Federal Register / Vol. 62, No. 236 / Tuesday, December 9, 1997 / Notices 64849

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Establishment of Prescription Drug

User Fee Rates for Fiscal Year 1998

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

rates for prescription drug user fees for

Fiscal Year (FY) 1998. The Prescription

Drug User Fee Act of 1992 (the PDUFA),

as amended by the Food and Drug

Administration Modernization Act of

1997 (the FDAMA), authorizes FDA to

collect user fees for certain applications

for approval of drug and biological

products, on establishments where the

products are made, and on such

products. Fees for applications for FY

1998 were set by the FDAMA, subject to

adjustment for inflation. Total

application fee revenues fluctuate with

FDA application review workload. Fees

for establishments and products are

based on the revenues to be derived

from applications.

FOR FURTHER INFORMATION CONTACT:

Michael E. Roosevelt, Office of

Financial Management (HFA–120),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–5088.

SUPPLEMENTARY INFORMATION:

I. Background

The PDUFA (Pub. L. 102–571), as

amended by the FDAMA (Pub. L. 105–

115), establishes three different kinds of

user fees. Fees are assessed on: (1)

Certain types of applications and

supplements for approval of drug and

biologic products, (2) certain

establishments where such products are

made, and (3) certain products (21

U.S.C. 379h(a)). When certain

conditions are met, FDA may waive or

reduce fees (21 U.S.C. 379h(d)). Under

the PDUFA, as amended, one-third of

the total user fee revenue for each FY

must come from each of the three types

of fees.

For 1998 through 2002, under the

amendments enacted in the FDAMA,

the total fee revenues and fee rates for

application fees are set in the statute,

but are to be adjusted annually for

cumulative inflation since 1997. In

addition, total application fee revenues

are structured to increase or decrease

each year as the number of applications

submitted to FDA increases or

decreases.

For 1998 through 2002, FDA is

authorized to set fee rates for

establishment and for product categories

each year, so that the total fee revenue

from each of these two categories will

equal the total revenue FDA expects to

collect from application fees that year.

This procedure continues the

arrangement under which one-third of

the total user fee revenue comes from

each of the three types of fees.

This notice establishes fee rates for FY

1998 for application, establishment, and

product fees. These fees are retroactive

to October 1, 1997, and will remain in

effect through September 30, 1998. Prior

to the enactment of the FDAMA, only

half of the application fee was due upon

submission of the application, and the

second half was due when FDA issued

an action letter after review of the

application. Beginning in FY 1998, the

entire application fee is due upon

submission of the application to FDA.

For fees already paid on applications

and supplements submitted on or after

October 1, 1997, FDA will bill

applicants for the difference between

fees paid and fees due under the new fee

schedules and under the new

requirement that application fees be

paid in full at the time an application

is submitted. For applications and

supplements submitted after December

31, 1997, the new fee schedule must be

used. Invoices for establishment and

product fees for FY 1998 will be issued

in December 1997, using the new fee

schedules.

II. Inflation and Workload Adjustment

Process

The PDUFA, as amended by the

FDAMA, provides that fee rates for each

FY shall be adjusted by notice in the

Federal Register. The adjustment must

reflect the greater of : (1) The total

percentage change that occurred during

the preceding FY in the Consumer Price

Index (the CPI) (all items; U.S. city

average), or (2) the total percentage pay

change for that FY for Federal

employees, as adjusted for any localitybased payment applicable to employees

stationed in the District of Columbia.

The FDAMA provides for this annual

adjustment to be cumulative and

compounded annually after 1997 (see 21

U.S.C. 379h(c)).

The FDAMA also structures the total

application fee revenue to increase or

decrease each year as the number of

applications submitted to FDA increases

or decreases. This provision allows

revenues to rise or fall as FDA’s

workload rises or falls. To implement

this provision each year, FDA will

estimate the number of applications it

anticipates receiving, based on its actual

receipts the previous year, and making

an allowance for waivers and refunds.

FDA has made similar estimates each

year since 1993 under the PDUFA fee

setting process. The number of

applications estimated by this process

will then be multiplied by the inflationadjusted statutory application fee. This

calculation will produce the FDA’s

estimate of total application fee

revenues to be received each year.

