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FY 2004 Annual Performance Plan
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FY 2002 Annual Performance Report

2.5 ANIMAL DRUGS AND FEEDS

2.5.1 Program Description, Context and Summary of Performance

As a consumer protection organization, the mission of the Animal Drugs and Feeds Program is to foster public and animal health by approving safe and effective products for animals and by enforcing applicable provisions of the Federal Food, Drug, and Cosmetic Act and other authorities. Two strategic goals support the mission of the program:

Strategic Goals:

1. Increase the availability and diversity of safe and effective animal drugs and feeds.
2. Reduce the risks associated with marketed animal products.

These strategic goals reflect FDA involvement in the animal drug development process from the point at which the drugs are first developed through the time they are on the market. This coverage of the entire drug development process enables the Animal Drugs and Feeds Program to address problems or safety issues before they become a threat to public health. The Animal Drugs and Feeds Program accomplishes these goals by working with partners in industry, academia, consumers, and other government agencies on: review of animal drugs, compliance and related actions, post-approval monitoring, animal feed safety, inspections, and collection and analysis of samples. The Animal Drugs and Feeds Program approach to achieving the strategic goals and a summary of the key performance goals are explained later in this document.

2.5.2 Strategic Goals

Strategic Goal 1:
Increase the availability and diversity of safe and effective animal drugs and feeds.

A. Strategic Goal Explanation

Veterinarians and the agricultural community need animal drugs to ensure a safe food supply and to ensure the health of animals. The availability of safe and effective drugs allows food animal producers to maintain healthy animals with assurance the resulting products will be safe, wholesome, and free of harmful drug residue when they reach the consumer. Also, the availability of safe and effective drugs ensures companion and service animals live healthier and longer lives.

The Animal Drugs and Feeds Program, working with industry sponsors, promotes the availability and diversity of animal drugs and feeds by being involved throughout the new animal drug development process. The Agency is committed to improving the review time for new animal drug applications, as well as continuing work to decrease the backlog of pending overdue submissions (Performance Goals 3 and 4). Development of an enhanced information system for electronic submission of applications and data will allow FDA to perform application review activities more efficiently (Performance Goal 5). To ensure that FDA has the science capability and intellectual capital necessary to assess data and make regulatory decisions, the framework for a staff college has been developed (Performance Goal 6).

These premarket performance goals help the Agency take the specific steps needed to achieve this strategic goal and therein: assure safer human food produced from animals; reduce the cost and time associated with animal drug development; and, improve quality of life for segments of our population because companion and service animals are healthier and live longer.

