4282 Federal Register / Vol. 80, No. 17 / Tuesday, January 27, 2015 / Notices 

the design and use of the device. This 

guidance is intended to provide 

information related to both indications, 

when the device is applied to nails with 

confirmed fungal infection. 

II. Significance of Guidance 

This draft guidance is being issued 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The draft guidance, when finalized, will 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 clinical trial design for the treatment 

or improvement in the appearance of 

fungally infected nails. 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 statute 

and regulations. 

III. Electronic Access 

Persons interested in obtaining a copy 

of the draft guidance may do so by 

downloading an electronic copy from 

the Internet. A search capability for all 

Center for Devices and Radiological 

Health guidance documents is available 

at http://www.fda.gov/MedicalDevices/

DeviceRegulationandGuidance/

GuidanceDocuments/default.htm. 

Guidance documents are also available 

at http://www.regulations.gov. Persons 

unable to download an electronic copy 

of ‘‘Medical Devices and Clinical Trial 

Design for the Treatment or 

Improvement in the Appearance of 

Fungally-Infected Nails’’ may send an 

email request to CDRH-Guidance@

fda.hhs.gov to receive an electronic 

copy of the document. Please use the 

document number 1400009 to identify 

the guidance you are requesting. 

IV. Paperwork Reduction Act of 1995 

This guidance refers to previously 

approved collections of information 

found in FDA regulations. These 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520). The collections of information in 

21 CFR part 812 have been approved 

under OMB control number 0910–0078; 

the collections of information in 21 CFR 

part 807, subpart E have been approved 

under OMB control number 0910–0120; 

the collections of information in 21 CFR 

part 814 have been approved under 

OMB control number 0910–0231; the 

collections of information regarding 

adverse events have been approved 

under OMB control number 0910–0471; 

and the collections of information in 21 

CFR part 801 have been approved under 

OMB control number 0910–0485. 

The labeling recommendations of this 

draft guidance are not subject to review 

by the Office of Management and 

Budget because they do not constitute a 

‘‘collection of information’’ under the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501–3520). Rather, the 

recommended labeling is a ‘‘public 

disclosure of information originally 

supplied by the Federal Government to 

the recipient for the purpose of 

disclosure to the public.’’ (see 5 CFR 

1320.3(c)(2)). 

V. 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. 

Dated: January 21, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–01407 Filed 1–26–15; 8:45 am] 

BILLING CODE 4164–01–P 

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. 

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 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 17 / Tuesday, January 27, 2015 / Notices 4283 

1See 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/GuidanceCompliance

RegulatoryInformation/Guidances/default.htm. 

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. 

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/Guidance

ComplianceRegulatoryInformation/

Guidances/default.htm, or http://

www.fda.gov/BiologicsBloodVaccines/

GuidanceComplianceRegulatory

Information/default.htm. 

Dated: January 22, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–01406 Filed 1–26–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–N–0045] 

International Drug Scheduling; 

Convention on Psychotropic 

Substances; Single Convention on 

Narcotic Drugs; World Health 

Organization; Scheduling 

Recommendations; AH-7921; GammaButyrolactone; 1,4-Butanediol; 

Ketamine; 9 Additional Substances; 

Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is providing 

interested persons with the opportunity 

to submit written comments and to 

request an informal public meeting 

concerning recommendations by the 

World Health Organization (WHO) to 

impose international manufacturing and 

distributing restrictions, under 

international treaties, on certain drug 

substances. The comments received in 

response to this notice and/or public 

meeting will be considered in preparing 

the United States position on these 

proposals for a meeting of the United 

Nations Commission on Narcotic Drugs 

(CND) in Vienna, Austria, in March 

2015. This notice is issued under the 

Controlled Substances Act (the CSA). 

DATES: Submit either electronic or 

written comments by February 26, 2015. 

Submit requests for a public meeting on 

or before February 6, 2015. (For 

additional information, see also section 

IV of this document). 

ADDRESSES: Submit electronic 

comments 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: 

James R. Hunter, Center for Drug 

Evaluation and Research, Controlled 

Substance Staff, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 5150, Silver Spring, 

MD 20993–0002, 301–796–3156, 

james.hunter@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 


asabaliauskas on DSK5VPTVN1PROD with NOTICES