Federal Register / Vol. 60, No. 81 / Thursday, April 27, 1995 / Notices 20737

Appendix M–VII–D. New Site/New

Investigator

This category includes the following:

(1) initiation of a protocol at an

additional site other than the site that

was originally approved by the RAC,

and (2) the investigator at the new site

is different than the investigator

approved for the original site.

Appendix M–VII–E. ‘‘Umbrella’’

Protocols

This category includes initiation of a

RAC-approved protocol at more than

one additional site (the Principal

Investigator may be the same or

different than the Principal Investigator

approved for the original site).

Appendix M–VII–F. Modifications

Related to Gene Transfer

This category includes experiments

involving a modification to the clinical

protocol that is not related to the gene

transfer portion of study.

Appendix M–VII–G. Gene Marking

Protocols

This category includes human gene

marking experiments involving vector

constructs that have previously been

approved by the RAC and: (1) minor

modifications to the vector constructs,

or (2) a different tumor cell target.

Appendix M–VIII. Reporting

Requirements—Human Gene Transfer

Protocols

Appendix M–VIII–A. Semiannual Data

Reporting

Investigators who have received

approval from the FDA to initiate a

human gene transfer protocol (whether

or not it has been reviewed by the RAC)

shall be required to comply with the

semiannual data reporting requirements.

Semi-annual Data Report forms will be

forwarded by NIH/ORDA to

investigators. Data submitted in these

reports will be evaluated by the RAC,

NIH/ORDA, and the FDA and reviewed

by the RAC at its next regularly

scheduled meeting.

Appendix M–VIII–B. Adverse Event

Reporting

Investigators who have received

approval from the FDA to initiate a

human gene transfer protocol (whether

or not it has been reviewed by the RAC)

must report any serious adverse event

immediately to the local IRB, IBC, NIH

Office for Protection from Research

Risks, NIH/ORDA, and FDA, followed

by the submission of a written report

filed with each group. Reports

submitted to NIH/ORDA shall be sent to

the Office of Recombinant DNA

Activities, National Institutes of Health,

6006 Executive Boulevard, Suite 323,

Bethesda, Maryland 20892–7052, (301)

496–9838.

Appendix M–IX. Footnotes of Appendix

M

Appendix M–IX–A. Human studies in

which the induction or enhancement of

an immune response to a vectorencoded microbial immunogen is the

major goal, such an immune response

has been demonstrated in model

systems, and the persistence of the

vector-encoded immunogen is not

expected, may be initiated without RAC

review if approved by another Federal

agency.

OMB’s ‘‘Mandatory Information

Requirements for Federal Assistance

Program Announcements’’ (45 FR

39592, June 11, 1980) requires a

statement concerning the official

government programs contained in the

Catalog of Federal Domestic Assistance.

Normally, NIH lists in its

announcements the number and title of

affected individual programs for the

guidance of the public. Because the

guidance in this notice covers not only

virtually every NIH program but also

essentially every Federal research

program in which DNA recombinant

molecule techniques could be used, it

has been determined not to be cost

effective or in the public interest to

attempt to list these programs. Such a

list would likely require several

additional pages. In addition, NIH could

not be certain that every Federal

program would be included as many

Federal agencies, as well as private

organizations, both national and

international, have elected to follow the

NIH Guidelines. In lieu of the individual

program listing, NIH invites readers to

direct questions to the information

address above about whether individual

programs listed in the Catalog of

Federal Domestic Assistance are

affected.

Effective Date: April 17, 1995.

Harold Varmus,

Director, National Institutes of Health.

[FR Doc. 95–10381 Filed 4–26–95; 8:45 am]

BILLING CODE 4140–01–P

Public Health Service

National Institutes of Health; Notice of

Meeting of the Panel to Assess the NIH

Investment in Research on Gene

Therapy

Notice is hereby given that the Panel

to Assess the NIH Investment in

Research on Gene Therapy, a factfinding group reporting to the Advisory

Committee to the Director (ACD),

National Institutes of Health (NIH), will

meet in public session at the William H.

Natcher Building (Building 45)

Conference Center, Board Room,

National Institutes of Health, Bethesda,

Maryland 20892, on May 15–16, 1995.

