[Federal Register Volume 78, Number 23 (Monday, February 4, 2013)]
[Notices]
[Pages 7786-7787]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-02296]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
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International Conference on Harmonisation; Draft Guidance on S10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availability of a draft guidance entitled ``S10 Photosafety Evaluation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 The draft guidance was prepared under the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 The draft guidance includes criteria for initiation of and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 The purpose of the draft guidance is to recommend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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by March 21, 2013.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information (HFD-240), Center for Drug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access to the draft guidance document.
Submit electronic comments on the draft guidance to http://www.regulations.gov.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.
FOR FURTHER INFORMATION CONTACT:
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,
301-796-8377.
SUPPLEMENTARY INFORMATION:
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
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; 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
Friday.
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]
BILLING CODE 4160-01-P