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Headquarters and Office of the Commissioner Performance Detail FY 2012 OPA

Table of Contents FY 2012 OPA

Long Term Objective: Manage for Organizational Excellence and Accountability
 
Office: Office of the Commissioner/Office of International Programs
 
Measure
FY
Target
Result
291301: The number of FDA foreign posts to increase collaboration with foreign counterparts. (Outcome)
2012
16
October, 2012
2011
14
October, 2011
2010
15
12 foreign posts
(Target Not Met)
2009
N/A
11 foreign posts
(Historical Actual)
2008
N/A
N/A
2007
N/A
N/A
291302: The number of agencies who participate in the Regulators Forum of the International Conference on Harmonization. (Outcome)
2012
16
October, 2012
2011
14
October, 2011
2010
12
12
(Target Met)
2009
N/A
10
(Historical Actual) 
2008
N/A
6
(Historical Actual)
2007
N/A
N/A
 
Measure
Data Source
Data Validation
291301
Internal Tracking, “Foreign Offices Approval Status” chart, which tracks the progress of steps involved in the approval process.
Foreign posts are considered established upon approval of the National Security Decision Directive (NSDD) 38.
 
 
291302
Regulatory Forums are invitation only events. An internal tracking system is used to record and monitor a list of invitees.
The meeting host records the names of attendees and reports this information as a part of the summary meeting report.
 
 
 
Office: Office of the Commissioner/Office of the Chief Scientist
 
Measure
FY
Target
Result
291101: Percentage of Fellows retained at FDA after completing the Fellowship program. (Outcome)
2012
Implement changes to achieve target identified in the 2011 review
October, 2012
2011
Set target based on data from pilot evaluation
October, 2011
2010
Develop pilot evaluation of program
Pilot evaluation of the Fellowship program developed
(Target Met)
2009
N/A
N/A
2008
N/A
N/A
2007
N/A
N/A
293206: Promote innovation and predictability in the development of safe and effective nanotechnology-based products by establishing scientific standards and evaluation frameworks to guide nanotechnology-related regulatory decisions.  (Outcome)
 
2012
Continue regulatory science studies on evaluating nanomaterials from 2011.
December, 2012
2011
Initiate multi-year studies on safety issues (1) for evaluating nanoparticles that cross multiple product areas and (2) surrounding use of nanoparticles in cosmetic products.  
December, 2011
2010
N/A
N/A
2009
N/A
N/A
2008
N/A
N/A
2007
N/A
N/A
 
 
Measure
Data Source
Data Validation
291101
FDA will develop an Internal Tracking System to track number of offers made to Fellows and number of Fellows that are hired.
FDA will utilize existing HR systems to validate the number of actual hires.
 
 
293206
FDA Nanotechnology Task Force; National Nanotechnology Initiative (NNI); Science Board to the FDA; FDA staff presentations at public meetings; and manuscripts and other written materials for publication in peer-reviewed journals and other communication forums.
FDA will validate its efforts in promoting innovation and predictability in the development of safe and effective nanotechnology-based products by assessing outcomes and other progress in five areas related to nanotechnology including science, research, policy, communication, and planning.   Information from several data sources and relevant FDA activities will provide measures in the five areas related to nanotechnology. Information will be gathered and documented from multiple data sources, which may include agency source data, agency guidance and other written materials, the NNI, cooperation and coordination with other regulatory agencies, public meetings, publications, and other areas.
 
Office: Office of the Commissioner/Office of Orphan Product Development
 
Measure
FY
Target
Result
293201: The total number of decisions on applications for promising orphan drug and humanitarian use device designations. (Output)
 
 
 
2012
335
October, 2012
2011
312
October, 2011
2010
246
301
(Target Exceeded)
2009
N/A
269
(Historical Actual)
2008
N/A
205
 (Historical Actual)
2007
N/A
201
(Historical Actual)
293202The number of medical devices facilitated in development by the new Pediatric Device Consortia Grant Program. (Output)
2012
100
October, 2012
2011
90
October, 2011
2010
1
80
(Target Exceeded)
2009
N/A
N/A
2008
N/A
N/A
2007
N/A
N/A
 
Measure
Data Source
Data Validation
293201
The data will be pulled from the OPD data base, which is updated daily.
Every decision has a written and signed document that is scanned into the data base; the original is filed and can be retrieved by hand.
293202
Each pediatric device consortia grantee submits a quarterly report that provides a description of the medical devices they are facilitating in development.
The OPD grant officers will monitor the grants and follow-up with the grantees to validate the information provided in the quarterly reports.
 
 
 
Office: Office of the Commissioner/Office of Pediatric Therapeutics
 
Measure
FY
Target
Result
293203: Number of pediatric scientific and ethical product and product class issues identified through collaboration with the 27 European Union countries coordinated with the EMA and through collaboration with Latin America. (Output)
2012
36
October, 2012
2011
36
October, 2011
2010
10
62
(Target Exceeded)
2009
N/A
10
(Historical Actual)
2008
N/A
N/A
2007
N/A
N/A
 
Measure
Data Source
Data Validation
293203
Nvivo 8 Software, which is maintained by OPT, is used to track the monthly exchange of pediatric information between FDA and the European Medicine Agency (EMA). The information tracked includes the number of Pediatric Investigational Plans (PIPs) received from EMA, the number of PIPs for which OPT provided information to EMA and the number of PIPs and general topics discussed. Since Nvivo is text-based software, it also captures and stores FDA’s and EMA’s background information for each product discussed at the monthly exchanges. This background information is obtained from various FDA databases, such as DARRTS, and from EMA’s Summary Reports. Following each monthly exchange, notes are written to capture the scientific and ethical issues discussed.
Quality control of the Nvivo 8 Software is performed, which includes identification of duplicate reports, to assure reliability of the data.  
 
