Animal Drug User Fee Programs

Congressional research reportJan 12, 2018

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R45077

Animal Drug User Fee Programs

Summary

The Food and Drug Administration’s (FDA’s) review of brand-name and generic animal drug

applications is funded through a combination of annual discretionary appropriations from

Congress and user fees collected from the regulated industry.

The Animal Drug User Fee Act of 2003 (ADUFA I, P.L. 108-130) gave FDA initial authority to

collect user fees from sponsors to improve the timeliness of review of animal drug applications.

ADUFA I did not cover generic animal drugs. In 2008, in response to concerns regarding generic

drug application review times and a backlog of applications, Congress passed legislation that

reauthorized ADUFA and created a new user fee program for generic animal drugs. Title II of P.L.

110-316, the Animal Generic Drug User Fee Act (AGDUFA I), provided FDA with authority to

collect user fees for the review of generic animal drug applications.

Under both its brand-name and generic animal drug authorities, FDA may use fee revenue only

for the costs of “the process for the review” of the respective animal drug type, which includes

the following: review of applications and other submissions; facility inspections; oversight of

research to support the application/submission; issuance of regulations, policies, standards, and

action letters; and review of labeling and advertising prior to approval. Neither authority permits

postmarket review activities under current law.

Authority to collect user fees for animal drug review has been written to sunset at five-year

intervals; as a result, reauthorization is often considered to be “must pass” legislation. Congress

last reauthorized ADUFA and AGDUFA through September 30, 2018, via the Animal Drug and

Animal Generic Drug User Fee Reauthorization Act of 2013 (P.L. 113-14). ADUFA and

AGDUFA reauthorization consists of two parts: (1) statutory language that reauthorizes the

programs, and (2) the negotiated agreement on performance goals and procedures between FDA

and industry for the upcoming five-year interval. FDA is tasked by law with specific

responsibilities in the reauthorization process.

As required for the upcoming reauthorization, in May 2016 FDA held two public meetings, one

each for ADUFA and AGDUFA, to begin the process. For the next several months through early

2017, FDA held separate negotiations with the brand-name and generic animal drug industries,

and met with other stakeholder groups (scientific and academic experts, veterinary professionals,

patient and consumer advocacy groups). On October 25, 2017, FDA published in the Federal

negotiated with industry. On November 2, 2017, the agency held two public meetings, one each

for ADUFA and AGDUFA, to discuss the proposed recommendations and commitments. Pursuant

to the statute, these recommendations must be submitted to Congress by January 15, 2018.

Unlike user fee authorities which sunset every five years, provisions in law that address FDA’s

regulation of animal drugs are typically permanent. They are not part of the statutory language

that authorizes user fees, and they are not subject to sunset. However, ADUFA /AGDUFA

reauthorization offers a rare, “must pass” legislative focus on animal drug issues. Amendments

dealing with other animal drug issues of interest to Congress, such as the use of antimicrobial

drugs in food-producing animals, are often considered during the reauthorization process.

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Contents

Background ..................................................................................................................................... 1

Introduction ............................................................................................................................... 1

Review of Animal Drugs ........................................................................................................... 2

Brand-Name (Pioneer) Animal Drugs ................................................................................ 2

Generic Animal Drugs ........................................................................................................ 3

Drug Use in Food-Producing Animals ...................................................................................... 4

User Fees and the FDA Budget ................................................................................................. 6

Animal Drug User Fee Programs .................................................................................................... 7

Brand-Name (Pioneer) Animal Drugs and ADUFA .................................................................. 7

Types of Fees and Fee Waivers ........................................................................................... 7

Fee “Triggers”: Authority to Collect Fees .......................................................................... 8

Performance ........................................................................................................................ 8

Reauthorization ................................................................................................................... 9

Proposed ADUFA IV ........................................................................................................ 10

Generic Animal Drugs and AGDUFA ..................................................................................... 12

Types of Fees and Fee Waivers ......................................................................................... 12

Fee “Triggers”: Authority to Collect Fees ........................................................................ 13

Performance ...................................................................................................................... 13

Reauthorization ................................................................................................................. 15

Proposed AGDUFA III ...................................................................................................... 15

Figures

Figure B-1. FDA Animal Drug User Fee Programs: Total Costs, by Funding Source .................. 18

Tables

Table 1. Statutory Fee Revenue Amounts for Brand-Name Animal Drug Review:

FY2014-FY2018 .......................................................................................................................... 7

Table 2. ADUFA Final Performance for FY2015 ............................................................................ 9

Table 3. Selected ADUFA III and Proposed ADUFA IV Performance Goals ............................... 10

Table 4. Statutory Fee Revenue Amounts for Generic Animal Drug Review: FY2014FY2018 ....................................................................................................................................... 13

Table 5. AGDUFA I Performance Goals ....................................................................................... 14

Table 6. AGDUFA Final Performance for FY2015 ....................................................................... 14

Table 7. AGDUFA II and Proposed AGDUFA III Performance Goals.......................................... 16

Table A-1. Summary of FDA Animal Drug User Fee Programs ................................................... 17

Table C-1. Animal Drug Program Activity Data ........................................................................... 19

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Appendixes

Appendix A. FDA Animal Drug User Fee Programs: Selected Legislative History ..................... 17

Appendix B. User Fees and Appropriations .................................................................................. 18

Appendix C. Animal Drug Program Activities .............................................................................. 19

Contacts

Author Contact Information .......................................................................................................... 20

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Background

Introduction

The Federal Food, Drug, and Cosmetic Act (FFDCA) authorizes the Food and Drug

Administration (FDA) to regulate the safety and effectiveness of animal drugs. FDA’s review of

brand-name and generic animal drug applications is funded through a combination of annual

discretionary appropriations from Congress and user fees collected from the regulated industry.

Congress first authorized FDA’s collection of user fees for brand-name animal drugs for FY2004

in the Animal Drug User Fee Act of 2003 (now called ADUFA I, P.L. 108-130), generally

following the model established for human drugs a decade earlier.1 At that time, representatives

of brand-name animal drug research and development companies said that an animal drug could

take 7 to 10 years to develop, at a cost of $100 million or more, and that review of these products

had not always been timely or predictable.2

Authority to collect user fees for brand-name (pioneer) animal drugs has been written to sunset at

five-year intervals, and was reauthorized in 2008 and 2013 in laws referred to as ADUFA II and

ADUFA III, respectively. This authority is due to sunset at the end of FY2018. As required by

law, FDA has published the results of negotiations with animal drug sponsors, which it refers to

as ADUFA IV.3

Congress first authorized FDA’s collection of user fees for generic animal drugs for FY2009 in

the Animal Generic Drug User Fee Act of 2008 (AGDUFA I, P.L. 110-316), coincident with

ADUFA II. AGDUFA was reauthorized in 2013 as AGDUFA II, and, like ADUFA III, is also due

to sunset at the end of FY2018. As required by law, FDA has published the results of negotiations

with generic animal drug sponsors, which it refers to as AGDUFA III.4

Appendix A provides a snapshot of the legislative histories, statutory citations, and key statistics

for both user fee programs.

