Draft Guidance for Industry on Immunogenicity Assessment for Therapeutic Protein Products; Availability, 9702-9703 [2013-03019]

Download as PDF 9702 Federal Register / Vol. 78, No. 28 / Monday, February 11, 2013 / Notices riskassessmentsafetyassessment/ and at http://www.regulations.gov. erowe on DSK2VPTVN1PROD with NOTICES V. References The following references have been placed on display in the Division of Dockets Management (see ADDRESSES) and may be seen by interested persons between 9 a.m. and 4 p.m. Monday through Friday, and are available electronically at http:// www.regulations.gov. (FDA has verified the Web site addresses in this reference section, but FDA is not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register.) 1. Goulet, V., M. Hebert, C. Hedberg, et al., ‘‘Incidence of Listeriosis and Related Mortality Among Groups at Risk of Acquiring Listeriosis.’’ Clinical Infectious Diseases, 54(5): 652–660, 2012. 2. Scallan, E., R. M. Hoekstra, F. J. Angulo, et al., ‘‘Foodborne Illness Acquired in the United States—Major Pathogens,’’ Emerging Infectious Diseases, 17(1): 7–12, 2011. 3. U.S. Food and Drug Administration and Health Canada (2012). ‘‘Joint Food and Drug Administration/Health Canada— ´ Sante Canada Quantitative Assessment of the Risk of Listeriosis from Soft-Ripened Cheese Consumption in the United States and Canada: Draft Interpretative Summary.’’ Accessible at http:// www.fda.gov/Food/ScienceResearch/ ResearchAreas/RiskAssessment SafetyAssessment/default.htm. 4. U.S. Food and Drug Administration and Health Canada (2012). ‘‘Joint Food and Drug Administration/Health Canada— ´ Sante Canada Quantitative Assessment of the Risk of Listeriosis from Soft-Ripened Cheese Consumption in the United States and Canada: Draft Technical Report.’’ Accessible at http://www.fda.gov/Food/ ScienceResearch/ResearchAreas/ RiskAssessmentSafetyAssessment/ default.htm. 5. U.S. Food and Drug Administration and Health Canada (2012). ‘‘Joint Food and Drug Administration/Health Canada— ´ Sante Canada Quantitative Assessment of the Risk of Listeriosis from Soft-Ripened Cheese Consumption in the United States and Canada: Draft Technical Report Appendices.’’ Accessible at http:// www.fda.gov/Food/ScienceResearch/ ResearchAreas/RiskAssessmentSafety Assessment/default.htm. 6. U.S. Food and Drug Administration and Health Canada (2012). ‘‘Joint Food and Drug Administration/Health Canada— ´ Sante Canada Quantitative Assessment of the Risk of Listeriosis from Soft-Ripened Cheese Consumption in the United States and Canada: Draft Risk Assessment Model.’’ Analytica file. Accessible at http://www.fda.gov/Food/ ScienceResearch/ResearchAreas/ RiskAssessmentSafetyAssessment/ default.htm. 7. U.S. Food and Drug Administration and Health Canada (2012). ‘‘Joint Food and VerDate Mar<15>2010 14:26 Feb 08, 2013 Jkt 229001 Drug Administration/Health Canada— ´ Sante Canada Quantitative Assessment of the Risk of Listeriosis from Soft-Ripened Cheese Consumption in the United States and Canada: Answer to the Peer Review.’’ Accessible at http://www.fda.gov/Science Research/SpecialTopics/PeerReviewof ScientificInformationandAssessments/ ucm079120.htm. Dated: February 5, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–02960 Filed 2–8–13; 8:45 am] BILLING CODE 4160–01–P 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. 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 lifethreatening 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, SUMMARY: PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 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 E:\FR\FM\11FEN1.SGM 11FEN1 9703 Federal Register / Vol. 78, No. 28 / Monday, February 11, 2013 / Notices 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/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm, http:// www.fda.gov/BiologicsBloodVaccines/ GuidanceComplianceRegulatory Information/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] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0001] Food and Drug Administration/Xavier University PharmaLink Conference— Quality in a Global Supply Chain AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public conference. The Food and Drug Administration (FDA) Cincinnati District, in cosponsorship with Xavier University, is announcing a public conference entitled ‘‘FDA/Xavier University PharmaLink Conference.’’ The PharmaLink conference seeks solutions to important and complicated issues by aligning with the strategic priorities of FDA, and includes presentations from key FDA officials, global regulators, and industry experts. Each presentation challenges the status quo and conventional wisdom of our industry to create synergies focused on finding solutions which make a difference. Every discussion, exploration, and solution is framed by the goal of delivering increased patient health and safety through topics such as a working session with the Office of the Commissioner on the implementation of the FDA Safety and Innovation Act, Business Impact of Outsourcing, Supplier Management Models that Work, Implementing Quality by Design (QbD) Successfully—like other industries, lunch with global regulators (FDA, Medicines and Healthcare SUMMARY: products Regulatory Agency (MHRA), Fimea, and Swissmedic), and many more. The experience level of our audience has fostered engaged dialog that has led to innovative initiatives. DATES: The public conference will be held on March 12, 2013, from 8:30 a.m. to 5 p.m.; March 13, 2013, from 8:30 a.m. to 5 p.m.; and March 14, 2013, from 8:30 a.m. to 12:45 p.m. ADDRESSES: The public conference will be held on the campus of Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207, 513–745–3073 or 513–745–3396. FOR FURTHER INFORMATION CONTACT: For information regarding this notice: Steven Eastham, Office of Regulatory Affairs, Food and Drug Administration, Cincinnati South Office, 36 East 7th Street, suite 1910, Cincinnati, OH 45202, 513–246–4134, email: steven.eastham@fda.hhs.gov. For information regarding the conference and registration: Marla Phillips, Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207, 513–745–3073, email: phillipsm4@xavier.edu. SUPPLEMENTARY INFORMATION: Registration: There is a registration fee. The conference registration fees cover the cost of the presentations, training materials, receptions, breakfasts, lunches, and dinners for the 21⁄2 days of the conference. Advanced registration rate ends February 18, 2013. Standard registration rates begin on February 19, 2013. There will also be onsite registration. The cost of registration is as follows: TABLE 1—REGISTRATION FEES 1 Attendee type Fee Jan. 23–Feb. 18 Industry Small Business (<100 employees) Consultants Startup Manufacturer Academic Media Government erowe on DSK2VPTVN1PROD with NOTICES 1 The $1,295 900 600 250 250 Free Free Fee after Feb. 18 $1,495 1,000 700 300 300 Free Free fourth registration from the same company is free—all four attendees must register at the same time. The following forms of payment will be accepted: American Express, Visa, Mastercard, and company checks. To register online for the public conference, please visit the ‘‘Registration’’ link on the conference Web site at http:// www.XavierPharmaLink.com. FDA has verified the Web site address, but is not responsible for subsequent changes to the Web site after this document publishes in the Federal Register. VerDate Mar<15>2010 14:26 Feb 08, 2013 Jkt 229001 To register by mail, please send your name, title, firm name, address, telephone and fax numbers, email, and payment information for the fee to Xavier University, Attention: Susan Bensman, 3800 Victory Pkwy., Cincinnati, OH 45207. An email will be sent confirming your registration. Attendees are responsible for their own accommodations. The conference headquarter hotel is the Downtown Cincinnati Hilton Netherlands Plaza, 35 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 West 5th Street, Cincinnati, OH 45202, 513–421–9100. To make reservations online, please visit the ‘‘Venue & Logistics’’ link at http:// www.XavierPharmaLink.com. The hotel is expected to sell out during this timeframe, so early reservation in the conference room block is encouraged. If you need special accommodations due to a disability, please contact Marla Phillips (see FOR FURTHER INFORMATION E:\FR\FM\11FEN1.SGM 11FEN1

Agencies

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


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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]
BILLING CODE 4160-01-P