| Goal ID | Original FY 2000 Goal Statement* | Disposition | Revised FY 2000 Targets | Explanation |
| FOODS | ||||
|
11001 |
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 40 percent of food and color additive petitions within 360 days of receipt. | Unchanged | ||
|
11002 |
Reduce the percentage of overdue food and color additive petitions (i.e., under review for more than 360 days) to 20 percent of petitions under review. | Dropped | Dropped in order to streamline the Performance Plan for purposes of clearer external communication. Goal will be used for internal management. | |
|
11003 |
Complete processing of 80 percent of generally recognized as safe (GRAS) notifications within the time frame established by the final rule. | Revised | FY 00: Finalize GRAS Rule ; 80% | New target incorporates unfinished FY 99 target in addition to the unchanged FY 00 target. |
|
11004 |
Eighty percent of the domestic seafood industry will be operating preventive controls for safety as evidenced by functioning Hazard Analysis and Critical Control Point (HACCP) systems. | Dropped | Dropped in order to streamline the Performance Plan for purposes of clearer external communication. Goal will be used for internal management. | |
|
11005 |
Continue to develop and implement voluntary guidance and other efforts to improve the safety of fresh fruits and vegetables, and work with USDA to conduct a 1999-2001 National Agricultural Statistics Survey (NASS) of microbial contamination of fresh produce to collect the data required to evaluate program effectiveness. | Dropped | Dropped in order to streamline the Performance Plan for purposes of clearer external communication. Goal will be used for internal management. | |
|
11006 |
Initiate HACCP in the juice industry. | Dropped | Dropped in order to streamline the Performance Plan for purposes of clearer external communication. Goal will be used for internal management. | |
|
11007 |
Increase to at least 55 percent the proportion of adults who report changing their decision to buy or use a food product because they read the food label. | Unchanged | ||
|
11008 |
Work with the CDC, USDA, and states to increase food safety surveillance and to improve responses to foodborne illness outbreaks. | Dropped | Dropped in order to streamline the Performance Plan for purposes of clearer external communication. Goal will be used for internal management. | |
|
11009 |
Establish an integrated adverse event reporting system for food and cosmetic products, with emphasis on increasing efforts to design and implement modules needed to record dietary supplement adverse event information. | Dropped | Dropped in order to streamline the Performance Plan for purposes of clearer external communication. Goal will be used for internal management. | |
|
11010 |
Achieve adoption of the Food Code by at least 35 percent of the states. | Revised | FY 00: 18 states | Changed target from a percent to the number of states. |
|
11011 |
Assure that FDA inspections of domestic food establishments (excludes domestic seafood establishments), in conjunction with the timely correction of serious deficiencies identified in these inspections, result in a high rate of conformance (at least 90 percent) with FDA requirements. | Unchanged | ||
|
11012 |
Develop and make available an improved method for the detection of hepatitis A virus, Cyclospora cayetanensis and Escherichia coli O157:H7 on additional fruits and vegetables, and provide knowledge and technologies needed to develop guidance and methods for the control and elimination of pathogens on particular fruits and vegetables such as Escherichia coli O157:H7 and Salmonella spp. from juices, leafy vegetables and sprouted seeds and Cyclospora from soft fruit (e.g., berries). | Dropped | Dropped in order to streamline the Performance Plan for purposes of clearer external communication. Goal will be used for internal management. | |
|
11013 |
Develop modeling techniques to assess human exposure and dose-response to certain foodborne pathogens, the potential risk for those pathogens causing human illness, and the setting of safety performance standards to regulate microbial content of food towards reducing incidence of foodborne disease. | Dropped | Dropped in order to streamline the Performance Plan for purposes of clearer external communication. Goal will be used for internal management. | |
|
11018 |
Complete initial processing of 80 percent of biotechnology consultations within established time frames. | Dropped | Dropped in order to streamline the Performance Plan for purposes of clearer external communication. Goal will be used for internal management. | |
|
11019 |
Respond to 95 percent of nutrient content claim and health claim petitions/notifications within the statutory and regulatory time frames. | Dropped | Dropped in order to streamline the Performance Plan for purposes of clearer external communication. Goal will be used for internal management. | |
|
11020 |
Increase the frequency of high-risk domestic food establishment inspections to once every one to two years, and annually beginning in FY 2001. | Revised | FY 00: 90 -100% Once every one to two years | Reduced funding and increased workload. |
|
11021.01 |
Increase the number of inspections/evaluations of foreign food establishments from 100 to 250. | Dropped | Dropped in order to streamline the Performance Plan for purposes of clearer external communication. Goal will be used for internal management. | |
|
11022 |
Develop more rapid and accurate analytical methods for foodborne chemical contaminants (including bacterial toxins). | Dropped | Dropped in order to streamline the Performance Plan for purposes of clearer external communication. Goal will be used for internal management. | |
|
11023 |
Maintain the restored level of activity for cosmetic voluntary reporting to protect consumers against potentially hazardous cosmetic ingredients or products | Dropped | Dropped in order to streamline the Performance Plan for purposes of clearer external communication. Goal will be used for internal management. | |
|
11026 |
Finalize guidance and regulations necessary to support operations of the premarket notification program for food contact substances established by FDAMA and as set out in Sec. 409(h) of the FD&C Act. | Dropped | Dropped in order to streamline the Performance Plan for purposes of clearer external communication. Goal will be used for internal management. | |
| HUMAN DRUGS | ||||
|
12001 |
Review and act on 90% of standard new drug applications (NDAs) filed within 12 months after receipt (30% within 10 months of receipt); and 90% of priority applications within six months. | Revised |
Standard NDAs within 12 months: FY 00: 90% Standard NDAs within 10 months: FY 00: 50% Priority NDAs within 6 months: FY 00: 90% |
Original FY 00 target was incorrect. The revised target now matches PDUFA goals. |
|
12004 |
Review and act on 90 percent of standard efficacy supplements within 12 months of receipt (50 percent within 10 months); and 90 percent of priority efficacy supplements within 6 months. | Dropped | Dropped in order to streamline the Performance Plan for purposes of clearer external communication. Goal will be used for internal management. | |
|
12006 |
Assure the FDA inspections of domestic drug manufacturing and repacking establishments in conjunction with the timely correction of serious deficiencies identified in these inspections, result in a high rate of conformance (at least 90%) with FDA requirements by the end of the fiscal year. | Unchanged | ||
|
12007 |
Expedite processing and evaluation of adverse drug events through implementation of the Adverse Events Reporting System (AERS) which allows for electronic periodic data entry and acquisition of fully coded information from drug companies. | Revised | FY 00: Implement software to make the AERS more compatible with International Conference on Harmonization requirements. Develop next generation of the AERS to enhance functionality. | More specific target. |
|
12008 |
Establish the capability and capacity to receive and archive ANDAs submitted electronically. | Dropped | Dropped in order to streamline the Performance Plan for purposes of clearer external communication. Goal will be used for internal management. | |
|
12011 |
Provide written responses to industry within 14 days of receipt on 80 percent of formal meeting requests; make meeting minutes available to sponsors within 30 calendar days for 80 percent of meetings; and, ensure that 80 percent of Type A meetings are scheduled within 30 calendar days of receipt of the meeting request, Type B within 60 calendar days of receipt of meeting request, and Type C meetings within 75 calendar days of receipt of meeting request. | Dropped | Dropped in order to streamline the Performance Plan for purposes of clearer external communication. Goal will be used for internal management. | |
|
12012 |
Make new drug approval information increasingly available and targeted and promoted to specific user groups, such as consumers, patients, health-care practitioners and industry via the internet, resulting in a decrease in serious medication errors. | Revised | Goal was combined with 12025 and incorporated into new goal 12027. | |
|
12014 |
Complete 75 percent of projects identified in CDER's OTR Research Plan (dated November 24, 1997) designed to lead to appropriate policy for applying modern in vitro and ex vivo technology to assess of drug metabolism and drug interactions. | Dropped | Dropped in order to streamline the Performance Plan for purposes of clearer external communication. Goal will be used for internal management. | |
|