Under both its brand-name and generic animal drug authorities, FDA shall use fee revenue for the

costs of “the process for the review” of the respective animal drug type, which includes the

following: review of applications and other submissions; facility inspections; oversight of

research to support the application/submission; issuance of regulations, policies, standards, and

action letters; and review of labeling and advertising prior to approval.5 Neither authority permits

postmarket review activities under current law.

CRS Report RL34459, Animal Drug User Fee Programs, by (name redacted). For information about the human

medical products user fees, see CRS Report R44750, FDA Human Medical Product User Fee Programs: In Brief, by

(name redacted) et al.

See comments of Dr. Richard Carnavale, Vice President for Scientific and Regulatory Affairs, Animal Health

Institute, at FDA public meeting on ADUFA reauthorization, March 11, 2008, at http://www.fda.gov/cvm/

ADUFA032008Transcript.htm. Many of these companies are members of the Animal Health Institute, the trade

association that represents their interests, at http://www.ahi.org/.

FFDCA §740A(d)(6). Food and Drug Administration (FDA), “Animal Drug User Fee Act (ADUFA),”

https://www.fda.gov/ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/default.htm.

FFDCA §742(d)(6). FDA, “Animal Generic Drug User Fee Act (AGDUFA),” https://www.fda.gov/ForIndustry/

UserFees/AnimalGenericDrugUserFeeActAGDUFA/default.htm.

For brand-name animal drugs, FFDCA Section 739(8); 21 U.S.C. §379j–11(8). For generic animal drugs, FFDCA

Section 741(k)(10); 21 U.S.C. 379j–21(k)(10).

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Sunset provisions, which are found in other FDA user fee authorities (such as those for human

drugs and devices), may set a more strict reauthorization timeline for Congress and the agency

than do the more common expirations of authority for appropriations. Despite a lapsed

authorization of appropriations, HHS agencies may invoke general authorities to continue their

work on a matter as the authority to conduct the activity remains. A sunset, in contrast, bars the

agency from continuing such work beyond the sunset date, unless or until Congress reauthorizes

the provision or otherwise lifts the sunset.

The key consequence for FDA and drug sponsors of a lapse in user fee authority is that continued

payment of FDA review personnel is prohibited, and the agency may have to lay off animal drug

review staff. These personnel are highly specialized and not easily replaced. As a result, user fee

reauthorizations are often considered “must pass,” and Congress has consistently reauthorized

ADUFA and AGDUFA before their sunset dates.

Review of Animal Drugs

Brand-Name (Pioneer) Animal Drugs

Authorities governing FDA’s review of animal drugs are found in FFDCA Section 512, which

cross-references additional sections of the Act. Regulations are at 21 C.F.R. Chapter I, Subchapter

E, which also cross-references other regulations.

FDA does not oversee veterinary biologics (e.g.,

Brand-name Animal Drug Submission Types:

vaccines), which are regulated by the Department



NADA – New Animal Drug Application,

of Agriculture’s Animal and Plant Health

including all amendments and supplements

Inspection Service (APHIS). The FDA’s Office of



INAD – Investigational New Animal Drug

New Animal Drug Evaluation (ONADE)



QLS – Qualifying Labeling Supplements

determines whether or not a new animal drug

application (NADA) should be approved for

marketing. According to ONADE, in order to approve and sustain a new animal drug for

commercial use, five standards must be met.

1. The drug must be safe for the animal, for humans consuming food derived from a

treated food-producing animal, and for the person administering the drug.

2. The drug must be effective for its intended uses, i.e., the uses prescribed,

recommended or suggested in the labeling of the product.

3. The drug must be a quality manufactured product, being the result of a validated

manufacturing process conducted in accordance with current Good

Manufacturing Practice (GMP) regulations.

4. The drug must be properly labeled to inform the user of the product not only how

to use the product but also safety considerations, procedures for use in foodproducing animals, and procedures for storage and handling.6

5. Under the National Environmental Policy Act, FDA must consider, during the

review process, the environmental impact of an animal drug’s postmarket use

(e.g., medicated feed waste and potential runoff).7

FDA, “Office of New Animal Drug Evaluation,” https://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/

CVM/WhatWeDo/ucm077923.htm.

FDA, “Environmental Impact Considerations,” https://www.fda.gov/AnimalVeterinary/

DevelopmentApprovalProcess/EnvironmentalAssessments/default.htm.

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In 2004 Congress addressed concerns about the availability of some animal drugs that are not

commercially attractive, and enacted the Minor Use and Minor Species Animal Health Act

(MUMS, P.L. 108-282), modeled after the authority for “orphan” human drugs. A minor use is a

use in a major species (horses, dogs, cats, cattle, pigs, turkeys, and chickens) for a disease that

occurs infrequently, involving only a small number of animals annually. Minor species are all

other nonhuman animal species (except for the above listed major species)—such as zoo animals,

fish, and pet birds and rodents—including some species of food-producing animals—such as

sheep, goats, catfish, game birds, and honey bees, among others. MUMS allows conditional

approval (marketing before all effectiveness data are available) and a period of marketing

exclusivity, during which FDA may not approve an application for the generic copy of the

approved brand-name drug.8 FDA may waive user fee requirements under ADUFA and AGDUFA

for MUMS drugs.

As with human medical products, it is the responsibility of the drug sponsor to conduct the

necessary tests to demonstrate a product’s safety and effectiveness for review purposes. Once the

drug is on the market, FDA continues to monitor the animal drug’s safety and effectiveness,

manufacturing processes, labeling, and marketing communications.9

For the basic types of applications and other submissions in the review of a brand-name animal

drug, as well as commonly used acronyms, see text box, above.

Generic Animal Drugs

Like brand-name animal drugs, authorities governing FDA’s review of generic animal drugs are

found in FFDCA Section 512, and regulations are at 21 C.F.R. Chapter I, Subchapter E. The

Generic Animal Drug and Patent Term Restoration Act of 1988 (P.L. 100-670) created an

expedited pathway for the review of generic animal drugs. This pathway allows a sponsor to

submit an abbreviated new animal drug

application (ANADA) to FDA for premarket

Generic Animal Drug Submissions and

References:

review rather than the full NADA required for

a brand-name animal drug. The process is



ANADA – Abbreviated New Animal Drug

Application, including all amendments and

called “abbreviated” because instead of

supplements

conducting new safety and effectiveness



JINAD – Generic Investigational New Animal Drug

testing, the ANADA sponsor establishes that



RLNAD — Reference-Listed New Animal Drug,

the generic animal drug is the same as the

the brand drug to which the generic is compared

reference-listed new animal drug product

(RLNAD, which is the brand drug), thereby

relying on FDA’s determination that the brand drug is safe and effective. In the ANADA, the

generic drug sponsor must show: that the generic copy has the same active ingredient, strength,

dosage form, dosing regimen, and route of administration as the RLNAD; that it is bioequivalent

(or that the bioequivalence requirement has been waived); and that it is the same in identity,

strength, purity, and quality.10 The labeling for the generic animal drug also must be the same as

the brand, with some exceptions (e.g., company name and address). An ANADA also must

FDA, “Minor Use/Minor Species,” https://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/

MinorUseMinorSpecies/default.htm.

