Department of Health and Human Services April 2009 – Federal Register Recent Federal Regulation Documents
Results 101 - 150 of 301
Meeting of the Advisory Committee on Minority Health
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (DHHS) is hereby giving notice that the Advisory Committee on Minority Health (ACMH) will hold a meeting. This meeting is open to the public. Preregistration is required for both public attendance and comment. Any individual who wishes to attend the meeting and/or participate in the public comment session should e-mail acmh@osophs.dhhs.gov.
Notice of Availability of Federal Matching Shares for Medicaid and Foster Care and Adoption Assistance
The Federal Medical Assistance Percentages (FMAPs) for the first two quarters of Fiscal Year 2009 have been recalculated pursuant to the American Recovery and Reinvestment Act (ARRA). These percentages will be effective from October 1, 2008 through March 31, 2009. This notice announces the calculated FMAPs that the U.S. Department of Health and Human Services (HHS) will use in determining the amount of Federal matching for State medical assistance under Title XIX and Title IV-E. The table gives figures for each of the 50 States and the District of Columbia. Adjusted figures are not shown for Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Commonwealth of the Northern Mariana Islands since territories have a choice between two methodologies to determine their recalculated figures. Programs under title XIX of the Act exist in each jurisdiction. The percentages in this notice only apply to State expenditures for most medical services and medical insurance services. The statute provides separately for Federal matching of administrative costs.
Guidance for Industry on Integrated Summaries of Effectiveness and Safety: Location Within the Common Technical Document; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Integrated Summaries of Effectiveness and Safety: Location Within the Common Technical Document.'' Since FDA began accepting new drug application (NDA) and biologics license application (BLA) submissions in the common technical document (CTD) format, there has been confusion regarding where within the CTD to include an integrated summary of effectiveness (ISE) and integrated summary of safety (ISS), both of which are required components of an NDA submission and recommended components of a BLA submission. This guidance informs applicants where to place the ISE and
Risk Evaluation and Mitigation Strategies for Certain Opioid Drugs; Notice of Public Meeting
The Food and Drug Administration (FDA) is announcing a public meeting to obtain input on developing Risk Evaluation and Mitigation Strategies (REMS) for certain opioid drugs. The REMS would be intended to ensure that the benefits of these drugs continue to outweigh certain risks. The agency has long been concerned about adverse events associated with this class of drug and has taken steps in cooperation
Agency Information Collection Activities; Proposed Collection; Comment Request; Draft Guidance, Emergency Use Authorization of Medical Products
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 proposed extension of the collection of information related to emergency use authorizations (EUAs) by the agency.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry: Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guidance for Industry: Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Draft Guidance for Industry on the Submission of Summary Bioequivalence Data for Abbreviated New Drug Applications; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Submission of Summary Bioequivalence Data for ANDAs.'' The draft guidance is intended to assist abbreviated new drug application (ANDA) applicants in complying with the new requirements in the final rule on the submission of bioequivalence data published in the Federal Register in January 2009. The final rule requires ANDA applicants to submit data from all bioequivalence studies (BE studies) the applicant conducts on a drug product formulation submitted for approval, including both studies that demonstrate and studies that fail to demonstrate that a generic product meets the current bioequivalence criteria. The draft guidance provides recommendations to applicants planning to include BE studies for submission in ANDAs, and is applicable to BE studies conducted during both preapproval and postapproval periods.
Meeting of the National Vaccine Advisory Committee
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the National Vaccine Advisory Committee (NVAC) will hold a meeting, to be held by teleconference. This meeting will be equivalent to an in-person meeting and will be open to the public. Pre- registration is required for both public attendance by phone as well as public comment. Any individual who wishes to attend the meeting and/or participate in the public comment session should e-mail nvpo@hhs.gov.
Oral Dosage Form New Animal Drugs; Fenbendazole Suspension
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 Intervet, Inc. The supplemental NADA provides for a revised human food safety warning for use of fenbendazole suspension in horses.
Agency Information Collection Activities: Submission for OMB Review; Comment Request; Retraction
On Friday, March 6, 2009 (74 FR 9820), the Centers for Medicare & Medicaid Services (CMS) published a Notice document titled ``Agency Information Collection Activities; Proposed Collection; Comment Request''. That notice invited public comments on one information collection. Through the publication of this document, CMS is retracting that notice requesting public comment on the Information Collection Requirement titled ``Electronic Health Records (EHR) Demonstration Web Enabled Application for Phase II'', form number CMS- 10165 (OMB 0938-0965).
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Current Good Manufacturing Practices and Related Regulations for Blood and Blood Components; and Requirements for Donor Testing, Donor Notification, and “Lookback”
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Current Good Manufacturing Practices and Related Regulations for Blood and Blood Components; and Requirements for Donor Testing, Donor Notification, and `Lookback''' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Draft Guidance for Industry and Food and Drug Administration Staff; Investigational Device Exemption Guidance for Retinal Prostheses; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Investigational Device Exemption (IDE) Guidance for Retinal Prostheses.'' This draft guidance document provides recommendations to industry about developing pre- clinical and clinical tests of retinal prosthetic devices for submission to FDA in an IDE application. This draft guidance is not final nor is it in effect at this time.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use
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.
Privacy Act of 1974; Notice of Modified System of Records
In accordance with the requirements of the Privacy Act of 1974, CMS is proposing to make minor amendments to an existing system of records (SOR) titled, ``Performance Measurement and Reporting System (PMRS),'' System No. 09-70-0584, published at 72 Federal Register 52133 (September 12, 2007), as amended by 73 Federal Register 80412 (December 31, 2008). PMRS serves as a master system of records to assist in projects that provide transparency in health care on a broad-scale enabling consumers to compare the quality and price of health care services so that they can make informed choices among individual physicians, practitioners, and other providers of services. We are making minor amendments to PMRS to include an additional legal authority: Section 109 of the Tax Relief and Health Care Act of 2006 (TRHCA) (Pub. L. 109-432). Section 109 of the TRHCA amended Section 1833(t) of the Social Security Act (42 U.S.C. 1395l(t)). This section mandates the establishment of a program for quality data reporting for hospital outpatient services and allow for the establishment of a program to require quality data reporting for ambulatory surgical center services. Accordingly, CMS is adding section 109 of TRCHA (42 U.S.C. 1395l(t)) and section 1833(t) of the Act to the PMRS' legal authority section.
Preparation for International Conference on Harmonisation Meetings in Yokohama, Japan; Public Meeting
The Food and Drug Administration (FDA) is announcing a public meeting entitled ``Preparation for ICH meetings in Yokohama, Japan'' to provide information and receive comments on the International Conference on Harmonisation (ICH) as well as the upcoming meetings in Yokohama, Japan. The topics to be discussed are the topics for discussion at the forthcoming ICH Steering Committee Meeting. The purpose of the meeting is to solicit public input prior to the next Steering Committee and Expert Working Groups meetings in Yokohama, Japan, scheduled for June 6 through 11, 2009, at which discussion of the topics underway and the future of ICH will continue, as well as provide comprehensive updates of the various ICH topics.
State Parent Locator Service; Safeguarding Child Support Information: Proposed Delay of Effective Date
In accordance with the Memorandum of January 20, 2009, from the Assistant to the President and Chief of Staff entitled ``Regulatory Review'' [74 FR 4435], the Department published a document in the Federal Register on March 3, 2009 [74 FR 9171], seeking public comment on a contemplated delay of 60 days in the effective date of the rule entitled ``State Parent Locator Service; Safeguarding Child Support Information,'' published in the Federal Register on September 26, 2008
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