The PDUFA also provides that FDA

shall adjust the rates for establishment

and product fees so that the total

revenues from each of these categories

will be equal to the revenues FDA

expects to collect from application fees

that year. The PDUFA, as amended,

provides that the new fee rates based on

these calculations be published within

60 days after the end of each FY (21

U.S.C. 379h(c)(2)).

III. Inflation and Workload Adjustment

for Application Fees and Total

Application Fee Revenue

The FDAMA provides that the

application fee rates set out in the

statute be adjusted each year for

cumulative inflation. It also provides for

total application fee revenues to

increase or decrease, based on increases

or decreases in FDA’s application

review workload.

A. Inflation Adjustment to Application

Fees

Application fees are assessed at

different rates for qualifying

applications depending on whether the

applications require clinical data on

safety or effectiveness (other than

bioavailability or bioequivalence

studies) (21 U.S.C. 379h(a)(1)(A), and

379(h)(b)). Applications that require

clinical data are subject to the full

application fee. Applications that do not

require clinical data and supplements

that require clinical data are assessed

one-half the fee of applications that

require clinical data. If FDA refuses to

file an application or supplement, 75

percent of the application fee is

refunded to the applicant (21 U.S.C.

379h(a)(1)(D)).

The application fees described above

are set out in the FDAMA for 1998

($250,704 for applications requiring

clinical data, and $125,352 for

applications not requiring clinical data

or supplements requiring clinical data)

(21 U.S.C. 379h(b)(1)), but must be

adjusted for inflation. For FY 1997, the

total increase in the CPI was 2.15

percent, whereas the increase in

applicable Federal salaries for FY 1998

is 2.45 percent. The higher of these, 2.45

percent, is to be used for computing the

inflation adjustment for FY 1998. Since
64850 Federal Register / Vol. 62, No. 236 / Tuesday, December 9, 1997 / Notices

1998 is the first year after 1997, the base

year from which inflation accumulates

and is compounded, there is no

cumulative, compounded inflation from

previous years to be added to this

percentage for FY 1998. The adjusted

application fee rates are computed by

applying the inflation percentage for FY

1998 (102.45 percent) to the FY 1998

statutory application fee rates stated

above. For FY 1998 the adjusted

application fee rates are $256,846 for

applications requiring clinical data, and

$128,423 for applications not requiring

clinical data or supplements requiring

clinical data. These amounts must be

submitted with all applications during

FY 1998.

B. Workload Adjustment and Total

Application Fee Revenue

Total application fee revenues for

1998 will be determined by the number

of applications FDA receives from

October 1, 1997, through September 30,

1998, multiplied by the fee rates

calculated in the preceding paragraph.

Before fees can be set for establishment

and product fee categories, each of

which are to equal total revenues FDA

collects from application fees, FDA

must estimate its total 1998 application

fee revenues. To do this, FDA calculates

the number of full application fees FDA

received in 1997 and uses that figure as

a basis for estimating 1998 application

volume.

For FY 1997, FDA received, filed, and

assessed fees for 118 applications that

require clinical data, 19 applications

that did not require clinical data, and

127 supplements that require clinical

data. Because applications that do not

require clinical data and supplements

that require clinical data are assessed

only one-half the full fee, the equivalent

number of these applications subject to

the full fee is determined by summing

these categories and dividing by 2. This

amount is then added to the number of

applications that require clinical data to

arrive at the equivalent number of

applications subject to full application

fees.

In addition, as of September 30, 1997,

FDA assessed fees for one application

that required clinical data, one

application that did not require clinical

data, and one supplement, all of which

were refused filing or withdrawn before

filing. After refunds, the full application

paid one-fourth the full application fee

and is counted as one-fourth of an

application, and the application that did

not require clinical data and the

supplement each paid one-eighth of the

full application fee and are each

counted as one-eighth of an application.