The meeting will begin at approximately

9:00 a.m. to recess on May 15, and from

approximately 9:00 a.m. to 1:00 p.m. on

May 16.

The goal of the Panel is to make

recommendations to the ACD about the

scientific areas that NIH should

emphasize and the funding mechanisms

that should be employed in order best

to advance the development of gene

therapy. The purpose of the meeting is

to provide the Panel with an

opportunity to hear presentations

regarding the current and anticipated

research activities relevant to gene

therapy that are supported by the

various components of NIH, and to

discuss how to proceed with its

assessment of NIH’s investment in gene

therapy.

Individuals who plan to attend and

need special assistance, such as sign

language interpretation or other special

accommodations, should contact the

person named below in advance of the

hearing.

Attendance may be limited to seat

availability. If you plan to attend the

meeting as an observer or if you wish

additional information, please contact

Ms. Janice Ramsden, National Institutes

of Health, Shannon Building, Room 235,

1 Center Drive MSC 0159, Bethesda,

Maryland 20892–0159, telephone (301)

496–0959, fax (301) 496–7451, by May

10.

Ruth L. Kirschstein,

Deputy Director, NIH.

[FR Doc. 95–10382 Filed 4–26–95; 8:45 am]

BILLING CODE 4140–01–P

DEPARTMENT OF THE INTERIOR

Bureau of Land Management

[AZ-020–05–1330–00]

Notice of Availability of the Cyprus

Tohono Corporation Proposed Mine

Expansion Final Environmental Impact

Statement, Phoenix District, Arizona

AGENCY: Bureau of Land Management,

Interior.

ACTION: Final environmental impact

statement.

SUMMARY: In compliance with the

Federal Land Policy and Management

Act of 1976, section 102(2)(c) of the

National Environmental Policy Act of
20738 Federal Register / Vol. 60, No. 81 / Thursday, April 27, 1995 / Notices

1969, and The United States Department

of the Interior Secretarial Order No.

3087, Section 5, Amendment No. 1, The

Bureau of Land Management (BLM) has

prepared an Environmental Impact

Statement (EIS) for the Cyprus Tohono

Corporation’s (Cyprus) proposed mine

expansion on the Tohono O’odham

Nation (Nation), Papago Indian

Reservation. The proposed action

(Alternate B) consists of the conversion

from in situ to open pit mining

operations at Cyprus, the creation of a

new overburden storage site, and a new

copper oxide ore heap leach pad.

Cyprus proposes production of

approximately one billion pounds of

copper during the thirteen year life of

the proposal. A description of existing

facilities and a detailed proposed plan

of operations is presented in the Mine

Plan of Operations for Expanded Open

Pit and Heap Leach Operation (Cyprus

Tohono Corporation, March 1995). The

project was developed in response to

three underlying needs: Mining lease

compliance, continued industrial

economic support for the Nation, and

copper production.

Implementation of Alternative B

would result in the disturbance of a

total of approximately 1,850 acres, or

approximately 0.06 percent of total

Nation lands. Alternative B Mine Plan

of Operations involves the development,

operation, performance and

maintenance of the following major

project components: Open pit mine

expansion, overburden disposal area,

heap leach pads and ponds, stormwater

collection and recycling, processing

facilities, access and service roads,

support facilities, utilities, spill

prevention, control health and safety

plans, reclamation and closure. There

would be increases in royalties and

employment. Scholarships would be

established. Each of the major project

components are described in the main

body of the EIS. Alternative B Mine Plan

of Operations was developed to

minimize potential impacts to biological

and visual resources. Alternative B

Mine Plan of Operations moved some of

proposed mine components south of an

existing access road. Movement of the

proposed project elements south of the

existing mine access road serves to limit

disturbance of natural drainages, reduce

potential disturbance to bat colonies

north of the site, and to provide a visual

screen of existing mine plant site

structures.

DATES: Appeals must be filed within 30

days of the Notice of Filing by the

United States Environmental Protection

Agency in the Federal Register. These

procedures can be found in the Code of

Federal Regulations (43 CPR 1610.5–2).

