FOODS

11001

Complete first action on 50% of food and color additive petitions within 360 days of receipt.

Unchanged

11003

Complete processing of 80% of GRAS notifications within the time frame established by the final rule.

Unchanged

11007

Increase to at least 55% the proportion of adults who report changing their decision to buy or use a food product because they read the food label.

Dropped

This goal was dropped in FY99 due to lack of resources. It was in the table of the FY01 CJ mistakenly. The context of goal section in the 01 CJ stated that this goal was discontinued after FY 99.

11010

Achieve adoption of the Food Code by at least 25 states in the USA.

Revised

Achieve adoption of the Food Code by at least one state agency in 25 states in the USA.

The goal language has been changed from "at least 25 states" to "at least one agency in 25 states" to reflect the fact that state agencies are not the only agencies that can adopt the Food Code, but Federal, tribal, and local as well.

11011

Assure that FDA inspections of domestic food establishments (including domestic seafood establishments), in conjunction with the timely correction of serious deficiencies identified in these inspections, result in a high rate of conformance 90% - 100% with FDA requirements.

Unchanged

Assure that FDA inspections of domestic food establishments (including domestic seafood establishments), in conjunction with the timely correction of serious deficiencies identified in these inspections, result in a high rate of conformance to at least 90%.

Made the target more specific based on OMB recommendation.

11020

Increase the percentage of high-risk domestic food establishment inspections to 90 ‚ 100 % once every year.

Revised

Increase the percentage of high-risk domestic food establishment inspections to at least 90% once every year.

Made the target more specific based on OMB recommendation.

11021.02

Increase the number of import exams of high-risk food products to 66,700.

Revised

Increase the number of import exams of food products to 60,000.

The phrase "high-risk" was taken out because imports are not technically tracked by high or low risk. The previous target of 66,700 was too high based on the issuance of the final field plan, planned figures. Therefore, the target was changed to 60,000.

11025

Respond to 90% of notifications for dietary supplements containing "new ingredients" within 75 days.

Unchanged

11027

Expand monitoring for pesticides and environmental contaminants in foods through the collection and analysis of a targeted cohort of 11,000 samples.

Revised

Expand monitoring for pesticides and environmental contaminants in foods through the collection and analysis of a targeted cohort of 8000+ samples.

The number was lowered due to reexamination of previous data. This goal was originally set too high. In FY99, FDA analyzed 9400 samples and is setting the goal to 8000+ for 2001 and beyond.

11028

Increase the number of audits and assessments to 10 of foreign food safety systems, with an emphasis on high volume exporters to the U.S. to ensure a level of food safety protection comparable to domestically produced foods.

Unchanged

HUMAN DRUGS

12001

Review and act on 90% of standard new drug applications (NDAs) filed within 12 months after receipt (70% within 10 months of receipt); and 90% of priority applications within six months.

Unchanged

12003

Review and act upon 50% of fileable original generic drug applications within 6 months after submission date.

Unchanged

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.

Unchanged

12007

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. 01 Target: Separate data entry and retrieval functions throughout new drug review divisions. Pilot test advanced analytical techniques. Develop and implement special report module.

Revised

Issue Proposed Rule on adverse event reporting requirements. Issue Guidance on electronic submission of adverse event reports. Grant waivers to companies wishing to submit adverse event reports electronically. Continue AERS development (post 2.0 functionality). Roll out AERS datamart to medical officer in new drug review divisions.

Updated to reflect current status of the goal.

12016

Initiate all research programs approved by the PQRI Steering Committee in FY 01 and complete 50% of the projects initiated in FY 99 under the auspices of the 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.

Revised

CDER will initiate laboratory research on at least three projects identified and related to the mission of PQRI.

PQRI is now an independent organization that partners with FDA via a MOU. FDA initiated 3 projects that were identified through the PQRI process.

12020

Inspect 28% of registered human drug manufacturers, repackers, relabelers and medical gas repackers.

Revised

Inspect 26% of registered human drug manufacturers, repackers, relabelers and medical gas repackers.

Reduced funding level required lowering target level

12026

Implement, evaluate, track and report on the clinical trials FDA is requesting under FDAMA or requiring under the Pediatric Rule; conduct research initiatives and activities to define the quality of the clinical studies, usefulness of data generated from these trials, changes in drug product labeling and resultant public health benefits for children.

Unchanged

12027

Make available to consumers and health professionals more easily-understandable information on choosing and taking prescription and OTC drugs to prevent and reduce their misuse, take more of an activist role in how consumers use these drugs, and improve drug risk management, analysis, and communication procedures.

