Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act, 48433-48435 [2018-20766]
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Federal Register / Vol. 83, No. 186 / Tuesday, September 25, 2018 / Notices
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on the content and
format of ANDA submissions. It does
not establish any rights for any person
and is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations. This
guidance is not subject to Executive
Order 12866.
daltland on DSKBBV9HB2PROD with NOTICES
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
21 CFR 314 (including subpart C)
related to the content and format of
ANDAs submitted by applicants and
approved by FDA is approved under
OMB control number 0910–0001.
Applicant submission of controlled
correspondence related to generic drug
development and FDA approval is
approved under OMB control number
0910–0797.
The collection of information for
Form FDA 356h (NDA and ANDA cover
sheet) has been approved under OMB
control number 0910–0338. The
collection of information for Form FDA
3674 (application certification) has been
approved under OMB control number
0910–0616. The collection of
information for Form FDA 3794
(GDUFA cover sheet) has been approved
under OMB control number 0910–0727.
The collection of information for Form
FDA 3454 and Form FDA 3455 (clinical
investigator financial interest) has been
approved under control number 0910–
0396.
The submission of petitions under 21
CFR part 10 (Administrative Practices
and Procedures) has been approved
under OMB control number 0910–0191.
The collection information in 21 CFR
part 11 (electronic records) has been
approved under OMB control number
0910–0303. Information about the
manufacture of the drug product under
21 CFR part 211 has been approved
under OMB control number 0910–0139.
Persons with access to the internet
may obtain the guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
VerDate Sep<11>2014
17:40 Sep 24, 2018
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[FR Doc. 2018–20790 Filed 9–24–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–3344]
II. Paperwork Reduction Act of 1995
III. Electronic Access
Dated: September 19, 2018.
Leslie Kux,
Associate Commissioner for Policy.
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Adverse Event
Reporting and Recordkeeping for
Dietary Supplements as Required by
the Dietary Supplement and
Nonprescription Drug Consumer
Protection Act
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
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 associated with adverse
event reporting and recordkeeping for
dietary supplements as required by the
Dietary Supplement and
Nonprescription Drug Consumer
Protection Act (DSNDCPA).
DATES: Submit either electronic or
written comments on the collection of
information by November 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 November 26,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of November 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:
PO 00000
Frm 00025
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48433
• 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–3344 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Adverse
Event Reporting and Recordkeeping for
Dietary Supplements as Required by the
Dietary Supplement and
Nonprescription Drug Consumer
Protection Act.’’ 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
E:\FR\FM\25SEN1.SGM
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48434
Federal Register / Vol. 83, No. 186 / Tuesday, September 25, 2018 / Notices
daltland on DSKBBV9HB2PROD with NOTICES
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
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.
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
VerDate Sep<11>2014
17:40 Sep 24, 2018
Jkt 244001
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.
Adverse Event Reporting and
Recordkeeping for Dietary Supplements
as Required by the Dietary Supplement
and Nonprescription Drug Consumer
Protection Act
OMB Control Number 0910–0635—
Extension
The DSNDCPA (Pub. L. 109–462)
amended the Federal Food, Drug, and
Cosmetic Act (FD&C Act) with respect
to serious adverse event reporting and
recordkeeping for dietary supplements
and non-prescription drugs marketed
without an approved application.
Section 761(b)(1) of the FD&C Act (21
U.S.C. 379aa–1) requires the
manufacturer, packer, or distributor
whose name appears on the label of a
dietary supplement marketed in the
United States to submit to us all serious
adverse event reports associated with
the use of a dietary supplement,
accompanied by a copy of the product
label. The manufacturer, packer, or
distributor of a dietary supplement is
required by the DSNDCPA to use the
MedWatch form (Form FDA 3500A)
when submitting a serious adverse event
PO 00000
Frm 00026
Fmt 4703
Sfmt 4703
report to FDA. In addition, section
761(c)(2) of the FD&C Act requires the
submitter of the serious adverse event
report (referred to in the statute as the
‘‘responsible person’’) to submit to FDA
a followup report of any related new
medical information the responsible
person receives within 1 year of the
initial report.