FDA, “Animal Drugs Marketed as Animal Devices,” Post-Market Monitoring of Approved Animal Drugs,

https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/ComplianceEnforcement/UnapprovedAnim

alDrugs/ucm229088.htm.

FDA, “Generic Animal Drug and Patent Term Restoration Act (GADPTRA),” https://www.fda.gov/

AnimalVeterinary/GuidanceComplianceEnforcement/ActsRulesRegulations/ucm049100.htm.

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contain an environmental assessment (EA) or a request for categorical exclusion from the EA,

among other information.11

For basic types of applications, other submissions, and product references in the review of a

generic animal drug, as well as commonly used acronyms, see text box, above.

Drug Use in Food-Producing Animals

As noted, FDA must consider public health and environmental impacts in its safety assessment of

a proposed new animal drug. This is most evident in FDA’s regulation of drugs used in foodproducing animals, where use of drugs can affect the safety of meat and milk products consumed

by humans or other animals. FDA applies the following approaches, among others, to the review,

approval, and use of these drugs.



Tolerances and Withdrawal/Withholding/Discard Periods. Drug sponsors are

required to study the persistence of a drug (called a “residue”) in the tissues of

food-producing animals and demonstrate a safe management approach, such as

the minimum number of days after drug treatment ends that an animal must be

held untreated before it can go to slaughter (called a “withdrawal period”), or that

a cow’s milk must be discarded rather than marketed.12

Limitations on “Extra-Label” Prescribing. Veterinarians are generally permitted

to prescribe and/or dispense medications for indications not stated on the label

(referred to as “off-label” in human medicine) and for species not stated on the

label. This provides the basis of authority for veterinarians to prescribe or

dispense human medications for use in animals. However, this practice is limited

in a number of ways for uses in food-producing animals, in order to keep the

food supply free of potentially harmful drug residues.13

Judicious Use of Medically Important Antimicrobial Drugs. According to FDA,

“Antimicrobial use in animals can contribute to the emergence of antimicrobial

resistance in bacteria that may be transferred to humans, thereby reducing the

effectiveness of antimicrobial drugs for treating human disease.”14 The agency

has focused attention in particular on food-producing animals, which can

transmit foodborne infections in their meat or milk, and on what it calls

“production uses” of antimicrobial drugs, intended to promote weight gain or

growth efficiency rather than as treatment for specific diseases. In 2010, FDA

published draft guidance (which it finalized in 2012) stating principles for

limiting medically important antimicrobial drugs to uses in food-producing

animals that are considered necessary for assuring animal health, and limiting

such drugs to uses in food-producing animals that include veterinary oversight or

21 C.F.R 25.

FFDCA §512(b)(1)(G). When an animal-based food is found to contain an unacceptable or “violative” residue, FDA

considers the product to be adulterated under the FFDCA.

For more information see FDA, “The Ins and Outs of Extra-Label Drug Use in Animals: A Resource for

Veterinarians,” https://www.fda.gov/animalveterinary/resourcesforyou/ucm380135.htm.

FDA, “Antimicrobial Resistance,” https://www.fda.gov/AnimalVeterinary/SafetyHealth/AntimicrobialResistance/

default.htm. The term “antimicrobial” is often used synonymously with “antibiotic,” the latter being a drug that affects

bacteria. Antimicrobial drugs include antibiotics as well as antiviral and antifungal drugs. Each type of pathogen—

bacteria, viruses, and fungi—has been shown to develop resistance to drugs used to treat the infections they cause.

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

consultation.15 This effectively limited new approvals to drugs for which there

was evidence of effectiveness against a specific disease or condition, and

eliminated new approvals for over-the-counter antimicrobial uses. In 2013, FDA

asked sponsors of already approved antimicrobial drugs used in food-producing

animals to either demonstrate evidence of effectiveness for a disease treatment or

prevention indication, or to voluntarily withdraw the drug.16 In January 2017,

FDA announced the completion of this process, which resulted in 84 voluntary

product withdrawals and enhanced controls over the ongoing use of remaining

products in food-producing animals.17

Regulation of Feed Mills. Food-producing animals are often fed blended feed

mixtures containing vitamins and minerals, to which drugs are also sometimes

added. These blends are produced commercially by feed mills, which came under

increased scrutiny pursuant to the Animal Drug Availability Act of 1996 (P.L.

104-250). In 2015, through rulemaking, FDA expanded the role of veterinarians

in the use of antimicrobial drugs in blended feeds (called the “Veterinary Feed

Directive” or VFD) in order to assure the safe use of these drugs in foodproducing animals.18

Reporting of Antimicrobial Animal Drug Sales and Distribution. Section 105 of

ADUFA II requires that drug sponsors annually report to FDA the amount of

antimicrobial drugs they sell or distribute for use in food-producing animals, and

requires FDA to issue annual summary reports of the sales and distribution data.19

Sponsors have said that they are not in a position to know how products are

actually used once distributed (e.g., the species or condition being treated),

although such usage information is potentially valuable in monitoring and

addressing concerns about antimicrobial resistance. In 2016, through rulemaking,

FDA began requiring sponsors to provide FDA with estimates of sales broken out

by major food-producing species (cattle, swine, chickens, and turkeys).20

Authorities that address FDA’s regulation of animal drugs used in food-producing animals are

generally permanent. They are not part of the statutory language in FFDCA Title VII that

authorizes user fees and is subject to sunset. However, ADUFA /AGDUFA reauthorization offers

a rare legislative focus on animal drug issues, and amendments dealing with these and other

aspects of animal drug use are often considered by Congress during the reauthorization process.

FDA, “Timeline of FDA Action on Antimicrobial Resistance,” https://www.fda.gov/AnimalVeterinary/SafetyHealth/

AntimicrobialResistance/ucm438426.htm.

CRS In Focus IF10190, Antibiotic Use in Food Animals: FDA’s Current Activities.

FDA, “FDA Announces Implementation of [Guidance for Industry] #213, Outlines Continuing Efforts to Address

Antimicrobial Resistance,” press release, January 3, 2017, https://www.fda.gov/AnimalVeterinary/NewsEvents/

CVMUpdates/ucm535154.htm.

FDA, “Veterinary Feed Directive (VFD),” https://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/

ucm071807.htm.

FDA, “Antimicrobial Drug Sales/Distribution Summary Data,” https://www.fda.gov/AnimalVeterinary/

SafetyHealth/AntimicrobialResistance/default.htm#Sales%20Data.

FDA, “Questions and Answers: Summary Report on Antimicrobials Sold or Distributed for Use in Food-Producing

Animals,” https://www.fda.gov/ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/ucm236149.htm.

