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Summary of Full Cost FY 2012 OPA

Table of Contents FY 2012 OPA

(Budgetary Resources in Millions)

 
OPDIV
HHS Strategic Goals and Objectives
FY 2010
FY 2011
FY 2012
1 Transform Health Care
 
 
 
1.A Make coverage more secure for those who have insurance, and extend affordable coverage to the uninsured
 
 
 
1.B Improve health care quality and patient safety
$1,829
$1,918
$2,319
214208: Number of consumers who are aware of FDA’s Adverse Event Reporting System for Cosmetics.
8
8
8
223201: Percentage of Standard NDAs/BLAs within 10 months.
433
470
607
223202: Percentage of Priority NDAs/BLAs within 6 months.
83
90
108
223205: The total number of actions taken on abbreviated new drug applications in a fiscal year.
115
116
149
222303: Improve the safe use of drugs by patients and health care providers by reviewing safety labeling changes required under FDAAA within the timeframes established by FDAAA.
43
46
56
222201: The Unit Cost associated with turning a submitted Adverse Event Report into a verified record in the database.
23
28
31
222203: The percent of manufacturer submitted expedited adverse event reports received electronically compared to all expedited adverse event reports received from industry.
23
28
31
292202: Number of people for whom FDA is able to evaluate product safety through miniature Sentinel*pilots. 
65
64
96
292203: Number of safety analyses that are conducted using Medicare and Medicaid SafeRx* pilot.  
25
21
23
222302: Percentage of television advertisements requiring submission reviewed within 45 days. 
27
27
29
224201: Number of foreign and domestic high-risk human drug inspections.  
185
192
231
233201: Complete review and action on standard original PDUFA NDA/BLA submissions within 10 months of receipt.
64
72
90
233202: Complete review and action on priority original PDUFA NDA/BLA submissions within 6 months of receipt.
41
44
54
233203: Complete review and action on standard PDUFA efficacy supplements within 10 months of receipt.
97
106
131
233205: Complete review and action on complete blood bank and source plasma BLA submissions within 12 months after submission date.
23
28
36
233206: Complete review and action on complete blood bank and source plasma BLA supplements within 12 months after submission date.
22
27
35
234202: Number of registered domestic blood bank and biologics manufacturing inspections.  
29
28
29
234203: Number of foreign and domestic human tissue establishment inspections.   
16
16
19
242201: Review adverse event reports to detect animal product hazards early.
55
56
64
243201: Complete review and action on original New Animal Drug Applications (NADAs) & reactivations of such applications received during the fiscal year.
10
10
11
243202: Complete review and action on Non-administrative original Abbreviated New Animal Drug Applications (ANADAs) and reactivations of such applications received during the fiscal year.
3
3
4
244204: Complete review and action on warning letters received within 15 working days to better safeguard our food supply by alerting firms to identified deviations in order to become compliant.
9
9
11
244202: Number of domestic and foreign high risk animal drug and feed inspections.  
33
38
47
244203: Number of targeted prohibited material Bovine Spongiform Encephalopathy (BSE) inspections. 
40
34
38
253203: Percentage of received Original Premarket Approval (PMA), Panel-track PMA Supplement, and Premarket Report Submissions reviewed and decided upon within 180 and 295 days.
50
48
52
253204: Percentage of 180 day PMA supplements reviewed and decided upon within 180 and 210 days.
18
18
19
253205: Percentage of 510 (k)s (Premarket Notifications) reviewed and decided upon within 90 and 150 days.
110
106
115
252201: The minimum number of reports per year that 80 percent of MedSun hospitals, enrolled for at least 11 months in the program will submit.
29
28
30
252202: By 2013, enroll 80% of the top 15 MDR reporters by volume in the voluntary eMDR (Medical Device Reporting) program.
43
42
44
254202: Increase percentage of time CDRH meets the targeted deadline of 45 working days to review GMP information and issue Device Warning Letters.
34
34
36
253201: Number of Medical Device Bioresearch Monitoring (BIMO) inspections.
17
17
18
254201: Number of domestic and foreign Class II and Class III device inspections.  
55
62
68
1.C Emphasize primary and preventive care linked with community prevention services
 
 
 
1.D Reduce the growth of health care costs while promoting high-value, effective care
 
 
 
1.E Ensure access to quality, culturally competent care for vulnerable populations
 
 
 
1.F Promote the adoption of health information technology
 
 
 
2 Advance Scientific Knowledge and Innovation
 
 
 
2.A Accelerate the process of scientific discovery to improve patient care
 
 
 
2.B Foster innovation at HHS to create shared solutions
 
 
 
