jurisdiction: US

text: b"Department of Health and Human Services\n OFFICE OF\n INSPECTOR GENERAL\n\n\n\n\n NIH ADMINISTRATION OF THE\n CLINICAL AND TRANSLATIONAL\n SCIENCE AWARDS PROGRAM\n\n\n\n\n Daniel R. Levinson\n Inspector General\n\n December 2011\n OEI-07-09-00300\n\x0c\xef\x80\xb0 E X E C U T I V E S U M M A R Y\n\n\n OBJECTIVES\n 1. To determine the extent to which the National Institutes of\n Health (NIH) administered the Clinical and Translational\n Science Award (CTSA) program in accordance with Federal\n regulations and Department of Health and Human Services\n (HHS) and NIH policies for:\n \xe2\x80\xa2 monitoring awardee progress in achieving the goals and\n milestones of the program (awardee progress),\n \xe2\x80\xa2 ensuring timely submission of reports, and\n \xe2\x80\xa2 maintaining official files.\n 2. To determine whether CTSA program staff provided substantial\n involvement to awardees in accordance with Federal regulations\n and HHS and NIH policies.\n\n\n BACKGROUND\n In 2006, NIH\xe2\x80\x99s National Center for Research Resources (NCRR)\n established the CTSA program to provide external research awards for\n expediting scientific research for new medical treatments. As of\n March 2011, NCRR had awarded CTSA research awards to 55 domestic\n graduate schools, with planned 5-year funding of more than $2.2 billion.\n The role of NIH grants management staff, including CTSA program\n staff, is to oversee awardees to ensure that they follow all applicable\n Federal regulations, departmental and agency policies, and terms and\n conditions of awards. CTSA program staff must ensure that awardees\n submit annual progress reports and financial status reports and must\n determine whether awardee progress remains satisfactory before\n awardees receive continued funding.\n NIH uses three funding mechanisms for research awards: grants,\n cooperative agreements, and contracts. The CTSA program uses\n cooperative agreements. Under cooperative agreements, NIH staff\n provide assistance to awardees above and beyond the levels usually\n required for program stewardship of grants. This level of stewardship is\n known as substantial involvement. CTSA program staff assign NIH\n Project Scientists to awardees to provide substantial involvement\n through technical assistance, advice, and coordination. Names of\n substantially involved staff and an annual summary of staff\n involvement should be documented in the official files.\n\nOEI-07-09-00300 N I H A D M I N I S T R AT I O N O F T H E C L I N I C A L A N D T R A N S L AT I O N A L S C I E N C E AW A R D S P R O G R A M i\n\x0cE X E C U T I V E S U M M A R Y\n\n\n We reviewed files for the 38 CTSA cooperative agreements awarded in\n fiscal years (FY) 2006 through 2008 to determine whether CTSA\n program staff administered the program in compliance with Federal\n requirements and HHS and NIH policies and whether they provided\n substantial involvement to awardees.\n\n\n FINDINGS\n Despite completing basic checklists, CTSA program staff did not\n document awardees\xe2\x80\x99 progress in compliance with NIH policy. For\n only 1 of 38 awardees, CTSA program staff documented a comparison of\n accomplishments to research objectives. Although reviews for six\n awardees\xe2\x80\x99 files mentioned an inability to fulfill goals, only one file\n included a note from CTSA program staff regarding resolution.\n Similarly, plans for the upcoming year were noted in only one file.\n Awardees were frequently late in submitting required reports; CTSA\n program staff did not take action to address timeliness. Most\n progress reports and one-half of financial status reports were late, yet\n the CTSA files contained no evidence that staff tried to obtain\n delinquent reports. Also, despite widespread report delinquency, no\n enforcement actions were documented in official files.\n Official CTSA files were not maintained in accordance with HHS\n policy. Official CTSA files were incomplete, were not current, were\n often not separated by budget period, and did not enable third-party\n review.\n No files contained evidence that CTSA program staff provided\n substantial involvement to awardees in accordance with Federal\n regulations and NIH policy. The CTSA files contained no evidence of\n expected substantial involvement by Project Scientists. Additionally,\n the files contained no other evidence of substantial involvement by any\n CTSA program staff beyond usual program stewardship activities.\n\n\n RECOMMENDATIONS\n For better oversight of the CTSA program, we recommend that NIH\n ensure that CTSA program staff:\n Document their monitoring of awardee progress. NIH must ensure that\n staff document awardee accomplishments toward meeting project goals;\n reasons for not meeting project goals, if applicable; and plans for activities\n during the coming year.\n\n OEI-07-09-00300 N I H A D M I N I S T R AT I O N O F T H E C L I N I C A L A N D T R A N S L AT I O N A L S C I E N C E AW A R D S P R O G R A M ii\n\x0cE X E C U T I V E S U M M A R Y\n\n\n Ensure timely submission of required reports. NIH should ensure that\n staff document correspondence with awardees as they act to obtain\n delinquent progress reports and financial status reports.\n Maintain official files in accordance with HHS policy. NIH must\n establish a single comprehensive filing system in which files are\n complete, current, easy to identify, easy to access, and separated by\n budget period. This would promote a coordinated approach to oversight\n for NIH staff and third-party reviewers.\n Provide substantial involvement to CTSA awardees. At a minimum,\n staff must clearly list the Project Scientists involved and include the\n annual summary of involvement within the award files.\n\n\n AGENCY COMMENTS AND OFFICE OF INSPECTOR GENERAL\n RESPONSE\n NIH concurred with our recommendations. NIH stated that it (1) will\n issue specific guidance on documentation requirements for monitoring\n awardee progress and obtaining delinquent reports, (2) has already\n implemented the recommendation to maintain official files in\n accordance with HHS policy, and (3) will work with NCRR to revise\n its cooperative agreement terms of award.\n\n\n\n\n OEI-07-09-00300 N I H A D M I N I S T R AT I O N O F T H E C L I N I C A L A N D T R A N S L AT I O N A L S C I E N C E AW A R D S P R O G R A M iii\n\x0c\xef\x80\xb0 T A B L E O F C O N T E N T S\n\n\n\n EXECUTIVE SUMMARY ..................................... i\n\n\n\n INTRODUCTION............................................ 1\n\n\n\n F I N D I N G S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10\n Despite completing basic checklists, CTSA program staff\n did not document awardees\xe2\x80\x99 progress in compliance\n with NIH policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10\n\n Awardees were frequently late in submitting required\n reports; CTSA program staff did not take action to\n address timeliness . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11\n\n Official CTSA files were not maintained in accordance with HHS\n policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13\n\n No files contained evidence that CTSA program staff provided\n substantial involvement to awardees in accordance with Federal\n regulations and NIH policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15\n\n\n R E C O M M E N D A T I O N S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17\n Agency Comments and Office of Inspector General Response . . . 18\n\n\n\n A P P E N D I X E S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19\n A: Responsibilities of Clinical and Translational Science Award\n Program Staff. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19\n\n B: Example of Awardee Goals and Milestones . . . . . . . . . . . . . . . 20\n\n C: Agency Comments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21\n\n\n\n A C K N O W L E D G M E N T S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30\n\n\n\n\nOEI-07-09-00300 N I H A D M I N I S T R AT I O N O F T H E C L I N I C A L A N D T R A N S L AT I O N A L S C I E N C E AW A R D S P R O G R A M i\n\x0c\xef\x80\xb0 I N T R O D U C T I O N\n\n\n\n\n OBJECTIVES\n 1. To determine the extent to which the National Institutes of\n Health (NIH) administered the Clinical and Translational\n Science Award (CTSA) program in accordance with Federal\n regulations and Department of Health and Human Services\n (HHS) and NIH policies for:\n \xe2\x80\xa2 monitoring awardee progress in achieving the goals and\n milestones of the program (awardee progress),\n \xe2\x80\xa2 ensuring timely submission of reports, and\n \xe2\x80\xa2 maintaining official files.\n 2. To determine whether CTSA program staff provided substantial\n involvement to awardees in accordance with Federal regulations\n and HHS and NIH policies.\n\n\n BACKGROUND\n The National Center for Research Resources (NCRR) is one of the\n funding institutes or centers within NIH.1 NCRR established the CTSA\n program to provide external research awards for scientists to transform\n basic research and patient observations into clinical practice and new\n treatments. 