
[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]


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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.

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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\
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                                                     Number of                        Average
        21 U.S.C. Section           Number  of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
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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....................
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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 
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\
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                                                     Number of                        Average
        21 U.S.C. Section            Number of      records per    Total annual     burden per      Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
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Dietary supplement adverse event           1,700              74         125,800             0.5          62,900
 records (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 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


