Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Recall Authority, 7740-7742 [2018-03605]
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<![CDATA[
7740
Federal Register / Vol. 83, No. 36 / Thursday, February 22, 2018 / Notices
TABLE 1—Continued
Application No.
Drug
Applicant
ANDA 087766 ....
Thioridazine HCl Oral Concentrate, 30 mg/mL .......................
ANDA 087858 ....
Isoetharine Mesylate Metered Dose Inhaler, 0.34 mg/inhalation.
Phentermine HCl Capsules USP, 30 mg .................................
Hydroxyzine HCl Tablets USP, 10 mg ....................................
Hydroxyzine HCl Tablets USP, 25 mg ....................................
Hydroxyzine HCl Tablets USP, 50 mg ....................................
Acetaminophen and Codeine Phosphate Tablets USP, 300
mg/15 mg.
Acetaminophen and Codeine Phosphate Tablets USP, 300
mg/30 mg.
Diphenhydramine HCl Capsules, 50 mg .................................
Furosemide Tablets USP, 20 mg, 40 mg, and 80 mg ............
Dexilant Solutab (dexlansoprazole) Delayed-Release Orally
Disintegrating Tablets, 30 mg.
Alpharma US Pharms., Subsidiary of Teva Pharmaceuticals
USA, Inc., 425 Privet Rd., Horsham, PA 19044.
Do.
ANDA
ANDA
ANDA
ANDA
ANDA
088430
089381
089382
089383
089481
....
....
....
....
....
ANDA 089482 ....
ANDA 089489 ....
ANDA 091258 ....
NDA 208056 ......
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of March 26,
2018. Introduction or delivery for
introduction into interstate commerce of
products without approved new drug
applications violates section 301(a) and
(d) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331(a) and (d)).
Drug products that are listed in the table
that are in inventory on March 26, 2018
may continue to be dispensed until the
inventories have been depleted or the
drug products have reached their
expiration dates or otherwise become
violative, whichever occurs first.
Dated: February 15, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–03607 Filed 2–21–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–0405]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Medical Device
Recall Authority
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
daltland on DSKBBV9HB2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
20:10 Feb 21, 2018
Jkt 244001
Upsher-Smith Laboratories, LLC.
Sun Pharmaceutical Industries, Inc.
Do.
Do.
American Therapeutics, Inc., 89 Carlough Rd., Bohemia, NY
11716.
Do.
Sun Pharmaceutical Industries, Inc.
Do.
Takeda Pharmaceuticals U.S.A., Inc., One Takeda Pkwy.,
Deerfield, IL 60015.
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 related to Medical Device
Recall Authority.
DATES: Submit either electronic or
written comments on the collection of
information by April 23, 2018.
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 April 23,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of April 23, 2018. 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
PO 00000
Frm 00087
Fmt 4703
Sfmt 4703
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–
2018–N–0405 for ‘‘Medical Device
Recall Authority.’’ 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
E:\FR\FM\22FEN1.SGM
22FEN1
7741
Federal Register / Vol. 83, No. 36 / Thursday, February 22, 2018 / Notices
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.
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. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
SUPPLEMENTARY INFORMATION:
Medical Device Recall Authority—21
CFR Part 810
OMB Control Number 0910–0432—
Extension
This collection of information
implements section 518(e) of the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 360h(e)) and part
810 (21 CFR part 810), mandatory
medical device recall authority
provisions. Section 518(e) of the FD&C
Act provides FDA with the authority to
issue an order requiring an appropriate
person, including manufacturers,
importers, distributors, and retailers of a
device, if FDA finds that there is
reasonable probability that the device
intended for human use would cause
serious adverse health consequences or
death, to: (1) Immediately cease
distribution of such device and (2)
immediately notify health professionals
and device-user facilities of the order
and to instruct such professionals and
facilities to cease use of such device.
FDA will then provide the person
named in the cease distribution and
notification order with the opportunity
for an informal hearing on whether the
order should be amended to require a
mandatory recall of the device.
If, after providing the opportunity for
an informal hearing, FDA determines
that such an order is necessary, the
Agency may amend the order to require
a mandatory recall.