Using this methodology, the

approximate equivalent number of

applications that required clinical data

and were assessed fees in FY 1997 was

192, before any further decisions were

made on requests for waivers or

reductions. Under the FDAMA small

businesses will receive a full waiver for

their first application (rather than

waiver of half the fee as was the case

under the PDUFA). In addition, the

FDAMA excludes from fees bulk

biological products that are further

manufactured, and provides new

exceptions for certain orphan product

applications and certain supplements

for pediatric indications. Because of

these changes, in FY 1998 FDA

estimates that approximately 40 fewer

equivalents of full applications will

generate fees, or fees for them will be

subject to waivers or reductions. This

number is a substantial increase over

the estimate that FDA would waive or

reduce 16 equivalents of full fee

applications made 1 year ago when fees

for 1997 were established. Therefore,

FDA estimates that approximately 152

equivalent applications that require

clinical data will qualify for fees in FY

1998, after allowing for possible waivers

or reductions.

The following calculations summarize

the determination of FY 1998

application estimates, based on 1997

data:

• 118 applications that require clinical

data, + (19÷2) applications that do not

require clinical data, + (127÷2)

supplements that require clinical data, +

(1÷4) applications that require clinical

data and which FDA refuses to file or

the sponsor withdraws before filing +

(2÷8) supplements which FDA refuses

to file or the sponsor withdraws before

filing minus 40 waivers, reductions or

exceptions = 152 (the estimated number

of ‘‘full fee’’ applications for FY 1998

based on FY 1997 experience, and

rounded up).

The total FY 1998 application fee

revenue is estimated by multiplying the

adjusted application fee rate ($256,846)

by the equivalent number of

applications projected to qualify for fees

in FY 1998 (152), for a total estimated

application fee revenue in 1998 of

$39,040,592. This is the amount of

revenue that FDA is also expected to

derive from establishment fees and from

product fees.

IV. Fee Calculations for Establishment,

and Product Fees

A. Establishment Fees

The FY 1997 establishment fee was

based on an estimate of 250

establishments subject to fees. In FY

1997, 263 establishments qualified for

fees before any decisions on requests for

waivers or reductions were made. Under

the FDAMA, the basis for assessment of

establishment fees is amended. The

responsibility for the fee is placed on

the applicant whose product is

manufactured at the facility, and not on

the owner of the facility. Contract

manufacturing establishments will now

be subject to fees, to be paid by the

applicant whose product is

manufactured at that establishment.

FDA believes this will subject

additional establishments to fees, and

estimates that approximately 275

establishments will qualify for fees in

FY 1998 after allowing for possible

waivers or reductions. Thus, the number

275 is used in setting the new

establishment fee rate. The fee per

establishment is determined by dividing

the adjusted total fee revenue to be

derived from establishments

($39,040,592), by the estimated 275

establishments, for an establishment fee

rate for FY 1998 of $141,966 (rounded

to the nearest dollar).

B. Product Fees

The FY 1997 product fee was based

on an estimate that 2,200 products

would be subject to product fees in FY

1997. For FY 1997, 2,267 products

qualified for fees before any decisions

on requests for waivers or reductions

were made. FDA estimates that only

2,100 products will qualify for product

fees in FY 1998, after allowing for the

fact that about 140 antibiotic products

and 11 products manufactured by state

governments that paid fees in 1997 will

no longer be subject to fees in 1998

under the FDAMA, and for the fact that

an additional 17 large volume parenteral

products that were subject to fees in

1997 are now regulated as generic drugs

and will not be subject to fees in 1998.

Accordingly, the FY 1998 product fee

rate is determined by dividing the

adjusted total fee revenue to be derived

from product fees ($39,040,592) by the

estimated 2,100 products for a product

fee rate of $18,591 (rounded to the

nearest dollar).

V. Adjusted Fee Schedules for FY 1998

The fee rates for FY 1998 are set out

in the following table:

Fee category Fee rates for FY

1997

Applications

Requiring clinical

data ...................... $256,846

Not requiring clinical

data ...................... $128,423
Federal Register / Vol. 62, No. 236 / Tuesday, December 9, 1997 / Notices 64851

Fee category Fee rates for FY

1997

Supplements requiring clinical data .... $128,423

Establishments ............ $141,966

Products ...................... $18,591

VI. Implementation of Adjusted Fee

Schedule

A. Application Fees

Any application or supplement

subject to fees under the PDUFA that is

submitted after December 31, 1997,

must be accompanied by the

appropriate application fee established

in the new fee schedule. FDA will bill

applicants who submitted application

fees between October 1, 1997, and

December 31, 1997, based on the

adjusted rate schedule.

