
[Federal Register Volume 80, Number 102 (Thursday, May 28, 2015)]
[Notices]
[Pages 30465-30466]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-12752]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0369]


M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities 
in Pharmaceuticals to Limit Potential Carcinogenic Risk; International 
Conference on Harmonisation; 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 guidance entitled ``M7 Assessment and Control of 
DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit 
Potential Carcinogenic Risk.'' The guidance was prepared under the 
auspices of the International Conference on Harmonisation of Technical

[[Page 30466]]

Requirements for Registration of Pharmaceuticals for Human Use (ICH). 
The guidance emphasizes considerations of both safety and quality risk 
management in establishing levels of mutagenic impurities that are 
expected to pose negligible carcinogenic risk. It outlines 
recommendations for assessment and control of mutagenic impurities that 
reside or are reasonably expected to reside in a final drug substance 
or product, taking into consideration the intended conditions of human 
use. The guidance is intended to provide guidance for new drug 
substances and new drug products during their clinical development and 
subsequent applications for marketing.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: Submit written requests for single copies of the 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; 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 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 guidance document.
    Submit electronic comments on the 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.
    Regarding the ICH: Michelle Limoli, Center for Drug Evaluation and 
Research, International Programs, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 51, Rm. 1174, Rockville, 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 the United States. The six 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; 
and the Pharmaceutical Research and Manufacturers of America. 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, Health Canada, and the European Free Trade Area.
    In the Federal Register of April 15, 2013 (72 FR 22269), FDA 
published a notice announcing the availability of a draft guidance 
entitled ``M7 Assessment and Control of DNA Reactive (Mutagenic) 
Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk'' 
The notice gave interested persons an opportunity to submit comments by 
June 14, 2013. Changes made to the guidance took into consideration 
written comments received. Minor editorial changes were made to improve 
clarity.
    After consideration of the comments received and revisions to the 
guidance, a final draft of the guidance was submitted to the ICH 
Steering Committee and endorsed by the three participating regulatory 
agencies in June 2014.
    The guidance provides guidance on the regulation of genotoxic 
impurities in new drug substances and drug products.
    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 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: May 20, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-12752 Filed 5-27-15; 8:45 am]
 BILLING CODE 4164-01-P