FDA issued part 810 to implement the
provisions of section 518 of the FD&C
Act. The information collected under
the mandatory recall authority
provisions will be used by FDA to
implement mandatory recalls.
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
Collection activity/21 CFR section
Average
burden per
response
Total annual
responses
Total hours
Collections Specified in the Order—810.10(d) ....................
Request for Regulatory Hearing—810.11(a) .......................
Written Request for Review—810.12(a)-(b) ........................
Mandatory Recall Strategy—810.14 ....................................
Periodic Status Reports—810.16(a)-(b) ..............................
Termination Request—810.17(a) .........................................
2
1
1
2
2
2
1
1
1
1
12
1
2
1
1
2
24
2
8
8
8
16
40
8
16
8
8
32
960
16
Total Hours ...................................................................
........................
........................
........................
........................
1,040
daltland on DSKBBV9HB2PROD with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Documentation of Notifications to Recipients—810.15(b)
1 There
Number of
records per
recordkeeper
Number of
recordkeepers
Collection activity/21 CFR section
2
Average
burden per
recordkeeping
Total annual
records
1
1
are no capital costs or operating and maintenance costs associated with this collection of information.
VerDate Sep<11>2014
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Total hours
8
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Federal Register / Vol. 83, No. 36 / Thursday, February 22, 2018 / Notices
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
disclosures per
respondent
Number of
respondents
Collection activity/21 CFR section
Total annual
disclosures
Average
burden per
disclosure
Total hours
Notification to Recipients—810.15(a)–(c) ........................
Notification to Recipients; Follow-up—810.15(d) ............
Notification of Consignees by Recipients—810.15(e) .....
2
2
10
1
1
1
2
2
10
12
4
1
24
8
10
Total ..........................................................................
..........................
..........................
........................
........................
42
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The burden estimate has not changed
for information collection related to
section 518(e) of the FD&C Act and part
810 since the last OMB approval.
Dated: February 14, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–03605 Filed 2–21–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–2029]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Administrative
Practices and Procedures; Formal
Evidentiary Public Hearing
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 administrative
practices and procedures; formal
evidentiary public hearing.
DATES: Submit either electronic or
written comments on the collection of
information by April 23, 2018.
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 April 23,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
daltland on DSKBBV9HB2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
20:10 Feb 21, 2018
Jkt 244001
Instructions: All submissions received
must include the Docket No. FDA–
2014–N–2029 for ‘‘Administrative
Practices and Procedures; Formal
Evidentiary Public Hearing.’’ Received
comments, those filed in a timely
manner (see ADDRESSES), will be placed
in the docket and, except for those
Electronic Submissions
submitted as ‘‘Confidential
Submit electronic comments in the
Submissions,’’ publicly viewable at
following way:
https://www.regulations.gov or at the
• Federal eRulemaking Portal: https:// Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
www.regulations.gov. Follow the
Friday.
instructions for submitting comments.
Comments submitted electronically,
• Confidential Submissions—To
including attachments, to https://
submit a comment with confidential
www.regulations.gov will be posted to
information that you do not wish to be
the docket unchanged. Because your
made publicly available, submit your
comment will be made public, you are
comments only as a written/paper
solely responsible for ensuring that your submission. You should submit two
comment does not include any
copies total. One copy will include the
confidential information that you or a
information you claim to be confidential
third party may not wish to be posted,
with a heading or cover note that states
such as medical information, your or
‘‘THIS DOCUMENT CONTAINS
anyone else’s Social Security number, or CONFIDENTIAL INFORMATION.’’ The
confidential business information, such Agency will review this copy, including
as a manufacturing process. Please note
the claimed confidential information, in
that if you include your name, contact
its consideration of comments. The
information, or other information that
second copy, which will have the
identifies you in the body of your
claimed confidential information
comments, that information will be
redacted/blacked out, will be available
posted on https://www.regulations.gov.
for public viewing and posted on
https://www.regulations.gov. Submit
• If you want to submit a comment
both copies to the Dockets Management
with confidential information that you
Staff. If you do not wish your name and
do not wish to be made available to the
contact information to be made publicly
public, submit the comment as a
available, you can provide this
written/paper submission and in the
information on the cover sheet and not
manner detailed (see ‘‘Written/Paper
in the body of your comments and you
Submissions’’ and ‘‘Instructions’’).
