, . .

IMPLEMENTING USER FEES 

THE FOOD AND DRUG 

ADMINISTRATION 

A CASE STUDY


Richard P. Kusserow 

INSPECTOR GENERAL 

OEI-12-90-02020 

JULY 1990 
IMPLEMENTING USER FEES 


THE FOOD AND DRUG


ADMINISTRATION


A CASE STUDY


'i S f.IlVJC'rs. 

"b 

lr"ila 

OFFICE OF INSPECTOR GENERAL 

OFFICE OF EVALUATION AND INSPECTIONS 

JULY 1990 
, 

INTRODUCTION


PURPOSE 

In the past, the Office of Inspector General (OIG) has conducted audits of existing user fee systems and conducted analyses for the President's Council on Integrty and Efficiency on establishing and implementing user fee systems in the U.S. Department of Health and Human Servces (HHS). 

Over the past several years, HHS budget proposals have induded provisions for user

fees to support various program activities previously funded through general 

appropriations. In connection with these proposals, the Offce of Management and Budget has suggested that the Department develop an analytic framework for 

discussing and considering additional user fees in HHS. The purpose of this report is to provide such a framework using the Food and Drug Administration as the case 

study. 

BACKGROUND 

User fees are charges directed at specific beneficiaries of specific governmental 

activities. The HHS currently charges user fees for a variety of purposes. Additional 

fees will become effective soon, induding user charges to States (who are expected to recover the charge from end users) for using the Federal Parent Locator Servce 

in certain cases, and user charges to laboratories conducting medical testing to

recoup the cost of regulating those laboratories under the Clinical Laboratories 

Improvement Amendments of 1988 (CLIA). 

The Food and Drug Administration (FDA) currently imposes user fees for several 

activities, including color certification, reconditioning of products, and imported tea inspections. Previous work by the Office of Inspector General has examined the 

implementation of these user fees and th estimated costs that might be incurred and recovered for proposed new fees. 

General statutory autho ity for imposing user fees is found in title V of the 

Independent Offices Appropriation Act of 1952 (10M), currently codified at 31 

c. 9 9701. Under this statute (t)he head of each agency..may prescribe regulations establishing the charge for a servce or thing of value provided by the 

agency." Executive guidance on this subject is provided in Office of Management 

and Budget Circular A- , which outlines general policy for assessing and collecting fees. Circular A-25 states in part 
A user charge...will be assessed against each identifiable recipient for 

benefits derived from Federal activities beyond those received by the 

neral public....(S)pecial benefit will be considered to accrue and a 

user charge will be .imposed when a Government servce: (a) enables 

the beneficiary to obtain more immediate or substantial gains or 

values...than those that accrue to the general public..; or (b) provides business stabilty or contributes to public confdence in the business 

activity of the beneficiary..; or (c) is performed at the request of or for 

the convenience of the recipient, and is beyond the servces regularly 

received by other members of the same industry or group, or of the 

general public.... 

The Congress has also required agencies to impose user fees through specific authoriing legislation mandating collection of user fees for certain activities. 

Legislation directed HHS to charge users for use of the Federal Parent Locator 

System and regulating medical laboratories under CLIA. AIl user fees currently in 

place at the FDA are assessed in accordance with specific legislative guidance. For 

color certification and antibiotic certification, the Congress directed FDA to assess 

fees "as may be necessary to provide, maintain, and equip" the servce. (21 U. c. 9 

357(b) and 376(e). ) For tea imports, the Congress prescribed that "no tea...shall be 

examined for importation into the United States..unless the importor or consignee of 

such tea or merchandise, prior to such examination, has paid for deposit into the 

Treasury of the United States as miscellaneous receipts, a fee of 3.5 cents for each 

hundred weight or fraction thereof of such tea and merchandise." (21 U. c. 9 46a. 

For imports, Congress also directed the FDA to charge the owner or consignee for expenses incurred by the agency with respect to refused articles (e.g., travel, per diem or subsistence, and salaries of officers or employees involved in destruction or 

relabeling). (21 U. c. 9 381(c). 

For several years, budgets proposed by the Administration have included provisions 

for expanded user fees in FDA. Such proposals have never been enacted into law 

by the Congress. Nevertheless, the Presic.nt s 1991 budget includes a provision for 

collection of $152 milion in new user fees by FDA 

OBJECTIES AND METODOLOGY 

The FDA was chosen as our case study because it is frequently suggested and

debated as a program area that might be funded through a system of user fees and

because it provides a rich background against which to explore the complexities of

the arguments for and against imposing user fees. To conduct this study, the OIG: 

synthesized previous work done on user fees, especially as it relates to 

FDA and other regulatory environments, through an extensive literature 

review and analysis; 
assessed the experiences of selected Federal agencies and programs 

with established user fees, through intervews with officials in those 

agencies and review of relevant documents; and 

assessed the views of program officials, affected industry 

representatives, and others in regard tQ possible user fees in FDA. 
. .

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FINDINGS 

User fee are impose on indidua and busines by the Federa State and locl 

governents for a vaety of purse and progr. Some of the Federal actties 

for which usr fees are impose are simar to actties underten in the Foo and 

Drg Admjnj tration and paid for though genera appropriations. 

User fees are collected for a wide range of governental activities at the Federal 

State and local levels. Examples of these activities are listed in Exibits 1 and 

XHffITl. 

STATEILCALACfIVITIES FpRWFICH USER FEES ARE IMPOSED 

License applications: professionallicense busil1esslicense, liquor licens - Engineerig and building safety plan reView iindinpetiol1 .


Fire permits, inspe ions and plan revieW


- Receational facilty.us - Water and sewage supply 


- Emergency. and police .servces necestated by negligence or ilegal behavior 

EXHffIT2. 


FEDERALACfIVITIES FORWHlc:H USER FEES ARE IMPOSED


-; . Certain typesofirpeions . performedbytb l1mel1r()fAg(:lt\Jre. 

Patent. andtnideinrkservCeprbvdedbyt eJ)p8rtllent C9mer -. Pescie . regitration lit the ErivironmentaIPtOtectici.tenc. . - Fmgerprinting serves af the Federal Bureau ofIrivetigations . - Brodcat lii:ns from the Federal CommuriicationsCommiiori. . . 

