Animal Drug User Fee Programs

Animal Drug User Fee Programs
Updated August 4, 2008
Sarah A. Lister
Specialist in Public Health and Epidemiology
Domestic Social Policy Division

Animal Drug User Fee Programs
Summary
The Animal Drug User Fee Act of 2003 (ADUFA I, P.L. 108-130) gave the
Food and Drug Administration (FDA) initial authority to collect user fees from
sponsors for the review of animal drug applications. ADUFA mirrors fee programs
for human drugs and medical devices. Program authority sunsets October 1, 2008,
and FDA would have to lay off staff in its review program if the program were not
reauthorized by then. ADUFA supporters — including companies that make brand-
name animal drugs, and livestock producer groups — considered ADUFA^th
reauthorization to be “must pass” legislation in the 110 Congress. A coalition of
consumer groups opposed the program and its reauthorization, citing, in particular,
concerns about the safety of animal drugs used in livestock production.
After negotiations with brand-name animal drug companies, FDA made several
proposals for the reauthorization of ADUFA (ADUFA II), including a near-doubling
of the total amount of fees to be collected in the future. The proposed increase would
support continued enhancements of FDA’s review program, further improvements
in the timeliness of reviews, and the elimination of a backlog of pre-approval
inspections of foreign manufacturing facilities. FDA presented draft reauthorizing
legislation to Congress in April 2008. H.R. 6432, the Animal Drug User Fee
Amendments of 2008, a bill to reauthorize the program, was introduced on July 8,
2008. Subsequently, the bill was forwarded without amendment to the full
committee by the House Energy and Commerce Subcommittee on Health, and was
marked up by the full committee on July 16, 2008.
ADUFA does not cover generic animal drugs. FDA has not been able to
maintain the statutory requirement for timeliness of generic animal drug reviews
since ADUFA was enacted. FDA presented a draft Animal Generic Drug User Fee
Act (AGDUFA) to Congress in April 2008, separate from the ADUFA II draft bill.
H.R. 6433, the Animal Generic Drug User Fee Act of 2008, was introduced on July
8, 2008. Subsequently, the bill was forwarded without amendment to the full
committee by the House Energy and Commerce Subcommittee on Health, and was
marked up by the full committee on July 16, 2008.
On July 30, 2008, the House passed H.R. 6432, as amended, under suspension.
The engrossed (House-passed) bill incorporated an amended version of H.R. 6432
(ADUFA reauthorization), as reported, and H.R. 6433 (AGDUFA), as reported,
without amendment. On August 1, 2008, the Senate took up the House-passed
measure and passed it by unanimous consent. The measure has been sent to the
President, who is expected to sign it.
This report discusses aspects of ADUFA I, including funding and program
performance; FDA’s ADUFA II and AGDUFA proposals; congressional activity; and
relevant issues. Appendix A provides a summary of ADUFA I. Appendix B
describes the FDA process for approval of animal drugs. This report will be updated
to incorporate legislative actions and other events as they unfold.

Contents
Background ......................................................1
Overview of ADUFA I..............................................2
Legislative History.............................................2
Covered Products..............................................3
Covered Activities.............................................3
Fee “Triggers”: Authority to Collect Fees...........................3
Types of Fees.................................................4
Fee Waivers..................................................5
Program Performance..........................................5
Brand-Name Animal Drugs..................................5
Generic Animal Drugs......................................7
Program Funding and Financial Reports............................9
Sunset Provision.............................................10
FDA Proposal for ADUFA Reauthorization............................11
Timeline ....................................................11
Content .....................................................11
Program Financing........................................11
Enhancements to Performance Goals.........................12
FDA Proposal for Generic Animal Drug User Fees......................12
Congressional Action..............................................14
Hearings ....................................................14
Legislation ..................................................14
Overview ...............................................14
House Action............................................15
Senate Action............................................16
Issues for Congress...............................................17
ADUFA Program Performance..................................17
ADUFA Program Costs........................................17
Animal Drug Safety and Postmarket Review.......................18
Antimicrobial Resistance.......................................18
Appendix A. Summary of Provisions in ADUFA I.......................20
Appendix B. The Animal Drug Approval Process.......................22
List of Tables
Table 1. ADUFA I Performance Goals.................................6
Table 2. Animal Drug Program Activities...............................8
Table 3. ADUFA I Funding History, FY2003-FY2008....................10
Table 4. FDA Proposed ADUFA II Funding Levels, FY2009-FY2013.......12

Table 6. Terms Used in the Animal Drug Approval Process................23

Animal Drug User Fee Programs
Background
The Animal Drug User Fee Act of 2003 (ADUFA I, P.L. 108-130) was signed
by the President in November 2003. It established a new requirement, effective in
FY2004, for FDA to collect fees from sponsors of brand-name animal drugs in order
to reduce the backlog of reviews for those products, decrease the time required for
future reviews, and improve the predictability of the review process. Representatives
of animal drug research and development companies say that an animal drug can take
7 to 10 years to develop, at a cost of $100 million or more.¹ Predictable and timely
review is important to these companies. Companies that make generic animal drugs,
which are not currently covered by a user fee program, want review of their products²
to be timely and predictable as well. Moreover, veterinarians, animal producers, pet
owners, and consumers have an interest in the safety, availability, and affordability
of animal drugs, including their safety when used in livestock production.
Animal drug user fee authority sunsets October 1, 2008.³ If the program were
not reauthorized by then, FDA would have been prohibited at that time from
collecting user fees, and would have to lay off animal drug review staff. FDA began
discussions with animal drug sponsors regarding ADUFA reauthorization (ADUFA
II) in the spring of 2007. In 2008, FDA published its reauthorization proposal in the
Federal Register in February, held a public meeting in March, and accepted public
comments through mid-April. On April 24, 2008, FDA published draft legislation
to reauthorize ADUFA, along with a proposal for a new user fee authority for generic
animal drug reviews. On July 8, 2008, bills were introduced in the House to
reauthorize ADUFA (H.R. 6432) and to establish a user fee program for generic
animal drugs (H.R. 6433). Both bills were forwarded without amendment to the full
committee by the House Energy and Commerce Subcommittee on Health the
following day, and were marked up by the full committee on July 16, 2008. On July
30, 2008, the House passed H.R. 6432, as amended, under suspension. The
engrossed bill incorporated an amended version of H.R. 6432, as it was reported by
the full committee, and H.R. 6433, the proposal for generic animal drugs, as it was

¹ 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/].
² Many of these companies have formed the Generic Animal Drug Alliance, at
[http://www.fda.gov/ cvm/ ADUF AIIPresBatliner.htm] .
³ The law says that ADUFA user fee authority “shall not be in effect after October 1, 2008”
(emphasis added). [21 U.S.C. § 379j-11 note].

reported. On August 1, 2008, the Senate took up the House-passed measure and
passed it by unanimous consent. The measure has been sent to the President, who
is expected to sign it.
Reauthorization of the existing user fee program was supported by animal drug
research and development companies, livestock producers, and the American
Veterinary Medical Association. Because a sunset of program authority would have
been highly disruptive to the animal drug review process, many supporters felt that
ADUFA reauthorization was “must pass” legislation in the 110^th Congress. A
coalition of consumer groups opposed the user fee program and its reauthorization,
however, citing concerns about the safety of animal drugs approved for livestock
production.
This report discusses aspects of ADUFA I, including funding and program
performance; FDA’s proposed changes for ADUFA II; FDA’s proposal for a new
generic animal drug user fee program; congressional activity; and relevant issues.
Appendix A provides a summary of ADUFA I. Appendix B describes the FDA
process for approval of animal drugs. This report will be updated to incorporate
legislative actions and other events as they unfold. References in this report to “the
Secretary” refer to the Secretary of Health and Human Services (HHS).
Overview of ADUFA I
Legislative History
The Animal Drug User Fee Act of 2003 (ADUFA I, P.L. 108-130) established,
for the first time, effective in FY2004, authority for FDA to collect fees from
sponsors of animal drugs in order to reduce the backlog of application reviews for
those products, and to decrease the time required for future reviews. The act
mirrored many provisions from the existing prescription drug and medical device
user fee programs.⁴ ADUFA authority is in sections 739-740 of the FFDCA [21
U.S.C. §§ 379j-11 and -12]. With the exception of one technical and one conforming
amendment in 2007, the law has not been amended since its original passage.⁵
ADUFA I authority sunsets October 1, 2008, the beginning of the FY2009 fiscal year.
A summary of the law is provided in Appendix A.
The bills that were ultimately enacted in the 108^th Congress were H.R. 1260 and
S. 313. In its report on the House bill, the House Committee on Energy and
Commerce noted that in 1992, FDA was required to report to Congress regarding the

⁴ See CRS Report RL33914, The Prescription Drug User Fee Act (PDUFA): History,
Reauthorization in 2007, and Effect on FDA, by Susan Thaul, and CRS Report RL34571,
Medical Device User Fees and User Fee Acts, by Erin D. Williams.
⁵ P.L. 110-85, The Food and Drug Administration Amendments Act of 2007, § 109, 121
Stat. 842, September 27, 2007.

feasibility of a user fee program to improve the review process for animal drugs.⁶ In

1994, FDA reported that inadequate review resources, a growing workload, and low-

quality applications submitted by industry had slowed the approval process to an
unacceptable rate. The FDA report noted that if Congress were to consider
legislation authorizing FDA to impose and collect user fees, approximately $11
million in fees would be needed annually. The committee reported that as of 2003,
the situation had not improved, and may have worsened.
In its report on the Senate bill, the Senate Committee on Health, Education,
Labor, and Pensions said that animal drug user fee authority should allow FDA to (1)
eliminate existing backlogs of applications within two years; (2) over a five-year
period, move toward the goal of completing the review of 90% of new animal drug
applications within 180 days; (3) resolve new and emerging scientific issues that
affect the ability of FDA to make approval decisions; and (4) achieve an enhanced
and predictable review performance.⁷
Covered Products
ADUFA I authorizes the collection of user fees for the review of pioneer animal
drugs, the so-called “(b)(1)” animal drugs. It does not authorize the collection of fees
for ANADAs, the so-called “(b)(2)” generic animal drugs.⁸ The law requires the
Secretary, to the extent practicable, to segregate the review of ANADAs from that
of NADAs, and adopt other administrative procedures to ensure that review times of
ANADAs do not increase because of activities under the user fee program.
Covered Activities
ADUFA I defines the activities and costs that are allowable under the user fee
program, including those related to personnel, management of information and⁹
facilities, and fee collection, for the review of applications. The definitions do not
include any postmarket activities, and expressly prohibit the use of user fees to
review advertising and labeling after an animal drug has been approved.
Fee “Triggers”: Authority to Collect Fees
Congress established, in ADUFA I, three funding “triggers” that prohibit FDA
from collecting user fees for animal drug review unless certain conditions are met
each year. This was done to ensure that user fees supplement, rather than replace,
appropriated funds. Two of the triggers set FY2003 as a baseline, a minimum level
of non-user fee appropriations (adjusted for inflation) that must be maintained each