Unchanged

BIOLOGICS

13001

Review and act on 90% of standard original NDA, PLA, and BLA submissions within 12 months of receipt (70% within 10 months); and review and act on 90% of priority original NDA/PLA/BLA submissions within 6 months of receipt.

Unchanged

13002

Review and act on 90% of standard efficacy supplements within 12 months of receipt (70% within 10 months); and review and act on 90% of priority efficacy supplements within 6 months of receipt.

Unchanged

13003

Review and act on 90% of manufacturing supplements within 6 months of receipt, and review act on 70% within 4 months of receipt.

Unchanged

13004

Review and act on 90% of Class 1 resubmitted original applications within 2 months; and review and act on 90% of Class 2 resubmitted original applications within 6 months of receipt.

Unchanged

13005

Review and act on 85% of complete blood bank and source PLA/BLA submissions, and 90% of PLA/BLA Major supplements within 12 months after submission date.

Revised

Review and act on 90% of complete blood bank and source PLA/BLA submissions, and 90% of PLA/BLA Major supplements within 12 months after submission date.

The FY 01 performance target has been revised from 85% to 90% because of review initiatives that have been initiated by CBER.

13007

Assure that FDA inspections of domestic biologics manufacturing, repacking and blood banks 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%)

Unchanged

13008

Maintain the percentage of plasma fractionator establishments in compliance with CGMPs at 80%.

Unchanged

13012

Meet the biennial inspection statutory requirement by inspecting 50% of registered blood banks, source plasma operations and biologics manufacturing establishments.

Unchanged

ANIMAL DRUGS AND FEEDS

14001

Revise and develop 14 guidances for the regulated veterinary industry. 01 Target: 3 manufacturing, 10 new drug approval process and 1 Veterinary International Conference on Harmonization (VICH) guidances.

Unchanged

14002

Reduce drug development and review time by initiating a process for receiving protocol submissions electronically.

Unchanged

14003

Develop an antibiotic risk assessment model using FLQ as the antibiotic, Chickens as the animal species and Campylobacter as the bacterial isolate. 01 Target: Perform 2 risk assessments.

Unchanged

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%) with FDA requirements.

Unchanged

14005

Increase the overall isolate testing rate for Salmonella in NARMS to 7200 for human and animal isolates.

Revised

Increase isolate testing rate for Salmonella in NARMS to 12,000.

Increased the target level based on latest performance data.

14007

Increase the level of pre-submission conferences with industry sponsors to 80%.

Unchanged

14009

Improve biennial inspection coverage by inspecting 46% of registered animal drug and feed establishments.

Unchanged

14017

Review and act on 70% of NADAs/ANADAs within 180 days of receipt.

Revised

Review and act on 75% of NADAs/ANADAs within 180 days of receipt.

Target increase due to Budget increase

14018

Leverage our intellectual capital by initiating the development of a Staff College in the CVM to increase and maintain the scientific expertise in the Center.

Unchanged

MEDICAL DEVICES AND RADIOLOGICAL HEALTH

15001

Increase the on-time percentage of Premarket Approval Application (PMA) first actions (within 180 days) and HDE first actions (within 75 days) completed to 90% in FY 01.

Revised

Maintain the on-time percentage of Premarket Approval Application (PMA) first actions within 180 days.

Modified to remove HDEs, humanitarian use devices intended to benefit patients by treating or diagnosing a disease or condition that affects fewer than 4,000 invididuals in the U.S. per year. Very few HDEs are actually submitted to FDA, and these are normally completed within the 75-day FDAMA prescribed timeframe.

15002

None

New Goal

Review and complete 95% of 510(k) (Premarket Notification) first actions within 90 days in FY01

This is a FY99 goal, dropped in FY00, and picked back up for FY01 and FY 02, as a more meaningful measure of performance in this area. This goal for first actions on 510(k)s within 90 days addresses the statutory requirement to review a 510(k) within 90 days.

15003

Participate in the development of 20 to 25 standards to be used in application review.

Unchanged

15005.01

Improve inspection coverage for Class II and Class III domestic medical device manufacturers to 28%.

Revised

Improve inspection coverage for Class II and Class III domestic medical device manufacturers to 17%.

Reduced funding level required lowering target level.

