[Federal Register Volume 78, Number 28 (Monday, February 11, 2013)]
[Notices]
[Pages 9702-9703]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-03019]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0092]


Draft Guidance for Industry on Immunogenicity Assessment for 
Therapeutic Protein Products; 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availability of a draft guidance for industry entitled ``Immunogenicity 
Assessment for Therapeutic Protein Products.'' Therapeutic protein 
products may elicit immune responses, and these responses may lead to 
serious or life-threatening adverse events for the patient or loss of 
efficacy of the product. This draft guidance is intended to assist 
manufacturers to develop a risk-based approach in both the preclinical 
and clinical phases of the development of therapeutic protein products 
to evaluate and mitigate immune responses that may adversely affect 
their safety and efficacy.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by April 12, 2013.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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, or 
Office of Communication, Outreach and Development (HFM-40), Center for 
Biologics Evaluation and Research (CBER), Food and Drug Administration, 
1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448. Send one 
self-addressed adhesive label to assist that office in processing your 
requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Amy Rosenberg, Center for Drug 
Evaluation and Research, Food and Drug Administration, 8800 Rockville 
Pike, Bldg. 29A, rm. 2D-16, Bethesda, MD 20892, 301-827-1790; 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 ``Immunogenicity Assessment for Therapeutic Protein 
Products.'' The purpose of this document is to assist manufacturers and 
clinical investigators involved in the development of therapeutic 
protein products for human use. The guidance outlines, and recommends 
adoption of, a risk-based approach to evaluating and mitigating the 
potential for immunogenicity that may affect the safety and efficacy of 
therapeutic protein products. The guidance describes various product- 
and patient-specific factors that can affect the immunogenicity of 
protein therapeutics and provides recommendations pertaining to each of 
these factors that may reduce the likelihood that these products will 
generate an immune response. In addition, the guidance offers a series 
of recommendations for risk mitigation in the clinical phase of 
development of protein therapeutics. The draft guidance also provides 
supplemental information on the diagnosis and management of particular 
adverse consequences of immune responses to protein therapeutics and 
contains brief discussions of the uses of animal studies and the 
conduct of comparative immunogenicity studies.
    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 
immunogenicity assessment of therapeutic protein products. It does not

[[Page 9703]]

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 either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments 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, and will be posted to the docket at http://www.regulations.gov.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or http://www.regulations.gov.

    Dated: February 5, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-03019 Filed 2-8-13; 8:45 am]
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