⁶ H.Rept. 108-287, to accompany H.R. 1260, the Animal Drug User Fee Act of 2003,
referring to P.L. 102-571, the Prescription Drug User Fee Act of 1992, § 108(a).
⁷ S.Rept. 108-51, to accompany S. 313, the Animal Drug User Fee Act of 2003.
⁸ If safety or effectiveness data are required for a request to change an approved generic
animal drug application (such as approval for a new species) it is considered a supplemental
animal drug application, and is subject to a user fee under ADUFA.
⁹ FFDCA §§ 739(8) and (9) [21 U.S.C. §§ 379j-11(8) and (9)].

year. One of these triggers requires that this level be maintained across the agency.
The other requires that it be maintained specifically for animal drug review activities.
The third trigger prohibits FDA from collecting user fees unless an explicit amount
for such fees is authorized in annual appropriations. The triggers are as follows:
^!FDA’s overall appropriation for salaries and expenses for a given
fiscal year, excluding fees, must exceed the agency’s overall
appropriation for salaries and expenses for FY2003 (prior to the user
fee program), excluding fees, and adjusted for inflation.¹⁰
^!FDA must spend, for animal drug review, from appropriated funds,
an amount not more than 3% below the amount spent for animal
drug review, from appropriated funds, in FY2003 (prior to the user
fee program), under certain conditions. Under no condition may
such amount be more than 5% below the FY2003 amount.
(Amounts in either case are adjusted for inflation).¹¹
^!Fees shall be collected and available for obligation only to the extent
and in the amount provided in advance in annual appropriations
act s.¹²
In its annual financial reports to Congress for fiscal years 2004 through 2006 (the
most recent available), as required by ADUFA I, FDA reports that each of the fee
triggers was met each year.¹³
Types of Fees
Experience from the human drug and medical device user fee programs showed
that because the number of applications varies from year to year, basing a user fee
program solely on application fees did not provide predictable funding streams.
From the outset, ADUFA I authorized several types of user fees. The act also
authorized the total revenues for each fee type that may be collected each fiscal year,
which are to be adjusted annually for inflation and workload. The act required the
Secretary to set annual fees at least 60 days before the start of each fiscal year and to
publish the fees and methodology in the Federal Register. The types of animal drug
user fees, and the fee amounts for FY2008, are as follows:
^!Application fees: One-time fees for new animal drug applications
(NADAs), and NADA supplements for which safety or effectiveness
data are required.¹⁴ Supplement fees are half the amount of the
NADA fee. The FY2008 amounts are $172,500 per NADA and
$86,250 for a NADA supplement for which safety or effectiveness
data are required.

¹⁰ FFDCA § 740(f)(1), [21 U.S.C. § 379j-12(f)(1)].
¹¹ FFDCA § 740(g)(2), [21 U.S.C. § 379j-12(g)(2)].
¹² FFDCA § 740(g)(1), [21 U.S.C. § 379j-12(g)(1)].
¹³ ADUFA reports are available at [http://www.fda.gov/cvm/adufa.htm].
¹⁴ See Appendix B for a description of the FDA approval process for animal drugs.

^!Product fees: Annual fees for each of a sponsor’s products to which
ADUFA is applicable, including approved and pending applications.
The FY2008 amount is $4,125.
^!Establishment fees: Annual fees for each of a sponsor’s
manufacturing establishments, unless the product is not
manufactured in the year the fee would be assessed. The FY2008
amount is $52,700.
^!Sponsor fees: Annual fees for each sponsor of an approved or
pending application. The FY2008 amount is $43,900.¹⁵
Sponsor fees apply only if the sponsor has had, since September 1, 2003, a pending
NADA, NADA supplement or investigational new animal drug (INAD) submission.
Product and establishment fees apply only if the sponsor has had, since September
1, 2003, a pending NADA or NADA supplement. ADUFA I establishes that total
revenues for each type of fee should comprise one-fourth of total fee revenues, but
the actual proportion of each type of fee collected each year typically varies slightly
from these projections. FDA publishes information about fee collections in its
annual financial reports to Congress, as required by ADUFA I.
Fee Waivers
ADUFA I authorizes the Secretary to waive or reduce fees if he determines that
one or more of the following applies:
^!Assessing the fee would be a barrier to innovation.
^!Fees would exceed FDA’s present and anticipated future costs for
conducting reviews.
^!The application is intended solely for a minor reformulation of an
approved drug for use in animal feed.
^!The application is intended solely to provide for a minor use or
minor species indication.
^!The sponsor is a small business submitting its first animal drug
application. The law defines a small business as one having fewer
than 500 employees, including employees of affiliates.
Information about the numbers and value of waivers and reductions granted and used
is provided in FDA’s annual financial reports. The most common waivers granted
were fees for sponsors of approved or pending applications for minor use or minor
species indications.
Program Performance
Brand-Name Animal Drugs. ADUFA I performance goals were developed
following consultation between FDA and the regulated industry, primarily to address
the backlog of animal drug reviews and to shorten review times in the future. The
goals were not incorporated in the statute, which instead refers to the goals as
identified in the Secretary’s letter to the chairmen and ranking members of the House

¹⁵ ADUFA fee information is available at [http://www.fda.gov/cvm/adufa.htm].

Committee on Energy and Commerce, and the Senate Committee on Health,
Education, Labor, and Pensions.¹⁶ Animal drug submissions to FDA vary
considerably in their complexity. By agreement between FDA and the industry, a
subset of six submission types were chosen as being the most meaningful for
performance measurement, and are referred to as sentinel submissions. Table 1
displays the performance goals that apply to the five-year ADUFA I performance
period of FY2004 through FY2008. FDA was to review and act on 90% of sentinel
submissions within the specified amounts of time. The goals were to be phased in to
achieve progressive improvements in the timeliness of review.
Table 1. ADUFA I Performance Goals
^{FDA Rev}ⁱ^ew^Tⁱ^m^e^(da^y^s⁾
^Acti^vi^ty^FY²⁰⁰⁴^FY²⁰⁰⁵^FY²⁰⁰⁶^FY²⁰⁰⁷^FY²⁰⁰⁸
^T^h^{e goal}ⁱ^s^{to revi}^e^w^an^d^{act on}^90%^{of s}^u^b^mⁱ^s^sⁱ^on^s^wⁱ^thⁱⁿ^th^{e s}^t^ated^ti^m^e^.
^N^oⁿ^-^admⁱⁿⁱ^s^t^ratⁱ^v^{e N}^A^D^A^s^an^{d react}ⁱ^v^atⁱ^oⁿ^s²⁹⁵²⁷⁰²³⁰²⁰⁰¹⁸⁰
^N^o^n-m^a^nufa^c^t^urⁱ^{ng sup}^p^l^e^m^eⁿ^t^a^l^N^A^D^A^{s a}ⁿ^d^a³²⁰²⁸⁵²³⁵²⁰⁰¹⁸⁰
^r^eactiv^atioⁿ^s
^Man^u^f^actu^rⁱⁿ^g^s^u^pplem^en^{tal NA}^DA^s^an^d^b²²⁵¹⁹⁰¹⁴⁰¹²⁰¹²⁰
^r^eactiv^atioⁿ^s
^IN^A^D^s^u^bmⁱ^s^sⁱ^on^s^of^s^t^u^d^y^dat^a³²⁰²⁸⁵²³⁵²⁰⁰¹⁸⁰
^IN^A^D^s^u^bmⁱ^s^sⁱ^on^s^of^s^t^u^d^y^prot^ocol^s¹²⁵¹⁰⁰⁸⁰⁶⁰⁵⁰
^A^d^mⁱⁿⁱ^strativ^{e NA}^DA^s⁹⁰⁸⁵⁸⁰⁷⁰⁶⁰
^Iⁿ^teri^m^b^a^ck^l^{og goal}^s
^R^e^vⁱ^ew^an^{d act}^on^pen^dⁱⁿ^g^applⁱ^catⁱ^oⁿ^s^{, s}^u^ppl^em^en^{tal ap}^p^licatioⁿ^s^{, an}^d^I^N^A^D^su^b^m^issioⁿ^s
^w^ithⁱⁿ²⁴^m^oⁿ^t^h^s^o^fⁱⁿ^itiatioⁿ^o^f^u^s^er^f^{ee p}^a^y^m^en^ts.
^A^d^dⁱ^ti^on^alⁱⁿ^teri^m^goal^s
^Fⁱ^f^t^y^percen^t^of^F^D^Aⁱⁿ^crem^en^t^a^l^revⁱ^ew^s^t^af^f^recruⁱ^t^e^{d an}^{d on}^{board by}^fⁱ^rs^t^qu^art^e^{r of}^F^Y^2006.
^T^o^t^a^l^s^t^af^fⁱⁿ^crem^en^t^on^{board by}^en^{d of}^F^Y^2008.
^FDA^w^{ill rev}ⁱ^ew^{all su}^b^m^issioⁿ^{s in}^acco^rd^an^{ce w}^ith^p^r^o^ced^u^r^{es f}^o^{r w}^o^rkⁱⁿ^g^w^ithⁱⁿ^{a q}^u^eu^{e. A}ⁿ
^ap^p^licatioⁿ^/^su^b^m^issioⁿ^th^{at is n}^o^{t r}^e^vⁱ^ew^ed^w^ithⁱⁿ^th^{e ap}^p^licab^{le tim}^{e f}^r^am^{e w}^{ill b}^e^r^e^vⁱ^ew^ed
^w^ith^th^{e h}ⁱ^g^h^e^{st p}^o^ssib^l^{e p}^r^io^r^ity^am^oⁿ^g^th^o^s^{e p}^eⁿ^dⁱⁿ^g^.
^a.^Non^-^m^aⁿ^u^f^actu^rⁱⁿ^g^s^u^pplem^en^tal^application^s^{are th}^os^{e th}^{at requ}^{ire s}^a^f^e^ty^an^{d ef}^f^ectiv^en^es^s^data.
^{b. Man}^u^f^actu^rⁱⁿ^g^s^u^pplem^ent^a^l^a^pplication^s^are^ty^pⁱ^cally^{less co}^m^p^licated^{, r}^e^q^u^irⁱⁿ^g^d^a^{ta o}ⁿ
^m^aⁿ^u^f^actu^rⁱⁿ^g^,^p^r^o^cessin^g^,^p^ack^agⁱⁿ^g^an^d^r^e^lated^activ^ities.
According to the required annual performance reports for FY2004 through
FY2006 (the most recent available), FDA says that all timeliness goals were met or
exceeded during each year of program performance. Also, the agency reports that,
as proposed, the submission backlog was eliminated by the end of FY2004, the goal
of having 50% of additional review staff recruited and on-board by the first quarter
of FY2006 was met, improvements were made in staff training and business systems,
and several guidance documents were published.

¹⁶ This letter, dated November 13, 2003, is published as an appendix in FDA’s annual
ADUFA performance reports, at [http://www.fda.gov/cvm/adufa.htm].

Generic Animal Drugs. Section 512(c)(1) of the FFDCA requires FDA to
review and act on abbreviated new animal drug applications (ANADAs, which are¹⁷
generic animal drug applications) within 180 days of submission. 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 FY2000.¹⁸ The review of ANADAs is funded entirely through
appropriations. ADUFA user fee funds may not be applied to generic animal drug
reviews.
The Secretary’s letter to congressional committees regarding ADUFA
performance goals did not address goals for the review of ANADAs. ADUFA I
requires that the Secretary, to the extent practicable, segregate the review of
ANADAs from the process for user fee-funded reviews and adopt other
administrative procedures to ensure that review times for ANADAs do not increase
as a result of activities under the user fee program. The act also requires that FDA
include, in its annual performance reports to Congress, information about review
times for ANADAs, and about the required administrative procedures. The annual
performance reports do not provide quantitative information regarding ANADA
submissions and review times. They note that FDA maintains separate staffing and
queues for ANADAs, and has defined baseline performance levels from FY2001
through FY2003, against which to measure current performance. In its annual
performance reports, FDA says that ANADA review times did not increase in
FY2004, but did increase in FY2005 and FY2006, which the agency attributes to
understaffing.
Table 2 compiles CVM workload data for the animal drug program overall (i.e.,
for both brand-name and generic drugs) for FY2004 through FY2009, noting the
numbers of submissions received, completed, approved, and pending. It is not valid
to directly compare program outputs for ADUFA activities in Table 2 against the
goals in Table 1. Table 2 does not present information about review times, and it is
not possible to know which submissions in Table 2 represent the sentinel
submissions to which the performance goals are applied. Also, submissions acted
upon (or not) in a given year are not necessarily subsets of the number of submissions
received that year. Nonetheless, Table 2 (shaded rows) shows a steady increase in
the number of pending ANADA supplements and a decline in the number of them
completed each year, neither of which appears to be explained by the annual number
of applications.

¹⁷ 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. See Appendix B for a description
of the FDA approval process for animal drugs.
¹⁸ 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^th^nd
2008 and the Animal Generic Drug User Fee Act of 2008,” June 5, 2008, 110 Cong., 2
Sess., Washington, DC.

Table 2. Animal Drug Program Activities
^FY²⁰⁰⁴^FY²⁰⁰⁵^FY²⁰⁰⁶^FY²⁰⁰⁷^FY²⁰⁰⁸^FY²⁰⁰⁹
^Subm^issioⁿ^t^y^pe^actu^al^actu^al^actu^al^actu^al^es^ti^m^a^te^es^tim^a^te
^{Applications and acti}^{vities covered by ADUF}^{A I user fee authority}
^NADAs
^R^eceiv^e^d¹⁵¹¹¹⁶²¹²⁰²⁰
^C^o^m^p^l^e^t^e^d²³⁹¹³²²²²²³
^A^pprov^ed¹⁸⁷⁶¹⁸¹⁹¹⁹
^P^eⁿ^dⁱ^g³⁵⁸⁷⁵²
^{NADA supplem}^ents
^R^eceiv^e^d⁴⁰⁸⁴⁵¹⁵⁹⁸⁶⁰⁵⁶⁰⁵⁶⁰⁵
^C^o^m^p^l^e^t^e^d⁴⁷⁶⁴⁴⁹⁵⁶¹⁶¹⁰⁶¹⁸⁶²⁷
^A^pprov^ed³⁵⁶³¹⁹⁴³⁰⁴⁹⁶⁵⁴⁰⁵⁴⁰
^Pen^dⁱⁿ^g¹⁵⁶¹⁵⁹¹⁹⁵¹⁸⁷¹⁷⁴¹⁵²
^Inv^e^stig^a^t^io^na^{l new}^aⁿ^im^a^l^drug^{(INAD) files}
^R^eceiv^e^d²^,138^1,888^2,193^2,457^2,457^2,464
^C^o^m^p^l^e^t^e^d²^,200^1,767^2,231^2,491^2,491^2,491
^Pen^dⁱⁿ^g²⁶⁴³⁸⁶³⁵¹³²⁰²⁸⁶²⁵⁹
^{Applications and activi}^{ties not covered by ADUF}^{A I user fee authority}
^ANADAs
^R^eceiv^e^d⁶¹⁴⁹⁴⁵²³²⁴²⁷
^C^o^m^p^l^e^t^d⁵⁵⁴⁶⁴³³⁷³⁵³²
^A^pprov^ed¹⁹¹³¹⁷²⁰¹⁸¹⁸
^P^eⁿ^dⁱ^g⁴⁷⁵⁰⁵²³⁸²⁷²
^{ANADA supplem}^ents
^R^eceiv^e^d²¹¹¹¹⁶¹²⁷¹⁴²¹⁴³¹⁴⁹
^C^o^m^p^l^e^t^e^d¹⁹⁵⁹⁷¹²⁰⁸⁸⁸⁶⁸²
^A^pprov^ed¹⁶³⁷¹⁸⁰⁷¹⁶⁹⁶⁹
^Pen^dⁱⁿ^g⁷⁸⁹⁹¹⁰⁴¹⁵⁷²¹⁴²⁸¹
^G^e^{neric inv}^e^stig^a^t^io^na^{l new}^aⁿ^im^a^l^drug^(J^{INAD) files}
^R^eceiv^e^d¹⁷⁰³³⁵¹⁹¹¹⁴⁵¹⁶⁰¹⁶⁰
^C^o^m^p^l^e^t^e^d¹³⁰²²⁹³²¹¹⁴⁹¹⁴⁰¹⁴⁰
^Pen^dⁱⁿ^g⁶⁶¹⁷³⁴²³⁸⁵⁸⁷⁸
^Source:^A^nnua^l^FD^A^Co^ngr^e^ssi^oⁿ^a^l^B^u^d^g^e^t^J^u^stⁱ^fⁱ^c^a^tⁱ^o^ns,^FY^{2006 t}^h^ro^{ugh FY}^{2009, A}ⁿⁱ^m^al^D^r^u^g^s
^an^{d Feeds}^s^ection^s^{, A}ⁿ^im^{al Dru}^g^s^an^{d Feeds}^P^r^og^ram^A^c^tiv^ity^{Data (P}^A^D^{) tables}^.

Program Funding and Financial Reports
ADUFA I authorized the following funding levels for its five-year program
period, from FY2004 through FY2008, as follows:
^!$5 million for FY2004,
^!$8 million for FY2005, and
^!$10 million for each of fiscal years 2006 through 2008.
Each amount is subject to the inflationary and workload adjustments required by
ADUFA I. The Secretary also has authority, but is not required, to apply a final-year
adjustment to the FY2008 amount, to provide up to three months of carryover into
FY2009. An adjustment for the full three months was included in the agency’s
FY2008 budget request and was provided in the amount authorized in FY2008
appropriations.
ADUFA I requires the Secretary to submit to Congress, within 120 days of the
end of each fiscal year, annual financial reports about the user fee program. FDA has
published reports for fiscal years 2004 through 2006.¹⁹ The reports address the three
funding triggers, each of which has been met each fiscal year. They also present total
costs for the process of review of animal drug applications, as defined in ADUFA I,
and the amounts paid from user fee revenues and appropriations. These costs are
principally borne by FDA CVM, but also, to a lesser extent, by the Office of the
Commissioner (OC) and the Office of Regulatory Affairs (ORA). OC supports
general and administrative functions. ORA supports pre-approval inspections of
manufacturing facilities, investigations of clinical studies, and analytical testing of
samples that are counted for the review process for animal drug applications.
Table 3 presents the funding history for the ADUFA I program period of
FY2004 through FY2008, with FY2003 provided as a baseline. (FY2003
appropriations levels for animal drug review serve as the baseline for one of the three
funding triggers.) User fee funds have grown as a proportion of total funding for
animal drug review, accounting for almost one-fourth of total funding in FY2006.²⁰
Obligations from direct appropriations grew by about 12% overall between FY2003
and FY2006. User fee revenues available during the ADUFA I program period
totaled almost $50 million, including the final year adjustment in FY2008 for
carryover into FY2009.

¹⁹ See [http://www.fda.gov/cvm/adufa.htm].
²⁰ User fees made up a larger proportion of total funds available for human drug reviews
during the same period. See Table 2B in CRS Report RL33914, The Prescription Drug
User Fee Act (PDUFA): History, Reauthorization in 2007, and Effect on FDA, by Susan
Thaul. User fees made up a smaller proportion of total funds for medical device reviews.
See Table 4 in CRS Report RL33981, Medical Device User Fee and Modernization Act
(MDUFMA) Reauthorization, by Erin D. Williams.