Section 761(e)(1) of the FD&C Act
requires that responsible persons
maintain records related to the dietary
supplement adverse event reports they
receive, whether or not the adverse
event is serious, for a period of 6 years.
As required by the DSNDCPA, we
issued guidance to describe the
minimum data elements for serious
adverse event reports for dietary
supplements. The guidance entitled
‘‘Guidance for Industry: Questions and
Answers Regarding Adverse Event
Reporting and Recordkeeping for
Dietary Supplements as Required by the
Dietary Supplement and
Nonprescription Drug Consumer
Protection Act’’ is available at https://
www.fda.gov/Food/Guidance
Regulation/GuidanceDocuments
RegulatoryInformation/default.htm. It
discusses how, when, and where to
submit serious adverse event reports for
dietary supplements and followup
reports. The guidance also provides our
recommendation on records
maintenance and access for serious and
non-serious adverse event reports and
related documents.
The guidance recommends that the
responsible person document their
attempts to obtain the minimum data
elements for a serious adverse event
report. Along with these records, the
guidance recommends that the
responsible person keep the following
other records: (1) Communications
between the responsible person and the
initial reporter of the adverse event and
between the responsible person and any
other person(s) who provided
information about the adverse event; (2)
the responsible person’s serious adverse
event report to us with attachments; (3)
any new information about the adverse
event received by the responsible
person; and (4) any reports to us of new
information related to the serious
adverse event report.
FDA estimates the burden of this
collection of information as follows:
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Federal Register / Vol. 83, No. 186 / Tuesday, September 25, 2018 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 U.S.C. section
21 U.S.C. 379aa–1(b)(1)—serious adverse event reports
for dietary supplements ....................................................
21 U.S.C. 379aa–1(c)(2)—followup reports of new medical
information ........................................................................
Total ..............................................................................
1 There
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
230
12
2,760
2
5,520
58
12
696
1
696
........................
........................
........................
........................
6,216
are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimated burden for the
information collection reflects an
annual decrease of 219 hours for
reporting. We attribute this adjustment
to a decrease in the number of reports
we received over the last few years.
This estimate is based on our
experience with similar adverse event
reporting programs and the number of
serious adverse event reports and
followup reports received in the past 3
years. All dietary supplement
manufacturers, packers, or distributors
are subject to serious adverse event
mandatory reporting.
In the past 3 years, we received an
average of 2,760 initial serious adverse
event reports. We also estimated an
average number of firms filing reports to
be 230. Finally, we estimate that it will
take respondents an average of 2 hours
per report to collect information about
a serious adverse event associated with
a dietary supplement and report the
information to us on Form FDA 3500A.
Thus, the estimated burden associated
with submitting initial dietary
supplement serious adverse event
reports is 5,520 hours (2,760 responses
× 2 hours) as shown in row 1 of
table 1.
If a respondent that has submitted a
serious adverse event report receives
new information related to the serious
adverse event within 1 year of
submitting the initial report, the
respondent must provide the new
information to us in a followup report.
We estimate that around 25 percent of
serious adverse event reports related to
dietary supplements will have a
followup report submitted, resulting in
approximately 696 followup reports
submitted annually. Dividing the annual
number of reports among the 230 firms
reporting results in approximately 12
reports for 58 respondents. We estimate
that each followup report will require
an hour to assemble and submit,
including the time needed to copy and
attach the initial serious adverse event
report as recommended in the guidance.
Thus, the estimated burden for followup
reports of new information is 696 hours
(696 responses × 1 hour) as shown in
row 2 of table 1.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 U.S.C. section
21 U.S.C. 379aa–1(e)(1))—dietary supplement adverse events records.
daltland on DSKBBV9HB2PROD with NOTICES
1 There
Number of
records per
recordkeeper
1,815
Total annual
records
72
130,680
Average burden per
recordkeeping
Total hours
0.5 (30 minutes) ........
