Federal Register / Vol. 62, No. 28 / Tuesday, February 11, 1997 / Notices 6261

reserve their heavy hand for conduct

that falls within standards for per se

illegality clearly enunciated by the

Supreme Court. Accordingly, I cannot

support the proposed enforcement

action made public today.

[FR Doc. 97–3341 Filed 2–10–97; 8:45 am]

BILLING CODE 6750–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

[30DAY–28]

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.

The following request has been

submitted for review since the last

publication date on February 4, 1997.

Proposed Project

1. Biomechanical Stress Control in

Drywall Installation—New-Drywall

installers represented approximately

1.42% of the construction workforce in

1992. Based on analysis of the

Supplementary Data System (BLS) of 21

states, the compensable injury/

incidence rate (27.5 cases per 100

workers for this group) was nearly three

times the injury rate of 9.5 for all other

construction occupations combined, in

1987. Data from the 1992 and 1993

Annual Survey of Occupational Injuries

and Illnesses (BLS) indicated that there

were an estimated 4,680 traumatic

injuries among drywall installers

involving days away from work in the

construction industry in 1992, and

4,122 in 1993. In 1993, bodily reaction

and exertion (31.8%), falls (28.6%), and

contact with objects (24.6%) were the

leading events of injury and illness

involving days away from work. As a

result, sprains and strains (40.6%)

constituted the most frequent nature of

injuries and illnesses category in 1994.

To gain an understanding of these

injuries, NIOSH has initiated this

project to examine different approaches

in both field and laboratory settings to

identify and control the high-risk

activities associated with the traumatic

injuries and overexertion hazards of

drywall installation work. One of the

field study components for this project

is to identify high-risk tasks and

activities for drywall installers, using a

drywall installation survey which was

developed at NIOSH. The findings of

this survey will provide further

understanding and focus laboratory

research efforts on the most hazardous

tasks/activities of drywall-installation

work. Study populations will include

drywall installers or construction

workers with drywall installation

experience. Each questionnaire will take

approximately 20 minutes to complete.

The total annual burden is 30.

Respondents Number of

respondents

Number of

responses/

respondent

Average

burden/response

(in hrs.)

Drywall Installers ...................................................................................................................................... 120 1 .25

Dated: February 5, 1997.

Wilma G. Johnson,

Acting Associate Director for Policy Planning

and Evaluation, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 97–3332 Filed 2–10–97; 8:45 am]

BILLING CODE 4163–18–P

Food and Drug Administration

[Docket No. 96E–0388]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; MERREM I.V.

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for

MERREM I.V. 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 MERREM I.V.

(meropenem). MERREM I.V. is

indicated as single agent therapy for the

treatment of the following infections
6262 Federal Register / Vol. 62, No. 28 / Tuesday, February 11, 1997 / Notices

when caused by susceptible strains of

the following designated

microorgranisms: Intra-abdominal

Infections: Complicated appendicitis

and peritonitis caused by viridans group

streptococci, Escherichia coli, Klebsiella

pneumoniae, Pseudomonas aeruginosa,

Bacteroides fragilis, B.

thetaiotaomicron, and

Peptostreptococcus species. Bacterial

Meningitis (pediatric patients ≥ 3

months only): Bacterial meningitis

caused by Streptococcus pneumoniae,

Haemophilus influenzae (β-lactamase

and non-β-lactamase-producing strains),

and Neisseria meningitidis. Subsequent

to this approval, the Patent and

Trademark Office received a patent term

restoration application for MERREM

I.V. (U.S. Patent No. 4,943,569) from

Sumitomo Pharmaceutical Co., Ltd., and

the Patent and Trademark Office

requested FDA’s assistance in

determining this patent’s eligibility for

patent term restoration. In a letter dated

November 4, 1996, FDA advised the

Patent and Trademark Office that this

human drug product had undergone a

regulatory review period and that the

approval of MERREM I.V. 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

MERREM I.V. is 2,608 days. Of this

time, 1,640 days occurred during the

testing phase of the regulatory review

period, while 968 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: May 3, 1989. FDA has

verified the applicant’s claim that the

date that the investigational new drug

application became effective was on

May 3, 1989.

2. The date the application was

initially submitted with respect to the

human drug product under section 507

of the Federal Food, Drug, and Cosmetic

Act (21 U.S.C. 357): October 28, 1993.

FDA has verified the applicant’s claim

that the new drug application (NDA) for

MERREM I.V. (NDA 50–706) was

initially submitted on October 28, 1993.

3. The date the application was

approved: June 21, 1996. FDA has

verified the applicant’s claim that NDA

20–506 was approved on June 21, 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 1,063 days of patent

term extension.

Anyone with knowledge that any of

the dates as published is incorrect may,

on or before April 14, 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 August 11, 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: January 31, 1997.

Stuart L. Nightingale,

Associate Commissioner for Health Affairs.

[FR Doc. 97–3313 Filed 2–10–97; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 96E–0360]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; DIFFERIN Topical Gel

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for

DIFFERIN Topical Gel 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 DIFFERIN

Topical Gel (adapalene). DIFFERIN

Topical Gel is indicated for the topical

treatment of acne vulgaris. Subsequent

to this approval, the Patent and

Trademark Office received a patent term

restoration application for DIFFERIN

Topical Gel (U.S. Patent No. 4,717,720)

from Centre International de Recherches

Dermatologiques (CIRD), and the Patent

and Trademark Office requested FDA’s

assistance in determining this patent’s

eligibility for patent term restoration. In

a letter dated October 24, 1996, FDA

advised the Patent and Trademark

Office that this human drug product had

undergone a regulatory review period

and that the approval of DIFFERIN

Topical Gel represented the first

permitted commercial marketing or use

of the product. Shortly thereafter, the