81_FR_35888 81 FR 35781 - E18 Genomic Sampling and Management of Genomic Data; International Council for Harmonisation; Draft Guidance for Industry; Availability

81 FR 35781 - E18 Genomic Sampling and Management of Genomic Data; International Council for Harmonisation; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 107 (June 3, 2016)

Page Range35781-35782
FR Document2016-13168

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance entitled ``E18 Genomic Sampling and Management of Genomic Data.'' The draft guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The draft guidance pertains to genomic sampling and to the management of genomic data in clinical studies. The focus of this draft guidance is on the general principles of collecting, processing, transporting, storing, and disposing of genomic samples or data.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 The draft guidance is intended to provide harmonized principles of genomic sampling and of managing genomic data in clinical studies.

Federal Register, Volume 81 Issue 107 (Friday, June 3, 2016) 
[Federal Register Volume 81, Number 107 (Friday, June 3, 2016)]
[Notices]
[Pages 35781-35782]
From the Federal Register Online  [www.thefederalregister.org]
[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International Council for Harmonisation; Draft Guidance for Industry; 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the availability of a draft guidance entitled ``E18 Genomic Sampling 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 The draft guidance was prepared under 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 The draft 
guidance pertains to genomic sampling and to the management of genomic 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

Federal Register / Vol. 81, No. 107 / Friday, June 3, 2016 / Notices 35781 for clarification, the major changes guidance entitled ‘‘E18 Genomic • Mail/Hand delivery/Courier (for made to the guidance include adding Sampling and Management of Genomic written/paper submissions): Division of clarification about charging for certain Data.’’ The draft guidance was prepared Dockets Management (HFA–305), Food administrative costs in individual under the auspices of the International and Drug Administration, 5630 Fishers patient expanded access INDs and Council for Harmonisation (ICH), Lane, Rm. 1061, Rockville, MD 20852. protocols, and the timing for submitting formerly the International Conference • For written/paper comments a request to FDA to reauthorize on Harmonisation. The draft guidance submitted to the Division of Dockets charging. pertains to genomic sampling and to the Management, FDA will post your This guidance is being issued management of genomic data in clinical comment, as well as any attachments, consistent with FDA’s good guidance studies. The focus of this draft guidance except for information submitted, practices regulation (21 CFR 10.115). is on the general principles of marked and identified, as confidential, The guidance represents the current collecting, processing, transporting, if submitted as detailed in thinking of FDA on charging for storing, and disposing of genomic ‘‘Instructions.’’ investigational drugs under an IND. It samples or data. The technical aspects Instructions: All submissions received does not establish any rights for any of genomic sampling and research are must include the Docket No. FDA– person and is not binding on FDA or the also discussed when appropriate, 2016–D–1255 for ‘‘E18 Genomic public. You can use an alternative recognizing the rapidly evolving Sampling and Management of Genomic approach if it satisfies the requirements technological advances in these areas. Data.’’ Received comments will be of the applicable statutes and The draft guidance is intended to placed in the docket and, except for regulations. provide harmonized principles of those submitted as ‘‘Confidential genomic sampling and of managing Submissions,’’ publicly viewable at II. Paperwork Reduction Act of 1995 http://www.regulations.gov or at the genomic data in clinical studies. This guidance refers to previously Division of Dockets Management DATES: Although you can comment on approved collections of information between 9 a.m. and 4 p.m., Monday any guidance at any time (see 21 CFR through Friday. found in FDA regulations. These 10.115 (g)(5)), to ensure that the Agency • Confidential Submissions—To collections of information are subject to considers your comment on this draft submit a comment with confidential review by the Office of Management and guidance before it begins work on the information that you do not wish to be Budget (OMB) under the Paperwork final version of the guidance, submit made publicly available, submit your Reduction Act of 1995 (44 U.S.C. 3501– either electronic or written comments comments only as a written/paper 3520). The collections of information in on the draft guidance by August 2, 2016. submission. You should submit two 21 CFR 312.8 and 312.320 have been approved under OMB control number ADDRESSES: You may submit comments copies total. One copy will include the 0910–0014. as follows: information you claim to be confidential Electronic Submissions with a heading or cover note that states III. Electronic Access ‘‘THIS DOCUMENT CONTAINS Persons with access to the Internet Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The may obtain the document at http://www. following way: Agency will review this copy, including fda.gov/RegulatoryInformation/ • Federal eRulemaking Portal: http:// the claimed confidential information, in Guidances/default.htm, http://www.fda. www.regulations.gov. Follow the its consideration of comments. The gov/BiologicsBloodVaccines/Guidance instructions for submitting comments. second copy, which will have the ComplianceRegulatoryInformation/ Comments submitted electronically, claimed confidential information Guidances/default.htm, or http:// including attachments, to http:// redacted/blacked out, will be available www.regulations.gov. www.regulations.gov will be posted to for public viewing and posted on http:// the docket unchanged. Because your www.regulations.gov. Submit both Dated: May 31, 2016. comment will be made public, you are copies to the Division of Dockets Leslie Kux, solely responsible for ensuring that your Management. If you do not wish your Associate Commissioner for Policy. comment does not include any name and contact information to be [FR Doc. 2016–13166 Filed 6–2–16; 8:45 am] confidential information that you or a made publicly available, you can BILLING CODE 4164–01–P third party may not wish to be posted, provide this information on the cover such as medical information, your or sheet and not in the body of your anyone else’s Social Security number, or comments and you must identify this DEPARTMENT OF HEALTH AND confidential business information, such information as ‘‘confidential.’’ Any HUMAN SERVICES as a manufacturing process. Please note information marked as ‘‘confidential’’ Food and Drug Administration that if you include your name, contact will not be disclosed except in information, or other information that accordance with 21 CFR 10.20 and other [Docket No. FDA–2016–D–1255] identifies you in the body of your applicable disclosure law. For more comments, that information will be information about FDA’s posting of E18 Genomic Sampling and posted on http://www.regulations.gov. comments to public dockets, see 80 FR Management of Genomic Data; • If you want to submit a comment 56469, September 18, 2015, or access International Council for with confidential information that you the information at: http://www.fda.gov/ Harmonisation; Draft Guidance for do not wish to be made available to the regulatoryinformation/dockets/ Industry; Availability default.htm. mstockstill on DSK3G9T082PROD with NOTICES public, submit the comment as a AGENCY: Food and Drug Administration, written/paper submission and in the Docket: For access to the docket to HHS. manner detailed (see ‘‘Written/Paper read background documents or the ACTION: Notice of availability. Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments received, go to http:// SUMMARY: The Food and Drug Written/Paper Submissions www.regulations.gov and insert the Administration (FDA or Agency) is Submit written/paper submissions as docket number, found in brackets in the announcing the availability of a draft follows: heading of this document, into the VerDate Sep<11>2014 21:20 Jun 02, 2016 Jkt 238001 PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 E:\FR\FM\03JNN1.SGM 03JNN1

