Department of Health and Human Services June 2010 – Federal Register Recent Federal Regulation Documents
Results 201 - 250 of 316
National Toxicology Program (NTP); NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM): Availability of the Biennial Progress Report of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM)
NICEATM announces the availability of the Biennial Progress Report 2008-2009: Interagency Coordinating Committee on the Validation of Alternative Methods. In accordance with requirements of the ICCVAM Authorization Act of 2000 (Pub. L. 106-545, 42 U.S.C. 285l-3(e)(7)), this report describes progress and activities during 2008-2009 by ICCVAM and NICEATM. The report is available on the NICEATM-ICCVAM Web site at https://iccvam.niehs.nih.gov/about/ICCVAMrpts.htm. Copies can
Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
The Department of Health and Human Services (HHS) notifies Federal agencies of the laboratories currently certified to meet the standards of Subpart C of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908), on September 30, 1997 (62 FR 51118), and on April 13, 2004 (69 FR 19644).
Medicare Program; Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs; Corrections
This document corrects technical and typographical errors in the final rule that appeared in the April 15, 2010 Federal Register entitled ``Medicare Program; Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs.''
Determination of Regulatory Review Period for Purposes of Patent Extension; PROMACTA
The Food and Drug Administration (FDA) has determined the regulatory review period for PROMACTA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.
Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 024
The Food and Drug Administration (FDA) is announcing a publication containing modifications the agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA recognized consensus standards). This publication, entitled ``Modifications to the List of Recognized Standards, Recognition List Number: 024'' (Recognition List Number: 024), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.
Draft Guidance for Industry: Compliance With Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Draft Guidance for Industry: Compliance with Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco To Protect Children and Adolescents.'' The draft guidance is intended to help small entities comply with the final regulations restricting the sale and distribution of cigarettes and smokeless tobacco in order to protect children and adolescents.
Health Center Program
The Health Resources and Services Administration (HRSA) will be transferring Health Center Program (section 330 of the Public Health Service Act) Community Health Center (CHC), Increased Demand for Services (IDS), and Capital Improvement Program (CIP) funds originally awarded to Unadilla Health Care Center, Inc., to Albany Area Primary Health Care, Inc., to ensure the provision of critical primary health care services to underserved populations in Dooly County, Georgia.
Preparation for International Cooperation on Cosmetic Regulations; Public Meeting
The Food and Drug Administration (FDA) is announcing a public meeting entitled ``International Cooperation on Cosmetic Regulations (ICCR)Preparation for ICCR-4 Meetings in Toronto, Canada'' to provide information and receive comments on the ICCR as well as the upcoming meetings in Toronto, Canada. The topics to be discussed are the topics for discussion at the forthcoming ICCR Steering Committee meeting. The purpose of the meeting is to solicit public input prior to the next Steering Committee and expert working group meetings in Toronto, Canada the week of July 12, 2010.
Change of Contact Information; Technical Amendment
The Food and Drug Administration (FDA) is amending its regulations to reflect changes in the contact information for the FDA Emergency Call Center. This action is editorial in nature and is intended to improve the accuracy of the agency's regulations.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation and Suspension, Postmarketing Studies Status Reports, and Forms FDA 356h and 2567
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.
National Institute for Occupational Safety and Health; Designation of a Class of Employees for Addition to the Special Exposure Cohort
HHS gives notice of a decision to designate a class of employees from the Canoga Avenue Facility, 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 May 14, 2010, the Secretary of HHS designated the following class of employees as an addition to the SEC:
Discretionary Grant Program
HRSA will be issuing non-competitive supplemental funding under the Maternal Child and Health Bureau's Family to Family Health Information Centers Program. This will provide feasible time for the Maternal and Child Health Bureau (MCHB) to align fiscal resources and programmatic goals as outlined in changes that emerged as a result of enactment of the Patient Protection and Affordable Care Act (Pub. L. 111-148) with the least disruption to the States, communities, and constituencies that currently receive assistance and services from these grantees.
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: ``Spreading Techniques To Radically Reduce Antibiotic Resistant Bacteria (Methicillin Resistant Staphylococcus aureus, or MRSA).'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3520, AHRQ invites the public to comment on this proposed information collection.
Guidance for Industry: Enforcement Policy Concerning Rotational Warning Plans for Smokeless Tobacco; Availability
The Food and Drug Administration (FDA) is announcing the
Investigational New Drug Applications; Co-development of Investigational Drugs
The Food and Drug Administration (FDA) is establishing a
Array-Based Cytogenetic Tests: Questions on Performance Evaluation, Result Reporting and Interpretation; Public Meeting; Request for Comments
The Food and Drug Administration (FDA) is announcing the
Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Approval of Medical Devices
The Food and Drug Administration (FDA) is announcing an
Submission for OMB Review; Comment Request; The STAR METRICS Program
Under the provisions of Section 3507(a)(1)(D) of the Paperwork
National Institute of Child Health and Human Development; Revision to Proposed Collection; Comment Request; the National Children's Study (NCS), Vanguard (Pilot) Study, Recruitment Substudy Phase 1
Under the provisions of Section 3507(a)(1)(D) of the Paperwork
Office of the National Coordinator for Health Information Technology; HIT Standards Committee; Notice and Publication of Committee Recommendations to the National Coordinator for Health Information Technology
This notice publishes recommendations made by the HIT
Prescription Drug User Fee Act; Meetings on Reauthorization; Request for Notification of Stakeholder Intention to Participate
The Food and Drug Administration (FDA) is issuing this notice
Issues in the Development of Medical Products for the Prophylaxis and/or Treatment of Acute Antibody Mediated Rejection in Kidney Transplant Recipients; Public Workshop
The Food and Drug Administration (FDA) is announcing a public
Determination of Regulatory Review Period for Purposes of Patent Extension; ABLAVAR
The Food and Drug Administration (FDA) has determined the
Medicaid Program: Proposed Implementation of Section 614 of the Children's Health Insurance Program Reauthorization Act of 2009 for Adjustments to the Federal Medical Assistance Percentage for Medicaid Federal Matching Funds
For purposes of Title XIX (Medicaid) of the Social Security Act, the Federal Medical Assistance Percentage (FMAP), defined in section 1905(b) of the Social Security Act, for each state beginning with fiscal year 2006 is subject to adjustment pursuant to section 614 of the Children's Health Insurance Program Reauthorization Act of 2009 (CHIPRA), Public Law 111-3. Section 614 provides for a recalculation of the FMAP disregarding identifiable significantly disproportionate employer pension or insurance fund contributions for a state. These contributions, when counted, increase state personal income and, by operation of the statutory formula to calculate the FMAP, would decrease the FMAP for the state. This notice announces the proposed methodology that the U.S. Department of Health and Human Services will use to determine the need for, and amount of, any such recalculation of the FMAP for a state.
Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
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