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User Fees and the FDA Budget

FDA’s budget has two funding streams: annual appropriations (i.e., discretionary budget

authority) and industry user fees. In FDA’s annual appropriation, Congress sets both the total

amount of appropriated funds and the amount of user fees that the agency is authorized to collect

and obligate for that fiscal year. FDA’s program level (i.e., total budget) in FY2016 was $4.745

billion, with user fees accounting for 43% of the enacted program level.21

FDA’s Center for Veterinary Medicine (CVM) is responsible for ensuring the safety and

effectiveness of brand and generic animal drugs.22 FDA financial reports, required by statute,

provide the total amount spent on the ADUFA and AGDUFA programs, including the dollar

amount and percentage derived from user fees and nonuser fee appropriations. While most of

ADUFA and AGDUFA revenue supports activities managed by CVM, revenue from both user fee

programs also contributes to other FDA organizational components that support the ADUFA and

AGDUFA programs, including the Office of Regulatory Affairs (ORA) and FDA headquarters.

CVM incurs the cost for the review of application and investigational submissions; ORA incurs

field inspection, investigation, and laboratory costs; and FDA headquarters incurs general and

administrative costs.23

Animal drug user fees were first collected in FY2004 and since then, have generally comprised an

increasing proportion of the FDA’s budget that is focused on animal drug review. In FY2005,

animal drug user fees provided 20% of the ADUFA program total costs (appropriations covered

80%).24 In FY2016, user fees provided 34% of ADUFA total costs (appropriations covered

66%).25

Generic animal drug user fees were first collected in FY2009 and also have generally comprised

an increasing proportion of the FDA’s budget that is focused on generic animal drug submissions.

In FY2009, generic animal drug user fees comprised 22% of the AGDUFA program total costs

(appropriations covered 78%). In FY2016, user fees comprised 59% of AGDUFA total costs

(appropriations covered 41%).26

Appendix B provides information on the relative proportion of costs supported by user fee

revenue and appropriations for the ADUFA and AGDUFA programs.

FY2018 FDA Justification of Estimates for Appropriations Committees, All Purpose Table,

https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/BudgetReports/UCM566294.pdf.

FDA, “About the Center for Veterinary Medicine (CVM),” https://www.fda.gov/AboutFDA/CentersOffices/

OfficeofFoods/CVM/default.htm.

FDA, “FY2016 AGDUFA Financial Report Required by the Animal Generic Drug User Fee Act of 2008,” Appendix

D, https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/UserFeeReports/FinancialReports/

AGDUFA/UCM550547.pdf.

The FDA ADUFA financial reports do not provide this breakdown for FY2004. FDA, “FY2014 ADUFA Financial

Report Required by the Animal Drug User Fee Act,” https://wayback.archiveit.org/7993/20170113204610/http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/UserFeeRepo

rts/FinancialReports/ADUFA/UCM447958.pdf.

FDA, “FY2016 ADUFA Financial Report Required by the Animal Drug User Fee Act of 2003,”

https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/UserFeeReports/FinancialReports/

ADUFA/UCM550684.pdf.

FDA, “FY2016 AGDUFA Financial Report Required by the Animal Generic Drug User Fee Act of 2008,”

https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/UserFeeReports/FinancialReports/AGDUF

A/UCM550547.pdf.

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Brand-Name (Pioneer) Animal Drugs and ADUFA

Congress first authorized user fees for brand-name animal drug review in 2003 in response to the

same concerns from animal drug sponsors that had spurred establishment of a user fee program

for human drugs a decade earlier. Given the years of research and cost involved in animal drug

development, sponsors argued for these fees to counter increasing review backlogs, which

delayed market entry and therefore—they believed—compromised both animal health and future

drug development.27

Types of Fees and Fee Waivers

Current law authorizes the collection of four types of user fees for brand-name animal drugs, and

sets the total amount of revenue for each fee type for each covered fiscal year, to be adjusted

annually for inflation and workload, as specified. ADUFA III provided for a final year

adjustment, allowing the Secretary to increase fee amounts to provide for up to three months of

operating reserves of carryover user fees for reviewing NADAs in the first three months of

FY2019, unless FDA has carryover balances in excess of three months of such operating reserves.

The four types of brand-name animal drug user fees are as follows.



Application and supplement fee. A one-time fee for each NADA or supplement a

sponsor submits (20% of estimated revenue).28

Product fee. An annual fee for each new animal drug product a sponsor has

submitted an application for, including approved and pending NADAs and

supplemental applications (27% of estimated revenue).

Establishment fee. An annual fee for each establishment that manufactures an

animal drug product named in an approved or pending NADA or supplemental

application during the given fiscal year (26% of estimated revenue).

Sponsor fee. An annual fee for each sponsor of an approved or pending NADA,

supplemental application, or INAD submission (27% of estimated revenue).

The statutory fee revenue amounts for FY2014-FY2018, as established by ADUFA III, are listed

in Table 1.

Table 1. Statutory Fee Revenue Amounts for Brand-Name Animal Drug Review:

FY2014-FY2018

Dollars in thousands

Type of fee

FY2014

FY2015

FY2016

FY2017

FY2018

TOTAL

Application

4,720

4,320

22,000

Product

6,372

5,832

29,700

Establishment

6,136

5,616

28,600

Sponsor

6,372

5,832

29,700

CRS Report RL34459, Animal Drug User Fee Programs.

Application fees for NADA supplements are equal to 50% of the NADA fee.

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Type of fee

TOTAL

FY2014

23,600

FY2015

21,600

FY2016

21,600

FY2017

21,600

FY2018

21,600

TOTAL

110,000

Source: Calculated by Congressional Research Service from FFDCA §740(b).

Notes: Amounts do not reflect adjustments for inflation or review workload.

The law requires the Secretary to set and publish in the Federal Register annual fees, based on the

statutory revenue amounts and adjustments, 60 days before the start of each fiscal year. The

Secretary may waive or reduce fees if he or she determines (1) assessment of the fee would

present a significant barrier to innovation; (2) the fees to be paid will exceed expected review

costs; (3) the animal drug is intended to be used in a medicated feed;29 (4) the animal drug is

intended solely for a MUMS indication; or (5) the sponsor is a small business (defined as having

fewer than 500 employees) submitting its first animal drug application. Information about the

numbers and value of waivers and reductions granted and used is provided in FDA’s annual

ADUFA financial reports.30

Fee “Triggers”: Authority to Collect Fees

To ensure that user fees supplement, rather than replace, appropriated funds, the law includes

three funding "triggers" that prohibit FDA from collecting user fees for animal drug review unless

certain conditions are met each year. FDA may collect and use fees only if the nonuser fee

appropriations, both for the activities involved in the review of animal drug applications and for

FDA activities overall, remain at a level at least equal (adjusted for inflation) to FY2003.31 The

third trigger prohibits FDA from collecting user fees in excess of the amount specified in annual

appropriations or otherwise made available for obligation that fiscal year.32

Performance

ADUFA requires the Secretary to submit to Congress, not later than 120 days before the end of

each fiscal year for which fees are collected, a performance report concerning FDA’s progress in

achieving the performance goals identified in the ADUFA agreement letter, and a financial report

on the implementation of the user fee authority and the use of fees collected during that fiscal

year.33

In FY2011 FDA released an electronic tool for animal drug review submissions (called

eSubmitter), in order to improve review efficiency. In FY2015 and FY2016, about 70% of all

submissions were made electronically.34

According to FDA’s most recent performance report (for FY2016), the agency exceeded its

ADUFA III performance goals for FY2015 (as shown in Table 2), and for the first three quarters

of FY2016.35

As defined in 21 C.F.R 558.3(b)(3)-(4) or any successor regulation.

