Agency Information Collection Activities; Proposed Collection; Comment Request; Center for Devices and Radiological Health Appeals Processes, 63804-63806 [2015-26672]
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63804
Federal Register / Vol. 80, No. 203 / Wednesday, October 21, 2015 / Notices
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of the draft guidance may do so by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
CDRH guidance documents is available
at https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm.
Guidance documents are also available
at https://www.regulations.gov or from
CBER at https://www.fda.gov/Biologics
BloodVaccines/GuidanceCompliance
RegulatoryInformation/default.htm.
Persons unable to download an
electronic copy of ‘‘Manufacturing Site
Change Supplements: Content and
Submission’’ may send an email request
to CDRH-Guidance@fda.hhs.gov to
receive an electronic copy of the
document. Please use the document
number 1269 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This draft guidance refers to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
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR part 814,
subparts B and E have been approved
under OMB control number 0910–0231;
the collections of information in 21 CFR
part 814, subpart H have been approved
under OMB control number 0910–0332;
and the collections of information in 21
CFR part 820 have been approved under
OMB control number 0910–0073.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Administrative Practices and
Procedures; Formal Evidentiary Public
Hearing’’ has been approved by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
SUMMARY:
On May
12, 2015, the Agency submitted a
proposed collection of information
entitled ‘‘Administrative Practices and
Procedures; Formal Evidentiary Public
Hearing’’ to OMB for review and
clearance under 44 U.S.C. 3507. An
Agency may not conduct or sponsor,
and a person is not required to respond
to, a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0191. The
approval expires on September 30,
2018. A copy of the supporting
statement for this information collection
is available on the Internet at https://
www.reginfo.gov/public/do/PRAMain.
SUPPLEMENTARY INFORMATION:
Dated: October 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–26639 Filed 10–20–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: October 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
Food and Drug Administration
[FR Doc. 2015–26637 Filed 10–20–15; 8:45 am]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Center for Devices
and Radiological Health Appeals
Processes
[Docket No. FDA–2011–D–0893]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
Food and Drug Administration
Food and Drug Administration,
Notice.
tkelley on DSK3SPTVN1PROD with NOTICES
ACTION:
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Administrative Practices and
Procedures; Formal Evidentiary Public
Hearing
SUMMARY:
AGENCY:
Food and Drug Administration,
HHS.
VerDate Sep<11>2014
22:39 Oct 20, 2015
Jkt 238001
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
PO 00000
Frm 00068
Fmt 4703
Sfmt 4703
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
HHS.
[Docket No. FDA–2014–N–2029]
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
information collection associated with
the processes available to outside
stakeholders to request additional
review of decisions or actions by Center
for Devices and Radiological Health
(CDRH) employees.
DATES: Submit either electronic or
written comments on the collection of
information by December 21, 2015.
ADDRESSES: You may submit comments
as follows:
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–
2011–D–0893] for Agency Information
E:\FR\FM\21OCN1.SGM
21OCN1
tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 203 / Wednesday, October 21, 2015 / Notices
Collection Activities; Proposed
Collection; Comment Request; Center
for Devices and Radiological Health
Appeals Processes. 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.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
VerDate Sep<11>2014
22:39 Oct 20, 2015
Jkt 238001
Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
SUPPLEMENTARY INFORMATION:
Center for Devices and Radiological
Health Appeals Processes—OMB
Control Number 0910–0738—Extension
The guidance document entitled
‘‘Guidance for Industry and Food and
Drug Administration Staff; Center for
Devices and Radiological Health
Appeals Processes’’ describes the
processes available to outside
stakeholders to request additional
review of decisions or actions by CDRH
employees. FDA is seeking approval for
the new reporting burden associated
with requests for additional review of
decisions and actions by CDRH
employees as described in the guidance.
Individuals outside of FDA who
disagree with a decision or action taken
by CDRH and wish to have it reviewed
or reconsidered have several processes
for resolution from which to choose,
PO 00000
Frm 00069
Fmt 4703
Sfmt 4703
63805
including: Requests for supervisory
review of an action; petitions; and
hearings. Of these, by far the most
commonly used is a request for
supervisory review under 21 CFR 10.75
(a ‘‘10.75 appeal’’). Section 517A of the
FD&C Act, added by section 603 of the
FDA Safety and Innovation Act of 2012,
includes new requirements pertaining to
the process and timelines for 10.75
appeals of ‘‘significant decisions’’
regarding 510(k) premarket
notifications, applications for premarket
approvals (PMAs), and applications for
investigational device exemptions
(IDEs).
A request for review under section
10.75 should be based on the
information that was already present in
the administrative file at the time of the
decision that is being reviewed as
provided in 21 CFR 10.75(d). New
section 517A of the FD&C Act refers to
significant decisions regarding the
information in the administrative file for
premarket notifications (section 510(k));
PMAs (section 515); and IDEs (section
520(g)) submissions is collected under
existing regulations which specify the
information manufacturers must submit
so that FDA may properly evaluate the
safety and effectiveness of medical
devices. The information collections
associated with these regulations are
currently approved by the Office of
Management and Budget as follows: The
collections of information in 21 CFR
part 807, subpart E (premarket
notification) have been approved under
OMB control number 0910–0120; the
collections of information in 21 CFR
part 814 (premarket approval) have been
approved under OMB control number
0910–0231; and the collections of
information in 21 CFR part 812
(investigational device exemption) have
been approved under OMB control
number 0910–0078.
