Department of Health and Human Services July 9, 2014 – Federal Register Recent Federal Regulation Documents
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Proposed Collection; 60-Day Comment Request; Evaluation of the NIH Academic Research Enhancement Award (NIH OD)
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Written comments and/or suggestions from the public and affected agencies are invited to address one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To Submit Comments and for Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Michelle M. Timmerman, Ph.D., Director, AREA Program, Office of the Director, National Institutes of Health, 6705 Rockledge Drive, Bethesda, Maryland 20892; or call non-toll-free number 301-402-0672; or email your request, including your address to michelle.timmerman@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Proposed Collection: Evaluation of the NIH Academic Research Enhancement Award, 0925-New, Office of the Director (OD), National Institutes of Health (NIH). Need and Use of Information Collection: The Academic Research Enhancement Award (AREA) Program is a grant mechanism spanning most of the Institutes and Centers (ICs) of the National Institutes of Health (NIH). The AREA program was established by Congress in 1985 to provide support to scientists at public and private colleges and universities that receive relatively small amounts of NIH funding. The purpose of the program is to support meritorious research, expose undergraduate and graduate students to research, and strengthen the research environment of the institutions receiving the grants. In the past three years alone, the federal government has awarded approximately 78 million dollars annually in AREA grants. The evaluation will allow the NIH and Congress to assess the extent to which the AREA program is meeting its goals and make recommendations so that this significant investment of public funds may be used as effectively as possible. The evaluation will utilize the NIH's archived data on grants, institutions, Principal Investigators (PIs), and students funded with AREA monies. The evaluation will collect new data about (1) the quantity and quality of student participation in AREA projects, (2) records of PIs' subsequent funding histories, (3) applicants' experiences with the application process, (4) PIs' experiences implementing AREA Program objectives, and (5) the impact of AREA Program research participation on student career paths and outcomes. The results of the evaluation will indicate the extent to which the AREA Program is meeting its goals of supporting meritorious research, strengthening the research environment at institutions of higher education that are not research intensive, and recruiting and training subsequent generations of the United States' biomedical scientist workforce. Intended audiences include the United States Congress, staff at NIH ICs that make AREA awards, and staff of the NIHOD. OMB approval is requested for one year. There are no costs to respondents other than their time. The total estimated annualized burden hours are 629.
Request for Notification From Industry Organizations Interested in Participating in the Selection Process for a Nonvoting Industry Representative and Request for Nominations for Nonvoting Industry Representatives on the Cellular, Tissue, and Gene Therapies Advisory Committee
The Food and Drug Administration (FDA) is requesting that any industry organizations interested in participating in the selection of a nonvoting industry representative to serve on the Cellular, Tissue, and Gene Therapies Advisory Committee for the Center for Biologics Evaluation and Research notify FDA in writing. FDA is also requesting nominations for a nonvoting industry representative to serve on the Cellular, Tissue, and Gene Therapies Advisory Committee. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for current or upcoming vacancies effective with this notice.
Prospective Grant of Start-Up Exclusive Evaluation Option License Agreement: AAV Mediated Aquaporin-1 Gene Transfer To Treat Sjögren's Syndrome
This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is contemplating the grant of a Start- Up Exclusive Evaluation Option License Agreement to Milo, LLC, a company having its headquarters in Cleveland, Ohio, to practice the inventions embodied in U.S. Provisional Patent Application No. 61/ 695,753, filed 20 April 2011 (HHS Ref. No. E-139-2011/1-US-01]), and PCT Patent Application No. PCT/US13/57632, filed 30 August 2013 (HHS Ref. No. E-139-2011/1-PCT-02), entitled ``AAV Mediated Aquaporin-1 Gene Transfer to Treat Sj[ouml]gren's Syndrome.'' The patent rights in these inventions have been assigned to or exclusively licensed to the Government of the United States of America. The territory of the prospective license may be worldwide and the field of use may be limited to: ``the use of the Licensed Patent Rights, limited to AAV mediated aquaporin-1, for the treatment of Sj[ouml]gren's syndrome in humans.'' Upon the expiration or termination of the Start-Up Exclusive Evaluation Option License Agreement, Milo 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.
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. 209 and 37 CFR Part 404 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.
Agency Information Collection Activities: Proposed Collection; 30-Day Public Comment Request; Communications Testing for Comprehensive Communication Campaign for HITECH ACT
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the National Coordinator for Health Information Technology (ONC), Department of Health and Human Services, announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). The ICR is for extending the use of the approved information collection assigned OMB control number 0955-0005, which expires on July 31, 2014. Prior to submitting that ICR to OMB, ONC seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Office of the National Coordinator for Health Information Technology; Announcement of Requirements and Registration for “EHR Innovations for Improving Hypertension Challenge”
The goal of the EHR Innovations for Improving Hypertension Challenge is to seek practices that have used clinical decision support (CDS) to implement the most clinically successful examples of an evidence-based blood pressure treatment protocol, gather details about these tools and their implementation, and then drive widespread implementation of those tools by other providers. In Phase 1 (three months), practices will document the CDS tools they used to implement an evidence-based BP control protocol, as well as describe the details and results of the implementation. Practices must demonstrate high BP control levels and/ or improvement to ensure that tools and strategies merit replication across practice settings. In Phase 2 (nine months), practices and their partners will conduct, evaluate and document dissemination strategies for tools identified in Phase 1, emphasizing widespread, effective use of these tools by other practices. Submitters must demonstrate successful use of these tools in at least 2 additional practices. The statutory authority for this challenge competition is Section 105 of the America COMPETES Reauthorization Act of 2010 (Public L. No 111-358).
Agency Information Collection Activities; Proposed Collection; Comment Request; Certification to Accompany Drug, Biological Product, and Device Applications or Submissions
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 requirements for certain FDA applications or submissions to be accompanied by a certification, Form FDA 3674, to ensure all applicable statutory requirements have been met.
Draft Guidance for Industry: Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products'' dated July 2014. The draft guidance document provides sponsors of virus or bacteria-based gene therapy products (VBGT products) and oncolytic viruses or bacteria (oncolytic products) with recommendations on how to conduct shedding studies during preclinical and clinical development.
Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 036
The Food and Drug Administration (FDA or we) is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (``FDA Recognized Consensus Standards''). This publication, entitled ``Modifications to the List of Recognized Standards, Recognition List Number: 036'' (``Recognition List Number: 036''), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.
Decision To Evaluate a Petition To Designate a Class of Employees From the General Atomics Facility in La Jolla, California, To Be Included in the Special Exposure Cohort
NIOSH gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees from the General Atomics facility in La Jolla, California, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: General Atomics. Location: La Jolla, California. Job Titles and/or Job Duties: All Atomic Weapons Employees who worked for General Atomics at its facility in La Jolla, California, during the period from January 1, 1960 through December 31, 1969, for a number of work days aggregating at least 250 work days, occurring either solely under this employment or in combination with work days within the parameters established for one or more other classes of employees included in the Special Exposure Cohort. Period of Employment: January 1, 1960 through December 31, 1969.
Agency Information Collection Activities: Proposed Collection; Comment Request
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Improving Hospital Informed Consent With an Informed Consent Toolkit.'' In accordance with the Paperwork Reduction Act, AHRQ invites the public to comment on this proposed information collection.
Agency Information Collection Activities: Proposed Collection; Comment Request
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Taking Efficiency Interventions in Health Services Delivery to Scale.'' In accordance with the Paperwork Reduction Act of 1995, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on April 8th, 2014, and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment.
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