 
Measure
FY
Target
Result
293204: Number of new medical products studied in children with labeling changes and safety reviews completed. (Output)
2012
30
October, 2012
2011
30
October, 2011
2010
25
36
(Target Exceeded)
2009
N/A
21
(Historical actual)
2008
N/A
12
(Historical Actual)
2007
N/A
12
(Historical Actual)
 
Measure
Data Source
Data Validation
293204
Drug and Biologic Product labeling that relate to pediatrics are posted on the FDA OPT website  
All FDA drug and biologic products that receive new Pediatric Labeling changes are tracked and listed by the date of labeling change.
The list of labeling dates is reviewed by OPT personnel on a regular basis, 1-2 times a month, to track and determine the dates for mandated safety reviews to the PAC to occur within 2 years from date of labeling change.
Full listing of products with safety reporting to the PAC is updated after each PAC on the website with links to the meetings and background materials.
 
Office: Office of the Commissioner/Office of Combination Products
 
Measure
FY
Target
Result
293205: Percentage of requests for Designations processed within the 60 day statutory requirement.    (Output)
 
2012
95%
October, 2012
2011
95%
October, 2011
2010
95%
100%
(Target Exceeded)
2009
N/A
100%
(Historical Actual)
2008
N/A
100%
(Historical Actual)
2007
N/A
100%
(Historical Actual)
 
Measure
Data Source
Data Validation
293205
OCP’s internal tracking database
For every RFD submitted to OCP, the tracking database records the receipt date, the RFD filing and the date that the final decision is issued. Based on these dates, the tracking database calculates the number of days that OCP spent processing the RFD. The dates generated are compared against the 60 day statutory requirement of issuing a decision after filing. OCP's established administrative processes and procedures for RFDs ensure quality of the data. First, quality of the data is maintained through the issuance of dated letters to the submitter. When an RFD is filed, a letter is sent to the submitter informing them of the filing date. When a final decision is made, a designation letter is also sent to the submitter informing them of the final Agency’s determination. As such, if there is any discrepancy on these dates, the submitter will contact OCP and inform us of the potential error. Second, OCP manually checks, upon filing, the dates generated by the tracking database to ensure that the dates have been calculated correctly. If appropriate, the office will take the necessary steps to correct any error to make sure that the information contained in the database is accurate.        
 
Office: Office of the Commissioner/Office of Special Health Issues
 
Measure
FY
Target
Result
292301: The number of new multi-faceted educational programs for patient advocates and health professionals on major FDA public health issues. (Output)
2012
3
October, 2012
2011
3
October, 2011
2010
3
1
(Target Not Met)
2009
N/A
1
(Historical Actual)
2008
N/A
N/A
2007
N/A
N/A
 
Measure
Data Source
Data Validation
292301
Office of Special Health Issues Strategic Planning Assessments
The number of new multi-faceted educational programs is measured through the OSHI annual strategic planning efforts, where completed and ongoing projects are reviewed and the upcoming year's projects are prioritized. OSHI determines if the multi-faceted educational programs are carried out by using a monthly internal staff survey to capture the separate components of the programs (i.e. webinars, CME programs, journal articles, etc.). This information is summarized and assessed on a quarterly basis as part of the FDA-TRACK program. Both the primary data source (OSHI strategic planning assessments), and the secondary data source (FDA-TRACK monthly surveys), are compared to validate the data.
 
Office: Office of the Commissioner/Office of Women’s Health
 
Measure
FY
Target
Result
294201: Number of site visits of Office of Women’s Health-funded investigators (multiple year recipients) conducting laboratory-based research. (Output)
2012
9
October, 2012
2011
7
October, 2011
2010
5
5
(Target Met)
2009
N/A
4
(Historical Actual)
2008
N/A
4
(Historical Actual)
2007
N/A
N/A
291303: The number of collaborations and partnerships to maximize Outreach activities. (Output)
2012
400
October, 2012
2011
350
October, 2011
2010
300
300
(Target Met)
2009
N/A
250
(Historical Actual)
2008
N/A
250
(Historical Actual)
2007
N/A
N/A
 
Measure
Data Source
Data Validation
294201
 
Office of Women’s Health Internal ACCESS data base
Data is validated for these performance goals through the Unified Financial Management System (UFMS) and Gov Trip
291303
Office of Women’s Health internal ACCESS data base
Data is validated from several sources for these performance goals including the Federal Procurement Data System (FPDS), the Unified Financial Management System (UFMS) 
 