FDA, ADUFA Financial Reports, https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/UserFeeReports/

FinancialReports/ADUFA/default.htm.

FFDCA §740(f)(1) and FFDCA §740(g)(2)(A)(ii).

FFDCA §740(g)(2)(A)(i).

FFDCA §740A.

FDA, “FY 2016 Performance Report to Congress for the Animal Drug User Fee Act,” p. 11, undated,

https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/UserFeeReports/PerformanceReports/

ucm537556.htm.

Congressional Research Service

Animal Drug User Fee Programs

Table 2. ADUFA Final Performance for FY2015

Review Time

Goal: Act on

90% within:a

# Filedb

# Reviewed

on Time

# Overdue

% on

Time

Original NADAs and reactivations

180 days

100%

Administrative NADAs

60 days

100%

Nonmanufacturing supplemental NADAs

and reactivations

180 days

100%

Manufacturing supplemental NADAs and

reactivations

120 days

327

100%

Qualifying labeling supplements

60 days

100%

INAD studies

180 days

147

100%

INAD study protocols

60 days

248

246

99%

Submission Type

Source: Adapted by Congressional Research Service from FDA, “FY2016 Performance Report to Congress for

the Animal Drug User Fee Act,” p. 7, undated, https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/

UserFeeReports/PerformanceReports/ucm537556.htm.

Notes: For determining performance goals, FDA defines supplemental applications that are “major” (most

supplemental NADAs), “moderate,” or “minor,” depending on how likely the change is to have an adverse effect

on the identity, strength, quality, purity, or potency of the drug. A nonmanufacturing supplemental is considered

a major change. A manufacturing supplemental is limited to a manufacturing change necessitated by an

unforeseen event (such as a fire), for which expedited review is provided. FDA, “Guidance for Industry:

Chemistry, Manufacturing, and Controls Changes to an Approved NADA or ANADA,” p. 6, May 30, 2007.

a. FDA defines “act on” to mean that it completes review of a submission and issues a final letter to the

sponsor either stating approval (or, for an INAD, completeness of the submission), or setting forth the

deficiencies that need to be addressed as a condition of approval.

b. Excludes filings that were found to be insufficient on their face or that were withdrawn.

Reauthorization

FFDCA Section 740A(d), as amended by ADUFA III, sets forth the process for reauthorization,

directing FDA to develop recommendations for the following five fiscal years (i.e., FY2019FY2023) in consultation with specified congressional committees, scientific and academic

experts, veterinary professionals, patient and consumer advocacy groups, and the regulated

industry. Prior to negotiations with industry, FDA is required to request public input, hold a public

meeting, provide a 30-day comment period, and publish public comments on the agency’s

website. During negotiations with industry, not less frequently than once every four months, FDA

must hold discussions with representatives of veterinary, patient, and consumer advocacy groups

to receive their suggestions and discuss their views on the reauthorization. After negotiations with

industry are completed, FDA is required to present the recommendations to the specified

congressional committees, publish the recommendations in the Federal Register, provide a 30day public comment period, hold another public meeting to receive views from stakeholders, and

(...continued)

FDA, “FY 2016 Performance Report to Congress for the Animal Drug User Fee Act,” Executive Summary, undated,

https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/UserFeeReports/PerformanceReports/

ucm537556.htm.

Congressional Research Service

Animal Drug User Fee Programs

revise the recommendations as necessary. Minutes of all negotiation meetings between FDA and

industry must be posted on the FDA website.36

Proposed ADUFA IV

FDA has published on its website a summary of the ADUFA IV proposed statutory changes, as

well as a notice in the Federal Register announcing the availability of the ADUFA IV draft

recommendations.37 According to the agency’s summary, the proposed ADUFA IV agreement

with industry would:



require sponsors to submit all applications and other submissions electronically,

beginning October 1, 2018;

retain all performance goals from ADUFA III, with the exception of

manufacturing supplemental NADAs and supplements with changes being

effected, for which a longer review time was agreed upon (See Table 3); and

add performance goals for review of certain medicated feed applications, for

conduct of presubmission conferences, and for pilot studies on new test methods

to detect drug residues in tissues of food-producing animals.38

The draft ADUFA IV agreement also proposes several changes to ADUFA III authority,

specifically to:



continue the inflation adjustment, and the workload adjustment, as calculated per

CVM policy, except to reset the base years to FY2014 through FY2018, with no

workload adjustment for FY2019. The proposed FY2019 baseline for ADUFA IV

is $30,331,240, which includes a $400,000 one-time cost for information

technology enhancement. For FY2020- FY2023, annual statutory revenue

amounts would be further adjusted for inflation and workload, and would include

$900,000 per year for research on tissue testing methods;

eliminate the final year offset provision and make any excess collections

available to “enhance the review process in real time;” and

authorize the Secretary, when setting fees, to reduce a calculated workload

adjustment, as specified.

Table 3. Selected ADUFA III and Proposed ADUFA IV Performance Goals

Submission Type

Performance goal (in days): Act on

90% within:

ADUFA III

Original NADAs and Reactivations

180

ADUFA IV

180

FDA, “ADUFA Meetings,” https://www.fda.gov/ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/

ucm042891.htm.

FDA “ADUFA IV: Summary of the Proposed Changes to the [FFDCA] and Proposed Bill Language,”

https://www.fda.gov/downloads/ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/UCM581830.pdf. For the

draft recommendations, see “Animal Drug User Fee Act; Recommendations; Request for Comments; Extension of

Comment Period,” 82 FR 49380, October 25, 2017.

FDA, “Drug Residues,” https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/

ComplianceEnforcement/ucm264049.htm.

Congressional Research Service

Animal Drug User Fee Programs

Submission Type

Performance goal (in days): Act on

90% within:

Administrative NADAs

Nonmanufacturing Supplemental NADAs and Reactivations

180

Manufacturing Supplemental NADAs and Reactivations

120

Manufacturing Supplemental NADAs and Reactivations

(Changes Being Effected)

120

180

Qualifying Labeling Supplements

Investigational New Animal Drug (INAD) Studies

180

INAD Study Protocols

Source: 82 Federal Register 49380, October 25, 2017; and FDA Presentation, “Animal Drug User Fee Act

Reauthorization (ADUFA IV), FY 2019 –FY 2023” Public Meeting, November 2017, https://www.fda.gov/

downloads/ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/UCM585895.pdf.

Note: Supplementals for which changes are being effected are considered moderate changes that can be made

by the sponsor while FDA review is pending.

The total five-year revenue planned for ADUFA III was $114 million. It is estimated that the total

five-year revenue for ADUFA IV would be $150 million. The fee revenue distribution in ADUFA

IV would remain the same as ADUFA III: 20% from application fees; 27% from product fees;

26% from establishment fees; and 27% from sponsor fees.

