54640 Federal Register / Vol. 62, No. 203 / Tuesday, October 21, 1997 / Notices

Agenda: On November 13, 1997, the

committee will discuss new drug

application (NDA) 20–788, PropeciaTM

(finasteride 1 milligram tablets, Merck

Research Laboratories), for treatment of

androgenetic alopecia to increase hair

growth and to prevent further hair loss.

On November 14, 1997, the committee

will participate in a scientific

discussion of clinical trial design

questions for products intended for the

treatment of burn wounds. This is one

segment of an overall effort by the

agency to develop a guidance document

on wound healing products.

Procedure: 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 4, 1997. Oral

presentations from the public will be

scheduled between approximately 8:30

a.m. and 9 a.m., and between

approximately 1 p.m. and 1:30 p.m. on

both days. Time allotted for each

presentation may be limited. Those

desiring to make formal oral

presentations should notify the contact

person before November 4, 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.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: October 9, 1997.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 97–27816 Filed 10–20–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Radiological Devices Panel of the

Medical Devices 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). The meeting will be open to the

public.

Name of Committee: Radiological

Devices Panel of the Medical Devices

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 17, 1997, 8:30 a.m.

to 4:30 p.m.

Location: Corporate Bldg., conference

room 020B, 9200 Corporate Blvd.,

Rockville, MD.

Contact Person: John C. Monahan,

Center for Devices and Radiological

Health (HFZ–470), Food and Drug

Administration, 9200 Corporate Blvd.,

Rockville, MD 20850, 301–594–1212, or

FDA Advisory Committee Information

Line, 1–800–741–8138 (301–443–0572

in the Washington, DC area), code

12526. Please call the Information Line

for up-to-date information on this

meeting.

Agenda: The committee will discuss

general issues and vote on an original

premarket approval application (PMA)

for an ultrasound bone sonometer and

an original PMA for a breast impedance

scanner.

Procedure: 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 10, 1997. Oral

presentations from the public will be

scheduled between approximately 8:45

a.m. and 9:45 a.m. Time allotted for

each presentation may be limited. Those

desiring to make formal oral

presentations should notify the contact

person before November 10, 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.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: October 10, 1997.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 97–27817 Filed 10–20–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 95D–0349]

Guidance for Industry on SUPAC–IR:

Immediate Release Solid Oral Dosage

Forms, Manufacturing Equipment

Addendum; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a Level 1 guidance for

industry entitled ‘‘SUPAC–IR:

Immediate Release Solid Oral Dosage

Forms—Manufacturing Equipment

Addendum.’’ This guidance is intended

to provide insight and recommendations

to pharmaceutical sponsors of new drug

applications (NDA’s), abbreviated new

drug applications (ANDA’s), and

abbreviated antibiotic applications

(AADA’s) who wish to change

equipment during the postapproval

period. This guidance document

represents the agency’s current thinking

on scale-up and postapproval

equipment changes (SUPAC) for

immediate release dosage forms

regulated by the Center for Drug

Evaluation and Research (CDER).

DATES: Written comments may be

submitted at any time.

ADDRESSES: Submit written requests for

single copies of the guidance to the Drug

Information Branch (HFD–210), Center

for Drug Evaluation and Research, Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857. Send one

self-addressed adhesive label to assist

that office in processing your requests.

Submit written comments on the

guidance document to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857.

FOR FURTHER INFORMATION CONTACT: John

L. Smith, Office of Generic Drugs,

Center for Drug Evaluation and Research

(HFD–623), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–827–5848.

SUPPLEMENTARY INFORMATION: FDA is

announcing the availability of a

guidance for industry entitled ‘‘SUPAC–

IR: Immediate Release Solid Oral Dosage

Forms—Manufacturing Equipment

Addendum.’’ This guidance is intended

to provide recommendations to

pharmaceutical manufacturers using

CDER’S Guidance for Industry on

‘‘Immediate Release Solid Oral Dosage

Forms, Scale-Up and Post-Approval

Changes: Chemistry, Manufacturing and

Controls, In Vitro Dissolution Testing,

and In Vivo Bioequivalence

Documentation’’ (SUPAC–IR), which

was issued in November 1995. The

manufacturing equipment addendum

may be used in conjunction with the

SUPAC–IR guidance in determining

what documentation should be

submitted to FDA regarding equipment

changes made in accordance with the

recommendations in sections V and

VI.A of the SUPAC–IR guidance.
Federal Register / Vol. 62, No. 203 / Tuesday, October 21, 1997 / Notices 54641

This guidance for industry represents

the agency’s current thinking on scaleup and post approval equipment

changes for immediate release solid oral

dosage forms regulated by CDER. It does

not create or confer any rights for or on

any person and does not operate to bind

FDA or the public. An alternative

approach may be used if such approach

satisfies the requirements of the

applicable statute, regulations, or both.

Interested persons may, at any time,

submit written comments on the

guidance to the Dockets Management

Branch (address above). Two copies of

any comments are to be submitted,

except that individuals may submit one

copy. Comments and requests are to be

identified with the docket number

found in brackets in the heading of this

document. The guidance and received

comments may be seen in the office

above between 9 a.m. and 4 p.m.,

Monday through Friday.