12015 |
Develop a list of bulk drug substances that may be used in compounding and publish a rule to be used for pharmacy compounding. | Dropped | Dropped in order to streamline the Performance Plan for purposes of clearer external communication. Goal will be used for internal management. | |
|
12016 |
Complete 25 percent of the research projects started in FY 1999 under the auspices of the Product Quality Research Initiative (PQRI), a collaboration among FDA, industry and academia established to provide a scientific basis for policy and guidance development in CDER on issues of drug product quality and performance. | Unchanged | ||
|
12017 |
Complete 75 percent of research projects identified in the OTR Research Plan (dated November 24, 1997) designed to develop rational, scientific-based requirements for drug substances, drug products and excipients to ensure a high standard of drug product quality and product performance for making regulatory decisions. | Dropped | Dropped in order to streamline the Performance Plan for purposes of clearer external communication. Goal will be used for internal management. | |
|
12018 |
Reduce the number per application of post-approval changes requiring chemistry supplements. | Dropped | Dropped in order to streamline the Performance Plan for purposes of clearer external communication. Goal will be used for internal management. | |
|
12019 |
Process 75 percent of all review documents by implementing an Electronic Document Management System (EDMS) throughout new and generic drug review divisions. | Dropped | Dropped in order to streamline the Performance Plan for purposes of clearer external communication. Goal will be used for internal management. | |
|
12020 |
Improve inspection coverage by inspecting 36 percent of registered human drug manufacturers, repackers, relabelers and medical gas repackers. | Revised | FY 00: 22% | Reduced funding level required lowering target level. |
|
12024 |
Increase the average monthly number of actions (approvals, tentative approvals, not approvals, and facsimile requests ) completed on ANDAs by 3.2 percent from the FY 1997 level. | Dropped | Dropped in order to streamline the Performance Plan for purposes of clearer external communication. Goal will be used for internal management. | |
|
12025 |
Develop partnerships with 8 national organizations to disseminate educational information to consumers about choosing the right medications, taking medicines correctly and reporting adverse reactions. | Revised | Goal was combined with 12012 and incorporated into new goal 12027. | |
| BIOLOGICS | ||||
|
13001 |
Review and act on 90 percent of standard New Drug Applications (NDA), Product License Application (PLA) and Biologic License Application (BLA) submissions within 12 months of receipt (50 percent within 10 months); and review and act on 90 percent of priority original NDA/PLA/BLA submissions within 6 months of receipt. | Unchanged | ||
|
13002 |
Review and act on 90 percent of standard efficacy supplements within 12 months of receipt (50 percent within 10 months); and review and act on 90 percent of priority efficacy supplements within 6 months of receipt. | Unchanged | ||
|
13003 |
Review and act on 90 percent of manufacturing supplements within 6 months of receipt, and review and act on 50 percent within 4 months of receipt. | Unchanged | ||
|
13004 |
Review and act on 90 percent of Class 1 resubmitted original applications within 4 months of receipt (review 50 percent within 2 months); and review and act on 90 percent of Class 2 resubmitted original applications within 6 months of receipt. | Revised |
Class 1 resubmissions within 2 months: FY 00: 70 %& Class 1 resubmissions within 4 months: FY 00: 90% Class 2 resubmissions within 6 months: FY 00: 90% |
Additional target was added to conform to PDUFA goals. |
|
13005 |
Review and act on 85 percent of complete blood bank and source plasma Product License Application (PLA)/Biologic License Application (BLA) submissions and 90 percent of PLA/BLA Major supplements within 12 months after submission date. | Unchanged | ||
|
13007 |
Assure that FDA inspections of domestic biologics manufacturers and repacking establishments, in conjunction with the timely correction of serious deficiencies identified in these inspections, result in a high conformance rate with FDA requirements (at least 90 percent). | Unchanged | ||
|
13008 |
Increase the percentage of plasma fractionator establishments in compliance with Current Good Manufacturing Practices (CGMPs) to 80 percent. | Unchanged | ||
|
13012 |
Meet the biennial inspection statutory requirement by inspecting 50 percent of registered blood banks, source plasma operations and biologics manufacturing establishments. | Unchanged | ||
| ANIMAL DRUGS AND FEEDS | ||||
|
14001 |