- Applications to. acquirecommercial ' rightsprcidbytheInterstte Commeri:Commission 

Inspection servces ofth Immigration and. Naturaliztion.S Mce .. - Rulings, determination 1etters, and opinion leue'rfronithe Interal Revnue Servce


Copyght regisration by ihe Library of Congres .
 - Adminitration. of pipeline saety progrms by the Department of Transportatin
 Freeom of Informtion requests frm variou "agenci


Over time, various studies have found that the Federal Government is not recovering 

appropriate costs through user fees. In 1982, the President's Private Sector Survey on Cost Control concluded that recovering the full costs of Federal programs benefitting specific beneficiaries would save taxayers $21 bilion over 3 years. 

Assessing policies and practices regarding user fees in six executive departments in 
1989, the President s Council on Integrity and Efficiency found that the agencies have not "maxmized the opportunity to establish and collect user charges as a method of recovering costs incurred in providing benefits to identifiable recipients. 

However, as Exibit 2 demonstrates, numbers of Federal agencies do impose user fees--some of them for regulatory functions similar to those performed by FDA. Their experience is of special interest in examining the feasibility and method of instituting fees in FDA. (For a more complete description of these agencies' user fees systems, see appendix A. 

The Environmental Protection Agency 

Under the Federal Insecticide, Fungicide and Rodenticide Act (FIF), the
 Environmental Protection Agency (EP A) is responsible for regulating pesticides. In
 1972, EP A was charged with the task of reregistering all pesticides in order to assess safety and environmental impact based on current scientific dat and analysis. After numerous deadlines passed for completing the reregistration effort, the Congress established a 9-year program with user fees to supplement the reregistration effort. The EP A charges a one-time reregistration fee for reviewing an active ingredient and charges a maintenance or annual fee to product registrants

number of registrations held. , which is based on 

Apart from this program, manufacturers are required to register their products with
 EP A prior to marketing. The EP A had developed a fee schedule to charge
 manufacturers for processing applications for registering a pesticide product and 

asssessed these charges for a short time prior to the enactment of the accelerated reregistration program. These fees were suspended until 1997 by FIFR of 1988. Once the reregistration effort is complete, EP A will again charge these fees. Applications are categorized as new chemical registrations, new biochemical and microbial registrations, new use pattern registrations, old chemical registrations amendments and experimental use permits. Registration fees (based on 1988 costs) range from $184 500 for a new chemical review to $700 for an amendment review 

submitted at the time of fiing. 

The Federal Communications Commission 

The Federal Communications Commission (FCC) charges fees for processing applications for broadcast licenses based on authority granted the agency under the Consolidated Omnibus Budget Reconcilation Act of 1985 (COBRA). The COBRA established numerous categories and amounts of fees to be 

FCC in support of its application processing responsibilities.

assessed and collected by 
The Federal Energy Regulatory Commission 

The Federal Energy Regulatory Commission (FERC) assesses fees to regulated gas 

oil, electric and hydroelectric companies. Fees are charged for the following 

activities, among others: changes in producer rate schedules, producer certificates 

applications, pipeline certificate applications, and changes in electric rates. The 

general authority for collecting fees is found in the 10M and the Omnibus Budget 

Reconciliation Act of 1986. Fees are assessed at the time of filing. 

In addition to specific user charges for its review of various fings, FERC charges 

hydroelectric licensees annual charges to recover the costs of regulating the 

hydroelectric industry in accordance with the Federal Power Act. The FERC 

recovers the remainder of its budget through annual charges levied on regulated oil 

gas and electric firms based on broad authority granted the agency in the Omnibus 

Budget Reconcilation Act of 1986. 

The Nuclear Regulatory Commission 

The Nuclear Regulatory Commission (NRC) charges fees to its licensees for license 

reviews and inspections based on the general authority in IOAA In addition, NRC

assesses annual charges on operating nuclear power reactors based on authority 

granted the agency in the Consolidated Omnibus Budget Reconcilation Act of 1985 

as amended. These 10M and annual COBRA fees together are to amount to 

percent of the NRC budget. 

User fee represent an application of the "bnefit priciple" of tation: those who 

benefit from governenta proviion of a servce or goo should be requied to pay 

for it To appropriately determe what progr with the Foo and Drug Admitrtion could be fuded, paraly or in whole, though user charges, it is 

necess to fit ask: who benefits from FDA reguation? 

User fees are generally imposed when two basic conditions exist. First, certain 

identifiable individuals or businesses--as distinct from the general public--benefit from 

the servce or function. . Second, the servce or good is exclusionary in nature. 

other words, someone who has not paid for the servce or good can be excluded 

from obtaining it. 

According to the benefit principle of taxation, those who benefit from governmental 

activity should be required to pay for it. Governmental functions which benefit the 

common good" and which are indivisible in nature (national defense is the most 

obvious example) are to be funded through general taxation; special servces or 

benefits conferred on select groups or individuals (mail delivered by the U.S. Postal 

Servce, for example) are paid for by those select groups or individuals (the "users 
The principle itself is generally accepted as a valid premise on which to base revenue decisions. The Congress formally indicated its agreement with this principle in the 

early 1950s when it expressed concern that "the Government is not receiving full return from many of the servces for which it renders to special beneficiaries"4 and 

enacted the provision in 10M to allow agency heads to impose user fees for various servces or products or value so long as the charge was (l) fair; (2) based on
 governmental costs, value of the servce or product, public benefit, and other
 relevant facts ; and (3) not prohibited by statute.


Agreement in principle has not prevented controversy concerning the application of 

the principle to specific governmental functions and beneficiaries. A prime example is the disagreement which exists as to whether FDA should impose user fees for its 

regulatory activities. 

According to one view, FDA's regulatory activities in ensuring the safety of drugs 

devices, cosmetics and food entering the marketplace serve the public interest rather 

than commercial firms regulated under the Food, Drug and Cosmetic Act.5 For 

example, the Pharmaceutical Manufacturers Association, in testimony before
 Subcommittee on Rural Development, Agrculture, and Related Agencies on the
 President s 1991 budget, stated:


The FDA product review activities for which this tax would be imposed 

are not voluntary--a basic requirement to justify user fees under current 

Federal policy. Instead, they are required by law for the public benefit. The only private benefit--the second criterion for allowing user fees to be charged--that is received by regulated companies in the approval of 

health products premarking applications is that they are allowed to 

remain in business. 

Meanwhile, the alleged benefit of a so-called "seal of approval" by FDA on these products is discounted by the reality that the law prohibits any 

indication of such "approva1." Morever, FDA approval has not 

provided a defense, on the whole, from State product-liability laws to a manufacturer based on compliance with Federal Government standards 

of safety and effcacy. 