2 As of March 2011, NCRR had awarded CTSA research\n awards to 55 domestic graduate schools, with planned 5-year funding of\n more than $2.2 billion. 3\n Previous Office of Inspector General (OIG) reviews of award programs\n administered by NIH and other agencies highlighted opportunities for\n improvements in the oversight of grantee funds and compliance. 4\n\n\n 1 NIH, Institutes, Centers, and Offices. Accessed at http://www.nih.gov on April 25,\n\n 2011. See also NIH, Scientific Management Review Board Report on Translational\n Medicine and Therapeutics. Accessed at http://smrb.od.nih.gov on April 12, 2011.\n 2 NCRR, Clinical and Translational Science Awards Fact Sheet. Accessed at\n http://www.ncrr.nih.gov on August 26, 2010. NIH, \xe2\x80\x9cRequest for Applications RM-06-002:\n Institutional Clinical and Translational Science Award.\xe2\x80\x9d\n 3 NCRR, Clinical and Translational Science Awards and Five-Year Funding Amounts\n by Institution. Accessed at http://www.ncrr.nih.gov on March 30, 2011.\n 4 OIG, National Cancer Institute\xe2\x80\x99s Monitoring of Research Project Grants\n (OEI-07-07-00120) and Agency for Healthcare Research and Quality: Monitoring Patient\n Safety Grants (OEI-07-04-00460).\n\n\n\nOEI-07-09-00300 N I H A D M I N I S T R AT I O N OF THE CLINICAL AND T R A N S L AT I O N A L S C I E N C E AW A R D S P R O G R A M 1\n\x0cI N T R O D U C T I O N\n\n\n Award oversight is a top management challenge for the Department of\n Health and Human Services (HHS), as award programs are at risk of\n fraud, waste, abuse, and ineffectiveness without proper controls to\n ensure the appropriate use of Federal funds. 5 Moreover, expansion in\n the number and size of awards, such as that occurring in the CTSA\n program, will magnify oversight vulnerabilities. 6\n Federal Requirements and Departmental Guidance for Award Administration\n Federal regulations establish uniform administrative requirements\n governing HHS awards to institutions of higher education, hospitals,\n and other nonprofit organizations. 7 Guidance in implementing these\n regulatory requirements is contained in the HHS Grants Policy\n Directives (GPD), which apply to all organizational levels within HHS;\n the NIH Policy Manual, which applies to internal operations of NIH;\n and the CTSA Consortium Governance Manual, which is specific to the\n CTSA program.\n The role of NIH grants management staff, including CTSA program\n staff, 8 is to oversee awards to ensure that awardees use funding\n properly and prudently and follow all applicable laws, regulations, and\n policies.9 Grants management staff are responsible for usual program\n stewardship, including the business administration of award programs\n and resolving questions regarding the applicability of departmental and\n agency policies.10\n If awardees materially fail to comply with the terms and conditions of\n an award, the Grants Management Officer may take one or more of the\n following enforcement actions:\n \xe2\x80\xa2 temporarily withhold payments pending the correction of\n deficiencies,\n \xe2\x80\xa2 disallow funds on the cost of the activity not in compliance,\n\n 5 OIG, FY 2010 Top Management and Performance Challenges Identified by the Office\n\n of the Inspector General. Accessed at http://oig.hhs.gov on March 30, 2011.\n 6 Ibid.\n 7 45 CFR pt.74.\n 8 For the purposes of this report, CTSA program staff are the staff responsible for both\n the business and programmatic aspects of the CTSA awards, including Grants\n Management Officers, Grants Management Specialists, Program Officials, and Project\n Scientists.\n 9 See Appendix A for a listing of specific responsibilities of grants management staff,\n\n including Grants Management Officer business responsibilities and Program Official\n programmatic responsibilities.\n 10 HHS, GPD, pt. 1.02; NIH, Policy Manual, ch. 54444.\n\n\n\n OEI-07-09-00300 N I H A D M I N I S T R AT I O N OF THE CLINICAL AND T R A N S L AT I O N A L S C I E N C E AW A R D S P R O G R A M 2\n\x0cI N T R O D U C T I O N\n\n\n \xe2\x80\xa2 suspend or terminate the current award, and/or\n \xe2\x80\xa2 withhold further awards. 11\n Ensuring Submission of Required Reports\n All NIH awardees 12 must submit annual performance reports and\n financial status reports (FSR).13 The Grants Management Officer\n should not release continued funding until required reports are\n submitted. 14\n For many NIH research awards, including CTSA awards, annual\n progress reports are due 2 months before the beginning of the next\n budget period.15 Awardees must provide a comparison of the\n accomplishments during the progress period to the goals and milestones\n and, if applicable, reasons that the goals and milestones were not met.\n If an awardee is delinquent in submitting a progress report, the Grants\n Management Officer must:\n \xe2\x80\xa2 send an initial request letter to the awardee 30 days beyond the\n due date,\n \xe2\x80\xa2 send a second request letter to an official at the awardee\n institution 60 days beyond the due date,\n \xe2\x80\xa2 send a third request letter to the head of the awardee institution\n 90 days beyond the due date, and\n \xe2\x80\xa2 refer the matter to the designated NIH official if there is not an\n acceptable response 120 days beyond the due date. 16\n All NIH awardees, including CTSA awardees, must submit an FSR no\n later than 90 days after the close of the budget period. 17 The FSR\n shows the status of awarded funds for that budget period. When FSRs\n are 4 months overdue (i.e., when 7 months have elapsed since the end of\n the budget period), the Grants Management Officer must:\n\n\n 11 45 CFR \xc2\xa7 74.62.\n 12 For the purposes of this report, the term \xe2\x80\x9call awardees\xe2\x80\x9d refers to those subject to the\n Streamlined Noncompeting Award Process, including CTSA awardees.\n 13 45 CFR \xc2\xa7\xc2\xa7 74.51 and 74.52. NIH refers to the annual performance reports as\n \xe2\x80\x9cprogress reports.\xe2\x80\x9d NIH, Grants Policy Statement, pt. 1.\n 14 NIH, Policy Manual, ch. 55806. CTSA awards may include continued funding for\n 4 years after the initial award year, for a total of 5 years. NIH, \xe2\x80\x9cRequest for Applications\n RM-06-002: Institutional Clinical and Translational Science Award.\xe2\x80\x9d\n 15 Office of Management and Budget, U.S. Department of Health and Human Services\n\n Public Health Service Non-Competing Grant Progress Report (PHS [Public Health\n Service] 2590). Accessed at http://grants.nih.gov on December 6, 2010.\n 16 NIH, Policy Manual, ch. 55806.\n 17 45 CFR \xc2\xa7 74.52; NIHGPS, pt. 2, pt. II-87.\n\n\n\n\n OEI-07-09-00300 N I H A D M I N I S T R AT I O N OF THE CLINICAL AND T R A N S L AT I O N A L S C I E N C E AW A R D S P R O G R A M 3\n\x0cI N T R O D U C T I O N\n\n\n \xe2\x80\xa2 send a request letter to the awardee requesting submission of the\n report within 30 days,\n \xe2\x80\xa2 send a letter to the head of the awardee institution if there is no\n reply to the initial request within 30 days (i.e., 5 months beyond\n the due date),\n \xe2\x80\xa2 not make continuation awards until required reports have been\n received, and\n \xe2\x80\xa2 refer the matter to the designated NIH official if an awardee\n institution is consistently delinquent in submitting FSRs. 18\n Monitoring Awardee Progress\n Grants management staff must identify programmatic and financial\n deficiencies, if any, throughout the award period.19 This includes\n reviewing the annual progress reports to ensure that awardees achieve\n the goals and milestones of the program. Staff must also review FSRs\n to monitor awardees\xe2\x80\x99 expenditures and compliance with financial\n reporting requirements. When reviewing awardee progress, grants\n management staff must include, at a minimum, the following:\n \xe2\x80\xa2 evidence of accomplishments toward meeting project goals,\n \xe2\x80\xa2 reasons for not meeting project goals (if applicable), and\n \xe2\x80\xa2 plans for activities during the next year.20\n Grants management staff use award checklists to document their\n review of annual progress as reflected in the Award Worksheet\n Reports. 21\n Official File Maintenance\n As part of a coordinated approach to postaward administration,\n awarding offices, such as NCRR, must create and maintain files that\n enable a third party (e.g., auditor or other reviewer) to follow the life of\n the award, from initiation through closeout.22 A third-party reviewer\n should be able to view information regarding decisions made and\n actions taken throughout the entire award. An individual official file\n\n\n 18 NIH, Policy Manual, ch. 55806. The Manual does not define the term \xe2\x80\x9cconsistently\n delinquent.\xe2\x80\x9d\n 19 HHS, GPD, pt. 3.06; NIH, Policy Manual, ch. 54815 and 54444.\n 20 NIH, Policy Manual, ch. 55808.\n 21 NCRR staff use the same Award Worksheet Reports to document review of each\n\n awardee\xe2\x80\x99s annual progress report and FSR. NIH, Grants Management User Guide,\n System Version 2.16.0.0. Accessed at http://era.nih.gov on August 11, 2010.\n 22 HHS, GPD, pt. 3.06.