General Considerations for Animal Studies for Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability, 61820-61822 [2015-26055]
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Federal Register / Vol. 80, No. 198 / Wednesday, October 14, 2015 / Notices
OMB No.: 0970–0033
Description: The Annual Survey of
Refugees collects information on the
social and economic characteristics of a
random sample of refugees, Amerasians,
and entrants who arrived in the United
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Average burden hours per
response
Total burden
hours
ORR–9 Annual Survey of Refugees ...............................................................
Request for Participation Letter .......................................................................
2,000
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1
1
0.62
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1,240
100
Estimated Total Annual Burden Hours .....................................................
........................
........................
........................
1,340
tkelley on DSK3SPTVN1PROD with NOTICES
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20447, Attn: ACF Reports Clearance
Officer. Email address: infocollection@
acf.hhs.gov. All requests should be
identified by the title of the information
collection.
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comments on: (a) Whether the proposed
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Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2015–25998 Filed 10–13–15; 8:45 am]
BILLING CODE 4184–01–P
VerDate Sep<11>2014
16:39 Oct 13, 2015
Jkt 238001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–D–3419]
General Considerations for Animal
Studies for Medical Devices; Draft
Guidance for Industry and Food and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 or Agency) is
announcing the availability of the draft
guidance entitled ‘‘General
Considerations for Animal Studies for
Medical Devices.’’ FDA has developed
this guidance document to assist
industry in designing evaluation
strategies for, and reporting the results
of, animal studies for medical devices.
The intent of this draft guidance is to
provide a reference of best practices for
the approach to, and conduct of, animal
studies, and the presentation of animal
study data intended to demonstrate that
the device under study is sufficiently
safe for early human experience (e.g., to
support an investigational device
exemption (IDE) application) or to
demonstrate device safety in support of
a marketing application, while
incorporating modern animal care and
use strategies. 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 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 January 12,
2016.
SUMMARY:
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
ADDRESSES:
You may submit comments
as follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
E:\FR\FM\14OCN1.SGM
14OCN1
tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 198 / Wednesday, October 14, 2015 / Notices
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2015–D–3419 for ‘‘General
Considerations for Animal Studies for
Medical Devices.’’ Received comments
will be placed in the docket and, except
for those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION’’. The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on https://
www.regulations.gov. Submit both
copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
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
VerDate Sep<11>2014
16:39 Oct 13, 2015
Jkt 238001
document entitled ‘‘General
Considerations for Animal Studies for
Medical Devices’’ 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 selfaddressed adhesive label to assist that
office in processing your request.
FOR FURTHER INFORMATION CONTACT:
Rebecca Nipper, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1540, Silver Spring,
MD 20993–0002, 301–796–6527.
SUPPLEMENTARY INFORMATION:
I. Background
FDA has developed this guidance
document to assist industry in designing
evaluation strategies for, and reporting
the results of, animal studies for
medical devices. The animal studies
utilized for the assessment of these
devices typically provide initial
evidence of device safety, their potential
performance when used in a living
system, and the biologic response that a
living system may mount towards the
device. The intent of this guidance is to
provide a reference of best practices for
the approach to, and conduct of, animal
studies, and the presentation of animal
study data intended to demonstrate that
the device under study is sufficiently
safe for early human experience (e.g., to
support an investigational device
exemption application) or to
demonstrate device safety in support of
a marketing application, while
incorporating modern animal care and
use strategies. We encourage sponsors to
consult with us if it they wish to use a
non-animal testing method they believe
is suitable, adequate, validated, and
feasible. We will consider if such an
alternative method could be assessed for
equivalency to an animal test method.
This draft guidance, when finalized,
will supersede the July 2010 guidance
entitled ‘‘Guidance for Industry and
FDA Staff: General Considerations for
Animal Studies for Cardiovascular
Devices.’’
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 current thinking of FDA
on General Considerations for Animal
Studies for Medical Devices. It does not
establish any rights for any person and
is not binding on FDA or the public.
You can use an alternative approach if
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
61821
it satisfies the requirements of the
applicable statutes 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 ‘‘General Considerations for Animal
Studies for Medical Devices,’’ may send
an email request to CDRH-Guidance@
fda.hhs.gov to receive an electronic
copy of the document. Please use the
document number 1802 to identify the
guidance you are requesting.
IV. Paperwork Reduction Act of 1995
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
(PRA) (44 U.S.C. 3501–3520). The
collections of information in 21 CFR
part 58 have been approved under OMB
control number 0910–0119; 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 812 have been approved under
OMB control number 0910–0078; the
collections of information in 21 CFR
part 814, subparts A through E, have
been approved under OMB control
numbers 0910–0231; and the collections
of information in 21 CFR part 814,
subpart H have been approved under
OMB control number 0910–0332.
This draft guidance also refers to
proposed collections of information
described in FDA’s August 14, 2014,
draft guidance entitled, ‘‘De Novo
Classification Process (Evaluation of
Automatic Class III Designations)’’ (de
novo draft guidance) (79 FR 47651). The
proposed collections of information
described in the de novo draft guidance
are subject to review by OMB under the
PRA. As required by the PRA, FDA has
published an analysis of the proposed
information collection described in the
de novo draft guidance (79 FR 47651 at
47653) and has submitted them for OMB
approval.
E:\FR\FM\14OCN1.SGM
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61822
Federal Register / Vol. 80, No. 198 / Wednesday, October 14, 2015 / Notices
Dated: October 7, 2015.
Leslie Kux,
Associate Commissioner for Policy.
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
[FR Doc. 2015–26055 Filed 10–13–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0128]
Prescription Drug User Fee Act;
Reopening of Comment Period
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; reopening of comment
period.
