4300 Federal Register / Vol. 62, No. 19 / Wednesday, January 29, 1997 / Notices

Department’s Office of Special Counsel

for Ethics.

VIII. Establish a new ‘‘Chapter KV,’’ as

follows: Office of Administrative

Services and Facilities Management:

KV.00 Mission

KV.10 Organization

KV.20 Functions

KV.00 Mission. The Office of

Administrative Services and Facilities

Management (OASFM) is the principal

advisor to the Deputy Assistant

Secretary for Program Operations on all

areas of administrative services and

facilities management for the

Administration for Children and

Families (ACF).

KV.10 Organization. The Office of

Administrative Services and Facilities

Management (OASFM) is headed by a

Director who reports to the Deputy

Assistant Secretary for Program

Operations.

KV.20 Functions. The Office of

Administrative Services and Facilities

Management (OASFM) directs and

manages ACF’s administrative support

services, facilities management

programs and activities.

Provides agency-wide guidance on

administrative issues; prepares,

coordinates and disseminates

information, policy, and/or procedural

guidance on administrative and

facilities management issues. Directs

and/or coordinates management

initiatives to improve ACF

administrative and facilities

management services with the goal of

continually improving services while

reducing costs.

Maintains budgetary controls on

administrative services accounts,

reconciling accounting reports and

invoices, and monitoring all spending.

Controls OASFM Visa credit card for

small purchases. Establishes and

manages contracts and/or blanket

purchase agreements (BPAs) for

administrative support and facilities

management services, including space

design, building alteration and repair,

telecommunications, reprographics,

physical security, moving, labor, records

and property management and

inventory, systems furniture

acquisitions and assembly, fleet

management, and the Information

Resource Center (library).

Provides management and oversight

of ACF mail delivery services and

activities, including Federal and

contractor postal services nationwide,

covering all classes of U.S. Postal

Service mail, priority and express mail

services, and courier services, etc.

Directs all activities associated with

the ACF Master Housing Plan, including

coordination and development of the

agency long-range space budget;

planning, budgeting, identification,

solicitation, acceptance and utilization

of office and special purpose space,

repairs, and alterations; principal

liaison with General Services

Administration (GSA) and other Federal

agencies, building managers and

facilities engineers, architects and

commercial representatives, for space

acquisition, negotiation of lease terms,

dealing with sensitive issues such as

handicapped barriers, space shortages,

and security. Develops and maintains

space floor plans and inventories,

directory boards, and locator signs.

OASFM serves as the lead for ACF in

coordination and liaison with

Departmental, GSA, Federal Protective

Service, and other Federal agencies on

implementation of Federal security

directives. Responsible for planning and

executing the Agency’s environmental

health, safety, and physical security

programs, ensuring that appropriate

occupational health and safety and

occupant emergency evacuation plans

are in place. Serves as principal liaison

with private and/or Federal building

managers for all administrative services

and facilities management activities.

Responsible for issuing, and managing

and controlling badge and cardkey

systems to control access to agency

space for security purposes.

Develops and/or implements agency

telecommunications management policy

in accordance with Federal regulations

and procedures. Reviews and directs

payment of all agency telephone

invoices. Recommends and advises on

the design and function of

telecommunications systems, based on

user needs, costs and technological

availability. Communicates directly

with private industry service providers

to coordinate the acquisition,

installation and maintenance of voice/

data telecommunications equipment

and systems. Responsible for other

sources of communications capability

such as pagers, cellular phone service,

cable TV service, and audio

conferencing equipment and service.

Coordinates the implementation of

personal video and video conferencing.

Updates and maintains the ACF LANbased telephone directory, handles the

distribution of all commercial

directories, and updates and maintains

the databases for telephone lines, and

equipment inventories.

Plans, manages/operates employee

transportation programs, including

shuttle service and fleet management,

employee and visitor parking, and

commuter services and programs

including transit subsidies and

ridesharing. Develops and implements

ACF travel policies and procedures

consistent with Federal requirements.

