[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Draft Guidance for Industry on Immunogenicity Assessment for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availability of a draft guidance for industry entitled ``Immunogenicity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 This draft guidance is intended to assist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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by April 12, 2013.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug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access to the draft guidance document.
Submit electronic comments on the draft guidance to http://www.regulations.gov.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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