Department of Health and Human Services April 2012 – Federal Register Recent Federal Regulation Documents
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National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods: Call for Nominations of High Throughput Screening (HTS) Assays for the Tox21 Initiative
The multiagency Tox21 Initiative aims to improve hazard assessment of compounds potentially harmful to humans and the environment. This will be accomplished through the use of integrated high throughput screens that provide information on the ability of a substance to perturb biological pathways related to toxicity. On behalf of the Tox21 Consortium and its Assays and Pathways Working Group, the NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) is accepting nominations for HTS biochemical- or cell-based assays. Assays selected for further evaluation and found to be compatible with the HTS program will support Tox21 by providing data on endpoints that serve as markers for initiating or downstream events in toxicity pathways.
Submission for OMB Review; Comment Request; Solar Cell: A Mobile UV Manager for Smart Phones Phase II (NCI)
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Cancer Institute (NCI), the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on January 27, 2012 (77 FR 4334) and allowed 60-days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Proposed Collection: Title: Solar Cell: A Mobile UV Manager for Smart Phones Phase II (NCI). Type of Information Collection Request: New. Need and Use of Information Collection: The overall goal of the study is to design a smart phone application, Solar Cell, which uses smart phone technology to aid users in protecting their skin from damaging ultraviolet radiation (UV) in sunlight, a primary cause of skin cancer. The purpose of this part of the study is to produce, deploy, and evaluate the effectiveness of a state-of-the-art software application for smart phones (i.e., mobile application), ``Solar Cell.'' This software application supports decision-making related to sun protection and exposure by Americans to reduce the risk of developing skin cancer attributable to chronic and severe UV exposure and developing other cancers attributable to vitamin D deficiency. The Solar Cell mobile smart phone application combines personal and behavior data with geo-spatial data (i.e., UV Index forecast, time, and location) and delivers actionable sun protection advice to reduce risk of skin cancer. Frequency of Response: Once. Affected Public: Individuals. Type of Respondents: Adults (18 and over) from the U.S. population who own Android smart phones. The annual reporting burden is estimated at 308 hours (see Table below). There are no Capital Costs, Operating Costs, and/or Maintenance Costs to report.
Recruitment of Sites for Assignment of Corps Personnel Obligated Under the National Health Service Corps Scholarship Program
The Health Resources and Services Administration (HRSA) announces that the listing of entities, and their Health Professional Shortage Area (HPSA) scores, that will receive priority for the assignment of National Health Service Corps (NHSC) scholarship recipients (Corps Personnel, Corps members) during the period July 1, 2012, through June 30, 2013, is posted on the NHSC Web site at https:// datawarehouse.hrsa.gov/HGDWReports/ OneClickRptFilter.aspx?rptName=NHSCAppSiteList&rptFormat=HTML 3.2. This searchable database specifies all currently approved NHSC service sites, by State, and can be utilized to determine which entities are eligible to receive assignment of Corps members who are participating in the NHSC Scholarship Program based on the threshold HPSA score set forth below. Please note that entities on this list may or may not have current job opportunities for NHSC scholars. Furthermore, not all vacancies associated with sites on the list described below will be for Corps members, but could be for NHSC Scholarship Program participants serving their obligation through the Private Practice Option.
