Federal Register / Vol. 80, No. 17 / Tuesday, January 27, 2015 / Notices 4281 

comply with certain CGMP 

requirements addressed in part 4 by 

presenting compliance considerations 

for specific types of combination 

products. Throughout the guidance, 

reference is made to other existing 

guidance and additional sources of 

information addressing CGMP 

requirements for drugs, devices, 

biological products, and human cells, 

tissues, and cellular and tissue-based 

products (HCT/Ps). Concurrent with 

publication of this draft guidance, FDA 

is withdrawing the draft guidance for 

industry and FDA staff entitled ‘‘Current 

Good Manufacturing Practice for 

Combination Products,’’ which was 

issued in September 2004. 

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This draft guidance is being issued 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The draft guidance, when finalized, will 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 CGMP requirements for combination 

products. 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. Paperwork Reduction Act 

This draft guidance refers to 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). We note that the 

information collected under the 

underlying CGMP regulations for drugs, 

devices, and biological products, 

including current good tissue practices 

for HCT/Ps, found at 21 CFR parts 211, 

820, 600 through 680, and 1271, have 

already been approved and are in effect. 

The provisions of part 211 are approved 

under the Office of Management and 

Budget (OMB) control number 0910– 

0139. The provisions of part 820 are 

approved under OMB control number 

0910–0073. The provisions of parts 606, 

640, and 660 are approved under OMB 

control number 0910–0116. The 

provisions of part 610 are approved 

under OMB control number 0910–0116 

and OMB control number 0910–0338 

(also for part 680). The provisions of 

part 1271, subparts C and D, are 

approved under OMB control number 

0910–0543. 

IV. 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. 

V. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/Regulatory 

Information/Guidances/ucm126198.htm 

or http://www.regulations.gov. 

Dated: January 21, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–01410 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–2014–D–1849] 

Medical Devices and Clinical Trial 

Design for the Treatment or 

Improvement in the Appearance of 

Fungally-Infected Nails; Draft 

Guidance for Industry and Food and 

Drug Administration Staff; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the draft guidance 

entitled ‘‘Medical Devices and Clinical 

Trial Design for the Treatment or 

Improvement in the Appearance of 

Fungally-Infected Nails.’’ This guidance 

is intended to provide recommendations 

when finalized regarding clinical trial 

design for medical devices intended 

either to provide improvement in the 

appearance of nails affected by 

onychomycosis or to treat 

onychomycosis (fungal nail infection). 

This draft guidance is not final nor is it 

in effect at this time. 

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 of 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 April 27, 2015. 

ADDRESSES: An electronic copy of the 

guidance document is available for 

download from the Internet. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. Submit written requests for a 

single hard copy of the draft guidance 

document entitled ‘‘Medical Devices 

and Clinical Trial Design for the 

Treatment or Improvement in the 

Appearance of Fungally-Infected Nails’’ 

to the Office of the Center Director, 

Guidance and Policy Development, 

Center for Devices and Radiological 

Health, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 66, 

Rm. 5431, Silver Spring, MD 20993– 

0002. Send one self-addressed adhesive 

label to assist that office in processing 

your request. 

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. Identify 

comments with the docket number 

found in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: Neil 

Ogden, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. G414, Silver Spring, 

MD 20993–0002, 301–796–6397. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry and FDA 

staff entitled ‘‘Medical Devices and 

Clinical Trial Design for the Treatment 

or Improvement in the Appearance of 

Fungally-Infected Nails.’’ This guidance 

is intended to provide recommendations 

when finalized regarding clinical trial 

design for medical devices intended 

either: (1) To provide improvement in 

the appearance of nails affected by 

onychomycosis, that is, to affect the 

structure/function of the nails or (2) to 

treat onychomycosis (fungal nail 

infection). 

The FDA distinguishes these two 

conditions as target outcomes. The 

treatment of onychomycosis (an 

infectious disease) requires proof of 

stable elimination of the fungal 

organism, which is a medical endpoint. 

This outcome is distinct from outcomes 

limited to ‘‘temporary increase in clear 

nail’’ in nails which are fungally 

infected, which is considered an 

aesthetic endpoint, and does not 

connote successful eradication of fungal 

infection. The need for clinical 

performance data will be dependent on 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
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