13660 Federal Register / Vol. 62, No. 55 / Friday, March 21, 1997 / Notices

provides that a manufacturer who sells

covered outpatient drugs to eligible

(covered) entities must sign a

pharmaceutical pricing agreement with

the Secretary of HHS in which the

manufacturer agrees to charge a price for

covered outpatient drugs that will not

exceed that amount determined under a

statutory formula.

The purpose of this notice is to

withdraw the Federal Register notice

entitled, ‘‘Notice Regarding Section 602

of the Veterans Health Care Act of

l992—Rebate Mechanism,’’ published

on March 14, l997. This notice

requested comments on the proposal of

a rebate process for State AIDS Drug

Assistance Programs receiving funds

under Title XXVI of the PHS Act.

FOR FURTHER INFORMATION CONTACT:

Annette Byrne, R. Ph., Director, Office

of Drug Pricing, Bureau of Primary

Health Care, Health Resources and

Services Administration, 4350 East West

Highway, 10th Floor, Bethesda, MD

20814, Phone (301) 594–4353, Fax (301)

594–4982.

SUPPLEMENTARY INFORMATION: HRSA

guidance for the section 340B drug

program has described only a discount

process for accessing 340B pricing.

Although this discount system is

functioning successfully for most

covered entities, some State AIDS Drug

Assistance Programs (ADAPs) have drug

purchasing systems that have prevented

their participation in the 340B drug

program. The use of a rebate mechanism

(in addition to the discount mechanism)

should allow these groups to access

340B pricing.

Because the rebate mechanism is only

a part of a larger endeavor by HRSA to

develop the 340B drug program in such

a manner as to effectively reach all

covered entities, the notice outlining the

concept of a narrowly-focused rebate

mechanism is withdrawn for further

internal deliberation.

Dated: March 14, 1997.

Ciro V. Sumaya,

Administrator.

[FR Doc. 97–7142 Filed 3–20–97; 8:45 am]

BILLING CODE 4160–15–P

National Institutes of Health

Amended Notice of Meeting

Notice is hereby given of a change in

the meeting of the Advisory Committee

on Blood Safety and Availability,

Department of Health and Human

Services, March 20–21, 1997, which was

published in the Federal Register on

March 3, 1997 (62 FR 9441).

This meeting will be held on April

24–25, 1997, instead of the previously

stated March 20–21. The Advisory

meeting remains at the same time and

place, 8:30 a.m., National Institutes of

Health, Warren G. Magnuson Clinical

Center, Jack Masur Auditorium, 9000

Rockville Pike, Bethesda, Maryland

20892. As previously stated, this

meeting will be entirely open to the

public.

On April 24, the Committee will

discuss hepatitis C virus (HCV)

infection, its occurrence following blood

transfusion, other epidemiology of HCV

infection and appropriate ways of

approaching the public health aspects of

this infection. On April 25, the

Committee will address multiple

aspects of the theoretical possibility that

Creutzfeldt-Jakob disease (CJD) can be

transmitted by blood transfusion. For

each topic, a time will be set aside for

the public to comment. Prospective

speakers should notify the Executive

Secretary for this meeting of their wish

to present and should plan for no more

than 5 minutes of comments.

CONTACT: Paul R. McCurdy, M.D.,

Acting Executive Secretary, Advisory

Committee on Blood Safety and

Availability, Director, Blood Resources

Program, DBDR–MSC–7950, NHLBI,

NIH, Bethesda, Maryland 20892–7950.

Phone: 301/435–0065; Fax 301/480–

1060; E-Mail: paullmccurdy@nih.gov.

Dated: March 17, 1997.

LaVerne Y. Stringfield,

Committee Management Officer, NIH.

[FR Doc. 97–7129 Filed 3–20–97; 8:45 am]

BILLING CODE 4140–01–M

National Heart, Lung, and Blood

Institutes; Notice of Meeting

Pursuant to Pub. L. 92–463, notice is

hereby given of the meeting of the

following National Heart, Lung, and

Blood Institutes Special Emphasis

Panel.

The meeting will be open to the

public to provide concept review of

proposed contract or grant solicitations.

Individuals who plan to attend and

need special assistance, such as sign

language interpretation or other

reasonable accommodations, should

inform the Contract Person listed below

in advance of the meeting.

Name of Panel: Stem Cell Transplantation

in Sickle Cell Disease.

Dates of Meeting: April 30, 1997.

Time of Meeting: 10:00 a.m.

Place of Meeting: Two Rockledge Center,

Rm. 9112, 6701 Rockledge Drive, Bethesda,

Maryland 20892.

Agenda: To review current progress and

identify future initiatives in the use of stem

cell transplantation for the treatment of sickle

cell disease.