Provides technical assistance and

oversight; coordinates ACF use of the

Travel Management System; manages

employee participation in the American

Express Credit Card program for travel.

Purchases and tracks common use

supplies, stationery and publications;

manages equipment repair services and

reprographics management activities;

controls and maintains equipment and

personal property inventories; develops

and coordinates records (paper) and

forms management, and real property

activities.

Dated: January 14, 1997.

Olivia A. Golden,

Acting Assistant Secretary for Children and

Families.

[FR Doc. 97–2236 Filed 1–28–97; 8:45 am]

BILLING CODE 4184–01–P

Food and Drug Administration

[Docket No. 96E–0354]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; DIFFERIN Solution

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for

DIFFERIN Solution 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,
Federal Register / Vol. 62, No. 19 / Wednesday, January 29, 1997 / Notices 4301

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

Solution (adapalene). DIFFERIN

Solution 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

Solution (U.S. Patent No. Re. 34,440)

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

Solution 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

DIFFERIN Solution is 2,814 days. Of

this time, 1,651 days occurred during

the testing phase of the regulatory

review period, while 1,163 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: September 18, 1988.

FDA has verified the applicant’s claim

that the date that the investigational

new drug application became effective

was on September 18, 1988.

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, 1993. The

applicant claims March 19, 1993, as the

date the new drug application (NDA) for

DIFFERIN Solution (NDA 20–338) was

initially submitted. However, FDA

records indicate that NDA 20–338 was

submitted on March 26, 1993.

3. The date the application was

approved: May 31, 1996. FDA has

verified the applicant’s claim that NDA

20–338 was approved on May 31, 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 433 days of patent

term extension.

Anyone with knowledge that any of

the dates as published is incorrect may,

on or before March 31, 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 July 28, 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 17, 1997.

Stuart L. Nightingale,

Associate Commissioner for Health Affairs.

[FR Doc. 97–2141 Filed 1–28–97; 8:45 am]

BILLING CODE 4160–01–F

Advisory Committees; Notice of

Meetings

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: This notice announces

forthcoming meetings of public advisory

committees of the Food and Drug

Administration (FDA). This notice also

summarizes the procedures for the

meetings and methods by which

interested persons may participate in

open public hearings before FDA’s

advisory committees.

FDA has established an Advisory

Committee Information Hotline (the

hotline) using a voice-mail telephone

system. The hotline provides the public

with access to the most current

information on FDA advisory committee

meetings. The advisory committee

hotline, which will disseminate current

information and information updates,

can be accessed by dialing 1–800–741–

8138 or 301–443–0572. Each advisory

committee is assigned a 5-digit number.

This 5-digit number will appear in each

individual notice of meeting. The

hotline will enable the public to obtain

information about a particular advisory

committee by using the committee’s 5-

digit number. Information in the hotline

is preliminary and may change before a

meeting is actually held. The hotline

will be updated when such changes are

made.

MEETINGS: The following advisory

committee meetings are announced:

Drug Abuse Advisory Committee

Date, time, and place. February 10,

1997, 8:30 a.m., and February 11, 1997,

9 a.m., Holiday Inn—Gaithersburg,

Grand Ballroom, Two Montgomery

Village Ave., Gaithersburg, MD.

Type of meeting and contact person.

Open public hearing, February 10, 1997,

8:30 a.m. to 9:30 a.m.; unless public

participation does not last that long;

open committee discussion, 9:30 a.m. to

11 a.m.; closed presentation of data, 11

a.m. to 2 p.m.; closed committee

deliberations, 2 p.m. to 5:30 p.m.; open

public hearing, February 11, 1997, 9

a.m. to 10 a.m., unless public

participation does not last that long;

open committee discussion, 10 a.m. to

5:30 p.m.; Kimberly L. Topper, Center

for Drug Evaluation and Research (HFD–

21), Food and Drug Administration,

5600 Fishers Lane, Rockville, MD

20857, 301–443–5455, or FDA Advisory

Committee Information Hotline, 1–800–

741–8138 (301–443–0572 in the

Washington, DC area), Drug Abuse

Advisory Committee, code 12535.