Current Good Manufacturing Practice Requirements for Combination Products; Draft Guidance for Industry and Food and Drug Administration Staff; Availability, 4280-4281 [2015-01410]
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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 https://
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.
announcing ‘‘Modification to the List of
Recognized Standards, Recognition List
Number: 038’’ will be available at
https://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
https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
Standards.
VII. Submission of Comments and
Effective Date
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
V. Recommendation of Standards for
will be posted to the docket at https://
Recognition by FDA
www.regulations.gov. FDA will consider
Any person may recommend
any comments received in determining
consensus standards as candidates for
whether to amend the current listing of
recognition under section 514 of the
modifications to the list of recognized
FD&C Act by submitting such
standards, Recognition List Number:
recommendations, with reasons for the
038. These modifications to the list of
recommendation to standards@
recognized standards are effective upon
cdrh.fda.gov. To be properly considered, publication of this notice in the Federal
such recommendations should contain,
Register.
at a minimum, the following
Dated: January 22, 2015.
information: (1) Title of the standard, (2)
Leslie Kux,
any reference number and date, (3)
Associate Commissioner for Policy.
name and address of the national or
[FR Doc. 2015–01420 Filed 1–26–15; 8:45 am]
international standards development
BILLING CODE 4164–01–P
organization, (4) a proposed list of
devices for which a declaration of
conformity to this standard should
DEPARTMENT OF HEALTH AND
routinely apply, and (5) a brief
HUMAN SERVICES
identification of the testing or
Food and Drug Administration
VI. Electronic Access
asabaliauskas on DSK5VPTVN1PROD with NOTICES
performance or other characteristics of
the device(s) that would be addressed
by a declaration of conformity.
Current Good Manufacturing Practice
Requirements for Combination
Products; Draft Guidance for Industry
and Food and Drug Administration
Staff; Availability
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, https://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
VerDate Sep<11>2014
18:01 Jan 26, 2015
Jkt 235001
[Docket No. FDA–2015–D–0198]
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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
SUMMARY:
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
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 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: 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
E:\FR\FM\27JAN1.SGM
27JAN1
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
Frm 00039
Fmt 4703
Sfmt 4703
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
Agencies
[Federal Register Volume 80, Number 17 (Tuesday, January 27, 2015)]
[Notices]
[Pages 4280-4281]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-01410]
-----------------------------------------------------------------------
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 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: 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
[[Page 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 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