Office: Office of the Commissioner/Office of Financial Management
 
Measure
FY
Target
Result
291402: FDA’s implementation of HHS’s Unified Financial Management System (UFMS). (Efficiency)
2012
Continue to enhance training opportunities for all FDA stakeholders and continue to improve on Oracle Business Intelligence Enterprise Edition (OBIEE) reporting solution for management reports.
December, 2012
2011
Expand FDA’s reporting capabilities; define the TO-BE UFMS processes and a comprehensive training program.
December, 2011
2010
Continue OBI development, UFMS 2010 initiatives (to be defined), improve AS-IS UFMS processes to gain transparency, agility, and efficiency and in the process address deficiencies in the areas of SOD violations and other control deficiencies.     
OBI Beta Implementation, UFMS 2010 initiatives (Target Met) - 1. Performance Assessment and Business Availability (Target Met). 2. OCI Tactical and Strategic Enhancements (Target Met). 3. Improve CAN Realignment (Target Met). 4. Improve YE CAN Management (Target Met). 5. e2e Process Documentation (Target Met). 6. Training Redesign Pilot Program (Target Met). 7. Transition to a Role Based Access in UFMS. (Target Met). 8. During FY2010 there were 4 Point Releases to deploy enhancements and bug fixes. (Target Met)
2009
Begin migration to version 11-5-10 of ORACLE Federal Financials
UFMS was successfully upgraded to 11.5.10 for all Operating Divisions (OPDIVS). (Target Met)
2008
Stabilize UFMS environment Explore/ analyze effects of moving to a later version of ORACLE Federal Financials
All HHS OPDIVS are now in UFMS production. Stabilization for Indian Health Service (IHS) is underway
(Target Met)
2007
Finalize decision on an activity-based costing application and make it operational for its user fee programs
Finalized the decision on an activity-based costing application and made it operational for its user fee programs.
(Target Met)
 
Measure
Data Source
Data Validation
291402
FDA Office of Management & Systems, 2001 FAIR Act Inventory. The agency will rely on the data from the Federal Procurement Data System (FPDS). The sources encompassed in the General Ledger & Federal Administrator, the Purchasing & Accounts Payable; and the Accounts Receivable. These sources are being prepared to transition to the Financial Business solutions systems.   OMB Circular A-123, Appendix A requires proper controls over financial reporting.
FDA will ensure consistency in the tracking and reporting of the administrative management performance goals. In addition, FDA is taking steps to routinely monitor this data and take appropriate actions as needed. Data is from a variety of sources for these performance goals including the Annual Chief Financial Officer’s Report, Civilian and Commission Corps personnel databases, monthly and annual full-time equivalent (FTE) reports and data-runs, the FDA FAIR Act Inventory and the FY 2001 FDA Workforce Restructuring Plan, monthly statements from bank card companies and the FDA Small Purchase System.   FDA will ensure compliance within UFMS controls according to OMB Circular A-123, Appendix A over financial systems and reporting for 2011 and 2012 and ongoing.
 
Office: Office of the Commissioner/Office of Information Management
 
Measure
FY
Target
Result
291404: Percentage of servers that are high efficiency energy star compliant. (Output)
2012
95%
October, 2012
2011
95%
October, 2011
2010
50%
89.2%
(Target Exceeded)
2009
N/A
25%
(Historical Actual)
2008
N/A
5%
(Historical Actual)
2007
N/A
0%
(Historical Actual)
291405: Percentage of application availability during non-scheduled, emergency outages. (Output)
2012
99.9%
October 1, 2012
2011
99.9%
October 1, 2011
2010
98%
98.3%
(Target Exceeded)
2009
N/A
95%
(Historical Actual)
2008
N/A
95%
(Historical Actual)
2007
N/A
N/A
 
Measure
Data Source
Data Validation
291404
The FDA will use power consumption levels prior to and after migration to the new servers in addition to number of physical vs. virtual servers.
Due to the lack of power sub-metering in the agency’s current primary Parklawn facility (decommissioning by 12/31/10), the agency will calculate current power consumption based on “faceplate” figures. Reduction in power will be validated with sub-metered power figures at the new facilities. Further validation will be provided via pre- and post-migration physical and virtual server count comparisons. Equipment purchased or leased under current contracts must be Energy Star compliant where applicable. 
291405
Server utilization reports from automated data center server monitoring provide statistics regarding the availability of the servers that provide access to applications.
This is validated via outage reports provided by FDA users.
 
 
 
