[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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