According to the agency’s section by section summary of the proposed statutory changes, the

proposed ADUFA IV, in addition to codifying several of the proposals in the draft agreement,

would amend (1) the definition of “animal drug application” to include an application for

conditional approval under FFDCA Section 571,39 and (2) the definition of “process for the

review of animal drug applications” to include certain activities related to implementation of the

US-European Union GMP Mutual Inspection Agreement.40 The proposed statutory language also

would add an exemption from fees for certain labeling supplements (to add the number of the

approved application to the labeling).41

This refers to application for a MUMS drug. See FDA, “Conditional Approval Explained: A Resource for

Veterinarians,” https://www.fda.gov/AnimalVeterinary/ResourcesforYou/ucm413948.htm.

FDA, “ADUFA IV: Summary of the Proposed Changes to the [FFDCA] and Proposed Bill Language,”

https://www.fda.gov/downloads/ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/UCM581830.pdf. While the

Mutual Recognition Agreement is between the US and European Union, FDA conducts an assessment of each country's

regulatory authority individually. According to an FDA press release from October 31, 2017, FDA has determined that

it would “recognize eight European drug regulatory authorities as capable of conducting inspections of manufacturing

facilities that meet FDA requirements,” including France and the United Kingdom. See https://www.fda.gov/

NewsEvents/Newsroom/PressAnnouncements/ucm583057.htm. “The scope of the Agreement covers a broad range of

human drugs and biologics and veterinary drugs with specific exclusions. Veterinary products are not immediately

included within the scope of the agreement, but will be considered for inclusion within the product coverage of the

agreement by no later than July 15, 2019,” https://www.fda.gov/downloads/AboutFDA/CentersOffices/

OfficeofGlobalRegulatoryOperationsandPolicy/UCM544394.pdf.

ADUFA IV proposes to amend FFDCA §502 (Misbranded drugs and devices) by adding a subsection (w), which

would require the labeling of an approved animal drug to include on its labeling the application number. This would not

apply to labeling for certain medicated feeds.

Congressional Research Service

Animal Drug User Fee Programs

Generic Animal Drugs and AGDUFA

FFDCA Section 512(c)(1) requires FDA to review and act on ANADAs within 180 days of

submission.42 In congressional testimony in June 2008, FDA reported that in FY2007, the average

review time for ANADAs was 570 days, and there was a backlog of 446 of these submissions,

almost double the number in FY2000.43 At that time, the review of ANADAs was funded entirely

through appropriations, and ADUFA user fee funds were not authorized to be applied to generic

animal drug reviews. In 2008, Congress passed legislation authorizing FDA to assess and collect

fees from generic animal drug sponsors to support the review of ANADAs, supplemental

applications,44 and investigational submissions (i.e., generic investigational new animal drug

[JINAD] submissions).45 In exchange for the authority to collect user fees, AGDUFA requires

FDA to pursue certain performance goals negotiated between the agency and industry.

Types of Fees and Fee Waivers

Current law authorizes the collection of three types of user fees, and sets the total amount of

revenue for each fee type for each covered fiscal year, to be adjusted annually for workload. The

fee amounts established by AGDUFA I (for FY2009-FY2013) and AGDUFA II (for FY2014

through FY2018) included a fixed 4% inflation adjustment, and provided for a final year

adjustment, allowing the Secretary to increase fee amounts to provide for up to three months of

operating reserves of carryover user fees for reviewing ANADAs in the first three months of

FY2019, unless FDA has carryover balances in excess of three months of such operating reserves.

The three types of generic animal drug user fees are as follows.



Abbreviated application fee. A one-time fee for each ANADA a sponsor submits

(25% of estimated revenue).46

Product fee. An annual fee for each generic new animal drug product a sponsor

has submitted an application for, including approved and pending ANADAs and

supplemental applications (37.5% of estimated revenue).

Sponsor fee. An annual fee for each sponsor of an approved or pending ANADA,

supplemental application, or investigational submission (37.5% of estimated

revenue).47

The FDA must, within that time, either issue an order approving the application, or offer the sponsor a notice of

opportunity for hearing regarding the agency’s finding, pursuant to FFDCA §512(d)(1), of a basis for withholding

approval.

Testimony of Bernadette M. Dunham, Director, FDA CVM, before the House Committee on Energy and Commerce,

Subcommittee on Health, hearing on “Committee Prints on Administration Legislative Proposals on the Animal Drug

User Fee Act Amendments of 2008 and the Animal Generic Drug User Fee Act of 2008,” June 5, 2008, 110th Cong.,

2nd Sess., Washington, DC.

A supplemental abbreviated application refers to a sponsor’s request to change the conditions of an approved

ANADA (e.g., product manufacturing changes).

A JINAD submission refers to the submission of information by the sponsor of a generic new animal drug, for the

purpose of evaluation of safety or effectiveness by FDA, in the event of the filing of an ANADA or a supplemental

application for such drug.

Application fees for ANADAs for certain combination products subject to the criteria in FFDCA §512(d)(4) and

submitted on or after October 1, 2013 are equal to 50% of the ANADA fee.

The sponsor fee is tiered based on the number of approved ANADAs the sponsor holds. A sponsor with more than 6

approved ANADAs would pay 100% of the sponsor fee. A sponsor with more than 1 but less than 7 approved

ANADAs would pay 75% of the sponsor fee, and a sponsor with 1 or fewer ANADAs would pay 50% of the fee.

Congressional Research Service

Animal Drug User Fee Programs

The statutory fee revenue amounts for FY2014-FY2018, as established by AGDUFA II, are listed

in Table 4.

Table 4. Statutory Fee Revenue Amounts for Generic Animal Drug Review:

FY2014-FY2018

(dollars in thousands)

Type of Fee

FY2014

FY2015

FY2016

FY2017

FY2018

Total

Application fees

1,832

1,736

1,857

1,984

2,117

9,526

Product fees

2,748

2,604

2,786

2,976

3,175

14,289

Sponsor fees

2,748

2,604

2,786

2,976

3,175

14,289

TOTAL

7,328

6,944

7,429

7,936

8,467

38,104

Source: FFDCA §741(b).

Notes: Amounts do not reflect adjustments for inflation or review workload.

The law requires the Secretary to set and publish in the Federal Register annual fees, based on the

statutory revenue amounts and adjustments, at least 60 days before the start of each fiscal year.

The Secretary may waive or reduce fees if he or she determines that the generic new animal drug

is intended solely to provide for a MUMS indication.48 Information about the numbers and value

of waivers and reductions granted and used is provided in FDA’s annual AGDUFA financial

reports.49

Fee “Triggers”: Authority to Collect Fees

To ensure that user fees supplement, rather than replace, appropriated funds, the law includes

three funding “triggers” (similar to the triggers for the ADUFA fees) that prohibit FDA from

collecting user fees for generic animal drug review unless certain conditions are met each year.