35782 Federal Register / Vol. 81, No. 107 / Friday, June 3, 2016 / Notices ‘‘Search’’ box and follow the prompts harmonization of technical it satisfies the requirements of the and/or go to the Division of Dockets requirements for the registration of applicable statutes and regulations. Management, 5630 Fishers Lane, Rm. pharmaceutical products for human use II. Electronic Access 1061, Rockville, MD 20852. among regulators around the world. The Submit written requests for single six founding members of the ICH are the Persons with access to the Internet copies of this draft guidance to the European Commission; the European may obtain the document at http:// Division of Drug Information, Center for Federation of Pharmaceutical Industries www.regulations.gov, http:// Drug Evaluation and Research (CDER), Associations; the Japanese Ministry of www.fda.gov/Drugs/Guidance Food and Drug Administration, 10001 Health, Labour, and Welfare; the ComplianceRegulatoryInformation/ New Hampshire Ave., Hillandale Japanese Pharmaceutical Manufacturers Guidances/default.htm, or http:// Building, 4th Floor, Silver Spring, MD Association; CDER and CDRH, FDA; and www.fda.gov/MedicalDevices/device 20993–0002, or the Office of the Pharmaceutical Research and regulationandguidance/guidance Communication, and Education, Manufacturers of America. The standing documents/default.htm. (CDRH), Division of Industry and members of the ICH Association include Dated: May 31, 2016. Consumer Education, Center for Devices Health Canada and Swissmedic. Any Leslie Kux, and Radiological Health, Food and Drug party eligible as a member in Associate Commissioner for Policy. Administration, 10903 New Hampshire accordance with the ICH Articles of [FR Doc. 2016–13168 Filed 6–2–16; 8:45 am] Ave., Bldg. 66, Rm. 4621, Silver Spring, Association can apply for membership BILLING CODE 4164–01–P MD 20993–0002. Send one self- in writing to the ICH Secretariat. The addressed adhesive label to assist that ICH Secretariat, which coordinates the office in processing your requests. See preparation of documentation, operates DEPARTMENT OF HEALTH AND the SUPPLEMENTARY INFORMATION section as an international nonprofit HUMAN SERVICES for electronic access to the guidance organization and is funded by the document. members of the ICH Association. Food and Drug Administration The ICH Assembly includes FOR FURTHER INFORMATION CONTACT: [Docket No. FDA–2016–N–0001] representatives from each of the ICH Regarding the draft guidance: Christian members, as well as observers from the Grimstein, Center for Drug Evaluation World Health Organization and Drug Pharmacy Compounding Advisory and Research (CDER), Food and Drug Regulatory Authorities and Regional Committee; Notice of Meeting Administration, 10903 New Hampshire Harmonization Initiatives from around Ave., Bldg. 51, Rm. 3116, Silver Spring, AGENCY: Food and Drug Administration, the world. HHS. MD 20993–0002, 301–796–5189; or In December 2015, the ICH Assembly Eunice Lee, Center for Devices and ACTION: Notice. endorsed the draft guidance entitled Radiological Health (CDRH), Food and ‘‘E18 Genomic Sampling and SUMMARY: The Food and Drug Drug Administration, 10903 New Management of Genomic Data’’ and Administration (FDA) announces a Hampshire Ave., Bldg. 66, Rm. 5546, agreed that the guidance should be forthcoming public advisory committee Silver Spring, MD 20993–0002, 301– made available for public comment. The meeting of the Pharmacy Compounding 796–4808. draft guidance is the product of the Advisory Committee. The general Regarding the ICH: Amanda Roache, Efficacy Expert Working Group of the function of the committee is to provide Center for Drug Evaluation and Research ICH. Comments about this draft will be advice on scientific, technical, and (CDER), Food and Drug Administration, considered by FDA and the Efficacy medical issues concerning drug 10903 New Hampshire Ave., Bldg. 51, Expert Working Group. compounding under sections 503A and Rm. 1128, Silver Spring, MD 20993– The draft guidance provides guidance 503B of the Federal Food, Drug, and 0002, 301–796–4548. on genomic sampling and management Cosmetic Act (FD&C Act), and, as SUPPLEMENTARY INFORMATION: of genomic data from interventional and required, any other product for which non-interventional clinical studies. The FDA has regulatory responsibility, and I. Background draft guidance addresses use of genomic make appropriate recommendations to In recent years, many important samples and data irrespective of the the Agency. The meeting will be open initiatives have been undertaken by timing of analyses and both pre- to the public. regulatory authorities and industry specified and non-pre-specified use. DATES: The meeting will be held on June associations to promote international The focus is on the general principles of 23, 2016, from 8:30 a.m. to 5 p.m. harmonization of regulatory collecting, processing, transporting, requirements. FDA has participated in ADDRESSES: FDA White Oak Campus, storing and disposing of genomic many meetings designed to enhance samples or data, within the scope of an 10903 New Hampshire Ave., Bldg. 31 harmonization and is committed to informed consent. The technical aspects Conference Center, the Great Room (Rm. seeking scientifically based harmonized of genomic sampling and research are 1503), Silver Spring, MD 20993–0002. technical procedures for pharmaceutical also discussed when appropriate, Answers to commonly asked questions development. One of the goals of recognizing the rapidly evolving including information regarding special harmonization is to identify and then technological advances in these areas. accommodations due to a disability, reduce differences in technical This draft guidance is being issued visitor parking, and transportation may requirements for drug development consistent with FDA’s good guidance be accessed at: http://www.fda.gov/ among regulatory agencies. practices regulation (21 CFR 10.115). AdvisoryCommittees/ mstockstill on DSK3G9T082PROD with NOTICES ICH was organized to provide an The draft guidance, when finalized, will AboutAdvisoryCommittees/ opportunity for harmonization represent the current thinking of FDA ucm408555.htm. initiatives to be developed with input on ‘‘E18 Genomic Sampling and FOR FURTHER INFORMATION CONTACT: from both regulatory and industry Management of Genomic Data.’’ It does Cindy Hong, Center for Drug Evaluation representatives. FDA also seeks input not establish any rights for any person and Research, Food and Drug from consumer representatives and and is not binding on FDA or the public. Administration, 10903 New Hampshire others. ICH is concerned with You can use an alternative approach if Ave., Bldg. 31, Rm. 2417, Silver Spring, VerDate Sep<11>2014 21:20 Jun 02, 2016 Jkt 238001 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 E:\FR\FM\03JNN1.SGM 03JNN1


Document Created: 2018-02-08 07:29:33
Document Modified: 2018-02-08 07:29:33
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of availability.
DatesAlthough 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.
ContactRegarding 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.
FR Citation81 FR 35781 
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