Contact Person: Helena Mishoe, Ph.D.,

NHLBI/DBDR, Two Rockledge Center, 6701

Rockledge Drive, Rm. 10156, MSC 7950,

Bethesda, Maryland 20892, (301) 435–0050.

(Catalog of Federal Domestic Assistance

Programs Nos. 93.837, Heart and Vascular

Diseases Research; 93.838, Lung Diseases

Research; and 93.839, Blood Diseases and

Resources Research, National Institutes of

Health.)

Dated: March 17, 1997.

LaVerne Y. Stringfield,

Committee Management Officer, NIH.

[FR Doc. 97–7128 Filed 3–20–97; 8:45 am]

BILLING CODE 4140–01–M

Prospective Grant of Exclusive

License: Replicating Tumoricidal Viral

Therapy for Cancer Applications

AGENCY: National Institutes of Health,

Public Health Service, DHHS.

ACTION: Notice.

SUMMARY: This notice in accordance

with 35 U.S.C. 209(c)(1) and 37 CFR

404.7(a)(1)(i) that the National Institutes

of Health (NIH), Department of Health

and Human Services, is contemplating

the grant of a limited field of use

exclusive license worldwide to practice

the invention embodied in U.S. Patent

Application Number 07/725,076 (issued

on October 25, 1994 as U.S. Patent No.

5,358,866) entitled ‘‘Cytosine

Deaminase Negative Selection System

for Gene Transfer Techniques and

Therapies’’ and its divisional

applications 08/271,874, 08/447,580,

08/447,393, 08/445,203, 08/447,487, 08/

449,627, 08/448,867, 08/449,636, and all

related foreign filings, to ONYX, Inc.,

having a place of business in Richmond,

CA (USA). The patent rights in these

inventions have been assigned to the

United States of America.

The prospective exclusive license will

be royalty-bearing and will comply with

the terms and conditions of 35 U.S.C.

209 and 37 CFR 404.7. The prospective

exclusive license may be granted unless,

within 60 days from the date of this

published Notice, NIH receives written

evidence and argument that establishes

that the grant of the license would not

be consistent with the requirements of

35 U.S.C. 209 and 37 CFR 404.7. This

notice modifies a previous notice of

April 11, 1996 found in Volume 61,

Number 71 of the Federal Register.

The field of use would be limited to

Replicating Tumoricidal Viral Therapy

for Cancer applications.

The present inventions relate to a

modified bacterial gene for cytosine

deaminase. Specifically, the CD gene

can be used as a negative selectable
Federal Register / Vol. 62, No. 55 / Friday, March 21, 1997 / Notices 13661

marker to transfect a targeted cell and

deaminase a prodrug, 5-flourocytosine

(‘‘5FC’’), into 5-flourouricil (‘‘5FU’’)

which has cytotoxic effects on the

targeted cell.

ADDRESSES: Requests for copies of the

subject issued patent and pending

patent applications, inquiries,

comments and other materials relating

to the contemplated license should be

directed to: Mr. Larry M. Tiffany, Office

of Technology Transfer, National

Institutes of Health, 6011 Executive

Boulevard, Suite 325, Rockville, MD

20852; Telephone: (301) 496–7056, ext.

206; Facsimile: (301) 402–0220. A

signed Confidentiality Agreement will

be required to receive copies of the

pending patent applications.

Applications for a license to the field of

use described in this Notice will be

treated as objections to the

contemplated license. Only written

comments and/or applications for a

license which are received by the NIH

Office of Technology Transfer on or

before May 20, 1997 will be considered.

Comments and objections will not be

made available for public inspection

and, to the extent permitted by law, will

not be subject to disclosure under the

Freedom of Information Act, 5 U.S.C.

552.

Dated: March 11, 1997.

Barbara M. McGarey,

Deputy Director, Office of Technology

Transfer.

[FR Doc. 97–7127 Filed 3–20–97; 8:45 am]

BILLING CODE 4140–01–M

Substance Abuse and Mental Health

Services Administration (SAMHSA)

Notice of Meetings

Pursuant to Public Law 92–463,

notice is hereby given of the Special

Emphasis Panel II (SEP II) and the

Center for Mental Health Services

(CMHS) National Advisory Council

meetings in April.

The SEP II meetings will include the

review, discussion and evaluation of

individual contract proposals. These

discussions could reveal personal

information concerning individuals

associated with the proposals and

confidential and financial information

about an individual’s proposal. These

discussions may also reveal information

about procurement activities exempt

from disclosure by statute and trade

secrets and commercial or financial

information obtained from a person and

privileged and confidential.

Accordingly, the meetings are

concerned with matters exempt from

mandatory disclosure in Title 5 U.S.C.

