Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Notification, 71958-71961 [2019-28098]
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Federal Register / Vol. 84, No. 249 / Monday, December 30, 2019 / Notices
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 Dockets Management
Staff. 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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
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 Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of this draft guidance to the
Center for Tobacco Products, Food and
Drug Administration, Document Control
Center, Bldg. 71, Rm. G335, 10903 New
Hampshire Ave., Silver Spring, MD
20993–0002. Send one self-addressed
adhesive label to assist that office in
processing your request or include a fax
number to which the draft guidance
may be sent. See the SUPPLEMENTARY
INFORMATION section for information on
electronic access to the draft guidance.
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FOR FURTHER INFORMATION CONTACT:
Lauren Belcher or Annette Marthaler,
Center for Tobacco Products, Food and
Drug Administration, 10903 New
Hampshire Ave., Document Control
Center, Bldg. 71, Rm. G335, 10903 New
Hampshire Ave., Silver Spring, MD
20993–0002, 1–877–287–1373, email:
AskCTPRegulations@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
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I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Submission of Plans for Cigarette
Packages and Cigarette
Advertisements.’’ The Family Smoking
Prevention and Tobacco Control Act
(Tobacco Control Act) (Pub. L. 111–31)
was enacted on June 22, 2009, and
granted FDA important new authority to
regulate the manufacture, marketing,
and distribution of tobacco products.
The Tobacco Control Act also amended
section 4 of the Federal Cigarette
Labeling and Advertising Act (FCLAA)
to direct FDA to issue regulations
requiring each cigarette package and
advertisement to bear a new textual
warning label statement accompanied
by color graphics depicting the negative
health consequences of smoking
(section 201 of the Tobacco Control
Act). In enacting this legislation,
Congress also provided that FDA may
adjust the required warnings if FDA
found that such a change would
promote greater public understanding of
the risks associated with the use of
tobacco products (section 202 of the
Tobacco Control Act). The Tobacco
Control Act also modified the
requirements of the FCLAA regarding
the submission of cigarette plans for the
random and equal display and
distribution of required warnings on
cigarette packaging and quarterly
rotation of required warnings in
cigarette advertising. It also requires that
such cigarette plans be submitted to
FDA for review and approval, rather
than to the Federal Trade Commission.
FDA issued a proposed rule entitled
‘‘Tobacco Products; Required Warnings
for Cigarette Packages and
Advertisements’’ on August 16, 2019 (84
FR 42754). The proposed rule, once
finalized, would specify the color
graphics that must accompany the new
textual warning statements and
establish marketing requirements for
cigarette packages and advertisements.
The marketing requirements would
require, among other things, submission
of a cigarette plan that provides for the
random and equal display and
distribution of the required warnings on
cigarette packaging and quarterly
rotation of the required warnings in
cigarette advertising, as described under
section 4 of FCLAA. This draft guidance
provides recommendations related to
preparing and submitting those cigarette
plans.
II. Significance of Draft Guidance
FDA is issuing this draft guidance
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
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The draft guidance, when finalized, will
represent the current thinking of FDA
regarding the submission of cigarette
plans for cigarette packages and
advertisements. 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. Paperwork Reduction Act of 1995
This draft guidance refers to proposed
collections of information described in
FDA’s August 16, 2019, proposed rule
on ‘‘Tobacco Products; Required
Warnings for Cigarette Packages and
Advertisements’’, which this draft
guidance is intended to interpret. The
proposed collections of information in
the proposed rule are subject to review
by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (PRA) (44 U.S.C.
3501–3521). As required by the PRA,
FDA has published an analysis of the
information collection provisions of the
proposed rule (84 FR 42754 at 42787)
and has submitted them for OMB
approval.
IV. Electronic Access
Persons with access to the internet
may obtain an electronic version of the
draft guidance at either https://
www.regulations.gov or https://
www.fda.gov/TobaccoProducts/
GuidanceComplianceRegulatory
Information/default.htm.