B.   Summary of Performance Goals

Performance Goals	Targets	Actual Performance	Reference
1. Maintain the level of requested pre-submission conferences conducted with industry sponsors at 80%. (14007)	FY 04: NA FY 03: NA FY 02: 80% FY 01: 80% FY 00: 73%	FY 04: FY 03: FY 02: 85% FY 01: 80% FY 00: 75%	4
2. Complete review and action on 90% of all new animal drug applications and supplements received in FY 03 within 275 days; and Complete review and action on 90% of all investigational new animal drug submissions received in FY 03 within 325 days. (14017)	FY 04: NA FY 03: Complete review & action on 90% of all new animal drug applications and supplements received in FY 03 within 275 days and complete review & action on 90% of all investigational new animal drug submissions received in FY 03 within 325 days. FY 02: Complete review and action on 50% of NADAs/ANADAs within 180 days of receipt. FY 01: 75% FY 00: 73%	FY 04: FY 03: FY 02: 67%1932 of 2895 % completed on-time FY 01: 47%961 of 2044 % completed on-time FY 00: 84%1539 of 1841 % completed on-time	4
3. Reduce pending overdue Animal Drug submissions by 25%. (14019)	FY 04: 25% FY 03: 15% FY 02: 15%	FY 04: FY 03: FY 02: 64%	4
4. Complete review and action on 90% of NADAs & reactivations of such applications within 295 days; complete review and action on 90% of investigational animal drug study submissions within 320 days; and complete review and action on 90% of investigational animal drug submissions consisting of protocols, without substantial data, within 125 days. The benefits of the user fee program are provided under the goal presentation. FY 00-01 performance is provided as "baseline" information.(This goal is contingent upon the combined budget authority and user fees.) (14020)	NADAs & reactivations of such applications; FY 04: within 295 days. FY 03: NA Y 02: NA FY 01: FY 00: Investigational animal drug study submissions. FY 04: within 320 days: FY 03: NA FY 02: NA FY 01: FY 00: Investigational animal drug submissions consisting of protocols without substantial data; FY 04: within 125 days: FY 03: NA FY 02: NA FY 01: FY 00:	FY 04: FY 03: FY 02: 3/03 FY 01: w/in 776 days FY 00: w/in 588 days FY 04: FY 03: FY 02: 3/03 FY 01: w/in 625 days FY 00: w/in 498 days FY 04: FY 03: FY 02: 3/03 FY 01: w/in 199 days FY 00: w/in 179 days	4
5. Continue electronic submission enhancements. (14002)	FY 04: Continue to expand electronic submissions process & development of Corporate Document Management System. FY 03: Receive & act on protocols forms electronically. FY 02: Pilot and validate the procedure for receiving protocol submissions electronically. FY 01: Initiate the development of a method for receiving protocol submission electronically FY 00: Completed an additional 4 phases - Notices of Slaughter;Notices of Animal Final Disposition;Meeting Agendas;USDA Slaughter Reports FY 99: Complete 1 phase - Notices of Claimed Investigational Exemptions (NCIE).	FY 04: FY 03: FY 02: Electronic submission of protocols from industry pilot successfully validated. FY 01: Changed focus of protocol submission to hard media (e.g., tapes, cd-rom, hard drives). Implemented automated logging/ routing of e-mail electronic submissions. Posted standards on dockets for submission of electronic information in support of NADAs. On- going contract to develop CVM-specific guidance for file organization and format for hard media submissions. Expanded electronic archive to accept hard media submissions. FY 00: Wrote guidance on 4 phases. Developed technology for logging/routing of electronic submissions. FY 99: 1 phase completed (NCIE).	4, EfficiencyGoal
6. Continue development, expansion and integration of the Staff College. (14018)	FY04: Continue integration of LMS system w/Center and Agency infrastructure; continue to expand content of in-house programs. FY 03: Expand content of in-house programs. Research and develop components and integration of competency-based learning management system (LMS) with Center and Agency IT infrastructure. FY 02: Plan and design the option selected in Phase I. FY 01: Initiate the development of a Staff College (Phase I: further needs assessment, feasibility studies, and analysis of alternatives).	FY 04: FY 03: FY 02: Completed plan and design of Phase I. FY 01: Initiated the development of a Staff College (Phase I).
TOTAL FUNDING: ($ 000)	FY 04: 34,525 FY 03: 30,120 FY 02: 29,186 FY 01: 26,751 FY 00: 21,117	Numbers in the Reference column corresponds to the relevant strategic goal in the HHS Strategic Plan

C.   Goal-By-Goal Presentation of Performance

1. Maintain the level of requested pre-submission conferences conducted with industry sponsors at 80%. (14007)
Context of Goal: (Goal dropped in FY 03.) The Animal Drugs and Feeds Program informs and assists product sponsors throughout the approval process starting with the pre-submission conference. The focus is to inform and assist firms in complying with the Animal Drug Availability Act (ADAA) and to streamline the product review process through phased review. Instead of waiting until all stages of product development are completed before contacting FDA, phased review helps industry stay on course throughout the drug development process by communicating requirements (or standards or criteria) for approval at each stage of development.
Performance: Presubmission conference tracking was established in FY 00. The goal was met in FY 00, FY 01 and FY 02. This goal is dropped in FY 03 since the performance appears to be stable, and therefore, no longer provides a useful measurement for Center management.
Data Sources: Submission Tracking and Reporting System (STARS).