According to this view, regulatory activities do not constitute a benefit to commercial 

firms but rather a cost of doing business: to pay for the "
libert" of marketing a
 product is to pay tribute to the agency in a distorted variation of the privilege theory of taxation (those who exercise a privilege should pay for it). 

Others make an opposite case. While they may agree that FDA serves the public interest, they also see private benefits accruing to the regulated industry and the consumers of their products. They point to the wide range of functions at the local 
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State and Federal level supported in 

whole or in part by user fees; some of 

the agencies charging user fees are, like 

FDA, expressly constituted to protect 

the public from harm. Further, they 

suggest that the fact that regulation 


mandatory does not constitute pria facie evidence that regulated firms 

derive no benefit from FDA activities; 

nor does the fact that FDA product 

review activities are mandatory prevent 

imposition of user fees (even under the 

strict rules of 10M), because firms 

voluntarily enter a regulated business.7


In this view, the beneficiaries of FDA' 

regulatory activities include commercial 

firms and the consumers of their 

products. While public benefits accrue 

in the form of general improvement in 

health and safety, psychological 

reassurance regarding the availabilty of 

safe and effective drugs and devices 

and protection from the spread of 

communicable disease controlled 

through Fl)A-approved drugs, the 

consumers of such products and firms 

which manufacture the products derive 

special private benefit from FDA' 

regulatory activities. Consumers get 

safe and effective products; and while 

attaching a user fee to consumers of 

such products may not be practical, 

charging the manufacturer "provides a 

convenient, though admittedly imperfect 

conduit for passing through some or all 

of the costs of the reguatory agency forward to consumer beneficiaries."8 In 

addition, a regulated firm reaps certain 

benefits from FDA's review, approval 

inspection and enforcement activities: 

permission to market a product 

increased consumer confidence in 

. WHO BE? 

1bFDAis. not. theonJagency where 

geemerit ha. evedover "who benefits" 

fr9Dits regulatory acivti


TheNillearReguJatOCo ion. sucafull 

defende its fee: schellleln .. broughtbefore 

theoouribYPetitionersarguing they deried no

pri bCnefit from NRCaciVties.. The court 

agree thNRC' scontentionthar regulated firm dcfirdC: deri a priate benefit . from 

thiraCtivitil:. .fM isippi Powr& Light Co. . v':rC F1fth.. Circuit Court of. Appels
 rejececftl1 rgumenL thafthe NRC benefits


cjnlthe ger1atpublicand doe not confer .


fuat fits 9nlieens;... The. court's opinion 

sta1Ccibat;';Nationai Cable (Televiion 

ASi:ijon/lnc. v. Fcq. the court recognized 

theiluthorityof tbeFCC to asss a fee. even 

tfugh' themain function . of the Commision is 

to Saeg1ard thep blicinterest.' 415 U. 

341 94S.Ctarn49 The Court thus 

ackl0wledgedthe FCC's authority to asss 

againt applicants a fee for servces rendered 

nothwithStanding the strong public interest served 

in PrOvdirigJhe rvce;... 

Iicens. frrn the. NRCis an abslute 

piei uistetooperatingariuclear facility, and as 

sll iSa nefi' no shared by other members bfSoiety; .Aside from. the . benefit of being able to operate a busines, the. petitioners are. 

recpients9fother beriefitsflowg from the


grntor a licens . or pennit..(R Joutine inpei(). c6ducedby theNRC could uncoer 

hadous**nditions which ifallowed to (:tinu wot1ld jeopadize the Safe operation of license sfacility. Inshort, We are nm

ilprCSbythepeitioners argument that they

. reciVenObel1efitfrom the conferral of an NRC 

licens; . Even sO; to aCcpt. petitioners' argument
 would mcim that no federa agency could asss
 anyfeej sinee 311 publi agencies are constituted
 iI the. publi ter
es~ 

Th First Cin:uitCourt of Appels cotinued thi 

line of renig in holding in New England 

POwer. Company, et al. v. NRC that "revew work 

performed by the NRCat the reque:t or an 

applicant. constitues a. suffciently substantial and 

parlicularidbenefit to. the applicat to justify the impoition of fee" even where the 

application is voluntarily withdrawn. 

industry s products, reduced exposure (and potential liabilty) for businesses that 
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might have marketed a less-than-safe product except for FDA' s oversight, improved products resulting in better sales, and protection from unfair competition. 

The act of imposing a usr fee creates cert benefits and costs which may by themslves provde the pri impetu or impeent to the charge. These benefits and costs may accrue to the agency or program instituting the fee, to the users themselves, and to the general public. Exbits 3 and 4 list the possible benefits and costs to these groups.


EXHffIT3. . 

POTENT. :ENEFITS OFUS:ERFEES 

. n. "


To theAgency. To the Users To the PUblic


Peripberarbenefitso(cos . Can challenge ageI1CyoI1. . Relieved or cot. burden unless. accunting .servce cots . auser orditect beneficiary Revenues act as "demand . More rapid etfeciVe Qpportunity" benefit; . allow Signals" which allow the servce . exting reSurCe to be usd 

. agency to allocte resurces for other, more public goo . effciently improves governmenta 

effciency pruct and servces 

Increa reveues which. a)uld


be use. forexpnsi()o . of seCe
 . or improvment. in. exiStg servces


PpjXrtunit:" .. benefit; allO . exiing
 .resurces to. be. used forpther more


public gOo, proucts arid. seces


. AII() Jotr upmerif()(Cots frm
 thosootSidedirecttaba .


GOritrols llof servce or goo
 ul1gesmiuse courages
 eco 

The priary benefit of imposing user fees is generally considered the increased revenue they generate, which might be used to continue, expand or improve existing servce. For some, these increased revenues might be important enough to overrde 

other objections to the imposition of fees. However, it has been suggested that other 

benefits can accrue to the agency imposing the fee, the general public, and even the users themselves, when user fees are imposed. For example, the agency may become more aware of the costs of its activities, better able to identify needed system improvements, and more motivated to make those improvements. If fees are related to both intensity and tye of servce, the agency can use the fees as a measurement of resource requirements and a way of meeting those same resource demands, and users are more responsible for the use of resources. 
..... ... .. .. ... ... .. ....... . .. .. ........ ...,..... ..... ........... ..... ... ....... . ... .... .. ., . ..... . . .. .. ....... . .... . ... . ..., . .. ..... .. . . .. .. . ... . .. ... .......,. .. ... ... . ... . ,.. . ...... .. .. ...... ...... .. .... .. .. ,... . ...... .. . ,.... ..... ... ...... ..... ... ..... ....... ... . . . .. ... ..... . . .. .. ,. ..............,. ..... ....,....... .