\n\n\n\n OEI-07-09-00300 N I H A D M I N I S T R AT I O N OF THE CLINICAL AND T R A N S L AT I O N A L S C I E N C E AW A R D S P R O G R A M 4\n\x0cI N T R O D U C T I O N\n\n\n must be created for each award and must contain the following\n documentation:\n \xe2\x80\xa2 signed copies of applications and all documentation that supports\n the review and approval of the applications;\n \xe2\x80\xa2 Notices of Award;\n \xe2\x80\xa2 performance and financial reports and evidence of review and\n acceptance by the awarding agency;\n \xe2\x80\xa2 site visit reports, records of telephone calls, and documents to\n support postaward technical assistance provided; and\n \xe2\x80\xa2 documentation related to enforcement actions, including any\n award appeals. 23\n Official file contents must be current, easy to identify, easy to access,\n and separated by budget period to the extent possible. 24 Official files\n must also include hardcopies of electronically created or transmitted\n documents, including email, or be referenced to a separate file or\n repository. 25\n Cooperative Agreement Award Mechanism\n NIH uses three funding mechanisms for research awards: grants,\n cooperative agreements, and contracts. The CTSA program uses the\n cooperative agreement award mechanism. Federal requirements for\n award administration are generally the same for grants and cooperative\n agreements. Under cooperative agreements, however, NIH facilitates\n the awardees\xe2\x80\x99 performance of the funded activity in a \xe2\x80\x9cpartnership\xe2\x80\x9d\n role.26\n In such a partnership, NIH staff provide assistance to awardees above\n and beyond the levels usually required for program stewardship of\n grants, but without dominating the relationship. 27 This increased NIH\n staff involvement with awardees is known as substantial involvement. 28\n The NIH Policy Manual states that substantial involvement could\n include:\n\n\n\n 23 HHS, GPD, pt. 3.06; NIH, Policy Manual, ch. 55806.\n 24 HHS, GPD, pt. 3.06.\n 25 Ibid.\n 26 NIH, Policy Manual, chs.1820 and 54815.\n 27 Ibid.\n 28 The Federal Grant and Cooperative Agreement Act of 1977, 31 U.S.C. \xc2\xa7 6305; HHS,\n\n GPD, pts. 1.02 and 2.02.\n\n\n\n OEI-07-09-00300 N I H A D M I N I S T R AT I O N OF THE CLINICAL AND T R A N S L AT I O N A L S C I E N C E AW A R D S P R O G R A M 5\n\x0cI N T R O D U C T I O N\n\n\n \xe2\x80\xa2 cooperation, coordination, or participation in assisting awardees\n in performing project activities (e.g., development of research\n protocols; data collection, analyses, and interpretations; or\n reestablishment of objectives during the course of a project);\n \xe2\x80\xa2 an option to halt a project activity if technical performance\n requirements are not met;\n \xe2\x80\xa2 review or approval of one stage of a project before work may begin\n on a subsequent stage during a current approved project period;\n \xe2\x80\xa2 assistance with, or approval of, the selection of contractors or\n subawardees and of key project personnel other than principal\n investigators of projects or subprojects;\n \xe2\x80\xa2 technical monitoring to permit specified directions of the work,\n including approval of changes in experimental approaches; and\n \xe2\x80\xa2 participation on committees or in other functions responsible for\n helping to guide the course of long-term projects or activities. 29\n The NIH Policy Manual states that the names of substantially involved\n staff and an annual summary of staff involvement in the award must be\n documented in the award files. 30\n For the CTSA program, the Governance Manual indicates that at least\n one Project Scientist is assigned to each CTSA awardee to provide\n substantial involvement through technical assistance, advice, and\n coordination. 31 Project Scientists are not responsible for usual program\n stewardship. Instead, Project Scientists are responsible for reviewing\n and commenting on critical stages in implementation of the awards and\n for promoting collaboration among awardees. 32 See Appendix A for a\n listing of all responsibilities for Project Scientists (as well as the\n responsibilities of grants management staff).\n\n\n METHODOLOGY\n Scope\n This evaluation reviewed NIH\xe2\x80\x99s administration of the 38 CTSA research\n awards funded in fiscal years (FY) 2006 through 2008. 33 NIH awarded\n $606 million to these awardees during our 3-year review period. Since\n\n\n 29 NIH, Policy Manual, ch. 1820.\n 30 NIH, Policy Manual, ch. 54815.\n 31 CTSA Consortium, Governance Manual, Working Document, Version 2008.8.14.\n Accessed at http://www.ctsaweb.org on June 22, 2009.\n 32 Ibid.\n 33 The required reports for these awards were due during FYs 2007 to 2009.\n\n\n\n\n OEI-07-09-00300 N I H A D M I N I S T R AT I O N OF THE CLINICAL AND T R A N S L AT I O N A L S C I E N C E AW A R D S P R O G R A M 6\n\x0cI N T R O D U C T I O N\n\n\n all awardees requested 5 years of support, a total of 74 budget periods\n were reviewed for the 38 cooperative agreements during our review\n period\xe2\x80\x9412 awardees were in the third year of operation (36 budget\n periods), 12 were in the second year (24 budget periods), and 14 were in\n the first year (14 budget periods). See Table 1 for a description of the\n number of awards and budget periods by award year.\n\n Table 1: CTSA Award Summary\n\n Budget Total\n Number of\n Fiscal Year Periods Budget\n Awardees\n Reviewed Periods\n 2006 3 12 36\n 2007 2 12 24\n 2008 1 14 14\n Total 38 74\n Source: OIG analysis of CTSA files, 2009.\n\n\n\n We did not review the research or scientific outcomes described in the\n progress reports or the appropriateness of the information reported in\n FSRs. However, we did determine the extent to which CTSA program\n staff documented their own review of research or scientific outcomes\n when evaluating awardee progress.\n Data Sources\n NCRR staff scanned their official files for the 38 CTSA awards into an\n electronic format for our review. NCRR staff stated that the electronic\n files contained both the scanned versions of the paper files and\n supplemental information from NIH\xe2\x80\x99s electronic grants management\n system, Information for Management, Planning, Analysis, and\n Coordination (IMPAC II). For the purposes of our review, we refer to\n these scanned files as the official files.\n If documents were missing from the official files, we consulted two\n additional sources to complete our review: IMPAC II via direct access\n and electronic copies of the Award Worksheet Reports not present in\n IMPAC II.\n Data Collection and Analysis\n We reviewed the following documents when present in the CTSA files,\n regardless of data source:\n \xe2\x80\xa2 CTSA applications;\n\n OEI-07-09-00300 N I H A D M I N I S T R AT I O N OF THE CLINICAL AND T R A N S L AT I O N A L S C I E N C E AW A R D S P R O G R A M 7\n\x0cI N T R O D U C T I O N\n\n\n \xe2\x80\xa2 Award Worksheet Reports;\n \xe2\x80\xa2 Notices of Award;\n \xe2\x80\xa2 progress reports;\n \xe2\x80\xa2 FSRs; and\n \xe2\x80\xa2 any documentation of postaward assistance in emails, telephone\n records, reports, or other documents.\n We developed a checklist to conduct our review of these files to\n determine compliance with Federal regulations and HHS and NIH\n policies. We determined whether any CTSA program staff performed\n the following activities, regardless of which staff were charged with\n responsibility for each activity:\n Ensuring Submission of Required Reports. We reviewed the CTSA files to\n determine whether required progress reports:\n \xe2\x80\xa2 were submitted 2 months before the beginning of the next budget\n period;\n \xe2\x80\xa2 contained a self-reported comparison of accomplishments with\n awardee goals and milestones 34 established for the budget period;\n and\n \xe2\x80\xa2 explained the reasons that goals and milestones were not met, if\n applicable.\n We determined whether required FSRs were received within 90 days\n after the close of the budget period and whether they reflected the\n status of funds. We determined whether CTSA program staff ensured\n the submission of required progress reports and FSRs through\n correspondence with awardees to obtain delinquent reports and\n enforcement actions in the event of continued delinquency.\n Monitoring Awardee Progress. We reviewed Award Worksheet Reports to\n determine whether CTSA program staff reviewed annual awardee\n progress for continued funding. Specifically, we determined whether\n the following were documented:\n \xe2\x80\xa2 awardee accomplishments toward meeting project goals;\n \xe2\x80\xa2 reasons for not meeting project goals, if applicable; and\n \xe2\x80\xa2 plans for activities during the coming year.\n Award Worksheet Reports contain a yes/no option that enables grants\n management staff to indicate whether awardee progress was\n\n\n 34 See Appendix B for an example of the goals and milestones section of an application.\n\n\n\n\n OEI-07-09-00300 N I H A D M I N I S T R AT I O N OF THE CLINICAL AND T R A N S L AT I O N A L S C I E N C E AW A R D S P R O G R A M 8\n\x0cI N T R O D U C T I O N\n\n\n satisfactory. The Award Worksheet Reports also contain a narrative\n field for staff comments.