Findings of Research Misconduct
Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Peter J. Francis, M.D., Ph.D., Oregon Health Sciences University: Based on the report of an investigation conducted by Oregon Health Sciences University (OHSU) and additional analysis conducted by ORI in its oversight review, ORI found that Dr. Peter J. Francis, Associate Professor, Casey Eye Institute, OHSU, engaged in research misconduct in research reported in two grant applications, R01 EY021214-01 and resubmitted as R01 EY021214-01A1, that he submitted to the National Eye Institute (NEI), National Institutes of Health (NIH). Specifically, ORI finds that the Respondent fabricated results of a pilot experiment in which he claimed to have injected retinal pigment epithelial (RPE) cells obtained from Rhesus monkey embryonic stem cells (ECS) into a strain of rats (RCS) that develops retinal degeneration. Respondent claimed that after the injection of ECS-derived RPE cells 21 days postnatal, the rats were tested at day 60 postnatal for optomotor acuity, and that the retinal histology of eyes receiving ECS- derived RPE cells, compared to mock-injected controls, showed enhanced photoreceptor preservation and no adverse effects. Respondent admitted that this experiment had not been conducted either by the time the original grant application had been submitted or by the time the later R01 EY021214-01A1 application was submitted. Dr. Francis has entered into a Voluntary Settlement Agreement (Agreement) and has voluntarily agreed for a period of two (2) years, beginning on March 29, 2012: (1) To have his research supervised; Respondent agrees to ensure that prior to the submission of an application for U.S. Public Health Service (PHS) support for a research project on which the Respondent's participation is proposed and prior to Respondent's participation in any capacity on PHS-supported research, the institution employing him must submit a plan for supervision of Respondent's duties to ORI for approval; the plan for supervision must be designed to ensure the scientific integrity of Respondent's research contribution; Respondent agrees that he shall not participate in any PHS-supported research after sixty (60) days from the effective date of this Agreement until such a supervision plan is submitted to and approved by ORI; Respondent agrees to maintain responsibility for compliance with the agreed upon supervision plan; (2) that this supervisory plan provided by any institution employing him shall provide assurance that each application for PHS funds, or report, manuscript, or abstract involving PHS supported research in which Respondent was involved was based on actual experiments or was otherwise legitimately derived, that the data, procedures, and methodology were accurately reported in the application, report, manuscript, or abstract, and that the text in such submissions was his own or properly cited the source of copied language and ideas; and (3) to exclude himself from serving in any advisory capacity to PHS including, but not limited to, service on any PHS advisory committee, board, and/or peer review committee, or as a consultant.
Privacy Act of 1974, as Amended by Public Law 100-503; Notice of a Computer Matching Program
In compliance with the Privacy Act of 1974, as amended by Public Law 100-503, the Computer Matching and Privacy Protection Act of 1988, ACF is publishing a notice of a computer matching program. The purpose of this computer match is to identify specific individuals who receive benefits from the Department of Veterans Affairs (VA) and also receive payments pursuant to various benefit programs administered by both the Department of Health and Human Services (HHS) and the Department of Agriculture. ACF will facilitate this program on behalf of SPAAs that participate in PARIS for verification of continued eligibility for public assistance. The match will utilize VA and SPAA records.
Meeting of the President's Council on Fitness, Sports, and Nutrition
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services (DHHS) is hereby giving notice that the President's Council on Fitness, Sports, and Nutrition (PCFSN) will hold a meeting. The meeting will be open to the public.
Prospective Grant of Exclusive License: Development of Oncolytic Viral Cancer Therapies
This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR Part 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in the following U.S. Patents to Jennerex Biotherapeutics (``Jennerex'') located in San Francisco, CA, USA. Intellectual Property: 1. U.S. Patent No. 7,045,313 issued May 16, 2006 entitled, ``Recombinant Vaccinia Virus Containing a Chimeric Gene Having Foreign DNA Flanked by Vaccinia Regulatory DNA'' [HHS Ref. No. E-552-1982/2-US- 03]; 2. U.S. Patent No. 7,015,024 issued March 21, 2006 entitled, ``Compositions Containing Recombinant Poxviruses Having Foreign DNA Expressed under the Control of Poxvirus Regulatory Sequence'' [HHS Ref. No. E-552-1982/2-US-04]; 3. U.S. Patent No. 7,045,136 issued May 16, 2006 entitled, ``Methods of Immunization Using Recombinant Poxviruses Having Foreign DNA Expressed under the Control of Poxvirus Regulatory Sequence'' [HHS Ref. No. E-552-1982/2-US-05]; and 4. U.S. Patent No. 6,998,252 issued February 14, 2006 entitled, ``Recombinant Poxviruses Having Foreign DNA Expressed under the Control of Poxvirus Regulatory Sequence'' [HHS Ref. No. E-552-1982/2-US-06]. The patent rights in these inventions have been assigned to the United States of America. The prospective exclusive license territory may be the U.S. and the field of use may be the ``development and use of Licensed Patent Rights in combination with Licensee's proprietary or in-licensed technologies for the treatment of human cancers''.