XFmIT4. 

POTENTIA .COSTSOPUSER FEES. 

. Tgih &encY. ToihetJsi/fs TOlhiPublic 

RevenueSmayrif the . Le MfuentuScCs aLa Co ()f8diniiion.or . diSCintage . .....In ration 

OOlJecri mayJ:t .ri . . Disourages us ..Use. may adjust their fUnd to Want the effor Payingfor.8 baicse(V beJuvirin solly. ormafbe . toOsnuul undesrabJe .ways
 :haeaneffect9 .

. Cotsn-"u-r1 on to J':L1blic will not accpftJeJee

I)iS ageS u u . ;t:os:; . 

)hepr threby . 1I it 

i1c6 rages gaming . u


Redu. regularbudget .


appropritions.. . .


I.gal halJenges . 

Users themselves benefit from increased effciency and accountability in agency operations, as well as from system maintenance and expansion made possible as a 

result of collected revenues. In addition, users directly charged for servces are 

better able to document and challenge agency activities affecting their industry or 

business. 

At the same time, user fees have certain costs beyond the fee which the user must pay. As a practical matter, fees might be difcult to administer and may be too small to warrant the effort of assessment and collection. Further, the collection of fees may result in a reduction in agency appropriations in the amount of expected collections through fees, a signicant concern to program offcials worred about 

possible "shortfalls. 

The public may not respond positively to the imposition of fees, even where it relieves them of cost burdens, based on tneir fears that agency or user behavior

might be adversely or inappropriately affected. Regulatory offcials might be particularly concerned that the agency s role in protecting the public from undue health risks might be compromised by user fees; fis might charge that the agency

is conducting inspections only to increase revenues, or that it is reluctant to impose severe penalties on firms because such firms represent the funding source for the agency. Firms might be discouraged from or delay applying for agency approval to engage in various activities because of the user fee. 

The possibilty of legal challenge to the fee represents another possible cost of 

imposing a charge. Federal agencies have been challenged on 

institute fees and method for assessing fees. 

their authority to 
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Numerous considerations should be taen into accunt when developing the pricig and fee strcte of a usr charge. Some of these considerations are listed in Exibit 

.", n..


t6f prOvding thei. rVorprbdticL
 ':M*igin8I ofprodfugthe. Sece or product .


riIiti ;g:;publi benefits 


. FEff ODuse gaVior .


treciv fr 

4:; ??t1	 mceor. product 

';Yei'c ileq itY 

7Abilio6ft r to 

The degree to which each of these considerations is taken into account would 

signficantly affect how fees might be structured in FDA If we synthesize various approaches to developing fee schedules based on possible application to FDA 

activities, the following range of options emerges: 

Consideration	 ADDlication 

Cot	 Fees based on actual or estimated costs to the agency of processing applications, conducting inspections and surveilance. 

Firms applying for FDA approval or market clearance or being

inspected would be charged for the cost of providing that 

servce. 

Equity	 Fees based on abilty of firms to pay charges. Total agency costs for various functions might be allocated among regulated 

firms based on sales, profits, market share, or other indices. 

Industr Benefit	 Fees based on benefit of FDA regulatory activities. Fees 

discriminate among activities based on anticipated benefit to the 

firm, e.g., user charges might be applied to approved drug 

applications but not for nonapproved drug applications. 

Soal Benefit	 Fees based on social benefit of various industry activities, e.g.

full or partial waivers might be instituted for applications for 

important new drug therapies and applications for drugs to treat 

contagious diseases (one example might be AIDS drugs). 
Competition	 Fees based on market factors, e.g., larger firms might be charged at a higher rate than smaller fis to encourage new competitors in the market; firms requiring more frequent inspections because of past violations might be charged more than firms in 

continuous compliance to reflect comparative costs of oversight 

and to provide incentives for improved compliance performance. 

Accptace	 Fees based on expediency and past success of simiar user 

charges, e.g., fees might be developed to ensure acceptabilty to 

the Congress and the court, industry, agency offcials, and 

consumers. 

dmjnj~trtion	 Fees based on ease of administration , e.g., flat fees reflecting average agency costs for processing certain tyes of applications; fis must include payment along with applications rather than 

being biled.


In practice, user fee systems reflect consideration of many of these concepts. User fee schedules at EPA, FCC, FERC, and NRC are based primarily on cost to the agency. But the agencies have also instituted waiver systems to take into account

social or public benefit and effect of the fee on competition. For example, FERC bases user fees on costs to the agency, but allow waivers for certain licensees 

(municipalities and firms in financial diffculty); they recover the remaining portion of 

their budget through annual charges which are assessed based on the market 

standing of licensees. A somewhat similar system is in place at NRC and EP A and 

with the exception of annual charges, at FCC. 

Administrative feasibilty is also an important consideration. Complex systems which seek to impose user charges based on precise calculations of costs and complicated waiver criteria are diffcult to administer and resource-intensive. Agencies tyically try to strike a balance between such precision and administrative simplicity. 

Little consideration is given to industry benefit (although at EP 
A, registration for pesticides with "minor use" are exempt from the fee schedule to take effect in 1997; the equivalent exemption at FDA might be for orphan drugs). No system among the four agencies bases any. of its charges on whether the agency ultimately makes a decision that is favorable or unfavorable to the applicant. Offcials thought that

developing charges based on benefit to industry would be more difficult to develop and defend in court than charges based solely on costs, as well as creating larger conflct-of-interest problems for the agency. 
... . 

........ . . ... .... . . .. .. . .. .. .. .... . . . 

dmjnj~terig and collecg fee ca represnt a substatial inestment of agency resurce and tie. 

