FOODS

11001

Complete first action on 65% of food and color additive petitions within 360 days of receipt.

Revised

Complete first action on 60% of food and color additive petitions within 360 days of receipt

Target revised to a slightly lower level because of implementation of the Food Contact Substance Premarket Notification Program which changed the way these applications are submitted. Fewer but more complex applications are now expected.

11002

Reduce the number of remaining overdue food and color additive petitions by 50%.

Dropped

This backlog goal was dropped and assumed under the primary review goal for food and color additive petitions. (goal 11001)

11025

Respond to 95% of notifications for dietary supplements containing "new dietary ingredients" within 75 days.

Unchanged

11003

Complete processing of 85% of GRAS notifications within the time frame established by the final rule.

Dropped

This goal was dropped because there is no final rule and no statutory authority for this goal. It is strictly voluntary.

11034

Complete review of 100% of premarket notifications for food contact substances within 120 days.

Revised

Review 95 percent of premarket notifications for food contact substances in the receipt cohort of FY 2002 within the statutory time limit (120 days).

Target was lowered to 95% because 100% was an unrealistic target.

11035

Issue final rule to require premarket notification for bioengineered foods.

Dropped

The comments from the proposed rule have been received and analyzed, but no reaction has been received from the department or administration so publishing this in FY 2002 is unrealistic. However, this goal can be accomplished in FY 2003.

11010

Achieve adoption of the Food Code by at least one state agency in 28 states in the USA.

Unchanged

11020

Increase the percentage of high-risk domestic food establishment inspected once every year at least 95%.

Unchanged

11011

Assure that FDA inspections of domestic food establishments result in a high rate of conformance (at least 90%) with FDA requirements.

Dropped

This goal was dropped from each program because it was confusing and not a useful measure for performance. (See the context section for this goal in the Performance Plan for more details.)

11021.02

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

Dropped

Import exams are now measured by a new goal (goal 11036) which measures physical exams only and not the combination of physical and analytical exams like this one.

11028

Increase to 10 the number of audits and assessments of foreign food safety systems, with an emphasis on high volume exporters to the U.S.

Dropped

This goal was dropped because resources are not available to conduct the in-depth audits necessary to assess the efficacy of the entire foreign food safety system.

11027

Maintain current level of monitoring for pesticides and environmental contaminants in foods through the collection and analysis of a targeted cohort of 8,000+ samples.

Unchanged

11036

None

New Goal

Increase food import surveillance by hiring 300 new investigators and analysts who will increase the number of physical exams 97% (24,000 exams) and conduct sample analyses on products with suspect histories.

Goal added to reflect additional Agency Counter Terrorism efforts developed in response to the September 11 terrorism attack.

11037

None

New Goal

Extend import coverage to an additional 45 ports that handle significant quantities of FDA-regulated products.

Goal added to reflect additional Agency Counter Terrorism efforts developed in response to the September 11 terrorism attack.

DRUGS

12001

Review and act on 90% of standard original NDA submissions within 10 months of receipt and 90% of priority original NDA submissions within 6 months.

Unchanged

12003

Review and act upon fileable original generic drug applications within 6 months after submission date.(55%)

Revised

Review and act upon fileable original generic drug applications within 6 months after submission date.(65%)

Target raised due to resource increase for the Generic Drug Program.

12032

Protect human research subjects participation in drug studies and assess the quality of data from these studies by conducting approximately 780 onsite inspections and data audits annually.

Unchanged

12007

Streamline adverse drug event reporting system. (Issue final rules on ADRs and electronic submissions)

Revised

Accepting electronic submissions from companies and be current with MedDRA coding versions.

Updated to reflect current status of goal.

12016

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

Unchanged

12020

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

Revised

Inspect registered human drug manufacturers, repackers, relabelers and medical gas repackers. (20%)

The target decreased due to problems resulting from the transition to a new database (FIS to FACTS) in FY 2000, which caused some adjustments in the way inventory and inspectional coverage were calculated. FY 2001 actual performance data was 19%, not the expected 26%.

12006

Assure that FDA inspections of domestic drug manufacturing and repacking establishments result in a high rate of conformance (at least 90%) with FDA requirements.

Dropped

This goal was dropped from each program because it was confusing and not a useful measure for performance. (See the context section for this goal in the Performance Plan for more details.)

12026

Implement, evaluate, track and report on the clinical trials FDA is requesting under FDAMA or requiring under the Pediatric Rule

Unchanged

12027

Give consumers and health professionals more easily understandable OTC drug information.

Unchanged

12033

None

New Goal

Publish guidance for Industry on developing antimicrobial drugs for inhalational anthrax (post-exposure).

Goal added to reflect additional Agency Counter Terrorism efforts developed in response to the September 11 terrorism attack.

12034

None

New Goal

Facilitate the initiation of research in a non-human primate model of pneumonic plague.

Goal added to reflect additional Agency Counter Terrorism efforts developed in response to the September 11 terrorism attack.

12035

New Goal

Expeditite the review of protocols for investigational new drugs (INDs) to treat organophosphorous nerve agents in the event of chemical attack. Encourage sponsors of these new drug application (NDAs) to update current labling for Antidote Treatment Nerve Agent, Autoinjectors (ATNAA).

Goal added to reflect additional Agency Counter Terrorism efforts developed in response to the September 11 terrorism attack.

12040

None

Publish a final rule which allows the agency to approve new drug and biological products for the treatment of chemical, biological, radiological, or nuclear substances based on animal efficacy studies when adequate and well-controlled studies in humans cannot be ethically conducted and field studies are not feasible.

Goal added to reflect additional Agency Counter Terrorism efforts developed in response to the September 11 terrorism attack.

12042

None

New Goal

Publish a Notice of Proposed-Rulemaking to establish a web-based electronic animal and human drug and biologics registration and listing database to allow for complete and up-to-date data on all regulated drug products.

Goal added to reflect additional Agency Counter Terrorism efforts developed in response to the September 11 terrorism attack.

12043

None

New Goal

Publish a Notice in the Federal Register on doxycycline and penicillin G procaine dosing recommendations for inhalational anthrax.

Goal added to reflect additional Agency Counter Terrorism efforts developed in response to the September 11 terrorism attack.

12044

None

New Goal

Issue guidance on the use of potassium iodide (KI) as a thyroid blocking agent in radiation emergencies.

Goal added to reflect additional Agency Counter Terrorism efforts developed in response to the September 11 terrorism attack.

BIOLOGICS

13001

Review and act on 90% of standard original PDUFA NDA/PLA/BLA submissions within 10 months; and review and act on 90% of priority original PDUFA NDA/PLA/BLA submissions within 6 months of receipt.

Unchanged

13002

Review and act on 90% of standard PDUFA efficacy supplements within 10 months; and review and act on 90% of priority PDUFA efficacy supplements within 6 months of receipt

Unchanged

13003

Review and act on 90% of PDUFA manufacturing supplements within 6 months of receipt, and review and act on 90% of PDUFA manufacturing supplements requiring prior approval within 4 months of receipt.

Unchanged

13004

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

Unchanged

13005

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

Unchanged

13007

Assure that FDA inspections of domestic biologics manufacturing, repacking and blood banks establishments result in a high rate of conformance (at least 90%) with FDA requirements

Dropped

This goal was dropped from each program because it was confusing and not a useful measure for performance. (See the context section for this goal in the Performance Plan for more details.)

13008

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

Dropped

This goal was dropped for two reasons: 1) Plasma fractionator establishment compliance with CGMP' s is beyond the control of FDA. FDA can determine their CGMP compliance through inspections, but it cannot maintain their compliance for them. 2) The biennial inspection goal for biologic establishments (Goal 13012) includes inspections of plasma fractionator establishments.

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

14007

Maintain the level of requested pre-submission conferences conducted with industry sponsors at 80%.

Unchanged

14017

Review and act on 80% of NADAs/ Abbreviated New Animal Drug Applications (ANADAs) within 180 days of receipt.

Revised

Review and act on 50% of NADAs/ANADAs within 180 days of receipt.

The goal was revised from 80% to 50% because the Center has changed priorities and redirected resources from new reviews to clear the large backlog of animal drug applications. Decreasing the backlog was necessary in order to move CVM back on track towards meeting statutory and stakeholder requirements for new animal drug application review.

14019

None

New Goal

This goal was added to reflect the center' s commitment to reducing its backlog. Decreasing the backlog was necessary in order to move CVM back on track towards meeting statutory and stakeholder requirements for new animal drug application review.

14002

Pilot and validate the procedure for receiving protocol submissions electronically.

Unchanged

14018

Begin to design and implement a Staff College. FY 02: Plan and design the option selected in Phase I

Unchanged

14009

Maintain biennial inspection coverage by inspecting 50% of registered animal drug and feed establishments.

Unchanged

14004

Assure that FDA inspections of domestic animal drug and feed manufacturing establishments and repackers result in at least 90% conformance.

Dropped

This goal was dropped from each program because it was confusing and not a useful measure for performance. (See the context section for this goal in the Performance Plan for more details.)

14005

Increase isolate testing rate for Salmonella in the National Antimicrobial Resistance Monitoring System (NARMS) at 12,000.

Revised

Maintain isolate testing rate for Salmonella in the National Antimicrobial Resistance Monitoring System (NARMS) at 12,000.

14006

Assure 100% compliance with the BSE feed regulation through inspections and compliance actions.

Revised

Conduct targeted BSE inspections of 100% of all known renderers and feed mills handling prohibited material.

The scope of this goal was revised from "Assuring compliance" to "Conducting inspections" although the target of 100% remains the same. Realistically, assuring 100% compliance is too difficult to measure or attain.

