[Federal Register Volume 65, Number 224 (Monday, November 20, 2000)]
[Notices]
[Pages 69777-69778]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-29537]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 00D-0218]
Guidance for Reviewers: Potency Limits for Standardized Dust Mite
and Grass Allergen Vaccines: A Revised Protocol; 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 guidance document entitled ``Guidance for Reviewers:
Potency Limits for Standardized Dust Mite and Grass Allergen Vaccines:
A Revised Protocol'' dated October 2000. The guidance document provides
information on the revised release limits to be used by the Center for
Biologics Evaluation and Research (CBER) for its evaluation of
standardized dust mite and grass allergen vaccines submitted to CBER
for lot release. The establishment of suitable potency limits for
standardized allergen vaccines submitted to CBER for lot release is
necessary 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draft guidance entitled ``Guidance for Reviewers: Potency Limits for
Standardized Dust Mite and Grass Allergen Vaccines: A Revised
Protocol'' that was announced in the Federal Register on February 15,
2000.
DATES: Submit written comments at any time.
ADDRESSES: Submit written requests for single copies of ``Guidance for
Reviewers: Potency Limits for Standardized Dust Mite and Grass Allergen
Vaccines: A Revised Protocol'' 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 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:
[[Page 69778]]
I. Background
FDA is announcing the availability of a guidance document entitled
``Guidance for Reviewers: Potency Limits for Standardized Dust Mite and
Grass Allergen Vaccines: A Revised Protocol'' November July 2000. The
guidance document provides information to FDA reviewers regarding
broader relative potency limits for CBER evaluation of standardized
dust mite and grass allergen vaccines submitted to CBER for lot
release. Issues addressed in the guidance document include, but are not
limited to, the following: (1) Diagnostic equivalence, (2) theraputic
equivalence, (3) safety equivalence, (4) lot-to-lot variation in
allergen vaccine potency, and (5) current and broadened CBER release
limits for standardized dust mite and grass allergen vaccines submitted
to CBER for lot release. The guidance document announced in this notice
finalizes the draft guidance entitled, ``Guidance for Reviewers:
Potency Limits for Standardized Dust Mite and Grass Allergen Vaccines:
A Revised Protocol'' that was announced in the Federal Register on
February 15, 2000 (65 FR 7557).
This guidance document represents the agency's current thinking
with regard to the potency limits for standardized dust mite and grass
allergen vaccines. 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 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 submit to the Dockets Management Branch
(address above) written comments regarding this guidance document. Two
copies of any comments are to be submitted, except individuals may
submit one copy. Comments should be identified with the docket number
found in the 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: October 13, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-29537 Filed 11-17-00; 8:45 am]
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