27982 Federal Register / Vol. 60, No. 102 / Friday, May 26, 1995 / Notices

[Docket No. 95E–0046]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; Neurolite

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for

Neurolite and is publishing this notice

of that determination as required by

law. FDA has made the determination

because of the submission of an

application to the Commissioner of

Patents and Trademarks, Department of

Commerce, for the extension of a patent

which claims that human drug product.

ADDRESSES: Written comments and

petitions should be directed to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

rm. 1–23, 12420 Parklawn Dr.,

Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Brian J. Malkin, Office of Health Affairs

(HFY–20), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–443–1382.

SUPPLEMENTARY INFORMATION: The Drug

Price Competition and Patent Term

Restoration Act of 1984 (Pub. L. 98–417)

and the Generic Animal Drug and Patent

Term Restoration Act (Pub. L. 100–670)

generally provide that a patent may be

extended for a period of up to 5 years

so long as the patented item (human

drug product, animal drug product,

medical device, food additive, or color

additive) was subject to regulatory

review by FDA before the item was

marketed. Under these acts, a product’s

regulatory review period forms the basis

for determining the amount of extension

an applicant may receive.

A regulatory review period consists of

two periods of time: A testing phase and

an approval phase. For human drug

products, the testing phase begins when

the exemption to permit the clinical

investigations of the drug becomes

effective and runs until the approval

phase begins. The approval phase starts

with the initial submission of an

application to market the human drug

product and continues until FDA grants

permission to market the drug product.

Although only a portion of a regulatory

review period may count toward the

actual amount of extension that the

Commissioner of Patents and

Trademarks may award (for example,

half the testing phase must be

subtracted as well as any time that may

have occurred before the patent was

issued), FDA’s determination of the

length of a regulatory review period for

a human drug product will include all

of the testing phase and approval phase

as specified in 35 U.S.C. 156(g)(1)(B).

FDA recently approved for marketing

the human drug product Neurolite.

Neurolite (Technetium TC–99M

Bicisate) single photon emission

computerized tomography (SPECT) is

indicated as an adjunct to conventional

computed tomography (CT) or magnetic

resonance imaging (MRI) in the

localization of stroke in patients in

whom stroke has already been

diagnosed. Subsequent to this approval,

the Patent and Trademark Office

received a patent term restoration

application for Neurolite (U.S. Patent

No. 5,279,811) from Dupont Merck

Pharmaceutical Co., and the Patent and

Trademark Office requested FDA’s

assistance in determining this patent’s

eligibility for patent term restoration. In

a letter dated march 28, 1995, FDA

advised the Patent and Trademark

Office that this human drug product had

undergone a regulatory review period

and that the approval of Neurolite

represented the first permitted

commercial marketing or use of the

product. Shortly thereafter, the Patent

and Trademark Office requested that

FDA determine the product’s regulatory

review period.

FDA has determined that the

applicable regulatory review period for

Neurolite is 2,595 days. Of this time,

1,602 days occurred during the testing

phase of the regulatory review period,

while 993 days occurred during the

approval phase. These periods of time

were derived from the following dates:

1. The date an exemption under

section 505(i) of the Federal Food, Drug,

and Cosmetic Act (21 U.S.C. 355(i))

became effective: October 18, 1987. The

applicant claims September 18, 1987, as

the date the investigational new drug

application (IND) became effective.

However, FDA records indicate that the

IND effective date was October 18, 1987,

which was 30 days after FDA receipt of

the IND.

2. The date the human drug was

initially submitted with respect to the

human drug product under section

505(b) of the Federal Food, Drug, and

Cosmetic Act: March 6, 1992. The

applicant claims March 5, 1992, as the

date the new drug application (NDA) for

Neurolite (NDA 20–256) was initially

submitted. However, FDA records

indicate that NDA 20–256 was

submitted on March 6, 1992.

3. The date the application was

approved: November 23, 1994. FDA has

verified the applicant’s claim that NDA

20–256 was approved on November 23,

1994.

This determination of the regulatory

review period establishes the maximum

potential length of a patent extension.

However, the U.S. Patent and

Trademark Office applies several

statutory limitations in its calculations

of the actual period for patent extension.

In its application for patent extension,

this applicant seeks 156 days of patent

term extension.

