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FDAMA Plan Goal |
Changes to Goal |
FY 99 results |
Goal met? |
Comment |
|---|---|---|---|---|
| By the end of FY 2002, CDER will complete development of industry guidance required for electronic submission | Goal dropped in GPRA FY00 Performance Plan | Published guidance documents and held workshops for industry | Goal dropped | Goal dropped in GPRA FY99 Performance Plan |
| By the end of FY 99, CDER will achieve electronic submission capability for certificates to foreign governments | No GPRA-related or PDUFA-related goal | No | Goal not measurable | |
| By the end of FY 2002, CDER will achieve capability and capacity for electronic submission and archiving of information required to submit NDAs without paper copy | Goal dropped in GPRA FY00 Performance Plan | Approx. 40 percent of NDAs received include electronic submissions. Published guidance documents and held workshops for industry | Yes | |
| By the end of FY 2002 CDER will achieve capability and capacity for electronic submission and archiving of ANDAs | Goal dropped in GPRA FY00 Performance Plan | FDA published guidance provides assistance to applicants submitting ANDA data in electronic format. In FY99, FDA received 46 electronic submissions for bioequivalence and 69 for chemistry, manufacturing and controls | Yes | |
| By the end of FY 2002, CDER will make publicly releasable information available via the Internet | Goal dropped in GPRA FY99 Performance Plan, reinstated in FY00 Performance Plan, and dropped in the FY01 Performance Plan | There was no commitment to a specific FY99 target and therefore, no FY99 report. FDA used the internet to publish information on new and innovative drugs approved since Jan 1998. FDA's CDER website had 250,446 visitors | Goal dropped | Goal dropped in GPRA FY99 Performance Plan, reinstated in FY00 Performance Plan, and dropped in the FY01 Performance Plan |
| CVM will revise Investigational New Animal Drug Application procedural regulations and implement the provisions of the ADAA and CVM's REGO initiatives | FY99 GPRA goal changed to: Improve the application processing by implementing ADAA legislation and CVM REGO initiatives, including the Veterinary Feed Directive by establishing and/or revising regulations and guidance documents. FY00 GPRA goal: Update 10 percent of the animal drug review guidelines, which serve as aids to industry in the animal drug review process, FY99 GPRA target: Update 1 percent of guidelines | 8 guidelines: 3 FDAMA -related and 5 Veterinary International Harmonization (VICH) guidance documents | Yes | |
| CDRH will recognize over 415 standards for use in application review and update the list of recognized standards | 450 standards recognized and list of standards updated | Yes |
FDAMA Plan Goal |
Changes to Goal |
FY 99 results |
Goal met? |
Comment |
|---|---|---|---|---|
| FDA will a) evaluate the availability, quality, and usefulness of prescription drug information provided to 75 percent of individuals receiving new prescriptions; and b) complete two studies that will aid in development of comprehensive drug information | FY99 GPRA goal changed to: FDA will evaluate drug information provided to 75 percent of individuals receiving new prescriptions; goal dropped in GPRA FY00 Performance Plan | Completed study: 1998 National Telephone Survey completed showing that 70 percent of Americans received written information about their prescription medications that is longer than a brief sticker label, compared with 67 percent in 1996, 54 percent in 1994 and 24 percent in 1992. | Goal dropped | Goal dropped in GPRA FY00 Performance Plan |
| By the end of FY 2001, CDER will improve the legibility and clarity of OTC drug labels, improve the consumer's ability to read and understand important warnings and usage directions; and complete two studies that will aid in development of comprehensive drug information | Goal dropped in GPRA FY00 Performance Plan, See new goal: Make available to consumers and health professionals more easily-understandable information on choosing and taking prescription and OTC drugs to prevent and reduce their drug risk management, analysis, and communication procedures. | Final regulation was issued in 3/99 to require new, easy-to-understand labeling on OTC drugs | Yes | 2001 deadline |