Guidance for Industry on the Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry (GFI 209) entitled ``The Judicious Use of Medically Important Antimicrobial Drugs in Food- Producing Animals.'' This guidance is intended to inform the public of FDA's current thinking on the use of medically important antimicrobial drugs in animal agriculture.
Draft Guidance for Industry on New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions With GFI #209; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry (draft GFI 213) entitled ``New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food- Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions With GFI 209.'' The purpose of this document is to provide information to sponsors of certain new animal drug products who are interested in developing revised conditions of use for those products consistent with FDA's GFI 209, ``The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals'' and to set timelines for stakeholders wishing to comply voluntarily with this guidance.
Veterinary Feed Directive; Draft Text for Proposed Regulation
The Food and Drug Administration (FDA) is announcing the availability of draft text for a proposed regulation intended to improve the efficiency of FDA's Veterinary Feed Directive (VFD) program. The Agency is making this draft text for a proposal available because of the complex scientific and regulatory issues involved, and because of the potential impact that changes to the VFD regulations may have on stakeholders. The Agency invites the public to submit comments with questions and concerns about the draft text for a proposed regulation.
Common Formats for Patient Safety Data Collection and Event Reporting
As authorized by the Secretary of HHS, AHRQ coordinates the development of a set of common definitions and reporting formats (Common Formats) for reporting patient safety events to Patient Safety Organizations (PS0s). The purpose of this notice is to announce the availability of new Common FormatsHospital Version 1.2 for public review and comment.
Scientific Information Request on Treatment of Tinnitus
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from manufacturers of cochlear implants, sound masking devices, hearing aids, and transcranial magnetic stimulation medical devices. Scientific information is being solicited to inform our Comparative Effectiveness Review of Evaluation and Treatment of Tinnitus, which is currently being conducted by the Evidence-based Practice Centers for the AHRQ Effective Health Care Program. Access to published and unpublished pertinent scientific information on this device will improve the quality of this comparative effectiveness review. AHRQ is requesting this scientific information and conducting this comparative effectiveness review pursuant to Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Public Law 108-173.
Request for Notification From Industry Organizations Interested in Participating in the Selection Process for Nonvoting Industry Representative on the Blood Products Advisory Committee, and Request for Nominations for Nonvoting Industry Representatives on the Blood Products 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 Blood Products Advisory Committee for the Center for Biologics Evaluation and Research (CBER) notify FDA in writing. FDA is also requesting nominations for a nonvoting industry representative to serve on the Blood Products 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 vacancies effective with this notice.
Medicare Program; Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs for Contract Year 2013 and Other Changes
This final rule with comment period revises the Medicare Advantage (MA) program (Part C) regulations and prescription drug benefit program (Part D) regulations to implement new statutory requirements; strengthen beneficiary protections; exclude plan participants that perform poorly; improve program efficiencies; and clarify program requirements. It also responds to public comments regarding the long-term care facility conditions of participation pertaining to pharmacy services.
Risk Adjustment Meeting-May 7, 2012 and May 8, 2012
This notice announces a meeting on the risk adjustment program, which is open to the public. The purpose of this meeting is to provide information to States, issuers, and interested parties about the risk adjustment program. This meeting will include the following topics: The risk adjustment model, calculation of plan average actuarial risk, calculation of payments and charges, data collection approach, and the schedule for running risk adjustment. This meeting will provide an opportunity to hear from a variety of interested parties as the Federal risk adjustment methodology is being developed and we are working through operational issues.
