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Citation: 57 Fed. Reg. 13745 1992 

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Federal Register / Vol. 57, No. 75 / Friday, April 17. 1992 / Notices

treatment technologies for BAT

identification and costing purposes

which appears in a different document.)

Are the relevant available treatment

technologies and available disposal

practices correctly characterized?

2. The ODW compiled background

and technical criteria from many sources. Are the background materials

and numerical criteria used in creating

the 1990 Guidelines document still

scientifically supportable and current,

especially in terms of specific limits for

solid waste disposal?

3. Are the rationale and guidance for

selection of treatment technologies and

waste disposal practices clear?

4. Is the recommended radiation

exposure guidance for workers

complete, appropriate, and clear?

5. Are there other important issues

that should be addressed in the

Guidelines document?

Thirdly, the Committee will consider

additional activities for FY92.

For details concerning this meeting.

including a draft agenda, please contact

Mrs. Kathleen Conway (before May 1)

or Mrs. Dorothy Clark (until the date of

the meeting). Science Advisory Board

(A-101F). U.S. Environmental Protection

Agency, 401 M Street, SW.. Washington.

DC 20460. Telephone: (202) 260-6552 and

FAX: (202) 260-7118. Members of the

public who wish to make brief oral

presentations to the Committee should

contact Mrs. Conway no later than

Friday, May 1, 1992 in order to be

included on the Agenda. An additional

15 minutes will be reserved each day for

public comment not scheduled in

advance. Written statements of any

length (at least 30 copies) may be

provided to Mrs. Conway for

distribution to the Committee. Materials

received before May 1 will be mailed to

the Committee, materials which arrive

later will be distributed at the meeting.

The Science Advisory Board expects

that public statements presented at its

meetings will not be repetitive of

previously submitted oral or written

statements.

Dated: April 3,1992.

Donald G. Barnes,

Director. Science Advisory Board.

[FR Doc. 92-896 Filed 4-16-92. 8:45 amt

1ILLING CODE M60-SO-W

[FRL-4124-61

Bayou aux Carpes Site, LA;

Amendment to October 16, 1985 Clean

Water Act Section 404(c) Final

Determination

AGENCY: Environmental Protection

Agency.

ACTION: Notice of amendment of section

404(c) final determination and notice of

availability.

SUMMARY: The Environmental Protection

Agency (EPA) has amended the October

16, 1985 Clean Water Act section 404(c)

Final Determination concerning the

Bayou aux Carpes site in Jefferson

Parish, Louisiana. to add the following

exceptions: (1) Discharges of dredged or fill material for the purpose of relocating

the below ground Shell Pipe Line

Corporation (Shell) pipeline, and (2)

discharges of dredged or fill material for

purposes of conducting routine

operation and maintenance of this Shell

pipeline, provided dredged or fill

material is placed in piles with breaks in

between to allow sheet flow to adjacent

wetlands. EPA concludes that these

proposed activities will not result in

unacceptable adverse effects under

section 404(c). This amendment does not

provide authorization under section 10

of the Rivers and Harbors Act of 1899 or section 404 of the Clean Water Act for

Shell's proposed discharges. Shell must

obtain authorization from the Corps of

Engineers in order to proceed with the

discharges associated with its proposed

activities governed by these statutes at

the Bayou aux Carpes site.

EFFECT VE DATE: The amendment was

effective February 28,1992 upon

signature of EPA's Assistant

Administrator for Water.

FOR FURTHER INFORMATION CONTACT.

Specific details are available from

Joseph P. DaVia (EPA) at (202) 260-1602.

Copies of the amendment are available

through the EPA Wetlands Hotline at

(800] 832,7828.

SUPPLEMENTARY INFORMATION: Section

404(c) of the Clean Water Act authorizes

EPA to prohibit or restrict the use of

portions of waters of the United States

for discharging dredged or fill material.

In December, 1991, Shell Pipe Line

Corporation petitioned EPA to modify

its 1985 section 404(c) Final

Determination concerning the Bayou

aux Carpes site to enable it to relocate a

below ground pipeline to allow

completion of a Federal hurricane

protection levee project adjacent to the

site, and to conduct future routine

operation and maintenance of the

pipeline.

EPA announced Shell's request for

amendment of the Bayou aux Carpes

Final Determination and requested

public comment in the January 31,1992

Federal Register (57 FR 3757). EPA

formally notified the Corps of Engineers

Headquarters of the Shell petition and

requested any comments on Shell's

proposal. EPA also mailed copies of the

Federal Register notice to other parties

believed to be interested in the proposed

action.

There were no comments from the

public received by EPA in response to

the Federal Register notice. Corps

Headquarters responded in a February

18, 1992 letter to EPA and recommended

that EPA give full consideration to the

request by Shell to undertake the

activity. Corps Headquarters also stated

that based on information provided, it

appears that only minimal and

temporary impacts associated with the

project would be necessary to facilitate

pipeline relocation and maintenance.

Further, Corps Headquarters indicated

that they had coordinated their response

with the Corps of Engineers New

Orleans District Office and the District

was gathering information to review the

project in accordance with Corps of

Engineers regulatory requirements.

According to Corps Headquarters,

during the permit review process, the

District will consider permit conditions

to minimize impacts to wetlands within

the proposed project area.