Anyone with knowledge that any of

the dates as published is incorrect may,

on or before July 25, 1995, submit to the

Dockets Management Branch (address

above) written comments and ask for a

redetermination. Furthermore, any

interested person may petition FDA, on

or before November 22, 1995, for a

determination regarding whether the

applicant for extension acted with due

diligence during the regulatory review

period. To meet its burden, the petition

must contain sufficient facts to merit an

FDA investigation. (See H. Rept. 857,

part 1, 98th Cong., 2d sess., pp. 41–42,

1984.) Petitions should be in the format

specified in 21 CFR 10.30.

Comments and petitions should be

submitted to the Dockets Management

Branch (address above) in three copies

(except that individuals may submit

single copies) and identified with the

docket number found in brackets in the

heading of this document. Comments

and petitions may be seen in the

Dockets Management Branch between 9

a.m. and 4 p.m., Monday through

Friday.

Dated: May 15, 1995.

Stuart L. Nightingale,

Associate Commissioner for Health Affairs.

[FR Doc. 95–13033 Filed 5–25–95; 8:45 am]

BILLING CODE 4160–01–F

Health Resources and Services

Administration

National Practitioner Data Bank;

Change in Methods of Fee Payment

The Health Resources and Services

Administration (HRSA), Public Health

Service (PHS), Department of Health

and Human Services (DHHS), is

announcing a change in the method for

payment of fees that are charged entities

authorized to request information from

the National Practitioner Data Bank

(Data Bank).

The Data Bank is authorized by the

Health Care Quality Improvement Act of

1986 (the Act), title IV of Public Law

99–660, as amended (42 U.S.C. 11101 et

seq.). Regulations at 45 CFR Part 60

implementing the Data Bank authorize

the reporting and release of information

concerning: (1) Payments made for the

benefit of physicians, dentists, and other
Federal Register / Vol. 60, No. 102 / Friday, May 26, 1995 / Notices 27983

health care practitioners as a result of

medical malpractice actions or claims;

and (2) certain adverse actions taken

regarding the licenses and clinical

privileges of physicians and dentists.

Section 60.3 of these regulations should

be consulted for the definition of terms

used in this announcement.

Section 427(b)(4) of the Act authorizes

the establishment of fees for the costs of

processing requests for disclosure and of

providing such information. A final rule

published elsewhere in this issue of the

Federal Register amends the existing

Data Bank regulations (45 CFR part 60)

to remove regulatory restrictions on

allowable methods of payment to permit

the Secretary to announce alternate

payment methods through periodic

notice in the Federal Register. Section

60.12(c)(3) of the regulations states that

the Secretary shall announce the

method of payment of fees payable to

the Data Bank through periodic

announcement in the Federal Register.

In determining the method, the

Secretary shall consider efficiency,

effectiveness, and convenience for the

Data Bank users and the Department.

An assessment of the full operating

costs related to processing requests for

disclosure of Data Bank information as

required by the DHHS Appropriations

Act of 1994 (title II of Pub. L. 103–112,

dated October 21, 1993), as well as the

comparative costs of the various

methods for filing and paying for

queries has resulted in a decision to

expand the options for methods of

payment of Data Bank fees available to

users.

Effective upon publication, the

following methods of fee payment will

all be accepted by the Data Bank: credit

card, electronic funds transfer, check or

money order.

Allowable methods of fee payment

will be reviewed periodically and

revised as necessary, based upon

experience. Any changes in the methods

of fee payment accepted, and the

effective date of the change, will be

announced in the Federal Register.

Dated: March 14, 1995.

Ciro V. Sumaya,

Administrator.

[FR Doc. 95–12908 Filed 5–25–95; 8:45 am]

BILLING CODE 4160–15–P

Public Health Service

RIN 0905–ZA91

Notice Regarding Section 602 of the

Veterans Health Care Act of 1992 New

Drug Pricing

AGENCY: Public Health Service, HHS.

ACTION: Notice.

SUMMARY: Section 602 of Public Law

102–585, the ‘‘Veterans Health Care Act

of 1992,’’ enacted section 340B of the

Public Health Service Act (‘‘PHS Act’’),

‘‘Limitation on Prices of Drugs

Purchased by Covered Entities.’’ Section

340B provides that a manufacturer who

sells covered outpatient drugs to eligible

entities must sign a pharmaceutical

pricing agreement with the Secretary of

Health and Human Services in which

the manufacturer agrees to charge a

price for covered outpatient drugs that

will not exceed an amount determined

under a statutory formula.