Dated: December 20, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–27991 Filed 12–27–19; 8:45 am]
BILLING CODE 4164–01–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.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
SUMMARY:
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Federal Register / Vol. 84, No. 249 / Monday, December 30, 2019 / Notices
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 medical
device premarket notification (510(k)).
DATES: Submit either electronic or
written comments on the collection of
information by February 28, 2020.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before February 28,
2020. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of February 28, 2020.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
Electronic Submissions
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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): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
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• For written/paper comments
submitted to the Dockets Management
Staff, 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, those filed in a timely
manner (see ADDRESSES), will be placed
in the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff 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 Dockets Management
Staff. 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.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
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 Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
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71959
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
Under the
PRA (44 U.S.C. 3501–3521), 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:
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 (FD&C Act) (21
U.S.C. 360(k)) and the implementing
regulation under part 807 (21 CFR part
807, subpart E) require a person who
intends to market a medical device to
submit a 510(k) 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
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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
device exemption (HDE), request for an
evaluation of automatic class III
designation (De Novo request), or be
reclassified into class I or class II before
being marketed (see OMB control
numbers 0910–0231, 0910–0332, 0910–
0844, and 0910–0138). FDA makes the
final decision of whether a device is
substantially equivalent or not
substantially equivalent.
Section 807.81 states when a 510(k) is
required. A 510(k) 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; or (3) introducing or
reintroducing a device that is
significantly changed or modified in
design, components, method of
manufacturer, or the intended use that
could affect the safety and effectiveness
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).
Section 745A(b) of the FD&C Act,
amended by section 207 of the FDA
Reauthorization Act of 2017 (FDARA)
(Pub. L. 115–52), requires that
submissions for devices under section
510(k), among other submission types,
be submitted in electronic format
specified by FDA. In addition, in the
Medical Device User Fee Amendments
of 2017 (MDUFA IV) Commitment
Letter from the Secretary of Health and
Human Services to Congress,1 FDA
committed to developing ‘‘electronic
submission templates that will serve as
guided submission preparation tools for
industry to improve submission
consistency and enhance efficiency in
the review process.’’ The Electronic
Submission Template and Resource
(eSTAR) is such an electronic
submission template for 510(k)
submissions to facilitate the preparation
of submissions in electronic format.
FDA estimates the burden of this
collection of information as follows:
of the device. Section 807.87 lists the
information required in each 510(k).
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, De
Novo requests, HDEs, etc.
Section 204 of the Food and Drug
Administration Modernization Act of
1997 (FDAMA) (Pub. L. 105–115)
amended section 514 of the FD&C Act
(21 U.S.C. 360d). Amended section 514
of the FD&C Act allows FDA to
recognize consensus standards
developed by international and national
organizations for use in satisfying
portions of device premarket review
submissions including 510(k) or other
requirements. FDA has published and
updated regularly the list of recognized
standards since enactment of FDAMA
and has allowed 510(k) submitters to
certify conformance to recognized
standards to meet the requirements of
§ 807.87.
Under § 807.90(a)(3), inquiries
regarding a 510(k) submission should be
in writing and sent to one of the
addresses in § 807.90(a).
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity and 21 CFR part/
section
510(k) submission (807
subpart E).
Summary cover sheet
(807.87).
Status request
(807.90(a)(3)).
510(k) summary (807.92) ...
510(k) statement (807.93) ..
510(k) submission (807
subpart E)—via eSTAR.
eSTAR setup—(one-time
burden).
Total .............................
1 There
Form number
Number of
responses per
respondent
Number of
respondents
Total annual
responses
Average burden per
response 2
Total hours 2
FDA 3881
3,800
1
3,800
79.25 ..................................
301,150
FDA 3514
1,906
1
1,906
0.5 ......................................
953
........................
1
1
1
0.25 ....................................
1
........................
........................
FDA 4062
2,725
215
100
1
1
1
2,725
215
100
4 .........................................
10 .......................................
40 .......................................
10,900
2,150
4,000
........................