 
Office: Office of the Commissioner/Office of Crisis Management
 
Measure
FY
Target
Result
292201: Improve FDA’s ability to respond quickly and efficiently to crises and emergencies that involve FDA regulated products. (Output)
2012
Enhance FDA’s preparedness and planning capabilities by increasing participation in intra/interagency exercises by 25%. Emphasize evaluation of FDA responses to incidents and exercises by establishing a formal evaluation program which will include mandatory comprehensive lessons learned and after action reporting. Enhance interoperability of EON IMS with other systems including those administered by other agencies.
December, 2012
2011
Implement electronic notifications of Reportable Food Registry Reports to Federal and State Counterparts. In addition OCM will conduct training for FDA staff on the implementation of the FDA Emergency Operations Plan and its incident specific annexes. Expand the geospatial capabilities of EON IMS to increase usage during incident response and recovery by 25%.
December, 2011
2010
Pilot EON IMS data sharing with Federal and State counterparts.   Enhance surveillance and detection capabilities within the Office of Emergency Operations.
Revise and exercise FDA’s Emergency Operations Plan and provide training on the plan and annexes. Coordinate participation in inter-agency work-groups, and implement an Agency-wide National Incident Management System (NIMS) plan
Piloted a mechanism to use EON IMS to share data with Federal and State counterparts. Enhanced surveillance and detection capabilities within the Office of Emergency Operations through the further expansion of GIS. Revised and exercised FDA’s Emergency Operations Plan and designed and scheduled training on the plan and annexes. Coordinated participation in interagency work-groups, and implemented an Agency-wide National Incident Management System (NIMS) plan.(Target Met)
2009
Continued enhancement of EON IMS and GIS capabilities. Coordinate FDA’s participation in exercises and interagency work-groups, update remaining emergency response plans, and develop an Agency-wide National Incident Management System (NIMS) implementation plan.
EON IMS Version 3.3.4 implemented Aug 09. Includes a web-based portal for regulated industry; state and local health officials to submit reports of potentially harmful food as required by the Food & Drug Administration Amendment Act of 2007 (FDAAA). OCM updated the FDA Emergency Response Plan, 3 incident-specific emergency response plans and created a draft FDA NIMS Implementation Plan and agency Incident Command System (ICS) structure. (Target Met)
2008
Continued enhancement of EON IMS increased knowledge mgmt and GIS capabilities. Test FDA emergency response plan for pandemic flu and coordinate FDA’s participation in other exercises and workgroup.
EON IMS Version 3.3 implemented Aug 08. Includes significant enhancements to further its knowledge mgmt and GIS capabilities. FDA-wide Incident Command System (ICS) training conducted for Headquarters and field offices. Finalized Pandemic Influenza Emergency Response Plan and began planning an FDA Pandemic Influenza Exercise for Oct 2008. (Target Met)
2007
Continue Enhancement EON IMS Coordinate FDA’s participation in exercises, including TOPOFF 4 Develop an FDA emergency response plan for pandemic influenza
EON IMS version 3.2.1 implemented December 2007 and used in the preparation and response to natural disasters and crises and emergencies. FDA emergency response plan for pandemic influenza developed Sept 2007.
(Target Met)
 
Measure
Data Source
Data Validation
292201
Office of Crisis Management Emergency Operations Network Incident Management System (EON IMS) and Field Data Systems
 
 
Data validation is based on a review of the past period’s activities and the Emergency Operations Network Incident Management System plan and schedule. The percentage increase over FY2010 baseline will be based on the number of maps created for use during incident response and recovery. Improved accuracy and completeness of complaint data entered into FACTS for OCM/OEO review and processing.
 
1.      The number of FDA foreign posts to increase collaboration with foreign counterparts. (291301)
Context: The foreign posts will allow FDA to work more closely with its foreign counterparts to help ensure the safety and quality of FDA-regulated products. The activities of these offices include, gathering information on product manufacturing and transport, leveraging scientific and inspectional resources, working with third parties to assist in ensuring compliance, and providing technical assistance to increase the capacity of selected counterpart agencies.
Performance:   In FY 2009, we established 11 FDA overseas posts and staffed nine of those posts in China (Beijing, Shanghai, and Guangzhou), India (New Delhi and Mumbai), Europe (Brussels and London), and Latin America (San Jose and Santiago). In FY 2010, we staffed the two posts established but not staffed in FY 2009 in Parma and Mexico City and establish one additional overseas post in the Middle East (Tunis, Tunisia).   Due to refocusing of agency priorities the targeted posts changed effecting the processing of and subsequent approval of NSDD-38’s for the total of four additional posts in FY 2010 as previously planned. In FY 2011, we plan to staff the one post established but not staffed in FY 2010, and establish two additional overseas posts, and in FY 2012 two additional posts are planned. 
 
2. The number of agencies who participate in the Regulators Forum of the International Conference on Harmonization. (291302)
 
Context: FDA will work to increase the participation of counterpart agencies in the ICH Regulators Forum, which should hasten the implementation of the ICH-adopted harmonized guidelines for the regulation of drugs and biologics. These activities will increase consumer protection by improving the safety and quality of FDA-regulated products produced in other areas of the world. 
 
Performance: In FY 2010 there were 6 additional agencies (outside the routine ICH partners from Europe, the US, Japan, Canada, Switzerland, and WHO) present at these meetings. In FY 2011 we plan to work to have 2 additional agencies present per meeting, for a total of 14 agencies present at these meetings. In FY 2012, we plan to add an additional 2 additional agencies present per meeting, for a total of 16 agencies.
 
3. Percentage of Fellows retained at FDA after completing the Fellowship program. (291101)
 
Context:   The FDA Commissioner’s Fellowship Program was initiated in the fall of 2008 and is a two-year program designed to train a cadre of highly accomplished scientists in FDA regulatory science across devices, drugs, biologics, foods, and cosmetics. The Commissioner’s Fellowship Program brings highly motivated and promising individuals to FDA where they will contribute to and learn regulatory science and policy, enriching both their careers and FDA’s capacity. They will learn about FDA’s core mission, review processes, policies, and scientific and public health challenges, be supported in their professional development, and engage with a senior mentor in specific high priority projects directly related to FDA’s public health mission. Depending on agency need and resources, many Fellows may remain at FDA after completing the program; others will carry an understanding of FDA with them in their future careers. In FY 2012, a target for the percentage of Fellows retained will be established based on a planned evaluation program that will be developed and executed in FY 2011.
 
