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)

Page Range		9006-9008
FR Document		2018-04274

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 Issue 42 (Friday, March 2, 2018)

[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

[[Page 9007]]

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.

[[Page 9008]]

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

9008 Federal Register / Vol. 83, No. 42 / Friday, March 2, 2018 / Notices

III. Electronic Access was the first comprehensive guidelines Dated: February 21, 2018.
Persons with access to the internet on physical activity issued by the Don Wright,
may obtain the document at https:// federal government. The PAG serves as Deputy Assistant Secretary for Health, Office
the benchmark and primary, of Disease Prevention and Health Promotion.
www.regulations.gov, https://
www.fda.gov/Drugs/Guidance authoritative voice of the federal [FR Doc. 2018–04307 Filed 3–1–18; 8:45 am]
ComplianceRegulatoryInformation/ government for providing science-based BILLING CODE 4150–32–P

Guidances/default.htm, https:// guidance on physical activity, fitness,
www.fda.gov/MedicalDevices/Device and health for Americans. The second
RegulationandGuidance/ edition of the PAG will build upon the DEPARTMENT OF HEALTH AND
GuidanceDocuments/default.htm, or first edition and provide a foundation HUMAN SERVICES
https://www.fda.gov/Biologics for federal recommendations and
National Institutes of Health
BloodVaccines/GuidanceCompliance education for physical activity programs
RegulatoryInformation/Guidances/ for Americans, including those at risk National Institute on Aging; Notice of
default.htm. for chronic disease. Closed Meeting
Dated: February 27, 2018. Description of the Committee’s Pursuant to section 10(d) of the
Leslie Kux, Mission and Composition: The 2018 Federal Advisory Committee Act, as
Associate Commissioner for Policy. Physical Activity Guidelines Advisory amended, notice is hereby given of the
[FR Doc. 2018–04274 Filed 3–1–18; 8:45 am] Committee (Committee or PAGAC) was following meeting.
BILLING CODE 4164–01–P established to perform a single, time- The meeting will be closed to the
limited task. The work of the Committee public in accordance with the
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DEPARTMENT OF HEALTH AND charged to examine the current PAG, 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
HUMAN SERVICES take into consideration new scientific as amended. The contract proposals and
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Availability of the 2018 Physical documents, and develop a scientific confidential trade secrets or commercial
Activity Guidelines Advisory report to the Secretary of HHS that property such as patentable material,
Committee Scientific Report and outlines its science-based advice and and personal information concerning
Solicitation of Written Comments recommendations for development of individuals associated with the contract
AGENCY: Office of Disease Prevention the second edition of the PAG. The proposals, the disclosure of which
and Health Promotion, Office of the Committee consisted of 17 members, would constitute a clearly unwarranted
Assistant Secretary for Health, Office of who were appointed by the Secretary in invasion of personal privacy.
the Secretary, Department of Health and June 2016. The Committee disbanded Name of Committee: National Institute on
Human Services. upon submission of its Scientific Report Aging Special Emphasis Panel Second Stage
to the Secretary of HHS. Information on Review.
ACTION: Notice.
the Committee membership is available Date: March 16, 2018.
SUMMARY: The Department of Health and Time: 1:00 p.m. to 3:00 p.m.
at www.health.gov/paguidelines/second-
Agenda: To review and evaluate contract
Human Services (HHS) (a) announces edition/committee/. proposals.
the availability of the 2018 Physical Written Public Comments: Written Place: National Institute on Aging,
Activity Guidelines Advisory comments on the Scientific Report are Gateway Building, Room 2W200, 7201
Committee Scientific Report (Scientific encouraged from the public and will be Wisconsin Ave., Bethesda, MD 20892.
Report); and (b) solicits written Contact Person: Jeannette L. Johnson,
accepted through April 2, 2018. Written Ph.D., National Institute on Aging, National
comments on the Scientific Report.
public comments can be submitted and/ Institutes of Health, 7201 Wisconsin Avenue,
DATES: Written comments on the or viewed at www.health.gov/ Suite 2C212, Bethesda, MD 20892, 301–402–
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Designated Federal Officer, 2018 literature or other resources, complete Program Analyst, Office of Federal Advisory
Physical Activity Guidelines Advisory citations or abstracts and electronic Committee Policy.
Committee, Richard D. Olson, MD, MPH links to full articles or reports are [FR Doc. 2018–04221 Filed 3–1–18; 8:45 am]
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Officer, Katrina L. Piercy, Ph.D., RD, documents to the comment. The
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Document Created: 2018-03-01 23:56:53
Document Modified: 2018-03-01 23:56:53

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice of availability.
Dates		The announcement of the guidance is published in the Federal Register on March 2, 2018.
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.
FR Citation		83 FR 9006

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

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration