[Federal Register Volume 81, Number 107 (Friday, June 3, 2016)]
[Notices]
[Pages 35781-35782]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-13168]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-1255]


E18 Genomic Sampling and Management of Genomic Data; 
International Council for Harmonisation; Draft Guidance for Industry; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance entitled ``E18 Genomic Sampling 
and Management of Genomic Data.'' The draft guidance was prepared under 
the auspices of the International Council for Harmonisation (ICH), 
formerly the International Conference on Harmonisation. The draft 
guidance pertains to genomic sampling and to the management of genomic 
data in clinical studies. The focus of this draft guidance is on the 
general principles of collecting, processing, transporting, storing, 
and disposing of genomic samples or data. The technical aspects of 
genomic sampling and research are also discussed when appropriate, 
recognizing the rapidly evolving technological advances in these areas. 
The draft guidance is intended to provide harmonized principles of 
genomic sampling and of managing genomic data in clinical studies.

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this draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by August 2, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2016-D-1255 for ``E18 Genomic Sampling and Management of Genomic 
Data.'' Received comments will be placed in the docket and, except for 
those submitted as ``Confidential Submissions,'' publicly viewable at 
http://www.regulations.gov or at the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the

[[Page 35782]]

``Search'' box and follow the prompts and/or go to the Division of 
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of this draft guidance to 
the Division of Drug Information, Center for Drug Evaluation and 
Research (CDER), Food and Drug Administration, 10001 New Hampshire 
Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002, or 
the Office of Communication, and Education, (CDRH), Division of 
Industry and Consumer Education, Center for Devices and Radiological 
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
66, Rm. 4621, 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.

FOR FURTHER INFORMATION CONTACT: Regarding the draft guidance: 
Christian Grimstein, Center for Drug Evaluation and Research (CDER), 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 
3116, Silver Spring, MD 20993-0002, 301-796-5189; or Eunice Lee, Center 
for Devices and Radiological Health (CDRH), Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5546, Silver 
Spring, MD 20993-0002, 301-796-4808.
    Regarding the ICH: Amanda Roache, Center for Drug Evaluation and 
Research (CDER), Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 51, Rm. 1128, Silver Spring, MD 20993-0002, 301-796-4548.

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 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 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 
for human use among regulators around the world. The six founding 
members of the ICH are the European Commission; the European Federation 
of Pharmaceutical Industries Associations; the Japanese Ministry of 
Health, Labour, and Welfare; the Japanese Pharmaceutical Manufacturers 
Association; CDER and CDRH, FDA; and the Pharmaceutical Research and 
Manufacturers of America. The standing members of the ICH Association 
include Health Canada and Swissmedic. Any party eligible as a member in 
accordance with the ICH Articles of Association can apply for 
membership in writing to the ICH Secretariat. The ICH Secretariat, 
which coordinates the preparation of documentation, operates as an 
international nonprofit organization and is funded by the members of 
the ICH Association.
    The ICH Assembly includes representatives from each of the ICH 
members, as well as observers from the World Health Organization and 
Drug Regulatory Authorities and Regional Harmonization Initiatives from 
around the world.
    In December 2015, the ICH Assembly endorsed the draft guidance 
entitled ``E18 Genomic Sampling and Management of Genomic Data'' and 
agreed that the guidance should be made available for public comment. 
The draft guidance is the product of the Efficacy Expert Working Group 
of the ICH. Comments about this draft will be considered by FDA and the 
Efficacy Expert Working Group.
    The draft guidance provides guidance on genomic sampling and 
management of genomic data from interventional and non-interventional 
clinical studies. The draft guidance addresses use of genomic samples 
and data irrespective of the timing of analyses and both pre-specified 
and non-pre-specified use. The focus is on the general principles of 
collecting, processing, transporting, storing and disposing of genomic 
samples or data, within the scope of an informed consent. The technical 
aspects of genomic sampling and research are also discussed when 
appropriate, recognizing the rapidly evolving technological advances in 
these areas.
    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 current thinking of FDA on ``E18 Genomic 
Sampling and Management of Genomic Data.'' It does not establish any 
rights for any person and is not binding on FDA or the public. You can 
use an alternative approach if it satisfies the requirements of the 
applicable statutes and regulations.

II. 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/MedicalDevices/deviceregulationandguidance/guidancedocuments/default.htm.

    Dated: May 31, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-13168 Filed 6-2-16; 8:45 am]
 BILLING CODE 4164-01-P