[Federal Register Volume 59, Number 225 (Wednesday, November 23, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-28858]


[[Page Unknown]]

[Federal Register: November 23, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 94N-0012]

 

Methods of the Allergenic Products Testing Laboratory; 
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 ``Methods of the Allergenic 
Products Testing Laboratory'' (the methods document), dated October 
1993. The methods document provides the technical details for 
performing in vivo and in vitro analytical methods acceptable to FDA to 
ensure the identity and relative potency of allergenic extracts. The 
methods document is intended for use by manufacturers of licensed 
allergenic extracts, sponsors of investigational new drug applications 
for allergenic extracts, and other interested parties.

DATES: Written comments may be submitted at any time.

ADDRESSES: Submit written requests for single copies of the methods 
document to the Congressional and Consumer Affairs Branch (HFM-12), 
Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-
1448, or call FDA's automated information system at 301-594-1800. Send 
two self-addressed adhesive labels to assist that office in processing 
your requests. Persons with access to INTERNET may request the methods 
document from [email protected]. Submit written comments on 
the methods document to the Dockets Management Branch (HFA-305), Food 
and Drug Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 
20857. Requests and comments should be identified with the docket 
number found in brackets in the heading of this document. A copy of the 
methods 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.

FOR FURTHER INFORMATION CONTACT: Timothy W. Beth, Center for Biologics 
Evaluation and Research (HFM-635), Food and Drug Administration, 1401 
Rockville Pike, Rockville, MD 20852-1448, 301-594-3074.

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of the 
methods document that was prepared by the Laboratory of 
Immunobiochemistry (HFM-422), Division of Allergenic Products and 
Parasitology, Office of Vaccine Research and Review, Center for 
Biologics Evaluation and Research, FDA. This methods document is a 
revision of ``Methods of the Laboratory of Allergenic Products,'' dated 
March 1987, which previously was available to the public under 21 CFR 
part 20 and Sec. 10.90(b)(10) (21 CFR 10.90(b)(10)).
    The methods document sets forth the in vitro and in vivo methods 
used in the Laboratory of Immunobiochemistry for determining the 
identity and relative potency of investigational and approved 
allergenic extracts. The in vitro methods include the following 
qualitative and quantitative methods: Agarose diffusion, isoelectric 
focusing (IEF), radial immunodiffusion (RID), enzyme-linked 
immunosorbent assay (ELISA), radioallergosorbent test (RAST), 
ninhydrin, blotted isoelectric focusing-light (BIEF-LIGHT), and blotted 
radio-immuno isoelectric focusing (BRIEF). The in vivo methods include 
quantitative intradermal tests.
    The methods document is not intended to constitute a comprehensive 
reference of analytical methods appropriate for allergenic extract 
testing, and all methods described are not necessarily applicable to 
all allergenic extracts. Rather, the methods document provides 
representative analytical methods that would be acceptable to FDA for 
allergenic extract testing. The use of alternative analytical methods 
may be considered but should be discussed with FDA prior to use to 
prevent the possible expenditure of resources on methods that FDA may 
later determine to be unacceptable. This notice of availability is 
announced under Sec. 10.90(b)(10), which provides that particular 
analytical methods may be included in the public file for a particular 
purpose.
    FDA is requesting comments from interested parties concerning the 
methods document. These comments will be considered in determining 
whether further revision of the methods document is warranted.
    Interested persons may, at any time, submit to the Dockets 
Management Branch (address above) written comments on the methods 
document. Two copies of any comments are to be submitted, except that 
individuals may submit one copy. Comments are to be identified with the 
docket number found in brackets in the heading of this document. 
Received comments may be seen in the Dockets Management Branch between 
9 a.m. and 4 p.m., Monday through Friday.

    Dated: November 15, 1994.
William K. Hubbard,
Interim Deputy Commissioner for Policy.
[FR Doc. 94-28858 Filed 11-22-94; 8:45 am]
BILLING CODE 4160-01-F