B. Establishment and Product Fees

By December 31, 1997, FDA will issue

invoices for establishments and product

fees for FY 1998 under the new fee

schedules. Payment will be due by

January 31, 1998. FDA will issue

invoices in October 1998 for any

products and establishments subject to

fees for FY 1998 that qualify for fees

after the December 1997 billing.

Dated: December 3, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–32164 Filed 12–8–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0151]

Agency Information Collection

Activities; Announcement of OMB

Approval

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that a collection of information entitled

‘‘Applications for Exemption from

Preemptions of Medical Device

Requirements’’ has been approved by

the Office of Management and Budget

(OMB) under the Paperwork Reduction

Act of 1995 (the PRA).

FOR FURTHER INFORMATION CONTACT:

Margaret R. Schlosburg, Office of

Information Resources Management

(HFA–250), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–1223.

SUPPLEMENTARY INFORMATION: In the

Federal Register of May 16, 1997 (62 FR

27059), the agency announced that the

proposed information collection had

been submitted to OMB for review and

clearance under section 3507 of the PRA

(44 U.S.C. 3507). An agency may not

conduct or sponsor, and a person is not

required to respond to, a collection of

information unless it displays a

currently valid OMB control number.

OMB has now approved the information

collection and has assigned OMB

control number 0910–0129. The

approval expires on July 31, 2000.

Dated: December 2, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–32166 Filed 12–8–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0266]

Agency Information Collection

Activities; Announcement of OMB

Approval

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that a collection of information entitled

‘‘Administrative Detention and Banned

Medical Devices’’ has been approved by

the Office of Management and Budget

(OMB) under the Paperwork Reduction

Act of 1995 (the PRA).

FOR FURTHER INFORMATION CONTACT:

Margaret R. Schlosburg, Office of

Information Resources Management

(HFA–250), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–1223.

SUPPLEMENTARY INFORMATION: In the

Federal Register of July 16, 1997 (62 FR

38095), the agency announced that the

proposed information 3collection had

been submitted to OMB for review and

clearance under section 3507 of the PRA

(44 U.S.C. 3507). An agency may not

conduct or sponsor, and a person is not

required to respond to, a collection of

information unless it displays a

currently valid OMB control number.

OMB has now approved the information

collection and has assigned OMB

control number 0910–0114. The

approval expires on September 30,

2000.

Dated: November 30, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–32167 Filed 12–8–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–484]

Agency Information Collection

Activities: Submission for OMB

Review; Comment Request

In compliance with the requirement

of section 3506(c)(2)(A) of the

Paperwork Reduction Act of 1995, the

Health Care Financing Administration

(HCFA), Department of Health and

Human Services, has submitted to the

Office of Management and Budget

(OMB) the following proposal for the

collection of information. Interested

persons are invited to send comments

regarding the burden estimate or any

other aspect of this collection of

information, including any of the

following subjects: (1) The necessity and

utility of the proposed information

collection for the proper performance of

the agency’s functions; (2) the accuracy

of the estimated burden; (3) ways to

enhance the quality, utility, and clarity

of the information to be collected; and

(4) the use of automated collection

techniques or other forms of information

technology to minimize the information

collection burden.

Type of Information Collection

Request: Extension of a currently

approved collection without change;

Title of Information Collection:

Attending Physician’s Certification of

Medical Necessity for Home Oxygen

Therapy and Supporting Regulations 42

CFR 410.38 and 42 CFR 424.5; Form

Number: HCFA–484 (OMB approval

#0938–0534); Use: To determine oxygen

is reasonable and necessary pursuant to

Medicare Statute, Medicare claims for

home oxygen therapy must be

supported by the treating physician’s

statement and other information

including estimate length of need (# of

months), diagnosis codes (ICD–9) and:

1. Results and date of the most recent

arterial blood gas PO2 and/or oxygen

saturation tests.

2. The most recent arterial blood gas

PO2 and/or oxygen saturation test

performed EITHER with the patient in a

chronic stable state as an outpatient, OR