Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act, 3438-3439 [2016-01103]
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Federal Register / Vol. 81, No. 13 / Thursday, January 21, 2016 / Notices
document supersedes ‘‘Updated 510(k)
Sterility Review Guidance K90–1’’ dated
August 30, 2002.
II. Significance of Guidance
Persons interested in obtaining a copy
of the guidance may do so by
downloading an electronic copy from
the Internet. A search capability for all
Center for Devices and Radiological
Health guidance documents is available
at https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm.
Guidance documents are also available
at https://www.fda.gov/BiologicsBlood
Vaccines/GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm or https://
www.regulations.gov. Persons unable to
download an electronic copy of
‘‘Submission and Review of Sterility
Information in Premarket Notification
(510(k)) Submissions for Devices
Labeled as Sterile’’ may send an email
request to CDRH-Guidance@fda.hhs.gov
to receive an electronic copy of the
document. Please use the document
number 1615 to identify the guidance
you are requesting.
IV. Paperwork Reduction Act of 1995
asabaliauskas on DSK9F6TC42PROD with NOTICES
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Adverse Event
Reporting and Recordkeeping for
Dietary Supplements as Required by
the Dietary Supplement and
Nonprescription Drug Consumer
Protection Act
AGENCY:
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 part 807, subpart E, have been
approved under OMB control number
0910–0120; and the collections of
information in 21 CFR part 820 have
been approved under OMB control
number 0910–0073.
Dated: January 14, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–01093 Filed 1–20–16; 8:45 am]
BILLING CODE 4164–01–P
Jkt 238001
Food and Drug Administration,
HHS.
ACTION:
III. Electronic Access
18:26 Jan 20, 2016
Food and Drug Administration
[Docket No. FDA–2007–D–0372]
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on submission and
review of sterility information in 510(k)s
for devices labeled as sterile. 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.
VerDate Sep<11>2014
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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 February
22, 2016.
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
OMB control number 0910–0635. 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:
Adverse Event Reporting and
Recordkeeping for Dietary Supplements
as Required by the Dietary Supplement
and Nonprescription Drug Consumer
Protection Act—21 U.S.C. 379aa–1(b)(1)
OMB Control Number 0910–0635—
Extension
The Dietary Supplement and
Nonprescription Drug Consumer
Protection Act (the DSNDCPA) (Pub. L.
109–462, 120 Stat. 3469) amends the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) with respect to serious
PO 00000
Frm 00062
Fmt 4703
Sfmt 4703
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
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 (21
U.S.C. 379aa–1(e)(1)) 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 follow-up 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
E:\FR\FM\21JAN1.SGM
21JAN1
3439
Federal Register / Vol. 81, No. 13 / Thursday, January 21, 2016 / Notices
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.
In the Federal Register of October 21,
2015 (80 FR 63797), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number
of respondents
Number of
responses per
respondent
21 U.S.C. 379aa–1(b)(1)—serious adverse event reports
for dietary supplements ....................................................
21 U.S.C. 379aa–1(c)(2)— follow-up reports of new medical information .................................................................
170
17
2,860
2
5,720
42
17
715
1
715
Total ..............................................................................
........................
........................
........................
........................
6,435
21 U.S.C. Section
1 There
Total annual
responses
Average
burden per
response
Total hours
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
follow-up 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 ten) 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 ten).
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
× 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 follow-up report.
We estimate that 25 percent of serious
adverse event reports related to dietary
supplements will have a follow-up
report submitted, resulting in
approximately 715 follow-up 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
follow-up 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 follow-up reports
of new information is 715 hours (715
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
Dietary supplement adverse event records (21 U.S.C.
379aa–1(e)(1)) ..................................................................
asabaliauskas on DSK9F6TC42PROD with NOTICES
1 There
Number of
records per
recordkeeper
1,700
74
Total annual
records
Average
burden per
recordkeeping
125,800
Total hours
0.5
62,900
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
VerDate Sep<11>2014
18:26 Jan 20, 2016
Jkt 238001
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 pursuant to 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.
PO 00000
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Fmt 4703
Sfmt 9990
Dated: January 14, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–01103 Filed 1–20–16; 8:45 am]
BILLING CODE 4164–01–P
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21JAN1
]]>Agencies
[Federal Register Volume 81, Number 13 (Thursday, January 21, 2016)]
[Notices]
[Pages 3438-3439]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-01103]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2007-D-0372]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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) 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
February 22, 2016.
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 OMB control number 0910-0635.
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.
Adverse Event Reporting and Recordkeeping for Dietary Supplements as
Required by the Dietary Supplement and Nonprescription Drug Consumer
Protection Act--21 U.S.C. 379aa-1(b)(1) OMB Control Number 0910-0635--
Extension
The Dietary Supplement and Nonprescription Drug Consumer Protection
Act (the DSNDCPA) (Pub. L. 109-462, 120 Stat. 3469) 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 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 (21 U.S.C. 379aa-1(e)(1))
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 follow-up 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
[[Page 3439]]
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.
In the Federal Register of October 21, 2015 (80 FR 63797), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
We estimate the 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)-- follow- 42 17 715 1 715
up reports of new medical
information....................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 6,435
----------------------------------------------------------------------------------------------------------------
\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
follow-up 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 ten) 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 ten). 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 follow-up report. We estimate that 25
percent of serious adverse event reports related to dietary supplements
will have a follow-up report submitted, resulting in approximately 715
follow-up 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
follow-up 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
follow-up reports of new information is 715 hours (715 responses x 1
hour) as shown in row 2 of table 1.
Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
21 U.S.C. Section Number of records per Total annual burden per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
Dietary supplement adverse event 1,700 74 125,800 0.5 62,900
records (21 U.S.C. 379aa-
1(e)(1)).......................
----------------------------------------------------------------------------------------------------------------
\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 pursuant to 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: January 14, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-01103 Filed 1-20-16; 8:45 am]
BILLING CODE 4164-01-P
