Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic Submission of Medical Device Registration and Listing, 62583-62585 [2018-26303]
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Federal Register / Vol. 83, No. 233 / Tuesday, December 4, 2018 / Notices
the development of drugs for this
indication. This draft guidance does not
address the clinical development of
drugs for the treatment of cirrhosis
caused by NASH.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on ‘‘Non-Cirrhotic Nonalcoholic
Steatohepatitis with Liver Fibrosis:
Developing Drugs for Treatment.’’ 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. This guidance is not subject
to Executive Order 12866.
II. 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This draft guidance refers to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 312
addressing investigational new drug
applications and 21 CFR part 314
addressing new drug applications have
been approved under OMB control
numbers 0910–0014 and 0910–0001,
respectively. The collections of
information in 21 CFR parts 50 and 56
(Protection of Human Subjects:
Informed Consent; Institutional Review
Boards) have been approved under OMB
control number 0910–0755.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/Drugs/
GuidanceComplianceRegulatory
Information/Guidances/default.htm or
https://www.regulations.gov.
Dated: November 29, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–26333 Filed 12–3–18; 8:45 am]
BILLING CODE 4164–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–3815]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Electronic
Submission of Medical Device
Registration and Listing
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) 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
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 electronic
submission of medical device
registration and listing.
DATES: Submit either electronic or
written comments on the collection of
information by February 4, 2019.
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 4,
2019. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of February 4, 2019.
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.
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
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62583
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–
2015–N–3815 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Electronic Submission of Medical
Device Registration and Listing.’’
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
E:\FR\FM\04DEN1.SGM
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Federal Register / Vol. 83, No. 233 / Tuesday, December 4, 2018 / Notices
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.
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.
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.
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
OMB Control Number 0910–0625—
Extension
Under section 510 of the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 360) and part 807,
subparts A through D (21 CFR part 807,
subparts A through D), medical device
establishment owners and operators are
required to electronically submit
establishment registration and device
listing information.
Complete and accurate registration
and listing information is necessary to
accomplish a number of statutory and
regulatory objectives, such as: (1)
SUPPLEMENTARY INFORMATION:
Electronic Submission of Medical
Device Registration and Listing—21
CFR Part 807, Subparts A Through D
Identification of establishments
producing marketed medical devices,
(2) identification of establishments
producing a specific device when that
device is in short supply or is needed
for national emergency, (3) facilitation
of recalls for devices marketed by
owners and operators of device
establishments, (4) identification and
cataloguing of marketed devices, (5)
administering postmarketing
surveillance programs for devices, (6)
identification of devices marketed in
violation of the law, (7) identification
and control of devices imported into the
country from foreign establishments, (8)
and scheduling and planning
inspections of registered establishments
under section 704 of the FD&C Act (21
U.S.C. 374).
Respondents to this information
collection are owners or operators of
establishments that engage in the
manufacturing, preparation,
propagation, compounding, or
processing of a device or devices, who
must register their establishments and
submit listing information for each of
their devices in commercial
distribution. Notwithstanding certain
exceptions, foreign device
establishments that manufacture,
prepare, propagate, compound, or
process a device that is imported or
offered for import into the United States
must also comply with the registration
and listing requirements. The number of
respondents is based on data from the
FDA Unified Registration and Listing
System.
Burden estimates are based on recent
experience with the existing medical
device registration and listing program,
electronic system operating experience,
and previous data estimates.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR section
FDA form No.
807.20(a)(5) 2—Submittal of Manufacturer Information by Initial Importers ....
807.20(a)(5) 3—Submittal of Manufacturer Information by Initial Importers ....
807.21(a) 2—Creation of Electronic System Account .........................................
807.21(b) 3—Annual Request for Waiver
from Electronic Registration and Listing .........................................................
807.21(b) 2—Initial Request for Waiver
from Electronic Registration and Listing for ...................................................
807.22(a) 2—Initial Registration and Listing .........................................................
807.22(b)(1) 3—Annual Registration ........
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Annual
frequency
per response
Number of
respondents
Total annual
responses
Hours per
response
Total hours
3673
5,736
1
5,736
1.75
10,038
3673
5,736
1
5,736
0.1
574
3673
2,937
1
2,937
0.5
1,469
........................
1
1
1
1
1
........................
1
1
1
1
1
3673
3673
3,467
23,403
1
1
3,467
23,403
1
0.5
3,467
11,702
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Federal Register / Vol. 83, No. 233 / Tuesday, December 4, 2018 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
21 CFR section
FDA form No.
807.22(b)(2) 3—Other Updates of Registration .................................................