2. Complete review and action on 90% of all new animal drug applications and supplements received in FY 03 within 275 days and complete review and action on 90% of all investigational new animal drug submissions received in FY 03 within 325 days. (14017)
Context of Goal: In FY 03, CVM changed this performance goal to a new measure that is more useful for both Center management and industry. Key industry stakeholders have told us that 'how long an application takes to get reviewed' is more meaningful to them than 'what percent is reviewed on time'. CVM has also introduced a new performance goal (Goal 3) to emphasize its commitment to reducing the current backlog in submissions. FDA is taking steps to move closer to statutory requirements in future years. Additionally, these steps are contingent on the combined budget authority and user fees.
When a new animal drug application is submitted, CVM evaluates the information contained or referenced in the application. A determination is made whether the application is approved or not approved. The sponsor receives a letter informing them either of the approval or describing the deficiencies in the application.
The "days to review" refers to the time it takes to review and take an action on the original submission, or if needed, on subsequent recycles. This is different from total approval time which is the time it takes from the original receipt of the application until it is finally approved, which may take more than one review cycle. This includes the time we spend reviewing the application in each of the review cycles plus the time taken by the sponsor to respond to the issues raised in the not approved letter(s) and resubmit the application for review.
Performance: The performance reporting for FY 00 through FY 02 pertains to the review and action on NADAs and ANADAs within 180 days of receipt. CVM exceeded the FY 00 target with a performance rate of 84%.
CVM found it necessary to shift focus in its performance regarding animal drug application review in FY 2000. The Office of New Animal Drug Evaluation (ONADE) needed to reduce the backlog of overdue submissions. This required working on the oldest, already overdue submissions. 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. By taking the step of closing out the most overdue submissions, CVM's on time completion rate for NADAs and ANADAs was adversely affected in FY 01 with 47% of NADAs and ANADAs reviewed on time.
The goal for FY 02 was revised to complete review and action 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 to clear the large backlog of animal drug applications. In FY 02, the Animal Drugs and Feeds Program achieved 67% performance for this goal.
Data Sources: Submission Tracking and Reporting System (STARS).

3. Reduce pending overdue Animal Drug submissions by 25%. (14019)
Context of Goal: During FY 2000, the Animal Drugs and Feeds Program conducted an evaluation of performance in the new animal drug review process and determined that priorities needed to shift in order to eliminate the growing backlog in pending new animal drug submissions. This goal was created to facilitate that process and to provide the needed emphasis on this strategic goal of making more animal drugs available. The Animal Drugs and Feeds program will reduce the backlog of pending overdue animal drug submissions by 15% in both FY 02 and FY 03. The target is increased to 25% in FY 04.
Performance: In FY 02, the Animal Drugs and Feeds Program reduced its backlog of pending overdue submissions 64%.
Data Sources: Submission Tracking and Reporting System (STARS).

4. Complete review and action on 90% of NADAs & reactivations of such applications within 295 days; complete review and action on 90% of investigational animal drug study submissions within 320 days; and complete review and action on 90% investigational animal drug submissions consisting of protocols, without substantial data, within 125 days. (14020)
Context of Goal: Established for FY 04, this performance measure is consistent with goals industry has agreed to for user fees. These goals reflect a representative portion of the user fee goals. The benefits provided by the proposed user fee program include: an increase in the reduction rate of the backlog; shorter review times; a more meaningful measure for industry; a more predictable and stable review process; and, an overall reduction in drug development time. (This goal is contingent upon the combined budget authority and user fees.)
When a new animal drug application is submitted, CVM evaluates the information contained or referenced in the application. A determination is made whether the application is approved or not approved. The sponsor receives a letter informing them either of the approval or describing the deficiencies in the application.
The "days to review" refers to the time it takes to review and take an action on the original submission, or if needed, on subsequent recycles. This is different from total approval time which is the time it takes from the original receipt of the application until it is finally approved, which may take more than one review cycle. This includes the time we spend reviewing the application in each of the review cycles plus the time taken by the sponsor to respond to the issues raised in the not approved letter(s) and resubmit the application for review.
Performance: As mentioned above, for the first time the Animal Drugs and Feeds Program will initiate a user fee program. The user fee program, proposed to start in FY 04, reflects the implementation of a five (5) year plan to improve the performance for animal drug review. A "baseline" reference to performance of the representative user fee goals reflects the effort to eliminate the backlog in pending overdue new animal drug submissions
The following are is the review time in "number of days" for fiscal years 2000 and 2001

NADAs & reactivations of such applications: FY 2000 - 588, FY2001 - 776
Investigational animal drug study submissions: FY 2000 - 498, FY2001 - 625
Investigational animal drug submissions consisting of protocols without substantial data: FY2000 - 179 , FY2001 - 199
Data Sources: Submission Tracking and Reporting System (STARS).

