4272 Federal Register / Vol. 63, No. 18 /Wednesday, January 28, 1998 / Notices

Committee Name Dates of Meetings InformationLine Code

June 11–12

September 10–11

December 7–8

Obstetrics and Gynecology Devices Panel January 27–28 ............................................................. 12524

April 6–7

July 20–21

October 19–20

Ophthalmic Devices Panel February 12–13 ............................................................ 12396

April 23–24

July 23–24

October 22–23

Orthopaedic and Rehabilitation Devices Panel January 12–13 ............................................................. 12521

April 27–28

July 9–10

October 8–9

Radiological Devices Panel February 23 .................................................................. 12525

May 11

August 17

November 16

National Mammography Quality Assurance Advisory Committee May 13 ......................................................................... 12397

Technical Electronic Product Radiation Safety Standards CommitteeSeptember 22 .............................................................. 12399

CENTER FOR VETERINARY MEDICINE

Veterinary Medicine Advisory Committee No meetings planned ................................................... 12546

NATIONAL CENTER FOR TOXICOLOGICAL RESEARCH

Advisory Committee on Special Studies Relating to the Possible

Long-Term Health Effects of Phenoxy Herbicides and Contaminants

April 10–11 ................................................................... 12560

Science Board to the National Center for Toxicological Research March 24–25 ................................................................ 12559

Dated: January 22, 1998.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 98–2025 Filed 1–27–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D–0021]

Draft Guidance for Industry; Container

and Closure Integrity Testing in Lieu of

Sterility Testing as a Component of the

Stability Protocol for Sterile Products;

Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of the draft guidance

entitled ‘‘Guidance for Industry:

Container and Closure Integrity Testing

in Lieu of Sterility Testing as a

Component of the Stability Protocol for

Sterile Products.’’ The draft guidance is

intended to provide recommendations

and offer alternative methods for

sterility testing to confirm the integrity

of container and closure systems for

sterile biological products, human and

veterinary drugs, and medical devices.

The draft guidance applies only to the

replacement of the sterility test with an

appropriate container and closure

integrity test in the stability protocol,

and it is not offered as a replacement for

sterility testing for product release.

DATES: Written comments may be

provided at any time, however, to

ensure comments are considered for the

next revision they should be submitted

by March 30, 1998.

ADDRESSES: Submit written comments

on the draft guidance to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857. Submit written requests for

single copies of the draft guidance

entitled ‘‘Guidance for Industry:

Container and Closure Integrity Testing

in Lieu of Sterility Testing as a

Component of the Stability Protocol for

Sterile Products’’ to the Office of

Communication, Training, and

Manufacturers Assistance (HFM–40),

Center for Biologics Evaluation and

Research, Food and Drug

Administration, 1401 Rockville Pike,

Rockville, MD 20852–1448. Send one

self-addressed adhesive label to assist

that office in processing your requests.

The document may also be obtained by

mail by calling the CBER Voice

Information System at 1–800–835–4709

or 301–827–1800, or by fax by calling

the FAX Information System at 1–888–

CBER–FAX or 301–827–3844. See the

SUPPLEMENTARY INFORMATION

section for electronic access to the draft

guidance.

FOR FURTHER INFORMATION CONTACT:

Valerie A. Butler, Center for Biologics

Evaluation and Research (HFM–17),

Food and Drug Administration, 1401

Rockville Pike, suite 200N, Rockville,

MD 20852–1448, 301–827–6210.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of

a draft guidance entitled ‘‘Guidance for

Industry: Container and Closure

Integrity Testing in Lieu of Sterility

Testing as a Component of the Stability

Protocol for Sterile Products.’’ The draft

guidance provides general information

on procedures and practices that should

be considered when a manufacturer

selects alternative methods to confirm

sterility during stability studies of

sterile biological products, human and

veterinary drugs, and medical devices.

All sterile products are required to

have adequate container and closure

integrity and to remain free from

contamination throughout the product’s

entire dating period. As a consequence
Federal Register / Vol. 63, No. 18 /Wednesday, January 28, 1998 / Notices 4273

of the limitations of sterility testing,

FDA has determined that alternative

methods are available that may more

reliably confirm the integrity of the

container and closure system in the

final form throughout the entire dating

period.

The draft guidance was prepared

jointly by the following Centers: Center

for Biologics Evaluation and Research

(CBER), Center for Drug Evaluation and

Research (CDER), Center for Veterinary

Medicine (CVM), and Center for Devices

and Radiological Health (CDRH). At the

request of CBER’s Stability and

Formulation Committee, representatives

from the Centers met on May 19, 1994,

to discuss sterility testing as a

component of the stability protocol. The

ability of containers/packaging to

maintain sterility should be proven for

all sterile products.