The purpose of this notice is to inform

interested parties of the following

proposed guidelines relative to new

drug pricing. Public comment is invited.

DATES: The public is invited to submit

comments on the proposed guidelines

by June 26, 1995. After consideration of

the comments submitted, the Secretary

will issue the final guidelines.

FOR FURTHER INFORMATION CONTACT:

Marsha Alvarez, R. Ph., Director, Drug

Pricing Program, Bureau of Primary

Health Care, Health Resources and

Services Administration, 4350 East West

Highway, 10th Floor, Bethesda, MD

20814, Phone (301) 594–4353, FAX

(301) 594–4982.

SUPPLEMENTARY INFORMATION: The Office

of Drug Pricing has developed the

following guidelines to facilitate

program implementation:

New Drug Pricing

Calculation of the current quarter PHS

ceiling price for each covered outpatient

drug, as provided in section 340B(a)(1)

of the PHS Act, is based upon data

supplied to the Medicaid Drug Rebate

Program (i.e., average manufacturer

price, ‘‘AMP,’’ and Best Price, ‘‘BP’’).

The manufacturer calculates pricing

information for all of its covered

outpatient drugs and sends this pricing

data to the Health Care Financing

Administration (HCFA) within 30 days

after the end of the quarter. HCFA

provides PHS with the data necessary

for PHS to determine the ceiling price.

PHS determines the ceiling price based

on the rebate required under the

Medicaid drug rebate program. For

calendar year 1995, the Medicaid basic

rebate for single source and innovator

multiple source drugs is the greater of

15.2 percent of the AMP or the AMP

minus best price. In calendar year 1996

and thereafter, the rebate percentage

decreases to 15.1 percent. An additional

rebate must also be paid for single

source and innovator multiple source

drugs in the amount by which the

increase in the AMP exceeds the

increase in the Consumer Price Index—

Urban (CPI–U). The PHS ceiling price is

computed based on the combined basic

and additional rebate amounts under

the Medicaid program. For noninnovator multiple source drugs, the

rebate percentage is 11 percent of the

AMP.

For PHS pricing purposes, the

timeframe for reporting the pricing data

is a problem with respect to new drugs

because there is a two quarter lag for

new drug pricing information. For new

drugs, AMP is not available until after

the end of the first full quarter after the

day on which the drug was first sold.

For example, if a new drug was first

sold on January 15, the AMP for the first

full quarter would not be available until

after June 30. Manufacturers would

report the baseline AMP for this new

drug to HCFA by July 31.

This time lag is not a problem for the

State Medicaid agencies because they

bill manufacturers for a rebate after the

covered outpatient drugs are dispensed

to Medicaid beneficiaries. However, to

comply with the requirements of section

340B of the PHS Act, the PHS ceiling

price must be determined before the

covered outpatient drug is sold to the

covered entity.

Because there is no sales data for a

new drug from which to determine the

PHS ceiling price, the Office of Drug

Pricing is proposing to utilize a ceiling

price estimated by the manufacturer

until sufficient data is available to

calculate the AMP and BP of the new

drug. Any adjustments necessary to

reconcile differences between the

estimated and the actual ceiling price

will be in the form of a retroactive

charge back or rebate after the actual

ceiling price is established.

Because the manufacturer calculates

the PHS ceiling price using a two

quarter data lag, the manufacturer could

estimate the new drug ceiling price for

three quarters. For example, a new drug

that comes on the market in February

(January–March quarter) will have an

estimated PHS ceiling price for that

quarter. AMP and BP data will be

collected during the second quarter

(April–June) and submitted to HCFA

within 30 days after the third quarter

(July–September) for calculation of the

rebate percentage. Because pricing

needs to be transmitted to wholesalers

two weeks before the beginning of the

quarter, an accurate PHS ceiling price

for the third quarter will not be

available at that time. The manufacturer

must continue to estimate the PHS

ceiling price for the second and third

quarters, and will be able to calculate an

accurate PHS ceiling price for the fourth