\n Maintaining Official Files. We determined whether official files enabled a\n third party to follow the life of CTSA awards. Specifically, we\n determined whether file contents were current, easy to identify, easy to\n access, and separated by budget period. We also determined whether\n files were complete, containing the following documentation specified in\n HHS and NIH policy:\n \xe2\x80\xa2 signed copies of applications and documentation that supports the\n review and approval of the applications (e.g., Award Worksheet\n Reports);\n \xe2\x80\xa2 Notices of Award;\n \xe2\x80\xa2 progress and financial reports and evidence of review and\n acceptance by the awarding agency;\n \xe2\x80\xa2 site visit reports, records of telephone calls, and documents to\n support postaward technical assistance provided; and\n \xe2\x80\xa2 documentation related to enforcement actions, including any\n award appeals.\n Providing Substantial Involvement. We reviewed the CTSA files for\n evidence of substantial involvement by CTSA program staff, including\n technical or scientific assistance from Project Scientists regarding\n program implementation 35 and any other assistance beyond usual\n program stewardship. We determined whether files contained the\n names of substantially involved staff and the annual summaries of staff\n involvement specified in agency policy.\n Standards\n This study was conducted in accordance with the Quality Standards for\n Inspection and Evaluation issued by the Council of the Inspectors\n General on Integrity and Efficiency.\n\n\n\n\n 35 See Appendix A for information from the CTSA Governance Manual regarding\n\n Project Scientists\xe2\x80\x99 responsibilities with regard to programmatic involvement.\n\n\n\n OEI-07-09-00300 N I H A D M I N I S T R AT I O N OF THE CLINICAL AND T R A N S L AT I O N A L S C I E N C E AW A R D S P R O G R A M 9\n\x0c\xef\x80\xb0 F I N D I N G S\n\nDespite completing basic checklists, CTSA We reviewed Award Worksheet\nprogram staff did not document awardees\xe2\x80\x99 Reports to determine whether\n progress in compliance with NIH policy CTSA program staff documented\n the following when reviewing\n awardees\xe2\x80\x99 progress: awardee accomplishments toward meeting project\n goals; reasons for not meeting goals, if applicable; and plans for\n activities during the coming year. For all but one file, a simple \xe2\x80\x9cyes/no\xe2\x80\x9d\n checklist item on these reports indicated that progress was satisfactory\n each year. However, CTSA program staff largely failed to document the\n support for their answers as specified in NIH policy.\n CTSA program staff documented their comparison of awardee\n accomplishments from the prior year to project goals for only 1 of the\n 38 files. For two other files, the section of the application outlining the\n goals and milestones was missing altogether, which prevented annual\n comparisons of progress to milestones. For the remaining 35 files, the\n goals and milestones sections of the application were present; however,\n comparisons to annual accomplishments were not documented.\n In the 38 files, 8 Award Worksheet Reports noted awardees\xe2\x80\x99 inability to\n fulfill project goals. CTSA program staff attributed most of these\n deficiencies to budget cuts, although one file indicated that the goal was\n too ambitious, and another did not provide a reason. Moreover, only one\n of these six files contained a plan for resolution. In this case, the\n awardee was producing less than other awardees and developed an\n advisory committee to address this concern. CTSA program staff noted\n that this strategy was likely to bring this awardee\xe2\x80\x99s production in line\n with that of the other awardees.\n Similarly, CTSA program staff noted only one awardee\xe2\x80\x99s plans for the\n upcoming year. In this case, the Award Worksheet Report narrative\n included a copy of an email from the awardee that described activities\n that occurred after the submission of the annual progress report and\n plans for the upcoming project period.\n\n\n\n\nOEI-07-09-00300 N I H A D M I N I S T R AT I O N OF THE CLINICAL AND T R A N S L AT I O N A L S C I E N C E AW A R D S P R O G R A M 10\n\x0cF I N D I N G S\n\n\n\n Awardees were frequently late in submitting Awardees commonly\n required reports; CTSA program staff did not submitted progress reports\n and FSRs late. Despite\n take action to address timeliness\n frequent delinquencies in the\n submission of required reports, CTSA program staff did not take action\n to address the noncompliance.\n Most progress reports and half of FSRs were late\n During our study period, 66 of the 74 (89 percent) progress reports were\n late. Progress reports were late an average of 12 days. Table 2\n summarizes the number of progress reports received late during each\n year of our review period.\n\n Table 2: Timeliness of Progress Reports Submitted From 2007 to 2009\n\n Total Progress Number Percentage\n Year CTSA Reports Received Received\n Awards Received Late Late\n\n 2007 12 12 11 92%\n\n 2008 24 24 20 83%\n\n 2009 38 38 35 92%\n\n Total 74 74 66 89%\n Source: OIG analysis of CTSA files, 2010.\n\n\n\n During our study period, 36 of 74 FSRs (49 percent) were late. FSRs\n were late an average of 113 days. One report was not submitted within\n the period of our review. Table 3 summarizes the number of FSRs\n received late during each year of our review period.\n\n Table 3: Timeliness of FSRs Submitted From 2007 to 2009\n\n Total Number Percentage\n FSRs\n Year CTSA Received Received\n Received\n Awards Late Late\n\n 2007 12 12 6 50%\n\n 2008 24 24 13 54%\n\n 2009 38 37 17 45%\n\n Total 74 73 36 49%\n Source: OIG analysis of CTSA files, 2010.\n\n\n\n\n OEI-07-09-00300 N I H A D M I N I S T R AT I O N OF THE CLINICAL AND T R A N S L AT I O N A L S C I E N C E AW A R D S P R O G R A M 11\n\x0cF I N D I N G S\n\n\n Staff did not ensure timely submission of required reports\n The NIH Policy Manual instructs CTSA program staff to document\n correspondence with awardees to obtain delinquent reports; however, no\n such documentation was present in the files.\n NIH policy requires CTSA program staff to send notices to awardees\n regarding delinquent reports when progress reports are 30, 60, 90, and\n 120 days late and when FSRs are 4 and 5 months late. None of the files\n contained these reminder notices. However, files contained 8 progress\n reports that were more than 30 days late; 4 of those were more than\n 60 days late. 36 Similarly, files contained 11 FSRs that were more than\n 4 months late and 9 of those FSRs were more than 5 months late.\n For all of the research awards, only one file contained documentation of\n an instance when CTSA program staff contacted an awardee about a\n late report, but this request was late and therefore was not in\n compliance with the NIH Policy Manual. To illustrate, the CTSA\n program staff member emailed the awardee to request an FSR that was\n due 9 months earlier. The awardee finally submitted the FSR to CTSA\n program staff 3 months after the request, nearly a year after the\n original due date.\n NIH policy also instructs CTSA program staff to document enforcement\n actions taken to address continued delinquency. Despite widespread\n report delinquency, no enforcement actions were documented. For\n example, one awardee\xe2\x80\x99s FSRs were 67 days late in 2007, 351 days late\n in 2008, and 184 days late in 2009. This awardee\xe2\x80\x99s progress reports\n were also late each year. Even though these reports were repeatedly\n late, no evidence in the files documented any of the enforcement actions\n that CTSA program staff could have taken to address this awardee\xe2\x80\x99s\n violation of the terms and conditions of award.\n\n\n\n\n 36 None of the progress reports were more than 90 days late.\n\n\n\n\n OEI-07-09-00300 N I H A D M I N I S T R AT I O N OF THE CLINICAL AND T R A N S L AT I O N A L S C I E N C E AW A R D S P R O G R A M 12\n\x0cF I N D I N G S\n\n\n\n Official CTSA files were not maintained in Official files must be complete,\n accordance with HHS policy current, easy to identify, easy to\n access, and separated by budget\n period. Official award files must also enable third-party review in order\n to provide a coordinated approach to award oversight. Official CTSA\n files maintained by NCRR did not meet these criteria.\n NCRR staff stated that the official files for the CTSA awards contained\n scanned versions of their paper files and supplemental information from\n IMPAC II. However, at least 1 required document was missing from the\n official file for each of the 38 awards. Table 4 provides a summary of\n the missing documents.\n Table 4: Summary of Documents Missing From Official CTSA Files\n Number Missing\n Number of\n Award Year Document From Official File\n Awards\n Source\n\n Entire application 7\n Prior to Award 38\n Implementation and Milestones\n 21\n eaSection of application\n\n FSR 6\n\n Progress Report 17\n Year 1 38\n Award Worksheet Report 16\n\n Notice of Award 12\n\n FSR 8\n\n Progress Report 15\n Year 2 24\n Award Worksheet Report 8\n\n Notice of Award 12\n\n FSR 5\n\n Progress Report 4\n Year 3 12\n Award Worksheet Report 1\n\n Notice of Award 6\n Source: OIG analysis of official CTSA files, 2009.