80 FR 58492 - E6(R2) Good Clinical Practice; International Conference on Harmonisation; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 188 (September 29, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 188 (September 29, 2015)
| Page Range | 58492-58493 | |
| FR Document | 2015-24623 |
[Federal Register Volume 80, Number 188 (Tuesday, September 29, 2015)] [Notices] [Pages 58492-58493] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-24623] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-D-3327] E6(R2) Good Clinical Practice; International Conference on Harmonisation; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance entitled ``E6(R2) Good Clinical Practice.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance amends the guidance entitled ``E6 Good Clinical Practice: Consolidated Guidance'' (E6(R1)) to encourage implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording, and reporting, and also updates standards regarding electronic records and essential documents. The draft guidance is intended to improve clinical trial quality and efficiency while maintaining human subject protection. FDA is making this draft guidance available for comment on the sections that are additions to ICH E6(R1) and marked as ``ADDENDUM.'' 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at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on the sections of this draft guidance marked as [[Page 58493]] ``ADDENDUM'' before it begins work on the final version of the guidance, submit either electronic or written comments on the ``ADDENDUM'' sections of the draft guidance by November 30, 2015. ADDRESSES: Submit written requests for single copies of the draft guidance to the Division of Drug Information (HFD-240), Center for Drug Evaluation and Research (CDER), Food and Drug Administration, 10001 New Hampshire Ave.,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 the office in processing your requests. The draft guidance may also be obtained by mail by calling CBER at 1-800-835-4709 or 240-402-7800. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Regarding the guidance: Dianne Paraoan, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 3326, Silver Spring, MD 20993-0002, 301-796-2500; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911. Regarding the ICH: Michelle Limoli, Center for Drug Evaluation and Research, International Programs, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, rm. 7208, Silver Spring, MD 20993-0002, 301-796-8377. 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 tripartite 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 among three regions: The European Union, Japan, and North America. The eight ICH sponsors 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; the Pharmaceutical Research and Manufacturers of America; Health Canada; and Swissmedic. The ICH Secretariat, which coordinates the preparation of documentation, is provided by the International Federation of Pharmaceutical Manufacturers Associations (IFPMA). The ICH Steering Committee includes representatives from each of the ICH sponsors and the IFPMA, as well as observers from the World Health Organization. In June 2015, the ICH Steering Committee agreed that a draft guidance entitled ``Good Clinical Practice E6(R2)'' should be made available for public comment. The draft guidance is the product of the ICH E6 Expert Working Group of the ICH. Comments about this draft will be considered by FDA and the ICH E6 Expert Working Group. The draft guidance provides guidance on approaches to clinical trial design, conduct, oversight, recording, and reporting as well as updated standards regarding electronic records and essential documents. The additions to ICH E6(R1) are intended to encourage implementation of the described approaches and processes to improve clinical trial quality and efficiency while maintaining human subject protection. Evolutions in technology and risk management processes offer new opportunities to increase clinical trial efficiency, in part by focusing on trial activities essential to ensuring human subject protection and the reliability of trial results. For example, the draft guidance recommends sponsors implement a system to manage quality throughout clinical trials and recommends sponsors develop a systematic, prioritized, risk-based approach to monitoring clinical trials. The draft guidance provides additional detail regarding recommendations for use of electronic trial data handling and remote electronic trial data systems. This draft guidance includes additions to ICH E6(R1) that are identified as ``ADDENDUM'' and are marked with vertical lines on both sides of the text. FDA is making the draft guidance available for comment on the ``ADDENDUM'' text added to ICH E6(R1). 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 E6(R2) Good Clinical Practice. 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. Comments Interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov. III. 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 23, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-24623 Filed 9-28-15; 8:45 am] BILLING CODE 4164-01-P
![58492 Federal Register / Vol. 80, No. 188 / Tuesday, September 29, 2015 / Notices
discussion here. Specifically, FDA comments, FDA is revising its and may be seen by interested persons
received numerous comments regarding recommendations related to such between 9 a.m. and 4 p.m., Monday
two categories of requests that FDA inquiries. As described in the guidance, through Friday, and is available
proposed in the draft guidance to if there is a better mechanism for a electronically at http://
exclude from the controlled requestor to obtain comment from FDA www.regulations.gov.
