Department of Health and Human Services May 8, 2013 – Federal Register Recent Federal Regulation Documents
Results 1 - 18 of 18
David Freeman: Debarment Order
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring David Freeman for 5 years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Mr. Freeman was convicted of introducing and delivering for introduction into interstate commerce of a misbranded drug, which relates to the development or approval, including the process for development or approval, of drug products and to the regulation of drug products under the FD&C Act. In addition, FDA determined that the type of conduct that served as the basis for Mr. Freeman's conviction undermines the process for the regulation of drugs. Mr. Freeman was given notice of the proposed debarment and an opportunity to request a hearing within the prescribed timeframe by regulation, but failed to respond. Mr. Freeman's failure to respond constitutes a waiver of his right to a hearing concerning this action.
Summary of Responses To Request for Information (RFI): Opportunities To Apply a Department of Health and Human Services Message Library To Advance Understanding About Toddler and Preschool Nutrition and Physical Activity
On January 29, 2013, the Health Resources and Services Administration (HRSA) issued a Request for Information (RFI) to solicit ideas and information related to ways in which the U.S. Department of Health and Human Services (HHS) can work with interested partners to disseminate and apply TXT4Tots, a library of short, evidence-based messages on nutrition and physical activity targeted to parents, caregivers, and health care providers of children ages 1-5 years. HRSA released the TXT4Tots library in English and Spanish on February 19, 2013; and followed with an Open Forum on February 20, 2013, to provide further opportunity for input on dissemination and application of the library of messages. HHS received over 25 written responses to the RFI, and approximately 100 individuals participated in the Open Forum. Comments and Responses: The written responses to the RFI as well as the comments received through the Open Forum indicate that TXT4Tots aligns with the activities of many existing organizations and programs. Several of the respondents expressed an interest in collaborative opportunities to incorporate the messages into current outreach and educational efforts. Some examples of current programs that could leverage the TXT4Tots messages include initiatives at the federal, state, and local levels. The majority of the suggested organizations and programs focus on promoting healthy choices for children and their families. Recommendations included integrating the TXT4Tots messages into their programs and services or using the internet to disseminate the information through Web sites and social media. Respondents also emphasized that mobile health, social media, and other innovative strategies are a valuable resource to reach a diverse population and can be effectively leveraged to support equitable access to health information. With regard to vehicles for dissemination of the TXT4Tots messages, respondents suggested that they needn't be complicated, but should be user friendly. In addition, respondents noted that the most effective tools for dissemination are those that can fully engage the end users. Specific suggestions for dissemination of the TXT4Tots messages included social media, existing tools and applications, existing Web sites and web services, and text messages, as well incorporating messages into baby product packaging, curricula, health fairs, emails, newsletters, and print materials. Emphasis was placed on leveraging existing platforms that promote healthy choices for young children and could readily integrate the TXT4Tots message content. Respondents also recommended that the TXT4Tots messages be linked to additional sources of information; for example, if utilized as a text message program, URLs could be included to link the message recipients to Web sites with additional information. In addition, social media posts could link to Web sites with ideas for healthy recipes and age-appropriate activities to compliment the messages. Some respondents indicated that the use of certain technology-based platforms may restrict access to the underserved, who might have limited access to smartphones or the internet. One additional concern that was voiced by numerous respondents was confusion regarding the purpose of TXT4Tots and how it is intended to be used. Specifically, it was unclear that this is a library of messages that could be used in a variety of existing platforms and products and not exclusively a text messaging service. Guidance regarding specific details about the use of the TXT4Tots messages has been added to the TXT4Tots Web page (https:// www.hrsa.gov/healthit/txt4tots). HRSA appreciates all of the thoughtful comments received either via the RFI or Open Forum. Guidance regarding specific details about the use of the TXT4Tots messages has been added to the TXT4Tots Web page (https://www.hrsa.gov/healthit/txt4tots). It is our hope that the thoughtful recommendations and comments will spur others to explore innovative ways for disseminating the TXT4Tots content.
Agency Information Collection Activities; Submission for OMB Review; Comment Request; State Program Report
The Administration for Community Living (ACL) is announcing that the proposed collection of information listed below 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: Evaluation of the Program for Enhanced Review Transparency and Communication for New Molecular Entity New Drug Applications and Original Biologics License Applications in Prescription Drug User Fee Act
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.
Guidance for Industry: Implementation of an Acceptable Abbreviated Donor History Questionnaire and Accompanying Materials for Use in Screening Frequent Donors of Blood and Blood Components; Availability
The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Implementation of an Acceptable Abbreviated Donor History Questionnaire and Accompanying Materials for Use in Screening Frequent Donors of Blood and Blood Components'' dated May 2013. The guidance document recognizes the abbreviated donor history questionnaire and accompanying materials (aDHQ documents), version 1.3 dated December 2012, prepared by the AABB Donor History Task Force, as an acceptable mechanism for collecting blood donor history information from frequent donors of blood and blood components that is consistent with FDA's requirements and recommendations for collecting donor history information. The aDHQ documents will provide blood establishments that collect blood and blood components with a specific process for administering questions to frequent donors of blood and blood components to determine their eligibility to donate. The guidance announced in this notice finalizes the draft guidance of the same title dated October 2011.