FDAMA Plan Goal |
Changes to Goal |
FY 99 results |
Goal met? |
Comment |
|---|---|---|---|---|
| Biennial GMP inspections for biologic firms Coverage: 46 percent | FY99 GPRA goal changed to: Inspect 43 percent of registered blood banks, source plasma operations and biologics manufacturing establishments. | 64 percent | Yes | |
| Biennial inspections of registered drug manufacturers, propagators, compounders, or processors (50%) annually Coverage : 23% | GPRA goal changed to 22% coverage for FY99, 22% for FY00, and 28% for FY01 | 26 percent | Yes | |
| Biennial inspections of registered class II and III medical device manufacturers, propagators, or processors (50%) Coverage 28% | FY99 GPRA goal changed to: Inspect 26% of class II and class III domestic medical device manufacturers; 24% for FY00; 28% for FY01 | 30 percent | Yes | |
| Annual inspections of mammography facilities Coverage: 8898 inspections | FY99 GPRA goal dropped | Goal dropped | Goal dropped to streamline the Performance Plan for purposes of clearer external communication. Goal will be used for internal management. | |
| Ensure that 50 percent of seafood industry operating under HACCP | Goal dropped in GPRA FY00 Performance Plan and combined with the performance goal for conformance rates for domestic seafood establishments | 56 percent | Yes | Goal dropped in GPRA FY00 Performance Plan |
| Develop the HACCP final rule for fruit and vegetable juices | Goal dropped in GPRA FY00 Performance Plan | Published the proposed HACCP rule for juices | Goal dropped | Goal dropped in GPRA FY00 Performance Plan |
| Biennial inspections of registered animal drug and feed establishments (50% annually) Coverage 20% | FY99 GPRA goal changed to 27%; FY00 goal is 50%; FY 2001 goal is 46% due to reduced resources | 20 percent | No | Higher priority health issues, such as compliance with BSE regulations, took precedence over biennial inspections |
Subobjective C1 Imports |
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FDAMA Plan Goal |
Changes to Goal |
FY 99 results |
Goal met? |
Comment |
| Enhance import screening capabilities for public health while ensuring that 55 percent of entries are released within 15 minutes | Goal dropped in GPRA FY00 Performance Plan | Goal dropped | Goal dropped in GPRA FY00 Performance Plan | |
| Assess potentially violative imports through direct examination of 3 percent on entries | Goal dropped in GPRA FY00 Performance Plan | Goal dropped | ||
| Enhance the safety of imported products through increased surveillance of imported food products at the border, increased foreign inspections (from a target level of 40 to 75-100), education, and outreach activities to foreign countries, and the evaluation of food production systems in foreign countries | Goal dropped in GPRA FY00 Performance Plan; incorporated into new goal: Increase the number of import exams of high-risk food products | 82 foreign inspections | Yes | Goal dropped in GPRA FY00 Performance Plan |
| Accept at least 20 percent of imports into the US market through evidence of equivalent source country quality systems/standards/audits | Goal dropped in GPRA FY00 Performance Plan | Goal dropped | ||
Subobjective C2 Adverse event reporting |
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FDAMA Plan Goal |
Changes to Goal |
FY 99 results |
Goal met? |
Comment |
| By the end of FY 99 Implement the Adverse Event Reporting System(AERS) for the electronic receipt and review of voluntary and mandatory ADR reports | FY99 GPRA goal changed to: Expedite processing and evaluation of adverse drug events through implementation of AERS which allows for electronic periodic data entry and acquisition of fully-coded information from drug companies; FY99 target: Implement AERS for the electronic receipt and review of voluntary and mandatory ADR reports. | The AERS has been operational for nearly three years. | Yes | |
| Evaluate pilot efforts for new sentinel device reporting system as alternative to universal user facility reporting | Goal changed in GPRA FY00 Performance Plan to: Develop MedSun Surveillance System for injury reporting based on approximately 75 to 90 representative user facilities. Evaluate pilot and report results to Congress; changed again in FY00 to: Recruit over 200 more hospitals into a MedSun System that uses improved data format and collection methods to enhance the validity and reliability of data provided, thus affording a high level of public health protection. | Pilot completed | Yes | |
