[Federal Register Volume 78, Number 23 (Monday, February 4, 2013)]
[Pages 7786-7787]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-02296]



Food and Drug Administration

[Docket No. FDA-2013-D-0068]

International Conference on Harmonisation; Draft Guidance on S10 
Photosafety Evaluation of Pharmaceuticals; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance entitled ``S10 Photosafety Evaluation 
of Pharmaceuticals.'' The draft guidance was prepared under the 
auspices of the International Conference on Harmonisation (ICH) of 
Technical Requirements for Registration of Pharmaceuticals for Human 
Use. The draft guidance includes criteria for initiation of and 
triggers for additional photosafety testing and should be read in 
conjunction with the ICH M3(R2) guidance, section XIV(14) Photosafety 
Testing. The purpose of the draft guidance is to recommend 
international standards for photosafety assessment and to harmonize 
such assessments that support human clinical trials and marketing 
authorization for pharmaceuticals.

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by March 21, 2013.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 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, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002. Send 
one self-addressed adhesive label to assist the office in processing 
your requests. 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access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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.

    Regarding the guidance: Abigail Jacobs, Center for Drug Evaluation 
and Research (ONDIO), Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 22, Rm. 6484, Silver Spring, MD 20993-0002, 301-796-0174.
    Regarding the ICH: Michelle Limoli, Center for Drug Evaluation and 
Research, International Programs, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 51, rm. 3342, Silver Spring, MD 20993-0002, 


I. Background

    In recent years, many important initiatives have been undertaken by 
regulatory authorities and industry

[[Page 7787]]

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 
    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; the Centers for Drug 
Evaluation and Research and Biologics Evaluation and Research, 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 November 2012, the ICH Steering Committee agreed that a draft 
guidance entitled ``S10 Photosafety Evaluation of Pharmaceuticals'' 
should be made available for public comment. The draft guidance is the 
product of the S10 Expert Working Group of the ICH. Comments about this 
draft will be considered by FDA and the S10 Expert Working Group.
    The ICH S10 draft guidance provides guidance on when photosafety 
testing is warranted, and on possible testing strategies. It represents 
the consensus that exists regarding assessment of photosafety to 
support clinical development and marketing authorization of 
pharmaceuticals. It supplements the ICH M3(R2) guidance,\1\ which (1) 
provides certain information regarding timing of photosafety testing 
relative to clinical development and (2) recommends that an initial 
assessment of photoreactive potential be conducted and, if appropriate, 
an experimental evaluation be undertaken before exposure of large 
numbers of subjects. However, the ICH M3(R2) guidance does not address 
testing strategies.

    \1\ See the ICH guidance ``M3(R2) Nonclinical Safety Studies for 
the Conduct of Human Clinical Trials and Marketing Authorization for 
Pharmaceuticals,'' available on the Internet at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.

    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 Agency's current thinking on this topic. 
It does not create or confer any rights for or on any person and does 
not operate to bind FDA or the public. An alternative approach may be 
used if such approach satisfies the requirements of the applicable 
statutes and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. 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 (see ADDRESSES) between 9 a.m. and 4 p.m., Monday through 

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://www.regulations.gov or http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.

    Dated: January 29, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-02296 Filed 2-1-13; 8:45 am]