\n\n\n\n\n OEI-07-09-00300 N I H A D M I N I S T R AT I O N OF THE CLINICAL AND T R A N S L AT I O N A L S C I E N C E AW A R D S P R O G R A M 13\n\x0cF I N D I N G S\n\n\n\n Official CTSA files were also not current. All CTSA awards were into\n the second quarter of a new budget period at the time of our request,\n and for this reason, the Notice of Award for the new budget period\n should have been filed by that time. However, none of the files\n contained information from that budget period (e.g., Notices of Award,\n site visit reports, records of telephone calls, or emails).\n Official CTSA files were often not separated by budget period. Files\n were not consistently separated by budget period for 16 of the 38 CTSA\n awards. Files for 13 awards combined 2 or more years into 1 section,\n while files for the other 3 awards divided single award years into\n multiple small sections.\n Additionally, official CTSA files do not enable third-party review.\n Because the official files maintained by NCRR are incomplete, a\n third-party review would be inaccurate if it relied solely on these files.\n To complete a comprehensive review of CTSA files, we consulted two\n additional file sources. Table 5 summarizes the file sources used and\n the extent to which they complied with Federal policy from a third-party\n perspective.\n\nTable 5: Extent to Which File Sources Met Requirements of Federal Policies for File Maintenance\n Files Are Files Are Files Are\n Access Files Are Files Are\n Data Source Easy to Easy to Separated by\n Date Complete Current\n Identify Access Budget Period\n\n October\n Official files No No No Yes Sometimes\n 2009\n\n March\n 2010 IMPAC II No Yes Yes No Yes\n\n\n April Electronic Award\n No Yes Yes No Yes\n 2010 Worksheet Reports\n\nSource: OIG analysis of CTSA files, 2010.\n\n\n\n\n No single file source met all the requirements of the Federal policies for\n maintaining files. IMPAC II contained all documents missing from the\n official file except the Award Worksheet Reports. NCRR could not\n locate four Award Worksheet Reports electronically; however, these\n reports were present in the official files for the respective awards.\n\n\n\n\n OEI-07-09-00300 N I H A D M I N I S T R AT I O N OF THE CLINICAL AND T R A N S L AT I O N A L S C I E N C E AW A R D S P R O G R A M 14\n\x0c F I N D I N G S\n\n\n According to Federal statute,\nNo files contained evidence that CTSA program\n cooperative agreements\n staff provided substantial involvement to\n necessitate substantial\n awardees in accordance with Federal involvement 37 by the awarding\n regulations and NIH policy agency in partnership with the\n awardee throughout the life of the\n award. NIH policy states that the names of substantially involved staff\n and annual summaries of substantial staff involvement in the\n cooperative agreements must be documented in the files. According to\n the CTSA Consortium Governance Manual, Project Scientists are\n responsible for providing substantial involvement for CTSA cooperative\n agreements. However, file documentation contained no evidence of this\n type of involvement by Project Scientists or any other CTSA staff.\n\n The CTSA files contained no evidence of substantial Project Scientist\n involvement\n The award files contained no documentation of technical assistance\n from Project Scientists regarding program implementation for any of\n the cooperative agreements. Additionally, files had no evidence that\n Project Scientists did any of the following:\n \xe2\x80\xa2 assisted awardees in performing project activities,\n \xe2\x80\xa2 halted a project activity if technical performance requirements\n were not met,\n \xe2\x80\xa2 reviewed or approved stages of a project,\n \xe2\x80\xa2 approved the selection of contractors or subawardees or key\n project personnel,\n \xe2\x80\xa2 conducted technical monitoring to permit specified directions of\n the work, or\n \xe2\x80\xa2 participated on committees.\n None of the files listed names of Project Scientists, and only two files\n contained any mention of a Project Scientist. In one instance, the\n Project Scientist emailed his intent to attend a teleconference with\n CTSA program staff and the awardee regarding restructuring of the\n CTSA program. However, the file contained no documentation\n explaining what, if any, technical advice the Project Scientist\n contributed during that meeting or documentation of any other\n\n\n 37 Substantial involvement includes activities beyond those usually required for\n\n program stewardship.\n\n\n\n OEI-07-09-00300 N I H A D M I N I S T R AT I O N OF THE CLINICAL AND T R A N S L AT I O N A L S C I E N C E AW A R D S P R O G R A M 15\n\x0cF I N D I N G S\n\n\n involvement. In the other instance, a Program Official with the title\n \xe2\x80\x9cScientific Project Officer\xe2\x80\x9d in her email signature emailed the Grants\n Management Specialist to inquire about the status of an awardee\xe2\x80\x99s\n request to purchase equipment.\n The CTSA files contained no other evidence of substantial involvement\n We searched for documentation of any involvement beyond usual\n program stewardship by CTSA program staff. A checklist item on\n Award Worksheet Reports indicates whether the annual summaries of\n substantial staff involvement in the awards were present in the file.\n Despite the fact that checklists for all but one of the files indicated that\n these summaries were present for at least 1 year of the project, they\n were not in the files.\n In 11 of the files, the annual summary consisted of a brief note from\n CTSA program staff stating that only usual program stewardship was\n provided or describing usual program stewardship activities, such as\n correspondence with awardees. In two other files, the brief note from\n the CTSA program staff instead described the awardees\xe2\x80\x99 level of\n involvement rather than NIH staff involvement. For the rest of the\n files, such notes were not provided.\n Throughout our review of the files, we were able to identify only\n documentation from CTSA program staff related to usual program\n stewardship, such as correction of financial information. Some of the\n documentation of usual program stewardship that had the potential to\n include evidence of substantial involvement was not present. For\n example, a few of the files indicated that site visits occurred, which is\n considered usual program stewardship. However, these same files\n contained no site visit reports. Consequently, we could not determine\n whether CTSA program staff provided involvement beyond usual\n program stewardship during these site visits.\n\n\n\n\n OEI-07-09-00300 N I H A D M I N I S T R AT I O N OF THE CLINICAL AND T R A N S L AT I O N A L S C I E N C E AW A R D S P R O G R A M 16\n\x0c\xef\x80\xb0 R E C O M M E N D A T I O N S\n\n Our review of files for FYs 2006 to 2008 demonstrated that\n administration of the CTSA program was noncompliant with the\n following: monitoring awardee progress, ensuring timely submission of\n required reports, and maintaining official files. Also, no files contained\n evidence that CTSA program staff provided substantial involvement to\n awardees in accordance with the cooperative agreement funding\n mechanism.\n For better oversight of the CTSA program, we recommend that NIH\n ensure that CTSA program staff:\n Document Their Monitoring of Awardee Progress\n When staff review awardee progress, NIH must ensure that they\n document awardee accomplishments toward meeting project goals;\n reasons for not meeting project goals, if applicable; and plans for\n activities during the coming year. To assist staff in documenting these\n elements of annual progress, NIH may consider revising the Award\n Worksheet Report to require a narrative related to awardee\n accomplishments. NIH also may consider formally tracking awardee\n goals and milestones from the time that they are submitted in the\n application through the life of the award, which would facilitate a\n streamlined comparison of accomplishments to goals and milestones\n when evaluating annual awardee progress. This could be accomplished\n through IMPAC II or another mechanism.\n Ensure Timely Submission of Required Reports\n NIH should ensure that staff document correspondence with awardees\n as they act to obtain delinquent reports.\n Maintain Official Files in Accordance With HHS Policy\n NIH must establish a single comprehensive filing system for the CTSA\n program in which files are complete, current, easy to identify, easy to\n access , and separated by budget period. This would promote a\n coordinated approach to award oversight by better enabling third-party\n review.\n Provide Substantial Involvement to CTSA Awardees\n NIH involvement may include collaboration, participation, and/or\n intervention in cooperative agreement activities. At a minimum, staff\n must clearly list within the award files the Project Scientists involved\n and include the annual summary of involvement.