Federal Register / Vol. 60, No. 65 / Wednesday, April 5, 1995 / Notices 17365

public comment period for a technical/

agency draft recovery plan: the second

revision of the Florida manatee

(Trichechus manatus latirostris)

Recovery Plan.

The Service solicits additional review

and comment from the public on this

plan. During the previous comment

period (December 27, 1994–February 27,

1995), there was some concern

expressed that certain individuals and/

or groups were not adequately informed

of the availability of the draft for public

review.

DATES: Comments on the draft recovery

plan revision must be received on or

before June 5, 1995 to receive

consideration by the Service.

ADDRESSES: Persons wishing to review

the draft recovery plan may obtain a

copy by contacting the Supervisor,

Jacksonville Field Office, U.S. Fish and

Wildlife Service, 6620 South Point Dr.,

South, Suite 310, Jacksonville, Florida

32216 (Telephone: 904–232–2580).

Written comments and materials

regarding the plan should be addressed

to David J. Wesley, Field Supervisor, at

the above Jacksonville, Florida address.

Comments and materials received are

available upon request for public

inspection, by appointment, and during

normal business hours at the above

Jacksonville, Florida address.

FOR FURTHER INFORMATION CONTACT:

Robert O. Turner, Manatee Coordinator,

at the Jacksonville, Florida, address

(Telephone: 904–232–2580).

SUPPLEMENTARY INFORMATION:

Background

Restoring endangered or threatened

animals and plants to the point where

they are again secure self-sustaining

members of their ecosystems is a

primary goal of the Service’s

endangered species program. To help

guide the recovery effort the Service is

working to prepare recovery plans for

most of the listed species native to the

United States. Recovery Plans describe

actions necessary for the conservation of

the species, establish criteria for the

recovery levels for downlisting or

delisting them, and estimate time and

cost for implementing the recovery

measures needed.

The Endangered Species Act of 1973

(Act), as amended (16 U.S.C. 1531 et

seq.) requires the development of

recovery plans for listed species unless

such a plan would not promote the

conservation of a particular species.

Section 4(f) of the Act, as amended in

1988, requires that public notice, and an

opportunity for public review and

comment be provided during recovery

plan development. The Service will

consider all information presented

during a public comment period prior to

approval of each new or revised

recovery plan. The Service and other

Federal agencies will take these

comments into account in the course of

implementing approved recovery plans.

The Florida Manatee, a subspecies of

the West Indian manatee, was originally

listed under the Endangered Species Act

on March 11, 1967. The Service

developed an initial recovery plan for

manatees in 1980. The 1980 plan

focused primarily, but not exclusively,

on manatees in Florida. In 1986 the

Service adopted a separate Recovery

Plan for manatees in Puerto Rico. To

reflect new information and planning

needs for manatees in Florida, the

Service revised the original plan in 1989

focusing exclusively on Florida’s

manatees. The revised plan covered a

five-year planning period ending in

Fiscal Year 1994. In view of progress

since 1989 and planning needs beyond

1994, the Service is once again updating

and revising the plan.

Public Comments Solicited

The Service solicits written comments

on the revised recovery plan described.

All comments received by the date

specified will be considered prior to the

approval of the plan.

Authority: The authority for this action is

section 4(f) of the Endangered Species Act,

16 U.S.C. 1533(f).

Dated: March 27, 1995.

David J. Wesley,

Field Supervisor.

[FR Doc. 95–8245 Filed 4–4–95; 8:45 am]

BILLING CODE 4310–55–M

Bureau of Reclamation

Central Valley Project Improvement

Act, Criteria for Evaluating Water

Conservation Plans

AGENCY: Bureau of Reclamation,

Interior.

ACTION: Notice of draft decision of

evaluation of water conservation plans.

SUMMARY: To meet the requirements of

the Central Valley Project Improvement

Act (CVPIA), the Bureau of Reclamation

(Reclamation) developed and published

the Criteria for Evaluating Water

Conservation Plans (Criteria) dated

April 30, 1993. Using this Criteria,

Reclamation evaluated the adequacy of

all water conservation plans developed

by project contractors, including those

required by the Reclamation Reform Act

of 1982. The Criteria was developed and

the plans evaluated for the purpose of

promoting the most efficient water use

reasonably achievable by Central Valley

Project (CVP) contractors. Reclamation

made a commitment (stated within the

Criteria) to publish a notice of its draft

determination on the adequacy of each

CVP contractor’s water conservation

plan in the Federal Register and to

allow the public a minimum of 30 days

to comment on its preliminary

determinations. This program is ongoing; an updated list will be published

to recognize districts as plans are

revised to meet the Criteria.

