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, 63797-63799 [2015-26673]
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Federal Register / Vol. 80, No. 203 / Wednesday, October 21, 2015 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–D–0372]
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 or we) is
announcing an opportunity for public
comment on the proposed collection of
certain information by our Agency.
Under the Paperwork Reduction Act of
1995 (the 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. 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 (the DSNDCPA).
DATES: Submit either electronic or
written comments on the collection of
information by December 21, 2015.
ADDRESSES: You may submit comments
as follows:
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
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.
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22:39 Oct 20, 2015
Jkt 238001
• 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): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, 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–
2007–D–0372 for the information
collection request entitled, ‘‘Adverse
Event Reporting and Recordkeeping for
Dietary Supplements as Required by the
DSNDCPA.’’
Received comments will be placed in
the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
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 Division of Dockets
Management. 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
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63797
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.fda.gov/
regulatoryinformation/dockets/
default.htm.
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 Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, 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, we are publishing this
notice of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, we invite
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.
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63798
Federal Register / Vol. 80, No. 203 / Wednesday, October 21, 2015 / Notices
Adverse Event Reporting and
Recordkeeping for Dietary Supplements
as Required by the DSNDCPA, 21 U.S.C.
379aa–1(b)(1) OMB Control Number
0910–0635—Extension
The DSNDCPA (Pub. L. 109–462)
amends the Federal Food, Drug, and
Cosmetic Act (the 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(b)(1))
requires the manufacturer, packer, or
distributor whose name under section
403(e)(1) of the FD&C Act (21 U.S.C.
343(e)(1)) 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, under
section 761(c)(2) of the FD&C Act, the
submitter of the serious adverse event
report (referred to in the statute as the
‘‘responsible person’’) is required to
submit to FDA a follow up 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. Under the statute, the
records must be retained for a period of
6 years.
As required by section 3(d)(3) of the
DSNDCPA, we issued guidance to
describe the minimum data elements for
serious adverse event reports for dietary
supplements. In the Federal Register of
July 14, 2009 (74 FR 34024), we
announced the availability of 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.’’ The guidance 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; (4) any reports to us of new
information related to the serious
adverse event report.
We estimate the annual reporting
burden of this collection of information
as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 U.S.C. section
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
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 ........................................................................
170
17
2,860
2
5,720
42
17
715
1
715
Total ..............................................................................
........................
........................
........................
........................
6,435
tkelley on DSK3SPTVN1PROD with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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.
We received 2,435 initial serious
adverse event reports in fiscal year (FY)
2012, 3,414 in FY2013, and 2,745 in
FY2014. We averaged these figures
(2,860 rounded to the nearest 10) as a
basis for our estimated number of
annual reports. We also used an average
of the number of firms filing reports
(170 rounded to the nearest 10). Finally,
we estimate that it will take respondents
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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 5,720
hours (2,860 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 25 percent of serious
adverse event reports related to dietary
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Sfmt 4703
supplements will have a followup
report submitted, resulting in
approximately 715 followup reports
submitted annually (2,860 × 0.25 = 715).
Dividing the annual number of reports
among the 170 firms reporting results in
approximately 17 reports for 42
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 715 hours (715
responses × 1 hour) as shown in row 2
of Table 1.
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Federal Register / Vol. 80, No. 203 / Wednesday, October 21, 2015 / Notices
63799
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
21 U.S.C. section
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average burden
per recordkeeping
Total hours
Dietary supplement adverse event records (21
U.S.C. 379aa–1(e)(1)).
1,700
74
125,800
0.5 (30 minutes) ........
62,900
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
All dietary supplement
manufacturers, packers, or distributors
are subject to serious adverse event
recordkeeping. We estimate that there
are 1,700 such respondents, based on
the figure 1,460 as provided in our final
rule of June 25, 2007 (72 FR 34751) on
the ‘‘Current Good Manufacturing
Practice in Manufacturing, Packaging,
Labeling, or Holding Operations for
Dietary Supplements,’’ and factoring a
two percent annual growth rate.