5. Continue electronic submission enhancements. (14002)
Context of Goal: Better-automated information systems, including those supporting electronic submission of applications by sponsors, are being developed to facilitate and expedite the review process. The Animal Drugs and Feeds Program has successfully completed several electronic submission processes for use by the animal industry. Our intention is to move toward a paperless office as rapidly as possible.
Performance: In FY 99, the Animal Drugs and Feeds Program completed implementing the electronic submission process for all Notices of Claimed Investigational Exemptions (NCIE) submissions. An evaluation indicated processing time was reduced to 1/3 the time required for paper processing. In FY 00, CVM published Federal Register Notices on four (4) draft guidance documents pertaining to electronic submissions.
In FY 01, all sponsors receiving instructions on submissions are advised of the availability of using the e-mail method for some submissions and directed to our website for instructions. A workshop was held to highlight new and improved systems and forms available for electronic information transfer. System modifications made smart form available to increase quality control of information input by submitters, and automated login to the Center's tracking system and forwarding for review. Use of the Center's e-mail to submit electronic information expanded from 13 to 15 sponsors. Currently available forms and types of submissions on the Agency's Electronic submission docket: Notices of Claimed Investigational Exemptions; Notice of Intent to Slaughter for Human Food Purposes; Notice of Final Disposition of Animals Not Intended for Immediate Slaughter; and Request for a Meeting or Teleconference. These are all supported by guidance documents and smart forms released February 2001. Information is available through our web page.
In July, 2001, the Center increased the automation of the NCIE, Intent to Slaughter, Notice of Final Disposition, and Meeting Request by providing the sponsors with a PDF fill-in form for submission by e-mail, allowing a higher degree of automated processing at CVM by uploading data in the STARS tracking database. The time required for verification of receipt to the sponsor has been decreased to a few minutes (down from a maximum of three days).
In 2001, the Center posted a reference on the electronic dockets that allows submission of data in electronic format in support of New Animal Drug Applications.
This allows interested parties, with the concurrence of the Center to submit more extensive data electronically. The Center is working toward a draft of CVM-specific guidance for file organization and format for hard media submissions. The Center is also expanding its current electronic archive to accept hard media submissions.
The Animal Drugs and Feeds Program has become active in coordinating the Agency effort to harmonize standards in the Agency, and has participated in the Agency-wide General Consideration Document that will publish for comment in October 2002. CVM will participate in the Agency guidance and acceptance of submission to the Agency of Manufacturing Stability data in extensible markup language (XML) format. The Center participated in an Agency Panel at the Drug Information Association Meetings in February 2002.
In FY 02, the draft guidance document and protocol submission were completed. The implementation plan for the pilot and validation of receipt of protocols was drafted. Recruitment of pilot partners began and modification of programming to support receipt of protocols through the Center's Electronic Submission System (ESS) email.
Additional phases of electronic submissions will be initiated in FY 03 in support of this goal. In FY 04, CVM will continue to expand the electronic submission process and development of the Corporate Document Management System.
Data Sources: CVM's priority project tracking system.

6. Continue development, expansion and integration of the Staff College. (14018)
Context of Goal: Staff College programs have been developed in FDA as a means of continuously building the scientific and intellectual capability of its staff. The Staff College will allow CVM to increase and maintain a level of scientific expertise that is critical in order for us to address evolving animal science and veterinary medicine issues. The Staff College will use funds to outsource the planning and implementation of training programs tailored to the needs of in-house scientists.
Performance:
FY 01: Initiated Phase I - conduct further needs assessment, feasibility studies, and analysis of alternatives:

• Contract awarded to perform needs assessment and begin building the Staff College infrastructure necessary for a competency based learning management system to enhance the science-base.
• Began the research and design of a training facility to support the infrastructure of the CVM Staff College. Awarded a facilities and equipment contract and construction of the training facility.
• Recruited a FDA/CVM Search Team to conduct a nationwide search for a qualified Staff College Director who could continue building the Staff College infrastructure. Reviewed 130 candidates.
• Conducted in-house development and implementation of seminars, professional meetings and courses that increased the science-based knowledge of the FDA's review staff which can help reduce review times and backlogs of pending applications.