| Increase the number of low-risk postmarket device reports received and processed in summary form. The total number summary reports will be increased from 20,000 in FY98 to over 25,000 in FY99. This will be done by using innovative surveillance methods and improving quality and analysis needed for Safety Alerts and other actions | Goal changed in GPRA FY00 Performance Plan to: Apply improved analytical methodology to approximately 30,000 manufacturer event reports, an increase of at least 20 percent over FY99 | 38,000 reports (estimated) | Yes | Goal dropped to streamline the Performance Plan for purposes of clearer external communication. Goal will be used for internal management. |
| Work with the CDC and other federal agencies to develop baseline surveillance data on foodborne illnesses required to evaluate the effectiveness of, set better priorities for, and determine appropriate outcomes for the Food Safety Initiative | Goal dropped in GPRA FY00 Performance Plan | Geographic coverage of FoodNet expanded to 32.2 million people or 12 percent of the American population; published report, "Food-related Illness and Death in the United States," which estimated the number of food-related illnesses; 3 other steps done--creation of a coordinating body to focus on a vision and next steps, establishment of work groups to draft proposed plans and projects solicitation of input from stakeholders. Also improved the geographic coverage of FoodNet | Goal dropped | Dropped in order to streamline the Performance Plan for purposes of clearer external communication. Goal will be used for internal management. |
| By the end of FY99, improve public access to timely information on adverse events related to dietary supplements, infant formulas, and medical foods by increasing the frequency of public releases of information in the Special Nutritionals Adverse Events Monitoring system from two to four per year | Goal dropped in GPRA FY00 Performance Plan | Released one summary of adverse events information from the Special Nutritionals Adverse Events Monitoring System to the public | Goal dropped | Goal dropped in GPRA FY00 Performance Plan. FDA is developing a single integrated adverse event reporting system combining the current four reporting systems. An internet webpage was developed and is now used to provide public with information on adverse events |
| Assure that food derived from animals and animal products is safe for human consumption by increasing the number of human and animal isolates in the National Antimicrobial Monitoring Program (NARMS) | Goal changed in GPRA FY00 Performance Plan to: Maintain the bacterial isolate testing rate from human and animal origin in NARMS database at 2,000 and 4,000 respectively; changed in FY01 Plan to 7200 isolates | 10,216 Salmonella isolates tested (1,706 human; 8,510 veterinary) | Yes | |
FDAMA Plan Goal |
Changes to Goal |
FY 99 results |
Goal met? |
Comment |
|---|---|---|---|---|
| Implement a multi-year research plan to develop and improve methods for the detection, control, and prevention of microbial contamination of fresh product | Goal dropped in GPRA FY00 Performance Plan | In August 1999, FDA finalized and distributed the Three-year Plan for Research | Yes | |
| Develop model to assess human exposure to a variety of foodborne pathogens | Goal dropped in GPRA FY00 Performance Plan | Completed and sent the draft risk assessments for Listeria monocytogenes and Vibrio parahaemolyticus to the Risk Assessment Consortium | Yes | Dropped in order to streamline the Performance Plan for purposes of clearer external communication. Goal will be used for internal management. |
| Work with industry and academia to develop new techniques for eliminating pathogens on fresh produce | FY99 GPRA goal changed to: During FY99, work with industry and academia to develop new techniques for eliminating pathogens on sprouts and in citrus juice and apple cider; goal dropped in GPRA FY00 Performance Plan | Generated data on the presence of S.aureus on three types of domestic sprouted seeds. Began testing imported sprouted seeds from the Import Compliance Program | GPRA goal dropped, partially met | Dropped in order to streamline the Performance Plan for purposes of clearer external communication. Goal will be used for internal management. |