MEDICAL DEVICES AND RADIOLOGICAL HEALTH

15001

Maintain the on-time percentage of Premarket Approval Application (PMA) first actions within 180 days. (90%)

Unchanged

15009

Review and complete 90 percent of PMA supplement final actions within 180 days in FY 2002

Unchanged

15002

Review and complete 95 percent of 510(k) (Premarket Notification) first actions within 90 days in FY 2002.

Unchanged

15024

Complete 95 percent of PMA "Determination" meetings within 30 days in FY 2002.

Unchanged

15003

Initiate development of 20 to 25 new or enhanced standards to be used in application review in FY 2002.

Unchanged

15025

Conduct 335 BIMO inspections with an emphasis on vulnerable populations (e.g., mentally impaired, pediatric, etc.)

Revised

Conduct 290 BIMO inspections with an emphasis on vulnerable populations (e.g., mentally impaired, pediatric, etc.)

Target level was decreased due to decrease in resources.

15005.01

Provide inspection coverage for Class II and Class Ill domestic medical device manufacturers at 20 percent in FY 2002.

Unchanged

15018

Assure FDA inspections of domestic medical device manufacturing establishments result in at least 90 percent conformance.

Dropped

This goal was dropped from each program because it was confusing and not a useful measure for performance. (See the context section for this goal in the Performance Plan for more details.)

15005.02

Maintain inspection coverage for Class II and Class Ill foreign medical device manufacturers in FY 2002. (9%)

Unchanged

15007

Ensure at least 97 percent of mammography facilities meet inspection standards, with less than 3 percent with Level I (serious) problems in FY 2002.

Unchanged

15026

Meet time frames of Reuse Regulatory Strategy

Dropped

This goal was included in the FY 02 CJ by mistake. It was intended to be a placeholder while a more specific goal was developed for this important issue, but it was inadvertently left in the goal table after the idea was dropped.

15012

Implement the MeDSuN System. 02: Recruit 75 to 100 new facilities

Revised

Implement MedSuN by recruiting a total of 80 facilities for the network

Target more specific

15029

None

New Goal

Implement Emergency Counter Terrorism Preparedness and Response Plan for radiation.

Goal added to reflect additional Agency Counter Terrorism efforts developed in response to the September 11 terrorism attack.

NATIONAL CENTER FOR TOXICOLOGICAL RESEARCH

16001

Introduce the knowledge of new genetic systems and computer-assisted toxicology (bioinformatics) into the application review process.

Unchanged

16002

Develop, with other organizations, gene chip and gene array technology.

Unchanged

16003

Develop computer-based models and infrastructure to predict the health impact of increased exposure to estrogens and anti-estrogen compounds.

Unchanged

16004

Study FDA-regulated compounds to relate the mechanism(s) by which a chemical causes toxicity.

Unchanged

16007

Develop methods and build biological dose-response models to replicate bacterial survival in the stomach.

Unchanged

16012

Catalogue biomarkers and develop standards to establish safety and effectiveness of imaging devices for potential use in the diagnosis of toxicity.

Revised

Recruit additional expertise in Computational Science, Chemistry and Microbiology.

Additional three targets added to reflect additional Agency Counter Terrorism efforts developed in response to the September 11 terrorism attack.

16013

Use new technologies (bioinformatics, imaging, proteomics, and metabonomics) for diagnosis of toxicity.

Unchanged

ADMINISTRATIVE MANAGEMENT

19001

None

New Goal

Develop and implement a plan to to delayer NCTR, CVM and CDRH.; Plan to transfer Legislative and Public Affairs function to DHHS

Goal added to reflect the Agency' s commitment to the Department' s Management Goals

19002

None

New Goal

Award contract of administrative functions to be completed by 9/02 with the Human Resources portion completed by May, 2002.

Goal added to reflect the Agency' s commitment to the Department' s Management Goals

19003

None

New Goal

Increase the percentage of Commercial FTEs that will be reviewed for outsourcing. (5%)

Goal added to reflect the Agency' s commitment to the Department' s Management Goals

19004

None

New Goal

Increase the percentage of electronically purchased transactions (89%)

Goal added to reflect the Agency' s commitment to the Department' s Management Goals

19005

None

New Goal

Maintain a clean (or unqualified) audit opinion with no material weakness. (yes)

Goal added to reflect the Agency' s commitment to the Department' s Management Goals

19006

None

New Goal

Increase percentage of contract dollars to performance based contracts from 23.6% to 25%

Goal added to reflect the Agency' s commitment to the Department' s Management Goals

19007

None

New Goal

Develop Agency Continuity of operations plan; Participate with PSC to develop COOP

Goal added to reflect the Agency' s commitment to the Department' s Management Goals

19008

None

New Goal

Enhance the Agency Emergency Preparedness Plan to establish protocols for responding to terrorist attacks.

Goal added to reflect additional Agency Counter Terrorism efforts developed in response to the September 11 terrorism attack.