83 FR 9006 - E18 Genomic Sampling and Management of Genomic Data; International Council for Harmonisation; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 42 (March 2, 2018)

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``E18 Genomic Sampling and Management of Genomic Data.'' The guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. This guidance focuses on the general principles of collecting, processing, transporting, storing, and disposing of genomic samples or data in clinical studies. The guidance is intended to provide harmonized principles of genomic sampling and of management of genomic data in clinical studies to foster interactions amongst stakeholders, including drug developers, investigators, and regulators; and to encourage genomic research within clinical studies.

[Federal Register Volume 83, Number 42 (Friday, March 2, 2018)]
[Notices]
[Pages 9006-9008]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-04274]


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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; 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 guidance for industry entitled ``E18 Genomic 
Sampling and Management of Genomic Data.'' The guidance was prepared 
under the auspices of the International Council for Harmonisation 
(ICH), formerly the International Conference on Harmonisation. This 
guidance focuses on the general principles of collecting, processing, 
transporting, storing, and disposing of genomic samples or data in 
clinical studies. The guidance is intended to provide harmonized 
principles of genomic sampling and of management of genomic data in 
clinical studies to foster interactions amongst stakeholders, including 
drug developers, investigators, and regulators; and to encourage 
genomic research within clinical studies.

DATES: The announcement of the guidance is published in the Federal 
Register on March 2, 2018.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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; International Council for Harmonisation; Guidance for Industry.'' 
Received comments will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. 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

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more information about FDA's posting of comments to public dockets, see 
80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the 
Division of Drug Information, Center for Drug Evaluation and Research, 
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale 
Building, 4th Floor, Silver Spring, MD 20993-0002; the Office of 
Communication and Education, 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; or the Office of Communication, Outreach and 
Development, Center for Biologics Evaluation and Research, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, 
Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to 
assist that office in processing your requests. The guidance may also 
be obtained by mail by calling the Center for Biologics Evaluation and 
Research at 1-800-835-4709 or 240-402-8010. 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 guidance: Christian 
Grimstein, Center for Drug Evaluation and Research, 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, 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, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
51, Rm. 1176, Silver Spring, MD 20993-0002, 301-796-4548.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``E18 Genomic Sampling and Management of Genomic Data; 
International Council for Harmonisation.'' In recent years, regulatory 
authorities and industry associations from around the world have 
participated in many important initiatives to promote international 
harmonization of regulatory requirements under the ICH. FDA has 
participated in several ICH meetings designed to enhance harmonization 
and FDA is committed to seeking scientifically based harmonized 
technical procedures for pharmaceutical development. One of the goals 
of harmonization is to identify and reduce differences in technical 
requirements for drug development among regulatory agencies.
    ICH was established 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; FDA; the Japanese Ministry 
of Health, Labour, and Welfare; the Japanese Pharmaceutical 
Manufacturers Association; 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 is the overarching body of the Association and 
includes representatives from each of the ICH members and observers. 
The ICH Assembly is responsible for the endorsement of draft guidelines 
and adoption of final guidelines. FDA publishes ICH guidelines as FDA 
guidance.
    In the Federal Register of June 3, 2016 (81 FR 35781), FDA 
published a notice announcing the availability of a draft guidance 
entitled ``E18 Genomic Sampling and Management of Genomic Data.'' The 
notice gave interested persons an opportunity to submit comments by 
August 2, 2016.
    After consideration of the comments received and revisions to the 
guideline, a final draft of the guideline was submitted to the ICH 
Assembly and endorsed by the regulatory agencies in September 2017.
    The guidance provides guidance on genomic sampling and management 
of genomic data from interventional and non-interventional clinical 
studies. The guidance addresses use of genomic samples and data 
irrespective of the timing of analyses and both prespecified and non-
prespecified 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 policy or practice. The 
technical aspects of genomic sampling are also discussed when 
appropriate, recognizing the rapidly evolving technological advances in 
genomic sampling and data generation. The guidance also intends to 
increase awareness and provide a reminder regarding subjects' privacy, 
protection of the data generated, the need to obtain suitable informed 
consent, and the need to consider transparency of findings in line with 
local legislation and regulations.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents 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. This guidance is not subject to Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information that are subject to review by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in 21 CFR parts 312 and 314 have 
been approved under OMB control numbers 0910-0014 and 0910-0001, 
respectively. The collections of information in 21 CFR parts 50 and 56 
have been approved under OMB control number 0910-0755. The collections 
of information in the guidance ``E6(R2) Good Clinical Practice: 
Integrated Addendum to ICH E6(R1)'' have been approved under 0910-0843.

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III. Electronic Access

    Persons with access to the internet may obtain the document at 
https://www.regulations.gov, https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm, or https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.

    Dated: February 27, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-04274 Filed 3-1-18; 8:45 am]
 BILLING CODE 4164-01-P