must identify this information as
Written/Paper Submissions
‘‘confidential.’’ Any information marked
Submit written/paper submissions as
as ‘‘confidential’’ will not be disclosed
follows:
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
• Mail/Hand delivery/Courier (for
more information about FDA’s posting
written/paper submissions): Dockets
Management Staff (HFA–305), Food and of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
Drug Administration, 5630 Fishers
the information at: https://www.gpo.gov/
Lane, Rm. 1061, Rockville, MD 20852.
fdsys/pkg/FR-2015-09-18/pdf/2015• For written/paper comments
23389.pdf.
submitted to the Dockets Management
Docket: For access to the docket to
Staff, FDA will post your comment, as
read background documents or the
well as any attachments, except for
electronic and written/paper comments
information submitted, marked and
received, go to https://
identified, as confidential, if submitted
www.regulations.gov and insert the
as detailed in ‘‘Instructions.’’
at the end of April 23, 2018. 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.
PO 00000
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Sfmt 4703
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]]>Agencies
[Federal Register Volume 83, Number 36 (Thursday, February 22, 2018)]
[Notices]
[Pages 7740-7742]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-03605]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-0405]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Medical Device Recall Authority
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 related to Medical
Device Recall Authority.
DATES: Submit either electronic or written comments on the collection
of information by April 23, 2018.
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 April 23, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of April 23, 2018. 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-2018-N-0405 for ``Medical Device Recall Authority.'' 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
[[Page 7741]]
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/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.
Medical Device Recall Authority--21 CFR Part 810
OMB Control Number 0910-0432--Extension
This collection of information implements section 518(e) of the
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360h(e)) and
part 810 (21 CFR part 810), mandatory medical device recall authority
provisions. Section 518(e) of the FD&C Act provides FDA with the
authority to issue an order requiring an appropriate person, including
manufacturers, importers, distributors, and retailers of a device, if
FDA finds that there is reasonable probability that the device intended
for human use would cause serious adverse health consequences or death,
to: (1) Immediately cease distribution of such device and (2)
immediately notify health professionals and device-user facilities of
the order and to instruct such professionals and facilities to cease
use of such device.
FDA will then provide the person named in the cease distribution
and notification order with the opportunity for an informal hearing on
whether the order should be amended to require a mandatory recall of
the device.
If, after providing the opportunity for an informal hearing, FDA
determines that such an order is necessary, the Agency may amend the
order to require a mandatory recall.
FDA issued part 810 to implement the provisions of section 518 of
the FD&C Act. The information collected under the mandatory recall
authority provisions will be used by FDA to implement mandatory
recalls.
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
Collection activity/21 CFR Number of responses per Total annual burden per Total hours
section respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
Collections Specified in the 2 1 2 8 16
Order--810.10(d)...............
Request for Regulatory Hearing-- 1 1 1 8 8
810.11(a)......................
Written Request for Review-- 1 1 1 8 8
810.12(a)-(b)..................
Mandatory Recall Strategy-- 2 1 2 16 32
810.14.........................
Periodic Status Reports-- 2 12 24 40 960
810.16(a)-(b)..................
Termination Request--810.17(a).. 2 1 2 8 16
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
Total Hours................. .............. .............. .............. .............. 1,040
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Collection activity/21 CFR Number of records per Total annual per Total hours
section recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
Documentation of Notifications 2 1 1 8 8
to Recipients--810.15(b)......
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 7742]]
Table 3--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
Collection activity/21 CFR Number of disclosures per Total annual burden per Total hours
section respondents respondent disclosures disclosure
----------------------------------------------------------------------------------------------------------------
Notification to Recipients-- 2 1 2 12 24
810.15(a)-(c)................
Notification to Recipients; 2 1 2 4 8
Follow-up--810.15(d).........
Notification of Consignees by 10 1 10 1 10
Recipients--810.15(e)........
---------------------------------------------------------------------------------
Total..................... ............... ............... .............. .............. 42
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The burden estimate has not changed for information collection
related to section 518(e) of the FD&C Act and part 810 since the last
OMB approval.
Dated: February 14, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-03605 Filed 2-21-18; 8:45 am]
BILLING CODE 4164-01-P