15005.02

Maintain inspection coverage for Class II and Class III foreign medical device manufacturers. 01 Target: 10%

Revised

Maintain inspection coverage for Class II and Class III foreign medical device manufacturers. 01 Target: 9%

Reduced funding level required lowering target level

15007

Ensure that at least 97% of mammography facilities meet inspection standards, with less than 3% of facilities with Level 1 (serious) inspection problems.

Unchanged

15009

Review and complete 90% of Premarket Approval Application (PMA) supplement final actions within 180 days.

Unchanged

15012

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 higher level of public health protection.

Revised

Recruit 75 to 100 hospitals report adverse events associated with medical devices.

Reduced funding level required lowering target level

15015

Complete 100% of Investigational Device Exemption (IDE) "Agreement" meetings within 30 days.

Unchanged

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%) with FDA requirements.

Unchanged

15021

Review and complete 75% of 510(k) (Premarket Notification) final actions within 90 days in FY 01.

Dropped

First time actions have been determined to be a more meaningful measure of performance in this area.

15024

Complete 95% of Pre-market Approval Application (PMA) "Determination" meetings within 30 days.

Unchanged

15025

None

New Goal

Conduct 260 BIMO inspections with an emphasis on vulnerable populations (e.g., mentally impaired, pediatric, etc.)

This is a new goal to reflect the priority for human subjects protection.

NATIONAL CENTER FOR TOXICOLOGICAL RESEARCH

16001

Introduce the knowledge of new genetic systems, specifically transgenic systems and data, into the application review process. 01 Target: Provide peer reviewed articles on new genetic and transgenic systems and knowledge to product reviewers.

Revised

Introduce the knowledge of new genetic systems and computer assisted toxicology (bioinformatics) into the application review process. Target 01: Provide peer reviewed articles on new genetic and transgenic systems and knowledge to product reviewers

Clarify language. Goal statement changed for 01 target did not.

16002

Develop, in partnership with industry, academia, and government, gene chip and gene array technology to provide high volume screening of biomarkers for susceptible subpopulations identified in molecular epidemiology. 01 Target: Develop, "risk chip" technology to screen large numbers of people for biomarkers simultaneously.

Revised

Develop gene chip and gene array technology. 01 Target: Develop, "risk chip" technology to screen large numbers of people for biomarkers simultaneously.

Clarify language. Goal statement changed for 01 target did not.

16003

Develop a computer based model to predict the impact of increased exposure to estrogens and anti-estrogen compounds on public health. 01 Target Validate a predictive model for androgens.

Revised

Develop computer based models and infrastructure to predict the impact of increased exposure to estrogens and anti-estrogen compounds. 01 Target: Validate a predictive model for androgens.

Clarify language. Goal statement changed for 01 target did not.

16004

Conduct studies on FDA-regulated compounds to relate the mechanism(s) by which a chemical causes toxicity to the biological outcome. These studies enhance the relevance of the data for prediction of human toxicity; expand the number of FDA compounds studied by two per year. 01 Target: Study two or more FDA-regulated compounds.

Unchanged

.

16007

Develop methods and build biological dose-response models to replicate bacterial survival in the stomach to quickly and accurately predict risks associated with antimicrobial resistance and foodborne pathogens/contaminants. 01 Target: Provide model to replicate bacterial survival in stomach.

Revised

Develop methods and build biological dose-response models to replicate bacterial survival in the stomach. 01 Target: Provide model to replicate bacterial survival in stomach.

Clarify language. Goal statement changed for 01 target did not.

16012

Identify biomarkers of toxicity associated with biological warfare agents using innovative new technologies. 01 Target: Publish and disseminate list of biomarkers to FDA product reviewers and other interested scientists.

Dropped

Reduced funding level

16013

Use new technologies (bioinformatics, imaging, proteomics, and metabonomics for diagnosis of toxicity. 01 Target: Publish at least three concept papers exploring new technologies for the assessment of toxicity.

New Goal

TOBACCO

17001

Target 50 top media markets; distribute new retailer kit to 200,000 retailers; and increase retailer recognition program to 10,000 retailers. Maintain retailer awareness of FDA tobacco rule at 90% or above.

Dropped

Program ended on 3/21/00 per order of U.S. Supreme Court

17003

Increase distribution of multimedia advertising campaign to 50 top media markets; create, print, test and distribute new retailer kit to 200,000 retailers; and increase retailer recognition program to 10,000 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 double the percentage of retailers who understand the age and ID provisions and the consequences of not complying with the rule in all markets subject to the intensified media campaign.

Dropped

Program ended on 3/21/00 per order of U.S. Supreme Court