65,340
are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimated burden for the
information collection reflects an
annual increase of 2,440 hours for
recordkeeping. We attribute this
adjustment to an increase in the number
of reports we received over the last few
years.
All dietary supplement
manufacturers, packers, or distributors
are subject to serious adverse event
recordkeeping. We estimate that there
are 1,815 such respondents. Estimating
that each recordkeeper will keep
approximately 72 records per year
results in an annual burden of 130,680
records. Estimating that assembling and
filing these records, including any
necessary photocopying, will take
approximately 30 minutes, or 0.5 hour,
per record, results in an annual burden
of 65,340 hours (130,680 records × 0.5
hour).
Once the documents pertaining to an
adverse event report have been
VerDate Sep<11>2014
17:40 Sep 24, 2018
Jkt 244001
assembled and filed in accordance with
the safety reporting portal, we expect
the records retention burden to be
minimal, as we believe most
establishments would normally keep
this kind of record for at least several
years after receiving the report, as a
matter of usual and customary business
practice.
Dated: September 19, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–20766 Filed 9–24–18; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–D–3103]
Good Review Management Principles
and Practices for New Drug
Applications and Biologics License
Applications; Draft Guidance for
Industry and Review Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
BILLING CODE 4164–01–P
PO 00000
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry and review staff
entitled ‘‘Good Review Management
Principles and Practices for New Drug
Applications and Biologics License
Applications.’’ This draft guidance
describes the fundamental values and
SUMMARY:
Frm 00027
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]]>Agencies
[Federal Register Volume 83, Number 186 (Tuesday, September 25, 2018)]
[Notices]
[Pages 48433-48435]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-20766]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-3344]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Adverse Event Reporting and Recordkeeping for Dietary
Supplements as Required by the Dietary Supplement and Nonprescription
Drug Consumer Protection Act
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
associated with adverse event reporting and recordkeeping for dietary
supplements as required by the Dietary Supplement and Nonprescription
Drug Consumer Protection Act (DSNDCPA).
DATES: Submit either electronic or written comments on the collection
of information by November 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 November 26, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of November 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-2018-N-3344 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Adverse Event Reporting and
Recordkeeping for Dietary Supplements as Required by the Dietary
Supplement and Nonprescription Drug Consumer Protection Act.'' 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
[[Page 48434]]
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.
Adverse Event Reporting and Recordkeeping for Dietary Supplements as
Required by the Dietary Supplement and Nonprescription Drug Consumer
Protection Act
OMB Control Number 0910-0635--Extension
The DSNDCPA (Pub. L. 109-462) amended the Federal Food, Drug, and
Cosmetic Act (FD&C Act) with respect to serious adverse event reporting
and recordkeeping for dietary supplements and non-prescription drugs
marketed without an approved application. Section 761(b)(1) of the FD&C
Act (21 U.S.C. 379aa-1) requires the manufacturer, packer, or
distributor whose name appears on the label of a dietary supplement
marketed in the United States to submit to us all serious adverse event
reports associated with the use of a dietary supplement, accompanied by
a copy of the product label. The manufacturer, packer, or distributor
of a dietary supplement is required by the DSNDCPA to use the MedWatch
form (Form FDA 3500A) when submitting a serious adverse event report to
FDA. In addition, section 761(c)(2) of the FD&C Act requires the
submitter of the serious adverse event report (referred to in the
statute as the ``responsible person'') to submit to FDA a followup
report of any related new medical information the responsible person
receives within 1 year of the initial report.
Section 761(e)(1) of the FD&C Act requires that responsible persons
maintain records related to the dietary supplement adverse event
reports they receive, whether or not the adverse event is serious, for
a period of 6 years.
As required by the DSNDCPA, we issued guidance to describe the
minimum data elements for serious adverse event reports for dietary
supplements. The guidance entitled ``Guidance for Industry: Questions
and Answers Regarding Adverse Event Reporting and Recordkeeping for
Dietary Supplements as Required by the Dietary Supplement and
Nonprescription Drug Consumer Protection Act'' is available at https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/default.htm. It discusses how,
when, and where to submit serious adverse event reports for dietary
supplements and followup reports. The guidance also provides our
recommendation on records maintenance and access for serious and non-
serious adverse event reports and related documents.