80
1
80
0.08 (5 minutes) .................
6
........................
........................
........................
........................
.............................................
319,160
are no capital costs or operating and maintenance costs associated with this collection of information.
have been rounded.
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2 Numbers
Upon review of this information
collection, we have made the following
changes:
• We have updated the burden
estimate consistent with new provisions
in § 807.87(j) regarding ‘‘Human Subject
Protection; Acceptance of Data from
Clinical Investigations for Medical
Devices’’ (83 FR 7366; February 21,
2018) (approved under OMB control
number 0910–0741). Section 807.87 was
amended to address requirements for
510(k) submissions supported by
clinical data. For clinical investigations
conducted in the United States,
submitters are required to submit a
1 See 163 CONG. REC. S4729–S4736 (daily ed.
August 2, 2017) (Food and Drug Administration
User Fee Reauthorization), also available at https://
www.fda.gov/media/102699/download.
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statement as described in § 807.87(j)(1).
For clinical investigations conducted
outside the United States, submitters are
required to submit the information as
described in § 807.87(j)(2). Consistent
with our estimate in OMB control
number 0910–0741, this revision
increases our burden estimate for a
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Federal Register / Vol. 84, No. 249 / Monday, December 30, 2019 / Notices
510(k) submission by 15 minutes per
submission.
• We corrected the burden table to
include a line for the ‘‘510(k) Summary’’
under § 807.92. This section was
inadvertently removed from the
previous version of the information
collection request (ICR).
• We are making available Form FDA
3881 ‘‘Indications for Use’’ that
respondents include as part of a medical
device 510(k). The information provided
via the form is already approved under
this ICR. The form does not ask for new
information and does not bear on the
underlying program or on the hour or
cost burden associated with the
information collection, rather it
provides a fillable, 508-compliant
format for respondents to use for the
‘‘Indications for Use’’ portion of their
510(k) submission.
• We updated the guidance ‘‘Refuse
to Accept Policy for 510(k)s’’ to
explicitly recommend providing an
Acceptance Checklist in the 510(k)
submission. The guidance previously
provided the checklist as an example of
a tool that FDA staff use when
reviewing a 510(k) submission. While it
was not explicitly recommended,
respondents had used the example and
had included it with their 510(k)
submission. We believe the checklist
can be a helpful tool for both reviewers
and 510(k) submitters and have
therefore updated the guidance to
explicitly recommend inclusion of the
checklist in the 510(k) submission.
Because most submitters included the
checklist on their own initiative and
because it may simplify preparation of
the 510(k), we do not believe adding the
checklist to this ICR affects the overall
burden for a 510(k) submission.
Additionally, we have updated the
checklist to include combination
products, as appropriate. The estimated
number of responses as updated with
current data in this submission, reflects
the inclusion of combination products.
• We revised and reformatted Form
FDA 3514, ‘‘CDRH Premarket Review
Submission Cover Sheet,’’ to improve
usability and to be inclusive of most
medical device product submission
types. Form FDA 3514, a summary
cover sheet form, assists respondents in
categorizing 510(k) information for
submission to FDA. This form also
assists respondents in categorizing
information for other FDA medical
device programs. The total burden for
Form FDA 3514 and for the 510(k)
program is estimated in this ICR. The
burden for the other medical device
programs listed on Form FDA 3514 are
approved under the corresponding
product submission ICRs as follows:
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premarket approval applications (OMB
control number 0910–0231),
investigational device exemptions (OMB
control number 0910–0078),
humanitarian device exemptions
(control number 0910–0332), CLIA
waivers (OMB control number 0910–
0598), Q-Submissions (OMB control
number 0910–0756), De Novo requests
(OMB control number 0910–0844),
Emergency Use Authorizations (OMB
control number 0910–0595), 513(g)
requests (OMB control number 0910–
0705); and Appeals (OMB control
number 0910–0738).
• Certain revisions to Form FDA
3514, as previously described, eliminate
the need for Form FDA 3654,
‘‘Standards Data Report for 510(k)s.’’