Performance:  The FDA Commissioner’s Fellowship Program is new with 50 fellows who began the two-year Program in the fall of 2008 graduating in the fall of 2010. Fifty Fellows began the program in fall of 2009, and 45 Fellows began the program in the fall of 2010. In FY 2010, the performance target was met with a pilot evaluation of the entire program completed and a retention metric, based on the 2008 Fellows’ retention, was identified. In FY 2011, a full formal evaluation of the program will be completed with the identification of a hiring target. In FY 2012, changes to the program to meet the target will be implemented. 
 
4. Promote innovation and predictability in the development of safe and effective nanotechnology-based products by establishing scientific standards and evaluation frameworks to guide nanotechnology-related regulatory decisions. (293206)
 
Context: For the FDA, a science-based regulatory agency whose mission is to protect and promote public health, nanotechnology poses regulatory challenges that are inherent in emerging technologies. Like many emerging technologies, there is the potential benefit that nanotechnology can bring to food, medicine, and other FDA-regulated product areas, but the risks to human and animal health are not yet completely identified or understood.
 
Performance: In FY 2010, FDA received notice of the first proposed FY 2011 funding for nanotechnology. In February 2010, the FDA Nanotechnology Task Force (Task Force) developed and published the agency’s FY 2011 regulatory science research plan for nanotechnology that enables regulatory science studies relevant for the development of safe and effective nanotechnology-based products (http://www.nano.gov/NNI_2011_budget_supplement.pdf).   The Task Force presented the agency’s FY 2011 research plan to the Science Board to the FDA (Science Board) in a public forum in August 2010, and solicited comments from Science Board and the public. The Science Board concurred with FDA’s FY 2011 research plan, including supporting studies such as those described above for the responsible development of nanotechnology. In FY 2011, FDA plans to implement its proposed regulatory science research plan for nanotechnology, including developing the CORES (Collaborative Opportunities for Research Excellence in Science) Program to support studies that can serve as a platform for the targets above, building laboratory capacity to assess nanotechnology products, and investing in training and staff development in the area of nanotechnology.
 
5. The total number of decisions on applications for promising orphan drug and humanitarian use device designations.   (293201)
 
Context:   FDA has a public health mission, as mandated by the Orphan Drug Act of 1983, and the Safe Medical Devices Act of 1990, to provide incentives for the development of promising new drugs and medical devices, respectively, for people with rare diseases and conditions, which is estimated to be more than 25 million people in the United States. This measure is an indication of the amount of progress by drug and medical device sponsors in getting an eventual market approval for these promising orphan products. OOPD does a significant amount of outreach to increase awareness of the statutory incentives and grants programs, and assists sponsors in moving promising products towards market approvals.   The OOPD has a grant program to promote clinical research studies for promising orphan products (drugs, biologics, medical devices, and medical foods) and another grant program to promote the development of pediatric medical devices.
 
Performance:    In FY 2009, OOPD made 248 decisions on orphan drug designation applications and 18 decisions on humanitarian device designation applications.   In FY 2010, OOPD has made 273 decisions on orphan drug designation applications and 28 decisions on humanitarian device designation applications. This result exceeded the target partly as a result of new initiatives by OOPD in FY 2010 to stimulate designation application development. In FY 2011, OOPD expects to achieve the FY 2010 totals, and increase this amount by 4 percent. In FY 2012, OOPD expects to achieve the FY 2011 totals, and increase this amount by 7.5 percent.
 
6. The number of medical devices facilitated in development by the new Pediatric Device Consortia Grant Program. (293202)
 
Context: The goal of the statutory Pediatric Device Consortia Grant Program is to promote pediatric device development, which has lagged far behind the development of device technology for adults. The Pediatric Device Consortia grants facilitate the development of needed medical devices for children. According to statute, the consortia will facilitate the development, production, and distribution of medical devices for children by: (1) Encouraging innovation and connecting qualified individuals with pediatric device ideas with potential manufacturers; (2) Mentoring and managing pediatric device projects through the development process, from concept formation, to prototype development, to clinical development, to marketing; (3) Connecting innovators and physicians to existing Federal and non-Federal resources for funding of device development; (4) Assessing the scientific and technical merit of proposed pediatric device projects; and (5) Providing assistance as needed on business development, personnel training, prototype development, post-market and other activities.
 
Performance:   So far, four Pediatric Device Consortia have been established under this program; collectively they have helped facilitate the early development of 80 potential medical devices for children." This result exceeded the stated target because the original target metric of having one device approved for marketing was replaced with number of devices under development. The four consortia are as follows:
  • The Pediatric Cardiovascular Device Consortium, based out of Boston Children’s Hospital,
  • The UCSF Pediatric Device Consortium, based out of the University of California at San Francisco      (http://www.pediatricdeviceconsortium.org/),
  • The Michigan Pediatric Device (M-PED) Consortium, in partnership with the Pediatric Medical Devices Institute, of Roanoke, VA, based out of the University of Michigan    (http://peddev.org/),
  • The MISTRAL (Multidisciplinary Initiative for Surgical Technology Research Advanced Laboratory) Collaborative based out of SRI International in Stanford, California (http://mistralpediatric.org/).
In FY 2011, we anticipate the number of devices to increase to 90 devices under development, and in FY 2012, we anticipate the number of devices to increase to 100 devices under development.
 
