Department of Health and Human Services June 2009 – Federal Register Recent Federal Regulation Documents
Results 201 - 250 of 315
Reimbursement Rates for Calendar Year 2009
Notice is given that the Director of Indian Health Service (IHS), under the authority of sections 321(a) and 322(b) of the Public Health Service Act (42 U.S.C. 248 and 249(b)), Public Law 83-568 (42 U.S.C. 2001 (a)), and the Indian Health Care Improvement Act (25 U.S.C. 1601 et seq.), has approved the following rates for inpatient and outpatient medical care provided by IHS facilities for Calendar Year 2009 for Medicare and Medicaid beneficiaries and beneficiaries of other Federal programs. The Medicare Part A inpatient rates are excluded from the table below as they are paid based on the prospective payment system. Since the inpatient rates set forth below do not include all physician services and practitioner services, additional payment may be available to the extent that those services meet applicable requirements. Section 1880 of the Social Security Act authorizes Medicare Part B payment to hospitals and ambulatory care clinics operated by IHS or by an Indian Tribe or Tribal organization.
Office of the National Coordinator for Health Information Technology; HIT Standards Committee Meeting
This notice announces the second meeting of the HIT Standards Committee in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.).
Proposed Collection; Comment Request; Investigator Registration and Financial Disclosure for Investigational Trials in Cancer Treatment (NCI)
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 Cancer Institute, the National Cancer Institute (NIH) will publish periodic summaries to the Office of Management and Budget (OMB) for review and approval.
Issues in the Design of Clinical Trials of Antimycobacterial Drugs for Treatment of Tuberculosis; Public Workshop
The Food and Drug Administration (FDA) is announcing a public workshop regarding scientific issues in clinical trial design for the treatment of tuberculosis. This public workshop is intended to bring together public health experts, health care providers, academia, and industry to share perspectives on scientific aspects of antimicrobial drug development for tuberculosis. Topics will include considerations in the development of clinical trials to study treatments for tuberculosis, including enrollment of patients, the effect of antimicrobial treatment, study endpoints, and statistical issues in analysis of results. The input from this public workshop will help in developing topics for further public discussion.
Interagency Retail Listeria monocytogenes Risk Assessment: Notice of a Public Meeting
The Food Safety and Inspection Service (FSIS) and the Food and Drug Administration/Center for Food Safety and Applied Nutrition (FDA/ CFSAN) are holding a public meeting to present the background, approach, scope, and data needs for a recently initiated interagency risk assessment of the public health impact of foodborne Listeria monocytogenes (L. monocytogenes) in some ready-to-eat foods that are sliced, prepared, or packaged in retail facilities. The purpose of this ``Interagency Retail L. monocytogenes Risk Assessment'' is to ascertain the effect on the public health of current practices and potential interventions that reduce or prevent L. monocytogenes contamination in ready-to-eat foods. FSIS and FDA invite interested individuals, organizations, and other stakeholders to participate in the meeting and comment on this topic.
International Conference on Harmonisation; Guidance on Q8(R1) Pharmaceutical Development; Addition of Annex; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Q8(R1) Pharmaceutical Development.'' 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 ICH Q8(R1) guidance includes the previously published parent guidance entitled ``Q8 Pharmaceutical Development'' (Q8 parent guidance) (71 FR 29344; May 22, 2006) and a newly added annex. The annex provides further clarification of key concepts outlined in the Q8 parent guidance and describes the principles of quality by design (QbD). The annex is intended to show how concepts and tools (e.g., design space) outlined in the Q8 parent guidance could be put into practice by the applicant for all dosage forms.
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.
Maternal Child Health Bureau, Healthy Start Eliminating Disparities in Perinatal Health
The Health Resources and Services Administration (HRSA) is issuing non-competitive supplemental funding under the Maternal Child Health Bureau, Healthy Start Eliminating Disparities in Perinatal Health program to ensure that the Northern Manhattan Perinatal Partnership (NMPP), the primary provider of prenatal services in Central Harlem, can continue to provide much needed services to help stem the rise in and ultimately reduce the Infant Mortality Rate (IMR) in the affected service area.
Agency Information Collection Activities; Proposed Collection; Comment Request; User Fee Cover Sheet; Form FDA 3397
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, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on Form FDA 3397, User Fee Cover Sheet, that must be submitted along with certain drug and biologic product applications and supplements.
Submission for OMB Review; Comment Request; Generic Clearance To Conduct Voluntary Customer/Partner Surveys
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Library of Medicine (NLM), 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 March 30, 2009 (Vol. 74, No. 59, Pg. 14137) and allowed 60-days for public comment. One public comment was received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.
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