Federal Register / Vol. 62, No. 65 / Friday, April 4, 1997 / Notices 16167

(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 MERETEK

UBTTM Breath Test (urea, C–13).

MERETEK UBTTM Breath Test is

intended for use in the qualitative

detection of urease associated with

Helicobacter pylori in the human

stomach and as an aid in the diagnosis

of H. pylori infection in adult patients.

Subsequent to this approval, the Patent

and Trademark Office received a patent

term restoration application for

MERETEK UBTTM Breath Test (U.S.

Patent No. 4,830,010) from

Meretekdiagnostics, Inc., 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 21, 1997, FDA

advised the Patent and Trademark

Office that this human drug product had

undergone a regulatory review period

and that the approval of MERETEK

UBTTM Breath Test 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

MERETEK UBTTM Breath Test is 2,023

days. Of this time, 1,527 days occurred

during the testing phase of the

regulatory review period, while 496

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: March 7, 1991. The

applicant claims January 19, 1990, as

the date the investigational new drug

application (IND) for MERETEK UBTTM

Breath Test (IND 26,861) became

effective. However, FDA records

indicate that IND 26,861 was received

by the agency on August 7, 1985. The

protocol that first contained the Urea

Breath Test was received by the agency

on February 5, 1991, as part of this IND.

Using February 5, 1991, as the

beginning date plus adding 30 days for

the receipt date of the modification,

results in an effective date of March 7,

1991, for the testing phase of the active

ingredient of this product.

2. The date the application was

initially submitted with respect to the

human drug product under section

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

Cosmetic Act: May 11, 1995. FDA has

verified the applicant’s claim that the

new drug application (NDA) for

MERETEK UBTTM Breath Test (NDA

20–586) was initially submitted on May

11, 1995.

3. The date the application was

approved: September 17, 1996. FDA has

verified the applicant’s claim that NDA

20–586 was approved on September 17,

1996.

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 780 days of patent

term extension.

Anyone with knowledge that any of

the dates as published is incorrect may,

on or before June 3, 1997 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 October 1, 1997 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: March 27, 1997.

Allen B. Duncan,

Acting Associate Commissioner for Health

Affairs.

[FR Doc. 97–8625 Filed 4–3–97; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 97E–0014]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; Astelin Nasal Spray

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for

Astelin Nasal Spray 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
16168 Federal Register / Vol. 62, No. 65 / Friday, April 4, 1997 / Notices

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 Astelin Nasal

Spray (azelastine hydrochloride).

Astelin Nasal Spray is indicated for

the treatment of the symptoms of

seasonal allergic rhinitis such as

rhinorrhea, sneezing, and nasal pruritus

in adults and children 12 years and

older. Subsequent to this approval, the

Patent and Trademark Office received a

patent term restoration application for

Astelin Nasal Spray (U.S. Patent No.

5,164,194) from Astra Medica AG, 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 Astelin Nasal Spray

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

Astelin Nasal Spray is 2,797 days. Of

this time, 749 days occurred during the

testing phase of the regulatory review

period, while 2,048 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: March 8, 1989. The

applicant claims February 6, 1989, as

the date the investigational new drug

application (IND) became effective.

However, FDA records indicate that the

IND effective date was March 8, 1989,

which was 30 days after FDA receipt of

the IND on February 6, 1989.

2. The date the application was

initially submitted with respect to the

human drug product under section

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

Cosmetic Act: March 26, 1991. FDA has

verified the applicant’s claim that the

new drug application (NDA) for

Astelin Nasal Spray (NDA 20–114)

was initially submitted on March 26,

1991.

3. The date the application was

approved: November 1, 1996. FDA has

verified the applicant’s claim that NDA

20–114 was approved on November 1,

1996.

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 349 days of patent

term extension.

Anyone with knowledge that any of

the dates as published is incorrect may,

on or before June 3, 1997 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 October 1, 1997 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: March 27, 1997.

Allen B. Duncan,

Acting Associate Commissioner for Health

Affairs.

[FR Doc. 97–8626 Filed 4–3–97; 8:45 am]

BILLING CODE 4160–01–F

National Institutes of Health

Pretesting of Office of Cancer

Communications Messages; Proposed

Collection; Comment Request

Summary: In compliance with the

requirements of Section 3506(c)(2)(A) of

the Paperwork Reduction Act of 1995,

for opportunity for public comment on

proposed data collection projects, the

National Cancer Institute (NCI), the

National Institutes of Health (NIH) will

publish periodic summaries of proposed

projects to be submitted to the Office of

Management and Budget (OMB) for

review and approval.

Proposed Collection

Title: Pretesting of Office of Cancer

Communications Messages.

Type of Information Collection

Request: EXTENSION (OMB # 0925–

0046, expires 8/31/97).

Need and Use of Information

Collection: In order to carry out NCI’s

legislative mandate to educate and

disseminate information about cancer

prevention, detection diagnosis, and

treatment to a wide variety of audiences

and organizations (e.g. cancer patients,

their families, the general public, health

providers, the media, voluntary groups,

scientific and medical organizations),

the Office of Cancer Communications

(OCC) needs to pretest its

communications strategies, concepts,

and messages while they are under

development. The primary purpose of

this pretesting, or formative evaluation,

is to ensure that the messages,

communications materials, and

information services created by OCC

have the greatest capacity of being

received, understood, and accepted by

their target audiences. By utilizing

appropriate qualitative and quantitative

methodologies, OCC is able to (1)

Understand characteristics of the

intended target audience—their

attitudes, beliefs and behaviors—and

use this information in the development

of effective communications tools; (2)

produce or refine messages that have the

greatest potential to influence target

audience attitudes and behavior in a

positive manner; and (3) expend limited

program resources dollars wisely and

effectively. Frequency of Response: On

occasion. Affected public: Individuals or

households; Businesses or other for