2.C Invest in the regulatory sciences to improve food and medical product safety
$114
$114
$127
214306: The average number of days to serotype priority pathogens in food (Screening Only).
5
5
8
252101: Number of technical analyses of postmarket device problems and performance.
20
20
26
253207: Number of technical reviews of new applications and data supporting requests for premarket approvals.
20
19
22
262401: Develop biomarkers to assist in identifying the correlation between an individual’s nutrition, genetic profile, health, and susceptibility to chronic disease in support of personalized nutrition and health.
0
29
28
263101: Use new omics technologies and pattern-recognition algorithms to analyze imaging data for early-stage disease diagnosis and to study how an FDA-regulated compound or product interacts with the human body.
34
10
10
263102: Develop computer-based models and infrastructure to predict the health risk of biologically active products.
13
7
7
263201: Develop science base for supporting FDA regulatory review of new and emerging technologies.
6
7
9
264101: Develop risk assessment methods and build biological dose-response models in support of food protection.
15
16
17
2.D Increase our understanding of what works in public health and human service practice
 
 
 
3 Advance the Health, Safety and Well-Being of the American People
 
 
 
3.A Ensure the safety, well-being, and healthy development of children and youth
 
 
 
3.B Promote economic and social well-being for individuals, families and communities
 
 
 
3.C Improve the accessibility and quality of supportive services for people with disabilities and older adults
 
 
 
3.D Promote prevention and wellness
$895
$1,060
$1,574
213301: Complete review and action on the safety evaluation of direct and indirect food and color additive petitions, within 360 days of receipt.
21
22
23
214101: Number of state, local, and tribal regulatory agencies in the U.S. and its Territories enrolled in the draft Voluntary National Retail Food Regulatory Program Standards. 
40
40
52
214207: The number of assessments/questionnaires completed to initiate the process of establishing comparability of foreign country food safety systems to that of the US relative to public health outcomes.
23
23
39
212408: The number of American consumers who recognize dietary steps that they can take to reduce their risk of chronic disease.
29
29
34
214201: Number of prior notice import security reviews.  
9
10
11
214202: Number of import food field exams. 
112
114
187
214203: Number of Filer Evaluations.
36
37
53
214204: Number of examinations of FDA refused entries.     
36
37
53
214205: Number of high risk food inspections.  
269
271
366
214206: Maintain accreditation for ORA labs. 
217
219
245
244301: The total number of collaborating laboratories that will provide coordinated response to high priority chemical and microbial animal feed contamination events.  
4
4
5
254101: Percentage of an estimated 8,700 domestic mammography facilities that meet inspection standards, with less than 3% with Level I (serious) problems.
28
31
33
280001: Protect the public health by developing and issuing regulations related to tobacco control and limiting access to tobacco products by youth.
10
40
92
280002: Develop a scientific base to understand and reduce harm from tobacco products by initiating a testing program to support tobacco product standards development, which will include a review of tobacco product ingredients. 
24
66
163
280003: Increase compliance with tobacco product regulation by increasing the percentage of States and Territories with which FDA has developed a contract program to support the enforcement and public health goals of the 1996 rule to assure that retailers refuse sales of cigarettes and smokeless tobacco products to adolescents under the age of 18.  
24
71
108
280004: Educate stakeholders and the general public about the new tobacco products regulations and the health effects of tobacco use.
10
47
110
3.E Reduce the occurrence of infectious diseases
$136
$137
$174
212404: Reduce the incidence of infection caused by key pathogens commonly transmitted by food: Campylobacter species.
34
34
44
212405: Reduce the incidence of infection caused by key pathogens commonly transmitted by food: Shiga toxin-producing Escherichia coli O157:H7.
34
34
44
212406: Reduce the incidence of infection caused by key pathogens commonly transmitted by food: Listeria monocytogenes.
34
34
44
212407: Reduce the incidence of infection caused by key pathogens commonly transmitted by food: Salmonella species.
0
0
0
212409: Decrease the rate of Salmonella Enteritidis (SE) illness in the population (cases per 100,000).
34
34
44
3.F Protect Americans’ health and safety during emergencies, and foster resilience in response to emergencies
$58
$59
$66
234101: Increase manufacturing diversity and capacity for pandemic influenza vaccine production.
38
37
44
214305: Increase laboratory surge capacity in the event of terrorist attack on the food supply. (Radiological and chemical samples/week). 
20
21
21
4 Increase Efficiency, Transparency, and Accountability of HHS Programs
 
 
 
4.A Ensure program integrity and responsible stewardship of resources
 
 
 
4.B Fight fraud and work to eliminate improper payments
 
 
 
4.C Use HHS data to improve the health and well-being of the American people
 
 
 
4.D Improve HHS environmental, energy, and economic performance to promote sustainability
 
 
 
5 Strengthen the Nation's Health and Human Service Infrastructure and Workforce
 
 
 
5.A Invest in the HHS workforce to meet America’s health and human services needs today and tomorrow
 
 
 
5.B Ensure that the Nation’s health care workforce can meet increased demands
 
 
 
5.C Enhance the ability of the public health workforce to improve public health at home and abroad
 
 
 
5.D Strengthen the Nation’s human services workforce
 
 
 
5.E Improve national, state, and local surveillance and epidemiology capacity
$2
$3
$3
214303: Convert data from new eLEXNET participating laboratories via automated exchange or convert data from existing manual data streams to automated data exchange.   
2
3
3
Total
$3,033
$3,290
$4,262

 


Findings and Recommendations for FDA Evaluations Completed in FY 2010

 
 
1.      Safety and Transparency of Pediatric Drug Trials
 
Purpose      Medication adverse events in children often differ from those in adults, particularly those that are neuropsychiatric in nature. Although this information is provided to FDA, it may not be disseminated in reputable journals. Therefore, FDA decided to quantify the frequency and type of new safety information arising from studies performed under the auspices of the Pediatric Exclusivity Program, to describe the dissemination of these findings in the peer-reviewed literature and compare this with the FDA review, and to describe their effect on pediatric labeling.
 
Findings     A total of 137 labeling changes were identified, with 8 selective serotonin reuptake inhibitors excluded from the review, for a total of 129 labeling changes evaluated.
Thirty-three products (26 percent) had pediatric safety information added to the labeling. Of these, 12 products had neuropsychiatric safety findings and 21 had other important safety findings. Only 16 of 33 of these trials (48 percent) were reported in the peer-reviewed literature; however, 7 of 16 focused on findings substantively different from those highlighted in the FDA reviews and labeling changes.
 
Labeling changes for pediatric use demonstrate that pediatric drug studies provide valuable and unique safety data that can guide the use of these drugs in children. Unfortunately, most of these articles are not published, and almost half of the published articles focus their attention away from the crucial safety data.
 
Recommendations
 
No recommendations were presented in the study.
 
 
2.      Final Report to the FDA Science Board: Research, Support Programs, and Alignment with Regulatory Responsibilities of the Center for Food Safety and Applied Nutrition (CFSAN)
 
Purpose      The review of CFSAN’s science and research program was completed by the CFSAN Research Review Subcommittee of the FDA Science Board, with the results shared with the full FDA Science Board. The purpose of the review was to provide recommendations and observations to improve and strengthen CFSAN’s science and research program to increase its capacity to support CFSAN’s mission.
 
Findings    Non-laboratory research, especially in areas where food science, nutrition, and consumer areas integrate and connect, appears to receive lower priority and attention. Applied research areas related to food science, food processing, food technology and nutritional science with regulatory implications also appear to receive less attention.
 
                   Risk, regulatory science, and consumer communication, including evaluation of the impact of communication on consumer understanding and behavior appear to lack the attention and resources required for the current challenges.
                  
                   Increased connectivity, interaction, alignment, and visibility within CFSAN and with other key external and professional organizations, at the national and international levels are essential, but insufficient within the current structure and focus.
 
Programmatic and regulatory outcomes related to CFSAN’s role and responsibilities for research prioritization appear to lack insufficient focus.
 
                   Since 2002, the number of research FTEs at CFSAN has remained essentially the same despite the fact that the Center’s responsibilities have continued to increase. Resources (number, depth, and subject matter expertise) are lacking at multiple levels, and will likely become more acute as the demand grows for expertise in areas of cutting-edge science.
 
There was insufficient support staffing in administrative and technical positions. The ratio of scientists to support staff was unbalanced and inefficient.
 
                   A separate review of the Office of Cosmetics should be done to address any outstanding issues and concerns (e.g., regulatory authority, framework).
 
Recommendations
 
  • Create opportunities to meet with and participate in scientific exchanges with world experts from academia, other governmental organizations, and industry to consider topics relevant to the research agenda for CFSAN’s regulatory science mission.
  • Establish a formalized process for identifying and prioritizing emerging issues to include representatives from both internal and external stakeholders and include means to systematically capture and evaluate concerns that may arise from either scientific, regulatory, or societal challenges.
  • Create a Board of External Scientific Counselors to provide rigorous, ongoing review of science with CFSAN.
  • Develop a list of organizations against which to benchmark CFSAN’s research planning process.
  • Establish a competitive, nationwide extramural research program as part of the FDA budget request.
  • Build capacity to advance and lead new regulatory science in those areas key to CFSAN’s mission to include risk analysis, food safety, food science, food processing, nutrition, communication science, and regulatory science.
 