Additionally, the ability for Form FDA
3514 to be expandable for the number
of standards cited will increase
awareness of actual standards in a
submission and how they were used on
a single form (compared to including
several Form FDA 3654 documents). In
the rare occasions where the sponsor
elects to not use Form FDA 3514 for
standards, this would not have any
effect on the review outcome, with
regard to standards, as the form serves
as a means to identify what standards
are cited, how they are used, and where
in the submission they are located.
• We have removed Form FDA 3541,
‘‘Status Request.’’ In practice, Form FDA
3541 is rarely used. We have adjusted
the burden estimate to reflect this
removal. Under § 807.90(a)(3), all
inquiries regarding a premarket
notification submission should be in
writing and sent to one of the addresses
listed in § 807.90(a).
• We have added burden estimates
for the eSTAR and eSTAR setup (onetime burden). Under section 745A(b) of
FD&C Act, amended by section 207 of
FDARA (Pub. L. 115–52), and consistent
with the MDUFA IV Commitment
Letter, FDA has developed the eSTAR
(eSTAR, Form FDA 4062) for 510(k)
submissions to facilitate the preparation
of submissions in electronic format. We
expect to receive approximately 100
510(k) submissions via eSTAR per year.
We estimate that eSTAR submissions
will take approximately 40 hours per
submission. Additionally, we’ve
estimated a one-time setup burden of 5
minutes for approximately 80 new
eSTAR users annually.
The adjustments and revisions
previously mentioned have resulted in a
39,473-hour decrease in the total hour
burden estimate since the last OMB
approval.
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71961
Dated: December 13, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–28098 Filed 12–27–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–D–5743]
Importation of Certain Food and Drug
Administration-Approved Human
Prescription Drugs, Including
Biological Products, Under Section
801(d)(1)(B) of the Federal Food, Drug,
and Cosmetic Act; Draft Guidance for
Industry; Availability; Correction
AGENCY:
Food and Drug Administration,
HHS.
Notice of availability;
correction.
ACTION:
This document corrects the
Notice of Availability from the Food and
Drug Administration (FDA, Agency, or
we) announcing the availability of a
draft guidance for industry entitled
‘‘Importation of Certain FDA-Approved
Human Prescription Drugs, Including
Biological Products, under Section
801(d)(1)(B) of the Federal Food, Drug,
and Cosmetic Act,’’ which published in
the Federal Register on Monday,
December 23, 2019. This draft guidance
describes procedures to obtain a
National Drug Code (NDC) for an FDAapproved prescription drug that is
imported into the United States in
compliance with the Federal Food,
Drug, and Cosmetic Act (FD&C Act),
which would provide an additional
avenue through which drugs could be
sold at a lower cost in the U.S. market.
This draft guidance is intended to
address certain challenges in the private
market faced by manufacturers seeking
to sell their drugs at lower costs. The
Notice was published with two
omissions. This document corrects
those omissions by republishing the
Notice in its entirety to include the
omitted language.
DATES: Submit either electronic or
written comments on the draft guidance
by February 21, 2020, to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
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Agencies
[Federal Register Volume 84, Number 249 (Monday, December 30, 2019)]
[Notices]
[Pages 71958-71961]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-28098]
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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.
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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (PRA), Federal Agencies are required to publish notice in the
[[Page 71959]]
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 medical device premarket notification (510(k)).
DATES: Submit either electronic or written comments on the collection
of information by February 28, 2020.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before February 28, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of February 28, 2020. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.
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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, 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, those filed in a timely manner (see ADDRESSES), will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 Dockets Management Staff. 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.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
[email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), 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 (FD&C
Act) (21 U.S.C. 360(k)) and the implementing regulation under part 807
(21 CFR part 807, subpart E) require a person who intends to market a
medical device to submit a 510(k) 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
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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 device exemption (HDE), request for
an evaluation of automatic class III designation (De Novo request), or
be reclassified into class I or class II before being marketed (see OMB
control numbers 0910-0231, 0910-0332, 0910-0844, and 0910-0138). FDA
makes the final decision of whether a device is substantially
equivalent or not substantially equivalent.
