Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Notification, 81772-81774 [2016-27851]
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Federal Register / Vol. 81, No. 223 / Friday, November 18, 2016 / Notices
comments will become a matter of
public record.
Sharon B. Arnold,
Deputy Director.
[FR Doc. 2016–27705 Filed 11–17–16; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–R–244]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid Services, HHS.
ACTION: Notice.
AGENCY:
The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. 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 or reinstatement of an existing
collection of information) and to allow
60 days for public comment on the
proposed action. Interested persons are
invited to send comments regarding our
burden estimates or any other aspect of
this collection of information, including
any of the following subjects: (1) The
necessity and utility of the proposed
information collection for the proper
performance of the agency’s functions;
(2) the accuracy of the estimated
burden; (3) ways to enhance the quality,
utility, and clarity of the information to
be collected; and (4) the use of
automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
DATES: Comments must be received by
January 17, 2017.
ADDRESSES: When commenting, please
reference the document identifier or
OMB control number. To be assured
consideration, comments and
recommendations must be submitted in
any one of the following ways:
1. Electronically. You may send your
comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) that are accepting
comments.
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SUMMARY:
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2. By regular mail. You may mail
written comments to the following
address: CMS, Office of Strategic
Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: Document Identifier/OMB
Control Number lll, Room C4–26–
05, 7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, you may make your request
using one of following:
1. Access CMS’ Web site address at
https://www.cms.hhs.gov/
PaperworkReductionActof1995.
2. Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov.
3. Call the Reports Clearance Office at
(410) 786–1326.
FOR FURTHER INFORMATION CONTACT:
Reports Clearance Office at (410) 786–
1326.
SUPPLEMENTARY INFORMATION:
Contents
This notice sets out a summary of the
use and burden associated with the
following information collections. More
detailed information can be found in
each collection’s supporting statement
and associated materials (see
ADDRESSES).
CMS–R–244 Programs for AllInclusive Care of the Elderly (PACE) and
Supporting Regulations in 42 CFR Part
460
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.
The term ‘‘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
requires federal agencies to publish a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, before
submitting the collection to OMB for
approval. To comply with this
requirement, CMS is publishing this
notice.
Information Collection: Programs for
All-inclusive Care of the Elderly (PACE)
and Supporting Regulations in 42 CFR
part 460; Use: This information
collection addresses all operational
components of the PACE program (as
defined in 42 CFR part 460) with the
exception of the application process
(§ 460.12). In this iteration the
application is removed from this control
number and moved under a new
information collection request with a
new CMS identification number (CMS–
10631). An OMB control number
specific to the application process is
pending.
The CMS–10631 information
collection request was submitted to
OMB on October 6, 2016, under ICR
Reference No: 201610–0938–001. When
approved, the control number can be
found on www.reginfo.gov/public/.
We are removing the application
requirements and burden since this
CMS–R–244 package is lengthy and we
recognize that it can be somewhat time
consuming to review. We believe the
change will help streamline the public
and OMB’s review of the application as
well as the remaining requirements and
burden under this CMS–R–244 package.
Form Number: CMS–R–244 (OMB
control number: 0938–0790); Frequency:
Once and occasionally; Affected Public:
Private sector (Business or other forprofits and Not-for-profit institutions);
Number of Respondents: 130; Total
Annual Responses: 145,455; Total
Annual Hours: 61,350. (For policy
questions regarding this collection
contact Debbie Van Hoven at 410–786–
6625).
Dated: November 15, 2016.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2016–27836 Filed 11–17–16; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0804]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Premarket
Notification
AGENCY:
Food and Drug Administration,
HHS.
Notice.
Information Collection
ACTION:
1. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
SUMMARY:
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The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
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Federal Register / Vol. 81, No. 223 / Friday, November 18, 2016 / Notices
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
medical device premarket notification.
DATES: Submit either electronic or
written comments on the collection of
information by January 17, 2017.
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’’).
mstockstill on DSK3G9T082PROD with NOTICES
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–
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20:21 Nov 17, 2016
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2013–N–0804 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Premarket Notification.’’ 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, Three White
Flint North, 10A63, 11601 Landsdown
St., North Bethesda, MD 20852,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
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81773
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.
Premarket Notification—21 CFR Part
807, Subpart E OMB Control Number
0910–0120—Extension
Section 510(k) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act)
(21 U.S.C. 360(k)) and the implementing
regulation under part 807 (21 CFR part
807, subpart E) requires a person who
intends to market a medical device to
submit a premarket notification
submission to FDA at least 90 days
before proposing to begin the
introduction, or delivery for
introduction into interstate commerce,
for commercial distribution of a device
intended for human use. Based on the
information provided in the
notification, FDA must determine
whether the new device is substantially
equivalent to a legally marketed device,
as defined in § 807.92(a)(3) (21 CFR
807.92(a)(3)). If the device is determined
to be not substantially equivalent to a
legally marketed device, it must have an
approved premarket approval
application (PMA), product
development protocol, humanitarian
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Federal Register / Vol. 81, No. 223 / Friday, November 18, 2016 / Notices
device exemption (HDE), petition for
Evaluation of Automatic Class III
Designation (de novo), or be reclassified
into class I or class II before being
marketed. FDA makes the final decision
of whether a device is substantially
equivalent or not equivalent.