Persons with access to the Internet

may obtain copies of ‘‘SUPAC–IR:

Immediate Release Solid Oral Dosage

Forms—Manufacturing Equipment

Addendum’’ by using the World Wide

Web (WWW) and going to ‘‘http://

www.fda.gov/cder/guidance/

index.htm’’.

Dated: October 14, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–27738 Filed 10-20-97; 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

contacting George Keller, Ph.D.,

Technology Licensing Specialist, at the

Office of Technology Transfer, National

Institutes of Health, 6011 Executive

Boulevard, Suite 325, Rockville,

Maryland 20852–3804; telephone: 301/

496–7057, ext. 246; fax: 301/402–0220;

e-mail: KellerG@od.nih.gov. A signed

Confidential Disclosure Agreement will

be required to receive copies of the

patent applications.

Diagnostic Reagents and Vaccines for

Multiple Genotypes of Hepatitis C Virus

J Bukh, RH Miller, RH Purcell (NIAID)

Serial Nos. 08/466,601 and 08/468,570

filed 06 Jun 95 (DIV of U.S. Patent

5,514,539 issued 07 May 96)

The invention describes the complete

nucleotide and deduced amino acid

sequences of the envelope 1 (E1) gene of

51 hepatitis C virus (HCV) isolates from

around the world and the grouping of

these isolates into twelve distinct HCV

genotypes. More specifically, this

invention relates to the

oligonucleotides, peptides and

recombinant proteins derived from the

envelope 1 gene sequences of these

isolates and to diagnostic methods and

vaccines that employ these reagents.

Antigenic Protein of Borrelia

Burgdorferi

WJ Simpson, TG Schwan (NIAID)

Serial No. 08/396,957 filed 01 Mar 95

(DIV of U.S. Patent 5,470,712 issued

28 Nov 95)

This patent application describes a 39

kDA protein (P39) that is speciesspecific and expressed by all North

American and European B. burgdorferi

isolates. The discovery includes the

cloning and expression of the gene for

P39 in E. coli and the use of P39 as a

diagnostic antigen for the serodiagnosis

of Lyme borreliosis. The P39 described

in this invention report has been found

not only to be species-specific, but

reactive only with human Lyme

borreliosis sera. This suggests that any

patient’s serum that is shown to react to

P39, irrespective of the patient’s clinical

picture, can be diagnosed as having or

having had Lyme borreliosis.

Versatile Reagent for Detecting Murine

Leukemia Viruses

LH Evans, WJ Britt (NIAID)

Serial No. 08/046,352 filed 08 Apr 93

Monoclonal antibodies directed at the

proteins of murine leukemia viruses

(MuLVS) have some value as

immunological reagents, but differ

greatly in their applicability. The kit

described in this invention uses a

monoclonal antibody designated 83A25,

which identifies almost all ecotropic,

xenotropic, polytropic, and

amphotropic MuLVs. It can be used in

a wide variety of procedures, including

focal immunofluorescence assays on

live or fixed monolayers,

immunoblotting, immunoprecipitation,

immunohistochemical, and flow

cytometric procedures. This kit

overcomes some of the problems

associated with prior methods, which

may not effectively precipitate proteins

or react in immunoblots, are not capable

of detecting MuLVs belonging to all

classes with a single reagent, and may

not efficiently neutralize all MuLVs.

Dated: October 7, 1997.

Barbara M. McGarey, J.D.

Deputy Director, Office of Technology

Transfer.

[FR Doc. 97–27864 Filed 10–20–97; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute of Allergy and

Infectious Diseases; Notice of Closed

Meeting

Pursuant to Section 10(d) of the

Federal Advisory Committee Act, as

amended (5 U.S.C. Appendix 2), notice

is hereby given of the following

National Institute of Allergy and

Infectious Diseases Special Emphasis

Panel (SEP) meeting:

Name of SEP: Therapeutic Strategies for

Papillomavirus (Telephone Conference Call).

Date: October 29, 1997.

Time: 2:00 p.m. to Adjournment.

Place: Teleconference, 6003 Executive

Boulevard, Solar Building, Room 1A1,

Bethesda, MD 20892, (301) 402–0747.

Contact Person: Dr. Sayeed Quraishi,

Scientific Review Adm., 6003 Executive

Boulevard, Solar Bldg., Room 4C22,

Bethesda, MD 20892, (301) 496–7465.

Purpose/Agenda: To evaluate contract

proposals.

The meeting will be closed in accordance

with the provisions set forth in secs.

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

Applications and/or proposals and the

discussions could reveal confidential trade

secrets or commercial property such as

patentable material and personal information

concerning individuals associated with the

applications and/or proposals, the disclosure

of which would constitute a clearly

unwarranted invasion of personal privacy.

This notice is being published less than 15

days prior to the meetings due to the urgent

need to meet timing limitations imposed by

the review and funding cycle.

(Catalog of Federal Domestic Assistance

Programs Nos. 93.855, Immunology, Allergic

and Immunologic Diseases Research; 93.856,

Microbiology and Infectious Diseases

Research, National Institutes of Health)