
[Federal Register: December 4, 2009 (Volume 74, Number 232)]
[Notices]               
[Page 63758]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04de09-86]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0539]

 
Draft Guidance for Industry on Assay Development for 
Immunogenicity Testing of Therapeutic Proteins; 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availability of a draft guidance for industry entitled ``Assay 
Development for Immunogenicity Testing of Therapeutic Proteins.'' The 
draft guidance provides recommendations to facilitate industry's 
development of immune assays for assessment of the immunogenicity of 
therapeutic proteins during clinical trials.

DATES: Submit written or electronic comments on the draft guidance by 
February 2, 2010. General comments on agency guidance documents are 
welcome at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002; 
Office of Communication, Outreach, and Development (HFM-40), Center for 
Biologics Evaluation and Research, Food and Drug Administration, 1401 
Rockville Pike, Rockville, MD 20852-1448. Send one self-addressed 
adhesive label to assist that office in processing your requests. 
Submit written comments on the draft guidance to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments 
to http://www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the draft guidance 
document.

FOR FURTHER INFORMATION CONTACT:
    Susan Kirshner, Center for Drug Evaluation and Research (HFD-122), 
Food and Drug Administration, 8800 Rockville Pike, Bldg. N29A, rm. 
2D16, Bethesda, MD 20892, 301-827-1731; or
    Stephen Ripley, Center for Biologics Evaluation and Research (HFM-
17), Food and Drug Administration, 1401 Rockville Pike, Suite 200N, 
Rockville, MD 20852-1448, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Assay Development for Immunogenicity Testing of Therapeutic 
Proteins.'' This guidance was created by a working group that consisted 
of staff from the Center for Drug Evaluation and Research (CDER) and 
the Center for Biologics Evaluation and Research (CBER). Because 
clinicians rely on the observed immunogenicity rates listed in the 
``Immunogenicity'' section of drug labeling, development of validated, 
sensitive immune assays is critical to patient care. This guidance 
discusses immunogenicity testing during drug product development and 
provides recommendations on assay development, clinical aspects of 
assay validation, assay validation, assay testing implementation, and 
other aspects of immunogenicity testing.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the agency's current thinking on the 
development of immune assays for assessment of the immunogenicity of 
therapeutic proteins during clinical trials. 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.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper 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 
Division of Dockets Management 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 
either http://www.fda.gov/Drugs/
GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http:/
/www.regulations.gov.

    Dated: December 1, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-28960 Filed 12-3-09; 8:45 am]

BILLING CODE 4160-01-S
