[Federal Register: November 20, 2000 (Volume 65, Number 224)]
[Notices]               
[Page 69777-69778]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20no00-80]                         

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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draft guidance entitled ``Guidance for Reviewers: Potency Limits for 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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]
BILLING CODE 4160-01-F