FDA may collect and use fees only if the nonuser fee appropriations for FDA activities overall

remain at a level at least equal (adjusted for inflation) to FY2003, and if the nonuser fee

appropriations for activities involved in the review of generic animal drug applications remain at

a level at least equal (adjusted for inflation) to FY2008.50 The third trigger prohibits FDA from

collecting user fees in excess of the amount specified in annual appropriations or otherwise made

available for obligation that fiscal year.51

Performance

AGDUFA requires the Secretary to submit to Congress, not later than 120 days before the end of

each fiscal year for which fees are collected, a performance report concerning FDA’s progress in

achieving the performance goals identified in the AGDUFA agreement letter and a financial

report on the implementation of the user fee authority and the use of the fees collected during that

fiscal year. AGDUFA I eliminated a backlog of 680 submissions, reduced submission review

times from 700 days to 270 days, and met performance goals for all years with the exception of

FFDCA §741(d).

FDA, AGDUFA Financial Reports, https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/

UserFeeReports/FinancialReports/AGDUFA/default.htm.

FFDCA §741(f)(1) and FFDCA §741(g)(2)(A)(ii).

FFDCA §741(g)(2)(A)(i).

Congressional Research Service

Animal Drug User Fee Programs

one goal (for JINAD protocols) in 2009.52 AGDUFA I phased in more challenging review goals

over a five-year period (see Table 5).

Table 5. AGDUFA I Performance Goals

Submission Type

Performance goal (in days): Act on 90% within:

FY2009

FY2010

FY2011

FY2012

FY2013

Original ANADAs and Reactivations

700

680

500

380

270

Administrative ANADAs

120

115

110

105

100

Manufacturing Supplemental ANADAs and

Reactivations

600

570

420

270

JINAD Studies

700

680

500

380

270

JINAD Protocols

400

390

290

190

100

Source: FDA, Animal Generic Drug User Fee Act Performance Goals and Procedures,

https://www.fda.gov/ForIndustry/UserFees/AnimalGenericDrugUserFeeActAGDUFA/ucm181567.htm.

Notes: An original application ANADA refers to an application that contains all the data for review as part of a

complete application. An administrative application ANADA refers to an original or supplemental application for

which data supporting discrete technical sections is submitted during the investigational phase of new animal drug

review, allowing for “phased review” of the data. A JINAD study refers to a submission that contains both the

data and conclusions of a study to be considered in support of the approval of a generic new animal drug. A

JINAD protocol refers to a submission consisting of a protocol(s) or plan for conducting a study without

substantial data.

AGDUFA II continued the review performance goals from FY2013, but added flexibility with a

shortened review-time process for certain submissions, developed electronic submission

capability, added a preapproval foreign inspection goal, and developed a question-based review

for bioequivalence, among other things.53 According to FDA’s most recent performance report

(for FY2016), the agency exceeded its AGDUFA II performance goals for FY2015 (as shown in

Table 6) and was on track to exceed all performance goals for FY2016.

Table 6. AGDUFA Final Performance for FY2015

Review Time Goal:

Act on 90% within:

# Filed

# Reviewed

on Time

# Overdue

% on

Time

Original ANADAs and Reactivations

270 days

100%

Administrative ANADAs

100 days

100%

Manufacturing Supplemental

ANADAs and Reactivations

270 days

152

151

99%

JINAD Studies

270 days

98%

JINAD Protocols

100 days

100%

Submission Type

“FY2013 Performance Report to Congress for the Animal Generic Drug User Fee Act,” https://wayback.archiveit.org/7993/20170114024611/http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/UserFeeRepo

rts/PerformanceReports/UCM384050.pdf. FDA Presentation, “Animal Generic Drug User Fee Act Reauthorization

(AGDUFA III) FY2019 – FY2023,” Public Meeting November 2017, https://www.fda.gov/downloads/ForIndustry/

UserFees/AnimalGenericDrugUserFeeActAGDUFA/UCM585851.pdf.

Ibid.

Congressional Research Service

Animal Drug User Fee Programs

Source: Adapted by Congressional Research Service from FDA, “FY2016 Performance Report to Congress for

the Animal Generic Drug User Fee Act,” p. 13, undated, https://www.fda.gov/downloads/AboutFDA/

ReportsManualsForms/Reports/UserFeeReports/PerformanceReports/UCM537571.pdf.

Reauthorization

FFDCA Section 742(d), as amended by AGDUFA II, sets forth the process for reauthorization of

AGDUFA II, directing FDA to develop recommendations for the following five fiscal years in

consultation with specified congressional committees, scientific and academic experts, veterinary

professionals, patient and consumer advocacy groups, and the regulated industry. Prior to

negotiations with industry, FDA is required to request public input, hold a public meeting,

provide a 30-day comment period, and publish public comments on the agency’s website. During

negotiations with industry, not less frequently than once every four months, FDA must hold

discussions with representatives of veterinary, patient, and consumer advocacy groups to receive

their suggestions and discuss their views on the reauthorization. After negotiations with industry

are completed, FDA is required to present the recommendations to the specified congressional

committees, publish the recommendations in the Federal Register, provide a 30-day public

comment period, hold another public meeting to receive views from stakeholders, and revise the

recommendations as necessary. Minutes of all negotiation meetings between FDA and industry

are required to be posted on the FDA website.54

Proposed AGDUFA III

FDA has published on its website a summary of the AGDUFA III proposed statutory changes and

proposed bill language, as well as a notice in the Federal Register announcing the availability of

the AGDUFA III draft recommendations.55 The draft AGDUFA III agreement proposes to

continue several commitments from AGDUFA II:



FDA will continue to allow two-phased Chemistry, Manufacturing, and Controls

technical section submissions under the JINAD process;

FDA and industry remain committed to improving the review and business

processes to facilitate the scheduling and conducting of preapproval inspections

(PAIs); and

FDA and industry agree to the importance of using both formal meetings and

informal communication to ensure high quality submissions so that performance

goals can be achieved.

The draft AGDUFA III agreement also proposes several changes to AGDUFA II, specifically to:



require all submissions to be electronic beginning in FY2019;

modify the inflation adjuster from a fixed 4% to a variable inflation adjuster

calculated using payroll cost and benefits and the Consumer Price Index less food

and energy;

FDA, “AGDUFA Meetings,” https://www.fda.gov/ForIndustry/UserFees/AnimalGenericDrugUserFeeActAGDUFA/

ucm270232.htm.

FDA “AGDUFA III: Summary of the Proposed Changes to the [FFDCA] and Proposed Bill Language,”

https://www.fda.gov/downloads/ForIndustry/UserFees/AnimalGenericDrugUserFeeActAGDUFA/UCM581832.pdf.

For the draft recommendations, see “Animal Generic Drug User Fee Act; Recommendations; Request for Comments;

Extension of Comment Period,” 82 FR 49377, October 25, 2017.

