16162 Federal Register / Vol. 62, No. 65 / Friday, April 4, 1997 / Notices

Director, Office of the Assistant Secretary for

Planning and Evaluation, DHHS, Room 440–

D, Humphrey Building, 200 Independence

Avenue SW., Washington, DC 20201,

telephone (202) 690–7100, or Marjorie S.

Greenberg, Acting Executive Secretary,

NCVHS, NCHS, CDC, Room 1100,

Presidential Building, 6525 Belcrest Road,

Hyattsville, Maryland 20782, telephone (301)

436–7050. Information also is available on

the NCVHS home page of the HHS website:

http://aspe.os.dhhs.gov/ncvhs.

Dated: March 26, 1997.

James Scanlon,

Director, Division of Data Policy, Office of

the Assistant Secretary for Planning and

Evaluation.

[FR Doc. 97–8597 Filed 4–3–97; 8:45 am]

BILLING CODE 4151–04–M

Centers for Disease Control and

Prevention

[30 DAY–3–97]

Agency Forms Undergoing Paperwork

Reduction Act Review

The Centers for Disease Control and

Prevention (CDC) publishes a list of

information collection requests under

review by the Office of Management and

Budget (OMB) in compliance with the

Paperwork Reduction Act (44 U.S.C.

Chapter 35). To request a copy of these

requests, call the CDC Reports Clearance

Office on (404) 639–7090. Send written

comments to CDC, Desk Officer; Human

Resources and Housing Branch, New

Executive Office Building, Room 10235;

Washington, DC 20503. Written

comments should be received within 30

days of this notice.

Proposed Project

1. Congenital Syphilis Case

Investigation and Report Form (CDC

73.126 REV 09–91)–(0920–0128). This

request is for a 3-year extension of

clearance. Reducing congenital syphilis

(CS) is a national objective in the DHHS

Report entitled Healthy People 2000:

Midcourse Review and 1995 Revisions.

Objective 19.4 of this document states

the goal: ‘‘reduce congenital syphilis to

an incidence of no more than 40 cases

per 100,000 live births’’ by the year

2000. In order to meet this national

objective, an effective surveillance

system for CS must be continued in

order to monitor current levels of

disease and progress towards the year

2000 objective. This data will also be

used to develop intervention strategies

and to evaluate ongoing control efforts.

The total annual burden hours are 500.

Respondents

Number

of respondents

Number

of responses/

respondent (in

hrs.)

Average

burden/

response

(in hrs.)

State and

local

health department .. 2000 1 0.25

Dated: March 28, 1997.

Wilma G. Johnson,

Acting Associate Director for Policy Planning

and Evaluation, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 97–8618 Filed 4–3–97; 8:45 am]

BILLING CODE 4163–18–P

Food and Drug Administration

[Docket No. 96E–0503]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; XALATANTM

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for

XALATANTM 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,

12420 Parklawn Dr., rm. 1–23,

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 XALATANTM

(latanoprost). XALATANTM is indicated

for the reduction of elevated intraocular

pressure in patents with open-angle

glaucoma and ocular hypertension who

are intolerant of other intraocular

pressure lowering medications or

insufficiently responsive (failed to

achieve target IOP determined after

multiple measurements over time) to

another intraocular pressure lowering

medication. Subsequent to this

approval, the Patent and Trademark

Office received a patent term restoration

application for XALATANTM (U.S.

Patent No. 4,599,353) from the Trustees

of Columbia University in the City of

New York, and the Patent and

Trademark Office requested FDA’s

assistance in determining this patent’s

eligibility for patent term restoration. In

a letter dated February 18, 1997, FDA

advised the Patent and Trademark

Office that this human drug product had

undergone a regulatory review period

and that the approval of XALATANTM

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

XALATANTM is 1,875 days. Of this

time, 1,519 days occurred during the

testing phase of the regulatory review

period, while 356 days occurred during

the approval phase. These periods of

time were derived from the following

dates: