Agency Information Collection Activities; Proposed Collection; Comment Request; Prescription Drug Product Labeling; Medication Guide Requirements, 54110-54112 [2018-23422]
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Federal Register / Vol. 83, No. 208 / Friday, October 26, 2018 / Notices
U.S.C. 262): March 23, 2015. FDA has
verified the applicant’s claim that the
biologics license application (BLA) for
TALTZ (BLA 125521) was initially
submitted on March 23, 2015.
3. The date the application was
approved: March 22, 2016. FDA has
verified the applicant’s claim that BLA
125521 was approved on March 22,
2016.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the USPTO applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its applications for patent extension,
this applicant seeks 1,156 days or 935
days of patent term extension.
III. Petitions
Anyone with knowledge that any of
the dates as published are incorrect may
submit either electronic or written
comments and, under 21 CFR 60.24, ask
for a redetermination (see DATES).
Furthermore, as specified in § 60.30 (21
CFR 60.30), any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period. To
meet its burden, the petition must
comply with all the requirements of
§ 60.30, including but not limited to:
Must be timely (see DATES), must be
filed in accordance with § 10.20, must
contain sufficient facts to merit an FDA
investigation, and must certify that a
true and complete copy of the petition
has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th
Cong., 2d sess., pp. 41–42, 1984.)
Petitions should be in the format
specified in 21 CFR 10.30.
Submit petitions electronically to
https://www.regulations.gov at Docket
No. FDA–2013–S–0610. Submit written
petitions (two copies are required) to the
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852.
khammond on DSK30JT082PROD with NOTICES
Dated: October 22, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–23438 Filed 10–25–18; 8:45 am]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
18:32 Oct 25, 2018
Jkt 247001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0902]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Prescription Drug
Product Labeling; Medication Guide
Requirements
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 regulations
requiring distribution of patient
labeling, called Medication Guides, for
certain products that pose a serious and
significant public health concern.
DATES: Submit either electronic or
written comments on the collection of
information by December 26, 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 December 26,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of December 26, 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.
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,
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
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–
2011–N–0902 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Prescription Drug Product Labeling;
Medication Guide Requirements.’’
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
E:\FR\FM\26OCN1.SGM
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54111
Federal Register / Vol. 83, No. 208 / Friday, October 26, 2018 / Notices
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: Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Prescription Drug Product Labeling;
Medication Guide Requirements
OMB Control Number 0910–0393–
Extension
FDA regulations require the
distribution of patient labeling, called
Medication Guides, for certain
prescription human drug and biological
products used primarily on an
outpatient basis that pose a serious and
significant public health concern.
Medication Guides provide patients the
most important information about drug
products, including the drugs’ approved
uses, contraindications, adverse drug
reactions, and cautions for specific
populations. These regulations are
intended to improve the public health
by providing information necessary for
patients to use certain medications
safely and effectively.
The regulations contain the following
reporting requirements that are subject
to the PRA:
• 21 CFR 208.20—Applicants must
submit draft Medication Guides for FDA
approval according to the prescribed
content and format.
• 21 CFR 314.70(b)(3)(ii) and 21 CFR
601.12(f)—Application holders must
submit changes to Medication Guides as
supplements to their applications to
FDA for approval.
• 21 CFR 208.24(c)—Each distributor
or packer who receives Medication
Guides, or the means to produce
Medication Guides, from a manufacturer
under paragraph (b) of this section shall
provide those Medication Guides to
each authorized dispenser to whom it
ships a drug product.
• 21 CFR 208.24(e)—Each authorized
dispenser of a prescription drug product
for which a Medication Guide is
required must provide a Medication
Guide directly to each patient when
dispensing the product to the patient or
to the patient’s agent, unless an
exemption applies under 21 CFR
208.26.
• 21 CFR 208.26(a)—Requests may be
submitted for an exemption or a deferral
from particular Medication Guide
content or format requirements.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR section
Average
burden per
response
Total annual
responses
Total hours
Content and Format of a Medication Guide—§ 208.20 .......
Supplements and Other Changes to an Approved Application—§§ 314.70(b)(3)(ii) and 601.12(f) .............................
Exemptions and Deferrals—§ 208.26(a) ..............................
61
1
61
320
19,520
155
1
1
1
155
1
72
4
11,160
4
Total ..............................................................................
........................
........................
........................
........................
30,684
1 There
khammond on DSK30JT082PROD with NOTICES
Number of
responses per
respondent
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
respondents
21 CFR section
Distributing Medication Guide to Authorized Dispenser—§ 208.24(c) .....................................................
VerDate Sep<11>2014
18:32 Oct 25, 2018
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Frm 00032
Number of
disclosures
per respondent
191
Fmt 4703
9,000
Sfmt 4703
Total annual
disclosures
1,719,000
E:\FR\FM\26OCN1.SGM
26OCN1
Average
burden per
disclosure
1.25
Total hours
2,148,750
54112
Federal Register / Vol. 83, No. 208 / Friday, October 26, 2018 / Notices
TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1—Continued
Number of
respondents
21 CFR section
Number of
disclosures
per respondent
Total annual
disclosures
Average
burden per
disclosure
Total hours
Distributing and Dispensing a Medication Guide to Patient—§ 208.24(e) .........................................................
88,736
5,705
506,238,880
* 0.05
25,311,944
Total ..........................................................................
........................
............................
........................
........................
27,460,694
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
* 3 minutes.