Congressional Research Service

Animal Drug User Fee Programs



continue using the workload adjustment, as calculated per CVM policy, except to

reset the base years to FY2014 through FY2018, with no workload adjustment

for FY2019. The proposed FY2019 baseline for AGDUFA III is $18,336,340. For

FY2020-FY2023, annual statutory revenue amounts would be further adjusted

for inflation and workload;

eliminate the final year offset provision and making any excess collections

available to “enhance the review process in real time;” and

authorize the Secretary, when setting fees, to reduce a calculated workload

adjustment, as specified.

According to the draft agreement, the planned total five-year revenue for AGDUFA III is $95

million, compared to $38.1 million for AGDUFA II and $27.1 million for AGDUFA I.56

Table 7 shows the proposed AGDUFA III performance goals compared to AGDUFA II.

Table 7. AGDUFA II and Proposed AGDUFA III Performance Goals

Submission Type

Performance goal (in days): Act on

90% within:

AGDUFA II

AGDUFA III

Original ANADAs and Reactivations

270

240

Administrative ANADAs

100

Manufacturing Supplemental ANADAs and Reactivations

270

180

JINAD Studies

270

180

JINAD Protocols

100

Source: 82 Federal Register 49377, October 25, 2017. FDA Presentation, “Animal Generic Drug User Fee Act

Reauthorization (AGDUFA III) FY2019 – FY2023,” Public Meeting November 2017, https://www.fda.gov/

downloads/ForIndustry/UserFees/AnimalGenericDrugUserFeeActAGDUFA/UCM585851.pdf.

According to the agency’s section by section summary of the proposed statutory changes, the

proposed AGDUFA III, in addition to codifying several of the proposals in the draft agreement,

would amend the definition of the “process for the review of abbreviated applications for generic

new animal drugs” to include processing of Freedom of Information Act requests, and would add

an exemption from fees for certain labeling supplements (to add the number of the approved

application to the labeling).57

82 Federal Register 49379, October 25, 2017.

AGDUFA III proposes to amend FFDCA §502 (Misbranded drugs and devices) by adding a subsection (w), which

would require the labeling of an approved animal drug to include on its labeling the application number.

Congressional Research Service

Animal Drug User Fee Programs

Appendix A. FDA Animal Drug User Fee Programs:

Selected Legislative History

Table A-1. Summary of FDA Animal Drug User Fee Programs

Animal Drugs and Generic Animal Drugs

ADUFA

AGDUFA

Original

authorizing law

Animal Drug User Fee Act, 2003 (ADUFA I;

P.L. 108-130)

Animal Generic Drug User Fee Act, 2008

(AGDUFA I; P.L. 110-316)

FFDCA sections

§§739, 740, and 740A

[21 U.S.C. §§379j-11, -12, and -13]

§§741-742

[21 U.S.C. §§379j-21 and -22]

Reauthorizations



ADUFA II, 2008 (P.L. 110-316)



ADUFA III, 2013 (P.L. 113-14), Tile I of

the Animal Drug and Animal Generic

Drug User Fee Reauthorization Act



AGDUFA II, 2013 (P.L. 113-14): Title II of the

Animal Drug and Animal Generic Drug User

Fee Reauthorization Act

Percent of

program budget

paid by user fees

in FY2016

34%

59%

Total Full-time

Equivalents

(FTEs) in FY2016

319

Fee schedule for

FY2018

Application (NADA) fee

$238,100

Abbreviated Application fee except

those subject to §512(d)(4)

$193,000

Supplemental w/ safety or

effectiveness data

$119,050

Abbreviated Application fee for those

subject to §512(d)(4)a

$96,500

Product fee

$6,175

Product fee

$8,195

Establishment fee

$88,750

Sponsor fee (100%)b

$76,250

Sponsor fee

$75,150

Sponsor fee (75%)

$57,188

Sponsor fee (50%)

$38,125

Source: FFDCA §§739-742. 82 FR 35957, August 2, 2017. 82 FR 35966, August 2, 2017. FDA, “FY2016 ADUFA

Financial Report Required by the Animal Drug User Fee Act of 2003.” FDA, “FY2016 AGDUFA Financial Report

Required by the Animal Generic Drug User Fee Act of 2008.”

a. FFDCA §512(d)(4) refers to certain combination animal drugs.

b. The sponsor fee is tiered based on the number of approved ANADAs the sponsor of an application holds.

A sponsor with more than 6 approved ANADAs would pay 100% of the sponsor fee. A sponsor with more

than 1 but less than 7 approved ANADAs would pay 75% of the sponsor fee, and a sponsor with 1 or fewer

ANADAs would pay 50% of the fee.

Congressional Research Service

Animal Drug User Fee Programs

Appendix B. User Fees and Appropriations

Figure B-1. FDA Animal Drug User Fee Programs: Total Costs, by Funding Source

Source: Graphic created by Congressional Research Service using data from the following reports: FDA,

FY2016 ADUFA Financial Report, Table 7: ADUFA Program—Historical Trend of Total Costs by Funding

Source as of September 30 of Each Fiscal Year, pg. 12, and FDA, FY2016 AGDUFA Financial Report, Table 7:

AGDUFA Program—Historical Trend of Total Costs by Funding Source as of September 30 of Each Fiscal Year,

pg. 11.

Congressional Research Service

Animal Drug User Fee Programs

Appendix C. Animal Drug Program Activities

Table C-1. Animal Drug Program Activity Data

2009

Actual

2010

Actual

2011

Actual

2012

Actual

2013

Actual

2014

Actual

2015

Actual

2016

Actual

2017

Est.

New Animal Drug Submissions

New Animal Drug Applications (NADAs)

Received

Completed

Approved

Pending

New Animal Drug Application Supplements

Received

521

552

538

417

409

474

514

544

675

Completed

545

493

606

458

410

455

516

443

550

Approved

399

344

497

386

334

390

407

333

400

Pending

137

212

142

101

118

116

217

342

Investigational New Animal Drug (INAD) Files

Received

2,812

3,377

2,720

2,372

3,560

2,782

3,734

3,198

3,500

Completed

2,758

3,088

3,050

2,388

3,538

2,853

3,805

3,156

3,250

409

702

361

345

402

331

335

627

877

Pending

Generic Animal Drug Submissions

Abbreviated New Animal Drug Applications (ANADAs)

Received

Completed

Approved

Pending

Abbreviated New Animal Drug Application Supplements

Received

144

187

199

177

193

221

227

340

Completed

179

196

238

221

162

229

225

204

300

Approved

112

154

171

127

162

166

123

200

Pending

170

166

126

112

104

116

189

229

Generic Investigational New Animal Drug (JINAD) Files

Received

305

271

219

304

498

497

354

502

750

Completed

327

269

214

305

489

476

358

469

675

Pending

476

551

Source: Annual FDA Congressional Budget Justifications, FY2011 through FY2018, Animal Drugs and Feeds

sections, Animal Drugs and Feeds Program Activity Data (PAD) tables.

Congressional Research Service

Animal Drug User Fee Programs

Author Contact Information

(name redacted)

Analyst in Health Policy

[redacted]@crs.loc.gov , 7-....

Congressional Research Service

(name redacted)

Specialist in Public Health and Epidemiology

[redacted]@crs.loc.gov

, 7-....

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