correspondence process. First, FDA on the subject of the request than (FDA has verified the Web site address in
received comments requesting that the through a controlled correspondence, this reference section, but we are not
Agency refrain from excluding requests the Agency will direct the requestor to responsible for any subsequent changes to
for product-specific guidance on such a mechanism, e.g., a pre- the Web site after this document publishes in
the Federal Register.)
demonstrating bioequivalence. FDA abbreviated new drug application 1. Generic Drug User Fee Act Program
declines to revise the guidance in this meeting request or the Regulatory Performance Goals and Procedures (GDUFA
fashion. As set out in the draft guidance, Science Initiative. For requests for Commitment Letter) for fiscal years 2013
the short timeframe contemplated for which the controlled correspondence through 2017, available at http://www.fda.
the controlled correspondence pathway is the best mechanism, but that gov/downloads/ForIndustry/UserFees/
responses is inconsistent with the well- raise issues for which FDA has not GenericDrugUserFees/UCM282505.pdf.
established process for issuing product- determined appropriate policy, such Dated: September 22, 2015.
specific recommendations described in requests will remain open until such Leslie Kux,
the guidance for industry on policy decision is made. Associate Commissioner for Policy.
‘‘Bioequivalence Recommendations for This guidance is being issued
Specific Products (June 2010)’’, as well [FR Doc. 2015–24621 Filed 9–28–15; 8:45 am]
consistent with FDA’s good guidance
as with the principles in the GDUFA practices regulation (21 CFR 10.115). BILLING CODE 4164–01–P
Commitment Letter regarding the The guidance represents the current
Regulatory Science Initiative. Rather thinking of FDA on controlled
than incorporating such guidance DEPARTMENT OF HEALTH AND
correspondence related to generic drug
development into the controlled HUMAN SERVICES
development. It does not establish any
correspondence process, FDA’s Office of rights for any person and is not binding Food and Drug Administration
Generic Drugs (OGD) is developing a on FDA or the public. You can use an
separate process for product-specific alternative approach if it satisfies the [Docket No. FDA–2015–D–3327]
guidance development. requirements of the applicable statutes
This approach is being managed by and regulations. E6(R2) Good Clinical Practice;
the Division of Therapeutic Performance International Conference on
(DTP) within OGD’s Office of Research II. Paperwork Reduction Act of 1995 Harmonisation; Draft Guidance for
and Standards, involves representatives This guidance refers to collections of Industry; Availability
from numerous divisions and offices information that are subject to review by AGENCY: Food and Drug Administration,
within OGD, and provides for timely the Office of Management and Budget HHS.
posting of product-specific (OMB) under the Paperwork Reduction
recommendations to facilitate generic ACTION: Notice.
Act of 1995 (44 U.S.C. 3501–3520). The
drug development. Requests for collection of information has been SUMMARY: The Food and Drug
product-specific guidance development approved under OMB control number Administration (FDA or Agency) is
received through the general Generic 0910–0797. announcing the availability of a draft
Drugs@fda.hhs.gov email account are
III. Comments guidance entitled ‘‘E6(R2) Good Clinical
forwarded directly to DTP for
Practice.’’ The draft guidance was
consideration and tracking. Interested persons may submit either prepared under the auspices of the
Prioritization of guidance development electronic comments regarding this International Conference on
is based on a variety of factors, document to http://www.regulations.gov Harmonisation of Technical
including public health needs, industry or written comments to the Division of Requirements for Registration of
demand for generic development, Dockets Management (see ADDRESSES). It Pharmaceuticals for Human Use (ICH).
anticipated expiration of reference listed is only necessary to send one set of The draft guidance amends the guidance
drug exclusivity, formulation features comments. Identify comments with the
and predictability of in vivo entitled ‘‘E6 Good Clinical Practice:
docket number found in brackets in the Consolidated Guidance’’ (E6(R1)) to
performance, OGD experience with heading of this document. Received
similar formulations or product types, encourage implementation of improved
comments may be seen in the Division and more efficient approaches to
and the feasibility of different of Dockets Management between 9 a.m.