Table 3. ADUFA I Funding History, FY2003-FY2008
(dollars in thousands)
^Obligations^from^Direct^a^b^Us^{er Fees}^/
^Fi^s^c^al^Y^e^ar^Appro^p^ria^t^io^ns^Us^{er Fees}^To^t^a^l^T^o^tal^(%)
^F^Y²⁰⁰³^$32,748^N^A^$32,748⁰
^F^Y²⁰⁰⁴^31,774^c^5,000^36,774^13.6
^F^Y²⁰⁰⁵^34,408^8,354^42,762^19.5
^F^Y²⁰⁰⁶^36,637^11,318^47,955^23.6
^F^Y²⁰⁰⁷ⁿ^o^t^pu^blⁱ^s^h^e^d^11,604^N^A^N^A
^F^Y²⁰⁰⁸ⁿ^o^t^pu^blⁱ^s^h^e^d^13,696^d^NA^NA
^T^o^{tal: ADUFA I}^N^A^$49,972^NA^NA
^No^tes:^N^Aⁱ^sⁿ^o^t^applⁱ^cabl^e^{. U}^s^{er f}^ees^w^e^{re f}ⁱ^rs^t^au^t^h^ori^{zed f}^o^{r F}^Y^2004.^F^D^A^h^a^s^pu^blⁱ^s^h^e^{d am}^ouⁿ^t^s
^oblig^{ated to}^t^h^{e an}^im^{al dru}^g^revⁱ^ew^prog^ram^f^r^om^di^rect^appropri^a^tⁱ^oⁿ^s^on^l^y^f^o^{r f}ⁱ^s^cal^y^ears
^{2003 t}^h^rou^g^h^{2006. A}^nnua^l^p^e^r^c^eⁿ^t^a^ge^{s a}ⁿ^d^t^o^t^a^l^s^c^aⁿ^b^e^c^a^l^c^u^l^a^t^e^d^oⁿ^l^y^fo^r^t^h^o^s^e^y^e^a^r^{s fo}^r
^w^h^ich^th^{ere are pu}^blis^h^e^{d am}^o^uⁿ^t^{s f}^o^r^th^{ese o}^b^lig^atioⁿ^s^.
^A^DUFA^I^d^o^e^{s n}^o^{t h}^a^v^e^ex^p^{licit r}^e^q^u^ir^em^en^{ts r}^e^g^a^r^dⁱⁿ^g^f^u^ll-^tim^e^eq^uⁱ^v^a^len^t⁽^F^T^E⁾^staf^fⁱⁿ^g^p^o^s^itioⁿ^s
^f^o^r^an^im^{al d}^r^u^g^r^e^vⁱ^ew^{, an}^d^FDA^h^a^{s n}^o^{t p}^u^b^lish^e^dⁱⁿ^f^o^r^m^a^tⁱ^oⁿ^a^b^o^u^t^th^{ese p}^o^s^itioⁿ^s^th^{at is}
^com^p^{arable f}^r^om^on^{e f}ⁱ^s^{cal y}^{ear to th}^{e n}^e^x^t^.
^a^.^Fr^o^m^FD^A^A^nnua^l^A^D^U^F^A^Fi^na^ncⁱ^a^l^Re^p^o^r^t^s^fo^r^F^Y^{2004 t}^h^r^o^{ugh FY}^{2006, at}
^[^h^t^t^p^:^/^/^www.^f^d^a^.^g^o^v^/^c^v^m/^a^d^u^f^a^.^h^t^m#^R^e^p^o^r^t^s^]^.^Iⁿ^c^l^u^d^e^s^oⁿ^l^y^dⁱ^r^e^c^t^a^p^p^r^o^p^rⁱ^a^tⁱ^oⁿ^s^,ⁿ^o^t^u^s^e^r^f^e^e
^a^m^o^unt^{s sp}^e^cⁱ^fi^e^dⁱⁿ^a^nnua^l^a^p^p^r^o^p^rⁱ^a^tⁱ^o^{ns a}^c^t^s.
^b^.^A^m^o^unt^{s a}^s^sp^e^cⁱ^fi^e^dⁱⁿ^a^nnua^l^a^p^p^r^o^p^rⁱ^a^tⁱ^o^{ns a}^c^t^s.
^c^.^T^h^o^ugh^t^hⁱ^s^a^m^o^untⁱ^s^l^e^{ss t}^h^aⁿ^t^h^e^FY^{2003 bas}^e^lⁱⁿ^{e, t}^hⁱ^s^t^rⁱ^g^g^e^{r i}ⁿ^A^D^U^F^A^{I prov}ⁱ^d^es^t^h^at^F^D^A
^m^a^y^{collect u}^s^er^f^ees^as^lon^g^as^th^{e am}^ouⁿ^t^ob^lig^{ated f}^o^{r an}^im^{al dru}^g^revⁱ^ew^s^isⁿ^o^{t m}^o^{re th}^an
^3%^below^th^{e F}^Y^{2003 bas}^e^lin^{e, adj}^u^s^t^{ed f}^o^{r in}^f^l^ation^.^Because^o^f^t^h^e³^%^cu^s^h^ion^,^th^is
^requⁱ^r^em^en^t^w^a^s^m^e^tⁱⁿ^F^Y^2004.
^d^.^Am^o^uⁿ^t^r^e^f^l^{ects, in}^ad^d^itioⁿ^toⁱⁿ^f^l^atioⁿ^a^r^y^an^d^w^o^r^k^lo^ad^ad^j^u^stm^eⁿ^t^{s, th}^{e f}ⁱⁿ^a^{l y}^ear^ad^j^u^stm^eⁿ^t^,
^pu^rs^u^aⁿ^t^t^o^A^D^U^F^A^I^at^F^F^D^C^A^{§ 740(c)(3) [21 U}^.^S^.^C^.^{§ 379j}^-^{12(c)(3)], f}^o^{r carry}^ov^{er i}ⁿ^t^o^t^h^e
^fⁱ^rs^t^t^h^{ree m}^oⁿ^t^h^s^of^F^Y^2009.
Sunset Provision
ADUFA I user fee authority sunsets October 1, 2008. FDA would have been
prohibited from collecting user fees after this date, unless the program were
reauthorized.²¹ If not, absent other sources of funds, the agency would have to lay off
animal drug review staff.²² Personnel regulations require that federal agencies give

²¹ ADUFA’s requirements for reports to Congress sunset 120 days later, which maintains
the annual performance and financial reporting requirement for FY2008, whether or not the
program were reauthorized.
²² FDA estimated that 58 employees would have been affected by such layoffs. See
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.

staff 60 days notice of an impending reduction in force (RIF).²³ In 2007, as similar
authorities for human drugs and devices were about to sunset, the FDA
Commissioner expressed concern to Congress about the potential attrition of staff
who feared losing their jobs, and the desire to avoid having to send the required RIF
not i ce.²⁴
FDA Proposal for ADUFA Reauthorization
Timeline
ADUFA I directs FDA to (1) develop a reauthorization proposal for fiscal years

2009 through 2013 (ADUFA II), in consultation with Congress and stakeholders; (2)

publish its proposed recommendations in the Federal Register; (3) hold a public
meeting thereafter; (4) provide a 30-day public comment period; and, finally, (5)
present its final recommendations to the Congress. On February 21, 2008, FDA
published its proposal for ADUFA II, which was developed based on a public
meeting in April 2007 and discussions with the regulated industry.²⁵ FDA held
another public meeting to present its proposal and receive comments on March 11,
2008. Written comments were due to the agency on April 14, 2008. FDA’s
legislative proposal to the Congress was published on April 24, 2008.²⁶
Content
According to the Federal Register notice, FDA’s proposed reauthorization
would maintain most of the basic architecture of ADUFA I. The draft ADUFA II
legislation, published on April 24, 2008, largely reflects the Federal Register
proposal. Significant proposed changes to program financing and performance goals
are discussed in greater depth below.²⁷ The agency’s proposal does not address
matters related to postmarket activities. A separate proposal to establish a user fee
program for the review of generic animal drugs is discussed in a subsequent section
of this CRS report.
Program Financing. FDA says that user fees have not kept up with the
increase in program costs that result from what the agency calculates as 5.9% annual
inflationary growth in pay and benefits, and rent and rent-related costs, over the

²³ See U.S. Office of Personnel Management, “Summary of Reduction in Force Under
OPM’s Regulations,” at [http://www.opm.gov/rif/general/rifguide.asp].
²⁴ See “FDA Chief Again Presses Congress On User Fees, Says 1997 Delay Caused Severe
Setbacks,” InsideHealthPolicy.com, September 17, 2007.
²⁵ 73 Federal Register 9571-9575, February 21, 2008.
²⁶ FDA, “Animal Drug User Fees,” April 24, 2008, at [http://www.fda.gov/oc/opacom/
hottopics/adufa_agduf a/adufareauth.html ].
²⁷ The reauthorization proposal also includes several technical changes. FDA has listed the
differences between ADUFA I and its ADUFA II legislative proposal at
[ h t t p : / / www.f d a . go v/ oc / opa c o m/ hot t opi c s / ADUFA_AgDUFA/ ADUFAIIs umma r y.ht ml ] .

ADUFA I program period. The agency proposes higher levels of fee revenues for the
ADUFA II program period, above those that would result solely from the inflation
adjustments in current authority. Table 4 presents FDA’s proposed authorization
levels for ADUFA II fee revenues, based on the agency’s projections. The
recommended levels total $98 million over five years, almost twice the funding level
of the five-year ADUFA I program period (see Table 3). FDA proposes to eliminate
the current inflation adjustment provisions for fee revenues (because such
adjustments are incorporated in the proposed revenue targets), and suggests a number
of additional technical changes to fee authority. The agency proposes to leave the
current fee triggers unchanged throughout the ADUFA II program period.
Table 4. FDA Proposed ADUFA II Funding Levels,
FY2009-FY2013
(dollars in thousands)
^Fi^s^c^al^Y^e^ar^FY²⁰⁰⁹^FY²⁰¹⁰^FY²⁰¹¹^FY²⁰¹²^FY²⁰¹³^T^o^tal
^A^u^th^o^r^izatioⁿ^o^f^15,260^17,280^19,448^21,768^24,244^$98,000
^appropri^a^tⁱ^oⁿ^s
^Source:⁷³^Feder^a^{l Regis}^t^er^9571-^{9575, F}^e^bru^a^ry^{21, 2008.}
Enhancements to Performance Goals.²⁸ FDA proposes to retain the
same initial time frames for review throughout the ADUFA II program period as
those in place in FY2008 (see Table 1). Per discussions with industry, the agency
proposes to add an “end review amendment” process. It would allow the agency to
work with sponsors to make minor amendments to a submission, rather than
designating the review as incomplete, which “re-sets the clock” for an additional²⁹
review cycle. Other proposals agreed to by FDA and the industry include holding
public workshops, implementing procedures to streamline scheduling of foreign
facility pre-approval inspections, and discussing the applicability of pharmacokinetic
and pharmacodynamic data in the review process, among others. In addition, FDA
proposes to develop an electronic tool for industry submissions and online review
capability within 24 months of an ADUFA appropriation for FY2009.
FDA Proposal for Generic Animal Drug User Fees
Though ADUFA I required FDA to take steps to ensure that the user fee
program did not compromise the timeliness of generic animal drug reviews, FDA has
had difficulty keeping up with these reviews, and has not generally met the statutory
requirement to act on ANADAs within 180 days. (See the earlier section on
“Program Performance.”) It is not clear whether this is a result of the user fee

²⁸ FDA has published its proposed performance goals and procedures for ADUFA
reauthorization at [http://www.fda.gov/cvm/ADUFAIIreauthorization.htm].
²⁹ The process is described in the transcript of the FDA public meeting on ADUFA
reauthorization, March 11, 2008 (hereafter referred to as ADUFA meeting transcript), at
[http://www.fda.gov/cvm/ ADUFA032008Transcript.htm].

program, a result of a failure of non-fee funding to keep pace with demand in the
generics program (which may have occurred regardless of the user fee program), or
other factors. In its FY2009 budget request, FDA proposed, for the first time, a user
fee program to support reviews of generic animal drugs. At an ADUFA public
meeting in 2007, a representative of the Generic Animal Drug Alliance (GADA)
announced the Alliance’s support for a generic animal drug user fee program.³⁰
On April 24, 2008, FDA published a draft legislative proposal for the Animal
Generic Drug User Fee Act (AGDUFA), accompanied by performance goals for
generic animal drug review that were agreed to in consultation with the industry.³¹
The agency noted the increasing review times for generic animal drugs, saying that
the workload was likely to grow, because patent protection on approximately 49
animal drugs will expire between FY2009 and FY2011. The AGDUFA proposal is
similar in design to ADUFA I, including, for example, comparable fee triggers (one
of them requiring maintenance of non-user fee funding for generic animal drug
reviews), fee-setting requirements, workload adjustments, and reporting
requirements. Like FDA’s ADUFA II proposal, the AGDUFA proposal has fixed
annual increases instead of the ADUFA I inflation adjuster. Notable differences
between ADUFA I and the AGDUFA proposal include the following:
^!AGDUFA authority to collect application, product, and sponsor fees,
but not establishment fees.
^!AGDUFA sponsor fees (for which a given sponsor would pay only
one fee per year) that are tiered according to the number of a
sponsor’s currently approved ANADAs.
^!AGDUFA authority to waive or reduce fees only if the drug is
intended for a minor use or minor species indication.
Table 5 presents FDA’s proposed authorization levels for AGDUFA fee revenues
for FY2009 through FY2013.
Table 5. FDA Proposed AGDUFA Funding Levels,
FY2009-FY2013
(dollars in thousands)
^Fi^s^c^al^Y^e^ar^FY²⁰⁰⁹^FY²⁰¹⁰^FY²⁰¹¹^FY²⁰¹²^FY²⁰¹³^T^o^tal
^A^u^th^o^r^izatioⁿ^o^f^4,831^5,106^5,397^5,706^6,031^$27,071
^appropri^a^tⁱ^oⁿ^s
^Source:^F^D^A^,^“^Aⁿⁱ^m^a^l^D^r^u^g^U^s^e^r^F^e^e^s^{,” A}^p^{ril 24, 2008, at [h}^ttp://^www.^f^d^a^.^g^o^v^/^o^c^/^o^p^a^c^o^m/^h^o^t^t^o^pⁱ^c^s^/
^adu^f^a_ag^du^f^a^/adu^f^a^reau^th^.h^tm^l].

³⁰ Presentation of Stephanie Batliner, representing the Generic Animal Drug Alliance,
ADUFA public meeting, April 27, 2007, at [http://www.fda.gov/cvm/ADUFA07PM.htm].
³¹ FDA, “Animal Drug User Fees,” April 24, 2008, at [http://www.fda.gov/oc/opacom/
hottopics/adufa_agduf a/adufareauth.html ].

FDA’s proposed performance goals for AGDUFA are similar to those for
ADUFA I. The agency proposes to review and act on 90% of five “sentinel” types
of generic animal drug submissions within specific time frames, which decrease
steadily from FY2009 through FY2013. (As noted earlier, FFDCA §512(c)(1)
requires the FDA to act on all such submissions within 180 days.) In FY2009, the
proposed target to act on certain submissions is as long as 700 days (almost two
years). By FY2013, the longest proposed target is 270 days. The agency did not
propose any AGDUFA performance goals regarding the backlog of reviews, or other
matters.
In congressional testimony in June 2008, a witness representing GADA testified
that according to its agreement with FDA regarding an animal generic drug user fee
program (as reflected in FDA’s AGDUFA proposal), “the performance goals for
AGDUFA do not return generic application review times to [the statutory
requirement of 180 days]. Rather, 270 days is the highest level of performance that
the generic animal drug industry could afford.”³²
Congressional Action
Hearings
On June 5, 2008, the House Energy and Commerce Subcommittee on Health
held a hearing on ADUFA reauthorization and the Administration’s ADUFA II and
AGDUFA proposals.³³ Subcommittee Members in attendance expressed a number
of points of view regarding the forthcoming legislative process. While all of them
expressed general support for both proposals, some stated a preference for efficient
passage of a “clean” ADUFA reauthorization, while others suggested that one or the
other proposal could serve as a vehicle for additional subject matter that was not part
of the FDA-industry agreements. Such subject matter included postmarket safety —
in particular, public health concerns about antimicrobial resistance — and certain
expansions of FDA’s enforcement authority that are currently under consideration in
the House and Senate. These matters are discussed in greater detail in the next
section of this CRS report, “Issues for Congress.”
Legislation
Overview. On July 8, 2008, bills were introduced in the House to reauthorize
ADUFA (H.R. 6432) and to establish a user fee program for generic animal drugs
(H.R. 6433). Both bills were forwarded without amendment to the full committee
by the House Energy and Commerce Subcommittee on Health on July 9, and marked

³² Testimony of Stephanie Batliner, representing GADA, 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^th^nd
2008 and the Animal Generic Drug User Fee Act of 2008,” June 5, 2008, 110 Cong., 2
Sess., Washington, DC, hereinafter referred to as House Subcommittee hearing.
³³ House Subcommittee hearing.

up and passed by the full committee on July 16. On July 30, 2008, the House passed
H.R. 6432, as amended, under suspension. The engrossed bill incorporated an
amended version of H.R. 6432 (ADUFA reauthorization) as reported, and H.R. 6433
(AGDUFA), as reported. On August 1, 2008, the Senate took up the House-passed
measure, and passed it by unanimous consent. The measure has been sent to the
President, who is expected to sign it.
House Action. H.R. 6432, the Animal Drug User Fee Amendments of 2008,
as introduced, would reauthorize ADUFA, largely in line with FDA’s proposal.
Rather than the inflation adjuster in current law, the bill would authorize a total of
$98 million for the program over the five-year period from FY2009 through FY2013,
as requested by FDA and depicted in Table 4. The bill would extend, among other
provisions, (1) existing authority for the collection of application, product,
establishment, and sponsor fees (with authority to collect larger aggregate amounts
of each type of fee in each successive fiscal year); (2) the fee triggers; and (3)
requirements for annual fiscal and performance reports. Program authority would
sunset on October 1, 2013, and reporting requirements would sunset four months
later, on January 31, 2014. The bill would not explicitly establish performance goals.
Rather, it refers in a finding to goals as laid out in a letter from the Secretary to the
Congress. Upon the bill’s passage, such a letter would presumably be included in the
Congressional Record as stated in the finding, and comport with the goals as
published by FDA in its reauthorization proposal,³⁴ unless the goals were modified
during passage.
H.R. 6432, as introduced, contains two provisions that were in neither ADUFA
I nor the FDA reauthorization proposal. The first are new requirements for public
involvement in the reauthorization planning that would begin prior to the FY2013
sunset. Provisions in Section 4 of the bill would require the Secretary to (1) seek
public input before beginning negotiations with industry to reauthorize the program;
(2) hold periodic consultations with other stakeholder groups (e.g., consumer
representatives) during such negotiations; and (3) publish transcripts of all
negotiation meetings between the FDA and the regulated industry. These
requirements would be in addition to the current requirement to seek public input at
the conclusion of negotiations with industry. The second new provision, in Section
5 of the bill, would alter the reporting period for required drug experience reports
(i.e., reports that companies must make to FDA if they are aware of a product
problem or defect), as currently required by regulation. The bill, as introduced, would
not authorize FDA to use program fees for postmarket activities, and would not
establish any new data reporting requirements for industry.
H.R. 6433, the Animal Generic Drug User Fee Act of 2008, as introduced,
would establish a new animal generic drug user fee program, largely in line with
FDA’s proposal. The bill would establish authority to collect application, product,
and tiered sponsor fees (but not establishment fees), and would establish fee triggers,
fee-setting requirements, workload adjustments, and reporting requirements. Rather
than using an inflation adjuster, the bill would authorize a total of about $27 million

³⁴ FDA has published its proposed performance goals and procedures for ADUFA
reauthorization at [http://www.fda.gov/cvm/ADUFAIIreauthorization.htm].

for the program over the five-year period from FY2009 through FY2013, as
requested by FDA and depicted in Table 5. Program authority would sunset on
October 1, 2013, and reporting requirements would sunset four months later, on
January 31, 2014. As with H.R. 6432, the generics bill would not explicitly establish³⁵
performance goals, but refers to such goals in a finding. Also as with H.R. 6432,
the bill would require the Secretary to seek public input before beginning
negotiations with industry to reauthorize the program, hold periodic consultations
with other stakeholder groups during such negotiations, and publish transcripts of all
negotiation meetings between the FDA and the regulated industry, in addition to a
requirement to seek public input at the conclusion of negotiations with industry.
Finally, as with H.R. 6432, the bill, as introduced, would not authorize FDA to use
program fees for postmarket activities, and would not establish any new data
reporting requirements for industry.
Both H.R. 6432 and H.R. 6433 were marked up and passed by the full House
Energy and Commerce Committee on July 16, 2008. The committee amended H.R.
6432 (ADUFA reauthorization) to make several technical and minor changes, and
two substantive changes. First, animal drug sponsors would be required to provide
annual reports to FDA regarding any of their animal drugs that contain an
antimicrobial active ingredient. Such reports must include specified information
about drug distribution, proposed usage, and other matters, and the Secretary would
be required to publish such information in a manner that is consistent with national
security and business confidentiality concerns. Second, the Secretary would be
required to refuse admission to any imported animal drug that appears to be³⁶
counterfeit, and to destroy any such items, under certain conditions. H.R. 6433 was
amended to make several technical and minor changes, but no substantive changes.
On July 30, 2008, the House passed an amended version of H.R. 6432 under
suspension of the rules. The engrossed (House-passed) version of H.R. 6432
incorporated, as Title I, an amended version of the H.R. 6432 ADUFA
reauthorization bill that was reported by the full Energy and Commerce Committee,
and, as Title II, all provisions of H.R. 6433 (AGDUFA) as reported, without any
substantive changes. The provisions in House-passed Title I of the bill had been
amended to remove the earlier amendment made by the full committee regarding
refusal of admission and destruction of animal drugs that appear to be counterfeit.
The earlier amendment regarding reporting of information regarding animal
antimicrobial drugs was retained. The House-passed bill also contained, as Title III,
two technical corrections to the Food and Drug Administration Amendments Act of

2007 (FDAAA, P.L. 110-85) that do not apply to animal drugs.

Senate Action. On August 1, 2008, the Senate took up the engrossed (House-
passed) version of H.R. 6432 (including reauthorization of ADUFA, the user fee
program for generic animal drugs, and the FDAAA technical corrections) and passed
it by unanimous consent. The measure has been sent to the President, who is
expected to sign it.

³⁵ FDA has published its proposed performance goals and procedures for AGDUFA at
[ h t t p : / / www.f d a . go v/ oc / opa c o m/ hot t opi c s / ADUFA_AgDUFA/ AgDUFApe r f goa l s .ht ml ] .
³⁶ This provision would amend FFDCA § 801(a) [21 U.S.C. § 381(a)] regarding imports.

