Department of Health and Human Services 2007 – Federal Register Recent Federal Regulation Documents
Results 101 - 150 of 3,398
Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the agency's Division of Dockets Management.
Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 019
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: 019'' (Recognition List Number: 019), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.
Solicitation of New Safe Harbors and Special Fraud Alerts
In accordance with section 205 of the Health Insurance Portability and Accountability Act (HIPAA) of 1996, this annual notice solicits proposals and recommendations for developing new and modifying existing safe harbor provisions under the Federal anti-kickback statute (section 1128B(b) of the Social Security Act), as well as developing new OIG Special Fraud Alerts.
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.
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.
Over-the-Counter Vaginal Contraceptive and Spermicide Drug Products Containing Nonoxynol 9; Required Labeling
The Food and Drug Administration (FDA) is issuing a final rule establishing new warning statements and other labeling information for all over-the-counter (OTC) vaginal contraceptive drug products (also known as spermicides, hereinafter referred to as vaginal contraceptives or vaginal contraceptives/spermicides) containing nonoxynol 9 (N9). These warning statements will advise consumers that vaginal contraceptives/spermicides containing N9 do not protect against infection from the human immunodeficiency virus (HIV), the virus that causes acquired immunodeficiency syndrome (AIDS), or against getting other sexually transmitted diseases (STDs). The warnings and labeling information will also advise consumers that use of vaginal contraceptives and spermicides containing N9 can irritate the vagina and rectum and may increase the risk of getting the AIDS virus (HIV) from an infected partner. This final rule is part of FDA's ongoing review of OTC drug products. FDA is issuing this final rule after considering public comments on its proposed regulation, and all relevant data and information on N9 that have come to our attention.
State Children's Health Insurance Program (SCHIP); Additional Allotments To Eliminate FY 2007 Funding Shortfalls
This notice describes the methodology and process we are using for determining the amounts of certain States' remaining SCHIP funding shortfalls in Federal fiscal year (FY) 2007, in accordance with the provisions of the U.S. Troop Readiness, Veteran's Care, Katrina Recovery, and Iraq Accountability Appropriations Act, 2007. This notice also contains the amounts of the additional allotments to be provided to such States to eliminate such FY 2007 funding shortfalls, determined in accordance with this methodology.
Revisit User Fee Program for Medicare Survey and Certification Activities
This interim final rule with comment period implements the continuation of the revisit user fee program for Medicare Survey and Certification activities, in accordance with the statutory authority in the Further Continuing Appropriations, 2008 Resolution (``Continuing Resolution'') budget legislation passed by the Congress and signed by the President on November 13, 2007. On September 19, 2007, we published a final rule that established a system of revisit user fees applicable to health care facilities that have been cited for deficiencies during initial certification, recertification or substantiated complaint surveys and require a revisit to confirm that previously-identified deficiencies have been corrected.
Part C HIV Early Intervention Services Grant
HRSA will be providing temporary critical HIV medical care and treatment services through Chase Brexton Health Services to avoid a disruption of HIV clinical care to homeless populations in the Baltimore, Maryland, area.
International Conference on Harmonisation; Draft Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 2 on Test for Extractable Volume of Parenteral Preparations General Chapter; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 2: Test for Extractable Volume of Parenteral Preparations General Chapter.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance provides the results of the ICH Q4B evaluation of the Test for Extractable Volume of Parenteral Preparations General Chapter harmonized text from each of the three pharmacopoeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The draft guidance conveys recognition of the three pharmacopoeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The draft guidance is intended to recognize the interchangeability between the local regional pharmacopoeias, thus avoiding redundant testing in favor of a common testing strategy in each regulatory region. This is the second annex to the core Q4B guidance, which was made available in draft in August 2006 (71 FR 45059, August 8, 2006).
International Conference on Harmonisation; Draft Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 3 on Test for Particulate Contamination: Subvisible Particles General Chapter; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 3: Test for Particulate Contamination: Subvisible Particles General Chapter.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance provides the results of the ICH Q4B evaluation of the Test for Particulate Contamination: Subvisible Particles General Chapter harmonized text from each of the three pharmacopoeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The draft guidance conveys recognition of the three pharmacopoeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The draft guidance is intended to recognize the interchangeability between the local regional pharmacopoeias, thus avoiding redundant testing in favor of a common testing strategy in each regulatory region. This is the third annex to the core Q4B guidance, which was made available in draft in the Federal Register of August 8, 2006 (71 FR 45059).
National Institute for Occupational Safety and Health; Decision To Evaluate a Petition To Designate a Class of Employees at the Pantex Plant, Amarillo, TX, 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 Pantex Plant, Amarillo, Texas, 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: Pantex Plant. Location: Amarillo, Texas. Job Titles and/or Job Duties: Production workers, technicians, including radiography, guards, physical plant, maintenance, administrative and support staff, contractors, and Atomic Energy Commission staff. Period of Employment: January 1, 1950 through December 31, 1991.
Guidance for Industry and Food and Drug Administration Review Staff: Collection of Platelets by Automated Methods; Availability
The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry and FDA Review Staff: Collection of Platelets by Automated Methods,'' dated December 2007. The guidance document provides to blood establishments and FDA staff revised recommendations for the collection of Platelets by automated methods (plateletpheresis). The guidance is intended to help blood establishments ensure donor safety and the safety, purity, and potency of Platelets collected by an automated blood cell separator device. For the purpose of this document, Platelets collected by automated methods will be referred to by the product name ``Platelets, Pheresis.'' The document contains recommendations for appropriate criteria for a biologics license application or supplement for manufacturing Platelets, Pheresis. The guidance announced in this notice finalizes the draft guidance of the same title dated September 2005, and supersedes the guidance entitled ``Revised Guideline for the Collection of Platelets, Pheresis,'' dated October 1988.
