[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Draft Guidance for Industry on Testing Limits in Stability 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availability of a draft guidance document entitled ``Guidance for 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 This draft guidance document is 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draft guidance document may also be obtained by mail by calling the 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    Submit written comments on the draft guidance document to the 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draft guidance document entitled ``Guidance for Industry on Testing 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