Issues for Congress
This section discusses issues germane to congressional consideration of
ADUFA reauthorization and the establishment of a user fee program for generic
animal drugs. Actual consideration of these issues in moving legislation is tracked
in the previous section of this CRS report, “Congressional Action.”
ADUFA Program Performance³⁷
Generally, companies that research and develop animal drugs have been
satisfied that ADUFA I has eliminated the review backlog for brand-name animal
drugs, improved the timeliness and predictability of reviews, and improved
communication with FDA throughout the process. The industry’s focus for ADUFA
II was to continue the enhancement of FDA review capacity, including more support
for increasingly complex reviews. Also, at the public meeting in March 2008, both
FDA and industry speakers discussed a growing backlog of premarket inspections of
foreign animal drug producing facilities, which has not been remedied by the current
user fee program.
ADUFA Program Costs
The centerpiece of FDA’s reauthorization proposal, as negotiated with industry,
was an increase in user fee revenues to reflect cost growth in excess of authorized
inflationary adjustments.³⁸ The proposal would authorize FDA to collect almost
twice as much in animal drug user fees during the five-year ADUFA II program
period (FY2009 through FY2013) as it could during ADUFA I (FY2004 through
FY2008). Much of the growth in program costs that FDA cited is driven by factors
outside of the agency’s control, such as growth in the costs of employee salaries and
benefits, and rents.³⁹
Although a backlog of premarket foreign facility inspections was discussed at
the March 2008 public meeting, the FDA proposal did not explicitly address the cost
of these inspections. Given recent concerns about the safety of imported drugs and
foods, FDA has been under pressure to expand its oversight of foreign facilities that
manufacture products it regulates. FDA has not, however, signaled any particular
safety concern about foreign plants that manufacture animal drugs, or any changes
to the premarket inspections of these plants that are conducted for purpose of
application review. At present, establishment fees may be assessed for these plants,
when applicable, but the fees are not directly linked to inspection costs, and do not
distinguish between domestic and foreign facilities.

³⁷ See public comments of Dr. Steven D. Vaughn, Director of FDA/CVM/ONADE, and Dr.
Richard Carnavale, Vice President for Scientific and Regulatory Affairs, Animal Health
Institute, ADUFA meeting transcript.
³⁸ See public comments of Gary Claywell, Deputy Director, FDA/CVM Office of
Management, ADUFA meeting transcript.
³⁹ Claywell notes that pay and benefit costs grew by 5.9% annually over the ADUFA I
program period, while appropriations grew by 2.6%.

Animal Drug Safety and Postmarket Review
The aim of drug user fees programs is to speed the evaluation of drugs for safety
and effectiveness, without shortchanging the rigor of the evaluation or compromising
the actual safety and effectiveness of approved drugs. Critics have charged that the
user fee program for human drugs (PDUFA) places too much influence in the hands
of industry, and speeds drugs to market with inadequate safety review. They note
that the industry is actively involved in establishing performance benchmarks, for
example. Also, some feel that consumer confidence in FDA’s review process is
important, and that a perception of conflicts in the user fee programs may undermine
this confidence.⁴⁰
It has been difficult to measure the effect of PDUFA, if any, on the safety of
human drugs, and unequivocal evidence of such an effect is lacking. The law has,
since its second reauthorization, allowed FDA to carry out certain postmarket safety
activities with user fee funds. ADUFA I does not have a comparable authority. No
postmarket activities are listed in the definition of activities for which fees may be
used.⁴¹ For animal drugs, postmarket safety concerns arise on occasion, resulting in
withdrawals or label warnings, but noteworthy recent examples preceded ADUFA.
FDA’s proposal for ADUFA II, as negotiated with industry, did not seek authority
to use animal drug user fees for any postmarket activities. It is reported that during
ADUFA reauthorization negotiations, FDA sought to have authority to spend user
fees on some postmarket antimicrobial resistance activities (discussed further below),
but drug companies objected.⁴²
Antimicrobial Resistance
Concerns about the effects of ADUFA on animal drug safety often play out in
a different context than that for the safety of human drugs. Some critics of the law
are concerned about the safety of drugs approved for animal agriculture with respect
to public health and the environment, rather than safety for the treated animal. In
particular, they are concerned about antimicrobials (e.g., antibiotics) used in food-
producing animals, and the risk of transmitting antimicrobial resistant infections to⁴³
people through food. In general, animal drug companies and livestock producers

⁴⁰ See CRS Report RL33914, The Prescription Drug User Fee Act (PDUFA): History,
Reauthorization in 2007, and Effect on FDA, by Susan Thaul.
⁴¹ FFDCA §§ 739(8) and 739(9).
⁴² See “Antibiotic Measures That Were Axed From ADUFA May Still Be Included,”
InsideHealthPolicy.com, July 9, 2008.
⁴³ Antimicrobial resistance occurs when microbes — usually bacteria, though resistance can
also be seen in viruses, fungi, and parasites — are able to resist the effects of antimicrobial
drugs in stopping microbial growth and reproduction. Microbes have a number of
mechanisms to resist antimicrobial drug effects. These mechanisms are often coded in
microbial genes, may be transferred between microbes, and often proliferate when microbes
are exposed to antimicrobial drugs. Antibiotics are a type of antimicrobial drug. For
background, see the section “Antimicrobial Resistance,” in CRS Report RL31853, Food
(continued...)

are concerned that overly stringent regulation of this class of animal drugs could
compromise their availability and have harmful effects on animal health without an
attendant public health benefit.
FDA has asserted that there is a preponderance of evidence that the use of
antimicrobials in food-producing animals has adverse public health consequences,
and that there is little evidence to the contrary.⁴⁴ In 2003, FDA published guidance
for industry, laying out the agency’s information requirements and processes for
evaluating animal antimicrobial drugs that may pose this risk.⁴⁵ Review of this class
of animal drugs may be more complex than is typical. FDA has not, however,
published information about submissions, review times, outcomes, costs, or other
metrics specific to this class.
A coalition of consumer groups opposed reauthorization of ADUFA, but in the
event of its reauthorization, called for it to authorize the use of ADUFA funds for the
following postmarket activities related to antimicrobial resistance: safety reviews of
currently approved antimicrobial drugs, the collection of veterinary drug use data to
support antimicrobial risk assessments, and enhanced surveillance for antimicrobial
resistance related to animal drug use.⁴⁶

⁴³ (...continued)
Safety Issues in the 109th Congress, by Donna U. Vogt.
⁴⁴ FDA presents its rationale in its comments on a 2004 Government Accountability Office
(GAO) report, “Antibiotic Resistance: Federal Agencies Need to Better Focus Efforts to
Address Risk to Humans from Antibiotic Use in Animals,” GAO-04-490, April 2004, pp.

88-94.

⁴⁵ FDA, “FDA Issues Guidance on Evaluating the Safety of Antimicrobial New Animal
Drugs to Help Prevent Creating New Resistant Bacteria,” news release, October 23, 2003,
at [http://www.fda.gov/bbs/topics/NEWS/2003/NEW00964.html].
⁴⁶ See public comments of Brise Tencer, the Keep Antibiotics Working Coalition, ADUFA
meeting transcript, and “Advocates Want Animal Drug User Fees Spent on Post-Market
Safety,” FDA Week, April 18, 2008. Groups in the Coalition include Center for Science in
the Public Interest, Food Animal Concerns Trust, Humane Society of the United States, and
Union of Concerned Scientists, among others. The coalition’s comments of April 14, 2008,
regarding ADUFA reauthorization are available at [http://www.keepantibioticsworking.org/
new/resources_library.cfm?RefID=102290].