EPA carefully reviewed Shelrs

proposal, comments submitted by the

Corps of Engineers, and the existing

Bayou aux Carpes section 404(c)

administrative record. Based on this

review, EPA concluded that

environmental impacts associated with

the Shell pipeline relocation activity

would not result in unacceptable

adverse effects to the Bayou aux Carpes

section 404(c) area. In reaching this

decision, EPA considered that (1) the

environmental impacts are minor and

temporary because the project is

confined to an area approximately 0.43

acres in size and the project involves a

maximum discharge of 300 cubic yards

of dredged or fill material for a period of

approximately two weeks; (2) the

impacted area will be restored to preproject contours when the project is

complete; (3) the Shell pipeline

relocation is a precautionary action

necessary to facilitate the enlargement

of a Federal hurricane protection levee

adjacent to the section 404(c) area; and

(4) Shell evaluated and attempted

alternate methods of pipeline relocation

which were unsuccessful.

With regard to the Shell request to

except from the Bayou aux Carpes Final

Determination future discharges

associated with routine operation and

maintenance of this pipeline, EPA has

determined that this request is

equivalent to the existing exception

described in the October 16, 1985 Bayou

aux Carpes Final Determination for

routine operation and maintenance

activities of the Southern Natural Gas

13745

137 ..
Federal Register / Vol. 57, No. 75 / Friday, April 17, 1992 / Notices

Company pipeline also located within

the area restricted by EPA's action

under section 404(c). No information has

been provided which suggests that such

maintenance has had greater impacts

than expected.

Dated: March 31, 1992.

Martha G. Prothro,

Acting Assistant Administrator for Water.

[FR Doc. 92--8965 Filed 4-16-92; 8:45 am]

BLLNG CODE 656O-50-M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control

Technical Advisory Committee for

Diabetes Translation and Community

Control Programs: Meeting

In accordance with section 10(a)(2) of

the Federal Advisory Committee Act

(Pub. L. 92-463), the Centers for Disease

Control (CDC) announces the following

committee meeting.

Name: Technical Advisory Committee for

Diabetes Translation and Community Control

Programs.

Time and Date: 8 a.m.-4:30 p.m., Tuesday.

May 19,1992.

Place: Ramada Renaissance Hotel Atlanta

Airport, 4736 Best Road, College Park,

Georgia 30337. (Exit Riverdale Road off 1-85.)

Status: Open to the public, limited only by

the space available.

Purpose: This committee is charged with

advising the Director, CDC, regarding

priorities and feasible goals for translation

activities and community control programs

designed to reduce risk factors, morbidity,

and mortality associated with diabetes and

its complications. The Committee advises

regarding policies, strategies, goals and

objectives, and priorities; identifies research

advances and technologies ready for

translation into widespread community

practice; recommends public health strategies

to be implemented through community

interventions: advises on operational

research and outcome evaluation

methodologies; identifies research issues for

further clinical Investigation; and advises

regarding the coordination of programs with

Federal, voluntary, and private resources involved in the provision of services to

people with diabetes.

Matters to be Discussed: The Committee

will continue to discuss specific objectives

related to translation for Technical Advisory

Committee for Diabetes Translation and

Community Control Programs. In addition,

the Committee will discuss issues related to

current research and science that is ready for

translation into communitywide practice.

Division of Diabetes Translation staff will

provide updates on diabetes control activities

and programs currently operational within

and outside of the Division.

Agenda items are subject to change as

priorities dictate.

Contact Person for More Information:

Frederick G. Murphy, Program Analyst,

Division of Diabetes Translation, National

Center for Chronic Disease Prevention and

Health Promotion, CDC, 1600 Clifton Road,

NE, (K-10), Atlanta, Georgia 30333, telephone

404/488-5005 or FTS 236-5005.

Dated: April 10, 1992.

Elvin Hilyer.

Associate Director for Policy Coordination

Centers for Disease Control.

[FR Doc. 92-8912 Filed 4-16-92; 8:45 am]

BILUNG COO 4160-18-M

National Committee on Vital and

Health Statistics (NCVHS)

Subcommittee on Mental Health

Statistics: Meeting

Pursuant to Public Law 92-463, the

National Center for Health Statistics

(NCHS), Centers for Disease Control,

announces the following committee

meeting.

Name: NCVHS Subcommittee on Mental

Health Statistics.

Time and Date: 9:30 a.m.-4 p.m., May 22,

1992.

Place: Room 337A-339A, Hubert H.

Humphrey Building, 200 Independence

Avenue, SW., Washington, DC 20201.

Status: Open.

Purpose: The subcommittee will continue

deliberations initiated at previous meetings

regarding the collection and analysis of

institutional and person oriented longitudinal

data on children and youth with mental

disorders. The subcommittee will also review

recent developments in the area of disability

statistics particularly as they relate to

proposed activities at NCHS and the National

Academy of Sciences.

Contact Person for More Information:

Substantive program information as well as summaries of the meeting and a roster of

committee members may be obtained from

Gail F. Fisher, Ph.D., Executive Secretary,

NCVHS, NCHS, room 1100, Presidential

Building, 6525 Belcrest Road, Hyattsville,

Maryland 20782, telephone number 301/436-

7050 or FTS 436-7070.

Dated: April 10, 1992.

Elvin Hilyer,

Associate Director for Policy Coordination.

Centers for Disease Control.

(FR Doc. 92-8911 Filed 4-16-92; 8:45 am]

BILLING CODE 4160-15-,

Food and Drug Administration

[Docket No. 91E-0476]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; DermatopV

AGENCY: Food and Drug Administration.

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for

Dermatop ® 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 HFA305), Food and Drug Administration, rm.

1-23, 12420 Parklawn Dr., Rockville, MD

20857.

FOR FURTHER INFORMATION CONTACT:

Joel Sparks, 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 Dermatop.

Dermatop® (prednicarbate) is indicated

for the relief of the inflammatory and

13746