Department of Health and Human Services January 2010 – Federal Register Recent Federal Regulation Documents
Results 51 - 100 of 267
Guidance for Industry on the Use of Mechanical Calibration of Dissolution Apparatus 1 and 2-Current Good Manufacturing Practice; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``The Use of Mechanical Calibration of Dissolution Apparatus 1 and 2Current Good Manufacturing Practice (CGMP).'' This guidance recommends an alternative method for manufacturers to comply with FDA's CGMP regulations that require laboratory apparatus be calibrated at suitable intervals in accordance with established written specifications. The guidance is intended to aid drug manufacturers (including ancillary testing laboratories) in calibrating U.S. Pharmacopeia (USP) Dissolution Apparatus 1 and 2 to help assure that critical parameters associated with the dissolution apparatus meet certain mechanical calibration (MC) tolerances.
Draft Guidance for Industry on Assessment of Abuse Potential of Drugs; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Assessment of Abuse Potential of Drugs.'' This draft guidance is intended to assist sponsors who are developing drug and other medical products with the potential for abuse that may need to be scheduled under the Controlled Substances Act. Drugs with abuse potential generally include drugs that affect the central nervous system, drugs that are chemically or pharmacologically similar to other drugs with known abuse potential, and drugs that produce psychoactive effects such as sedation, euphoria, or mood change.
Medicare Program; Meeting of the Medicare Evidence Development and Coverage Advisory Committee, March 24, 2010
This notice announces a public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) (``Committee'') on Wednesday, March 24, 2010. The Committee generally provides advice and recommendations concerning the adequacy of scientific evidence needed to determine whether certain medical items and services can be covered under the Medicare statute. This meeting will examine currently available evidence on the use of erythropoiesis stimulating agents (ESAs) to manage anemia in patients who have chronic kidney disease. This meeting is open to the public in accordance with the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)).
Medicare Program; Approval of Independent Accrediting Organizations To Participate in the Advanced Diagnostic Imaging Supplier Accreditation Program
This notice announces our approval of the following three national accreditation organizations to accredit suppliers seeking to furnish the technical component (TC) of advanced diagnostic imaging services under the Medicare program: the American College of Radiology (ACR); the Intersocietal Accreditation Commission (IAC); and The Joint Commission (TJC).
Agency Information Collection Activities; Proposed Collection; 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 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 the collection of information relating to general licensing provisions for biologics license applications (BLAs), changes to an approved application, labeling, revocation and suspension, postmarketing studies status reports, and Forms FDA 356h and 2567.
Agency Information Collection Activities; Proposed Collection; Comment Request; Export of Medical Devices-Foreign Letters of Approval
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 reporting requirements for firms that intend to export certain unapproved medical devices.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Interstate Shellfish Dealers Certificate
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Recordkeeping and Reporting Requirements for Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing, Material From Cattle
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Labeling; Notification Procedures for Statements on Dietary Supplements
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.
Submission for OMB Review; Comment Request; Next Series of Tobacco Use Supplements to the Current Population Survey (TUS-CPS) (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 November 6, 2009, (Vol. 74, No. 214, pp. 57496-97) and allowed 60 days for public comment. One request for information was received on November 6, 2009. A copy of the 2010-2011 TUS-CPS was e-mailed to the requestor reiterating our data collection plans as stated in the 60-day Federal Register Notice. Another comment was received on December 16, 2009 complimenting our inclusion in the 2010-2011 TUS-CPS of critically needed information on details about the types of cigars (especially small cigars) used by smokers and new and valuable information on menthol cigarette smoking. We thanked the requestor for the endorsement and agreed that we thought that was valuable and timely as well and that is why we have included the information in the proposed data collection. 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.
Request for Public Comment: 30-Day Proposed Information Collection: Indian Health Service Customer Satisfaction Survey
In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, which requires 30 days for public comment on proposed information collection projects, the Indian Health Service (IHS) 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 project was previously published in the Federal Register (74 FR 46201) on September 8, 2009 and allowed 60 days for public comment. No public comment was received in response to the notice. The purpose of this notice is to allow 30 days for public comment to be submitted directly to OMB.
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: ``Collection of Information for Agency for Healthcare Research and Quality's (AHRQ) Consumer Assessment of Healthcare Providers and Systems (CAHPS) Health Plan Survey Comparative Database.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3520, AHRQ invites the public to comment on this proposed information collection.
Medicare Program; Meeting of the Advisory Panel on Medicare Education; Cancellation of the February 3, 2010 Meeting and Announcement of the March 31, 2010 Meeting
This notice announces the cancellation of the meeting of the Advisory Panel on Medicare Education (the Panel) that was published in the December 18, 2009 Federal Register (74 FR 67240-67241). This notice also announces a public meeting on March 31, 2010. The Panel advises and makes recommendations to the Secretary of Health and Human Services and the Administrator of the Centers for Medicare & Medicaid Services on opportunities to enhance the effectiveness of consumer education strategies concerning the Medicare program. This meeting is open to the public.
Medicare Program; Meeting of the Practicing Physicians Advisory Council, March 8, 2010
This notice announces a quarterly meeting of the Practicing Physicians Advisory Council (the Council). The Council will meet to discuss certain proposed changes in regulations and manual instructions related to physicians' services, as identified by the Secretary of Health and Human Services. This meeting is open to the public.
2009 HHS Poverty Guidelines Extended Until March 1, 2010
This notice advises that, pursuant to section 1012 of the Department of Defense Appropriations Act, 2010, the 2009 Department of Health and Human Services (HHS) poverty guidelines will remain in effect until updated 2010 poverty guidelines are published, which shall not take place before March 1, 2010.
Announcement of the Fifth Dietary Guidelines Advisory Committee Meeting and Solicitation of Written Comments
The Department of Agriculture (USDA) and the Department of Health and Human Services (HHS) (a) provide notice of the fifth meeting of the Dietary Guidelines Advisory Committee, and (b) solicit written comments pertinent to the Dietary Guidelines for Americans.
Ryan White HIV/AIDS Part C Early Intervention Services (EIS) Program
The Health Resources and Services Administration (HRSA) is issuing a non-competitive replacement award to the Orange County Health Department, Orlando, Florida, that will ensure continuity of Part C, Early Intervention Services (EIS), HIV/AIDS care and treatment services to women, infants, and children without disruption from Orlando Health Incorporated's HUG-ME Program, in Orange County and the surrounding areas.
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