995 on Coal Mine Dust Exposures and Associated Health Outcomes
The National Institute for Occupational Safety and Health of the Centers for Disease Control and Prevention announces the availability of a draft Current Intelligence Bulletin entitled ``A Review of Information Published Since 1995 on Coal Mine Dust Exposures and Associated Health Outcomes'' now available for public comment. The draft document and instructions for submitting comments can be found at: https://www.cdc.gov/niosh/docket/review/docket210/default.html . This document updates and supports the coal mine dust Recommended Exposure Limit (REL) of 1 mg/m\3\ that was recommended in the 1995 document, ``Criteria for a Recommended Standard: Occupational Exposure to Respirable Coal Mine Dust, (1995-106)'' which can be viewed at: https:// www.cdc.gov/niosh/95-106.html.
Request for Comment: National Center for Complementary and Alternative Medicine Draft Strategic Plan
The National Center for Complementary and Alternative Medicine (NCCAM) is developing its third strategic plan and invites the public to provide comments on a draft. The draft will be publicly available through the NCCAM Web site at https://nccam.nih.gov from on or about August 30 through September 30, 2010. The public is invited to provide comments through the NCCAM Web site.
Proposed Collection; Comment Request; NCCAM Office of Communications and Public Liaison Communications Program Planning and Evaluation Research
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Center for Complementary and Alternative Medicine (NCCAM), at the National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Effective Date of Requirement for Premarket Approval for Four Class III Preamendments Devices
The Food and Drug Administration (FDA) is proposing to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the following four class III preamendments devices: Ventricular bypass (assist) device; pacemaker repair or replacement material; female condom; and transilluminator for breast evaluation. The agency is also summarizing its proposed findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring the devices to meet the statute's approval requirements and the benefits to the public from the use of the devices. In addition, FDA is announcing the opportunity for interested persons to request that the agency change the classification of any of the aforementioned devices based on new information. This action implements certain statutory requirements.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Experimental Study of Graphic Cigarette Warning Labels
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.
Draft National Conversation on Public Health and Chemical Exposures Work Group Reports; Opportunity for Public Comment
The National Conversation on Public Health and Chemical Exposures is a collaborative initiative through which many organizations and individuals are helping develop an action agenda for strengthening the nation's approach to protecting the public's health from harmful chemical exposures. This notice announces the availability of draft National Conversation work group reports for public review and comment. CDC/ATSDR has partnered with RESOLVE, a non-profit independent consensus-building organization, to manage aspects of the National Conversation project. RESOLVE is convening the National Conversation Leadership Council and facilitating the work group process.
Proposed Collection; Comment Request; Request; OMB No. 0925-0177 “Special Volunteer and Guest Researcher Assignment,” Form 590
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed information collection, the Office of Human Resources, the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Submission for OMB Review; Comment Request; Resource for the Collection and Evaluation of Human Tissues and Cells From Donors With an Epidemiology Profile (NCI)
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Cancer Institute (NCI), the National Institutes of Health (NIH), 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 on June 16, 2010 (75 FR 34146) and allowed 60-days for public comment. One public comment was received on 7/16/2010 from a business informing us that they are able to provide a time-saving ``batch processing service'' to
Guidance for Industry: Questions and Answers Regarding the Effect of Section 4205 of the Patient Protection and Affordable Care Act of 2010 on State and Local Menu and Vending Machine Labeling Laws; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Guidance for Industry: Questions and Answers Regarding the Effect of Section 4205 of the Patient Protection and Affordable Care Act of 2010 on State and Local Menu and Vending Machine Labeling Laws.'' Section 4205 of the Patient Protection and Affordable Care Act of 2010 (Affordable Care Act) establishes requirements for nutrition labeling of standard menu items for chain retail food establishments and chain vending machine operators. FDA is issuing this guidance to clarify section 4205's effect on State and local menu and vending machine labeling laws, and to ensure that industry and State and local government understand the immediate effects of the law.
Draft Guidance for Industry: Questions and Answers Regarding Implementation of the Menu Labeling Provisions of Section 4205 of the Patient Protection and Affordable Care Act of 2010; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Guidance for Industry: Questions and Answers Regarding Implementation of the Menu Labeling Provisions of Section 4205 of the Patient Protection and Affordable Care Act of 2010.'' Section 4205 of the Patient Protection and Affordable Care Act (Affordable Care Act) requires certain chain restaurants and similar retail food establishments with 20 or more locations (hereinafter ``chain retail food establishments'') to provide calorie information, and other nutrition information, for standard menu items, food on display, and self-service food. Section 4205 also requires vending machine operators who own or operate 20 or more machines (hereinafter ``chain vending machine operators'') to disclose calories for articles of food. Restaurants and similar retail food establishments with fewer than 20 locations and vending machine operators with fewer than 20 machines may elect to be subject to these Federal requirements by registering every other year with the FDA.
Findings of Scientific Misconduct
Notice is hereby given that the Office of Research Integrity (ORI) and the Assistant Secretary for Health have taken final action in the following case:
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: ``Eisenberg Center Voluntary Customer Survey Generic Clearance for the Agency for Healthcare Research and Quality.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3520, AHRQ invites the public to comment on this proposed information collection.
Menthol Report Subcommittee of the Tobacco Products Scientific Advisory Committee; Notice of Meeting
Decision To Evaluate a Petition To Designate a Class of Employees From the Norton Company, Worcester, MA, 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 the Norton Company, Worcester, Massachusetts, 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:
National Institute for Occupational Safety and Health; Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort
HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from the De Soto Avenue Facility in Los Angeles County, California, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On July 14, 2010, 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:
Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort
HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from the Downey Facility in Los Angeles County, California, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On July 13, 2010, 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:
Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort
HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from the Mound Plant in Miamisburg, Ohio, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On July 14, 2010, 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:
Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort
HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from the St. Louis Airport Storage Site in St. Louis, Missouri, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On July 14, 2010, 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:
Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort
HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from the Bethlehem Steel Corporation facility in Lackawanna, New York, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On July 14, 2010, 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:
Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort
HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from BWX Technologies, Inc., in Lynchburg, Virginia, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On July 13, 2010, 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:
Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort
HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from the Los Alamos National Laboratory in Los Alamos, New Mexico, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On July 13, 2010, 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:
National Institute for Occupational Safety and Health; Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort
HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from the University of Rochester Atomic Energy Project in Rochester, New York, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On July 13, 2010, 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:
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