Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application, 40520-40522 [2018-17526]
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40520
Federal Register / Vol. 83, No. 158 / Wednesday, August 15, 2018 / Notices
795–7732 or kristen.hudgins@
acl.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, ACL is publishing a notice
of the proposed collection of
information set forth in this document.
With respect to the following collection
of information, ACL invites comments
on our burden estimates or any other
aspect of this collection of information,
including:
(1) Whether the proposed collection
of information is necessary for the
proper performance of ACL’s functions,
including whether the information will
have practical utility;
(2) The accuracy of ACL’s estimate of
the burden of the proposed collection of
information, including the validity of
the methodology and assumptions used
to determine burden estimates;
(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.
The data collection materials for the
annual performance data for the
Administration for Community Living’s
American Indian, Alaskan Natives and
Native Hawaiian Programs (OAA Title
VI) is a revision of a currently approved
annual program performance data
collection (OMB# 0985–0059). These
data collection materials have been
updated to better align with comparable
data collected for ACL’s other
nutritional, supportive, and caregiving
grants. Proposed changes include
adding data components and updating
others for more accurate reporting of
persons served and activities provided
through the Title VI-funded programs.
The revised data collection will provide
data necessary to determine the
effectiveness of the program. Some
examples of these changes are updating
definitions in Title VI to be more in line
with Title III, asking for unduplicated
numbers of people served for different
services and the number of hours spent
providing said services. Additionally,
Number of
respondents
Respondent/data collection activity
the caregiver portion of the PPR has
been updated to collect more
information around types of caregivers
served and unduplicated numbers of
caregivers. Another element added has
to do with information on expenditures.
This data collection will also support
ACL in tracking performance outcomes
and efficiency measures with respect to
the annual and long-term performance
targets established in compliance with
the Government Performance Results
Modernization Act (GPRAMA).
The proposed data collection tools
may be found on the ACL website for
review at https://www.acl.gov/aboutacl/public-input.
Estimated Program Burden: Title VI
funding is broken into three categories.
Parts A and B are for nutritional and
supportive programming, and ask for
the same information. Part A is for
American Indian and Alaska Native
grantees, and Part B is for Native
Hawaiian grantees. Part C is for
caregiver programming. All Part C
grantees must have Part A/B funding;
but not all Part A/B grantees will have
Part C programs. Therefore, there are
270 unique respondents, but only 237
will have to complete all portions of the
PPR. ACL believes that the increase in
burden hours is justified by the
improved quality of the data and will
ultimately improve the services
provided to Native Elders.
Responses
per
respondent
Hours per
response
Annual
burden hours
PPR Part A/B ...................................................................................................
PPR Part C ......................................................................................................
270
237
1
1
1.83
1.66
494.1
393.4
Total: .........................................................................................................
........................
........................
........................
887.5
Dated: August 8, 2018.
Mary Lazare,
Principal Deputy Administrator.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2018–17576 Filed 8–14–18; 8:45 am]
daltland on DSKBBV9HB2PROD with NOTICES
BILLING CODE 4154–01–P
Food and Drug Administration
[Docket No. FDA–2011–N–0915]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Guidance for
Industry on Postmarketing Adverse
Event Reporting for Nonprescription
Human Drug Products Marketed
Without an Approved Application
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) is
SUMMARY:
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18:28 Aug 14, 2018
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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 the collection of
information entitled ‘‘Guidance for
Industry on Postmarketing Adverse
Event Reporting for Nonprescription
Human Drug Products Marketed
Without an Approved Application.’’
E:\FR\FM\15AUN1.SGM
15AUN1
Federal Register / Vol. 83, No. 158 / Wednesday, August 15, 2018 / Notices
Submit either electronic or
written comments on the collection of
information by October 15, 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 October 15,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of October 15, 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.
DATES:
daltland on DSKBBV9HB2PROD with NOTICES
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–0915 for ‘‘Guidance for
VerDate Sep<11>2014
18:28 Aug 14, 2018
Jkt 244001
Industry on Postmarketing Adverse
Event Reporting for Nonprescription
Human Drug Products Marketed
Without an Approved Application.’’