Officials at the four agencies we visited agreed that "user fees are work." Fee


schedules must be developed;


regulations published in the Federal 

Register outlinng the fee schedule (if 

not detailed in legislation) and the IMROVJG ADMITI..EFCICY 

collection mechanism; public comments 

received and considered; procedures To. iIIproveadministrntive effclencyand reduce 

adD1nistrativecOts for thecoJJ tion()fuser developed to account for incoming fee;tbeFCC ha entered. irtoa agreement 

funds, returned checks, insuffcient Withaldc boX"()perator FJrmssend. their 

appljctior, paynentand paynent amounts included with figs, and J()rmto the lok booPerat()rwbodepotsthefeeir the
 biling; and procedures instituted for .. tJ.s.Treaui'; f"Oresia1I)Iar fiings, the


adjusting the fees on a periodic basis. pa)'nt fornf!1d paYment resenttotheJock


Because of these complexities, offcials

. bo operator \Vfe the pplicati(mis depoited


. direetly With the FCX: The operation of the

estimated that FDA would require at . lOk booperatorisfundedby. the Treaury.


least 1 year to implement a user fee Jh FCC i1implemented. this approach to


collecion andaccoting. ba . on pat . system. eXprience, which wa not positive, of mairtaining acoUectionandaccounting operation withi the 

Officials at NRC and FERC, which 

COmmiion The FCC found this. internal 

operation to be difcult. to manage and to stff
 have annual charges to supplement and. exprience significant procesngbackJogs of


specific processing and inspection fees 2to3weeks, The FCC estimates thaUhe 

suggested that annual charges are easier averagetim 

the lock 

. for applications to be Pro bOoperator and received by FCC to administer. At FERC (though not at . Bureausror substative procing will. be 2 to 3 

NRC) officials thought annual charges daYs. .. 

were better accepted by industry because they are based on a measure of 

ability to pay," even though such charges can result in fis which have not received a particularized benefit from the agency s activities (for example, those that have not made a filing with the agency durig the year) being charged to support those

activities. But not aU annual fees are easy to administer--EP A reported diffculty in assessing its reregistration fees because tne Congress required the agency to prorate charges in certain cases based on market share. This approach requires the agency to maintain records of market share, an index constantly in flux and requiring 

continual adjustment.


Questions for policyakers considerig FDA usr fee include: (1) determg the actities to be included or 

asessment; (3) supported by the fee; (2) determg the tig settg the fee; (4) decidig where the fee should be deposited; and (5) relatig the fee to the procss. 
Determining the activities to be included or supported he fee 

One of the first decisions to be considered is what activities should be included in 

the user fee schedule. For example, to regulate new drug products, FDA requires submission of investigational new drug (INs) and new drug applications (NDAs). Once a product is approved, the agency conducts inspections of facilties producing approved drug products, collects and analyzes report of adverse drug reactions associated with approved drug products, and requires submission of NDA
 supplements when certain changes in manufacturig or labeling take place. 


similar set of activities takes place for generic drug and device clearance and
 approval.) Some proposals have focused on assessing fees for processing NDAs rather than the whole spectrum of activities associated with regulating new drug products. Ths approach has the advantage of adminstrative simplicity; it has the disadvantage of either limiting cost recovery for regulatory activities or of subsidizing these activities by charging higher fees for NDAs. While firms which submit NDAs for FDA approval may "use" more FDA servces in the way of IND review and consultation, inspection and other surveilance activities, this relationship is imperfect. Some firms may submit numerous INs for which an NDA is never submitted; some NDAs may not be approved, so no inspection or surveilance activity is required for that specific product. 

The most complex system is one is which each discrete function or tye of activity performed by the agency is charged to a specific user. However, this is not always feasible, equitable, or necessary. For many FDA functions, especially those other than premarket approvals and inspections, FDA would face a formidable task to identify the right firm to charge. In such cases, one manufacturer might initiate an action with benefits to a larger group of manufacturers (device reclassifications, OTC switches) or the identity of the manufacturer is obscure (e.g., standard setting, research, over-the-counter review, postmarketing surveilance reports). 

As a result of congressional authorization, other agencies have moved to a combination of user fees and annual fees which alleviates this difficulty. The NRC bils for application processing and inspectons while recovering an additional portion of regulatory costs of generic activities through annual charges. The FERC and EP have also moved to a combination of user fees and annual charges to more fully recover total agency costs. 

Determining the timing of assessment 

Another key decision for policymakers developing a fee system is when to actually assess a fee. For example, a user fee for NDAs might be assessed at the time of filng or at the time of approval. Assessing the charge at the time of filing more fully recovers agency costs, encourages manufacturers to submit only those applications with a reasonable chance of approval, and reduces possible conflcts of 
.. .... ... . . .. . ...

interest (agency incentives to approve products in order to increase revenues). 

Assessing a charge at the time of approval has the advantage of more clearly linking 

the fee to particularied benefits to the manufacturer. The Federal agencies which

we visited all assess charges at the time of filig, even though, lie FDA, they may take months or years to complete a review and make a determination that may 

ultimately be unfavorable. As discussed earlier, NRC successfully defended its practice of charging a fee even when a firm voluntarily withdraws its application on the basis that even applications which are withdrawn incur costs to the agency.

Thus, EP A, FERC, FCC and NRC all assess fees based on agency costs rather than a favorable agency decision. Officials believe that this approach, in addition to following the requirements of Circular A-25 (which indicates that costs should be 

recovered rather than the monetary equivalent of private benefits when Federal 

activities have incidental public benefits) is also easier to defend in court. 

Setting the fee


What are the agency costs to process 

various tyes of applications, inspect 

facilities and goods, and meet other 

regulatory obligations? The sidebar 

describes the approaches NRC, FERC 

EP A, and FCC have taken to answer 

this question. 

Ideally the agency should consider, in 

setting fees, the economic adjustments 

that will occur based on the fee amount 

and placement. Rational consumers


make economic adjustments on the 

basis of anticipated benefit and cost. 

Such decisions may work in favor of 

efficient use of servce, but underuse or 

overuse may also occur. Set too high, a 

fee can discourage manufacturers from 

producing drugs and devices. Too low 

a fee induces overuse of agency


resources and servces. ' In the case of 

FDA, althougl: manufacturers incur 

costs to prepare applications, the 

absence of a fee or too Iowa fee may 

nevertheless induce submission of 

applications that the manufacturer 

consideres to hold little prospect for success. 

WHT OOFSIT 

At NRCandFERC, fee are bad on strict 

tra nganddocumentation af co by agency employee. Employees supply infonnation on 

tie spnt on various categories of aCtivities; that 

information is. entered. into lime accounting 

. Sytems. Averagc:eotsby category of activity

aredeterminedby tabulating the number. of 

employee hours spnt on the activity, determining 

tbworkload for that activity. (e.g., number of 

oompItedQfiings), and delopig an average 

. /1l1r1 cot per employee. Hours . ar divided by 

ldoad an .l!ultiplibj~he hourly cot 


jjguraveragerots fo aciviies within that


categor, l1e fee schedule . .is.updtedannually ontheDewyea scIuian employee hours 

and rates (FERCis . starting to average cots over 

yea period). 