DATES: All public comments must be

received by Reclamation by May 5,

1995.

ADDRESSES: Please mail comments to

the address provided below.

FOR FURTHER INFORMATION CONTACT:

Betsy Reifsnider, Bureau of

Reclamation, 2800 Cottage Way, MP–

402, Sacramento, CA 95825. To be

placed on a mailing list for any

subsequent information, please write

Betsy Reifsnider or telephone at (916)

979–2397.

SUPPLEMENTARY INFORMATION: Under

provisions of Section 3405(e) of the

CVPIA (Title 34 of Public Law 102–575),

‘‘The Secretary [of the Interior] shall

establish and administer an office on

Central Valley Project water

conservation best management practices

that shall * * * develop criteria for

evaluating the adequacy of all water

conservation plans developed by project

contractors, including those plans

required by section 210 of the

Reclamation Reform Act of 1982.’’ Also,

according to Section 3405(e)(1), these

criteria will be developed ‘‘ * * * with

the purpose of promoting the highest

level of water use efficiency reasonably

achievable by project contractors using

best available cost-effective technology

and best management practices.’’

The Criteria states that all parties

(districts) that contract with

Reclamation for water supplies

(municipal and industrial contracts

greater than 2,000 acre feet and

agricultural contracts over 2,000

irrigable acres) will prepare water

conservation plans which will be

evaluated by Reclamation based on the

following required information:

1. Coordinate with other agencies and

the public

2. Describe the district

3. Inventory water resources

4. Review the past water conservation

plan and activities

5. Identify best management practices to

be implemented

6. Develop schedules, budgets and

projected results

7. Review, evaluate, and adopt the water

conservation plan
17366 Federal Register / Vol. 60, No. 65 / Wednesday, April 5, 1995 / Notices

8. Implement, monitor and update the

water conservation plan

The CVP contractors listed below

have developed water conservation

plans which Reclamation has evaluated

and preliminarily determined meet the

requirements of the Criteria.

• Arvin Edison Water Shortage

District.

• Bella Vista Water District.

• Colusa County Water District.

• Corning Water District.

• Dunnigan Water District.

• Gravelly-Food Water District.

• Monterey County Water Resources

Agency.

• Proberta Water District.

• San Juan Water District.

• Santa Barbara, City of.

• Santa Barbara, County of.

• Tea Pot Dome Water District.

• The West Side Irrigation District.

• Thomes Creek Water District.

• Westside Water District.

Public comment on Reclamation’s

preliminary (i.e., draft) determinations

at this time is invited. Copies of the

plans listed above will be available for

review at Reclamation’s Mid Pacific

(MP) Region Office and MP’s area

offices. If you wish to review a copy of

the plans, please contact Ms. Reifsnider

to find the office nearest you.

Dated: March 28, 1995.

Franklin E. Dimick,

Assistant Regional Director.

[FR Doc. 95–8320 Filed 4–4–95; 8:45 am]

BILLING CODE 4310–94–M

INTERNATIONAL TRADE

COMMISSION

[Investigation No. 337–TA–349]

Certain Diltiazem Hydrochloride and

Diltiazem Preparations; Notice of

Commission Decision to Review

Portions of an Initial Determination

AGENCY: U.S. International Trade

Commission.

ACTION: Notice.

SUMMARY: Notice is hereby given that

the U.S. International Trade

Commission has determined to review

certain portions of the initial

determination (ID) and Order No. 52

issued by the presiding administrative

law judge (ALJ) on February 2, 1995, in

the above-captioned investigation.

FOR FURTHER INFORMATION CONTACT:

Cynthia P. Johnson, Esq., Office of the

General Counsel, U.S. International

Trade Commission, telephone 202–205–

3098.