 
3.      Risk Evaluation and Mitigation Strategies (REMS) Retrospective Regulatory Decision Analysis
 
Purpose      The Food and Drug Administration Amendments Act of 2007 (FDAAA) provided the United States Food and Drug Administration (FDA) with additional requirements, authorities, and resources in both pre- and post-market drug safety, including authorities to require Risk Evaluation and Mitigation Strategies (REMS).  REMS can include a Medication Guide, Patient Package Insert, a communication plan, or other elements to assure safe use (ETASU). This study, conducted by Booz Allen Hamilton (BAH), focused on REMS with elements to assure safe use due to their complexity and the unique decision-making challenges they pose.
 
Findings     Due to the small size of the study cohort, no conclusions were made about how these factors influenced FDA’s decision making or how these factors changed over time.
 
                  Based on the analysis of FDA’s review documents, the factors were grouped into six categories: 1) Specific adverse events, 2) Overall risk profile, 3) Ability to mitigate risk, 4) Efficacy and benefit, 5) Characteristics of the disease the product treats, and 6) Characteristics of the product.
 
                   In the process of analyzing the factors cited in the review documents, it was determined that the documents had not adequately captured all of the reviewers’ considerations.
 
Recommendation
 
Conduct further study to comprehensively identify reviewers’ considerations in determining whether or not to implement a REMS with ETASU.

 
 
4.      Office of Generic Drugs Backlog Analysis
 
Purpose      Stakeholders have expressed concern about FDA’s backlog of unreviewed Abbreviated New Drug Applications (ANDAs), which appears to have grown dramatically in the past several years.
 
Findings     FDA’s old tracking system, COMIS, had undercounted the number of applications in the backlog by failing to count as part of the backlog those applications that had pending reviews in disciplines other than chemistry.
 
FDA’s new tracking system, DARRTS, overcounted the number of applications in the backlog, as it did not permit reviewers to issue “complete response” letters as they had in the past.
 
Recommendation
 
  • To help improve the tracking of DARRTS applications in the future, replace the existing backlog measure with two new measures: 1) Application Backlog: the number of applications with unfinished reviews, and 2) Review Backlog: the number of unfinished reviews.
 
5.      Office of Generic Drugs Consult Process
 
Purpose      During the 2007 Generic Drug User Fee negotiations, industry sought goals for timelines to resolve Office of Generic Drugs (OGD) consults to Office of New Drugs (OND). The user fee negotiations were unsuccessful, and no timelines for consults were established. This study intended to study the OGD consults process and its performance to OND and other offices in preparation for new user fee negotiations.
 
Findings     Depending on the level of difficultly and the priority given to the consults, completing a consult can take anywhere from a few days to several years.
 
                   Generally, consultative reviewers have been responsive to consult requests, particularly when Abbreviated New Drug Applications (ANDAs) are close to approval. 
 
                   Median consult completion times range from 3 to 6 months. However, consults can slow the approval decision process when the need for a consult is recognized late in the review process, because the reviewer’s workload is so great, and because the reviewer has conflicting priorities.  
 
Recommendations
 
No recommendations were presented in the study.
 
 
6.      Task Force on the Utilization of Science in Regulatory Decision Making – Preliminary Report and Recommendations
 
Purpose      The Task Force on the Utilization of Science in Regulatory Decision Making was convened in September 2009 to review how the Center for Devices and Radiological Health (CDRH) uses science in its regulatory decision making process, and to make recommendations on how the Center can quickly incorporate new science —including evolving information, novel technologies, and new scientific methods — into its decision making, while also maintaining as much predictability as is practical.
 
Preliminary Findings
 
                   It is difficult for CDRH staff to efficiently and effectively obtain complete information about the risks and benefits of regulated products across the total product life cycle. This can lead to unnecessary delays and burdens during premarket review and make it challenging for CDRH to identify and respond to postmarket trends quickly and appropriately.
 
                   It is difficult for CDRH staff to share scientific knowledge across the Center, in part due to staffing limitations, and to tap meaningful external scientific expertise in a timely manner.
 
                   CDRH has not yet articulated a business process to be followed across the Center for evaluating new scientific information and determining when that information warrants certain types of action, such as a change in premarket evidentiary expectations.
 
                   When new scientific information changes CDRH’s regulatory thinking, it is challenging for the Center to communicate the change and its basis to all affected parties in a meaningful and timely manner.
 
