Department of Health and Human Services July 16, 2014 – Federal Register Recent Federal Regulation Documents
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Food and Drug Administration Third Annual Patient Network Meeting; Under the Microscope: Pediatric Drug Development
The Food and Drug Administration (FDA), Office of Health and Constituent Affairs (OHCA) is announcing a 1-day meeting to explore challenges related to pediatric product development. The meeting will serve as a forum for FDA's stakeholders (patients, caregivers, patient advocates, healthcare professional groups, the general public, academia, and industry) to learn about regulations that encourage pediatric product development; to discuss ways to advance pediatric product development, how health disparities impact pediatric product development, the importance of transparency in pediatric clinical trials, and how analysis of information from failed pediatric clinical trials might improve future designs for pediatric trials; and to identify ways patient input can benefit clinical trial design for pediatric trials. The 1-day meeting will also provide an opportunity to participate in panel discussions on the challenges related to development of products used to treat pediatric patients, including pediatric patients with rare diseases and explore ways that patients/caregivers, FDA, and industry may work together to incorporate patient input in future pediatric product development and regulatory decisionmaking.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; User Fee Waivers, Reductions, and Refunds for Drug and Biological Products
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; Exception From General Requirements for Informed Consent
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.
Small Entity Compliance Guide: Requirements for the Submission of Data Needed To Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Requirements for the Submission of Data Needed to Calculate User Fees for Domestic Manufacturers and Importers of Tobacco ProductsSmall Entity Compliance Guide'' for a final rule published in the Federal Register of July 10, 2014. This small entity compliance guide (SECG) is intended to set forth in plain language the requirements of the regulation and to help small businesses understand and comply with the regulation.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile
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 (PRA).
Secretarial Review and Publication of the Annual Report to Congress and the Secretary Submitted by the Contracted Consensus-Based Entity Regarding Performance Measurement
This notice acknowledges the Secretary of the Department of Health and Human Services' (HHS) receipt and review of the 2014 Annual Report to Congress and the Secretary submitted by the contracted consensus-based entity (CBE) as mandated by section 1890(b)(5) of the Social Security Act, as created by section 183 of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) and amended by section 3014 of the Affordable Care Act of 2010. The statute requires the Secretary to review and publish the report in the Federal Register together with any comments of the Secretary on the report not later than six months after receiving the report. This notice fulfills those requirements.
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