The Food and Drug
Administration (FDA) is reopening until
April 29, 2016, the comment period for
the notice of public meeting that
appeared in the Federal Register of May
13, 2015 (80 FR 27323). In the notice of
public meeting, FDA invited public
comment as the Agency begins the
process to reauthorize the Prescription
Drug User Fee Act (PDUFA) in fiscal
years (FYs) 2018 to 2022. The Agency is
taking this action to allow interested
persons additional time to submit
comments.
DATES: FDA is reopening the comment
period on the notice of public meeting
published May 13, 2015 (80 FR 27323).
Submit either electronic or written
comments by April 29, 2016.
ADDRESSES: You may submit comments
as follows:
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
VerDate Sep<11>2014
16:39 Oct 13, 2015
Jkt 238001
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2010–N–0128 for ‘‘Prescription Drug
User Fee Act; Reopening of Comment
Period.’’ Received comments will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION’’. The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on https://
www.regulations.gov. Submit both
copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.fda.gov/
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
regulatoryinformation/dockets/
default.htm.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Graham Thompson, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1146,
Silver Spring, MD 20993–0002, 301–
796–5003.
SUPPLEMENTARY INFORMATION: In the
Federal Register of May 13, 2015, FDA
published a notice of public meeting
with a 30-day comment period
following the public meeting and
invited comments as the Agency began
the process to reauthorize PDUFA in
FYs 2018 to 2022.
FDA is reopening the comment period
until April 29, 2016. The Agency
believes that reopening the comment
period for the notice of public meeting
will allow adequate time for interested
persons to submit comments.
Dated: October 7, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–26052 Filed 10–13–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–D–3399]
Recommendations for Microbial
Vectors Used for Gene Therapy; Draft
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
document entitled ‘‘Recommendations
for Microbial Vectors Used for Gene
Therapy; Draft Guidance for Industry.’’
The draft guidance provides
investigational new drug application
(IND) sponsors, with recommendations
concerning IND submissions for
microbial vectors used for gene therapy
(MVGTs) in early-phase clinical trials.
MVGTs meet the regulatory definition of
SUMMARY:
E:\FR\FM\14OCN1.SGM
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]]>Agencies
[Federal Register Volume 80, Number 198 (Wednesday, October 14, 2015)]
[Notices]
[Pages 61820-61822]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-26055]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-D-3419]
General Considerations for Animal Studies for Medical Devices;
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 or Agency) is announcing
the availability of the draft guidance entitled ``General
Considerations for Animal Studies for Medical Devices.'' FDA has
developed this guidance document to assist industry in designing
evaluation strategies for, and reporting the results of, animal studies
for medical devices. The intent of this draft guidance is to provide a
reference of best practices for the approach to, and conduct of, animal
studies, and the presentation of animal study data intended to
demonstrate that the device under study is sufficiently safe for early
human experience (e.g., to support an investigational device exemption
(IDE) application) or to demonstrate device safety in support of a
marketing application, while incorporating modern animal care and use
strategies. 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 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 January 12, 2016.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential,
[[Page 61821]]
if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2015-D-3419 for ``General Considerations for Animal Studies for
Medical Devices.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
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
``General Considerations for Animal Studies for Medical Devices'' 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.
FOR FURTHER INFORMATION CONTACT: Rebecca Nipper, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1540, Silver Spring, MD 20993-0002, 301-796-6527.
SUPPLEMENTARY INFORMATION:
I. Background
FDA has developed this guidance document to assist industry in
designing evaluation strategies for, and reporting the results of,
animal studies for medical devices. The animal studies utilized for the
assessment of these devices typically provide initial evidence of
device safety, their potential performance when used in a living
system, and the biologic response that a living system may mount
towards the device. The intent of this guidance is to provide a
reference of best practices for the approach to, and conduct of, animal
studies, and the presentation of animal study data intended to
demonstrate that the device under study is sufficiently safe for early
human experience (e.g., to support an investigational device exemption
application) or to demonstrate device safety in support of a marketing
application, while incorporating modern animal care and use strategies.
We encourage sponsors to consult with us if it they wish to use a non-
animal testing method they believe is suitable, adequate, validated,
and feasible. We will consider if such an alternative method could be
assessed for equivalency to an animal test method.
This draft guidance, when finalized, will supersede the July 2010
guidance entitled ``Guidance for Industry and FDA Staff: General
Considerations for Animal Studies for Cardiovascular Devices.''
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 current thinking of FDA on General
Considerations for Animal Studies for Medical Devices. It does not
establish any rights for any person and is not binding on FDA or the
public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes 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 ``General Considerations for
Animal Studies for Medical Devices,'' may send an email request to
CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the
document. Please use the document number 1802 to identify the guidance
you are requesting.
IV. Paperwork Reduction Act of 1995
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 (PRA) (44 U.S.C. 3501-3520).
The collections of information in 21 CFR part 58 have been approved
under OMB control number 0910-0119; 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 812 have been
approved under OMB control number 0910-0078; the collections of
information in 21 CFR part 814, subparts A through E, have been
approved under OMB control numbers 0910-0231; and the collections of
information in 21 CFR part 814, subpart H have been approved under OMB
control number 0910-0332.
This draft guidance also refers to proposed collections of
information described in FDA's August 14, 2014, draft guidance
entitled, ``De Novo Classification Process (Evaluation of Automatic
Class III Designations)'' (de novo draft guidance) (79 FR 47651). The
proposed collections of information described in the de novo draft
guidance are subject to review by OMB under the PRA. As required by the
PRA, FDA has published an analysis of the proposed information
collection described in the de novo draft guidance (79 FR 47651 at
47653) and has submitted them for OMB approval.
[[Page 61822]]
Dated: October 7, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-26055 Filed 10-13-15; 8:45 am]
BILLING CODE 4164-01-P
