[Federal Register Volume 62, Number 164 (Monday, August 25, 1997)]
[Notices]
[Pages 44975-44976]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-22421]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97D-3010]
Draft Guidance for Industry on Testing Limits in Stability
Protocols for Standardized Grass Pollen Extracts; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance document entitled ``Guidance for
Industry on Testing Limits in Stability Protocols for Standardized
Grass Pollen Extracts (July 1997).'' This draft guidance document is
intended to provide information to manufacturers regarding the
development of stability studies to determine the shelf life of
standardized grass pollen extracts to help ensure the safety, purity,
and potency of these products.
DATES: Written comments may be submitted at any time, however, to
ensure comments are considered for the next revision they should be
submitted by October 24, 1997.
ADDRESSES: Submit written requests for single copies of ``Guidance for
Industry on Testing Limits in Stability Protocols for Standardized
Grass Pollen Extracts (July 1997)'' to the Center for Biologics
Evaluation and Research, Food and Drug Administration, Office of
Communication, Training, and Manufacturers Assistance (HFM-40), 1401
Rockville Pike, Rockville, MD 20852-1448. Send one self-addressed
adhesive label to assist that office in processing your request. The
draft guidance document may also be obtained by mail by calling the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.
Submit written comments on the draft guidance document to the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: Timothy W. Beth, Center for Biologics
Evaluation and Research (HFM-630), Food and Drug Administration, 1401
Rockville Pike, Rockville, MD 20852-1448, 301-594-3074.
SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a
draft guidance document entitled ``Guidance for Industry on Testing
Limits in Stability Protocols for Standardized Grass Pollen Extracts
(July 1997).'' The draft guidance document provides a discussion of
issues that should be considered in the development of stability
protocols for allergenic extracts derived from grass pollen for
diagnostic and immunotherapeutic uses.
The draft guidance document is intended to provide information to
manufacturers regarding stability studies on grass pollen extracts.
Such stability studies are used to empirically determine the shelf life
of the product. This draft guidance document does not, however, change
lot release criteria for these products. Issues addressed in the draft
guidance document include but are not limited to: (1) Current lot
release criteria, (2) lot release versus stability protocol, (3)
modified stability protocol, (4) retesting, (5) dealing with test
failure, and (6) extension of dating.
As with other guidance documents, FDA does not intend this draft
guidance document to be all-inclusive and cautions that not all
information may be applicable to all situations. The draft guidance
document is intended to provide information and does not set forth
requirements. The methods and procedures presented in the draft
guidance document are suggestions. FDA anticipates that sponsors and
investigators may develop alternative methods and procedures and
discuss them with FDA. FDA may find those alternative methods and
procedures acceptable. FDA recognizes that
[[Page 44976]]
advances will continue in the area of allergenic extracts and that this
document may become outdated as those advances occur. This draft
guidance document represents the agency's current thinking on testing
limits in stability protocols for standardized grass pollen extracts.
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 submit written comments on the draft
guidance document to the Dockets Management Branch (address above). Two
copies of any comments are to be submitted, except that individuals may
submit one. Requests and comments should be identified with the docket
number found in brackets in the heading of this document. The draft
guidance document and received comments are available for public
examination in the office above between 9 a.m. and 4 p.m., Monday
through Friday. Comments received will be considered in determining
whether further revision of the draft guidance document is warranted.
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''.
Dated: August 15, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-22421 Filed 8-22-97; 8:45 am]
BILLING CODE 4160-01-F