The goal to plan and design Phase I of the Staff College was completed:

• Developed and implemented a CVM Competency Model through the automated Knowledge Center (KC). The KC is a Learning Management System (LMS) that has and will continue to help reduce administrative costs associated with managing and tracking training and development for the Center. This allows Staff College personnel to devote more time towards development of substantive programs that are responsive to the needs of the Center. The KC also creates and automates an Individual Development Plan (IDP) process for every employee to ensure that both the organizational and individual employee training and developmental needs are addressed.
• Built state-of-the-art training facilities to accommodate distance learning initiatives as well as other traditional learning venues.
• Continuing development of several in-house scientific/reviewer training programs.

Data Sources: CVM's priority project tracking system.

Strategic Goal 2:
Reduce the risks associated with marketed animal products.

A. Strategic Goal Explanation

Once animal drugs are on the market, the Animal Drugs and Feeds Program continues managing public health risks through post-market surveillance activities such as inspections, monitoring, and research. The Animal Drugs and Feeds Program strategies for assuring safety compliance and scientific monitoring are made possible through partnerships with industry and the states. Surveillance of marketed products and industry is accomplished through review of drug experience reports and compliance programs. This involves inspections, sample collections and analysis, investigations, and other activities (Performance Goal 7). Regulatory actions are taken as needed to control violative goods and firms.

The Animal Drugs and Feeds surveillance systems identify potential human and/or animal health hazards. The surveillance systems also help develop procedures and strategies to prevent, minimize, or contain problems (such as informing the veterinary community of adverse reactions due to drug interactions that were not apparent in clinical trials or withdraw marketed drugs as necessary to protect human and animal health). The desired outcome is to assure that marketed animal drugs and human food products derived from animals are safe, and ensure quality health care of animals.

The National Antimicrobial Resistance Monitoring System (NARMS) tells FDA when foodborne bacteria that causes disease in humans begins to develop resistance to antimicrobials used in food animals. NARMS (Performance Goal 8), developed in conjunction with USDA and CDC, has greatly improved our ability to detect emerging antibiotic resistance among foodborne pathogens. This helps ensure the continued effectiveness of both human and veterinary drugs and aids in increasing the availability of effective drugs for treatment of foodborne disease.

A critical FDA goal is to prevent the introduction and spread of Bovine Spongiform Encephalopathy (BSE) into the U.S. herd and human food chain. There is strong scientific evidence (epidemiological and laboratory) that the agent that causes BSE in cattle is the agent that causes variant Creutzfeldt-Jakob Disease (vCJD) in people. If BSE emerged in the U.S. it could pose a serious health risk to humans and be financially devastating to the U.S. beef industry. The Animal Drugs and Feeds Program plans to conduct 100% inspections of all known renderers and feed mills processing products containing prohibited material in order to maintain compliance with the BSE feed regulation (Performance Goal 9).

B. Summary of Performance Goals

C.   Goal-By-Goal Presentation of Performance

7. Maintain biennial inspection coverage by inspecting 50% of 1,440 registered animal drug and feed establishments. (14009)

Context of Goal: FDA exercises considerable discretion regarding the frequency and comprehensiveness of inspections. The Animal Drugs and Feeds Program has a statutory obligation to inspect all regulated animal drug and medicated feed establishments once every two years. Routine inspections have lower priority than inspection of firms producing high profile products. This has an impact on the pre-approval process that requires a "recent" inspection before approval of a new animal drug. This includes inspections done by FDA directly, or through state contracts or partnership agreements on manufacturers, repackers and relabelers (drugs), and manufacturers and growers requiring a Medicated Feed Mill License.
Performance: : FY 99 = 25%; FY 00 = 39%; FY 01 = 37%; FY 02 = 56%. In FY 99, 25% of registered animal drug and feed establishments were inspected. The FY 99 actual performance fell short of the 27% target based on the fact that the initial inspection percentages were estimates, due to the complexity and number of inspections, and re-inspections. In FY 00, FDA inspected 39% of the establishments in the Official Establishment Inventory, exceeding the goal of 27%. Due to a few problems resulting from the transition to a new database (FIS to FACTS) in FY 2000, some adjustments in counting the inventory and inspectional coverage were necessary.
The goal was not met in FY 2001. The program did accomplish 37% biennial inspection coverage of registered animal drug and feed establishments. Due to the increase in reported cases of BSE in Europe, in FY 2001 FDA concentrated its efforts on performing BSE inspections in the U.S. This intense inspection effort was intended to prevent an outbreak of BSE in the U.S by completing 100% inspection of all firms. In FY 02, FDA inspected 56% of the 1,440 registered animal drug and feed establishments.
Data Sources: Field Accomplishment Compliance Tracking System (FACTS) [formerly known as the Program Oriented Data System (PODS)], Official Establishment Inventory.