7. Number of pediatric scientific and ethical product and product class issues identified through collaboration with the 27 European countries coordinated with the EMA and through collaboration with Latin America.   (293203)
 
Context: The goal of our international collaborations is to prevent children from becoming a global commodity by conducting trials of the highest ethical and scientific rigor and decreasing their risk.  This involves intense coordination of hundreds of protocols being submitted to the various agencies for identification of potential problems/issues. At present, OPT coordinates at least monthly teleconference exchanges between FDA (CDER and CBER) and the European Medicines Agency (EMA).  Issues identified at each of these monthly teleconferences pertain to safety, clinical trial design, endpoints or ethics.  These issues are ones that require additional collaboration. An example of an issue pertains to heart safety concerns with a product (Aplidin), which is under investigation to treat a specific cancer in children (neuroblastoma).  OPT identified this issue and invited all involved parties to a discussion of this issue, which resulted in additional safety monitoring by EMA. In FY 2010, Japan and Canada joined the monthly pediatric teleconference exchanges as observers. Also, in FY 2010, the Health Science Administrator position for Latin America was filled. In FY 2011, the Medical Officer position for Latin America was filled. Both of these FTE positions for expansion to Latin America are being funded by the Office of International Programs (OIP) until FY 2012. In 2009, the monthly International Exchange changed to address only identified scientific, ethical, product and product class issues.
 
Performance: The exchange of scientific information between FDA and the European Medicines Agency began in September 2007 and through December 2010, information has been exchanged for over 450 products. Of these, 221 products have been discussed at monthly teleconferences as well as 18 general topics.  Ten scientific/ethical issues requiring further discussion or oversight were identified in FY 2008 and in FY 2009. In FY 2010, 62 new or additional issues were identified. We project identification of 36 new or follow-up issues in FY 2011 and FY 2012. In FY 2010, the target was exceeded because it reflects the actual number of issues discussed per product as well as the number of general topic issues discussed during monthly teleconference.
 
8. Number of new medical products studied in children with labeling and safety reviews completed. (293204)
 
Context: The Office of Pediatric Therapeutics has been statutorily charged by Congress to report to the Pediatric Advisory Committee (PAC) all adverse events for products studied under the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA). Originally, the mandate applied to drugs granted pediatric exclusivity under the Best Pharmaceuticals for Children Act (BPCA). FDAAA 2007 expanded the mandate to include drugs receiving a pediatric labeling change under BPCA, as well as drugs and biologicals under the Pediatric Research Equity Act (PREA) and pediatric devices that receive a Humanitarian Device Exemption (HDE). As a result, OPT has assumed greater responsibility and workload for safety reviews and public reporting and vetting of adverse events. In addition, OPT works with all involved FDA and external constituents to facilitate and enhance pediatric studies in order to obtain additional labeling information on efficacy, safety and dosing for children. OPT publicly posts summaries of safety reporting updates presented to the PAC as well as the PAC recommendations for products studied and labeled under FDAAA. In FY 2011, the target is 30, and in FY 2012, the target is 30 new medical products studied in children.
 
Performance:   The number of new medical products studied in children, labeling changes and safety reviews completed under the Congressionally mandated pediatric legislation, BPCA and PREA, are:   FY 2006: 12; FY 2007: 13; FY 2008: 12; FY 2009: 21; FY 2010: 36. The FY 2010 target was exceeded because FDAAA expanded the pediatric safety reporting requirement to include products receiving pediatric labeling under PREA for drugs and biologics as well as HDE pediatric devices. Further it reflects the growing number of pediatric labeling changes resulting from BPCA and/ or PREA studies. 
 
9. Percentage of requests for Designations processed within the 60-day statutory requirement. (293205)
 
Context:  By statute, OCP determines the classification and assignment of a drug, device, biological product and combination product. Under 21 CFR Part 3, an RFD (request for designation) is the regulatory vehicle used for that purpose. As technology advances, sometimes product classification and assignment is unclear. A company submits an RFD requesting a formal determination from OCP. The RFD determination made by OCP is a legally binding action that also identifies such things as the key governing regulations, the center/OCP contacts for next steps. In so doing, this should assist developers by decreasing uncertainty and allowing the firm to move directly to their next development steps. The FY 2010, 2011 and 2012 targets are set at 95% processed within the 60 days requirement.
 
Performance: In FY 2010, a total of 52 requests for designation were active. This includes 7 RFDs that were pending and not overdue at the beginning of 2010.  Of these, 3 RFDs were withdrawn by the sponsor and 5 were remaining at the end of 2010 but not overdue. Of the remaining 44 requests that were eligible for determination, 44 (100%) were processed within the 60-day statutory requirement, which exceeded the target of 95% due to a commitment to make these decisions as quickly as possible. Over half (32 of 44) of product assignment requests were determined to be combination products. Of the 32 combination products; 23 were drug-device combinations, 4 were drug-biologic combinations, 3 were device-biologic combinations and 2 were drug-device-biologic combinations. Of the 12 designations that were not combination products, 7 were designated as drugs, 3 as biologic or tissues, and 2 as devices.
 
10. The number of new multi-faceted educational programs for patient advocates and health professionals on major FDA public health issues. (292301)
 
Context:  Multi-faceted educational programs for patient advocates and health professionals are important ways for these groups to understand FDA’s role and decision-making process on issues that are critical to them. Meetings and workshops allow FDA and participants to engage actively in dialogue, ask questions, and provide feedback on important aspects that might be unknown to each side. Web-based webinars, accredited continuing education modules, and written journal or newsletter articles allow patients and health professionals to more deeply explore and understand the far-reaching impact of the issues with which FDA grapples to protect the public health.   
 