At EPA, cots of the registration program were domented. using information from. the. agency 

tjme. accntig, tracng, management, and 

ficil syem, along with input from program 

offcial. The FCC us a more general 

approach to develop estimated cots for 

procssing. various. ty of filings and conducting 

inspections. The FCC Schedule, while very 

detailed, is ba primarily on its budget and COt alloctions within. its bureaus. 

(Such "overuse" of FDA resources 
might be indicated by the volume of withdrawn applications or approved applications 

yielding no marketed product.) 

Regardless of where the fee is set, some degree of economic adjustment wil1 occur. The net effect of these economic adjustments may be either positive or negative. Where a fee is charged for a previously "free" servce, some reduction in demand can be expected to occur, although in a regulated industry with fees imposed on profit­ makig fis, the effect may be muted (especial1y if marginal costs are relatively low). Firs may also merge capital and resources in order to reduce marginal costs. While offcials at FERC and NRC saw little to no effect on industry as a result of 

their fee systems, EP A offcials did report that smaller businesses were adversely affected by their reregistration fees; a number left the pesticide market, resulting in a smaller number of fee payers and higher charges for those remainng. 

Waivers may be one solution to correct undesirable economic adjustments, although a waiver system increases administrative complexity. Waivers can be based on the 

characteristics of the applicant (e. , smal1 businesses, nonprofit businesses) or on the nature of the activity (e.g., products with substantial ''benefit spilovers " to the general public, such as drugs or devices representing important new therapies or drugs to 

prevent the spread of communicable disease). Waivers will also tend to encourage the activity to which they are applied: higher fees for certain activities will 

encourage firms to move resources towards those activities for which lower charges 

are assessed.


Generally it is assumed that FDA user fees would result in consumers paying higher costs for products regulated by the agency. To the extent that fees assessed by FDA 

raise a fi's overall costs, the firm may increase prices. (Price increases and fees would not likely be linked product-by-product when a fi sells a lie of products. To some extent any additional costs passed on to the .consumer would be offset by a reduced tax burden. However, this shifting of costs might prove troublesome to those already concerned about the high price of drugs and medical devices, or who are concerned about trading a progressive (income-based) funding source for a regressive (flat) funding source. The higner price would also induce consumers to reduce purchases or substitute out of the higher-priced products. If fees were to become a significant part of overall costs, affected products would be placed at a disadvantage in competition with substitute products not burdened by significant fee expenses, and consumers might be made worse off as a result of having to make substitutions in the face of higher prices. 

Deciding where the fee should be deposited 

Revenues from user fees can be deposited as miscellaneous receipts in the general fund of the U.S. Treasury, to reduce the budget deficit or to offset agency appropriations, or can be directed to the agency for general or specific use, as 
through a special revolving fund. 

Earmarking the revenues for use by the 

agency for specific purposes (e.g., to 

F.A'S. REOLVIG 

fund improvements and expansions in Fund colleced through EP Nsuser fee charges 

existing servce areas for which the user for reregitiOn pring and . maintenance 

fee is imposed) may increase the fee are depoted in a newly created reregitrtion . and exted. proing fund lielihood of their acceptance by th. S; Treaury, . available to . the 

industry and others. Fungibilty of funds 

AdmiisratO, without . fiyear limitation, to 

carr out . reregitration an exted proing. may be such that earmarkig of similar applications,
 is largely Th singiJlar legislation

cosmetic. Special arrangements have reqires that collec. funds are earmarked to 

supp. the actties . been devised to improve credibilty that fOr whih . they wee

coJIected andaIlbw the agency flexibilty in using earmarked funds will be used in a the funds thought the reregiration period as 

particular way. The EP A's arrangement irne the.. The EP A is using some of thes fu to iiprov its data management sytems ( see sidebar) for the disposition of fees and internal pr. and procdures an the is unique, and EP A officials considered bulk . of the monies to . expnd . the agency


this element of the user fee system to scentific exrtis and stff.


be critical in obtaining the necessary


industry support for the fee program. 

ReJating the fee to the process


Another key consideration is how the user fee wil affect and reflect how FDA does its business. For example, some drug manufacturers, in a previous study conducted by the Offce of Inspector General, criticized the FDA for inconsistency in reviewing and approving applications for new and generic drugS.l0 An audit conducted by the OIG confirmed that there is significant variation in elapsed time to approval for applications submitted by different manufacturers to different reviewers for the same generic drug product.ll If such variabilty is due to differences among FDA 

defensible to develop a fee which represents the average cost of 

reviewers in workload, skill level, and requirements they impose, then it is more 

processing a
 category of application. Thus, manufacturers whose applications are assigned to less experienced reviewers

with more stringent standards

, reviewers who hav more applications to review, or reviewers , are not unfairly penalized by the assignment. On the other hand, if the differences in review times are attributable to 

adequacy of applications submitted by manufacturers differences in the 

, it might be more defensible to charge a fee based on actual costs so that manufacturers which prepare better 

applications are not subsidizing those firms which submit less than adequate applications. 

As experts review FDA's mission and performance, procedures and protocols might be altered. Significant changes in FDA functions or procedures might affect 

advisabilty of charging a fee for a particular function the 

, and might create a greater or lesser case for imposition of a fee. 
For example, some manufacturers have that FDA reduce its suggested involvement in the IND stage of product development while 
others want increased FDA involvement at this stage.12 One possible response is for 

FDA to make its involvement at the IND stage voluntary. Manufacturers who wanted to consult with FDA at this stage in order to better ensure that their NDA 

would pass muster could do so, while those that felt they had sufficient in-house knowledge could proceed without FDA oversight. Under such a system, a user fee for IND review and consultation would appear to be very appropriate: manufacturers who feel they need and benefit from FDA advice and guidance would be charged a 

fee for that consultation.


User fees to recover the costs of inspection activities represent another area where 

process is an important consideration. The amount of variabilty and discretion in 

how inspections are conducted leads to a set of questions similar to those we rais in regard to drug application review. Further, if routine inspections are conducted randomly, with some facilties never or infrequently visited by FDA, charging the establishment under review a fee for the cost of inspection unfairly penalizes the firm randomly selected for review. However, if every manufacturig or processing site is 

inspected within a certain period (even if the period is one of years, as with drug and device manufacturing inspections), an equitable fee may be more easily assessed. For some of these areas where the nature of the activity precludes easy assessment of a fee, annual charges spread throughout industry might be the preferred solution. 
SUMMARY 

The question of whether to assess user fees in Federal programs is a contentious one. Considering user fees as a method of funding for a particular program or agency precipitates debate which continues as any legislation and implementing 

regulations take form. Because imposition of fees involves charging users for previously funded through general appropriations servces 

externalities naturally arise. , questions of equity, effciency, and 

Based on our review, we believe that user fees in the Food and Drug Administration (FDA), properly instituted, represent a legitimate method to recover regulatory Such fees would be consistent with fee costs. 

systems in other Federal regulatory
 environments. However, as this report demonstrates, developing a fee FDA is not a system simple matter. Even so, while time and resource intensive of developing a fee system might , the process have its own benefits 

of procedures and tasks and the ncluding increased scrutiny 

costs of doing business.


In all four cases we examined, the Envionmental Protection Agency (EP Federal Communications A), the Commission (FCC), the Federal Energy Regulatory Commission (FER C), and the Nuclear Regulatory Commission (NRC), the Congress has passed and the President has signed into law specific components of their user fee systems. While such legislation can range from the more general (authorizing agencies to collect annual charges, as with FERC and NRC) to the more specific (delineating an actual fee schedule, as with FCC) it is generally considered preferable to sole reliance on the general authority in the Independent 

Act. Offices Appropriations Specific authoriing legislation allows for expanded authority, more flexibility,
 and greater protection from legal challenge.


While we have not attempted to examine exhaustively how user fees might be implemented in FDA, our review does suggest a number of issues for consideration. One of these is possible use of a hybrid system of annual charges and specific user fees. Annual fees at EP A, NRC, and FERC have worked well, especially in concert with specific user charges. Such a hybrid system has increased cost recovery without

requiring detailed assessment of charges for every agency activity. 

The framework provided by this report might be used by other 

S. Department of Health and Human Servces (HHS) as theyagencies within the 

consider implementing user fees in other areas. While this report is specifically tailored 

questions may remain much the same for any HHS program.

toward examination of our case study, FDA, the structure of considerations and 
APPENDIX A 

SUMMARIES OF USER FEE SYSTEMS


IN OTHER FEDERAL REGULATORY AGENCIES

Appendix A: Summaries of User Fee Systems in 

Other Federal Regulatory Agencies


ENONMNTAL PROTECI0N AGENCY (EA) (1) 

Type of fee 

Amount of fee 

Legal authority 

Disposition of fee 

WaiveT: 

Adjustments 

Reregistration fees and maintenance (annual) fees. 

Reregistration fees are variable, and based on characteristics of the pesticide such as the number and tye of active ingredients and end use. Fees are paid collectively by all registrants of the pesticide. One-time reregistration fees range from $50 000 to $150 000. Maintenance fees are based on number of product 

registrations held. Maintenance fees in FY 1990 are $650 for the first product and $1 300 for additional registrations, with caps on the total fee for anyone part holding registrations. 

Public Law 100-532, enacted October 25, 1988 and effective 60 

days later. Authority terminates in 1997.


Reregistration and expedited processing fund in the U. 

Treasury, "available to the Administrator, without fiscal year limitation, to carr out reregistration and expedited processing of 

similar applications" (e.g., so-called "me-too" applications). Pub. 

L. 100-532 s 102(k)(2). 

For reregistration of pesticides for minor use and partial waivers 

for small businesses.


Fees subject to adjustment by EP A Administrator in order to 

collect $14 000 000 each fiscal year, except that maxmum maintenance fee for Ji registrant with 50 or less registrations is $20 000, and for a registrant with more than 50 registrations 

$35 000. 

A -1

, 

Appendix A: Summaries of User Fee Systems in 

Other Federal Regulatory Agencies


ENVONMNTAL PROTECTON AGENCY (EA) (2) 

Type of fee 

Amount of fee 

Legal authority 

Disposition of fee 

Waivers 

A pending fee schedule (to be implemented in 1997) will 

establish registration fees for (1) new chemical registration 

reviews; (2) new biochemical and microbial registration reviews; 

(3) new use pattern registration reviews; (4) old chemical 

registration reviews; (5) amendment review; (6) experimental use 

permt reviews. (This fee schedule was in effect for a period 

6 months prior to its suspension under FIF of 1988. 

The pending fee schedule establishes the following charges (1988 

costs): $184 500 for new chemical registration reviews; $64 000 

for new biochemical and microbial registration review; $33 800 

for new use pattern registration review; $4 500 for experimental 

use permit review; $4 000 for old chemical registration review; 

$700 for amendment review. 

31 U. c. 9701 and Public Law 100-202. Proposed rules 

implementing the fee schedule were published citing the 

authority under 31 U. C. 9701. Subsequently, EPA's FY 1988 

appropriation (Public Law 100-202) authorized EP A to collect 

not more than $25 milion for its regulatory activities. The final 

rule implementing EPA's fee schedule cited both 31 U. c. 9701 

and Public Law 100-202 as its authority. EP A's proposed rule 

was published November 1986; the final rule was published May 

1988. Public Law 100-532, FIFRA of 1988, postponed 

implementation of the fee schedule until September 1997. 

Under Public Law 100-202, fees for the agency s regulatory 

activities will be deposited in a special fund available for 

appropriation to carr out the agency s activities in the programs 

for which the charges are made. 

The agency may waive the fee when (1) it initiates the 

amendment; (2) the anticipated revenues from the uses 

described in the application are insufficient to cover the fee; (3) 

the applicant will experience severe economic hardship; and (4) 

applications are for pesticides servng significant public interests 

(e. pesticides offering unique advantages for reducing public 

health risks, those that significantly reduce a current 

environmental risk, or a product with extraordinary utility in use 

A - 2

Appendix A: Summaries of User Fee Systems in 

Other Federal Regulatory Agencies 

in Integrated Pest Management"). Firms must submit a waiver 

request, and pay a fee for the review of the request. If the waiver is granted, the fee is refunded; if the waiver is denied 

the agency retains the fee. 

Adjustments	 Based on periodic review of agency costs. New fees will be 

established through rule making. 

