[Federal Register Volume 80, Number 187 (Monday, September 28, 2015)]
[Notices]
[Pages 58261-58262]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-24510]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-D-0369]
M7(R1) Addendum to ICH M7; International Conference on
Harmonisation; Draft Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance entitled ``M7(R1) Addendum to ICH
M7: Assessment and Control of DNA Reactive (Mutagenic) Impurities in
Pharmaceuticals to Limit Potential Carcinogenic Risk; Application of
the Principles of the ICH M7 Guidance to Calculation of Compound-
Specific Acceptable Intakes.'' The draft guidance was prepared under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). This draft guidance, an addendum to the ICH M7 guidance of
May 28, 2015, provides guidance on acceptable intake limits derived for
some chemicals that are considered to be mutagens and carcinogens, and
that were selected because they are commonly used in pharmaceutical
manufacturing or are useful in illustrating the principles for deriving
compound-specific intakes as described in ICH M7. The draft
[[Page 58262]]
guidance is intended to provide guidance for new drug substances and
new drug products during their clinical development and subsequent
applications for marketing.
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this draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by November 27, 2015.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug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, 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 240-402-8010. 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: Aisar
Atrakchi, Center for Drug Evaluation and Research, Food and Drug
Administration, Bldg. 22, Rm. 4118, Silver Spring, MD 20993-0002, 301-
796-1036; or Anne Pilaro, Center for Biologics Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm.
4025, Silver Spring, MD 20993-0002, 240-402-8341.
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: Europe, 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 the following
draft guidance should be made available for public comment: ``M7(R1)
Addendum to ICH M7: Assessment and Control of DNA Reactive (Mutagenic)
Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk;
Application of the Principles of the ICH M7 Guidance to Calculation of
Compound-Specific Acceptable Intakes.'' The draft guidance is the
product of the Expert Working Group of the ICH. Comments about this
draft will be considered by FDA and the Expert Working Group.
The draft guidance provides guidance on acceptable intake limits
derived for some chemicals that are considered to be mutagens and
carcinogens and that were selected because they are commonly used in
pharmaceutical manufacturing or are useful in illustrating the
principles of deriving compound-specific intakes as described in ICH
M7. The default method from ICH M7 of linear extrapolation from the
cancer potency estimate, TD50, is used as the primary method
to derive the acceptable intakes for carcinogens with likely mutagenic
mode of action.
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 this topic. 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 22, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-24510 Filed 9-25-15; 8:45 am]
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