SUPPLEMENTARY INFORMATION: A limited

number of copies of the Final EIS are

available upon request to the: District

Manager, Phoenix District Office,

Bureau of Land Management, 2015 West

Deer Valley Road, Phoenix, Arizona

85027. There are also copies available

for review at the above location.

FOR FURTHER INFORMATION CONTACT:

Bureau of Land Management, Attn:

Moon Hom, 2015 West Deer Valley

Road, Phoenix, Arizona 85027; (602)

780–8090.

Dated: April 19, 1995.

David J. Miller,

Associate District Manager.

[FR Doc. 95–10341 Filed 4–26–95; 8:45 am]

BILLING CODE 4310–32–P

[CO–934–95–4110–03; COC54300]

Colorado; Proposed Reinstatement of

Terminated Oil and Gas Lease

Under the provisions of Pub. L. 97–

451, a petition for reinstatement of oil

and gas lease COC 54300, Moffat

County, Colorado, was timely filed and

was accompanied by all required rentals

and royalties accruing from November

1, 1994, the date of termination.

No valid lease has been issued

affecting the lands. The lessee has

agreed to new lease terms for rentals

and royalties at rates of $5 per acre and

162⁄3 percent, respectively. The lessee

has paid the required $500

administrative fee for the lease and has

reimbursed the Bureau of Land

Management for the cost of this Federal

Register notice.

Having met all the requirements for

reinstatement of the lease as set out in

section 31(d) and (e) of the Mineral

Leasing Act of 1920, as amended, (30

U.S.C. 188(d) and (e), the Bureau of

Land Management is proposing to

reinstate the lease effective November 1,

1994, subject to the original terms and

condition of the lease and the increased

rental and royalty rates cited above.

Questions concerning this notice may

be directed to Milada Krasilinec of the

Colorado State Office (303) 239–3767.

Dated: March 24, 1995.

Milada Krasilinec,

Land Law Examiner, Oil and Gas Lease

Management Team.

[FR Doc. 95–10345 Filed 4–26–95; 8:45 am]

BILLING CODE 4310–9B–M

[ID–060–1220–00–60016]

Restriction Order for Public Land at

Blackwell Island, Cougar Bay and Ross

Point

AGENCY: Bureau of Land Management,

Coeur d’Alene Office, Idaho.

ACTION: Notice of Restriction Order for

Public Land at Blackwell Island, Cougar

Bay and Ross Point, Order No. ID060–

13.

SUMMARY: By order, the following

closure applies to Blackwell Island,

described as all public land in Section

11: lot 23 (portion), Section 14: lots 3–

6 (portion) and Section 15: lot 5

(portion), T.50N., R.4W., B.M.; Cougar

Bay, described as all public land in

Section 15, S1/2SW1⁄4 (portion), and

Section 22, N1⁄2 NW1⁄4 (portion), T.50N.,

R.4W., B.M.; and Ross Point, described

as all public land in Section 7: lot 5

(portion) and Section 8: lot 1 (portion)

T.50N., R.4W., B.M.:

Overnight camping is prohibited.

Maps depicting the restricted area are

available for public inspection at the

BLM, Coeur d’Alene Office, 1808 North

Third St., Coeur d’Alene, Idaho.

The authority for establishing this

restriction is Title 43, Code of Federal

Regulations, 8364.1.

This restriction becomes effective

immediately and shall remain in effect

until revoked and/or replaced with

supplemental rules.

This restriction does not apply to:

(1) Any Federal, State, or local official

or member of an organized rescue or fire

fighting force while in the performance

of an official duty.

(2) Any Bureau of Land Management

employee, agent, contractor, or

cooperator while in the performance of

an official duty.

This restriction is necessary because

the three sites do not have facilities

which can accommodate overnight

camping and the activities associated

with long-term occupancy. In addition,

due to the small acreage of these sites,

the general urban surroundings and the

sensitive combination of resources that

are being protected, overnight camping

is not a compatible recreation use.

Violation of this order is punishable

by a fine not to exceed $1,000 and/or

imprisonment not to exceed 12 months.

FOR FURTHER INFORMATION CONTACT:

Eric Thomson, Area Manager, Bureau of

Land Management, 1808 North Third

St., Coeur d’Alene, ID 83814.

Signed at Coeur d’Alene, Idaho this 20th

day of April, 1995.