Department of Health and Human Services April 2014 – Federal Register Recent Federal Regulation Documents

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 Institute of Mental Health (NIMH), 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 on 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: Keisha Shropshire, NIMH Project Clearance Liaison, Science Policy and Evaluation Branch, OSPPC, NIMH, NIH, Neuroscience Center, 6001 Executive Boulevard, MSC 9667, Rockville Pike, Bethesda, MD 20892, or call 301-443-4335 or Email your request, including your address to: kshropsh@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: NIMH Database of Cognitive Training and Remediation Studies, 0925-New; National Institute of Mental Health (NIMH), National Institutes of Health (NIH). Need and Use of Information Collection: The NIMH Database of Cognitive Training and Remediation Studies (DCTRS) is an integrated database that includes study- and subject-level data from studies of cognitive remediation (CR) in schizophrenia. DCTRS will allow NIMH staff and interested investigators to examine the ways in which various patient characteristics, intervention approaches and features, and treatment combinations affect responses to remediation. The DCTRS Study Information Form and Data Submission Agreement are necessary for the ``Submitter'' to request permission to submit study data to the NIMH DCTRS for general research purposes. The primary use of this information is to collect submitter information and study information for inclusion in the NIMH DCTRS database. The DCTRS data submission agreement includes two forms: (1) The data submission form that includes the terms, agreement, submitter information and certifications, and (2) the study information form which collects de- identified data for each study. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 60.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during March 2014. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of sponsorship for an ANADA.

This document announces a public hearing to receive information and views on the Notice of Proposed Rulemaking (NPRM) entitled ``National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table.''

This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant to University of Texas MD Anderson Cancer Center, of an exclusive option license to practice the inventions embodied in the following US Patents and US Patent Applications (and all foreign counterparts) for the continued research and development of the inventions: US Patent Application Serial No. 13/ 890,502, entitled, ``Viral Chemokine-antigen Fusion Proteins'' [HHS Ref. No. E-194-2000/0-US-06] and in US Patent Serial No. 8,258,278 and US Patent Application Serial No.13/587,515, both entitled ``Methods and Compositions for the Treatment and Prevention of Cancer'' [HHS Ref. Nos. E-271-2006/0-US-03 and E-271-2006/0-US-04, respectively]. The patent rights in this invention have been assigned to the Government of the United States of America. The exclusive option license may be term-limited, the prospective territory may be worldwide, and the field of use may be limited to:

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the National Biodefense Science Board (NBSB) will be holding a public meeting on April 29, 2014.

The Health Resources and Services Administration (HRSA) announces that the listing of entities and associated Health Professional Shortage Area (HPSA) scores that will receive priority for the assignment of National Health Service Corps (NHSC) scholarship recipients serving as Corps members, as well as those serving under the Private Practice Option (``NHSC scholars'' collectively), during the period July 1, 2014, through September 30, 2015, is posted on the NHSC Web site at https://nhscjobs.hrsa.gov. The NHSC Jobs Center includes all sites that are approved for performance of service by NHSC scholars; however, note that entities on this list may or may not have current job vacancies.

This notice of proposed rulemaking would establish program performance standards for Runaway and Homeless Youth grantees providing services to eligible youth and their families. It also proposes revisions to reflect statutory changes, and to update procedures for soliciting and awarding grants. The proposed performance standards would be newly specified in regulation, but would build on standards already used by the program as priorities in funding opportunity solicitations and awards, in technical assistance, and in reporting requirements.

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. 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 or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

The Administration for Community Living (ACL) 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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection requirements relating to the Supplemental Form to the Financial Status Report for all ACL/AoA Title III Grantees.

The Administration for Community Living (ACL) is proud to announce the Paralysis Resource Center (PRC) is moving to ACL as a result of the 2014 budget recently signed by President Obama. ACL was formed in April 2012 to advance policy and implement programs that support the rights of older Americans and people with disabilities to live in their communities throughout their lifespan. The mission of the PRC aligns perfectly with ACL's mission and provides the Administration with important new programmatic opportunities to help persons with physical disabilities as well as older adults and people with developmental disabilities. The PRC provides a comprehensive, national source of information for people living with paralysis and their families to promote health, foster involvement in the community, and improve quality of life. Resources on spinal cord injury, paralysis and mobility-related disabilities, including information and referral by phone and email are available in English and Spanish. The PRC currently operates through a cooperative agreement between the Christopher & Dana Reeve Foundation and the U.S. Department of Health and Human Services (HHS) Centers for Disease Control and Prevention (CDC). ACL will be working with the CDC on transitioning the program to ACL. Program Name: Paralysis Resource Center. Award Amount: Up to $6,683,000. Project Period: 6/1/2014 to 5/31/2015. Award Type: Cooperative Agreement.

The Food and Drug Administration (FDA) has determined that ZOVIRAX (acyclovir sodium) Injection, equivalent to (EQ) 250 milligrams (mg) base/vial, 500 mg base/vial, and 1gram (g) base/vial, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for ZOVIRAX (acyclovir sodium) Injection, EQ 250 mg base/vial, 500 mg base/vial, and 1 g base/vial, if all other legal and regulatory requirements are met.

The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the expanded safe use of spirulina extract as a color additive in food. This action is in response to a petition filed by GNT USA, Inc.

The National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) announces a ``Collaborative Workshop on Aquatic Models and 21st Century Toxicology.'' The workshop proposes to explore and discuss how small aquarium fish species may be used as model organisms to screen and prioritize compounds for further in vivo testing and assess mechanisms of chemical toxicity. Discussions will focus on the application of these models to the field of environmental health while leveraging the techniques and knowledge of broad-based, interdisciplinary research.