[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announced in this notice finalizes the draft guidance entitled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