8. Enhance the transparency of the NARMS program to stakeholders, the public, and other interested parties by increased reporting and communicating of NARMS results and program information. (14005)

Context of Goal: NARMS is a major national surveillance effort in cooperation with FDA, CDC, and USDA. NARMS detects emerging antibiotic resistance among foodborne pathogens and the possible associated health hazards through systematic collection, analysis and interpretation of antimicrobial susceptibility surveillance data. NARMS is adding to our knowledge of drug susceptibility and is helping ensure the continued effectiveness of human and veterinary drugs.
One of the NARMS program goals has always been to provide timely information on antibiotic resistance to physicians and veterinarians to allow them to make informed decisions on treatment options for their patients. For example, a multi-drug resistant variant of Salmonella Newport emerged in humans and animals and was detected in the NARMS data. The participating NARMS agencies alerted the human and veterinary medical communities to this emergence so that they were aware and could take appropriate actions in treating infections with this organism.
Performance: In CY 99 = collected 8,510 animal and 1,706 human isolates; CY 00 = collected 9,000 animal and 2,000 human isolates. CY 01 = collected 6,795 animal, 1,671 human and 433 retail meat isolates. Although, NARMS testing was expanded in CY 01 (retail meats sampling added), fewer veterinary isolates were available for study. Salmonella sampling was not a part of the 2001 USDA/APHIS National Animal Health Monitoring System (NAHMS) program; therefore, isolates were not received from that program for NARMS antimicrobial susceptibility testing in 2001. CY 02 performance is expected by March 2003. CVM revised the goal for FY 03. Previously, the goal reflected dependence on factors beyond FDA's control such as the number of humans contracting a foodborne disease as well as the sampling issue mentioned above. The goal has been revised to reflect how CVM will use NARMS data to communicate with the public on antibiotic resistance.
Data Sources: National Antimicrobial Resistance Monitoring System.

9. Conduct targeted BSE inspections of 100% of all known renderers and feed mills processing products containing prohibited material. (14006)

Context of Goal: FDA sought to protect the public through the development of a comprehensive strategy of education, inspection and enforcement action on industry. These activities were initiated to ensure compliance with the Bovine Spongiform Encephalopathy (BSE) feed regulations. Using an inventory of all known renderers and feed mills processing products containing prohibited material, FDA will conduct inspections to determine compliance with the BSE feed rule. Inventories of these firms may vary from year to year based on changes at the firm such as consolidations, business closures, relocations, etc. FDA will continue to update and improve the inventory of firms with information from states and other sources. The current inventory number for all known renders and feed mills processing products containing prohibited materials is 600.
Performance: On August 4, 1997 FDA's regulation 21 CFR 589.2000 (Animal Proteins Prohibited From Use in Animal Feed) became fully effective. The purpose of the regulation is to prevent the establishment and amplification of BSE through animal feed. The regulation prohibits the use of certain proteins derived from mammalian tissue in feeding to ruminant animals. FDA has developed a three-pronged approach in its efforts to realize 100% compliance with the 1997 feed rule-education, a strong and visible inspection presence, and enforcement action. More than 17,000 inspections have been done since 1997 at over 10,000 firms including renderers, feed mills, and protein blenders. Due to the increase in reported cases of BSE in Europe, in FY 2001 FDA concentrated its efforts on performing BSE inspections in the U.S. This intense inspection effort was intended to prevent an outbreak of BSE in the U.S by completing 100% inspection of all firms. This goal was revised based on evaluation of BSE inspection data, the BSE crisis in Europe, and to reflect a more accurate view of FDA efforts. FY 02 performance was 100%.
In FY 03, the goal is revised to reflect FDA's focus on inspection of firms which process products containing prohibited material.
Data Sources: FDA Field Data Systems.

Contact Information:
Planning Staff, Office of Planning, FDA
Phone: 301-827-5210

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