Department of Health and Human Services March 2013 – Federal Register Recent Federal Regulation Documents
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Special Fraud Alert: Physician-Owned Entities
This Special Fraud Alert addresses physician-owned entities that derive revenue from selling, or arranging for the sale of, implantable medical devices ordered by their physician-owners for use in procedures the physician-owners perform on their own patients at hospitals or ambulatory surgical centers (ASCs).
Proposed Collection; 60-day Comment Request: Quantification of Behavioral and Physiological Effects of Drugs Using a Mobile Scalable Device
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 on Drug Abuse (NIDA), 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 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 NIDA Program Official: Dr. Steve Gust, National Institute on Drug Abuse, 6001 Executive Blvd., Bethesda, MD 20892, or call non-toll-free number (301) 443-6480 or Email your request, including your address to: sgust@nida.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Comments 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: Quantification of Behavioral and Physiological Effects of Drugs Using a Mobile Scalable Device, 0925-New, National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH). Need and Use of Information Collection: This study will examine the effectiveness of a mobile scalable device to detect the impairing effects of different drugs. The primary purpose of the data collected is to determine eligibility in a driving simulation study and to verify the effectiveness of the experimental manipulations. The findings will provide valuable information concerning the utility and effectiveness of mobile, smartphone/tablet-based neurocognitive assessment that can provide a multifactorial evaluation of cognitive functioning associated with impaired driving. OMB approval is requested for 18 months. There are no costs to respondents other than their time. The total annualized burden hours are 58.
Medicare and Medicaid Programs; Announcement of Application From a Hospital Requesting Waiver for Organ Procurement Service Area
A hospital has requested a waiver of statutory requirements that would otherwise require the hospital to enter into an agreement with its designated Organ Procurement Organization (OPO). The request was made in accordance with section 1138(a)(2) of the Social Security Act (the Act). This notice requests comments from OPOs and the general public for our consideration in determining whether we should grant the requested waiver.
Draft Guidance for Industry on Bioequivalence Recommendations for Metronidazole Vaginal Gel; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Bioequivalence Recommendations for Metronidazole Vaginal Gel.'' The guidance provides specific recommendations on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for metronidazole vaginal gel.
Agency Information Collection Activities; Proposed Collection; Comment Request
In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Pub. L. 104-13), the Health Resources and Services Administration (HRSA) publishes periodic summaries of proposed projects being developed for submission to the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email paperwork@hrsa.gov or call the HRSA Reports Clearance Officer at (301) 443-1984. HRSA especially requests comments on: (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. Information Collection Request Title: The Health Education Assistance Loan (HEAL) Program: Physician's Certification of Borrower's Total and Permanent Disability Form (OMB No. 0915-0204)-Extension Abstract: The Health Education Assistance Loan (HEAL) program provided federally-insured loans to students in schools of allopathic medicine, osteopathic medicine, dentistry, veterinary medicine, optometry, podiatric medicine, pharmacy, public health, allied health, or chiropractic, and graduate students in health administration or clinical psychology through September 30, 1998. Eligible lenders, such as banks, savings and loan associations, credit unions, pension funds, state agencies, HEAL schools, and insurance companies, made new refinanced HEAL loans which are insured by the federal government against loss due to borrower's death, disability, bankruptcy, and default. The basic purpose of the program was to assure the availability of funds for loans to eligible students who needed to borrow money to pay for their educational loans. Currently, the program monitors the federal liability and assists in default prevention activities. The HEAL borrower, the borrower's physician, and the holder of the loan complete the Physician's Certification form to certify that the HEAL borrower meets the total and permanent disability provisions. The Department uses this form to obtain detailed information about disability claims which includes the following: (1) The borrower's consent to release medical records to the Department of Health and Human Services and to the holder of the borrower's HEAL loans; (2) pertinent information supplied by the certifying physician; (3) the physician's certification that the borrower is unable to engage in any substantial gainful activity because of a medically determinable impairment that is expected to continue for a long and indefinite period of time or to result in death; and (4) information from the lender on the unpaid balance. Failure to submit the required documentation will result in disapproval of a disability claim. No changes have been made to the current form. Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose or provide the information requested. This includes the time needed to review instructions, to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information, to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information, and to transmit or otherwise disclose the information. The total annual burden hours estimated for this Information Collection Request are summarized in the table below. The annual estimate of burden is as follows:
Ryan White HIV/AIDS Program, Part C Early Intervention Services Grant Under the Ryan White HIV/AIDS Program
To prevent a lapse in comprehensive primary care services for persons living with HIV/AIDS, HRSA will provide a one-time noncompetitive Part C funds award to the University of Alabama at Birmingham (UAB).
Prospective Grant of Start-Up Exclusive License: Photosensitizing Antibody-Fluorophore Conjugates for Photoimmunotherapy
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 (HHS), is contemplating the grant of a worldwide exclusive patent license, to practice the inventions embodied in PCT patent application PCT/US2012/044421, filed June 27, 2012 (HHS Reference E-205-2010/2-PCT-01), which is a continuation-in-part of U.S. Application No. 13/180,111 (E-205-2010/1- US-01) which claims priority to U.S. provisional application No. 61/ 363,079 (E-205-2010/0-US-01), and entitled ``Photosensitizing Antibody- Fluorophore Conjugates,'' to Aspyrian Therapeutics, Inc., a company incorporated under the laws of the State of Delaware, having its headquarters in San Diego, California. The United States of America is the assignee of the rights of the above invention. The field of use may be limited to ``use of photosensitizing antibody-fluorophore conjugate by itself for Photoimmunotherapy (PIT), or in combination with cancer therapeutic agents, to treat cancer or pre-cancerous hyperplasia'', and may be further limited to certain types of cancer and/or specific platforms. The license will include the priority case US 13/180,111, which is currently licensed to Aspyrian under an exclusive evaluation option license. The exclusive commercialization license proposed in this notice will supersede and replace the exclusive evaluation option license.