Update 10 percent of the animal drug review guidelines which serve as aids to industry in the animal drug review process. | Revised | FY 00: Update 12 guidelines (original target was 7 guidance documents which was 10 % of animal drug review guidances ). | More specific target. |
|
14002 |
Reduce drug development and review time through implementation of additional phases of electronic submission in the investigational new animal drug development process. | Revised | FY 00: 4 phases - Notices of Slaughter; Notices of Animal Final Disposition; Meeting Agendas; USDA Slaughter Reports | More specific target. |
|
14003 |
Increase the scientific basis for prioritizing research and surveillance activities by increasing the number of risk assessments performed regarding antimicrobial products to two per year. | Revised | FY 00 Goal: Generalize the model by performing risk assessments related to other antibiotics and other animal/bacterial species. | More specific target. |
|
14004 |
Assure that FDA inspections of domestic animal drug and feed manufacturing establishments and repackers, in conjunction with the timely correction of serious deficiencies identified in these inspections, result in a high level of conformance (at least 90 percent) with FDA requirements. | Unchanged | ||
|
14005 |
Maintain the bacterial isolate testing rate from human and animal origin in the National Antimicrobial Resistance Monitoring System (NARMS) database at 2,000 and 4,000 respectively | Unchanged | ||
|
14007 |
Maintain a 75 percent level for pre-submission conferences with industry sponsors. | Unchanged | ||
|
14009 |
Meet the statutory biennial inspection requirement by inspecting 50 percent of registered animal drug and feed establishments. | Revised | FY 00: 27% | Reduced funding level required lowering target level. |
|
14010 |
Maintain the number of Adverse Drug Event (ADE) reports reviewed at 7,000 through consumer participation in the pharmocovigilance program for veterinary drugs by publication and distribution of educational material. | Dropped | Dropped in order to streamline the Performance Plan for purposes of clearer external communication. Goal will be used for internal management. | |
|
14013 |
Properly target resources related to education and enforcement initiatives by maintaining the number of follow-up violative tissue residues investigations at 600 in targeted food producing animals. | Dropped | Dropped in order to streamline the Performance Plan for purposes of clearer external communication. Goal will be used for internal management. | |
|
14014 |
Expand the geographical scope and capacity of NARMS by the establishment of an international resistance database. | Dropped | Dropped in order to streamline the Performance Plan for purposes of clearer external communication. Goal will be used for internal management. | |
|
14015 |
Improve our ability to monitor for Adverse Events by initiating the development of an integrated agency-wide system. | Dropped | Dropped in order to streamline the Performance Plan for purposes of clearer external communication. Goal will be used for internal management. | |
|
14016 |
Increase bioresearch monitoring inspections completed and results received to 115. | Dropped | Dropped in order to streamline the Performance Plan for purposes of clearer external communication. Goal will be used for internal management. | |
|
14017 |
Review and act on 65 percent of New Animal Drug Applications (NADAs)/Abbreviated New Animal Drug Applications (ANADAs) within 180 days of receipt. | Unchanged | ||
| MEDICAL DEVICES AND RADIOLOGICAL HEALTH | ||||
|
15001 |
Increase the on-time percentage of Premarket Approval Application (PMA) first actions (within 180 days) and Humanitarian Device Exemption (HDE) first actions (within 75 days) completed from 67 percent in FY 1998 to 85 percent in FY 2000 and 95 percent by FY 2002. | Unchanged | ||
|
15002 |
Review and complete 95 percent of 510(k) (Premarket Notification) first actions within 90 days. | Dropped | Dropped in order to streamline the Performance Plan for purposes of clearer external communication. Goal will be used for internal management. | |
|
15003 |
Update list of recognized standards. | Dropped | Review 50 standards for continued applicability and review 50 standards for recognition. | More specific target. |
|
15004 |
Apply improved analytical methodology to approximately 30,000 manufacturer event reports, an increase of at least 20 percent over FY 1999. | Dropped | Dropped in order to streamline the Performance Plan for purposes of clearer external communication. Goal will be used for internal management. | |
|
15005.01 |
Improve inspection coverage for Class II and Class III domestic medical device manufacturers from 26 percent in FY 1999 to 39 percent in FY 2000. | Revised | FY 00: 24% | Reduced funding level required lowering target level. |