Section 807.81 states when a
premarket notification is required. A
premarket notification is required to be
submitted by a person who is: (1)
Introducing a device to the market for
the first time; (2) introducing a device
into commercial distribution for the first
time by a person who is required to
register; and (3) introducing or
reintroducing a device which is
significantly changed or modified in
design, components, method of
manufacturer, or the intended use that
could affect the safety and effectiveness
of the device.
Form FDA 3514, a summary cover
sheet form, assists respondents in
categorizing administrative 510(k)
information for submission to FDA. This
form also assists respondents in
categorizing information for other FDA
medical device programs such as PMAs,
investigational device exemptions, and
HDEs. Under § 807.87(h), each 510(k)
submitter must include in the 510(k)
either a summary of the information in
the 510(k) as required by § 807.92
(510(k) summary) or a statement
certifying that the submitter will make
available upon request the information
in the 510(k) with certain exceptions as
per § 807.93 (510(k) statement). If the
510(k) submitter includes a 510(k)
statement in the 510(k) submission,
§ 807.93 requires that the official
correspondent of the firm make
available within 30 days of a request all
information included in the submitted
premarket notification on safety and
effectiveness. This information will be
provided to any person within 30 days
of a request if the device described in
the 510(k) submission is determined to
be substantially equivalent. The
information provided will be a
duplicate of the 510(k) submission
including any safety and effectiveness
information, but excluding all patient
identifiers and trade secret and
commercial confidential information.
Section 204 of the Food and Drug
Administration Modernization Act
(FDAMA) (Pub. L. 105–115) amended
section 514 of the FD&C Act (21 U.S.C.
360d). Amended section 514 allows
FDA to recognize consensus standards
developed by international and national
organizations for use in satisfying
portions of device premarket review
submissions including premarket
notifications or other requirements. FDA
has published and updated the list of
recognized standards regularly since
enactment of FDAMA and has allowed
510(k) submitters to certify conformance
to recognized standards to meet the
requirements of § 807.87. Form FDA
3654, the 510(k) Standards Data Form,
standardizes the format for submitting
information on consensus standards that
a 510(k) submitter chooses to use as a
portion of their premarket notification
submission (Form FDA 3654 is not for
declarations of conformance to a
recognized standard). FDA believes that
use of this form will simplify the 510(k)
preparation and review process for
510(k).
Under § 807.90, submitters may
request information on their 510(k)
review status 90 days after the initial
login date of the 510(k). Thereafter, the
submitter may request status reports
every 30 days following the initial status
request. To obtain a 510(k) status report,
the submitter should complete the
status request form, Form FDA 3541,
and fax it to the Center for Devices and
Radiological Health office identified on
the form.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
Total
hours
Activity and 21 CFR Part/Section
Form No.
510(k) submission (807 subpart
E).
Summary cover sheet (807.87) ...
Status request (807.90(a)(3)) ......
Standards (807.87(d) and (f)) ......
510(k) statement (807.93) ...........
........................
3,900
1
3,900
79 ..............................
308,100
FDA 3514 ......
FDA 3541 ......
FDA 3654 ......
........................
1,956
218
2,700
225
1
1
1
10
1,956
218
2,700
2,250
0.5 (30 minutes) ........
0.25 (15 minutes) ......
10 ..............................
10 ..............................
978
55
27,000
22,500
Total ......................................
........................
........................
........................
........................
....................................
358,633
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: November 15, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–27851 Filed 11–17–16; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–D–0880]
BILLING CODE 4164–01–P
mstockstill on DSK3G9T082PROD with NOTICES
Generic Drug User Fee Amendments of
2012: Questions and Answers Related
to User Fee Assessments; Guidance
for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of guidance
for industry entitled ‘‘Generic Drug User
SUMMARY:
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20:21 Nov 17, 2016
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Fee Amendments of 2012: Questions
and Answers Related to User Fee
Assessments.’’ This guidance provides
updated answers to common questions
from the generic drug industry and
other interested parties involved in the
development and/or testing of generic
drug products regarding GDUFA user
fees and finalizes the revised version of
the guidance.
Submit either electronic or
written comments on Agency guidances
at any time.