World Trade Center Health Program Eligibility Requirements for Shanksville, Pennsylvania and Pentagon Responders
Title I of the James Zadroga 9/11 Health and Compensation Act of 2010 amended the Public Health Service Act (PHS Act) by adding Title XXXIII, which establishes the World Trade Center (WTC) Health Program. The WTC Health Program is administered by the Director of the National Institute for Occupational Safety and Health (NIOSH), within the Centers for Disease Control and Prevention (CDC), in the Department of Health and Human Services (HHS), and provides medical monitoring and treatment to eligible firefighters and related personnel, law enforcement officers, and rescue, recovery, and cleanup workers who responded to the September 11, 2001, terrorist attacks in New York City, Shanksville, Pennsylvania, and at the Pentagon, and to eligible survivors of the New York City attacks. Section 3311(a)(2)(C) of the PHS Act requires the WTC Program Administrator (Administrator) to develop eligibility criteria for enrollment of Shanksville, Pennsylvania and Pentagon responders. This interim final rule establishes those eligibility criteria.
Agency Information Collection Activities; Proposed Collection; Public Comment Request
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit a new Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting that ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Antibodies to Borrelia burgdorferi; Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Antibodies to Borrelia burgdorferi.'' FDA is issuing this guidance to provide industry and Agency staff with recommendations for studies to establish the analytical and clinical performance of in vitro diagnostic devices (IVDs) intended for the detection of antibodies to B. burgdorferi. These devices are used to aid in the diagnosis of Lyme disease.
Announcement of the Award of Fifteen Single-Source Program Expansion Supplement Grants to Unaccompanied Alien Children's Shelter Care Grantees
The Administration for Children and Families (ACF), Office of Refugee Resettlement (ORR) announces the award of fifteen single-source program expansion supplement grants to the following ten current grantees, for a total of $47,168,490.
Proposed Collection; 60-Day Comment Request; Web-based Media Literacy Parent Training for Substance Use Prevention in Rural Locations
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 on Drug Abuse (NIDA), 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 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, contact Dr. Augie Diana, Health Scientist Administrator, Prevention Research Branch, Division of Epidemiology, Services, and Prevention Research, NIDA, NIH, 6001 Executive Boulevard, Room 5163, Bethesda, MD 20892, or call non-toll- free number (301) 443-1942 or Email your request, including your address to: dianaa@nida.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Comments 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: Web-based Media Literacy Parent Training for Substance Use Prevention in Rural Locations, 0925-New, National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH). Need and Use of Information Collection: This study will develop a web-based media literacy substance use prevention intervention for use with parents and their elementary school children (approximately ages 7-12), and will evaluate the program in a randomized controlled trial to establish program efficacy in six rural communities in North Carolina and Texas. The primary objectives of the study are to assess the efficacy of a media literacy education program that is specifically designed to overcome barriers to prevention efforts in rural communities, and to provide the scientific basis for establishing the program, Media Detective Family, as an evidence-based substance use prevention curriculum. The information will provide valuable information concerning: (1) The appropriateness of using technology for substance use prevention programming (i.e., internet, Smartphone, or tablet-based applications) to reach rural families with elementary school-aged children; (2) improvements in parents' and children's critical thinking skills associated with intervention exposure; (3) improvements in parent-child communication about substances and the media associated with intervention exposure; and (4) reductions in children's behavioral intentions to use substances associated with intervention exposure. OMB approval is requested for two years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 1067.
Notice of the Implementation of the National Institutes of Health (NIH) Electronic Vendor Invoice Program (eVIP)
The purpose of this notice is to announce the future implementation of the Electronic Vendor Invoice Program (eVIP) at the National Institutes of Health (NIH) and the planned modification of NIH awards to require vendors to use the eVIP in future contracts.
Agency Information Collection Activities; Proposed Collection; Comment Request; Prevention of Salmonella Enteritidis in Shell Eggs During Production-Recordkeeping and Registration Provisions
The Food and Drug Administration (FDA or we) is announcing an opportunity for public comment on our proposed collection of certain information. 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 information collection provisions of FDA's recordkeeping and registration requirements for shell egg producers.
Summit on Color in Medical Imaging; Cosponsored Public Workshop; Request for Comments
The Food and Drug Administration (FDA) and cosponsor International Color Consortium (ICC) are announcing the following public workshop entitled ``Summit on Color in Medical Imaging: An International Workshop on the Technical Framework for Consistency and Interoperability Approaches for Dealing with Color in Medical Images.'' The purpose of the workshop is to bring together key stakeholders to clearly identify areas of need, investigate solutions, and propose best-practice approaches. The recommendations of the summit might include the creation of a technical special interest group either as part of the ICC or in some other forum and the establishment of best- practice guidelines for industry.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
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; Guidance for Industry on Tobacco Retailer Training Programs
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.
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