[Federal Register Volume 79, Number 157 (Thursday, August 14, 2014)]
[Notices]
[Pages 47649-47650]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-19267]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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 or the Agency) is 
announcing the availability of a guidance for industry entitled 
``Immunogenicity Assessment for Therapeutic Protein Products.'' 
Therapeutic protein products may elicit immune responses, which may 
lead to serious or life-threatening adverse events for the patient or 
loss of efficacy of the product. This guidance is intended to assist 
manufacturers and clinical investigators in developing a risk-based 
approach in both the nonclinical and clinical phases of product 
development that will allow them to evaluate and reduce the likelihood 
that the immunogenicity of the product will cause harm to patients. 
This guidance finalizes the draft guidance issued in February 2013.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: Submit written requests for single copies of this 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 the Office of 
Communication, Outreach and Development, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send 
one self-addressed adhesive label to assist that office in processing 
your requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance document.
    Submit electronic comments on the 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, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 2238, Silver Spring, MD 20892, 240-402-
9789; or Stephen Ripley, Center for Biologics Evaluation and Research, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 
7301, Rockville, MD 20993, 240-402-7911.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Immunogenicity Assessment for Therapeutic Protein 
Products.'' The purpose of this guidance is to assist

[[Page 47650]]

manufacturers and clinical investigators involved in the development of 
therapeutic protein products for human use in evaluating and reducing 
the risk of adverse events caused by immune responses to these 
products. The guidance: (1) Outlines and recommends adoption of a risk-
based approach to evaluating and mitigating potential immune responses 
to therapeutic protein products that may affect their safety and 
efficacy, (2) describes various product- and patient-specific factors 
that affect the immunogenicity of or immune responses to therapeutic 
protein products and provides recommendations pertaining to each factor 
that may reduce the likelihood that an immune response will be 
generated to the product, (3) offers a series of recommendations for 
risk mitigation in the clinical phase of development of therapeutic 
protein products, (4) provides supplemental information on the 
diagnosis and management of particular adverse consequences of immune 
responses to therapeutic protein products, and (5) discusses briefly 
the use of animal studies and the conduct of comparative immunogenicity 
studies.
    In the Federal Register of February 11, 2013 (78 FR 9702), FDA 
announced the availability of the draft guidance of the same title 
dated February 2013. FDA received numerous comments on the draft 
guidance, and those comments were considered as the guidance was 
finalized. In addition, editorial changes were made to improve clarity.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
Agency's current thinking on immunogenicity assessments for therapeutic 
protein products. 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 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/Guidances/default.htm; or 
http://www.regulations.gov.

    Dated: August 8, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-19267 Filed 8-13-14; 8:45 am]
BILLING CODE 4164-01-P