\n\n\n\n\nOEI-07-09-00300 N I H A D M I N I S T R AT I O N OF THE CLINICAL AND T R A N S L AT I O N A L S C I E N C E AW A R D S P R O G R A M 17\n\x0cR E C O M M E N D A T I O N S\n\n\n\n AGENCY COMMENTS AND OFFICE OF INSPECTOR GENERAL\n RESPONSE\n NIH concurred with our recommendations. In response to our first and\n second recommendations, NIH stated that it will issue specific guidance\n on documentation requirements for monitoring awardee progress and\n obtaining delinquent reports. NIH stated that it has already\n implemented our third recommendation by using electronic grant files.\n In response to our fourth recommendation, NIH stated that NCRR will\n revise its cooperative agreement terms of award to identify the names\n and titles of program staff who will provide substantial involvement as\n CTSA Project Collaborators. We did not make any changes to the report\n based on NIH\xe2\x80\x99s comments. For the full text of NIH\xe2\x80\x99s comments, see\n Appendix C.\n\n\n\n\n OEI-07-09-00300 N I H A D M I N I S T R AT I O N OF THE CLINICAL AND T R A N S L AT I O N A L S C I E N C E AW A R D S P R O G R A M 18\n\x0c \xef\x80\xb0 A P P E N D I X A\n\n Responsibilities of Clinical and Translational Science Awards Program Staff\n\n\n\n\nSource: National Institutes of Health, CTSA Consortium Governance Manual, version 2008.08.14; Department of Health and Human Services,\nGrants Policy Directives, pt. 1.01.\n\n\nNote on acronyms used in the table: CTSA is Clinical and Translational Science Award. NCRR is the National Center for Research Resources\n(NCRR). NIH is the National Institutes of Health.\n\n\n\n\n OEI-07-09-00300 N I H A D M I N I S T R AT I O N OF THE CLINICAL AND T R A N S L AT I O N A L S C I E N C E AW A R D S P R O G R A M 19\n\x0c\xef\x80\xb0 A P P E N D I X B\n\n Example of Awardee Goals and Milestones*\n\n\n\n\nSource: Excerpts from one Clinical and Translational Science Award application on file, accessed by the Office of Inspector General in\nOctober 2009.\nNote: Potentially identifying information (e.g., names of centers, studies, and committees) has been redacted.\nNote on acronym used in the table: IRB is Institutional Review Board.\n* Shaded areas under Years 1\xe2\x80\x935 indicate the quarter(s) in which the awardee intends to complete the listed activity.\n\n\n\n\n OEI-07-09-00300 N I H A D M I N I S T R AT I O N OF THE CLINICAL AND T R A N S L AT I O N A L S C I E N C E AW A R D S P R O G R A M 20\n\x0c.. APPENDIX C\n\nAgency Comments\n\n\n DDAllTMENT Of BIALTH .. HUMAN SlRVlCES PUbliC Hellth Service\n\n\n NedonellnSlItute$ 01 HealU1\n 8ethesda, Maryl.llnd 204!192\n\n\n\n\n TO: Stuart Wright\n Deputy Inspector Genem! for Inspection and Evaluations, OIG. HHS\n\n FROM: Direetor, NIH\n\n SUBJECT: NIH Comments to the Draft Office of Inspector General Report. NlR\n Administration ofthe Clinical and Trans/aliella} Science Awards Program\n (OEI-07..Q9..00300)\n\n\n Attached are the National Institutes of Health's comments on the draft 010 report entitltd,\n NIH Administration ofthe Clinical and TransJalianol Science Awards Program (OEl'()7\xc2\xb7\n 09-0(300).\n\n We appreciate the opportunity to review and comment on this important topic. Should you\n have questions or concerns regarding our comments, please contact Meredith Stein in the\n Office of Management Assessment at 301-402\xc2\xb78482.\n\n\n /S/\n Francis S. Collins, M.D., Ph.D.\n\n Attachment\n\n\n\n\n OEI\xc2\xb707\xc2\xb709\xc2\xb700300 NIH ADMINISTRATION OF THE CLINICAL AND TRANSLATIONAL SCIENCE AWARDS PROGRAM 21\n\x0cA P P E N D I X ~ C\n\n\n\n\n OEI-07-09-00300 N I H A D M I N I S T R AT I O N OF THE CLINICAL AND T R A N S L AT I O N A L S C I E N C E AW A R D S P R O G R A M 22\n\x0cA P P E N D I X ~ C\n\n\n\n\n OEI-07-09-00300 N I H A D M I N I S T R AT I O N OF THE CLINICAL AND T R A N S L AT I O N A L S C I E N C E AW A R D S P R O G R A M 23\n\x0cA P P E N D I X ~ C\n\n\n\n\n OEI-07-09-00300 N I H A D M I N I S T R AT I O N OF THE CLINICAL AND T R A N S L AT I O N A L S C I E N C E AW A R D S P R O G R A M 24\n\x0c A P P E N D I X ~ C\n\n\n\n\nA P P E N D I X ~ C\n\n\n\n\n OEI-07-09-00300 N I H A D M I N I S T R AT I O N OF THE CLINICAL AND T R A N S L AT I O N A L S C I E N C E AW A R D S P R O G R A M 25\n\x0cA P P E N D I X ~ C\n\n\n\n\n OEI-07-09-00300 N I H A D M I N I S T R AT I O N OF THE CLINICAL AND T R A N S L AT I O N A L S C I E N C E AW A R D S P R O G R A M 26\n\x0cA P P E N D I X ~ C\n\n\n\n\n OEI-07-09-00300 N I H A D M I N I S T R AT I O N OF THE CLINICAL AND T R A N S L AT I O N A L S C I E N C E AW A R D S P R O G R A M 27\n\x0cA P P E N D I X ~ C\n\n\n\n\n OEI-07-09-00300 N I H A D M I N I S T R AT I O N OF THE CLINICAL AND T R A N S L AT I O N A L S C I E N C E AW A R D S P R O G R A M 28\n\x0cA P P E N D I X ~ C\n\n\n\n\n OEI-07-09-00300 N I H A D M I N I S T R AT I O N OF THE CLINICAL AND T R A N S L AT I O N A L S C I E N C E AW A R D S P R O G R A M 29\n\x0c\xef\x80\xb0 A C K N O W L E D G M E N T S\n\n This report was prepared under the direction of Brian T. Pattison,\n Regional Inspector General for Evaluation and Inspections in the\n Kansas City regional office, and Deborah K. Walden, Deputy Regional\n Inspector General.\n Julie Dusold Culbertson served as the project leader for this study.\n Other principal Office of Evaluation and Inspections staff from the\n Kansas City regional office who contributed to the report include\n Perry Seaton and Dennis Tharp; central office staff who contributed\n include Pamela J. Langer and Talisha Searcy.\n\n\n\n\nOEI-07-09-00300 N I H A D M I N I S T R AT I O N OF THE CLINICAL AND T R A N S L AT I O N A L S C I E N C E AW A R D S P R O G R A M 30\n\x0c Office of Inspector General\n http://oig.hhs.gov\n\nThe mission of the Office of Inspector General (OIG), as mandated by Public Law 95-452, as\namended, is to protect the integrity of the Department of Health and Human Services\n(HHS) programs, as well as the health and welfare of beneficiaries served by those\nprograms. This statutory mission is carried out through a nationwide network of audits,\ninvestigations, and inspections conducted by the following operating components:\n\nOffice of Audit Services\nThe Office of Audit Services (OAS) provides auditing services for HHS, either by conducting\naudits with its own audit resources or by overseeing audit work done by others. Audits\nexamine the performance of HHS programs and/or its grantees and contractors in carrying\nout their respective responsibilities and are intended to provide independent assessments of\nHHS programs and operations. These assessments help reduce waste, abuse, and\nmismanagement and promote economy and efficiency throughout HHS.\n\nOffice of Evaluation and Inspections\nThe Office of Evaluation and Inspections (OEI) conducts national evaluations to provide\nHHS, Congress, and the public with timely, useful, and reliable information on significant\nissues. These evaluations focus on preventing fraud, waste, or abuse and promoting\neconomy, efficiency, and effectiveness of departmental programs. To promote impact, OEI\nreports also present practical recommendations for improving program operations.\n\nOffice of Investigations\nThe Office of Investigations (OI) conducts criminal, civil, and administrative investigations\nof fraud and misconduct related to HHS programs, operations, and beneficiaries. With\ninvestigators working in all 50 States and the District of Columbia, OI utilizes its resources\nby actively coordinating with the Department of Justice and other Federal, State, and local\nlaw enforcement authorities. The investigative efforts of OI often lead to criminal\nconvictions, administrative sanctions, and/or civil monetary penalties.\n\nOffice of Counsel to the Inspector General\nThe Office of Counsel to the Inspector General (OCIG) provides general legal services to\nOIG, rendering advice and opinions on HHS programs and operations and providing all\nlegal support for OIG\xe2\x80\x99s internal operations. OCIG represents OIG in all civil and\nadministrative fraud and abuse cases involving HHS programs, including False Claims Act,\nprogram exclusion, and civil monetary penalty cases. In connection with these cases, OCIG\nalso negotiates and monitors corporate integrity agreements. OCIG renders advisory\nopinions, issues compliance program guidance, publishes fraud alerts, and provides other\nguidance to the health care industry concerning the anti-kickback statute and other OIG\nenforcement authorities.\n\x0c"


type: caselaw

jurisdiction: EU

text:
 12.1.2015
 PL
 Dziennik Urzędowy Unii Europejskiej
 C 7/59
 Skarga wniesiona w dniu 27 października 2014 r. – ZZ przeciwko Komitetowi Regionów
 (Sprawa F-123/14)
 (2015/C 007/75)
 Język postępowania: francuski
 Strony
 Strona skarżąca: ZZ (przedstawiciele: adwokaci J.-N. Louis, R. Metz i D. Verbeke)
 Strona pozwana: Komitet Regionów
 Przedmiot i opis sporu
 Stwierdzenie nieważności decyzji Komitetu Regionów o obciążeniu wynagrodzenia skarżącego składką solidarnościowa od dnia 1 stycznia 2014 r. oraz o niedostosowaniu jego wynagrodzenia w okresie od dnia 1 stycznia 2014 r. do dnia 30 czerwca 2015 r.