A - 3

Appendix A: Summaries of User Fee Systems in 

Other Federal Regulatory Agencies


FEERA ENERGY REGUlTORY COMMSSION (FRC) 

TYpe of fee 

Amount of fee 

Legal authority 

Disposition of fee 

Waivers 

Adjustments 

Pilng fees for applications, petitions, requests for review and certifications. The FERC has established 31 different categories


of fiings for which fees are assessed. Annual charges for the cost of operating FERC which have not been recovered through. processing fees are assessed against companies that hold 

hydroelectric licenses, natural gas pipeline companies, public utilties, and oil pipeline companies. 

1990 filing fees range from $26 260 for a pipeline certificate application to $80 for review of jurisdictional 

determinations. agency 

For collection of filing fees, 31 U. c. 9701. Annual charges are authoried by the Federal Power Act, Part I (16 U. c. s 991­


828(e) and Pub. L. 99-509, s 3401(a)(1), Omnibus Budget


Reconciliation Act of 1986.


Credited to FERC's Proprietary Fund. Any revenues in excess of FERC' s appropriation are credited to the General Fund of 

the U.S. Treasury. 

If applicant is suffering severe economic hardship at the time of filing, a petition for a waiver may be fied. State, municipalities and anyone engaged in the offcial business of the Federal 

government are exempt and may file a petition exemption. requesting such 

Updated annually in the Federal Register. 

A - 4

Appendix A: Summaries of User Fee Systems in 

Other Federal Regulatory Agencies 

FEDERA COMMCATIONS COMMION 


(FCC)


Type of fee	 Applications for broadcast licenses. 

Amount of fee	 The COBRA of 1985 established 80 fee categories. Fees

from as low as $20 for renewal of a cellular range 

system license to as high as $18 00 for an application to launch and operate a space station. 

Legal authority	 Consolidated Omnibus Budget Reconciliation Act of 1985 

Law 99-272, Section 5002( e) and (f), codified at 47 U. 

, Public 

c. s 158.


Disposition of fee General fund of the U.S. Treasury "to reimburse the United States for amounts appropriated for use by the 

carrng out its functions..." 47 U. c. s 158( e). 

Commission in 

Waivers No charges to radio servces of local government
, police, fire
 highway maintenance, forestry-conservation, public safety and special emergency radio, or other government entities. No charges for good cause in the public interest. 

Adjustments	 Schedule to be reviewed every 2 years and adjusted to reflect 

changes in the Consumer Price Index. 

A - 5

, 

, , 

ENDNOTES 

1. Office of Inspector General Analysis of Costs Included in Current Food and 

Drug Administration User Fees and the Potential for Additional User Fees


December 1987, A-01-87-02522.


2. J. Peter Grace, Chairman, President's Private Sector Survey on Cost Control War 

on Waste (New York: MacMilan Publishing Company, 1984. 

3. Audit Committee, President s Council on Integrty and Efficiency, "Audit of the


Establishment and Collection of User Charges " p. 3.


4. House Report 82-384, p. 2­

5. At one time this view was widely held; as evidence, the 1959 version of OMB 

Circular A-25 which provides executive guidance on Federal user charges explicitly 

used FDA approval of new drugs as an example of an activity particularly il-suited for user fees. The latest version of OMB Circular A- , circulated in draft July 

1987, uses the same example to demonstrate appropriate application of user fees. 52 

Fed. Reg.


6. See Milton Kafoglis User Fees as a Regulatory Tool " in Thomas D. Hopkins Federal User Fees: Proceedings of a Symposium, Administrative Conference of the 

United States, Washington, D. , 1988, p. 18. 

7. In National Cable Television Assn. v. U.S. the Supreme Court distinguished taxes

which are levied by Congress, from fees which are levied by Federal agencies based 

on authority contained in 10M by developing this distinction: A fee "is incident to 

a voluntary act, e.g., a request that a public agency permit an applicant" to do 

something. Hence the Court took the view that applicants enter a regulated industry 

voluntarily, and thus amounts collected to support the activities of the regulating agency are "fees" rather than "taxes. 

8. Kafoglis, in Hopkins, p. 15. 

9. See for example, National Cable Television Asso. v Federal Communications 

Com. (1976) 180 App DC 235, 554 F2d 1094; Mississippi Power & Light Co. United States Nuclear Regulatory Com. (1979, CA5) 601 F2d 223, 51 ALR Fed 571 cert den 444 US 1102 62 L Ed 2d 787, 100 S Ct 1066; and Skinner v. Mid-America 

Pipeline Co. (1986) 87-2098, 57 LW 4458-4462. 

10. Office of Inspector General, Office of Evaluation and Inspections Perspectives of Drug Manufacturers: Investigational New Drug and New Drug Applications " and Perspectives of Drug Manufacturers: Abbreviated New Drug Applications " 12-90­

00770 and 12-90-00771, February 1990. 
, 

, p.

11. Office of Inspector General, Office of Audit Management Advisory Report: 

Vulnerabilties in the Food and Drug Administration s Generic Drug Approval 

Report;" August 1989, A- 15-89-00051. 

12. Office of Inspector General, Office of Evaluation and Inspections Perspectives of Drug Manufacturers: Investigational New Drug and New Drug Applications 

12. 
,. 

, , , , , , 

SELECTED REFERENCES


During the course of the OIG's literature review on user fees, the following references 

proved most helpful. Readers interested in more detail on Federal user fees should 

consult these sources.


Eastern Research Group Inc. Federal User Fees: Data Compilation with 

Addendum" (prepared for the Administrative Conference of the United States 

symposium on user fees), Washington, DC, May 3, 1988. 

Clayton P. Gilette and Thomas D. Hopkins Federal User Fees: A Legal and 

Economic Analysis Boston University Law Review. Volume 67, Number 5 

November 1987, 795-874. 

Thomas D. Hopkins, editor Federal User Fees: Proceedings of a Symposium 

Administrative Conference of the United States, Washington, DC, 1988. 

President' s Council on Integrity and Effciency, "Audit of the Establishment and 

Collection of User Charges " February 1989. 

United States Congress, Congressional Budget Offce Charging for Federal 

Servces " December 1983. 

S. Department of Health and Human Servces, Food and Drug Administration 

Offce of Planning and Evaluation User Charge Study," August 1983. 

s. Department of Health and Human Servces, Office of Inspector General, Office 

of Audit Analysis of Costs Included in Current Food and Drug Administration User 

Fees and the Potential for Additional User Fees " A-01-87-02522, December 1987. 

c - 1