CRS-20
Appendix A. Summary of Provisions in ADUFA I
^FFDCA^{U.S.C. Sectio}ⁿ
^Provi^sⁱ^on^Section⁽^T^it^{le 2}¹⁾^Sum^m^a^ry
ⁱⁿ^ition^s^{§ 739}^{§ 379j}^-¹¹^D^efⁱⁿ^es^cov^e^{red ty}^pes^of^application^s^,^s^pon^s^o^rs^{, proces}^s^e^s^,^allow^a^{ble activ}^ities^,^an^{d oth}^e^{r m}^a^tters^.
^of^f^ees^{§ 740(a)}^{§ 379j}^-^12(a)^R^e^quⁱ^r^es^t^h^{e S}^ecret^ary^t^o^col^l^ect^anⁱ^m^al^dru^g^u^s^{er f}^ees^f^o^{r appl}ⁱ^catⁱ^oⁿ^s^{, produ}^ct^s^,^es^t^a^blⁱ^s^h^m^en^t^s^{, an}^{d produ}^ct^s^pon^s^o^rs^.
^Estab^lish^e^{s r}^e^q^u^ir^em^en^{ts r}^e^g^a^r^dⁱⁿ^g^p^a^y^m^en^{t, r}^e^f^uⁿ^d^{s, an}^d^ex^cep^tioⁿ^s^.
^t^a^l^f^{ee rev}^eⁿ^u^e^s^§^740(b)^{§ 379j}^-^12(b)^Es^t^a^blⁱ^s^h^e^s^t^h^e^to^ta^{l reven}^u^e^s⁽ⁿ^{ot th}^{e in}^divⁱ^du^{al f}^ees^{) th}^{at m}^a^y^{be collected}^f^o^{r each}^ty^{pe of}^f^{ee abov}^{e, f}^o^{r each}^fⁱ^s^{cal y}^ear
^f^r^om^F^Y^{2004 —}^F^Y^2008.
^u^s^t^m^eⁿ^t^s^§^740(c)^{§ 379j}^-^12(c)^R^e^quⁱ^r^es^t^h^{e S}^ecret^ary^t^o^m^a^k^e^a^nnua^l^a^d^j^u^st^m^e^nt^{s t}^o^t^o^t^a^l^fe^e^r^e^ve^nue^{s b}^a^se^d^oⁿⁱⁿ^fl^a^tⁱ^o^{n a}ⁿ^d^w^o^r^k^l^o^a^d^.^T^h^e^w^o^r^k^l^o^a^d
^a^d^j^u^st^m^e^nt^sha^l^l^no^t^r^e^sul^tⁱⁿ^a^nnua^l^r^e^ve^nue^{s l}^o^w^e^r^t^h^aⁿ^t^h^o^s^e^a^u^t^h^o^rⁱ^z^e^dⁱⁿ^sub^s^e^c^tⁱ^o^{n (}^b⁾^,^a^d^j^u^st^e^d^fo^rⁱⁿ^fl^a^tⁱ^o^n.^Re^q^uⁱ^r^e^s^th^e
^Secr^etar^y^to^estab^{lish annual f}^{ees 6}⁰^d^a^y^s^p^r^io^r^to^{the st}^ar^{t o}^f^{each f}ⁱ^{scal y}^ear^,^and^p^u^b^{lish f}ⁱ^{nal f}^{ees and}^m^e^th^odol^og^yⁱⁿ^t^h^e
ⁱ^{ki/CRS-RL34459}^F^e^deral^R^e^gⁱ^s^t^{er. A}^u^t^h^ori^zes^t^h^{e S}^ecret^ary^,ⁱ^fⁿ^eces^s^a^ry^f^o^{r F}^Y^{2008, t}^o^s^e^t^rev^eⁿ^u^e^s^s^u^f^fⁱ^ci^en^t^f^o^{r u}^p^t^o^t^h^{ree m}^oⁿ^t^h^s^of^operatⁱⁿ^g^res^e^rv^{e, f}^o^{r carry}^ov^{er i}ⁿ^t^o^t^h^{e f}ⁱ^rs^t^t^h^{ree m}^oⁿ^t^h^s^of^F^Y^{2009. Proh}ⁱ^bⁱ^t^s^t^h^{e S}^ecret^ary^f^r^om^col^l^ectⁱⁿ^g^t^o^t^a^l^a^nnua^l
^g/w^r^e^{venues that exceed}^to^{tal annual co}^sts.
^s^.or
^le^ak^a^iv^ers^an^d^{§ 740(d)}^{§ 379j}^-^12(d)^R^e^quⁱ^r^es^t^h^{e S}^ecret^ary^t^o^g^r^an^t^f^{ee w}^aⁱ^v^ers^{or redu}^ctⁱ^oⁿ^sⁱ^f^h^e^fⁱⁿ^d^s^t^h^at^{(1) f}^ees^w^o^u^l^{d h}ⁱⁿ^d^{er i}ⁿⁿ^o^v^a^tⁱ^oⁿ^;^{(2) f}^ees^w^o^u^l^d
^u^ctioⁿ^s^ex^{ceed rev}ⁱ^ew^cos^t^s^;^{(3) th}^{e application}^is^s^o^lely^f^o^{r a m}ⁱⁿ^o^{r ref}^o^rm^u^l^ation^of^an^approv^{ed dru}^g^f^o^{r u}^s^{e in}^f^{eed; (4) th}^e
^://wiki^ap^p^licatioⁿ^{is so}^lely^f^o^r^{a m}ⁱⁿ^o^r^u^s^{e o}^r^mⁱⁿ^o^r^sp^{ecies in}^dⁱ^catioⁿ^;^o^r⁽⁵⁾^th^{e sp}^oⁿ^so^r^{is a sm}^{all b}^u^sin^e^{ss (}^aⁿ^en^tity^w^ith^f^e^w^e^r
^h^ttp^th^an^{500 em}^ploy^ees^{, in}^clu^dⁱⁿ^g^em^ploy^ees^of^af^f^iliates⁾^s^u^bm^ittiⁿ^g^its^fⁱ^rs^{t an}^im^{al dru}^g^appli^cation^.^Es^tablis^h^e^s^addition^a^l^r^e^q^u^ir^em^en^{ts r}^e^g^a^r^dⁱⁿ^g^th^{e sm}^{all b}^u^sin^e^{ss w}^a^iv^er^.
^{ect o}^f^f^a^ilu^r^e^to^{§ 740(e)}^{§ 379j}^-^12(e)^Es^t^a^blⁱ^s^h^e^s^t^h^at^f^o^{r n}^oⁿ^-^pay^m^en^t^of^f^ees^af^t^e^{r 30 day}^s^of^t^h^ei^{r du}^{e dat}^e^{, pen}^dⁱⁿ^g^applⁱ^catⁱ^oⁿ^s^{, s}^u^ppl^em^en^t^s^an^dⁱⁿ^v^e^stig^atioⁿ^a^l
^f^ees^an^im^{al dru}^g^s^u^bm^is^sⁱ^on^s^s^h^{all be con}^s^{idered in}^com^p^le^{te, an}^{d th}^{e Secretary}^m^a^y^dis^c^on^tin^u^e^th^{eir rev}ⁱ^ew^.
^ssm^eⁿ^{t o}^f^fe^e^s^{§ 740(f}⁾^{§ 379j}^-^12(f⁾^Prohⁱ^bⁱ^t^s^t^h^{e col}^l^ectⁱ^oⁿ^of^f^ees^uⁿ^l^es^s^F^D^A^s^a^l^a^ri^es^an^{d ex}^pen^s^es^f^o^{r a g}ⁱ^v^eⁿ^fⁱ^s^cal^y^{ear, ex}^cl^u^dⁱⁿ^g^f^ees^,^{are at leas}^{t equ}^a^{l to}
^fe^e^t^rⁱ^gge^r⁾^{appropriation}^s^f^o^{r FDA}^s^a^laries^an^{d ex}^pen^s^es^f^o^{r FY2003, ex}^clu^dⁱⁿ^g^f^ees^an^{d m}^u^{ltiplied by}^th^{e applicable adj}^u^s^t^m^eⁿ^t^f^actor.
^D^o^e^s^no^t^r^e^q^uⁱ^r^e^t^h^e^Se^c^r^e^t^a^r^y^t^o^m^o^dⁱ^fy^a^sse^sse^d^fe^e^sⁱ^f^t^hⁱ^s^t^rⁱ^gge^rⁱ^s^m^e^t^p^a^r^t^-w^a^y^t^h^r^o^{ugh a}^fi^sc^a^l^y^e^a^r^.
^a^tⁱ^oⁿ^s^{§ 740(g}⁾^{§ 379j}^-^12(g⁾^A^u^t^h^ori^zes^t^h^{e col}^l^ectⁱ^oⁿ^of^f^ees^on^l^yⁱ^f^au^t^h^ori^{zed i}ⁿ^adv^aⁿ^{ce i}ⁿ^a^nnua^l^a^p^p^r^o^p^rⁱ^a^tⁱ^o^ns.^Suc^h^a^m^o^unt^{s a}^r^e^a^v^aⁱ^l^a^b^l^e^untⁱ^l
^o^r^ity⁽^t^w^o^f^e^e^ex^pen^d^{ed. A}^u^th^orizes^th^{e collection}^of^f^ees^on^ly^if^FDA^s^p^en^ds^{, f}^o^{r th}^{e rev}ⁱ^ew^of^an^im^{al dru}^g^s^{, at leas}^{t as}^m^u^ch^as^{it s}^p^en^{t f}^or
^g^e^r^s⁾^t^hⁱ^s^pu^rpos^{e f}^r^om^appropri^a^tⁱ^oⁿ^sⁱⁿ^F^Y^{2003, adj}^u^s^t^{ed f}^o^{r i}ⁿ^f^l^atⁱ^oⁿ^,^uⁿ^l^es^s^t^h^{e am}^ouⁿ^tⁱ^s^wⁱ^t^hⁱⁿ^s^p^eci^fⁱ^{ed l}ⁱ^mⁱ^t^s^{. A}^u^t^h^ori^zes
^appropri^a^tⁱ^oⁿ^s^f^o^{r f}^ees^f^o^{r F}^Y^{2004 —}^F^Y^{2008, an}^{d prov}ⁱ^d^es^t^h^at^f^ees^col^l^ect^{ed i}ⁿ^ex^ces^s^of^a^nnua^l^a^m^o^unt^{s a}^u^t^h^o^rⁱ^z^e^d^m^a^y
^{be carried ov}^{er an}^{d s}^u^{btracted f}^r^om^f^u^tu^{re f}^{ee au}^th^ority^.
^llectioⁿ^o^f^{§ 740(h}⁾^{§ 379j}^-^12(h⁾^Es^t^a^blⁱ^s^h^e^s^t^h^atⁱ^f^as^s^e^s^s^e^{d f}^ees^{are n}^o^t^pai^d^wⁱ^t^hⁱⁿ^{30 day}^s^af^t^e^{r t}^h^ey^{are du}^{e, s}^u^ch^f^ees^s^h^al^l^{be t}^r^eat^e^{d as}^{a claim}^of^th^e
^{aid f}^ees^Uⁿⁱ^t^e^{d S}^t^at^es^G^o^v^e^rn^m^eⁿ^t^s^u^bj^ect^t^o^{31 U}^.^S^.^C^.^{§§ 3711}^{et s}^e^q^.

CRS-21
^FFDCA^{U.S.C. Sectio}ⁿ
^Provi^sⁱ^on^Section⁽^T^it^{le 2}¹⁾^Sum^m^a^ry
^iv^ers^an^d^{§ 740(i)}^{§ 379j}^-¹²⁽ⁱ⁾^R^e^qu^ires^th^{at requ}^es^ts^f^o^{r con}^s^ideration^f^o^{r f}^{ee w}^a^iv^ers^,^redu^ction^s^{or ref}^uⁿ^d^s^{be s}^u^bm^{itted to th}^{e Secreta}^r^yⁱⁿ^w^r^itin^gⁿ^o^{t later}
^u^ctioⁿ^s^t^h^an^{180 day}^s^af^t^e^{r s}^u^ch^f^{ee i}^s^du^e.
^o^f^{§ 740(j}⁾^{§ 379j}^-^12(j⁾^States^th^{at th}^is^s^ection^m^a^yⁿ^o^{t be con}^s^tru^e^{d to requ}^{ire th}^{at th}^{e n}^u^m^{ber of}^f^u^ll-^tim^{e equ}ⁱ^v^a^len^t^pos^ition^sⁱⁿ^H^H^S^,^fo^r^o^ffi^c^e^r^s,
^s^tr^u^c^tioⁿ^em^ploy^ees^{, an}^{d adv}ⁱ^s^o^ry^com^m^itteesⁿ^o^{t en}^g^a^g^e^{d in}^th^{e proces}^s^of^th^{e rev}ⁱ^ew^of^an^im^{al dru}^g^application^s^{, be redu}^{ced to of}^f^s^et
^th^{e n}^u^m^{ber of}^of^fⁱ^cers^,^em^ploy^ees^{, an}^{d adv}ⁱ^s^o^ry^com^m^ittees^s^o^en^g^a^g^e^d.
^AD^As⁽^g^eⁿ^e^rⁱ^c^{§ 740(k}⁾^{§ 379j}^-^12(k⁾^R^e^quⁱ^r^es^t^h^{e S}^ecret^ary^:^{(1) t}^o^t^h^{e ex}^t^eⁿ^t^practⁱ^cabl^e^{, t}^o^s^e^g^r^eg^at^{e t}^h^{e rev}ⁱ^ew^of^A^N^A^D^A^s^f^r^om^t^h^{e proces}^s^f^{or th}^{e rev}ⁱ^ew^of
^{al dru}^g^s⁾^N^A^D^A^s^;^an^{d (2) t}^o^adopt^ot^h^e^{r adm}ⁱⁿⁱ^s^t^ratⁱ^v^{e procedu}^r^es^t^o^en^s^u^{re t}^h^at^revⁱ^ew^tⁱ^m^es^of^A^N^A^D^A^s^{do n}^o^tⁱⁿ^creas^{e du}^{e t}^o
^activ^{ities u}ⁿ^d^er^th^{e u}^s^er^f^{ee p}^r^o^g^r^a^m^.
^th^o^r^izatioⁿ^:^N^A^{§ 379j}^-^{11 n}^o^t^e^R^e^quⁱ^r^es^t^h^{e S}^ecret^ary^,ⁱⁿ^dev^e^l^opiⁿ^g^recom^m^eⁿ^d^atⁱ^oⁿ^s^t^o^C^oⁿ^g^r^es^s^f^o^{r reau}^t^h^ori^zatⁱ^oⁿ^af^t^e^{r F}^Y^{2008, t}^o^con^s^u^l^t^w^ith
^s^u^ltatioⁿ^an^d^C^oⁿ^g^r^es^s^an^{d appl}ⁱ^cabl^e^s^t^ak^eh^ol^{der g}^r^ou^ps^{, pu}^blⁱ^s^h^recom^m^eⁿ^d^atⁱ^oⁿ^sⁱⁿ^th^{e Fed}^e^r^a^{l Reg}ⁱ^ster^{, h}^o^ld^{a p}^u^b^{lic m}^eetin^g^,^an^d^seek
^m^eⁿ^d^ation^s^pu^blⁱ^c^com^m^eⁿ^t^.
ⁱ^{ki/CRS-RL34459}ⁱ^r^{ed report}^s^N^A^{§ 379j}^-^{11 n}^o^t^e^R^e^quⁱ^r^es^t^h^{e S}^ecret^ary^t^o^report^t^o^C^oⁿ^g^r^es^s^a^nnua^l^l^y^r^e^ga^r^dⁱ^{ng p}^r^o^g^r^a^m^p^e^r^f^o^r^m^a^nc^e^aⁿ^d^fundⁱ^ng.
^g/w^s^et^provⁱ^sⁱ^oⁿ^s^N^A^{§ 379j}^-^{11 n}^o^t^e^Es^t^a^blⁱ^s^h^e^s^t^h^at^provⁱ^sⁱ^oⁿ^sⁱⁿ^F^F^D^C^A^{§ 740 s}^h^al^lⁿ^o^t^{be i}ⁿ^ef^f^ect^af^t^e^{r O}^c^t^{ober 1, 2008, an}^{d t}^h^a^{t p}^r^o^v^isioⁿ^s^r^e^g^a^r^dⁱⁿ^g
^s^.or^reau^t^h^ori^zatⁱ^oⁿ^con^s^u^l^t^a^tⁱ^oⁿ^an^{d requ}ⁱ^r^{ed report}^s^s^h^al^lⁿ^o^t^{be i}ⁿ^ef^f^ect^af^t^e^{r 120 day}^s^af^t^e^{r s}^u^ch^dat^e^.

