81 FR 62506 - E17 General Principles for Planning and Design of Multi-Regional Clinical Trials; International Council for Harmonisation; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 175 (September 9, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 175 (September 9, 2016)
| Page Range | 62506-62508 | |
| FR Document | 2016-21689 |
[Federal Register Volume 81, Number 175 (Friday, September 9, 2016)] [Notices] [Pages 62506-62508] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-21689] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-D-2567] E17 General Principles for Planning and Design of Multi-Regional Clinical Trials; International Council for Harmonisation; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance entitled ``E17 General Principles for Planning and Design of Multi-Regional Clinical Trials.'' The draft guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The draft guidance describes general principles for planning and designing multi-regional clinical trials (MRCT). MRCTs conducted according to the guidance will investigate treatment effects in overall populations with multiple ethnic factors (intrinsic and extrinsic factors as described in the ICH guidance entitled ``E5 Ethnic Factors in the Acceptability of Foreign Clinical Data'' (E5 guidance)) and evaluate the consistency of treatment effects across populations. The draft guidance is intended to increase the acceptability of data from MRCTs as the primary source of evidence supporting marketing approval in global regulatory submissions and to thereby facilitate more efficient drug development and earlier access to medicines. 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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by November 8, 2016.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 [[Page 62507]] 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-2567 for ``E17 General Principles for Planning and Design of Multi-Regional Clinical Trials; International Council for Harmonisation; Draft Guidance for Industry; Availability.'' 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 ``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 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, Outreach and Development, Center for Biologics Evaluation and Research (CBER), 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 CBER at 1-800-835-4709 or 240-402-8010. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: Regarding the guidance: Aloka Chakravarty, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 21, Rm. 3514, Silver Spring, MD 20993-0002, 301- 796-1655; or Douglas R. Pratt, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3066, Silver Spring, MD 20993-0002, 301-796-2640. 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 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 CBER, 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 is the overarching body of the Association and includes representatives from each of the ICH members and observers. In June 2016, the ICH Assembly endorsed the draft guidance entitled ``E17 General Principles for Planning and Design of Multi-Regional Clinical Trials'' 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 general principles for planning and designing MRCTs. Drug development has been globalized, and MRCTs for regulatory submission have widely been conducted in ICH regions and beyond. Regulatory agencies are currently facing some challenges in evaluating data from MRCTs for drug approval, and ICH is developing this harmonized international guidance to promote the appropriate conduct of MRCTs and to focus especially on scientific issues in planning and designing MRCTs. This new guidance will complement the E5 guidance on MRCTs and facilitate MRCT data acceptance by multiple regulatory agencies. [[Page 62508]] 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 ``E17 General Principles for Planning and Design of Multi-Regional Clinical Trials.'' 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/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. Dated: September 2, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-21689 Filed 9-8-16; 8:45 am] BILLING CODE 4164-01-P
![62506 Federal Register / Vol. 81, No. 175 / Friday, September 9, 2016 / Notices
the SUPPLEMENTARY INFORMATION section final rule on May 10, 2016 (81 FR guidance entitled ‘‘E17 General
for electronic access to the guidance 28974), and it became effective on Principles for Planning and Design of
document. August 8, 2016. Manufacturers and Multi-Regional Clinical Trials.’’ The
FOR FURTHER INFORMATION CONTACT: importers of tobacco products that have draft guidance was prepared under the
Katherine Collins, Center for Tobacco been deemed subject to the FD&C Act auspices of the International Council for
Products, Food and Drug are now required to comply with Harmonisation (ICH), formerly the
Administration, Document Control Chapter IX of the FD&C Act, including International Conference on
Center, Bldg. 71, Rm. G335, 10903 New section 904(a)(4). Harmonisation. The draft guidance
Hampshire Ave., Silver Spring, MD describes general principles for
II. Significance of Guidance
20993–2000, 1–877–287–1373, email: planning and designing multi-regional
FDA is issuing this revised draft clinical trials (MRCT). MRCTs
AskCTP@fda.hhs.gov.
