Department of Health and Human Services April 13, 2015 – Federal Register Recent Federal Regulation Documents
Results 1 - 10 of 10
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Evaluation of the Food and Drug Administration's ‘Fresh Empire’ Multicultural Youth Tobacco Prevention Campaign
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.
Expedited Access for Premarket Approval and De Novo Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions; Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or the Agency) is announcing the availability of the guidance entitled ``Expedited Access for Premarket Approval and De Novo Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions.'' This guidance outlines FDA's new, voluntary program for certain medical devices that demonstrate the potential to address unmet medical needs for life threatening or irreversibly debilitating diseases or conditions and that are subject to premarket approval (PMA) applications or de novo classifications. FDA believes that the Expedited Access Pathway (EAP) program will help patients have more timely access to these medical devices by expediting their development, assessment, and review, while preserving the statutory standard of reasonable assurance of safety and effectiveness for premarket approval, consistent with the Agency's mission to protect and promote public health. The document also discusses how the EAP program approaches the balance of premarket and postmarket data collection and incorporates a benefit-risk framework. The EAP program will become effective April 15, 2015.
Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval; Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval.'' This guidance clarifies FDA's current policy on balancing premarket and postmarket data collection during the Agency's review of premarket approval applications (PMA). Specifically, this guidance outlines how FDA considers the role of postmarket information in determining the appropriate type and amount of data that should be collected in the premarket setting to support premarket approval, while still meeting the statutory standard of safety and effectiveness. FDA believes this guidance will improve patient access to safe and effective medical devices that are important to public health by improving the predictability, consistency, transparency, and efficiency of the premarket process.
Determination of Regulatory Review Period for Purposes of Patent Extension; ELVITEGRAVIR
The Food and Drug Administration (FDA) has determined the regulatory review period for ELVITEGRAVIR (as a component of STRIBILD) and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Performance Standards for Ionizing Radiation Emitting Products; Fluoroscopic Equipment; Correction
The Food and Drug Administration (FDA) is proposing to amend a Federal performance standard for ionizing radiation to correct a drafting error regarding fluoroscopic equipment measurement. We are taking this action to ensure clarity and improve the accuracy of the regulations.
Performance Standards for Ionizing Radiation Emitting Products; Fluoroscopic Equipment; Correction
The Food and Drug Administration (FDA) is amending a Federal performance standard for ionizing radiation to correct a drafting error regarding fluoroscopic equipment measurement. We are taking this action to ensure clarity and improve the accuracy of the regulations.
Preparation for International Conference on Harmonization Steering Committee and Expert Working Group Meetings in Fukuoka, Japan; Public Meeting
The Food and Drug Administration (FDA) is announcing a regional public meeting entitled ``Preparation for ICH Steering Committee and Expert Working Group Meetings in Fukuoka, Japan'' to provide information and receive comments on the International Conference on Harmonization (ICH) as well as the upcoming meetings in Fukuoka, 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 Group meetings in Fukuoka, Japan, scheduled on June 6 through 11, 2015, at which the discussion of the topics underway and ICH reforms will continue.
Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request
In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for reinstatement of a previously-approved information collection assigned OMB control number 0990-0391, which expired on March 31, 2015. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