SUPPLEMENTARY INFORMATION: On

February 1, 1995, the presiding ALJ

issued his final ID finding that there was

no violation of section 337. He found

that claim 1 of U.S. Letters Patent

4,438,035 (′035 patent) was not

infringed by any of respondents’

processes, that claim 1 was invalid as

obvious under 35 U.S.C. 103, and that

the ′035 patent was unenforceable

because of complainants’ inequitable

conduct during reexamination

proceedings before the U.S. Patent and

Trademark Office. In a separate order

(Order No. 52), issued on the same date,

the ALJ granted respondents’ motion for

evidentiary sanctions. In that order, he

stated that because there is a

Commission preference for decisions on

the merits based on all the evidence

adduced, and because he believes that

the same conclusions of law regarding

infringement would be appropriate

whether or not the sanctions of Order

No. 52 are applied, he was imposing

sanctions on complainants only as

alternate relief, i.e., only if the

Commission determines based on all the

evidence of record that respondents

have infringed claim 1 of the ′035

patent.

On February 21, 1995, complainants

filed a petition for review of the ALJ’s

final ID. They also filed a separate

petition for review of Order No. 52. On

the same day, the Commission

investigative attorneys (IAs) filed a

petition for review of the ALJ’s finding

that a domestic industry exists.

On March 6, 1995, the IAs, the

Fermion respondents, and the

Profarmaco respondents filed

oppositions to complainants’ petition

for review. Respondent Gyma

Laboratories also filed an opposition to

petition for review indicating that it

principally relies on and concurs in the

response filed by the Profarmaco

respondents.

Having examined the record in this

investigation, including the ID and

Order No. 52, the Commission has

determined to review the issues of (1)

claim interpretation, (2) whether claim

1 of the ′035 patent is infringed by

respondents’ processes; (3) whether

claim 1 of the ′035 patent is invalid as

obvious under 35 U.S.C. § 103; (4)

whether the ′035 patent is

unenforceable; and (5) Order No. 52.

The Commission has determined not to

review the remainder of the ID. The

Commission regards the ID as including

Order No. 52. The Commission has also

denied complainants’ motion for leave

to file the affidavit of James Gambrell,

and denied complainants’ request for an

oral hearing. With regard to the

Gambrell affidavit, the Commission

believes that reopening the record to

accept the affidavit at this late stage of

the investigation would not be

appropriate.

On review, the Commission is

particularly interested in answers to the

following questions:

(1) Is claim 1 of the ′035 patent

entitled to any range of equivalents? If

not, why not? If so, does the range of

equivalents cover (1) use of methyl ethyl

ketone, the next higher homolog of

acetone, as a solvent when used with

potassium hydroxide as a base, or (2)

use of potassium carbonate and toluene

as the base-solvent combination? Why?

(2) What is the status of the Abic

group of respondents? Have they settled

their differences with complainants? If

so, will a motion to terminate the Abic

group of respondents from the

investigation be forthcoming?

(3) Is there any suggestion or

motivation in the prior art references as

a whole applied in the ID to combine

those references so as to render obvious

under 35 U.S.C. 103 the invention

claimed in claim 1 of the ’035 patent?

(4) Was there a sale in the United

States of the product produced by the

Tanabe trade secret KOH/DMSO process

within the meaning of 35 U.S.C. 102(b)?

Is there applicable case law relevant to

complainants’ contention that sales of a

product for the sole purpose of FDA

approval do not constitute an ‘‘on sale’’

bar within the meaning of 35 U.S.C.

102(b)? The Commission is interested in

an analysis, based on the evidence of

record, of whether sales made solely for

purposes of FDA approval constitute an

‘‘on sale’’ bar, taking into account the

analysis set forth by the Federal Circuit

in considering whether a prior use or

sale is a statutory bar in, e.g., Pennwalt

Corp. v. Akzona Inc. (and cases cited

therein) 740 F.2d 1573 (Fed. Cir. 1984).

The Commission is also interested in

any evidence of record relevant to

complainants’ contention that the only

sales in the United States of Tanabe’s

trade secret KOH/DMSO process were

for purposes of FDA approval. If the

Tanabe KOH/DMSO process is found to

be prior art, what suggestion or

motivation, if any, is there in the prior

art that the use of DMSO as a solvent

would have rendered the solvents of

claim 1 of the ’035 patent obvious under

35 U.S.C. 103? Finally, assuming that

the Tanabe KOH/DMSO process is prior

art, was it more pertinent than the

references before the examiner during

the reexamination proceedings?

In connection with final disposition

of this investigation, the Commission

may issue (1) an order that could result

in the exclusion of the subject articles

from entry into the United States, and/

or (2) cease and desist orders that could

result in respondents being required to