DATES:
ADDRESSES:
You may submit comments
as follows:
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]]>Agencies
[Federal Register Volume 81, Number 223 (Friday, November 18, 2016)]
[Notices]
[Pages 81772-81774]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-27851]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0804]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Premarket Notification
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the
[[Page 81773]]
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 medical device premarket notification.
DATES: Submit either electronic or written comments on the collection
of information by January 17, 2017.
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-2013-N-0804 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Premarket Notification.''
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, Three White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD 20852, 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.
Premarket Notification--21 CFR Part 807, Subpart E OMB Control Number
0910-0120--Extension
Section 510(k) of the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 360(k)) and the implementing regulation under part
807 (21 CFR part 807, subpart E) requires a person who intends to
market a medical device to submit a premarket notification submission
to FDA at least 90 days before proposing to begin the introduction, or
delivery for introduction into interstate commerce, for commercial
distribution of a device intended for human use. Based on the
information provided in the notification, FDA must determine whether
the new device is substantially equivalent to a legally marketed
device, as defined in Sec. 807.92(a)(3) (21 CFR 807.92(a)(3)). If the
device is determined to be not substantially equivalent to a legally
marketed device, it must have an approved premarket approval
application (PMA), product development protocol, humanitarian
[[Page 81774]]
device exemption (HDE), petition for Evaluation of Automatic Class III
Designation (de novo), or be reclassified into class I or class II
before being marketed. FDA makes the final decision of whether a device
is substantially equivalent or not equivalent.
Section 807.81 states when a premarket notification is required. A
premarket notification is required to be submitted by a person who is:
(1) Introducing a device to the market for the first time; (2)
introducing a device into commercial distribution for the first time by
a person who is required to register; and (3) introducing or
reintroducing a device which is significantly changed or modified in
design, components, method of manufacturer, or the intended use that
could affect the safety and effectiveness of the device.
Form FDA 3514, a summary cover sheet form, assists respondents in
categorizing administrative 510(k) information for submission to FDA.
This form also assists respondents in categorizing information for
other FDA medical device programs such as PMAs, investigational device
exemptions, and HDEs. Under Sec. 807.87(h), each 510(k) submitter must
include in the 510(k) either a summary of the information in the 510(k)
as required by Sec. 807.92 (510(k) summary) or a statement certifying
that the submitter will make available upon request the information in
the 510(k) with certain exceptions as per Sec. 807.93 (510(k)
statement). If the 510(k) submitter includes a 510(k) statement in the
510(k) submission, Sec. 807.93 requires that the official
correspondent of the firm make available within 30 days of a request
all information included in the submitted premarket notification on
safety and effectiveness. This information will be provided to any
person within 30 days of a request if the device described in the
510(k) submission is determined to be substantially equivalent. The
information provided will be a duplicate of the 510(k) submission
including any safety and effectiveness information, but excluding all
patient identifiers and trade secret and commercial confidential
information.
Section 204 of the Food and Drug Administration Modernization Act
(FDAMA) (Pub. L. 105-115) amended section 514 of the FD&C Act (21
U.S.C. 360d). Amended section 514 allows FDA to recognize consensus
standards developed by international and national organizations for use
in satisfying portions of device premarket review submissions including
premarket notifications or other requirements. FDA has published and
updated the list of recognized standards regularly since enactment of
FDAMA and has allowed 510(k) submitters to certify conformance to
recognized standards to meet the requirements of Sec. 807.87. Form FDA
3654, the 510(k) Standards Data Form, standardizes the format for
submitting information on consensus standards that a 510(k) submitter
chooses to use as a portion of their premarket notification submission
(Form FDA 3654 is not for declarations of conformance to a recognized
standard). FDA believes that use of this form will simplify the 510(k)
preparation and review process for 510(k).
Under Sec. 807.90, submitters may request information on their
510(k) review status 90 days after the initial login date of the
510(k). Thereafter, the submitter may request status reports every 30
days following the initial status request. To obtain a 510(k) status
report, the submitter should complete the status request form, Form FDA
3541, and fax it to the Center for Devices and Radiological Health
office identified on the form.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity and 21 CFR Part/Section Form No. Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
510(k) submission (807 subpart ...................... 3,900 1 3,900 79............................ 308,100
E).
Summary cover sheet (807.87).... FDA 3514.............. 1,956 1 1,956 0.5 (30 minutes).............. 978
Status request (807.90(a)(3))... FDA 3541.............. 218 1 218 0.25 (15 minutes)............. 55
Standards (807.87(d) and (f))... FDA 3654.............. 2,700 1 2,700 10............................ 27,000
510(k) statement (807.93)....... ...................... 225 10 2,250 10............................ 22,500
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Total....................... ...................... .............. .............. .............. .............................. 358,633
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: November 15, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-27851 Filed 11-17-16; 8:45 am]
BILLING CODE 4164-01-P
