Department of Health and Human Services May 18, 2015 – Federal Register Recent Federal Regulation Documents
Results 1 - 19 of 19
Notice of Intent To Award a Single Source Non-Competing Continuation Cooperative Agreement for Two National Activities Grant Projects Under Section 6 of the Assistive Technology Act of 1998,
The Administration for Community Living (ACL) is transitioning the Rehabilitation Engineering and Assistive Technology Society of North America (RESNA) Catalyst Project Assistive Technology Technical Assistance Center (AT TA Center) and the University of New Hampshire Institute on Disability Assistive Technology Public Internet Site (National AT Web site) to ACL as a result of the Workforce Opportunity Improvement Act (Pub. L. 113-128) signed by President Obama in July 2014. The RESNA Catalyst Project is a national training and technical assistance center for assistive technology programs that provides comprehensive information and state-specific, regional and national resources to entities funded under Sections 4 and 5 of the AT Act to improve the implementation and effectiveness of their programs, and to provide appropriate technical assistance and training to entities not funded under the AT Act to improve awareness of and access to assistive technology. The University of New Hampshire Institute on Disability supports the renovation, updating, and maintenance of an accessible National AT Web site that provides the public comprehensive, up-to-date information on accommodating individuals with disabilities and resources related to assistive technology, including but not limited to programs under the AT Act. The RESNA Catalyst Project and New Hampshire National AT Web site previously operated through a cooperative agreement with the U.S. Department of Education, Rehabilitation Services Administration. The Department of Health and Human Services is currently transitioning programs under the AT Act to ACL.
Cooperative Agreement to International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use
The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). The goal of the ICH is to bring together leading global drug regulatory agencies and pharmaceutical manufacturer associations to achieve greater harmonization of technical standards to ensure that safe, effective, and high-quality medicines are developed and registered in the most resource-efficient manner.
Electronic Study Data Submission; Data Standards; Study Data Standardization Plan Recommendations
The Food and Drug Administration (FDA) is announcing the availability of draft recommendations for preparing a Study Data Standardization Plan (Standardization Plan). The Standardization Plan is referenced in the Study Data Technical Conformance Guide (Guide). The Guide supplements the guidance for industry ``Providing Regulatory Submissions in Electronic FormatStandardized Study Data'' and provides specifications, recommendations, and general considerations on submitting standardized study data using FDA-supported data standards. The Guide recommends that, for clinical and nonclinical studies, sponsors include a plan that describes the submission of standardized study data to FDA. The proposed recommendations describe the information that should be included in the Standardization Plan. The proposed recommendations for creating a Standardization Plan are posted on FDA's Study Data Standards Resources Web page at https://www.fda.gov/ forindustry/datastandards/studydatastandards/default.htm.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Infant Formula Requirements
The Food and Drug Administration (FDA) is announcing that a collection of information entitled, ``Infant Formula Requirements'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Adaptive Designs for Medical Device Clinical Studies; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Adaptive Designs for Medical Device Clinical Studies; Draft Guidance for Industry and Food and Drug Administration Staff.'' This guidance provides sponsors and FDA staff with guidance on how to plan and implement adaptive designs for clinical studies when used in medical device development programs. An adaptive design for a medical device clinical study is defined as a clinical trial design that allows for prospectively planned modifications based on accumulating study data without undermining the trial's integrity and validity. Adaptive designs, when properly implemented, can reduce resource requirements and/or increase the chance of study success. This draft guidance is not final nor is it in effect at this time.
Patient Preference Information-Submission, Review in Premarket Approval Applications, Humanitarian Device Exemption Applications, and De Novo Requests, and Inclusion in Device Labeling; Draft Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Patient Preference InformationSubmission, Review in PMAs, HDE Applications, and De Novo Requests, and Inclusion in Device Labeling.'' This document provides guidance on collecting and submitting patient preference information that may be used by FDA staff in decisionmaking relating to premarket approval applications (PMAs), Humanitarian Device Exemption (HDE) applications, and de novo requests. This draft guidance also outlines considerations for including patient preference information in labeling for patients and health care professionals. This draft guidance is not final nor is it in effect at this time.
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