Estimating that each recordkeeper will
keep approximately 74 records per year
results in an annual burden of 125,800
records. Estimating that assembling and
filing these records, including any
necessary photocopying, will take
approximately 30 minutes, or 0.5 hours,
per record, results in an annual burden
of 62,900 hours (125,800 records × 0.50
hours = 62,900 total hours.
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: October 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–26673 Filed 10–20–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
tkelley on DSK3SPTVN1PROD with NOTICES
[Docket No. FDA–2015–N–2126]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Evaluation of the
Food and Drug Administration’s
Campaign To Reduce Tobacco Use
Among Lesbian, Gay, Bisexual, and
Transgender Young Adults
AGENCY:
Food and Drug Administration,
HHS.
VerDate Sep<11>2014
22:39 Oct 20, 2015
Jkt 238001
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by November
20, 2015.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
title ‘‘Evaluation of the Food and Drug
Administration’s Campaign to Reduce
Tobacco Use Among Lesbian, Gay,
Bisexual, and Transgender Young
Adults’’. Also include the FDA docket
number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUMMARY:
Evaluation of FDA’s Campaign To
Reduce Tobacco Use Among Lesbian,
Gay, Bisexual, and Transgender Young
Adults—OMB Control Number 0910—
New
The 2009 Family Smoking Prevention
and Tobacco Control Act (Tobacco
Control Act) (Pub. L. 111–31) amended
the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) to grant FDA
authority to regulate the manufacture,
marketing, and distribution of tobacco
products to protect public health and to
reduce tobacco use by minors. Section
1003(d)(2)(D) of the FD&C Act (21
U.S.C. 393(d)(2)(D)) supports the
development and implementation of
FDA public education campaigns
PO 00000
Frm 00063
Fmt 4703
Sfmt 4703
related to tobacco use. Accordingly,
FDA is currently developing and
implementing public education
campaigns to help prevent and reduce
tobacco use among lesbian, gay,
bisexual, and transgender (LGBT) young
adults and thereby reduce the public
health burden of tobacco. Overall the
campaigns will feature events;
advertisements on television and radio
and in print; digital communications
including social media; and other forms
of media.
In support of the provisions of the
Tobacco Control Act that require FDA to
protect the public health and to reduce
tobacco use, FDA requests OMB
approval to collect information needed
to evaluate FDA’s campaign to reduce
tobacco use among LGBT young adults.
Comprehensive evaluation of FDA’s
public education campaigns is needed
to ensure campaign messages are
effectively received, understood, and
accepted by those for whom they are
intended. Evaluation is an essential
organizational practice in public health
and a systematic way to account for and
improve public health actions.
FDA plans to conduct two studies to
evaluate the effectiveness of its LGBT
young adult tobacco prevention
campaign: (1) An outcome evaluation
study to evaluate the effectiveness of its
LGBT young adult tobacco prevention
campaign, and (2) a media tracking
questionnaire to assess awareness of and
receptivity to campaign messages. The
timing of these studies will be designed
to follow the multiple, discrete waves of
media advertising planned for the
campaigns.
I. Outcome Evaluation Study
Before the beginning of data
collection for the outcome evaluation
study, the 5-minute screening
instrument will be tested in a small
pilot study of LGBT young adults aged
18 to 24. The outcome evaluation study
will then begin with a baseline survey
of LGBT young adults aged 18 to 24
before the campaign launch. The
baseline will be followed by three
followup surveys of the target audience
of young adults at approximately 6month intervals after the campaign’s
launch. Information will be collected
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]]>Agencies
[Federal Register Volume 80, Number 203 (Wednesday, October 21, 2015)]
[Notices]
[Pages 63797-63799]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-26673]
[[Page 63797]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2007-D-0372]
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 or we) is announcing an
opportunity for public comment on the proposed collection of certain
information by our Agency. Under the Paperwork Reduction Act of 1995
(the 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. 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 (the DSNDCPA).
