4280 Federal Register / Vol. 80, No. 17 / Tuesday, January 27, 2015 / Notices 

IV. List of Recognized Standards 

FDA maintains the Agency’s current 

list of FDA Recognized Consensus 

Standards in a searchable database that 

may be accessed directly at FDA’s 

Internet site at http:// 

www.accessdata.fda.gov/scripts/cdrh/ 

cfdocs/cfStandards/search.cfm. FDA 

will incorporate the modifications and 

revisions described in this notice into 

the database and, upon publication in 

the Federal Register, this recognition of 

consensus standards will be effective. 

FDA will announce additional 

modifications and revisions to the list of 

recognized consensus standards, as 

needed, in the Federal Register once a 

year, or more often if necessary. 

Beginning with Recognition List 033, 

FDA no longer announces minor 

revisions to the list of recognized 

consensus standards such as technical 

contact person, devices affected, 

processes affected, Code of Federal 

Regulations citations, and product 

codes. 

V. Recommendation of Standards for 

Recognition by FDA 

Any person may recommend 

consensus standards as candidates for 

recognition under section 514 of the 

FD&C Act by submitting such 

recommendations, with reasons for the 

recommendation to standards@

cdrh.fda.gov. To be properly considered, 

such recommendations should contain, 

at a minimum, the following 

information: (1) Title of the standard, (2) 

any reference number and date, (3) 

name and address of the national or 

international standards development 

organization, (4) a proposed list of 

devices for which a declaration of 

conformity to this standard should 

routinely apply, and (5) a brief 

identification of the testing or 

performance or other characteristics of 

the device(s) that would be addressed 

by a declaration of conformity. 

VI. Electronic Access 

You may obtain a copy of ‘‘Guidance 

on the Recognition and Use of 

Consensus Standards’’ by using the 

Internet. The Center for Devices and 

Radiological Health (CDRH) maintains a 

site on the Internet for easy access to 

information including text, graphics, 

and files that you may download to a 

personal computer with access to the 

Internet. Updated on a regular basis, the 

CDRH home page, http://www.fda.gov/ 

MedicalDevices, includes a link to 

standards-related documents including 

the guidance and the current list of 

recognized standards. After publication 

in the Federal Register, this notice 

announcing ‘‘Modification to the List of 

Recognized Standards, Recognition List 

Number: 038’’ will be available at 

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

DeviceRegulationandGuidance/ 

Standards/ucm123792.htm. You may 

access ‘‘Guidance on the Recognition 

and Use of Consensus Standards,’’ and 

the searchable database for ‘‘FDA 

Recognized Consensus Standards’’ at 

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

DeviceRegulationandGuidance/ 

Standards. 

VII. Submission of Comments and 

Effective Date 

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. FDA will consider 

any comments received in determining 

whether to amend the current listing of 

modifications to the list of recognized 

standards, Recognition List Number: 

038. These modifications to the list of 

recognized standards are effective upon 

publication of this notice in the Federal 

Register. 

Dated: January 22, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–01420 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–D–0198] 

Current Good Manufacturing Practice 

Requirements for Combination 

Products; 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 a draft guidance for 

industry and FDA staff entitled ‘‘Current 

Good Manufacturing Practice 

Requirements for Combination 

Products.’’ The guidance describes and 

explains the final rule on current good 

manufacturing practice (CGMP) 

requirements for combination products, 

including presenting general 

considerations for CGMP compliance as 

well as analysis of hypothetical 

scenarios. 

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 30, 

2015. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance 

document entitled ‘‘Current Good 

Manufacturing Practice Requirements 

for Combination Products’’ to the Office 

of Combination Products, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 32, Rm. 5129, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

request. 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. Identify 

comments with the docket number 

found in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: John 

Barlow Weiner, Office of Combination 

Products, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, Rm. 5129, Silver Spring, 

MD 20993–0002, 301–796–8930. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry and FDA 

staff entitled ‘‘Current Good 

Manufacturing Practice Requirements 

for Combination Products.’’ The 

guidance provides background on 

combination products, including an 

overview of the final rule on CGMP 

requirements for combination products 

(78 FR 4307, January 22, 2013) (21 CFR 

part 4) and the role of the lead center 

and other Agency components with 

respect to combination product CGMP 

issues. The guidance addresses general 

considerations for CGMP requirements 

for combination products and the 

purpose and content of specific CGMP 

provisions addressed in part 4. The 

guidance also contains hypothetical 

scenarios intended to clarify how to 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
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