| Support product review by developing faster, more accurate tests on mechanism of toxic actions | Goal changed in FY01 GPRA Performance Plan to: Study FDA-related compounds to relate the mechanism(s) by which a chemical causes toxicity | The experimental portion of the two-year chronic study on urethane in ethanol has been completed and the malachite green animal studies continue. Preliminary studies to assess risk of alpha and beta hydroxy acids in skin formulations continue using hairless mice. Portions of the studies on genistein, an endocrine disrupter, are completed. The chronic two-year component is ongoing. | Yes | |
| Demonstrate a model toxicity knowledge base to support and expedite product review | In FY00 GPRA goal changed to: Develop computer-based models and infrastructure to predict the health impact of increased exposure to estrogen and anti-estrogen compounds | Thirty Chemicals for CFSAN and six for CDER have been used to confirm the predictive value of the computer modeling system. Partnering continues with other agencies (EPA, etc.) and with industry | Yes | Goal changed in FY00 GPRA Performance Plan |
| Develop better models to predict risk for cancer, reproductive, developmental, neurological, genetic, and acute toxicological outcomes | In FY00, this goal was combined with the GPRA goal, "Support product review by developing faster, more accurate tests on mechanism of toxic actions." | See GPRA goal, "Support product review by developing faster, more accurate tests on mechanism of toxic actions." | Not applicable | Goal combined |
FDAMA Plan Goal |
Changes to Goal |
FY 99 results |
Goal met? |
Comment |
|---|---|---|---|---|
| Review 90 percent of priority NDAs within 6 months | 100 percent | Yes | FY99 PDUFA goal | |
| Review 90 percent of standard NDAs within 12 months | FDA expects to meet goal; as of 6/00, 72 percent were within the time period for review | Data not available | FY99 PDUFA goal, data available in PDUFA Report, 12/00 | |
| Review 90 percent of priority NDAs/PLAs/BLAs within 6 months (biologics) | 100 percent | Yes | FY99 PDUFA goal | |
| Review 90 percent of standard NDAs/PLAs/BLAs within 12 months (biologics) | Data not available | FY99 PDUFA goal, data available in PDUFA Report, 12/00 | ||
| Review 90 percent of priority efficacy supplements within 6 months (drugs) | Goal dropped in GPRA FY00 Performance Plan | 87 percent | No | FY99 PDUFA goal Of the 15 priority efficacy supplements reviewed, only 2 of the supplements did not meet the goal |
| Review 90 percent of priority efficacy supplements within 6 months (biologics) | 100 percent | Yes | FY99 PDUFA goal | |
| Review 60 percent of ANDAs within 180 days | 28 percent | No | New procedures allowed for improved overall approval time: 75 percent of ANDAs approved in 8 months | |
| Review 70 percent of Blood PLAs/BLAs within 12 months | FY99 GPRA goal changed to 60 % and to 85 % in FY00 Performance Plan | Data not available | Data on the FY99 cohort of applications not available until 11/00 | |
| Review 50 percent of PMAs within 180 days | FY99 GPRA goal changed to: Maintain the on-time percentage of PMA first actions(within 180 days) and HDE first actions (within 75 days) completed at 65 percent, 85 percent in FY00 and to 90 percent in FY01 | 74 percent of PMAs and HDEs | Yes | |
| Review 90 percent of 510(k)s within 90 days of receipt | FY99 GPRA goal changed to: Review and complete 90 percent of 510(k)s first actions within 90 days. Expand third party 510(k) reviews and complete FDA action on 75 percent of them within 30 days; changed in FY00 Plan to: Review and complete 65 percent of 510(k) (Premarket Notifications) final actions within 90 days | 100 percent of first actions completed within 90 days and 76 percent of final actions completed within 90 days | Yes | 2001 deadline |
| Review 30 percent of food and color additive petitions within 360 days | FY99 GPRA goal changed to: Complete first action (i.e., review all parts of the petition and issue a "not approvable" letter, or publish a response in the Federal Register, if appropriate) on 30 percent of food and color additive petitions within 360 days of receipt. | 54 percent | Yes | |
