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Devices and Clinical Trial Design for the Treatment or Improvement in the Appearance of Fungally-Infected Nails; Draft Guidance for Industry and Food and Drug Administration Staff; Availability, 4281-4282 [2015-01407]
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Federal Register / Vol. 80, No. 17 / Tuesday, January 27, 2015 / Notices
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publication of this draft guidance, FDA
is withdrawing the draft guidance for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.
asabaliauskas on DSK5VPTVN1PROD with NOTICES
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This draft guidance is being issued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The draft guidance, when finalized, will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This draft guidance refers to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
VerDate Sep<11>2014
18:01 Jan 26, 2015
Jkt 235001
document to https://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 https://
www.regulations.gov.
V. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Regulatory
Information/Guidances/ucm126198.htm
or https://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.
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.
SUMMARY:
PO 00000
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4281
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 https://
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:
ADDRESSES:
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
E:\FR\FM\27JAN1.SGM
27JAN1
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 https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm.
Guidance documents are also available
at https://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.
asabaliauskas on DSK5VPTVN1PROD with NOTICES
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.
VerDate Sep<11>2014
18:01 Jan 26, 2015
Jkt 235001
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 https://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 https://
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.
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
SUMMARY:
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
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 https://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
E:\FR\FM\27JAN1.SGM
27JAN1
Agencies
[Federal Register Volume 80, Number 17 (Tuesday, January 27, 2015)]
[Notices]
[Pages 4281-4282]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-01407]
-----------------------------------------------------------------------
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 https://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
[[Page 4282]]
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 https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at https://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 https://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 https://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