Received comments, those filed in a
timely manner (see ADDRESSES), will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.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:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
PO 00000
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Fmt 4703
Sfmt 4703
40521
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:
Guidance for Industry on
Postmarketing Adverse Event Reporting
for Nonprescription Human Drug
Products Marketed Without an
Approved Application; OMB Control
Number 0910–0636—Extension
This information collection supports
Agency guidance directed to
manufacturers, packers, and/or
distributors whose names appear on the
label of a nonprescription drug
marketed in the United States under
section 502(b)(1) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 352(b)(1)). FDA is requesting
public comment on estimates of annual
submissions from these respondents, as
required by the Dietary Supplement and
Nonprescription Drug Consumer
Protection Act (Pub. L. 109–462) and
described in the guidance. The guidance
document discusses what should be
included in a serious adverse drug event
report submitted under section 760(b)(1)
E:\FR\FM\15AUN1.SGM
15AUN1
40522
Federal Register / Vol. 83, No. 158 / Wednesday, August 15, 2018 / Notices
of the FD&C Act (21 U.S.C. 379aa(b)(1)),
including followup reports under
760(c)(2) of the FD&C Act (21 U.S.C.
379aa(c)(2)), and how to submit these
reports. The estimates for the annual
reporting and recordkeeping burdens
are based on FDA data on the number
of adverse drug experience reports
submitted for nonprescription drug
products marketed without an approved
application and on prior input from
comments received from prior Federal
Register publications.
Based on FDA records, we received
194,449 total annual responses from
approximately 283 respondents for
nonprescription drugs marketed without
an approved application. We estimate
that each submission will take
approximately 6 hours to prepare and
submit.
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity
Number of
respondents
Number of
responses per
respondent
Total
annual
responses
Average
burden per
response
Total hours
Reports of serious adverse drug events (21 U.S.C.
379aa((b) and (c)) ............................................................
283
687.099
194,449
6
1,166,694
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Section 760(e) of the FD&C Act (21
U.S.C. 379aa(e)) also requires that
responsible persons maintain records of
nonprescription adverse event reports,
whether or not the event is serious, for
a period of 6 years. The guidance
recommends that respondents maintain
records of efforts to obtain the minimum
data elements for a report of a serious
adverse drug event and any followup
reports. We estimate that there are
approximately 265,700 records per year
maintained by approximately 300
respondents, and that it takes
approximately 8 hours to maintain each
record.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Activity
Number of
recordkeepers
Number of
records per
recordkeeper
Total
annual
records
Average
burden per
recordkeeping
Total hours
Recordkeeping (21 U.S.C. 379aa(e)(1)) ..............................
300
885.6667
265,700
8
2,125,600
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
[FR Doc. 2018–17526 Filed 8–14–18; 8:45 am]
and Clinical Pharmacology Advisory
Committee. The general function of the
committee is to provide advice and
recommendations to FDA on regulatory
issues. The meeting will be open to the
public. FDA is establishing a docket for
public comment on this document.
DATES: The meeting will be held on
September 20, 2018, from 8 a.m. to 5
p.m.
BILLING CODE 4164–01–P
ADDRESSES:
Our estimated burden for the
information collection reflects an
overall increase. We attribute this
adjustment to an increase in the number
of submissions we received in the last
few years.
Dated: August 9, 2018.
Leslie Kux,
Associate Commissioner for Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–2944]
Pharmaceutical Science and Clinical
Pharmacology Advisory Committee;
Notice of Meeting; Establishment of a
Public Docket; Request for Comments
daltland on DSKBBV9HB2PROD with NOTICES
AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of a
public docket; request for comments.
ACTION:
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Pharmaceutical Science
SUMMARY:
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18:28 Aug 14, 2018
Jkt 244001
FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993–0002.