Announcement of Requirements and Registration for “Reporting Patient Safety Events Challenge”
Patient Safety Organizations (PSOs) listed by the Agency for Healthcare Research and Quality (AHRQ) create a safe environment for health care providers to collect, aggregate, and analyze data without fear of legal discovery. Hospitals struggle to increase internal incident reporting, especially by busy physicians and nurses, and to create effective systems for the quality and risk management staff to do root cause analyses and follow-up. The ``Reporting Patient Safety Events Challenge'' asks multi-disciplinary teams to develop an application that facilitates the reporting of patient safety events, whether implemented in hospital or ambulatory settings. The solution needs to make it easier for any individual to file a report electronically, using Common Formats but allowing for additional elements and narratives. It must allow the hospital quality and risk management staff to add information from follow-up investigation, submit reports as appropriate to PSOs, the state, or the FDA (which may differ, and need to be tracked separately), and track follow-up activities. The statutory authority for this challenge competition is Section 105 of the America COMPETES Reauthorization Act of 2010 (Pub. L. 111- 358).
Guidance on Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography Drugs; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography (PET) Drugs.'' This guidance is intended to help manufacturers of PET drugs meet the requirements for the Agency's current good manufacturing practice regulations for PET drugs.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Experimental Study on Consumer Responses to Labeling Statements on Food Packages
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 (the PRA).
International Conference on Harmonisation; Draft Guidance for Industry on E2C(R2) Periodic Benefit-Risk Evaluation Report; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``E2C(R2) Periodic Benefit-Risk Evaluation Report.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance updates and combines two ICH guidances, ``E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs'' (E2C guidance) and ``Addendum to E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs'' (addendum to the E2C guidance). The draft guidance describes the format, content, and timing of a periodic benefit-risk evaluation report (PBRER) for an approved drug or biologic. The harmonized PBRER is intended to promote a consistent approach to periodic postmarket safety reporting among the ICH regions and to enhance efficiency by reducing the number of reports generated for submission to the regulatory authorities.
Expanded Charge for Peer Review of the NIOSH document Titled: “Criteria for a Recommended Standard: Occupational Exposure to Diacetyl and 2,3-pentanedione”
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) is undergoing peer review for the draft document, ``Criteria for a Recommended Standard: Occupational Exposure to Diacetyl and 2,3- pentanedione.'' NIOSH held a public meeting on August 26, 2011 in Washington, DC [76 FR 44338] to discuss and obtain comments on the draft document. Public comments were accepted into the NIOSH docket from August 12, 2011- November 18, 2011 [76 FR 64353]. The draft document and all public comments received are posted on the Internet at: https://www.cdc.gov/niosh/docket/archive/docket245.html for Docket number NIOSH-245. After consultation with the Occupational Safety and Health Administration, Department of Labor (OSHA/DOL), NIOSH has asked the peer reviewers seven additional questions for consideration which are posted here: https://www.cdc.gov/niosh/review/peer/HISA/diacetyl- pr.html. This entry serves as notice of the expanded charge to peer reviewers for this draft document.
Submission for OMB Review; Comment Request: Prevalence, Incidence, Epidemiology and Molecular Variants of HIV in Blood Donors in Brazil
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on January 13, 2012, page 2072, and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Proposed Collection: Title: Prevalence, Incidence, Epidemiology and Molecular Variants of HIV in Blood Donors in Brazil. Type of Information Collection Request: Reinstatement (OMB No. 0925-0597). Need and Use of Information Collection: Establishing and monitoring viral prevalence and incidence rates, and identifying behavioral risk behaviors for HIV infection among donors are critical steps to assessing and reducing risk of HIV transmission through blood transfusion. Detecting donors with recently acquired HIV infection is particularly critical as it enables characterization of the viral subtypes currently transmitted within the screened population. In addition to characterizing genotypes of recently infected donors for purposes of blood safety, molecular surveillance of incident HIV infections in blood donors serves important public health roles by identifying new HIV infections for anti-retroviral treatment, and enabling documentation of the rates of primary transmission of anti-viral drug resistant strains in the community. This study is a continuation of a previous research project which enrolled eligible HIV-positive blood donors and analyzed HIV molecular variants and their association with risk. This previous project was conducted by the NHLBI Retrovirus Epidemiology Donor StudyII (REDS-II) International