|
15005.02 |
Improve inspection coverage for Class II and Class III foreign medical device manufacturers from 12 percent in FY 1999 to 19 percent in FY 2000. | Revised | FY 00: 9% | Reduced funding level required lowering target level. |
|
15007 |
Ensure that at least 97 percent of mammography facilities meet inspection standards, with less than 3 percent of facilities with Level 1 (serious) inspection problems. | Unchanged | ||
|
15008 |
Maintain response to significant electronic product risk by initiating regulatory actions and recalls for 95 percent of identified high-risk, noncompliant or defective products within 30 days of discovery. | Dropped | Dropped in order to streamline the Performance Plan for purposes of clearer external communication. Goal will be used for internal management. | |
|
15009 |
Review and complete 85 percent of Premarket Approval Application (PMA) supplements for new indications within 180 days in FY 2000 and 95 percent by FY 2002. | Unchanged | ||
|
15010 |
Investigate correlation of device failures with aging biomaterials and provide quality assurance for device software. | Dropped | Dropped in order to streamline the Performance Plan for purposes of clearer external communication. Goal will be used for internal management. | |
|
15011 |
Maintain annual inspection coverage for mammography facilities (8,900 inspections of a total of approximately 10,000 facilities) in FY 2000. | Dropped | Dropped in order to streamline the Performance Plan for purposes of clearer external communication. Goal will be used for internal management. | |
|
15012 |
Develop Sentinel Surveillance System for injury reporting based on approximately 75 to 90 representative user facilities. | Revised | FY 00: Develop MedSun Surveillance System for injury reporting based on approximately 75 to 90 representative user facilities. Evaluate pilot and report results to Congress. | Additional targets were added. |
|
15013 |
Develop baseline data to estimate problem and risk magnitude for marketed medical devices. | Dropped | Dropped in order to streamline the Performance Plan for purposes of clearer external communication. Goal will be used for internal management. | |
|
15014 |
Review and complete 85 percent of complex 510(k) (Premarket Notification) final actions within 90 days in FY 2000 and 95 percent by FY 2002. | Dropped | Dropped due to change of policy regarding complex 510(k)s. There is a new final actions goal (15021) for all 510(k)s with a target of 65% for FY 00. | |
|
15015 |
Complete 95 percent of Investigational Device Exemption (IDE) "Agreement" meetings and Premarket Approval Application (PMA) "Determination" meetings within 30 days. | Revised | "Agreement" meetings FY 00: 80% "Determination" meetings FY 00: 95% | Goal was split into two separate goals to allow different target levels for these different meetings. |
|
15016 |
Improve quality conformance of high-risk products like cardiovascular devices by committing over 90 percent of inspection resources to high risk devices. | Dropped | Dropped in order to streamline the Performance Plan for purposes of clearer external communication. Goal will be used for internal management. | |
|
15018 |
Assure that FDA inspections of domestic medical device manufacturing establishments, in conjunction with the timely correction of serious deficiencies identified in these inspections, result in a high rate of conformance (at least 90 percent) with FDA requirements. | Unchanged | ||
|
15020 |
Implement the Mutual Recognition Agreement (MRA) with the European Union (EU). | Dropped | Dropped in order to streamline the Performance Plan for purposes of clearer external communication. Goal will be used for internal management. | |
| NATIONAL CENTER FOR TOXICOLOGICAL RESEARCH | ||||
|
16002 |
Develop a new biological assay to measure genetic change and validate two existing models that predict human genetic damage. | Revised | FY 00: Conduct molecular epidemiology studies to identify biomarkers of the most frequently occurring cancers in highly susceptible subpopulations. | Broadening of research efforts to involve private sector. |
|
16003 |
Conduct molecular epidemiology studies to identify biomarkers of the most frequently occurring cancers in highly susceptible subpopulations. | Revised | FY 00: Validate predictive model for estrogenic or estrogenic-like compounds. | Change of research focus. |
|
16004 |
Validate a model computer-based predictive system to support and expedite product review of estrogenic or estrogen-like compounds. | Revised | FY 00: Conduct studies that relate how a compound causes damage to the damage itself, in order to strengthen the scientific basis for regulation of compounds of FDA significance. | Broadening of research efforts to involve other agencies in a common interest. |
|
16005 |