guidance consistent with FDA’s good conducted according to the guidance
SUPPLEMENTARY INFORMATION: guidance practices regulation (21 CFR will investigate treatment effects in
I. Background 10.115). The draft guidance, when overall populations with multiple
finalized, represents the current ethnic factors (intrinsic and extrinsic
We are announcing the availability of
thinking of FDA on health document factors as described in the ICH guidance
a revised draft guidance for industry
submission requirements. It does not entitled ‘‘E5 Ethnic Factors in the
entitled ‘‘Health Document Submission
establish any rights for any person and Acceptability of Foreign Clinical Data’’
Requirements for Tobacco Products.’’
is not binding on FDA or the public. (E5 guidance)) and evaluate the
We are issuing this draft guidance
You can use an alternative approach if consistency of treatment effects across
consistent with our good guidance
it satisfies the requirements of the populations. The draft guidance is
practices (GGP) regulation (21 CFR
applicable statutes and regulations. intended to increase the acceptability of
10.115). The draft guidance, when
finalized, is intended to assist persons II. Paperwork Reduction Act of 1995 data from MRCTs as the primary source
making certain document submissions of evidence supporting marketing
This revised draft guidance also refers approval in global regulatory
to FDA as required by the Tobacco to previously approved collections of
Control Act. submissions and to thereby facilitate
information found in FDA statute. The more efficient drug development and
The Tobacco Control Act, enacted on revised draft guidance includes
June 22, 2009, amends the FD&C Act earlier access to medicines.
information and recommendations for
and provides FDA with the authority to DATES: Although you can comment on
how to provide health document
regulate the manufacture, marketing, any guidance at any time (see 21 CFR
submissions. The collections of
and distribution of tobacco products to 10.115(g)(5)), to ensure that the Agency
information in section 904(a)(4) of the
protect the public’s health (Pub. L. 111– considers your comment on this draft
FD&C Act have been approved under
31). Among other things, the Tobacco guidance before it begins work on the
OMB control number 0910–0654.
Control Act adds section 904(a)(4) to the final version of the guidance, submit
FD&C Act (21 U.S.C. 387d(a)(4)), IV. Electronic Access either electronic or written comments
requiring each tobacco product Persons with access to the Internet on the draft guidance by November 8,
manufacturer or importer, or agents may obtain an electronic version of the 2016.
thereof to submit all documents draft guidance at either http:// ADDRESSES: You may submit comments
developed after June 22, 2009, that www.regulations.gov or http:// as follows:
relate to any ‘‘health, toxicological, www.fda.gov/TobaccoProducts/
behavioral, or physiological effects of Labeling/RulesRegulationsGuidance/ Electronic Submissions
current or future tobacco products, their default.htm. Submit electronic comments in the
constituents (including smoke following way:
Dated: August 31, 2016.
constituents), ingredients, components, • Federal eRulemaking Portal: http://
Leslie Kux,
and additives.’’ www.regulations.gov. Follow the
The revised draft guidance includes Associate Commissioner for Policy. instructions for submitting comments.
guidance for manufacturers or importers [FR Doc. 2016–21686 Filed 9–8–16; 8:45 am] Comments submitted electronically,
of products that are newly deemed as BILLING CODE 4164–01–P including attachments, to http://
tobacco products that are subject to www.regulations.gov will be posted to
Chapter IX of the Federal Food, Drug, the docket unchanged. Because your
and Cosmetic Act (the FD&C Act). DEPARTMENT OF HEALTH AND comment will be made public, you are
Cigarettes, cigarette tobacco, roll-your- HUMAN SERVICES solely responsible for ensuring that your
own tobacco, and smokeless tobacco comment does not include any
Food and Drug Administration
were immediately subject to the tobacco confidential information that you or a
provisions of the FD&C Act, including [Docket No. FDA–2016–D–2567] third party may not wish to be posted,
section 904(a)(4), and to FDA’s such as medical information, your or
regulatory authority. As for other types E17 General Principles for Planning anyone else’s Social Security number, or
of tobacco products, section 901(b) of and Design of Multi-Regional Clinical confidential business information, such
the FD&C Act (21 U.S.C. 387a) grants Trials; International Council for as a manufacturing process. Please note
FDA authority to deem those products Harmonisation; Draft Guidance for that if you include your name, contact
asabaliauskas on DSK3SPTVN1PROD with NOTICES
subject to the law as well. Pursuant to Industry; Availability information, or other information that
that authority, FDA issued a rule AGENCY: Food and Drug Administration, identifies you in the body of your
deeming all other products that meet the HHS. comments, that information will be
statutory definition of ‘‘tobacco ACTION: Notice of availability. posted on http://www.regulations.gov.