DATES: Submit either electronic or written comments on the collection
of information by December 21, 2015.
ADDRESSES: 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, 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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, 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-2007-D-0372 for the information collection request entitled,
``Adverse Event Reporting and Recordkeeping for Dietary Supplements as
Required by the DSNDCPA.''
Received comments will be placed in the docket and, except for
those submitted as ``Confidential Submissions,'' publicly viewable at
https://www.regulations.gov or at the Division of Dockets Management
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 Division of Dockets Management. 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.fda.gov/regulatoryinformation/dockets/default.htm.
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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, 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, we are publishing this notice of the proposed
collection of information set forth in this document.
With respect to the following collection of information, we invite
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.
[[Page 63798]]
Adverse Event Reporting and Recordkeeping for Dietary Supplements as
Required by the DSNDCPA, 21 U.S.C. 379aa-1(b)(1) OMB Control Number
0910-0635--Extension
The DSNDCPA (Pub. L. 109-462) amends the Federal Food, Drug, and
Cosmetic Act (the 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(b)(1)) requires the
manufacturer, packer, or distributor whose name under section 403(e)(1)
of the FD&C Act (21 U.S.C. 343(e)(1)) 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, under section 761(c)(2) of
the FD&C Act, the submitter of the serious adverse event report
(referred to in the statute as the ``responsible person'') is required
to submit to FDA a follow up 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.
Under the statute, the records must be retained for a period of 6
years.
As required by section 3(d)(3) of the DSNDCPA, we issued guidance
to describe the minimum data elements for serious adverse event reports
for dietary supplements. In the Federal Register of July 14, 2009 (74
FR 34024), we announced the availability of 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.''
The guidance 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; (4) any reports to us of new information
related to the serious adverse event report.
We estimate the annual reporting burden of this collection of
information as follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
21 U.S.C. section Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
21 U.S.C. 379aa-1(b)(1)--serious 170 17 2,860 2 5,720
adverse event reports for
dietary supplements............
21 U.S.C. 379aa-1(c)(2)-- 42 17 715 1 715
followup reports of new medical
information....................
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Total....................... .............. .............. .............. .............. 6,435
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
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.
We received 2,435 initial serious adverse event reports in fiscal
year (FY) 2012, 3,414 in FY2013, and 2,745 in FY2014. We averaged these
figures (2,860 rounded to the nearest 10) as a basis for our estimated
number of annual reports. We also used an average of the number of
firms filing reports (170 rounded to the nearest 10). 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 5,720 hours (2,860
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 25 percent
of serious adverse event reports related to dietary supplements will
have a followup report submitted, resulting in approximately 715
followup reports submitted annually (2,860 x 0.25 = 715). Dividing the
annual number of reports among the 170 firms reporting results in
approximately 17 reports for 42 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 715 hours (715 responses x 1
hour) as shown in row 2 of Table 1.
[[Page 63799]]
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dietary supplement adverse event records 1,700 74 125,800 0.5 (30 minutes)........................ 62,900
(21 U.S.C. 379aa-1(e)(1)).
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
All dietary supplement manufacturers, packers, or distributors are
subject to serious adverse event recordkeeping. We estimate that there
are 1,700 such respondents, based on the figure 1,460 as provided in
our final rule of June 25, 2007 (72 FR 34751) on the ``Current Good
Manufacturing Practice in Manufacturing, Packaging, Labeling, or
Holding Operations for Dietary Supplements,'' and factoring a two
percent annual growth rate. Estimating that each recordkeeper will keep
approximately 74 records per year results in an annual burden of
125,800 records. Estimating that assembling and filing these records,
including any necessary photocopying, will take approximately 30
minutes, or 0.5 hours, per record, results in an annual burden of
62,900 hours (125,800 records x 0.50 hours = 62,900 total hours.
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: October 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-26673 Filed 10-20-15; 8:45 am]
BILLING CODE 4164-01-P
