[Federal Register Volume 65, Number 31 (Tuesday, February 15, 2000)]
[Notices]
[Pages 7557-7558]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-3407]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-0218]


Draft ``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 draft document entitled ``Guidance for Reviewers: 
Potency Limits for Standardized Dust Mite and Grass Allergen Vaccines: 
A Revised Protocol'' dated January, 2000. The draft guidance document 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 helps 
to ensure the safety, purity, and potency of these products.

DATES: Written comments may be submitted at any time, however, comments 
should be submitted by May 15, 2000, to ensure their adequate 
consideration in preparation of the final document.

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 January, 2000 to the Office of 
Communication, Training, and Manufacturers Assistance (HFM-40),

[[Page 7558]]

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to the draft guidance document.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:

I. Background

    FDA is announcing the availability of a draft document entitled 
``Guidance for Reviewers: Potency Limits for Standardized Dust Mite and 
Grass Allergen Vaccines: A Revised Protocol'' dated January, 2000. The 
draft guidance document, when finalized, would provide 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) therapeutic 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.
    This draft 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 
requirement of the applicable statute, regulations, or both. 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

    This draft document is being distributed for comment purposes only 
and is not intended for implementation at this time. Interested persons 
may submit to the Dockets Management Branch (address above) written 
comments regarding this draft guidance document. Submit Written 
comments at any time, however, comments should be submitted by May 15, 
2000, to ensure adequate consideration in preparation of the final 
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: February 8, 2000.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 00-3407 Filed 2-14-00; 8:45 am]
BILLING CODE 4160-01-F