Department of Health and Human Services March 2010 – Federal Register Recent Federal Regulation Documents
Results 251 - 300 of 369
Proposed Establishment of Certification Programs for Health Information Technology
Under the authority granted to the National Coordinator for Health Information Technology (the National Coordinator) by section 3001(c)(5) of the Public Health Service Act (PHSA) as added by the Health Information Technology for Economic and Clinical Health (HITECH) Act, this rule proposes the establishment of two certification programs for purposes of testing and certifying health information technology. While two certification programs are described in this proposed rule, we anticipate issuing separate final rules for each of the programs. The first proposal would establish a temporary certification program whereby the National Coordinator would authorize organizations to test and certify Complete EHRs and/or EHR Modules, thereby assuring the availability of Certified EHR Technology prior to the date on which health care providers seeking the incentive payments available under the Medicare and Medicaid EHR Incentives Program may begin demonstrating meaningful use of Certified EHR Technology. The second proposal would establish a permanent certification program to replace the temporary certification program. The permanent certification program would separate the responsibilities for performing testing and certification, introduce accreditation requirements, establish requirements for certification bodies authorized by the National Coordinator related to the surveillance of Certified EHR Technology, and would include the potential for certification bodies authorized by the National Coordinator to certify other types of health information technology besides Complete EHRs and EHR Modules.
Issuance of Final Policy Directive
The Administration for Native Americans (ANA) is issuing final interpretive rules, general statements of policy and rules of agency organization, procedure, or practice relating to the following Funding Opportunity Announcements (FOAs): Social and Economic Development Strategies (hereinafter referred to as SEDS), Social and Economic Development StrategiesSpecial Initiative (hereinafter referred to as SEDSSI), Native Language Preservation and Maintenance (hereinafter referred to as Language Preservation), Native Language Preservation and MaintenanceEsther Martinez Initiative (hereinafter referred to as LanguageEMI), and Environmental Regulatory Enhancement (hereinafter referred to as ERE). This notice also provides information about how ANA will administer these programs.
CIBA Vision Corp.; Withdrawal of Color Additive Petitions
The Food and Drug Administration (FDA) is announcing the withdrawal, without prejudice to a future filing, of three color additive petitions (CAP 5C0278, CAP 5C0279, and CAP 5C0280) proposing that the color additive regulations be amended to provide for the safe use of Color Index (C.I.) Pigment Violet 19, C.I. Pigment Yellow 154, and C.I. Pigment Red 122 as color additives in contact lenses.
Determination That DOVONEX (Calcipotriene) Ointment, 0.005%, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) is announcing its determination that DOVONEX (calcipotriene) Ointment, 0.005%, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for calcipotriene Ointment, 0.005%, if all other legal and regulatory requirements are met.
Training Program for Regulatory Project Managers; Information Available to Industry
The Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) is announcing the continuation of the Regulatory Project Management Site Tours and Regulatory Interaction Program (the Site Tours Program). The purpose of this document is to invite pharmaceutical companies interested in participating in this program to contact CDER.
New Animal Drug Applications; Confirmation of Effective Date
The Food and Drug Administration (FDA) is confirming the effective date of March 8, 2010, for the final rule that appeared in the Federal Register of October 23, 2009 (74 FR 54749). The direct final rule amends the regulations regarding new animal drug applications (NADAs). Specifically, this direct final rule is being issued to provide that NADAs shall be submitted in the described form, as appropriate for the particular submission. Currently, the regulation requires that all NADAs contain the same informational sections and does not explicitly provide the appropriate flexibility needed to
International Conference on Harmonisation; Guidance on S9 Nonclinical Evaluation for Anticancer Pharmaceuticals; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``S9 Nonclinical Evaluation for Anticancer Pharmaceuticals.'' 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 guidance provides recommendations for nonclinical studies for the development of pharmaceuticals, including both drugs and biotechnology derived products, intended to treat patients with advanced cancer. The recommendations describe the type and timing of nonclinical studies to support an investigational new drug application (IND) and the submission of a new drug application (NDA) or biologics license application (BLA). The guidance is intended to provide information on internationally accepted recommendations for nonclinical studies to facilitate the development of anticancer pharmaceuticals.
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.
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.
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.
Notice Regarding 340B Drug Pricing Program-Contract Pharmacy Services
Section 602 of Public Law 102-585, the ``Veterans Health Care Act of 1992'' enacted Section 340B of the Public Health Service Act (PHS). Section 340B implements a drug pricing program by which manufacturers who sell covered outpatient drugs to particular covered entities listed in the statute must agree to charge a price that will not exceed the amount determined under a statutory formula. The purpose of this Final Notice is to inform interested parties of final guidelines regarding the utilization of multiple contract pharmacies and suggested contract pharmacy provisions, which had been previously limited to the Alternative Methods Demonstration Project program.
Notice of Opportunity for a Hearing on Compliance of Missouri State Plan Provisions Concerning Payments for Home Health Services With Title XIX (Medicaid) of the Social Security Act
This notice announces the opportunity for an administrative hearing to be held no later than 60 days following publication in the Federal Register at the CMS Kansas City Regional Office, 601 E. 12th Street, Kansas City, Missouri 64106, to consider whether Missouri State plan provisions concerning payments for home health services comply with the requirements of the Social Security Act as discussed in the February 26, 2010 letter sent to the State and published herein.
Strengthening the Center for Devices and Radiological Health's 510(k) Review Process; Public Meeting; Extension of Comment Period
The Food and Drug Administration (FDA) is extending to March 19, 2010, the comment period for the notice that appeared in the Federal Register of Wednesday, January 27, 2010 (75 FR 4402). In the notice, FDA requested comments on a number of identified challenges associated with the 510(k) process. The agency is taking this action to allow interested persons additional time to submit comments.
Pandemic Influenza Vaccines-Amendment
Amendment to declaration issued on September 28, 2009 (74 FR 51153) pursuant to section 319F-3 of the Public Health Service Act (``the Act'') (42 U.S.C. 247d-6d) to revise covered countermeasures and extend effective date and republication of the declaration to reflect the declaration in its entirety, as amended.
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