 Żądania strony skarżącej
 —
 stwierdzenie niemożności stosowania rozporządzenia nr 1023/2013 w zakresie, w jakim przewiduje zawieszenie na okres od dnia 1 lipca 2013 r. do dnia 30 czerwca 2015 r. metody dostosowania wynagrodzenia ustalonej w załączniku XI do regulaminu pracowniczego z jednoczesnym przywróceniem na ten sam okres składki „solidarnościowej” w wysokości 6 %.
 —
 w konsekwencji stwierdzenie nieważności zaskarżonej decyzji;
 —
 obciążenie Komitetu Regionów kosztami postępowania.


type: wikipedia

text:
 Carriera
 Calciatore
 Club
 Gioca tutta la sua carriera in Francia, iniziando col , col quale mette insieme 29 presenze in Ligue 1 e gioca anche nelle coppe europee, nel 1997-1998 in Coppa Intertoto e in Coppa UEFA con 1 presenza per competizione, vincendo l'Intertoto. Successivamente scende di categoria e gioca 207 partite in Ligue 2 con le maglie di , , , , e e varie partite nelle leghe minori francesi.
 Note
 Collegamenti esterni


text:
 10.8.2015
 RO
 Jurnalul Oficial al Uniunii Europene
 C 262/18
 Hotărârea Tribunalului din 25 iunie 2015 – SACE și Sace BT/Comisia
 (Cauza T-305/13) (1)
 ((„Ajutoare de stat - Asigurarea creditelor la export - Reasigurare acordată de o întreprindere publică filialei sale - Aporturi de capital pentru a acoperi pierderile filialei - Noțiunea de ajutoare de stat - Imputabilitate în sarcina statului - Criteriul investitorului privat - Obligația de motivare”))
 (2015/C 262/23)
 Limba de procedură: italiana
 Părțile
 Reclamante: Servizi assicurativi del commercio estero SpA (SACE) (Roma, Italia) și Sace BT SpA (Roma) (reprezentanți: M. Siragusa și G. Rizza, avocați)
 Pârâtă: Comisia Europeană (reprezentanți: G. Conte, D. Grespan și K. Walkerová, agenți)
 Intervenientă în susținerea reclamantelor: Republica Italiană (reprezentanţi: G. Palmieri, agent, asistat de S. Fiorentino, avvocato dello Stato)
 Obiectul
 Cerere de anulare a Deciziei 2014/525/UE a Comisiei din 20 martie 2013 privind măsurile SA.23425 (11/C) (ex NN 41/10) puse în aplicare de Italia în anii 2004 și 2009 pentru Sace BT SpA (JO 2014, L 239, p. 24)
 Dispozitivul
 1)
 Anulează articolul 2 al doilea paragraf din Decizia 2014/525/UE a Comisiei din 20 martie 2013 privind măsurile SA.23425 (11/C) (ex NN 41/10) puse în aplicare de Italia în anii 2004 și 2009 pentru Sace BT SpA.
 2)
 Respinge în rest acțiunea.
 3)
 Servizi assicurativi del commercio estero SpA (SACE) și Sace BT suportă propriile cheltuieli de judecată, inclusiv cele aferente procedurii privind măsurile provizorii.
 4)
 Comisia Europeană suportă propriile cheltuieli de judecată, inclusiv pe cele aferente procedurii privind măsurile provizorii.
 5)
 Republica Italiană suportă propriile cheltuieli de judecată, inclusiv pe cele aferente procedurii privind măsurile provizorii.
 (1) JO C 207, 20.7.2013.


text:
17.4.2004
 DA
 Den Europæiske Unions Tidende
 C 94/13
 DOMSTOLENS KENDELSE
 (Femte Afdeling)
 af 12. december 2003
 i sag C-258/02 P, Bactria Industriehygiene-Service Verwaltungs GmbH mod Kommissionen for De Europæiske Fællesskaber (1).
 (Appel - forordning (EØF) nr. 1896/2000 - biocidholdige produkter - annullationssøgsmål - afvisning - åbenbart, at appellen skal forkastes)
 (2004/C 94/26)
 Processprog: engelsk
 I sag C-258/02 P, Bactria Industriehygiene-Service Verwaltungs GmbH, Kirchheimbolanden (Tyskland), ved advokaterne K. van Maldegem og C. Mereu), angående appel af kendelse afsagt den 29. april 2002 af De Europæiske Fællesskabers Ret i Første Instans (Anden Afdeling) i sag T-339/00, Bactria mod Kommissionen (Sml. II, s. 2287), hvori der er nedlagt påstand om ophævelse af denne kendelse — de andre parter i sagen er Kommissionen for De Europæiske Fællesskaber (befuldmægtigede: R.B. Wainwright og L. Ström), og med valgt adresse i Luxembourg, Eurobrom BV, Rijswijk (Nederlandene), Lonza GmbH, Wuppertal (Tyskland), Arch Chemicals SA, Paris (Frankrig), og Troy Chemical Company BV, Maassluis (Nederlandene), har Domstolen (Femte Afdeling), sammensat af afdelingsformanden, C. Gulmann (refererende dommer), og dommerne A. La Pergola og R. Silva de Lapuerta; generaladvokat: F.G. Jacobs; justitssekretær: R. Grass, den 12. december 2003 afsagt kendelse, hvis konklusion lyder således:
 1)
 Appellen forkastes.
 2)
 Bactria Industriehygiene-Service Verwaltungs GmbH betaler sagens omkostninger.
 (1) EFT C 233 af 28.9.2002.


type: other

text:
Decreto-Lei 108/2009
 Decreto-lei 108/2009, de 15 de Maio
 O Decreto-Lei 204/2000, de 1 de Setembro, estabeleceu, pela primeira vez, o enquadramento legal das actividades de animação turística. Com quase uma década de existência, revela-se hoje desajustado da realidade.
 O presente decreto-lei, juntamente com o Decreto-Lei 39/2008, de 7 de Março, que estabeleceu o novo regime jurídico da instalação, exploração e funcionamento dos empreendimentos turísticos, redefine o conceito de turismo de natureza e contribui para a dinamização do Programa Nacional de Turismo de Natureza, prevista no Programa do Governo. O reconhecimento de actividades de animação turística como turismo de natureza e a organização dessas actividades na Rede Nacional de Áreas Protegidas passam a estar isentos do pagamento de taxas específicas, anteriormente cobradas por cada área protegida em que as empresas pretendessem actuar.
 Congrega-se num único diploma, o regime de acesso à actividade, independentemente da modalidade de animação turística exercida, e cria-se o Registo Nacional dos Agentes de Animação Turística (RNAAT) - Empresas de Animação Turística e Operadores Marítimo-Turísticos - organizado pelo Turismo de Portugal, I.
