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)
54642 Federal Register / Vol. 62, No. 203 / Tuesday, October 21, 1997 / Notices

Dated: October 15, 1997.

LaVerne Y. Stringfield,

Committee Management Officer, NIH.

[FR Doc. 97–27860 Filed 10–20–97; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institutes of Dental Research;

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 Dental Research

Special Emphasis Panel (SEP) meetings:

Name of SEP: National Institute of Dental

Research Special Emphasis Panel—Review of

R03 grant (98–14).

Dates: November 5, 1997.

Time: 2:00 p.m.

Place: Natcher Building, Rm. 4AN–44F,

National Institutes of Health, Bethesda, MD

20892, (teleconference).

Contact Person: Dr. Philip Washko,

Scientist Review Administrator, 4500 Center

Drive, Natcher Building, Room 4AN–44F,

Bethesda, MD 20892, (301) 594–2372.

Purpose/Agenda: To evaluate and review

grant applications and/or contract proposals.

Name of SEP: National Institute of Dental

Research Special Emphasis Panel—Review of

R44 grant (98–12).

Dates: November 12, 1997.

Time: 10:00 a.m.

Place: Natcher Building, Rm. 4AN–44F,

National Institutes of Health, Bethesda, MD

20892, (teleconference).

Contact Person: Dr. Philip Washko,

Scientist Review Administrator, 4500 Center

Drive, Natcher Building, Room 4AN–44F,

Bethesda, MD 20892, (301) 594–2372.

Purpose/Agenda: To evaluate and review

grant applications and/or contract proposals.

Name of SEP: National Institute of Dental

Research Special Emphasis Panel—Review of

R03 grant (98–08).

Dates: November 17, 1997.

Time: 2:30 p.m.

Place: Natcher Building, Rm. 4AN–44F,

National Institutes of Health, Bethesda, MD

20892, (teleconference).

Contact Person: Dr. Philip Washko,

Scientist Review Administrator, 4500 Center

Drive, Natcher Building, Room 4AN–44F,

Bethesda, MD 20892, (301) 594–2372.

Purpose/Agenda: To evaluate and review

grant applications and/or contract proposals.

Name of SEP: National Institute of Dental

Research Special Emphasis Panel—Review of

R03 grant (98–13).

Dates: November 20, 1997.

Time: 12:00 noon.

Place: Natcher Building, Rm. 4AN–44F,

National Institutes of Health, Bethesda, MD

20892, (teleconference).

Contact Person: Dr. Philip Washko,

Scientist Review Administrator, 4500 Center

Drive, Natcher Building, Room 4AN–44F,

Bethesda, MD 20892, (301) 594–2372.

Purpose/Agenda: To evaluate and review

grant applications and/or contract proposals.

These meetings 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.

(Catalog of Federal Domestic Assistance

Program No. 93.121, Oral Diseases and

Disorders Research)

Dated: October 15, 1997.

LaVerne Y. Stringfield,

Committee Management Officer, NIH.

[FR Doc. 97–27861 Filed 10–20–97; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute on Deafness and

Other Communication Disorders;

Notice of Meeting of the Deafness and

Other Communication Disorders

Programs Advisory Committee

Pursuant to Pub. L. 92–463, notice is

hereby given of a meeting of the

Deafness and Other Communication

Disorders Programs Advisory

Committee.

Date: November 3, 1997.

Place: National Institutes of Health, 9000

Wisconsin Avenue, Building 31C, Conference

Room 7, Bethesda, MD 20892.

Time: 8 am to 4:30 pm.

Purpose/Agenda: To hold discussions on

Extramural Research programs.

Contact Person: Ralph F. Naunton, M.D.,

Director, Division of Human Communication,

NIH/NIDCD, 6120 Executive Boulevard, MSC

7180, Bethesda, MD 20892–7180, 301–496–

1804.

The entire meeting will be open to the

public, with attendance limited to space

available. A summary of the meeting and a

roster of the members may be obtained from

Dr. Naunton’s office. For individuals who

plan to attend and need special assistance

such as sign language interpretation or other

reasonable accommodation, please contact

Dr. Naunton prior to the meeting.

(Catalog of Federal Domestic Assistance

Program No. 93.173 Biological Research

Related to Deafness and Communication

Disorders)

Dated: October 15, 1997.

LaVerne Y. Stringfield,

Committee Management Officer, NIH.

[FR Doc. 97–27862 Filed 10–20–97; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Office of Research on Women’s

Health; Notice of Meeting—‘‘Beyond

Hunt Valley: Research on Women’s

Health for the 21st Century’’

Notice is hereby given that the Office

of Research on Women’s Health

(ORWH), Office of the Director, National

Institutes of Health (NIH), will convene

a meeting on November 17, 18, and 19,

1997, at the Bethesda Marriott (formerly

Pooks Hill Marriott), Bethesda,

Maryland.

The NIH/AES is accredited by the

Accreditation Council for Continuing

Medical Education to sponsor

continuing medical educations for

physicians.

The NIH/AES designates this

educational activity for a maximum of

10 hours in category 1 credit towards

the AMA Physician’s Recognition

Award. Each physician should claim

only those hours of credit that he/she

actually spent in the educational

activity.

The ORWH/NIH research agenda

recognizes the full spectrum of research

from basic to clinical research and trials,

epidemiological and population studies,

clinical applications and health

outcomes. Since September 1996, the

ORWH has convened a series of three

regional meetings for the purpose of

updating the NIH scientific agenda on

women’s health research to meet the

challenges of a changing scientific and

social world. This mechanism provides

an opportunity for the continued

collaboration between individuals and

groups of women and their families,

advocates, scientists, health care

practitioners and public health policy

makers with the NIH to update and

revise the national research agenda for

women’s health into the twenty-first

century. The purpose of this national

meeting will be to culminate the

dialogue conducted over the last year to

update and revise the current

biomedical research agenda for women’s

health, as originally presented in the

Report of the National Institutes of

Health; Opportunities for Research on

Women’s Health, a publication based on

a conference held in Hunt Valley,

Maryland, September 1991.

The first day of the national meeting,

November 17, will be devoted to

receiving public testimony from 1:00

p.m. to 6:00 p.m. The ORWH invites

individuals or individuals representing

organizations with an interest in

research areas related to women’s health