552b(c) (3),(4), and (6) and 5 U.S.C.

App. 2, § 10(d).

A summary of the meetings may be

obtained from: Ms. Dee Herman,

Committee Management Liaison,

SAMHSA Office of Extramural

Activities Review, 5600 Fishers Lane,

Room 17–89, Rockville, Maryland

20857. Telephone (301)443–4783.

Substantive program information may

be obtained from the individual named

as Contact for the meetings listed below.

Committee Name: SAMHSA Special

Emphasis Panel II.

Meeting Date: April 7, 1997.

Place: DoubleTree Hotel, Randolph Room,

1750 Rockville Pike, Rockville, MD 20852.

Closed: April 7, 1997, 9:00 a.m.–Noon.

Contact: Sandra E. Stephens, Room 17–89,

Parklawn Building, Telephone: (301) 443–

9915 and FAX: (301) 443–3437.

Committee Name: SAMHSA Special

Emphasis Panel II.

Meeting Date:April 7, 1997.

Place: DoubleTree Hotel, Randolph Room,

1750 Rockville Pike, Rockville, MD 20852.

Closed: April 7, 1997, 1:00 p.m.–4:00 p.m.

Contact: Sandra E. Stephens, Room 17–89,

Parklawn Building, Telephone: (301) 443–

9915 and FAX: (301) 443–3437.

The CMHS National Advisory Council

meeting will include an open session

with a roll call, general announcements

and a discussion of review procedures.

Public comments are welcome during

the open session. Please communicate

with the individual listed as Contact

below for guidance.

The meeting will also include the

review, discussion and evaluation of

individual contract proposals.

Therefore, a portion of the meeting will

be closed to the public as determined by

the Administrator, SAMHSA, in

accordance with Title 5 U.S.C. 552b(c)

(3), (4) and (6) and 5 U.S.C. App. 2,

Section 10(d).

An agenda for the meeting and a

roster of Council members may be

obtained from Ms. Patricia Gratton,

Committee Management Officer, CMHS,

Room 11C–26, Parklawn Building,

Rockville, Maryland. Telephone (301)

443–7987.

Substantive program information may

be obtained from the individual named

as Contact for the meeting listed below.

Committee Name: CMHS National

Advisory Council.

Meeting Dates: April 10–11, 1997.

Place: DoubleTree Hotel at Pentagon City,

Arlington North and South Conference

Room, 300 Army Navy Drive, Arlington,

Virginia 22202.

Closed: April 10, 8:30 a.m.–9:30 a.m.

Open: April 10, 9:30 a.m.–5:00 p.m.; April

11, 9:00 a.m.—Adjournment.

Contact: Ina B. Lyons, Room 13–103,

Parklawn Building, Telephone: (301) 443–

7586 and FAX: (301) 443–5163.

Dated: March 17, 1997.

Jeri Lipov,

Committee Management Officer, SAMHSA.

[FR Doc. 97–7146 Filed 3–20–97; 8:45 am]

BILLING CODE 4162–20–P

DEPARTMENT OF HOUSING AND

URBAN DEVELOPMENT

[Docket No. FR–4200–N–44]

Submission for OMB Review:

Comment Request

AGENCY: Office of Administration, HUD.

ACTION: Notice.

SUMMARY: The proposed information

collection requirement described below

has been submitted to the Office of

Management and Budget (OMB) for

review, as required by the Paperwork

Reduction Act. The Department is

soliciting public comments on the

subject proposal.

DATES: Comments due date: April 21,

1997.

ADDRESSES: Interested persons are

invited to submit comments regarding

this proposal. Comments must be

received within thirty (30) days from the

date of this Notice. Comments should

refer to the proposal by name and/or

OMB approval number should be sent

to: Joseph F. Lackey, Jr., OMB Desk

Officer, Office of Management and

Budget, Room 10235, New Executive

Office Building, Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT:

Kay F. Weaver, Reports Management

Officer, Department of Housing and

Urban Development, 451 7th Street,

Southwest, Washington, DC 20410,

telephone (202) 708–0050. This is not a

toll-free number. Copies of the proposed

forms and other available documents

submitted to OMB may be obtained

from Ms. Weaver.

SUPPLEMENTARY INFORMATION: The

Department has submitted the proposal

for the collection of information, as

described below, to OMB for review, as

required by the Paperwork Reduction

Act (44 U.S.C. Chapter 35).

The Notice lists the following

information: (1) The title of the

information collection proposal; (2) the

office of the agency to collect the

information; (3) the OMB approval

number, if applicable; (4) the

description of the need for the

information and its proposed use; (5)

the agency form number, if applicable;

(6) what members of the public will be

affected by the proposal; (7) how

frequently information submissions will

be required; (8) an estimate of the total