[Federal Register Volume 76, Number 155 (Thursday, August 11, 2011)]
[Notices]
[Pages 49773-49774]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-20386]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0324]


International Conference on Harmonisation; Guidance on E16 
Biomarkers Related to Drug or Biotechnology Product Development: 
Context, Structure, and Format of Qualification Submissions; 
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 guidance entitled ``E16 Biomarkers Related to Drug or 
Biotechnology Product Development: Context, Structure, and Format of 
Qualification Submissions.'' The guidance was prepared under the 
auspices of the International Conference on Harmonisation of Technical 
Requirements for Registration of Pharmaceuticals for Human Use (ICH). 
The guidance describes recommendations regarding the context, 
structure, and format of qualification submissions for clinical and 
nonclinical genomic biomarkers related to development of drug or 
biotechnology products, including translational medicine approaches, 
pharmacokinetics, pharmacodynamics, and efficacy and safety aspects. 
The guidance is intended to create a harmonized recommended structure 
for biomarker qualification applications that will foster consistency 
of applications across regions and facilitate discussions with and 
among regulatory authorities.

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

ADDRESSES: Submit written requests for single copies of the guidance to 
the Division of Drug Information (HFD-240), 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 (HFM-40), Center for Biologics 
Evaluation and Research (CBER), Food and Drug Administration, 1401 
Rockville Pike, Rockville, MD 20852-1448. Send one self-addressed 
adhesive label to assist the office in processing your requests. The 
guidance may also be obtained by mail by calling CBER at 1-800-835-4709 
or 301-827-1800. 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:
    Regarding the guidance:

Federico Goodsaid, Center for Drug Evaluation and Research, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2148, 
Silver Spring, MD 20903-0002, 301-796-1535; or
Jennifer Catalano, Center for Biologics and Evaluation Research (HFM-
735), Food and Drug Administration, 1401 Rockville Pike, suite 200N, 
Rockville, MD 20852-1448, 301-827-0706.

    Regarding the ICH:

Michelle Limoli, Office of International Programs (HFG-1), Food and 
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-
4480.

SUPPLEMENTARY INFORMATION:

I. Background

    In recent years, many important initiatives have been undertaken by 
regulatory authorities and industry associations to promote 
international harmonization of regulatory

[[Page 49774]]

requirements. FDA has participated in many meetings designed to enhance 
harmonization and is committed to seeking scientifically based 
harmonized technical procedures for pharmaceutical development. One of 
the goals of harmonization is to identify and then reduce differences 
in technical requirements for drug development among regulatory 
agencies.
    ICH was organized to provide an opportunity for tripartite 
harmonization initiatives to be developed with input from both 
regulatory and industry representatives. FDA also seeks input from 
consumer representatives and others. ICH is concerned with 
harmonization of technical requirements for the registration of 
pharmaceutical products among three regions: The European Union, Japan, 
and the United States. The six ICH sponsors are the European 
Commission; the European Federation of Pharmaceutical Industries 
Associations; the Japanese Ministry of Health, Labour, and Welfare; the 
Japanese Pharmaceutical Manufacturers Association; the Centers for Drug 
Evaluation and Research and Biologics Evaluation and Research, FDA; and 
the Pharmaceutical Research and Manufacturers of America. The ICH 
Secretariat, which coordinates the preparation of documentation, is 
provided by the International Federation of Pharmaceutical 
Manufacturers Associations (IFPMA).
    The ICH Steering Committee includes representatives from each of 
the ICH sponsors and the IFPMA, as well as observers from the World 
Health Organization, Health Canada, and the European Free Trade Area.
    In the Federal Register of July 30, 2009 (74 FR 38033), FDA 
published a notice announcing the availability of a draft guidance 
entitled ``E16 Genomic Biomarkers Related to Drug Response: Context, 
Structure, and Format of Qualification Submissions.'' The notice gave 
interested persons an opportunity to submit comments by September 28, 
2009.
    After consideration of the comments received and revisions to the 
guidance, a final draft of the guidance was submitted to the ICH 
Steering Committee and endorsed by the three participating regulatory 
agencies in September 2010.
    The guidance provides recommendations on the context, structure, 
and format of qualification submissions as follows:
     The proposed context of use of a biomarker corresponds to 
the data supporting its qualification. The context of use of a 
biomarker in a biomarker qualification can be narrow or broad--the 
biomarker(s) might be useful for only a single drug or biotechnology 
product, for several drug or biotechnology products in a drug class, or 
even across several drug classes.
     The structure of the submission should be consistent 
regardless of the context proposed and flexible enough to deal with the 
specific attributes of each submission. In addition, use of the 
recommended structure should facilitate submission and review of future 
biomarker qualification submissions expanding the use of the biomarker 
to new contexts, as would be the case if, for example, a nonclinical 
context of use expands to a clinical context of use.
     The format of the data for qualifying a biomarker can vary 
significantly depending on the context. The format should support an 
evaluation of the data and can include reports, tabulations, and raw 
data (if requested by regulatory authorities according to the relevant 
practices in place).
    The application structure described in this guidance is intended 
for biomarker qualification submissions after sufficient supporting 
data have been generated. However, this structure can also be 
considered for submissions intended to obtain scientific advice from 
regulatory authorities before or during the generation of the biomarker 
data intended to support qualification.
    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 this topic. 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) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed 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.

III. Electronic Access

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

    Dated: August 4, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-20386 Filed 8-10-11; 8:45 am]
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