approaches to demonstrate clinical trial design, conduct, oversight,
and 4 p.m., Monday through Friday, and recording, and reporting, and also
bioequivalence (e.g., pharmacokinetic/ will be posted to the docket at http://
pharmacodynamics studies, updates standards regarding electronic
www.regulations.gov. records and essential documents. The
comparative clinical endpoint studies,
and in vitro approaches). FDA IV. Electronic Access draft guidance is intended to improve
anticipates that this targeted Persons with access to the Internet clinical trial quality and efficiency
development approach will expedite the may obtain the document at either while maintaining human subject
protection. FDA is making this draft
asabaliauskas on DSK5VPTVN1PROD with NOTICES
availability of product-specific http://www.fda.gov/Drugs/Guidance
guidances while supporting the ComplianceRegulatoryInformation/ guidance available for comment on the
important policies of transparency and Guidances/default.htm or http:// sections that are additions to ICH E6(R1)
maximizing benefit to the public health. www.regulations.gov. and marked as ‘‘ADDENDUM.’’
Second, FDA received comments DATES: Although you can comment on
regarding its proposed method of V. Reference any guidance at any time (see 21 CFR
responding to requests related to issues The following reference has been 10.115(g)(5)), to ensure that the Agency
for which the Agency has not yet placed on display in the Division of considers your comment on the sections
determined a policy. Upon review of the Dockets Management (see ADDRESSES) of this draft guidance marked as
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![Federal Register / Vol. 80, No. 188 / Tuesday, September 29, 2015 / Notices 58493
‘‘ADDENDUM’’ before it begins work on harmonization is to identify and then The draft guidance provides additional
the final version of the guidance, submit reduce differences in technical detail regarding recommendations for
either electronic or written comments requirements for drug development use of electronic trial data handling and
on the ‘‘ADDENDUM’’ sections of the among regulatory agencies. remote electronic trial data systems.
draft guidance by November 30, 2015. ICH was organized to provide an This draft guidance includes
ADDRESSES: Submit written requests for opportunity for tripartite harmonization additions to ICH E6(R1) that are
single copies of the draft guidance to the initiatives to be developed with input identified as ‘‘ADDENDUM’’ and are
Division of Drug Information (HFD– from both regulatory and industry marked with vertical lines on both sides
240), Center for Drug Evaluation and representatives. FDA also seeks input of the text. FDA is making the draft
Research (CDER), Food and Drug from consumer representatives and guidance available for comment on the
Administration, 10001 New Hampshire others. ICH is concerned with ‘‘ADDENDUM’’ text added to ICH
Ave., Hillandale Building, 4th Floor, harmonization of technical E6(R1).
Silver Spring, MD 20993–0002, or the requirements for the registration of This draft guidance is being issued
Office of Communication, Outreach, and pharmaceutical products among three consistent with FDA’s good guidance
Development, Center for Biologics regions: The European Union, Japan, practices regulation (21 CFR 10.115).
Evaluation and Research (CBER), Food and North America. The eight ICH The draft guidance, when finalized, will
and Drug Administration, 10903 New sponsors are the European Commission; represent the current thinking of FDA
Hampshire Ave., Bldg. 71, Rm. 3128, the European Federation of on E6(R2) Good Clinical Practice. It does
Silver Spring, MD 20993–0002. Send Pharmaceutical Industries Associations; not establish any rights for any person
one self-addressed adhesive label to the Japanese Ministry of Health, Labour, and is not binding on FDA or the public.
assist the office in processing your and Welfare; the Japanese You can use an alternative approach if
requests. The draft guidance may also be Pharmaceutical Manufacturers it satisfies the requirements of the
obtained by mail by calling CBER at 1– Association; CDER and CBER, FDA; the applicable statutes and regulations.
800–835–4709 or 240–402–7800. See Pharmaceutical Research and
Manufacturers of America; Health II. Comments
the SUPPLEMENTARY INFORMATION section
Canada; and Swissmedic. The ICH Interested persons may submit either
for electronic access to the draft
Secretariat, which coordinates the electronic comments regarding this
guidance document.
Submit electronic comments on the preparation of documentation, is document to http://www.regulations.gov
provided by the International or written comments to the Division of
draft guidance to http://
Federation of Pharmaceutical Dockets Management (see ADDRESSES). It
www.regulations.gov. Submit written
Manufacturers Associations (IFPMA). is only necessary to send one set of
comments to the Division of Dockets The ICH Steering Committee includes
Management (HFA–305), Food and Drug comments. Identify comments with the
representatives from each of the ICH docket number found in brackets in the
Administration, 5630 Fishers Lane, Rm. sponsors and the IFPMA, as well as
1061, Rockville, MD 20852. heading of this document. Received
observers from the World Health comments may be seen in the Division
FOR FURTHER INFORMATION CONTACT: Organization. of Dockets Management between 9 a.m.
Regarding the guidance: Dianne In June 2015, the ICH Steering and 4 p.m., Monday through Friday, and
Paraoan, Center for Drug Evaluation and Committee agreed that a draft guidance will be posted to the docket at http://
Research, Food and Drug entitled ‘‘Good Clinical Practice E6(R2)’’ www.regulations.gov.
Administration, 10903 New Hampshire should be made available for public
Ave., Bldg. 51, Rm. 3326, Silver Spring, comment. The draft guidance is the III. Electronic Access
MD 20993–0002, 301–796–2500; or product of the ICH E6 Expert Working Persons with access to the Internet
Stephen Ripley, Center for Biologics Group of the ICH. Comments about this may obtain the document at http://
Evaluation and Research, Food and draft will be considered by FDA and the www.regulations.gov, http://www.fda.
Drug Administration, 10903 New ICH E6 Expert Working Group. gov/Drugs/GuidanceCompliance
Hampshire Ave., Bldg. 71, Rm. 7301, The draft guidance provides guidance RegulatoryInformation/Guidances/
Silver Spring, MD 20993–0002, 240– on approaches to clinical trial design, default.htm, or http://www.fda.gov/
402–7911. conduct, oversight, recording, and BiologicsBloodVaccines/Guidance
Regarding the ICH: Michelle Limoli, reporting as well as updated standards ComplianceRegulatoryInformation/
Center for Drug Evaluation and regarding electronic records and Guidances/default.htm.
Research, International Programs, Food essential documents. The additions to
and Drug Administration, 10903 New ICH E6(R1) are intended to encourage Dated: September 23, 2015.
Hampshire Ave., Bldg. 71, rm. 7208, implementation of the described Leslie Kux,
Silver Spring, MD 20993–0002, 301– approaches and processes to improve Associate Commissioner for Policy.
796–8377. clinical trial quality and efficiency [FR Doc. 2015–24623 Filed 9–28–15; 8:45 am]
SUPPLEMENTARY INFORMATION: while maintaining human subject BILLING CODE 4164–01–P
protection. Evolutions in technology
I. Background and risk management processes offer
In recent years, many important new opportunities to increase clinical DEPARTMENT OF HEALTH AND
initiatives have been undertaken by trial efficiency, in part by focusing on HUMAN SERVICES
regulatory authorities and industry trial activities essential to ensuring
asabaliauskas on DSK5VPTVN1PROD with NOTICES
associations to promote international human subject protection and the National Institutes of Health
harmonization of regulatory reliability of trial results. For example,
Prospective Intent To Grant Start-Up
requirements. FDA has participated in the draft guidance recommends
Exclusive Patent License: Real-Time
many meetings designed to enhance sponsors implement a system to manage
PCR Point Mutation Assays for
harmonization and is committed to quality throughout clinical trials and
Detecting HIV–1 Resistance to Antiviral
seeking scientifically based harmonized recommends sponsors develop a
Drugs
technical procedures for pharmaceutical systematic, prioritized, risk-based
development. One of the goals of approach to monitoring clinical trials. AGENCY: Public Health Service, HHS.
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Document Created: 2015-12-15 09:46:24
Document Modified: 2015-12-15 09:46:24
| 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. | |
| 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 the sections of this draft guidance marked as ``ADDENDUM'' before it begins work on the final version of the guidance, submit either electronic or written comments on the ``ADDENDUM'' sections of the draft guidance by November 30, 2015. | |
| Contact | Regarding the guidance: Dianne Paraoan, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 3326, Silver Spring, MD 20993-0002, 301-796-2500; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911. | |
| FR Citation | 80 FR 58492 |
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