| Review NADAs and ANADAs within 180 days | Goal changed in GPRA FY00 Performance Plan to 65 percent for FY99 and FY00, changed to 70 percent for FY01 | 73 percent | Yes |
FDAMA Plan Goal |
Changes to Goal |
FY 99 results |
Goal met? |
Comment |
|---|---|---|---|---|
| Review 30 percent of standard NDAs within 10 months | As of 6/00, 51 percent were within the time period for review | Yes | FY99 PDUFA goal | |
| Review 30 percent of standard NDAs/PLAs/BLAs within 10 months (biologics) | Data not available | FY99 PDUFA goal, data available in PDUFA Report, 12/00 | ||
| Review 90 percent of standard efficacy supplements within 12 months (drugs) | Goal dropped in GPRA FY00 Performance Plan | FDA expects to exceed this goal; as of 6/00, 89 percent were within the time period for review | Data not available | FY99 PDUFA goal, data available in PDUFA Report, 12/00 |
| Review 30 percent of standard efficacy supplements within 10 months (drugs) | Goal dropped in GPRA FY00 Performance Plan | As of 6/00, 77 percent were within the time period for review | Yes | FY99 PDUFA goal |
| Review 90 percent of standard efficacy supplements within 12 months (biologics) | Data not available | FY99 PDUFA goal, data available in PDUFA Report, 12/00 | ||
| Review 30 percent of standard efficacy supplements within 10 months (biologics) | Data not available | FY99 PDUFA goal, data available in PDUFA Report, 12/00 | ||
| Review 90 percent of manufacturing supplements within 6 months (drugs) | Goal dropped in GPRA FY00 Performance Plan | 99 percent | Yes | FY99 PDUFA goal |
| Review 30 percent of manufacturing supplements within 4 months (drugs) | Goal dropped in GPRA FY00 Performance Plan | 74 percent | Yes | FY99 PDUFA goal |
| Review 90 percent of manufacturing supplements within 6 months (biologics) | 98 percent | Yes | FY99 PDUFA goal | |
| Review 30 percent of manufacturing supplements requiring prior approval within 4 months (biologics) | Goal changed in GPRA FY00 Performance Plan to 50 percent and in FY01 Plan to 70 percent | 94 percent | Yes | FY99 PDUFA goal |
| Review 70 percent of Blood PLA/BLA major supplements within 12 months | Changed from 70% to 90% in FY99 Performance Plan | Data not available | Data on the FY99 cohort of applications not available until 11/00 | |
| Review 60 percent of Blood ELA major supplements within 12 months | No GPRA-related or PDUFA-related goal | Goal dropped | ELAs are no longer submitted to FDA | |
| Review PMA supplements within 180 days | No GPRA-related or PDUFA-related goal | 100 percent | Yes | |
| Decide fast track requests within 60 days | No GPRA-related or PDUFA-related goal | 77 percent within 60 days | Yes | |
| Review export applications for drugs and biologics within 30 days | No GPRA-related or PDUFA-related goal | Yes | ||
| Complete processing of generally recognized as safe (GRAS) notifications within time frame of final rule | Goal changed in GPRA FY00 Performance Plan to: Finalize the rulemaking creating a premarket notification process for independent GRAS determinations | Made substantial progress toward finalizing GRAS rule | No | Rule not finalized due to resource restraints and competing priorities, expect rule to be final in FY00 |
| Review dietary ingredient notifications within 75 days | No GPRA-related or PDUFA-related goal | 100 percent | Yes | |
| Review infant formula notifications within 90 days | No GPRA-related or PDUFA-related goal | 100 percent | Yes | |
| Review health claim petitions within 100 days | No GPRA-related or PDUFA-related goal | 100 percent | Yes | |
| Review nutrient content claim petitions within 100 days | No GPRA-related or PDUFA-related goal | None received in FY99 | Yes |
1) Most FDAMA goals are associated with GPRA or PDUFA goals. If the GPRA or PDUFA goal has changed since the FDAMA Plan was written, then the FDAMA goal has also changed.
2) If the related GPRA goal has been dropped, FY99 results may not be available
3) If a FDAMA goal is also a PDUFA goal, FY99 results may not be available until that report is published in 12/00
See also Report on FDA Plan for Statutory Compliance (August 2000).