 P., que contém uma relação actualizada dos agentes a operar no mercado, permitindo uma melhor monitorização e acompanhamento da evolução do sector, e uma melhor fiscalização por parte das entidades públicas.
 a) As agências de viagens, nos termos previstos no artigo 53.o-A do Decreto-Lei 209/97, de 13 de Agosto, alterado pelo Decreto-Lei 263/2007, de 20 de Julho;
 iii) Se dirija única e exclusivamente aos seus membros ou associados e não ao
 iv) Não utilizem meios publicitários para a promoção de actividades específicas
 dirigidos ao público em geral;
 Identificação das empresas de animação turística e dos operadores
 marítimo-turísticos
 3 - A utilização de marcas por empresas de animação turística e operadores marítimo-turísticos carece de comunicação ao Turismo de Portugal, I. P., nos termos do artigo 10.o 4 - A designação «turismo de natureza» e o respectivo logótipo só podem ser usados por empresas reconhecidas como tal nos termos do artigo 20.o 5 - O logótipo a que se refere o número anterior é aprovado por portaria conjunta dos membros do Governo responsáveis pelas áreas do ambiente e do turismo.
 1 - O exercício da actividade das empresas de animação turística e dos operadores marítimo-turísticos depende de inscrição no RNAAT e da contratação dos seguros previstos no artigo 27.o 2 - O requerimento de inscrição no RNAAT é dirigido ao Turismo de Portugal, I. P., através de formulário electrónico disponibilizado no seu sítio da Internet, do qual deve constar:
 3 - Com a inscrição no RNAAT, é emitido e enviado ao requerente, preferencialmente por via electrónica, um certificado de registo com os elementos referidos nas alíneas a) a g) do n.o 2 do artigo 9.o 4 - No prazo de 10 dias a contar da data do registo, o Turismo de Portugal, I. P., comunica ao Instituto Portuário e dos Transportes Marítimos, I. P. (IPTM, I. P.), ou à Direcção-Geral da Autoridade Marítima (DGAM), consoante os casos, e ao Instituto da Água, I. P., o registo de operadores marítimo-turísticos e de empresas de animação turística cujo projecto de actividades inclua o exercício de actividades marítimo-turísticas, e à Direcção-Geral das Pescas e Aquicultura (DGPA), quando o exercício destas actividades inclua a modalidade da pesca turística.
 a) (euro) 950, para empresas certificadas como microempresas de acordo com o previsto no Decreto-Lei 372/2007, de 6 de Novembro;
 c) Das taxas, incluindo a prestação de cauções, devidas pela emissão de títulos de utilização de recursos hídricos nos termos do disposto na Lei da Água, aprovada pela Lei 58/2005, de 29 de Dezembro, e respectiva legislação complementar e regulamentar.
 3 - Verificados os pressupostos referidos no número anterior, o Turismo de Portugal, I.
 P., procede ao registo da empresa no prazo máximo de 10 dias contados da recepção da declaração prévia de início de actividade.
 1 - As empresas de animação turística, os operadores marítimo-turísticos e as agências de viagens autorizadas a exercer actividades de animação turística nos termos previstos no artigo 53.o-A do Decreto-Lei 209/97, de 13 de Agosto, alterado pelo Decreto-Lei 263/2007, de 20 de Julho, que pretendam obter o reconhecimento das suas actividades como turismo de natureza devem apresentar o respectivo processo instruído com os seguintes elementos:
 2 - O projecto de conservação de natureza a que se refere a alínea c) do número anterior é opcional para empresas de animação turística ou operadores marítimo-turísticos que sejam certificados como microempresas, de acordo com o previsto no Decreto-Lei 372/2007, de 6 de Novembro.
 1 - Na Rede Nacional de Áreas Protegidas, fora dos perímetros urbanos, só podem ser oferecidas, por empresas que tenham obtido o seu reconhecimento como actividades de turismo de natureza, nos termos previstos no presente decreto-lei ou por empresas proprietárias ou exploradoras de empreendimentos de turismo de natureza, reconhecidos nos termos previstos no artigo 20.o do Decreto-Lei 39/2008, de 7 de Março, as seguintes actividades de animação turística:
 2 - Os veículos automóveis utilizados no exercício das actividades previstas no número anterior com lotação superior a nove lugares devem ser sujeitos a prévio licenciamento pelo Instituto da Mobilidade e dos Transportes Terrestres, I. P. (IMTT, I.
 P.), nos termos da legislação específica.
 3 - No caso dos operadores marítimo-turísticos e das empresas de animação turística que exerçam actividade marítimo-turística, o seguro de responsabilidade civil obrigatório fica ainda sujeito às regras específicas previstas no Regulamento da Actividade Marítimo-Turística, aprovado pelo Decreto-Lei 21/2002, de 31 de Janeiro, alterado pelo Decreto-Lei 269/2003, de 28 de Outubro.
 5 - Os montantes mínimos fixados nos n.os 2 e 3 são actualizados anualmente, em função do índice de inflação publicado pelo INE no ano imediatamente anterior, e os montantes decorrentes da actualização divulgados no portal do Turismo de Portugal, I.
 j) A não contratação dos seguros obrigatórios previstos no artigo 27.o 2 - As contra-ordenações previstas no número anterior são puníveis com coimas de (euro) 300 a (euro) 3740 ou de (euro) 500 a (euro) 15 000, consoante o infractor seja pessoa singular ou pessoa colectiva.
 4 - Constitui contra-ordenação ambiental leve, nos termos da Lei 50/2006, de 29 de Agosto, a prevista na alínea f) do n.o 1.
 6 - Às contra-ordenações previstas no presente decreto-lei é aplicável o regime geral das contra-ordenações, aprovado pelo Decreto-Lei 433/82, de 27 de Outubro, com excepção da contra-ordenação ambiental prevista no n.o 4 à qual se aplica a Lei 50/2006, de 29 de Agosto.
 Sempre que necessário pode ser determinada a apreensão provisória de bens e documentos, nos termos previstos no artigo 42.o da Lei 50/2006, de 29 de Agosto.
 3 - A repartição do produto das coimas resultantes das contra-ordenações ambientais previstas no n.o 4 do artigo 35.o da Lei 50/2006, de 29 de Agosto, é efectuada nos termos do seu artigo 73.o
 1 - As empresas de animação turística e operadores marítimo-turísticos devem dispor de livro de reclamações nos termos e condições estabelecidas no Decreto-Lei 156/2005, de 15 de Setembro, alterado pelo Decreto-Lei 371/2007, de 6 de Novembro.
 Alteração ao Decreto-Lei 21/2002, de 31 de Janeiro
 Os artigos 1.o e 2.o do Regulamento da Actividade Marítimo-Turística, aprovado pelo Decreto-Lei 21/2002, de 31 de Janeiro, alterado pelo Decreto-Lei 269/2003, de 28 de Outubro, passam a ter a seguinte redacção:
 a) O Decreto-Lei 204/2000, de 1 de Setembro, alterado pelo Decreto-Lei 108/2002, de 16 de Abril;
 b) Os n.os 2 e 3 do artigo 2.o e os artigos 8.o, 9.o e 12.o do Decreto-Lei 47/99, de 16 de Fevereiro, alterado pelo Decreto-Lei 56/2002, de 11 de Março;
 c) Os artigos 3.o a 15.o, 29.o a 32.o e os anexos i e ii do Regulamento aprovado pelo Decreto-Lei 21/2002 de 31 de Janeiro, alterado pelo Decreto-Lei 269/2003, de 28 de Outubro;
 d) O Decreto Regulamentar 18/99, de 27 de Agosto, com excepção do artigo 6.o;
 e) O Decreto Regulamentar 17/2003, de 10 de Outubro;
 f) A Portaria 138/2001, de 1 de Março;
 g) A Portaria 164/2005, de 11 de Fevereiro.
 Texto integral do documento: https://dre.tretas.org/pdfs/2009/05/15/plain-252081.pdf ;
 Extracto do Diário da República original: https://dre.tretas.org/dre/252081.dre.pdf .
 1997-08-13 - Decreto-Lei 209/97 - Ministério da Economia
 Regula o acesso e o exercício da actividade das agências de viagens e turismo. Estabelece normas sobre o licenciamento, as responsabilidades, garantias e sanções a aplicar às agências de viagens e turismo. Até à publicação da portaria prevista no no 5 do artigo 16o, as agências deverão utilizar o livro de reclamações aprovado pela Direcção Geral do Turismo de acordo com o artigo 13o do Decreto Lei 198/93, de 27 de Maio.
 2001-03-01 - Portaria 138/2001 - Ministérios das Finanças e da Economia
 Aprova as taxas devidas pela concessão de licenças relativas ao exercício da actividade das empresas de animação turística.
 2002-04-16 - Decreto-Lei 108/2002 - Ministério da Economia
 2009-06-12 - Portaria 651/2009 - Ministérios do Ambiente, do Ordenamento do Território e do Desenvolvimento Regional e da Economia e da Inovação
 Define e publica em anexo o Código de Conduta a adoptar pelas empresas de animação turística e dos operadores marítimo-turísticos, que exerçam actividades reconhecidas como turismo de natureza, assim como o logótipo que os identifica.
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