Section 807.81 states when a 510(k) is required. A 510(k) 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; or (3) introducing or reintroducing a device that 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. Section 807.87 lists the information
required in each 510(k).
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, De Novo requests, HDEs, etc.
Section 204 of the Food and Drug Administration Modernization Act
of 1997 (FDAMA) (Pub. L. 105-115) amended section 514 of the FD&C Act
(21 U.S.C. 360d). Amended section 514 of the FD&C Act allows FDA to
recognize consensus standards developed by international and national
organizations for use in satisfying portions of device premarket review
submissions including 510(k) or other requirements. FDA has published
and updated regularly the list of recognized standards since enactment
of FDAMA and has allowed 510(k) submitters to certify conformance to
recognized standards to meet the requirements of Sec. 807.87.
Under Sec. 807.90(a)(3), inquiries regarding a 510(k) submission
should be in writing and sent to one of the addresses in Sec.
807.90(a).
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).
Section 745A(b) of the FD&C Act, amended by section 207 of the FDA
Reauthorization Act of 2017 (FDARA) (Pub. L. 115-52), requires that
submissions for devices under section 510(k), among other submission
types, be submitted in electronic format specified by FDA. In addition,
in the Medical Device User Fee Amendments of 2017 (MDUFA IV) Commitment
Letter from the Secretary of Health and Human Services to Congress,\1\
FDA committed to developing ``electronic submission templates that will
serve as guided submission preparation tools for industry to improve
submission consistency and enhance efficiency in the review process.''
The Electronic Submission Template and Resource (eSTAR) is such an
electronic submission template for 510(k) submissions to facilitate the
preparation of submissions in electronic format.
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\1\ See 163 CONG. REC. S4729-S4736 (daily ed. August 2, 2017)
(Food and Drug Administration User Fee Reauthorization), also
available at https://www.fda.gov/media/102699/download.
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FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Activity and 21 CFR part/section Form number Number of responses per Total annual Average burden per response Total hours
respondents respondent responses \2\ \2\
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510(k) submission (807 subpart E)......... FDA 3881 3,800 1 3,800 79.25....................... 301,150
Summary cover sheet (807.87).............. FDA 3514 1,906 1 1,906 0.5......................... 953
Status request (807.90(a)(3))............. .............. 1 1 1 0.25........................ 1
510(k) summary (807.92)................... .............. 2,725 1 2,725 4........................... 10,900
510(k) statement (807.93)................. .............. 215 1 215 10.......................... 2,150
510(k) submission (807 subpart E)--via FDA 4062 100 1 100 40.......................... 4,000
eSTAR.
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eSTAR setup--(one-time burden)............ .............. 80 1 80 0.08 (5 minutes)............ 6
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Total................................. .............. .............. .............. .............. ............................ 319,160
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Numbers have been rounded.
Upon review of this information collection, we have made the
following changes:
We have updated the burden estimate consistent with new
provisions in Sec. 807.87(j) regarding ``Human Subject Protection;
Acceptance of Data from Clinical Investigations for Medical Devices''
(83 FR 7366; February 21, 2018) (approved under OMB control number
0910-0741). Section 807.87 was amended to address requirements for
510(k) submissions supported by clinical data. For clinical
investigations conducted in the United States, submitters are required
to submit a statement as described in Sec. 807.87(j)(1). For clinical
investigations conducted outside the United States, submitters are
required to submit the information as described in Sec. 807.87(j)(2).
Consistent with our estimate in OMB control number 0910-0741, this
revision increases our burden estimate for a
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510(k) submission by 15 minutes per submission.
We corrected the burden table to include a line for the
``510(k) Summary'' under Sec. 807.92. This section was inadvertently
removed from the previous version of the information collection request
(ICR).