Performance: In FY 2009 FDA developed one educational program on opioid REMS which consisted of an educational workshop; a webinar; four educational meetings with patient advocates and health professionals; and an article published in a health professional newsletter.  For FY 2010, OSHI developed one multi-faceted educational program on expanded access. The expanded access program, developed in conjunction with the American Society for Clinical Oncology consisted of a set of three online educational modules, including resources such as a glossary, an Expanded Access request checklist, and helpful templates for letters to manufacturers, consent forms, etc.   OSHI had planned to produce another multifaceted educational program on REMS. We did not fully meet that target; however, we made significant steps to do so. For example, during FY 2010 we hosted a webinar for patient representatives on REMS. Additionally, substantial progress was made in developing an accredited, web-based continuing educational module for health professionals on REMS. Considerable staff time was devoted to writing, editing, and finalizing the script; however, the project was not completed. In FY 2011, OSHI will develop one additional multi-faceted educational program for patients. The program will consist of an online educational module for patients to learn about FDA issues, a newsletter, an annual meeting, an article for patients in the Drug Information Association publication, and a networking website where patients and patient advocates can exchange ideas.  At the conclusion of FY 2011, OSHI plans to have a total of three multi-faceted educational programs.  In FY 2012, the target is being maintained at the FY 2011 level.
 
11. Number of site visits of Office of Women’s Health-funded investigators (multiple year recipients) conducting laboratory-based research. (294201)
 
Context: Site visits are an integral part of the FDA OWH Research & Development Program. They ensure that the research that investigators have proposed is being conducted as originally planned and to the highest scientific and ethical standards and that the funds received in this competitive scientific awards program are being appropriately used towards the intended scientific goal and that appropriate spending plans are in place.   
 
Performance: In FY 2009, OWH made 4 site visits to facilities conducting OWH-funded laboratory-based research. In FY 2010, OWH met its target and successfully completed 5 site visits inspecting the locations and the progress of the funded studies. All site visits had positive results. OWH is increasing the target to 7 total site visits in FY 2011, and to 9 in FY 2012.
 
12. The number of collaborations and partnerships to maximize Outreach activities. (291303)
 
Context: Partnerships and collaborations are an integral part of the FDA OWH Outreach Program. OWH creates easy to read, concise, and credible consumer health materials about FDA regulated products such as medications, LASIK surgery, HPV vaccine, and mammography, among others. These materials are focus group tested, available in English and Spanish, and readily available for download from the FDA website. Through a variety of partnerships and collaborations, the penetration of the OWH publications in the community is expanded. These partnerships will help maximize the offices’ collaboration efforts and educational program outcomes by reaching new audiences through these new partnerships through linking directly to the FDA OWH website and drive traffic from their websites to FDA OWH for consumer health information. Giving women health information empowers them to have discussions with their medical practitioner and enables them to make wise decisions for themselves and their families.
 
Performance: OWH developed 250 partnerships during Fiscal Years 2006 and 2007 maintaining these partnerships through FY 2008. OWH has met its FY 2010 target by increasing its existing partnerships from 250 in FY 2009 to 300 partnerships in FY 2010. OWH is increasing the target to 350 partnerships in FY 2011, and is planning 400 partnerships by the end of FY 2012. 
 
13.       FDA’s implementation of HHS’s Unified Financial Management System (UFMS). (291402)
 
Context: The Department announced in FY 2001 that it intended to establish a unified financial management system to replace its operating division's individual financial management systems. The goal of the UFMS project is to reduce costs, mitigate security risks, and provide timely and accurate information across DHHS. FDA, CDC, NIH, and the Program Support Center (which covers the remaining components other than CMS and its contractors) began the design of the UFMS. Although this goal had originally been dropped after FDA had implemented UFMS, FDA has continued to be involved in the implementation of the UFMS system across the Department. A new FY 2008 target has been added based on FDA’s efforts to stabilize the UFMS environment now that all OPDIVS have gone live, and to explore/analyze the effects of moving to a later version of ORACLE Federal Financials, bringing DHHS one step closer to FMFIA compliance. In FY 2009 the Department will migrate to Oracle Federal Financials version 11-5-10 and also implement iProcurement and PRISM as the global solutions for requisitioning and acquisitions. For FY 2010 FDA will implement the Oracle Business Intelligence Enterprise Edition (OBIEE) Reporting Solution on a beta basis. Other FDA initiatives for FY2010 include documenting the AS-IS end-to-end (e2e) business processes, a training redesign pilot program and transitioning to a role based access to UFMS. In FY2011 FDA plans to expand the OBIEE Reporting Solution across the Agency (all Centers and OC), complete documenting the AS-IS Business Processes and start defining the TO-BE Business Processes and expand the training redesign program to a more comprehensive training program. In FY2012 FDA will continue the training initiative and complete its development of a comprehensive training program, continued expansion of the OBIEE Reporting Solution and continue the e2e Business Process improvement initiative. 
 
