56194 Federal Register / Vol. 62, No. 209 / Wednesday, October 29, 1997 / Notices

notified FDA in writing that Sudafed 12-

Hour Capsules (pseudoephedrine

hydrochloride 120-mg extended-release

capsules, OTC) were no longer being

marketed under NDA 17–941 and

requested that approval of the

application be withdrawn. In the

Federal Register of September 29, 1995

(60 FR 50626), FDA withdrew approval

of NDA 17–941.

FDA has reviewed its records and,

under §§ 314.161 and 314.162(c), has

determined that pseudoephedrine

hydrochloride 120-mg extended-release

capsules (OTC) were not withdrawn

from sale for reasons of safety or

effectiveness. Accordingly, the agency

will maintain pseudoephedrine

hydrochloride 120-mg extended-release

capsules (OTC) in the ‘‘Discontinued

Drug Product List’’ section of the Orange

Book. The ‘‘Discontinued Drug Product

List’’ delineates, among other items,

drug products that have been

discontinued from marketing for reasons

other than safety or effectiveness.

ANDA’s that refer to pseudoephedrine

hydrochloride 120-mg extended-release

capsules (OTC) may be approved by the

agency.

Dated: October 23, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–28672 Filed 10–28–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Endocrinologic and Metabolic Drugs

Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

This notice announces a forthcoming

meeting of a public advisory committee

of the Food and Drug Administration

(FDA). At least one portion of the

meeting will be closed to the public.

Name of Committee: Endocrinologic

and Metabolic Drugs Advisory

Committee.

General Function of the Committee:

To provide advice and

recommendations to the agency on FDA

regulatory issues.

Date and Time: The meeting will be

held on November 19 and 20, 1997, 8

a.m. to 5 p.m., and on November 21,

1997, 8 a.m. to 3 p.m.

Location:

November 19, 1997: Bethesda Ramada

Inn, Embassy Ballroom, 8400

Wisconsin Ave., Bethesda, MD.

November 20 and 21, 1997: Holiday

Inn Bethesda, Versailles Ballrooms I

and II, 8120 Wisconsin Ave.,

Bethesda, MD.

Contact Person: Kathleen R. Reedy or

Karen M. Templeton-Somers, Center for

Drug Evaluation and Research (HFD–

21), Food and Drug Administration,

5600 Fishers Lane, Rockville MD 20857,

301–443–5455, or FDA Advisory

Committee Information Line, 1–800–

741–8138 (301–443–0572 in the

Washington, DC area), code 12536.

Please call the Information Line for upto-date information on this meeting.

Agenda: On November 19, 1997, the

committee will discuss new drug

application (NDA) 20–741, PrandinTM or

ActulinTM (repaglinide, Novo Nordisk)

for the treatment of type 2 diabetes in

patients whose hyperglycemia cannot be

controlled satisfactorily by diet and

exercise alone. On November 20, 1997,

the committee will discuss NDA 20–

815, EvistaTM (raloxifene hydrochloride,

Eli Lilly and Co.) for the prevention of

postmenopausal osteoporosis. On

November 21, 1997, the committee will

meet in closed session to permit

discussion and review of trade secret

and/or confidential information.

Procedure: On November 19 and 20,

1997, from 8 a.m. to 5 p.m., the meeting

is open to the public. Interested persons

may present data, information, or views,

orally or in writing, on issues pending

before the committee. Written

submissions may be made to the contact

person by November 14, 1997. Oral

presentations from the public will be

scheduled between approximately 8

a.m. and 8:30 a.m. on November 19 and

20, 1997. Time allotted for each

presentation may be limited. Those

desiring to make formal oral

presentations should notify the contact

person before November 14, 1997, and

submit a brief statement of the general

nature of the evidence or arguments

they wish to present, the names and

addresses of proposed participants, and

an indication of the approximate time

requested to make their presentation.

Closed Committee Deliberations: On

November 21, 1997, 8 a.m. to 3 p.m., the

meeting will be closed to permit

discussion and review of trade secret

and/or confidential information (5

U.S.C. 552b(c)(4)). The investigational

new drug (IND) and Phase I and II drug

products in process will be presented

and recent action on selected NDA’s

will be discussed.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: October 22, 1997.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 97–28556 Filed 10–28–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Government-Owned Inventions;

Availability for Licensing

AGENCY: National Institutes of Health.

ACTION: Notice.

SUMMARY: The inventions listed below

are owned by agencies of the U.S.

Government and are available for

licensing in the U.S. in accordance with

35 U.S.C. 207 to achieve expeditious

commercialization of results of

federally-funded research and

development. Foreign patent

applications are filed on selected

inventions to extend market coverage

for U.S. companies and may also be

available for licensing.

ADDRESSES: Licensing information and

copies of the U.S. patent applications

listed below may be obtained by writing

to the indicated licensing contact at the

Office of Technology Transfer, National

Institutes of Health, 6011 Executive

Boulevard, Suite 325, Rockville,

Maryland 20852–3804; telephone: 301/

496–7057; fax: 301/402–0220. A signed

Confidential Disclosure Agreement will

be required to receive copies of the

patent applications.

Identification of a Viral Etiology for BPrecursor Acute Lymphoblastic

Leukemia of Childhood

MA Smith (NCI)

Serial No. 60/036,991 filed 30 Jan 97

Licensing Contact: Joseph Contrera, 301/

496–7056 ext. 244.

The present invention claims that the

possible etiologic agent for some cases

of acute lymphoblastic leukemia (ALL)

in children is JC virus (a human

polyomavirus), and that infection in

utero can lead to subsequent

development of ALL during childhood.

JC virus was identified as a possible

etiologic agent based on specific

properties associated with the virus,

including: (1) Specificity for Blymphocytes as compared to Tlymphoctyes; (2) the ability to induce

genomic instability via its T antigen,

which interacts with cellular p53; and

(3) epidemiological data showing

concordance between the frequency of

‘‘susceptible’’ (i.e. previously not

exposed to JC virus and therefore