Conduct studies that relate how a compound causes damage to the damage itself, in order to strengthen the scientific basis for regulation of compounds of FDA significance. | Dropped | Dropped in order to streamline the Performance Plan for purposes of clearer external communication. Goal will be used for internal management. | |
|
16007 |
Develop partnerships with government, industry, and academic scientists to conduct studies that demonstrate cross-species comparability and eliminate assumptions necessary for extrapolating laboratory toxicity data to human disease. | Revised | FY 00 : Develop methods of predicting, more quickly and accurately, the risk associated with foodborne pathogens as Salmonella spp., Shigella spp., and Campylobacter spp. | Narrowing of research focus to support FSI. |
|
16008 |
Develop methods of predicting, more quickly and accurately, the risk associated with foodborne pathogens. | Dropped | Dropped in order to streamline the Performance Plan for purposes of clearer external communication. Goal will be used for internal management. | |
| TOBACCO | ||||
|
17001 |
Conduct 400,000 compliance checks and select certain sites to target for intensified enforcement efforts to determine the effectiveness of different levels of effort. | Revised | FY 00: Conduct 200,000 compliance checks and conduct follow-up compliance checks of 100% of retailers found to be in violation of the rule. | Reduced funding level required lowering target level. |
|
17002 |
Ensure the elimination of certain forms of advertising, especially outdoor advertising within 1000 feet of schools and playgrounds (including transit advertising) and specialty item distribution such as hats and tee shirts with tobacco logos. | Dropped | Dropped in order to streamline the Performance Plan for purposes of clearer external communication. Goal will be used for internal management. | |
|
17003 |
Maintain the percentage of known retailers of cigarettes and smokeless tobacco products who are aware of the FDA tobacco rule at no less than 90 percent and increase the percentage of retailers who understand the age and ID provisions of the rule to 50 percent. | Revised | FY 00: Conduct multimedia campaign in 40 top media markets for four-week flight to include: create and produce 2 radio, 1 TV, 3 billboard, and 3 print advertisements; run radio, billboard, and print ads in up to 40 major media markets; distribute 150,000 retailer kits; distribute 400,000 direct mail pieces to retailers. Visit up to 15,000 retailers to educate them about program; exhibit at 30 retailer or other trade shows and participate in up to 60 one-on-one meetings with retailers; pilot test retailer recognition program for 3,000 retailers. Maintain the percentage of known retailers of cigarettes and smokeless tobacco products who are aware of the FDA tobacco rule at no less than 90% and increase the percentage of retailers who understand the age and ID provisions of the rule to 50%. | Additional targets were added. |
|
17004 |
Promote availability of free FDA retailer information kits, used to remind customers and young people about the requirements of the FDA tobacco rule, to at least 400,000 retailers of cigarettes and smokeless tobacco products and provide kits to those who request them. | Dropped | Dropped in order to streamline the Performance Plan for purposes of clearer external communication. Goal will be used for internal management. | |
|
17005 |
To the fullest extent permitted under any court order, establish the scientific and regulatory framework to address the challenges posed by new and novel nicotine-containing tobacco products as well as issues raised by current products and replacement therapies. | Dropped | FY 00: NA | Dropped in order to streamline the Performance Plan for purposes of clearer external communication. Goal will be used for internal management. |
|
17006 |
Conduct follow-up compliance checks of 100 percent of retailers found to be in violation of the rule. | Dropped | Dropped in order to streamline the Performance Plan for purposes of clearer external communication. Goal will be used for internal management. | |
| IMPORTS | ||||
|
18002 |
Establish Agency screening guidelines that emphasize risk-based decisions through program Information. | Dropped | Dropped in order to streamline the Performance Plan for purposes of clearer external communication. Goal will be used for internal management. | |
|
18005 |
Complete analysis of variations in criteria used by FDA programs to screen import entries. Establish Agency screening guidelines that emphasize risk-based decisions through program information. | Dropped | Dropped in order to streamline the Performance Plan for purposes of clearer external communication. Goal will be used for internal management. | |
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