product’’, set forth in section 201(rr) of • If you want to submit a comment
the FD&C Act, except for accessories of SUMMARY: The Food and Drug with confidential information that you
those products, as subject to the FD&C Administration (FDA or Agency) is do not wish to be made available to the
Act (81 FR 28974). FDA published the announcing the availability of a draft public, submit the comment as a
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![62508 Federal Register / Vol. 81, No. 175 / Friday, September 9, 2016 / Notices
This draft guidance is being issued AdvisoryCommittees/ AdvisoryCommittees/Calendar/
consistent with FDA’s good guidance AboutAdvisoryCommittees/ default.htm. Scroll down to the
practices regulation (21 CFR 10.115). ucm408555.htm. appropriate advisory committee meeting
The draft guidance, when finalized, will FOR FURTHER INFORMATION CONTACT: link.
represent the current thinking of FDA Donna Mendrick, National Center for Procedure: On November 1, 2016,
on ‘‘E17 General Principles for Planning Toxicological Research, Food and Drug from 8 a.m. to 5:30 p.m., and November
and Design of Multi-Regional Clinical Administration, 10903 New Hampshire 2, 2016, from 8 a.m. to 11:40 a.m., the
Trials.’’ It does not establish any rights Ave., Bldg. 32, Rm. 2208, Silver Spring, meeting is open to the public. Interested
for any person and is not binding on MD 20993–0002, 301–796–8892 or FDA persons may present data, information,
FDA or the public. You can use an Advisory Committee Information Line, or views, orally or in writing, on issues
alternative approach if it satisfies the 1–800–741–8138 (301–443–0572 in the pending before the committee. Written
requirements of the applicable statutes Washington, DC area). A notice in the submissions may be made to the contact
and regulations. Federal Register about last minute person on or before October 25, 2016.
modifications that impact a previously Oral presentations from the public will
II. Electronic Access
announced advisory committee meeting be scheduled on November 1, 2016,
Persons with access to the Internet cannot always be published quickly between approximately 1:15 p.m. to
may obtain the document at http:// enough to provide timely notice. 2:15 p.m. Those individuals interested
www.regulations.gov, http:// Therefore, you should always check the in making formal oral presentations
www.fda.gov/Drugs/Guidance Agency’s Web site at http:// should notify the contact person and
ComplianceRegulatoryInformation/ www.fda.gov/AdvisoryCommittees/ submit a brief statement of the general
Guidances/default.htm, or http:// default.htm and scroll down to the nature of the evidence or arguments
www.fda.gov/BiologicsBloodVaccines/ appropriate advisory committee meeting they wish to present, the names and
GuidanceComplianceRegulatory link, or call the advisory committee addresses of proposed participants, and
Information/Guidances/default.htm. information line to learn about possible an indication of the approximate time
Dated: September 2, 2016. modifications before coming to the requested to make their presentation on
Leslie Kux, meeting. or before October 17, 2016. Time
Associate Commissioner for Policy. allotted for each presentation may be
SUPPLEMENTARY INFORMATION:
[FR Doc. 2016–21689 Filed 9–8–16; 8:45 am] Agenda: On November 1, 2016, the limited. If the number of registrants
SAB Chair will welcome the requesting to speak is greater than can
BILLING CODE 4164–01–P
participants, and the NCTR Director will be reasonably accommodated during the
provide a Center-wide update on scheduled open public hearing session,
DEPARTMENT OF HEALTH AND scientific initiatives and FDA may conduct a lottery to determine
HUMAN SERVICES accomplishments during the past year. the speakers for the scheduled open
The SAB will be presented with an public hearing session. The contact
Food and Drug Administration overview of the Division of person will notify interested persons
Bioinformatics and Biostatistics regarding their request to speak by
[Docket No. FDA–2016–N–0001]
Subcommittee and the Subcommittee October 18, 2016.
