[Federal Register Volume 80, Number 17 (Tuesday, January 27, 2015)]
[Notices]
[Pages 4282-4283]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-01406]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry entitled ``S10 Photosafety 
Evaluation of Pharmaceuticals.'' The guidance was prepared under the 
auspices of the International Conference on Harmonisation of Technical 
Requirements for Registration of Pharmaceuticals for Human Use (ICH). 
This guidance outlines details on when photosafety testing is warranted 
and on possible assessment strategies; it should be read in conjunction 
with the ICH M3(R2) guidance, section XIV(14) Photosafety Testing. The 
purpose of the guidance is to recommend international standards for 
photosafety assessment and to harmonize such assessments that support 
human clinical trials and marketing authorization for pharmaceuticals. 
This guidance finalizes the draft guidance issued on February 4, 2013.

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, 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. 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: Abigail 
Jacobs, Center for Drug Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6474, Silver 
Spring, MD 20993-0002;
    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, 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

[[Page 4283]]

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 February 4, 2013 (78 FR 7786), FDA 
published a notice announcing the availability of a draft guidance 
entitled ``S10 Photosafety Evaluation of Pharmaceuticals.'' The notice 
gave interested persons an opportunity to submit comments by March 21, 
2013. Changes made to the guidance took into consideration written 
comments received. In addition to editorial changes primarily for 
clarification, the major changes are as follows:
     The guidance further emphasizes the flexibility and 
optional nature of assessments for photosafety. This is reflected in 
revisions to Figure 1 and related text.
     The discussion about pharmaceuticals given via ocular 
routes was reduced because the ICH working group did not have useful 
guidance to provide for these products.
    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 November 2013.
    The ICH S10 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.
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    \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.
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    The guidance describes a flexible, integrated process that involves 
photochemical characteristics, data from nonclinical studies, and human 
safety information. Although the strategy is flexible and the options 
selected are the developer's choice, characterization of the 
ultraviolet-visible absorption spectrum is recommended as the initial 
assessment and can obviate any further photosafety evaluation. Results 
of the evaluation determine the need for risk minimization measures to 
prevent adverse events in humans.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents 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 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/default.htm.

    Dated: January 22, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-01406 Filed 1-26-15; 8:45 am]
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