^le^ak
^://wiki
^h^ttp

Appendix B. The Animal Drug Approval Process⁴⁷
Like human drugs, animal drugs must be shown to be safe and effective before
they can be marketed. The FDA Center for Veterinary Medicine (CVM), Office of
New Animal Drug Evaluation (ONADE), is responsible for the premarket review of
new animal drugs, and it grants approvals when requirements have been met. (CVM
also regulates veterinary devices but does not require their premarket approval.⁴⁸
Veterinary biologics are regulated by the U.S. Department of Agriculture.)
Specific statutory requirements for the approval of “new animal drugs” are
found in the Federal Food, Drug, and Cosmetic Act (FFDCA), section 512 [21
U.S.C. § 360b]. Specific regulations are primarily at 21 C.F.R. 510, et seq. In each
case, general provisions also apply, such as labeling requirements and enforcement
provisions. According to CVM, virtually all animal drugs meet the FFDCA
definition of “new animal drug.”⁴⁹ The term does not, as it may sound, distinguish
between pioneer (i.e., brand-name) and generic animal drugs. Several application
names and acronyms used in the animal drug approval process derive from the term
“new animal drug.” These names and acronyms are described in Table 6 and
discussed below. In this report, the terms “animal drug” and “new animal drug” are
used interchangeably. Requirements for the approval of pioneer animal drugs begin
at FFDCA section 512(b)(1), and those for the approval of generic animal drugs
begin at FFDCA section 512(b)(2). The respective products are often referred to as
“(b)(1)” or “(b)(2)” animal drugs.

⁴⁷ Information in this section is drawn from Carol J. Haley, “The Minor Use and Minor
Species Animal Health Act: Past, Present and Future,” Food and Drug Law Journal, vol.

61, pp. 13-43, 2006 (hereafter referred to as Haley MUMS article), and Steven D. Vaughn,

FDA/CVM “Overview of the Animal Drug Approval Process,” undated presentation, at
[ h t t p : / / www.f d a . go v/ c vm/ na da a ppr .ht m] .
⁴⁸ See FDA CVM, “How FDA Regulates Veterinary Devices,” May 2003, at
[http://www.fda.gov/cvm/regofdevices.htm]. Veterinary biologics (e.g., vaccines and
clinical laboratory tests) are regulated by the U.S. Department of Agriculture (USDA),
Animal and Plant Health Inspection Service, Center for Veterinary Biologics, at
[http://www.aphis.usda.gov/animal_health/vet_biologics/]. For more information about
CVM activities, see “Animal Drugs and Feeds” in CRS Report RL34334, The Food and
Drug Administration: Budget and Statutory History, FY1980-FY2007, by Judith A. Johnson
(Coordinator), Donna V. Porter, Susan Thaul, and Erin D. Williams.
⁴⁹ “New animal drug” is defined at FFDCA § 201(v) [21 U.S.C. § 321(v)].

Table 6. Terms Used in the Animal Drug Approval Process
TermDescription
Investigational NewA pioneer animal drug for which a sponsor seeks approval
Animal Drug (INAD)pursuant to FFDCA section 512(b)(1). The term is
commonly used to refer to the information file that is
developed for review.
New Animal DrugFormal application to FDA for approval of a pioneer animal
Application (NADA)drug. Refers to the entire process. Review is typically
conducted in stages.
Administrative NADAThe final step in applying to FDA for approval of a pioneer
animal drug, in which summaries of stepwise reviews and
other materials are presented.
Generic InvestigationalA generic animal drug for which a sponsor seeks approval
New Animal Drugpursuant to FFDCA section 512(b)(2). The term is
(JINAD)commonly used to refer to the information file that is
developed for review.
Abbreviated New AnimalFormal application to FDA for approval of a generic animal
Drug Applicationdrug.
(ANADA)
Veterinary Master FileA voluntary submission to FDA of confidential information
(VMF)about facilities, processes, or articles used in the
manufacturing, processing, packaging, and storing of animal
drugs, which FDA may use in evaluating applications.
Comparable to a Drug Master File (DMF) for human drugs.
Supplemental applicationFiled by sponsors seeking changes in the conditions of an
existing approved NADA or ANADA. Requested changes
may be significant (e.g., a new species or indication) or
routine (e.g., product manufacturing changes).
The animal drug approval process is generally similar to that for human drugs,
devices, and many biologics.⁵⁰ Animal drug sponsors conduct discovery research on
drug candidates, including pilot studies of dose and potential toxicity. Sponsors
seeking to develop a promising drug candidate (an Investigational New Animal Drug,
or INAD) submit relevant information to CVM. Usually, the process begins with a
sponsor’s request for an exemption, pursuant to FFDCA section 512(j), to allow for
the interstate shipment of the unapproved product in order that clinical trials of the
drug’s safety and effectiveness may be conducted. Sponsors wishing to begin the
FDA approval process for an INAD submit a New Animal Drug Application
(NADA) to CVM.

⁵⁰ See “FDA Approval of New Drugs,” in CRS Report RL32797, Drug Safety and
Effectiveness: Issues and Action Options After FDA Approval, by Susan Thaul;
“Background: FDA and Medical Device Regulation,” in CRS Report RL34571, Medical
Device User Fees and User Fee Acts, by Erin D. Williams; and “Regulatory Framework,”
in CRS Report RL34045, FDA Regulation of Follow-On Biologics, by Judith A. Johnson.

CVM generally conducts phased review of animal drugs, encouraging sponsors
to submit information about a product as it becomes available, rather than all at once,
and to maintain ongoing consultations with CVM about technical and other
requirements. Technical requirements include (1) the demonstration of safety in the
target species, as well as in the environment and in humans (including those handling
and administering the drug, and those consuming the products of food-producing
animals, if applicable); (2) the demonstration of effectiveness in the target species;
and (3) matters regarding manufacturing methods, controls, and product stability.
When all required information is available, sponsors submit a final
“Administrative NADA,” containing agency sign-off letters for all phases of review,
a labeling proposal, and other information. An approved NADA means the product
is safe and effective for its intended use, and that the methods, facilities, and controls
used for the manufacturing, processing, and packaging of the drug are adequate to
preserve its identity, strength, quality, and purity. As with approved human drugs,
sponsors of approved NADAs are required to notify FDA regarding an approved
drug’s postmarket performance, including any adverse events.
The animal drug approval process differs from the process for human products
in two important ways. First, to support the requirement for demonstration of safety
in humans, if an animal drug is intended for use in a food-producing animal, the
sponsor must develop methods to test for drug residues in the human food product
(e.g., meat, milk, eggs, honey). FDA determines whether the drug can be used safely
in food-producing animals, with respect to public health. If approved, the drug’s
label must address a “withdrawal time” if necessary (i.e., a period of time that the
drug must be withheld before an animal’s products can be marketed for human
consumption), allowing drug residues to fall below levels of concern.⁵¹
Second, although CVM requires clinical trials to demonstrate an animal drug’s
safety and effectiveness, these trials are, necessarily and as a matter of regulation,
somewhat different from clinical trials required for the approval of human drugs. An
approved animal drug may be labeled for use only in the species for which trials were
conducted. However, veterinarians are permitted, under certain conditions, to use
approved drugs for unapproved uses — so-called “extra-label” uses — such as use
in species other than those on the label, or for indications other than those on the
label.⁵² Also, clinical trials for animal drug approval need not be as extensive as
trials for human drugs. Among other things, initial testing of the animal drug may
begin in the target species, whereas candidate human drugs are studied to determine
their safety in animals first, before human trials are begun.
CVM also has authority to approve generic animal drugs.⁵³ Sponsors seeking
approval of a Generic Investigational New Animal Drug (JINAD) must submit an

⁵¹ These levels are called tolerances and are established for each approved drug by FDA,
using information submitted in the application, and from other sources.
⁵² P.L. 103-396, The Animal Medicinal Drug Use Clarification Act (AMDUCA), 1994.
AMDUCA also authorized veterinarians to use approved human drugs in animals. Certain
restrictions of extra-label use apply to the use of drugs in food-producing animals.
⁵³ P.L. 100-670, The Generic Animal Drug and Patent Term Restoration Act, 1988.

Abbreviated New Animal Drug Application (ANADA). The generic product and its
uses must be the same as those of an approved animal drug, with certain exceptions,
and it must be demonstrated that the generic product is bioequivalent to the approved
product.⁵⁴ Holders of approved or pending NADAs must submit certain patent
information to CVM. CVM publishes patent information on approved NADAs, and
requires ANADA applicants to certify that their product would not infringe upon a
current patent, or that any such current patent is invalid. Sponsors seeking to market
a generic version of an approved animal drug for a substantially different use than
that currently approved (such as a label indication for a new species) often must
conduct clinical trials, and typically need an investigational exemption pursuant to
FFDCA section 512(j) in order to ship the drug interstate.
Finally, CVM has authority for the conditional approval of drugs to treat minor
animal species (e.g., fish) and uncommon diseases in major animal species. This
allows sponsors to market a drug before collecting all necessary effectiveness data,
but after proving that the drug is safe.

⁵⁴ See FDA/CVM information at [http://www.fda.gov/cvm/gadaptra.html].