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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 ofspecific 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 ofthe public who wish to make brief oral presentations to the Committee should
contact Mrs. Conway no later than Friday, May 1, 1992in 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 ofany 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 themeeting. The Science Advisory Board expects that public statements presented at its meetings will notbe repetitive of previously submitted oral or written
statements.

Dated: April 3,1992.
Donald G. Barnes, Director. ScienceAdvisoryBoard.

[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 ofamendment 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 ofdredged or fill material forthe purpose ofrelocating the below ground Shell Pipe Line Corporation (Shell) pipeline, and (2) discharges of dredged orfill material for purposes ofconducting routine operation and maintenance ofthis 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 of1899 or section 404 ofthe Clean WaterAct 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. EFFECTVE 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 ofthe amendment are available through the EPA Wetlands Hotline at (800] 832,7828.
SUPPLEMENTARY INFORMATION: Section 404(c) ofthe Clean Water Act authorizes EPA to prohibit or restrict the useof portions ofwaters oftheUnited States for discharging dredged orfill material. In December, 1991, Shell PipeLine Corporation petitioned EPA to modify its 1985 section404(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 ofthe Bayou aux Carpes Final Determination andrequested public comment in theJanuary 31,1992 Federal Register (57 FR 3757). EPA formally notified the Corps ofEngineers Headquarters ofthe Shell petition and requested any comments on Shell's proposal. EPA also mailed copies ofthe 

### Federal Register notice to otherparties believed tobe interested in theproposed action.

There were nocomments from the public received byEPA in response to the Federal Register notice. Corps Headquarters responded ina February 18, 1992 letter to EPA and recommended that EPA give fullconsideration tothe request by Shell to undertake the activity. Corps Headquarters also stated that based oninformation provided, it appears that onlyminimal and temporary impacts associated with the project would be necessary to facilitate pipeline relocation and maintenance. Further, Corps Headquarters indicated that theyhad coordinated their response with theCorps ofEngineers New Orleans District Office and the District

was gathering information toreview the project inaccordance withCorps of Engineers regulatory requirements. According toCorps 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 ofEngineers, and the existing Bayou aux Carpes section 404(c) administrative record. Based on this review, EPA concluded that environmental impacts associatedwith the Shellpipeline relocation activity wouldnotresult inunacceptable adverse effects to the Bayou aux Carpes section 404(c) area. Inreaching this decision, EPA considered that (1)

### the environmental impacts areminor and temporary becausethe project is confined to an area approximately 0.43

acres in size and the project involves a maximum discharge of300cubic yards ofdredged orfill material for a period of approximately two weeks; (2)

### the impacted area willbe restored topreproject contours when the project is complete; (3)the Shellpipeline relocation is aprecautionary action necessary to facilitate theenlargement of a Federal hurricane protection levee adjacent to the section 404(c) area; and (4) Shell evaluated and attempted alternate methods ofpipeline relocation which were unsuccessful.

Withregard to the Shellrequest to except from the Bayou aux Carpes Final Determination future discharges associated with routine operation and maintenance ofthis pipeline, EPAhas determined that this request is equivalent to the existingexception described in the October 16, 1985Bayou

aux Carpes FinalDetermination for routine operation and maintenance activities ofthe 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, ActingAssistantAdministrator for Water. [FRDoc.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 AdvisoryCommittee 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 andCommunity Control Programs.

Time andDate:8 a.m.-4:30 p.m., Tuesday. May 19,1992.

Place:Ramada Renaissance HotelAtlanta Airport, 4736 Best Road,College Park, Georgia 30337. (Exit Riverdale Road off 1-85.)

Status:Open to thepublic, 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 ofprograms with Federal, voluntary, andprivate resources involved in the provision of services to people with diabetes.

MatterstobeDiscussed: 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 ofDiabetes Translation staffwill 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.

ContactPerson forMoreInformation: Frederick G.Murphy, Program Analyst, Divisionof Diabetes Translation, National Center for Chronic Disease Prevention and Health Promotion, CDC, 1600Clifton Road, NE, (K-10), Atlanta, Georgia 30333, telephone 404/488-5005 orFTS 236-5005.

Dated: April 10, 1992. ElvinHilyer.
AssociateDirector forPolicyCoordination Centers forDiseaseControl. [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 forHealth Statistics (NCHS), Centers for Disease Control,

announces the following committee meeting.

Name:NCVHS Subcommittee on Mental Health Statistics.

Time andDate: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 willcontinue deliberations initiated at previous meetings regarding the collection and analysis of institutional and person oriented longitudinal data on children andyouth with mental disorders. The subcommittee will also review recent developments in the area ofdisability statistics particularly as theyrelate to proposed activities at NCHS and the National Academy ofSciences.

ContactPerson forMoreInformation: Substantive programinformation as well as summaries ofthe meeting and a roster of committee members may be obtained from Gail F.Fisher,Ph.D., Executive Secretary, NCVHS, NCHS, room 1100, Presidential Building, 6525Belcrest Road, Hyattsville, Maryland 20782, telephone number 301/436- 7050or FTS436-7070.

Dated: April 10, 1992. ElvinHilyer, AssociateDirector forPolicyCoordination. Centers forDiseaseControl.
(FRDoc. 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 theregulatory review period for Dermatop®and is publishing this notice ofthat determination as required by law. FDA has made the determination because ofthe submission ofan application to the Commissioner of Patents and Trademarks, Department of Commerce, for the extension ofa 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 ofHealth 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 ofup to 5years 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 testingphase and

an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations ofthe 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. halfthe 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 ofa 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 forthe relief ofthe inflammatory and 

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