Science Advisory Board to the Site Visit Report and a response to this Closed Committee Deliberations: On
National Center for Toxicological review. There will be the public November 1, 2016, from 5:30 p.m. to 6
Research Advisory Committee; Notice comment session and an update from p.m., and November 2, 2016, from 11:40
of Meeting the NCTR Research Divisions. a.m. to 12:15 p.m., the meeting will be
On November 2, 2016, the Center for closed to permit discussion where
AGENCY: Food and Drug Administration, Biologics and Evaluation and Research, disclosure would constitute a clearly
HHS. Center for Drug Evaluation and unwarranted invasion of personal
ACTION: Notice. Research, Center for Devices and privacy (5 U.S.C. 552b(c)(6)). This
Radiological Health, Office of Food and portion of the meeting will be closed to
SUMMARY: The Food and Drug permit discussion of information
Veterinary Medicine, Center for Tobacco
Administration (FDA) announces a concerning individuals associated with
Products, and the Center for Veterinary
forthcoming public advisory committee the research programs at NCTR.
Medicine will each briefly discuss their
meeting of the Science Advisory Board Persons attending FDA’s advisory
center-specific research strategic needs
(SAB) to the National Center for committee meetings are advised that the
and potential areas of collaboration.
Toxicological Research (NCTR). The Following an open discussion of all Agency is not responsible for providing
general function of the committee is to the information presented, the open access to electrical outlets.
provide advice and recommendations to session of the meeting will close so the FDA welcomes the attendance of the
the Agency on FDA’s regulatory issues. SAB members can discuss personnel public at its advisory committee
At least one portion of the meeting will issues at NCTR at the end of each day. meetings and will make every effort to
be closed to the public. FDA intends to make background accommodate persons with disabilities.
DATES: The meeting will be held on material available to the public no later If you require accommodations due to a
November 1, 2016, from 8 a.m. to 5:30 than 2 business days before the meeting. disability, please contact Donna
p.m., and on November 2, 2016, from 8 If FDA is unable to post the background Mendrick at least 7 days in advance of
asabaliauskas on DSK3SPTVN1PROD with NOTICES
a.m. to 11:40 a.m. material on its Web site prior to the the meeting.
ADDRESSES: Crowne Plaza Hotel, 201 S. meeting, the background material will FDA is committed to the orderly
Shackleford Rd., Little Rock, AR 72211. be made publicly available at the conduct of its advisory committee
Answers to commonly asked questions location of the advisory committee meetings. Please visit our Web site at
including information regarding special meeting, and the background material http://www.fda.gov/
accommodations due to a disability, will be posted on FDA’s Web site after AdvisoryCommittees/
visitor parking, and transportation may the meeting. Background material is AboutAdvisoryCommittees/
be accessed at: http://www.fda.gov/ available at http://www.fda.gov/ ucm111462.htm for procedures on
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Document Created: 2018-02-09 13:15:14
Document Modified: 2018-02-09 13:15:14
| 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 | 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 November 8, 2016. | |
| Contact | Regarding the guidance: Aloka Chakravarty, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 21, Rm. 3514, Silver Spring, MD 20993-0002, 301- 796-1655; or Douglas R. Pratt, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3066, Silver Spring, MD 20993-0002, 301-796-2640. | |
| FR Citation | 81 FR 62506 |
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