Brazil program and included not only data collection on HIV seropositive donors but also collection of risk factor data on uninfected donors. The current Recipient Epidemiology and Donor Evaluation StudyIII (REDS-III) research proposal is a continuation of the previous REDS-II project at the same four blood centers in Brazil, located in the cities of S[atilde]o Paulo, Recife, Rio de Janeiro and Belo Horizonte, but this time restricted to the study of HIV-positive subjects. The primary study aims are to continue monitoring HIV molecular variants and risk behaviors in blood donors in Brazil, and to evaluate HIV subtype and drug resistance profiles among HIV-positive donors according to HIV infection status (recent versus long-standing infection), year of donation, and site of collection. Additional study objectives include determining trends in HIV molecular variants and risk factors associated with HIV infection by combining data collected in the previous REDS-II project with that which will be obtained in the planned research activities. Nucleic acid testing (NAT) for HIV is currently being implemented in Brazil. It will be important to continue to collect molecular surveillance and risk factor data on HIV infections, especially now that infections that might not have been identified by serology testing alone could be recognized through the use of NAT. NAT-only infections represent very recently acquired infections. The NAT assay will be used at the four REDS-III blood centers in Brazil during the planned research activities. In addition, in order to distinguish between recent seroconversion and long-standing infection, samples from all HIV antibody dual reactive donations and/or NAT positive donations will be tested by the Recent Infection Testing Algorithm (RITA) which is based on use of a sensitive/less-sensitive enzyme immunoassay (``detuned'' Enzyme Immunoassay). RITA testing will be performed by the Blood Systems Research Institute, San Francisco, California, USA, which is the REDS-III Central Laboratory. Subjects will be enrolled for a 5-year period from March 2012 (or when OMB approval is received) through 2017. According to the Brazilian guidelines, blood donors are requested to return to the blood bank for HIV confirmatory testing and HIV counseling. Donors will be invited to participate in the study through administration of informed consent when they return for HIV counseling. Once informed consent has been administered and enrollment has occurred, participants will be asked to complete a confidential self-administered risk factor questionnaire by computer. In addition, a small blood sample will be collected from each HIV-positive participant to be used for the genotyping and drug resistance testing. The results of the drug resistance testing will be communicated back to the HIV-positive participants during an in-person counseling session at the blood center. For those individuals who do not return for confirmatory testing, the samples will be anonymized and sent to the REDS-III Central Laboratory to perform the recent infection testing algorithm (RITA). This research effort will allow for an evaluation of trends in the trafficking of non-B HIV subtypes and rates of transmission of drug resistant viral strains in low risk blood donors. These data could also be compared with data from similar studies in higher risk populations. Monitoring drug resistance strains is extremely important in a country that provides free anti-retroviral therapy for HIV infected individuals, many of whom have low level education and modest resources, thus making compliance with drug regimens and hence the risk of drug resistant HIV a serious problem. The findings from this project will add to those obtained in the REDS-II study, allowing for extended trend analyses over a 10-year period and will complement similar monitoring of HIV prevalence, incidence, transfusion risk and molecular variants in the USA and other funded international REDS-III sites in South Africa and China, thus allowing direct comparisons of these parameters on a global level. Frequency of Response: Once. Affected Public: Individuals. Type of Respondents: Blood Donors 18 years old or older. The annual reporting burden is as follows: Estimated Number of Respondents: 100; Estimated Number of Responses per Respondent: 1; Average Burden of Hours per Response: 0.40 (including administration of the informed consent form and questionnaire completion instructions); and Estimated Total Annual Burden Hours Requested: 40. The annualized cost to respondents is estimated at: $260 (based on $6.50 per hour). There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.
Prospective Grant of Exclusive License: Method for Segmenting Medical Images and Detecting Surface Anomalies in Anatomical Structures
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. Patents: 6,246,784 filed August 18, 1998 and issued June 12, 2001; 6,345,112 filed January 19, 2001 and issued February 5, 2002; and 6,556,696 filed February 5, 2002 and issued April 29, 2003; each entitled ``Method for segmenting medical images and detecting surface anomalies in anatomical structures,'' by Ronald M. Summers et al., to iCAD, Inc. having a place of business in 98 Spit Brook Road, Suite 100, Nashua, NH 03062 USA. The patent rights in this invention have been assigned to the United States of America.
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