Preliminary Recommendations
 
  • Take proactive steps to improve the quality of premarket data, particularly clinical data; address review workload challenges; and develop better data sources, methods, and tools for collecting and analyzing meaningful postmarket information.
  • Conduct an assessment of CDRH’s staffing needs to accomplish its mission-critical functions and prepare for anticipated scientific challenges.
  • Take steps to improve knowledge management within CDRH and make better use of experts outside of the Center, in part by developing a web-based network of external experts, using social media technology.
  • Establish a CDRH Science Council, comprised of experienced employees and managers and under the direction of the Deputy Center Director for Science, to help ensure consistency across the Center in responding to new scientific information.
  • Make use of more rapid tools for broad communication on regulatory matters in addition to continuing ongoing efforts to streamline guidance development.
  • Adopt a uniform template and terminology for such letters, including clear and consistent language to indicate that CDRH has changed its regulatory expectations, the general nature of the change, and the rationale for the change.
  • Continue ongoing efforts to increase the transparency of decision making processes and rationale, in order to clarify the basis for any action CDRH takes in response to new scientific information.
 
 
7.      510(k) Premarket Notifications Working Group – Preliminary Report and Recommendations
 
Purpose      The 510(k) Working Group was convened in September 2009 as part of a two-pronged, comprehensive assessment of the 510(k) process. The other component of this assessment is an ongoing independent study by the Institute of Medicine (IOM) that is expected to conclude in the summer of 2011. The 510(k) Working Group was charged to evaluate the 510(k) program and explore actions the Center for Devices and Radiological Health (CDRH) could take to strengthen the program and improve the consistency of its decision making, with a principal focus on actions the Center could take in the short term under its existing statutory authority.
 
Preliminary Findings 
 
Key terms in the statutory definition of “substantial equivalence” have not been consistently interpreted by CDRH. In particular, there is insufficient clarity about what constitutes the same versus a new “intended use,” and about when “different technological characteristics” raise “different questions of safety and effectiveness.” Ambiguity at these critical decision points, at times, has contributed to inconsistency in CDRH’s 510(k) decision making.
 
                   While the concept of “substantial equivalence to a predicate” is generally reasonable, CDRH’s application of this standard has, in certain cases, raised concerns. Concerns have been raised that current FDA regulations and practice may allow for some types of predicate comparisons that are insufficient to consistently provide such assurance, including the use of predicates that have been withdrawn from the market due to issues of safety or effectiveness and the use of so-called “split predicates,” a term that refers to using one predicate as the basis for a comparison with respect to “intended use” and another predicate as the basis for a comparison with respect to “technological characteristics.”
 
                   In general, most instances where concerns were raised by industry and CDRH staff about problems with the 510(k) program involved the small subset of devices for which staff requested clinical information, either to answer questions appropriate for a substantial equivalence determination. Also involved concerns sometimes in cases where the sponsor had no advance notice that such information would be needed or to answer questions more appropriate for the de novo classification process. Both scenarios have contributed to less predictability and longer time-to-decision in the 510(k) program.
 
                   CDRH has a need for more robust systems and tools for quality assurance in the 510(k) program. Quality and consistency depend on a highly qualified, well-trained, and well-supported review staff, and on appropriate oversight.
 
                   There are insufficient tools and metrics in place to assess the consistency of decision making across the 510(k) program, and to track the program’s public health impact quantitatively. Although CDRH collects information on device performance in the postmarket setting, important limitations, including the inability to consistently link postmarket events to specific 510(k)s, make this information, in isolation, an unreliable measure of program effectiveness.
 
Preliminary Recommendations
 
  • Clearly define what constitutes the same versus a new “intended use,” and about when “different technological characteristics” raise “different questions of safety and effectiveness” in guidance and training for review staff and industry.
  • Consider taking steps, through guidance, to set forth factors regarding when a device should not be used as a predicate. Such factors should be well-reasoned, well-supported, and established with input from a range of stakeholders, and unintended consequences should be carefully considered.
  • Explore the possibility of explicitly disallowing the use of “split predicates.”
  • Explore the possibility of developing guidance to define, as a heuristic, a subset of class II devices called “class IIb” devices, for which clinical information, manufacturing information, or, potentially, additional evaluation in the postmarket setting, would typically be necessary to support a substantial equivalence determination.
  • Enhance CDRH’s support for training and professional development for review staff.
  • Develop program metrics and better systems for continuous monitoring of 510(k) program performance and effectiveness, in part through the oversight of a new CDRH Science Council comprised of experienced reviewers and managers, under the direction of the Deputy Center Director for Science.  

Next page: Findings and Recommendations for FDA Evaluations Completed in FY 2010 FY 2012 OPA