Our estimated annual reporting
burden for the information collection
reflects an increase of 51 respondents
and responses and a corresponding
overall increase of 4,664 total hours. We
attribute this adjustment to an increase
in the number of submissions we
received over the last few years. Based
on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our annual third-party
disclosure burden estimate, except for
correction in calculations.
Dated: October 22, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–23422 Filed 10–25–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2017–E–6904 and FDA–
2017–E–6909]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; REBINYN
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for REBINYN and is publishing this
notice of that determination as required
by law. FDA has made the
determination because of the
submission of applications to the
Director of the U.S. Patent and
Trademark Office (USPTO), Department
of Commerce, for the extension of a
patent which claims that human
biological product.
DATES: Anyone with knowledge that any
of the dates as published (see the
SUPPLEMENTARY INFORMATION section) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by December 26, 2018.
khammond on DSK30JT082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:32 Oct 25, 2018
Jkt 247001
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
April 24, 2019. See ‘‘Petitions’’ in the
SUPPLEMENTARY INFORMATION section for
more information.
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 December 26,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of December 26, 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.
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 Nos. FDA–
2017–E–6904 and FDA–2017–E–6909—
for ’’Determination of Regulatory
Review Period for Purposes of Patent
Extension; REBINYN.’’ 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
www.regulations.gov. Follow the
a.m. and 4 p.m., Monday through
instructions for submitting comments.
Friday.
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
• If you want to submit a comment
https://www.regulations.gov. Submit
with confidential information that you
both copies to the Dockets Management
do not wish to be made available to the
Staff. If you do not wish your name and
public, submit the comment as a
contact information to be made publicly
written/paper submission and in the
available, you can provide this
manner detailed (see ‘‘Written/Paper
information on the cover sheet and not
Submissions’’ and ‘‘Instructions’’).
in the body of your comments and you
PO 00000
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]]>Agencies
[Federal Register Volume 83, Number 208 (Friday, October 26, 2018)]
[Notices]
[Pages 54110-54112]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-23422]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0902]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Prescription Drug Product Labeling; Medication Guide
Requirements
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 regulations requiring distribution of
patient labeling, called Medication Guides, for certain products that
pose a serious and significant public health concern.
DATES: Submit either electronic or written comments on the collection
of information by December 26, 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 December 26, 2018. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of December 26, 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-2011-N-0902 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Prescription Drug Product
Labeling; Medication Guide Requirements.'' 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
[[Page 54111]]
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: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726,
[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.
Prescription Drug Product Labeling; Medication Guide Requirements
OMB Control Number 0910-0393-Extension
FDA regulations require the distribution of patient labeling,
called Medication Guides, for certain prescription human drug and
biological products used primarily on an outpatient basis that pose a
serious and significant public health concern. Medication Guides
provide patients the most important information about drug products,
including the drugs' approved uses, contraindications, adverse drug
reactions, and cautions for specific populations. These regulations are
intended to improve the public health by providing information
necessary for patients to use certain medications safely and
effectively.
The regulations contain the following reporting requirements that
are subject to the PRA:
21 CFR 208.20--Applicants must submit draft Medication
Guides for FDA approval according to the prescribed content and format.
21 CFR 314.70(b)(3)(ii) and 21 CFR 601.12(f)--Application
holders must submit changes to Medication Guides as supplements to
their applications to FDA for approval.
21 CFR 208.24(c)--Each distributor or packer who receives
Medication Guides, or the means to produce Medication Guides, from a
manufacturer under paragraph (b) of this section shall provide those
Medication Guides to each authorized dispenser to whom it ships a drug
product.
21 CFR 208.24(e)--Each authorized dispenser of a
prescription drug product for which a Medication Guide is required must
provide a Medication Guide directly to each patient when dispensing the
product to the patient or to the patient's agent, unless an exemption
applies under 21 CFR 208.26.
21 CFR 208.26(a)--Requests may be submitted for an
exemption or a deferral from particular Medication Guide content or
format requirements.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Content and Format of a 61 1 61 320 19,520
Medication Guide--Sec. 208.20
Supplements and Other Changes to 155 1 155 72 11,160
an Approved Application--Sec.
Sec. 314.70(b)(3)(ii) and
601.12(f)......................
Exemptions and Deferrals--Sec. 1 1 1 4 4
208.26(a)......................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 30,684
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR section Number of disclosures per Total annual Average burden Total hours
respondents respondent disclosures per disclosure
----------------------------------------------------------------------------------------------------------------
Distributing Medication Guide 191 9,000 1,719,000 1.25 2,148,750
to Authorized Dispenser--Sec.
208.24(c)..................
[[Page 54112]]
Distributing and Dispensing a 88,736 5,705 506,238,880 * 0.05 25,311,944
Medication Guide to Patient--
Sec. 208.24(e).............
---------------------------------------------------------------------------------
Total..................... .............. ................ .............. .............. 27,460,694
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
* 3 minutes.
Our estimated annual reporting burden for the information
collection reflects an increase of 51 respondents and responses and a
corresponding overall increase of 4,664 total hours. We attribute this
adjustment to an increase in the number of submissions we received over
the last few years. Based on a review of the information collection
since our last request for OMB approval, we have made no adjustments to
our annual third-party disclosure burden estimate, except for
correction in calculations.
Dated: October 22, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-23422 Filed 10-25-18; 8:45 am]
BILLING CODE 4164-01-P