Performance: UFMS has been fully implemented in FDA. Because UFMS is an integrated system and all OPDIVs must share it, FDA remains involved and participates in all future phased implementations of other OPDIVs in the Department.  In FY 2010, OFO successfully implemented a beta version of OBIEE for one of the Centers (CVM) and OFM. Completed deployment of the UFMS Supplier Management Automation Program and other UFMS 2010 initiatives (Performance Assessment and Business Availability (met the target of implementing to 10 solutions); Oracle Compuserve Interface (OCI) Tactical and Strategic Enhancements (met target of identifying all OCI related gaps); Improvement of CAN Realignment and Improve Year End CAN Management (met target by implementing Change Requests agreed to by all OpDivs); and, Continue the documentation and improvements of the e2e AS-IS UFMS processes to gain transparency, agility, and efficiency (completed documenting all the 12 Procure-to-Pay transactions and significant head-way in documenting the Collections-to-Budget transactions). Met significant milestones in the role based definition initiative of granting UFMS access based on roles. Subsequently, this will address deficiencies in the areas of Segregation of Duties (SOD) violations and other control deficiencies. Also met significant milestones in the development of the Training Redesign Pilot Program Courses by identifying and developing three pilot courses based on the training assessment results to be evaluated using best practice methodologies. Also during FY 2010 there were 4 UFMS Point Releases to deploy enhancements and bug fixes. In FY 2011, FDA will continue to be compliant with OMB Circular A-123, Appendix A for internal controls over financial reporting. In FY 2011 FDA will continue to improve business processes and improve training capabilities including the use of OBIEE reporting tools for management. In FY 2012 FDA will continue to expand management financial reporting capabilities along with expanding training curriculum and opportunities for financial managers.
 
14. Percentage of servers that are high efficiency energy star compliant. (291404)
 
Context: FDA’s server environment is outdated. FDA will replace current outdated data center servers with high efficiency energy star compliant servers for applications supporting the regulatory mission of the FDA. This will give the FDA the ability to collect, store, and analyze large volumes of regulatory, scientific, and risk based information from multiple internal and external sources promoting pro-active decisions and timely responses to issues impacting the Public Health.
 
Performance: The FDA began purchasing high efficiency energy star compliant servers in 2008 and replaced approximately 5% of the server environment by the end of FY 2008 with the high efficiency energy star compliant servers. By the end of FY 2009, 25% of the server environment was replaced with high efficiency energy star compliant servers. FDA exceeded the FY 2010 target by utilizing a highly virtualized and consolidated environment and achieved an 89.2% virtualization rate. This resulted in a significantly lower number of physical resources thus lowering energy use. By the end of FY 2011, 95% of the environment will be high efficiency energy star compliant servers.  For FY 2012, the target is being maintained at the FY 2011 level.  
 
15.   Percentage of application availability during non-scheduled, emergency outages. (291405)
 
Context: OIM must ensure that critical systems (i.e., Prior Notice, drug registry, etc.) are available 24x7 in order to carry out the mission of the FDA; reducing the risk of adulterated, misbranded or unapproved food and medical products entering commerce.  
 
Performance: The FDA exceeded the FY 2010 target by migrating production applications to a Tier IV facility in Ashburn, VA.  This facility provides redundant power and cooling and is a state-of-the art facility. This facility is currently performing at 99.9997% uptime.    By the end of FY 2011, FDA is targeting 99.9% availability to customers to utilize mission critical applications.  For FY 2012, the target is being maintained at the FY 2011 level.
 
16.        Improve FDA’s ability to respond quickly and efficiently to crises and emergencies that involve FDA regulated products. (292201) 
 
Context: FDA’s Office of Crisis Management (OCM), which includes the Office of Emergency Operations, is charged with meeting the DHHS goal to improve FDA’s ability to respond quickly and efficiently to crises and emergencies that involve FDA regulated products. OCM is responsible for ensuring that FDA’s emergency preparedness and response capabilities are in accordance with the requirements of the National Response Plan, National Incident Management System and several Homeland Security Presidential Directives (HSPD), including HSPD-5, “Management of Domestic Incidents,” HSPD-8, “National Preparedness,” and HSPD-9, “Defense of United States Agriculture and Food.” In FY 2009, FDA enhanced the Emergency Operations Network Incident Management System (EON IMS) and Geographic Information System (GIS) capabilities and continued to coordinate FDA’s participation in exercises and work-groups, including National Level Exercises (NLEs).
 
Performance: In FY 2010 OCM met their target performance measures by piloting a mechanism to use EON IMS to data share with Federal and State counterparts.   OCM enhanced surveillance and detection capabilities within the Office of Emergency Operations through the further expansion of GIS, revised and exercised FDA’s Emergency Operations Plan, and designed and scheduled training on the plan and its incident specific annexes.  OCM coordinated participation in inter-agency work-groups, and implemented an Agency-wide National Incident Management System (NIMS) plan. In FY 2011, OCM will fully implement electronic notifications of Reportable Food Registry Reports to Federal and State Counterparts. In addition OCM will conduct training for FDA staff on the implementation of the FDA Emergency Operations Plan and its incident specific annexes. OCM will expand the geospatial capabilities of EON IMS to increase usage during incident response and recovery. In FY 2012, OCM will enhance FDA’s preparedness and planning capabilities by increasing participation in intra/interagency exercises by 25%. OCM will emphasize the evaluation of FDA responses to incidents and exercises by establish a formal evaluation program of incident response and intra/interagency exercises to include mandatory comprehensive lessons learned and after action reporting. OCM will also enhance interoperability of EON IMS with other systems including those administered by other agencies.
 
Next page:  FDA Linkages to HHS Strategic Plan FY 2012 OPA