Answers to commonly asked questions
including information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/AboutAdvisory
Committees/ucm408555.htm.
FDA is establishing a docket for
public comment on this meeting. The
docket number is FDA–2018–N–2944.
The docket will close on September 19,
2018. Submit either electronic or
written comments on this public
meeting by September 19, 2018. Please
note that late, untimely filed comments
will not be considered. Electronic
comments must be submitted on or
before September 19, 2018. The https://
PO 00000
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Sfmt 4703
www.regulations.gov electronic filing
system will accept comments until
midnight Eastern Time at the end of
September 19, 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.
Comments received on or before
September 5, 2018, will be provided to
the committee. Comments received after
that date will be taken into
consideration by FDA.
You may submit comments as
follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
E:\FR\FM\15AUN1.SGM
15AUN1
Agencies
[Federal Register Volume 83, Number 158 (Wednesday, August 15, 2018)]
[Notices]
[Pages 40520-40522]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-17526]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0915]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Guidance for Industry on Postmarketing Adverse Event
Reporting for Nonprescription Human Drug Products Marketed Without an
Approved Application
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (PRA), Federal Agencies are required to publish notice in the
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 the collection of information
entitled ``Guidance for Industry on Postmarketing Adverse Event
Reporting for Nonprescription Human Drug Products Marketed Without an
Approved Application.''
[[Page 40521]]
DATES: Submit either electronic or written comments on the collection
of information by October 15, 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 October 15, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of October 15, 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-0915 for ``Guidance for Industry on Postmarketing Adverse
Event Reporting for Nonprescription Human Drug Products Marketed
Without an Approved Application.'' Received comments, those filed in a
timely manner (see ADDRESSES), will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.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: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[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.
Guidance for Industry on Postmarketing Adverse Event Reporting for
Nonprescription Human Drug Products Marketed Without an Approved
Application; OMB Control Number 0910-0636--Extension
This information collection supports Agency guidance directed to
manufacturers, packers, and/or distributors whose names appear on the
label of a nonprescription drug marketed in the United States under
section 502(b)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 352(b)(1)). FDA is requesting public comment on
estimates of annual submissions from these respondents, as required by
the Dietary Supplement and Nonprescription Drug Consumer Protection Act
(Pub. L. 109-462) and described in the guidance. The guidance document
discusses what should be included in a serious adverse drug event
report submitted under section 760(b)(1)
[[Page 40522]]
of the FD&C Act (21 U.S.C. 379aa(b)(1)), including followup reports
under 760(c)(2) of the FD&C Act (21 U.S.C. 379aa(c)(2)), and how to
submit these reports. The estimates for the annual reporting and
recordkeeping burdens are based on FDA data on the number of adverse
drug experience reports submitted for nonprescription drug products
marketed without an approved application and on prior input from
comments received from prior Federal Register publications.
Based on FDA records, we received 194,449 total annual responses
from approximately 283 respondents for nonprescription drugs marketed
without an approved application. We estimate that each submission will
take approximately 6 hours to prepare and submit.
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reports of serious adverse drug events (21 U.S.C. 379aa((b) and 283 687.099 194,449 6 1,166,694
(c))..............................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Section 760(e) of the FD&C Act (21 U.S.C. 379aa(e)) also requires
that responsible persons maintain records of nonprescription adverse
event reports, whether or not the event is serious, for a period of 6
years. The guidance recommends that respondents maintain records of
efforts to obtain the minimum data elements for a report of a serious
adverse drug event and any followup reports. We estimate that there are
approximately 265,700 records per year maintained by approximately 300
respondents, and that it takes approximately 8 hours to maintain each
record.
Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
Activity Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
Recordkeeping (21 U.S.C. 379aa(e)(1)).............................. 300 885.6667 265,700 8 2,125,600
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimated burden for the information collection reflects an
overall increase. We attribute this adjustment to an increase in the
number of submissions we received in the last few years.
Dated: August 9, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-17526 Filed 8-14-18; 8:45 am]
BILLING CODE 4164-01-P