807.22(b)(3) 3—Annual Update of Listing
Information ............................................
807.26(e) 3—Labeling and Advertisement
Submitted at FDA Request ..................
807.34(a) 2—Initial Registration and Listing when Electronic Filing Waiver
Granted .................................................
807.34(a) 3—Annual Registration and
Listing when Electronic Filing Waiver
Granted .................................................
807.40(b)(2) 3—Annual Update of US
Agent Information .................................
807.40(b)(3) 3—US Agent Responses to
FDA Requests for Information .............
807.41(a) 3—Identification of Initial Importers by Foreign Establishments ......
807.41(b) 3—Identification of Other Parties that Facilitate Import by Foreign
Establishments .....................................
Annual
frequency
per response
Number of
respondents
Total annual
responses
Hours per
response
Total hours
3673
2,687
1
2,687
0.5
1,344
3673
22,607
1
22,607
0.5
11,304
........................
71
1
71
1
71
........................
1
1
1
1
1
........................
1
1
1
1
1
3673
1,615
1
1,615
0.5
808
3673
1,535
1
1,535
0.25
384
3673
12,983
1
12,983
0.5
6,492
3673
12,983
1
12,983
0.5
6,492
Total One Time Burden ....................
........................
........................
........................
........................
........................
14,975
Total Recurring Burden .............
........................
........................
........................
........................
........................
39,173
1 Totals
are rounded to the nearest whole number.
Burden—Firm only provides initially.
Burden—Firm is required to review annually.
2 One-Time
3 Recurring
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
Number of
respondents
21 CFR section
Annual
frequency per
recordkeeper
Total annual
records
Hours per
record
Total hours
807.25(d) 2—List of Officers, Directors, and Partners .........
22,338
1
22,338
.25
(15 minutes)
5,585
807.26 2—Labeling and Advertisements Available for Review ..................................................................................
17,032
4
68,128
.5
(30 minutes)
34,064
Total ..............................................................................
........................
........................
........................
........................
39,649
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
burden—Firm is required to keep records.
2 Recurring
The following adjustments and
program changes resulted in a 5,672hour decrease to the overall total hour
burden estimate for this information
collection request.
• We adjusted the number of
respondents based on updated
registration and listing data.
• In the reporting burden table, we
corrected the table footnotes to
accurately indicate whether the
information collection (IC) is a one-time
or reoccurring burden.
• We also adjusted some of the IC
descriptions in the table for increased
clarity.
• We updated our estimate of Hours
per Response for ‘‘807.22(a) Initial
Registration and Listing’’ (+ 0.5 hours),
‘‘807.22(b)(1) Annual Registration’’
(¥ 0.25 hours), and ‘‘807.22(b)(3)
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Annual Update of Listing Information’’
(¥ 0.25 hours). Based on our review of
the program, we believe these changes
to the burden estimate will more
accurately reflect the current
preparation time for these ICs.
Dated: November 28, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–26303 Filed 12–3–18; 8:45 am]
BILLING CODE 4164–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–D–0609]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Drug Supply Chain
Security Act Implementation:
Identification of Suspect Product and
Notification
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
SUMMARY:
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]]>Agencies
[Federal Register Volume 83, Number 233 (Tuesday, December 4, 2018)]
[Notices]
[Pages 62583-62585]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-26303]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-3815]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Electronic Submission of Medical Device Registration
and Listing
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) 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 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
electronic submission of medical device registration and listing.
DATES: Submit either electronic or written comments on the collection
of information by February 4, 2019.
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 4, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of February 4, 2019. 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-2015-N-3815 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Electronic Submission of Medical
Device Registration and Listing.'' 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
[[Page 62584]]
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/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. 3501-3520), 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.
Electronic Submission of Medical Device Registration and Listing--21
CFR Part 807, Subparts A Through D
OMB Control Number 0910-0625--Extension
Under section 510 of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 360) and part 807, subparts A through D (21 CFR part
807, subparts A through D), medical device establishment owners and
operators are required to electronically submit establishment
registration and device listing information.
Complete and accurate registration and listing information is
necessary to accomplish a number of statutory and regulatory
objectives, such as: (1) Identification of establishments producing
marketed medical devices, (2) identification of establishments
producing a specific device when that device is in short supply or is
needed for national emergency, (3) facilitation of recalls for devices
marketed by owners and operators of device establishments, (4)
identification and cataloguing of marketed devices, (5) administering
postmarketing surveillance programs for devices, (6) identification of
devices marketed in violation of the law, (7) identification and
control of devices imported into the country from foreign
establishments, (8) and scheduling and planning inspections of
registered establishments under section 704 of the FD&C Act (21 U.S.C.
374).
Respondents to this information collection are owners or operators
of establishments that engage in the manufacturing, preparation,
propagation, compounding, or processing of a device or devices, who
must register their establishments and submit listing information for
each of their devices in commercial distribution. Notwithstanding
certain exceptions, foreign device establishments that manufacture,
prepare, propagate, compound, or process a device that is imported or
offered for import into the United States must also comply with the
registration and listing requirements. The number of respondents is
based on data from the FDA Unified Registration and Listing System.
Burden estimates are based on recent experience with the existing
medical device registration and listing program, electronic system
operating experience, and previous data estimates.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual
21 CFR section FDA form No. Number of frequency per Total annual Hours per Total hours
respondents response responses response
--------------------------------------------------------------------------------------------------------------------------------------------------------
807.20(a)(5) \2\--Submittal of Manufacturer Information 3673 5,736 1 5,736 1.75 10,038
by Initial Importers...................................
807.20(a)(5) \3\--Submittal of Manufacturer Information 3673 5,736 1 5,736 0.1 574
by Initial Importers...................................
807.21(a) \2\--Creation of Electronic System Account.... 3673 2,937 1 2,937 0.5 1,469
807.21(b) \3\--Annual Request for Waiver from Electronic .............. 1 1 1 1 1
Registration and Listing...............................
807.21(b) \2\--Initial Request for Waiver from .............. 1 1 1 1 1
Electronic Registration and Listing for................
807.22(a) \2\--Initial Registration and Listing......... 3673 3,467 1 3,467 1 3,467
807.22(b)(1) \3\--Annual Registration................... 3673 23,403 1 23,403 0.5 11,702
[[Page 62585]]
807.22(b)(2) \3\--Other Updates of Registration......... 3673 2,687 1 2,687 0.5 1,344
807.22(b)(3) \3\--Annual Update of Listing Information.. 3673 22,607 1 22,607 0.5 11,304
807.26(e) \3\--Labeling and Advertisement Submitted at .............. 71 1 71 1 71
FDA Request............................................
807.34(a) \2\--Initial Registration and Listing when .............. 1 1 1 1 1
Electronic Filing Waiver Granted.......................
807.34(a) \3\--Annual Registration and Listing when .............. 1 1 1 1 1
Electronic Filing Waiver Granted.......................
807.40(b)(2) \3\--Annual Update of US Agent Information. 3673 1,615 1 1,615 0.5 808
807.40(b)(3) \3\--US Agent Responses to FDA Requests for 3673 1,535 1 1,535 0.25 384
Information............................................
807.41(a) \3\--Identification of Initial Importers by 3673 12,983 1 12,983 0.5 6,492
Foreign Establishments.................................
807.41(b) \3\--Identification of Other Parties that 3673 12,983 1 12,983 0.5 6,492
Facilitate Import by Foreign Establishments............
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total One Time Burden............................... .............. .............. .............. .............. .............. 14,975
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Total Recurring Burden.......................... .............. .............. .............. .............. .............. 39,173
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\1\ Totals are rounded to the nearest whole number.
\2\ One-Time Burden--Firm only provides initially.
\3\ Recurring Burden--Firm is required to review annually.
Table 2--Estimated Annual Recordkeeping Burden\1\
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Annual
21 CFR section Number of frequency per Total annual Hours per Total hours
respondents recordkeeper records record
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807.25(d) \2\--List of Officers, 22,338 1 22,338 .25 5,585
Directors, and Partners........ (15 minutes)
807.26 \2\--Labeling and 17,032 4 68,128 .5 34,064
Advertisements Available for (30 minutes)
Review.........................
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Total....................... .............. .............. .............. .............. 39,649
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Recurring burden--Firm is required to keep records.
The following adjustments and program changes resulted in a 5,672-
hour decrease to the overall total hour burden estimate for this
information collection request.
We adjusted the number of respondents based on updated
registration and listing data.
In the reporting burden table, we corrected the table
footnotes to accurately indicate whether the information collection
(IC) is a one-time or reoccurring burden.
We also adjusted some of the IC descriptions in the table
for increased clarity.
We updated our estimate of Hours per Response for
``807.22(a) Initial Registration and Listing'' (+ 0.5 hours),
``807.22(b)(1) Annual Registration'' (- 0.25 hours), and ``807.22(b)(3)
Annual Update of Listing Information'' (- 0.25 hours). Based on our
review of the program, we believe these changes to the burden estimate
will more accurately reflect the current preparation time for these
ICs.
Dated: November 28, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-26303 Filed 12-3-18; 8:45 am]
BILLING CODE 4164-01-P