The guidance recommends that the responsible person document their
attempts to obtain the minimum data elements for a serious adverse
event report. Along with these records, the guidance recommends that
the responsible person keep the following other records: (1)
Communications between the responsible person and the initial reporter
of the adverse event and between the responsible person and any other
person(s) who provided information about the adverse event; (2) the
responsible person's serious adverse event report to us with
attachments; (3) any new information about the adverse event received
by the responsible person; and (4) any reports to us of new information
related to the serious adverse event report.
FDA estimates the burden of this collection of information as
follows:
[[Page 48435]]
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
21 U.S.C. section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
21 U.S.C. 379aa-1(b)(1)--serious 230 12 2,760 2 5,520
adverse event reports for
dietary supplements............
21 U.S.C. 379aa-1(c)(2)-- 58 12 696 1 696
followup reports of new medical
information....................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 6,216
----------------------------------------------------------------------------------------------------------------
\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
annual decrease of 219 hours for reporting. We attribute this
adjustment to a decrease in the number of reports we received over the
last few years.
This estimate is based on our experience with similar adverse event
reporting programs and the number of serious adverse event reports and
followup reports received in the past 3 years. All dietary supplement
manufacturers, packers, or distributors are subject to serious adverse
event mandatory reporting.
In the past 3 years, we received an average of 2,760 initial
serious adverse event reports. We also estimated an average number of
firms filing reports to be 230. Finally, we estimate that it will take
respondents an average of 2 hours per report to collect information
about a serious adverse event associated with a dietary supplement and
report the information to us on Form FDA 3500A. Thus, the estimated
burden associated with submitting initial dietary supplement serious
adverse event reports is 5,520 hours (2,760 responses x 2 hours) as
shown in row 1 of table 1.
If a respondent that has submitted a serious adverse event report
receives new information related to the serious adverse event within 1
year of submitting the initial report, the respondent must provide the
new information to us in a followup report. We estimate that around 25
percent of serious adverse event reports related to dietary supplements
will have a followup report submitted, resulting in approximately 696
followup reports submitted annually. Dividing the annual number of
reports among the 230 firms reporting results in approximately 12
reports for 58 respondents. We estimate that each followup report will
require an hour to assemble and submit, including the time needed to
copy and attach the initial serious adverse event report as recommended
in the guidance. Thus, the estimated burden for followup reports of new
information is 696 hours (696 responses x 1 hour) as shown in row 2 of
table 1.
Table 2--Estimated Annual Recordkeeping Burden \1\
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Number of
21 U.S.C. section Number of records per Total annual Average burden per recordkeeping Total hours
recordkeepers recordkeeper records
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21 U.S.C. 379aa-1(e)(1))--dietary supplement 1,815 72 130,680 0.5 (30 minutes).......................... 65,340
adverse events records.
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\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
annual increase of 2,440 hours for recordkeeping. We attribute this
adjustment to an increase in the number of reports we received over the
last few years.
All dietary supplement manufacturers, packers, or distributors are
subject to serious adverse event recordkeeping. We estimate that there
are 1,815 such respondents. Estimating that each recordkeeper will keep
approximately 72 records per year results in an annual burden of
130,680 records. Estimating that assembling and filing these records,
including any necessary photocopying, will take approximately 30
minutes, or 0.5 hour, per record, results in an annual burden of 65,340
hours (130,680 records x 0.5 hour).
Once the documents pertaining to an adverse event report have been
assembled and filed in accordance with the safety reporting portal, we
expect the records retention burden to be minimal, as we believe most
establishments would normally keep this kind of record for at least
several years after receiving the report, as a matter of usual and
customary business practice.
Dated: September 19, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-20766 Filed 9-24-18; 8:45 am]
BILLING CODE 4164-01-P