510(k) Device Modifications: Deciding When To Submit a 510(k) for a Change to an Existing Device; Public Meeting; Request for Comments
The Food and Drug Administration (FDA) is announcing the public meeting entitled ``510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device.'' The focus of this meeting is FDA's interpretation of its regulations concerning when a modification made to a 510(k)-cleared device requires a new 510(k) submission.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Public Health Service Guideline on Infectious Disease Issues on Xenotransplantation
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Public Health Service Guideline on Infectious Disease Issues on Xenotransplantation'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Administration for Native Americans Tribal Consultation; Notice of Meeting
The Department of Health and Human Services (HHS), Administration for Children and Families (ACF) will host a tribal consultation to consult on ACF programs and tribal priorities.
Prospective Grant of Start-Up Exclusive Evaluation Option License Agreement: Gene Therapy and Cell-Based Therapy for Cardiac Arrhythmias
This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of a Start-Up Exclusive Evaluation Option License Agreement to Pace Biologics, LLC, a company having a place of business in Elkridge, Maryland, to practice the inventions embodied in U.S. Provisional Patent Application No. 61/ 180,491, filed May 22, 2009 (HHS Ref. No. E-134-2009/0-US-01), PCT Patent Application No. PCT/US2010/035823, filed May 21, 2010 (HHS Ref. No. E-134-2009/0-PCT-02), and U.S. Patent Application No. 13/322,066, filed November 22, 2011 (HHS Ref. No. E-134-2009/0-US-03), all entitled ``Engineered Biological Pacemakers.'' The patent rights in these inventions have been assigned to the Government of the United States of America. The territory of the prospective Start-Up Exclusive Evaluation Option License Agreement may be worldwide, and the field of use may be limited to ``Gene therapy and cell-based therapy for cardiac arrhythmias in humans.'' Upon the expiration or termination of the Start-up Exclusive Evaluation Option License Agreement, Pace Biologics will have the exclusive right to execute a Start-Up Exclusive Patent License Agreement which will supersede and replace the Start-up Exclusive Evaluation Option License Agreement, with no greater field of use and territory than granted in the Start-up Exclusive Evaluation Option License Agreement.
Prospective Grant of Exclusive License: Use of Oligodeoxynucleotide as Neuroprotectants in Cerebral and Other Ischemic Injury
This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of an exclusive license to practice the inventions embodied in U.S. provisional patent application No. 60/176/115 (E-078-2000/0-US-01) filed 1/14/2000; PCT application No. PCT/US01/01122 (E-078-2000/0-PCT- 02) filed 1/12/2001; U.S. patent No. 7,521,063 (E-078-2000/1-US-01) filed 07/12/2002 and issued 04/21/2009; U.S. patent No. 7,919,477 (E- 078-2000/1-US-02) filed 05/10/2007and issued 04/05/2011; U.S. patent No. 8,232,259 (E-078-2000/1-US-03) filed 02/11/2011 and issued 07/31/ 2012; E.U. patent No. 1322655 (E-078-2000/0-EP-03) filed 1/12/2001 and issued 11/14/2007 and validated in AT, GB, and IE (E-078-2000/0-AT-05, E-078-2000/0-GB-07, & E-078-2000/0-IE-08) and issued 12/13/2007 as patent No. 6031430 and validated in Germany (E-078-2000/0-DE-06); and E.U. patent application No. 07021557.9 (E-078-2000/0-EP-04) filed 11/ 05/2007; each entitled ``Oligodeoxynucleotide and Its Use to Induce an Immune Response''; by Klinman et al. (FDA) to Oregon Health Sciences University having a place of business at 3181 SW. Sam Jackson Park Rd. Portland, Oregon 97239. The patent rights in this invention have been assigned to the United States of America.
Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2014
This proposed rule would update the prospective payment rates for inpatient rehabilitation facilities (IRFs) for federal fiscal year (FY) 2014 (for discharges occurring on or after October 1, 2013 and on or before September 30, 2014) as required by the statute. We are also proposing to revise the list of diagnosis codes that are used to determine presumptive compliance under the ``60 percent rule,'' update the IRF facility-level adjustment factors, revise sections of the Inpatient Rehabilitation Facility-Patient Assessment Instrument, revise requirements for acute care hospitals that have IRF units, clarify the IRF regulation text regarding limitation of review, update references to previously changed sections in the regulations text, and revise and update quality measures and reporting requirements under the IRF quality reporting program.
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