While CDRH already possesses in the
administrative file the information that
would form the basis of a decision on
a matter under appeal, the submission
of particular information regarding the
request itself and the data and
information relied on by the requestor
in the appeal would facilitate timely
resolution of the decision under review.
The guidance describes the collection of
information not expressly specified
under existing regulations: The
submission of the request for review,
minor clarifications as part of the
request, and supporting information.
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\21OCN1.SGM
21OCN1
63806
Federal Register / Vol. 80, No. 203 / Wednesday, October 21, 2015 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
CDRH Appeals Processes Guidance Document ................
50
1
50
8
400
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–26672 Filed 10–20–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0427]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Medical Devices;
Inspection by Accredited Persons
Program
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the Inspection by Accredited Persons
Program Under the Medical Device User
Fee and Modernization Act of 2002.
DATES: Submit either electronic or
written comments on the collection of
information by December 21, 2015.
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
VerDate Sep<11>2014
22:39 Oct 20, 2015
Jkt 238001
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,
if submitted as detailed in
‘‘Instructions’’.
Instructions: All submissions received
must include the Docket No.FDA–2012–
N–0427 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Medical
Devices; Inspection by Accredited
Persons Program’’. 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
PO 00000
Frm 00070
Fmt 4703
Sfmt 4703
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.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
SUPPLEMENTARY INFORMATION:
E:\FR\FM\21OCN1.SGM
21OCN1
]]>Agencies
[Federal Register Volume 80, Number 203 (Wednesday, October 21, 2015)]
[Notices]
[Pages 63804-63806]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-26672]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-D-0893]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Center for Devices and Radiological Health Appeals
Processes
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on information collection
associated with the processes available to outside stakeholders to
request additional review of decisions or actions by Center for Devices
and Radiological Health (CDRH) employees.
DATES: Submit either electronic or written comments on the collection
of information by December 21, 2015.
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, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
[FDA-2011-D-0893] for Agency Information
[[Page 63805]]
Collection Activities; Proposed Collection; Comment Request; Center for
Devices and Radiological Health Appeals Processes. 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.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Center for Devices and Radiological Health Appeals Processes--OMB
Control Number 0910-0738--Extension
The guidance document entitled ``Guidance for Industry and Food and
Drug Administration Staff; Center for Devices and Radiological Health
Appeals Processes'' describes the processes available to outside
stakeholders to request additional review of decisions or actions by
CDRH employees. FDA is seeking approval for the new reporting burden
associated with requests for additional review of decisions and actions
by CDRH employees as described in the guidance.
Individuals outside of FDA who disagree with a decision or action
taken by CDRH and wish to have it reviewed or reconsidered have several
processes for resolution from which to choose, including: Requests for
supervisory review of an action; petitions; and hearings. Of these, by
far the most commonly used is a request for supervisory review under 21
CFR 10.75 (a ``10.75 appeal''). Section 517A of the FD&C Act, added by
section 603 of the FDA Safety and Innovation Act of 2012, includes new
requirements pertaining to the process and timelines for 10.75 appeals
of ``significant decisions'' regarding 510(k) premarket notifications,
applications for premarket approvals (PMAs), and applications for
investigational device exemptions (IDEs).
A request for review under section 10.75 should be based on the
information that was already present in the administrative file at the
time of the decision that is being reviewed as provided in 21 CFR
10.75(d). New section 517A of the FD&C Act refers to significant
decisions regarding the information in the administrative file for
premarket notifications (section 510(k)); PMAs (section 515); and IDEs
(section 520(g)) submissions is collected under existing regulations
which specify the information manufacturers must submit so that FDA may
properly evaluate the safety and effectiveness of medical devices. The
information collections associated with these regulations are currently
approved by the Office of Management and Budget as follows: The
collections of information in 21 CFR part 807, subpart E (premarket
notification) have been approved under OMB control number 0910-0120;
the collections of information in 21 CFR part 814 (premarket approval)
have been approved under OMB control number 0910-0231; and the
collections of information in 21 CFR part 812 (investigational device
exemption) have been approved under OMB control number 0910-0078.
While CDRH already possesses in the administrative file the
information that would form the basis of a decision on a matter under
appeal, the submission of particular information regarding the request
itself and the data and information relied on by the requestor in the
appeal would facilitate timely resolution of the decision under review.
The guidance describes the collection of information not expressly
specified under existing regulations: The submission of the request for
review, minor clarifications as part of the request, and supporting
information.
FDA estimates the burden of this collection of information as
follows:
[[Page 63806]]
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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CDRH Appeals Processes Guidance Document........................... 50 1 50 8 400
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-26672 Filed 10-20-15; 8:45 am]
BILLING CODE 4164-01-P