We are making available Form FDA 3881 ``Indications for
Use'' that respondents include as part of a medical device 510(k). The
information provided via the form is already approved under this ICR.
The form does not ask for new information and does not bear on the
underlying program or on the hour or cost burden associated with the
information collection, rather it provides a fillable, 508-compliant
format for respondents to use for the ``Indications for Use'' portion
of their 510(k) submission.
We updated the guidance ``Refuse to Accept Policy for
510(k)s'' to explicitly recommend providing an Acceptance Checklist in
the 510(k) submission. The guidance previously provided the checklist
as an example of a tool that FDA staff use when reviewing a 510(k)
submission. While it was not explicitly recommended, respondents had
used the example and had included it with their 510(k) submission. We
believe the checklist can be a helpful tool for both reviewers and
510(k) submitters and have therefore updated the guidance to explicitly
recommend inclusion of the checklist in the 510(k) submission. Because
most submitters included the checklist on their own initiative and
because it may simplify preparation of the 510(k), we do not believe
adding the checklist to this ICR affects the overall burden for a
510(k) submission. Additionally, we have updated the checklist to
include combination products, as appropriate. The estimated number of
responses as updated with current data in this submission, reflects the
inclusion of combination products.
We revised and reformatted Form FDA 3514, ``CDRH Premarket
Review Submission Cover Sheet,'' to improve usability and to be
inclusive of most medical device product submission types. Form FDA
3514, a summary cover sheet form, assists respondents in categorizing
510(k) information for submission to FDA. This form also assists
respondents in categorizing information for other FDA medical device
programs. The total burden for Form FDA 3514 and for the 510(k) program
is estimated in this ICR. The burden for the other medical device
programs listed on Form FDA 3514 are approved under the corresponding
product submission ICRs as follows: premarket approval applications
(OMB control number 0910-0231), investigational device exemptions (OMB
control number 0910-0078), humanitarian device exemptions (control
number 0910-0332), CLIA waivers (OMB control number 0910-0598), Q-
Submissions (OMB control number 0910-0756), De Novo requests (OMB
control number 0910-0844), Emergency Use Authorizations (OMB control
number 0910-0595), 513(g) requests (OMB control number 0910-0705); and
Appeals (OMB control number 0910-0738).
Certain revisions to Form FDA 3514, as previously
described, eliminate the need for Form FDA 3654, ``Standards Data
Report for 510(k)s.'' Additionally, the ability for Form FDA 3514 to be
expandable for the number of standards cited will increase awareness of
actual standards in a submission and how they were used on a single
form (compared to including several Form FDA 3654 documents). In the
rare occasions where the sponsor elects to not use Form FDA 3514 for
standards, this would not have any effect on the review outcome, with
regard to standards, as the form serves as a means to identify what
standards are cited, how they are used, and where in the submission
they are located.
We have removed Form FDA 3541, ``Status Request.'' In
practice, Form FDA 3541 is rarely used. We have adjusted the burden
estimate to reflect this removal. Under Sec. 807.90(a)(3), all
inquiries regarding a premarket notification submission should be in
writing and sent to one of the addresses listed in Sec. 807.90(a).
We have added burden estimates for the eSTAR and eSTAR
setup (one-time burden). Under section 745A(b) of FD&C Act, amended by
section 207 of FDARA (Pub. L. 115-52), and consistent with the MDUFA IV
Commitment Letter, FDA has developed the eSTAR (eSTAR, Form FDA 4062)
for 510(k) submissions to facilitate the preparation of submissions in
electronic format. We expect to receive approximately 100 510(k)
submissions via eSTAR per year. We estimate that eSTAR submissions will
take approximately 40 hours per submission. Additionally, we've
estimated a one-time setup burden of 5 minutes for approximately 80 new
eSTAR users annually.
The adjustments and revisions previously mentioned have resulted in
a 39,473-hour decrease in the total hour burden estimate since the last
OMB approval.
Dated: December 13, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-28098 Filed 12-27-19; 8:45 am]
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