Additional Consolidated Health Information (CHI) Health Information Technology Standards
This notice identifies three (3) additional Consolidated Health Informatics (CHI) messaging and vocabulary standards (Multimedia, Allergy, and Disability and Assessments) adopted for use in Federal government health information technology systems. This work supplements the work to further the adoption of the first set of 5 standards adopted on March 21, 2003 and second set of 15 standards adopted on May 6, 2004, as published in the December 23, 2005 Federal Register (70 FR 76287). The CHI initiative began in October 2001 as one of 24 E-Government initiatives included in the President's Management Agenda (PMA). The CHI collaborative worked to adopt Federal government-wide health information interoperability standards to be implemented by Federal agencies in order to enable the Fedral government to exchange electronic health information. By publication of this document, we are informing the public of the adoption of three new CHI standards, Multimedia, Allergy and Disability and Assessment (adoption reports available at: https://www.hhs.gov/healthit/chiinitiative.html).
Expert Meeting on Disease Management Outcomes Measurement
This notice announces the date and location of the Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation (HHS/ASPE) Expert Meeting on Disease Management Outcomes Measurement. The objective of the meeting is to convene a panel of experts from government, academia, and private industry to discuss measurement of the impact of disease management on health outcomes and costs of care, with a focus on potential for public sector programs.
New Animal Drugs for Use in Animal Feeds; Oxytetracycline
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Pennfield Oil Co. that provides for a zero- day preslaughter withdrawal time following use of oxytetracycline in turkey and swine feed.
New Animal Drugs For Use in Animal Feeds; Ractopamine
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Elanco Animal Health. The supplemental NADA provides for an increased level of monensin in three-way combination Type C medicated feeds containing ractopamine, melengestrol, and monensin for heifers fed in confinement for slaughter.
Quality System Regulation Educational Forum on Design Controls; Public Workshop; Amendment of Notice
The Food and Drug Administration (FDA) is announcing an amendment to the notice of public workshop entitled ``Quality System Regulation Educational Forum on Design Controls.'' This workshop was announced in the Federal Register of October 11, 2007 (72 FR 57951). The amendment is made to reflect a change in the Location portion of the document. There are no other changes.
Privacy Act of 1974; New System of Records
In accordance with the requirements of the Privacy Act, the Centers for Disease Control and Prevention (CDC) is proposing to establish a new system of records (SOR), 09-20-0171, ``Quarantine and Traveler-Related Activities, Including Records for Contact Tracing Investigation and Notification Under 42 CFR Parts 70 and 71, HHS/CDC/ CCID.'' The purpose of the system is to maintain records on the conduct of activities (e.g., quarantine, isolation) that fulfill HHS's and CDC's statutory authority under sections 311 and 361-368 of the Public Health Service Act: To prevent the introduction, transmission and spread of serious communicable diseases from persons arriving into the United States from foreign countries or engaged in interstate or international movement. Identifiable records are collected when an individual known or suspected to have been exposed to such communicable diseases arrives in the U.S. from a foreign country or travels from one state or possession to another state or possession. These records are used to: (1) Document reports of illness on airplanes, maritime vessels, and at land-border crossings of persons that may pose a public health risk and who are arriving from foreign countries or traveling between states; (2) perform contact tracing investigations and notifications of passengers and crew when known or suspected exposures to serious communicable diseases occur on board a conveyance arriving in the United States from a foreign country or while traveling from one state or possession to another; (3) inform state or local public health authorities so that these authorities may act to protect public health or safety; and (4) take actions (e.g., quarantine or isolation) as necessary to prevent the introduction, transmission, and spread of serious communicable diseases from persons arriving into the United States from foreign countries or persons engaged in interstate or international movement. Additional background information about the new system is included in the SUPPLEMENTARY INFORMATION section below.
National Toxicology Program (NTP); Office of Liaison, Policy and Review; Meeting of the NTP Board of Scientific Counselors Technical Reports Review Subcommittee
Pursuant to Public Law 92-463, notice is hereby given of a meeting of the NTP Board of Scientific Counselors Technical Reports Review Subcommittee (TRR Subcommittee). The primary agenda topic is the peer review of the findings and conclusions presented in seven draft NTP Technical Reports of rodent toxicology and carcinogenicity studies in conventional rats and mice, one draft NTP Technical Report on a study in Crl:SKH-1 hairless mice, and one draft NTP Toxicity Report (see Preliminary Agenda below). The TRR Subcommittee meeting is open to the public with time scheduled for oral public comment. The NTP also invites written comments on any draft report discussed at the meeting (see ``Request for Comments'' below). The TRR Subcommittee deliberations on the draft reports will be reported to the NTP Board of Scientific Counselors (BSC) at a future date.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Health and Diet Survey
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
The Department of Health and Human Services (HHS) gives notice of a decision to designate a class of employees at the Nuclear Materials and Equipment Corporation (NUMEC) in Apollo, Pennsylvania, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On November 29, 2007, the Secretary of HHS designated the following class of employees as an addition to the SEC:
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