[Federal Register Volume 65, Number 224 (Monday, November 20, 2000)]
[Notices]
[Pages 69778-69779]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-29535]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 97D-3010]


``Guidance for Industry: 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 document entitled ``Guidance for Industry: Testing 
Limits in Stability Protocols for Standardized Grass Pollen Extracts'' 
dated November 2000. The guidance document provides information on 
developing stability protocols for standardized grass pollen extracts. 
The development of suitable stability studies is necessary to determine 
the shelf life of standardized grass pollen extracts to help ensure the 
safety, purity, and potency of these products. The guidance document 
announced in this notice finalizes the draft guidance entitled 
``Guidance for Industry on Testing Limits in Stability Protocols for 
Standardized Grass Pollen Extracts'' that was announced in the Federal 
Register of August 25, 1997.

DATES: Submit written comments at any time.

ADDRESSES: Submit written requests for single copies of the guidance 
entitled ``Guidance for Industry: Testing Limits in Stability Protocols 
for Standardized Grass Pollen Extracts'' dated November 2000 to the 
Office of Communication, Training, and Manufacturers Assistance (HFM-
40), Center for Biologics Evaluation and Research (CBER), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448. Send one 
self-addressed adhesive label to assist the 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 guidance document.
    Submit written comments on the guidance document to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Joseph L. Okrasinski, Center for 
Biologics Evaluation and Research (HFM-17), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-
6210.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a document entitled 
``Guidance for Industry: Testing Limits in Stability Protocols for 
Standardized Grass Pollen Extracts'' dated November 2000. The guidance 
document is intended to provide information to manufacturers regarding 
stability studies on grass pollen extracts. Such stability studies are 
used to determine the shelf life of the product. This guidance document 
does not, however, change lot release criteria for these products. 
Issues addressed in the 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. The guidance document 
announced in this notice finalizes the draft guidance entitled 
``Guidance for Industry on Testing Limits in Stability Protocols for 
Standardized Grass Pollen Extracts'' that was announced in the Federal 
Register of August 25, 1997 (62 FR 44975).
    This guidance document represents the agency's current thinking 
with regard to the testing limits in stability protocols for 
standardized grass pollen extract. 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 requirement of the applicable statutes and regulations. 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.

II. Comments

    Interested persons may, at any time, submit written comments to the 
Dockets Management Branch (address above) regarding this guidance 
document. Two

[[Page 69779]]

copies of any comments are to be submitted, except individuals may 
submit one copy. Comments should be identified with the docket number 
found in brackets in the heading of this document. A copy of the 
document 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

    Persons with access to the Internet may obtain the document at 
http://www.fda.gov/cber/guidelines.htm.

    Dated: November 6, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-29535 Filed 11-12-00; 8:45 am]
BILLING CODE 4160-01-F