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
Federal Register / Vol. 62, No. 65 / Friday, April 4, 1997 / Notices 16169

profit; Not-for-profit institutions;

Federal Government; State, Local or

Tribal Government. Type of

Respondents: Adult cancer patients;

members of the public; health care

professionals; organizational

representatives. The annual reporting

burden is as follows: Estimated Number

of Respondents: 13,780; Estimated

Number of Responses per Respondent:

1; Average Burden Hours Per Response;

1458; and Estimated Total Annual

Burden Hours Requested: 2,010. There

are no Capital Costs, Operating Costs

and/or Maintenance Costs to report.

Request for Comments

Written comments and/or suggestions

from the public and affected agencies

are invited on one or more of the

following points: (1) Whether the

proposed collection of information is

necessary for the proper performance of

the function of the agency, including

whether the information will have

practical utility; (2) The accuracy of the

agency’s estimate of the burden of the

proposed collection of information,

including the validity of the

methodology and assumptions used; (3)

Ways to enhance the quality, utility, and

clarity of the information to be

collected; and (4) Ways to minimize the

burden of the collection of information

on those who are to respond, including

the use of appropriate automated,

electronic, mechanical, or other

technological collection techniques or

their forms of information technology.

For Further Information Contact: To

request more information on the

proposed project or to obtain a copy of

the data collection plans and

instruments, contact Ellen Eisner,

Communications Research Manager,

Health Promotion Branch, OCC, NCI,

NIH, Building 31, Room 10A03, 9000

Rockville Pike, Bethesda, MD 20892, or

call non-toll-free number (301) 496–

6667 or E-mail your request, including

your address to

EisnerE@occ.nci.nih.gov.

Comments Due Date: Comments

regarding this information collection are

best assured of having their full effect if

received by June 3, 1997.

Dated: March 27, 1997.

Nancie L. Bliss,

Project Clearance Liaison, NCI.

[FR Doc. 97–8595 Filed 4–3–97; 8:45 am]

BILLING CODE 4140–01–M

A Comprehensive Alcohol Education

Program for Pre-Adolescents Using

Interactive Multimedia; Submission for

OMB Review; Comment Request

SUMMARY: Under the provisions of

Section 3506  (2) (A) of the Paperwork

Reduction Act of 1995, the National

Institute on Alcohol Abuse and

Alcoholism (NIAAA), National

Institutes of Health (NIH) has submitted

to the Office of Management and Budget

(OMB) a request to review and approve

the information collection listed below.

This proposed information collection

was previously in the Federal Register

on March 22, 1996, and allowed 60 days

for public comment. No public

comments were received. The purpose

of this notice is to allow an additional

30 days for public comment. The NIH

may not conduct or sponsor, and the

respondent is not required to respond

to, an information collection that has

been extended, revised, or implemented

on or after September 28, 1997, unless

it displays a currently valid OMB

control number.

PROPOSED COLLECTION: Title: A

Comprehensive Alcohol Education

Program for Pre-Adolescents Using

Interactive Multimedia. Type of

Information Collection request: NEW.

Need and Use of Information Collection:

The information proposed for collection

will be used by the NIAAA to determine

the efficacy of interactive multimedia

for delaying the onset of drinking among

7th and 8th grade males and females.

Interactive multimedia enables the

combination of the elements of

television and movies that engage and

motivate the target populations with

computer-based interaction,

simulations, and games to (1) increase

information about the negative

consequences of teen drinking and (2)

teach practical skills for avoiding and

refusing alcohol. Subject participation

will involve (1) focus groups, during

development of the multimedia

program, and (2) post-development

behavioral trials.

Frequency of Response: On Occasion.

Affected Public: Pre-adolescents.

Type of Respondents: Minor Students

(Grades 7th and 8th).

Estimated Number of Respondents:

308.

Estimated Number of Responses per

Respondent: 1.

Average Burden Hours per Response:

.281.

And Estimated Total Annual Burden

Hours Requested: 89.2.

There are no Capital Costs to report.

There are no Operating or Maintenance

Costs to report.

The annual burden estimates are as

follows:

Type and number of respondents

Responses

per respondent

Total responses Hours Total hours

Focus Group Subjects 40 ................................................................................................. 1 40 0.5 20

Trial Subjects 268 ............................................................................................................. 4 1072 0.5 536

Total Number of Respondents: 308.

Total Number of Responses: 1112.

Total Hours: 556.

REQUEST FOR COMMENTS: Comments are

invited on: (a) whether the proposed

collection is necessary, including

whether the information has practical

use; (b) ways to enhance the clarity,

quality, and use of the information to be

collected; the accuracy of the agency

estimate of burden of the proposed

collection; and (d) ways to minimize the

collection burden of the respondents.

Send written comments to Dr. Kendall

Bryant, Prevention Research Branch,

Division of Clinical and Prevention

Research (DCPR), NIAAA, NIH, Willco

Building, Room 505, 6000 Executive

Boulevard, MSC 7003, Bethesda,

Maryland 20892–7003.

DIRECT COMMENTS TO OMB: Written

comments and/or suggestions regarding

the item(s) contained in this notice,

especially regarding the estimated

public burden and associated response

time should be directed to the Office of

Management and Budget, Office of

Regulatory Affairs, New Executive

Office Building, Room 10235,

Washington, DC 20503, Attention: Desk

Officer for NIH.

FOR FURTHER INFORMATION CONTACT: To

request more information on the

proposed project or to obtain a copy of

the data collection plans, contact Dr.

Kendall Bryant, Prevention Research

Branch, Division of Clinical and

Prevention Research (DCPR), NIAAA,

NIH, Willco Building, Room 505, 6000

Executive Boulevard, MSC 7003,

Bethesda, Maryland 20892–7003, or call

non-toll-free number (301) 443–8820.

COMMENTS DUE DATE: Comments

regarding this information collection are