As with other guidance documents,

FDA does not intend this document to

be all-inclusive and cautions that not all

information may be applicable to all

situations. The document is intended to

provide information and does not set

forth requirements. Alternative

approaches may be warranted in

specific situations, and certain aspects

may not be applicable to all situations.

If a manufacturer believes that the

procedure described in the draft

guidance is inapplicable to a particular

method and other procedures are

appropriate for FDA’s consideration, the

manufacturer may wish to discuss the

matter further with the agency to

prevent expenditure of money and effort

on activities that later may be

determined to be unacceptable by FDA.

FDA will continue to review alternative

methods on a case-by-case basis.

The draft guidance represents the

agency’s current thinking on container

and closure integrity testing during

stability monitoring for sterile products.

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. The draft guidance

document is being distributed for

comment purposes only and is not

intended for implementation at this

time.

II. Request for Comments

Interested persons may, at any time,

submit written comments to the Dockets

Management Branch (address above)

regarding this draft guidance document.

Two copies of any comments are to be

submitted, except that individuals may

submit one copy. Comments and

requests for copies are to be identified

with the docket number found in the

brackets in the heading of this

document. A copy of the draft guidance

and received comments are available for

public examination in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

III. Electronic Access

In order to receive the ‘‘Guidance for

Industry: Container and Closure

Integrity Testing in Lieu of Sterility

Testing as a Component of the Stability

Protocol for Sterile Products’’ via your

fax machine, call the FAX Information

System at 1–888–CBER–FAX or 301–

827–3844.

Persons with access to the Internet

may obtain the draft guidance document

by using the World Wide Web (WWW).

For WWW access, connect to CBER at

‘‘http://www.fda.gov/cber/

guidelines.htm’’. Received comments

will be considered in determining

whether further revision of the draft

guidance document is warranted.

Dated: January 21, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–2021 Filed 1–27–98; 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,

HHS.

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 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.

Novel Attenuated Strains

Mycobacterium Tuberculosis

CE Barry, Y. Yuan (NIAID).

Serial No.: 60/025,199 filed 10 July

97.

Licensing Contact: Carol Salata, 301/

496–7735 ext 232.

This invention provides for novel

attenuated strains of Mycobacterium

tuberculosis and M. bovis. Attenuation

is achieved by down-regulating the

expression of the α-crystallin heat shock

protein gene (‘‘acr gene’’). This gene is

essential for virulence of the organism.

Since this strain is isogenic with

virulent M. tuberculosis but for this

deletion, the full complement of

antigens remains present and the

organism is viable in vitro. The

invention provides for vaccines and

methods of vaccinating mammals for

protection against Mycobacterium sp.

that cause tuberculosis.

Method of Promoting Tumor Necrosis

Using MIG

G Tosato (FDA), J Farber (NIAID), C

Sgardari (FDA).

Serial No.: 08/850,914 filed 2 May 97.

Licensing Contact: Jaconda Wagner,

301/496–7735 ext 284.

Monokine induced by IFN–γ (Mig),

which is structurally related to

interferon-inducible protein 10 (IP–10),

has been shown to exhibit antitumor

activity. Mig is a member of the α

chemokine family. Members of this

chemokine family, PF4, PBP, CTAP–III

βTG, NAP–2, IL–8 GROα, GROβ, GROγ,

and IP–10, have been shown to act as an

angiogenic or angiostatic factor. This

invention relates to the use of Mig to

promote the death of tumor tissue. It

also relates to a method of inhibiting

angiogenesis at a tumor site using Mig.

This research has been published in

Blood 1997 Apr 15;89(8):2635–43 and J

Leukoc Biol 1997 Mar;61(3):246–57.

A related case is also available for

licensing: Serial No. 08/455,079 filed 31

May 95 entitled ‘‘Interferon-Inducible

10 (IP–10) is a Potent Inhibitor of

Angiogenesis’’; inventors are G Tosato,

AL Angiolillo, and C Sgardari.

Formation of Human Bone In Vivo

PG Robey (NIDR), P Bianco

(Universita dell Aquilla), Sa Kuznetsov

(NIDR), PH Krebsback (NIDR), DW Rowe

(University of Connecticut.

Serial No.: 08/798, 715 filed 12 Feb.

97.

Licensing Contact: Jaconda Wagner,

301/496–7735 ext 284.

This invention provides a model for

studying human bone metabolism in