[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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
              21 U.S.C. section                  Number of      records per    Total annual        Average burden per recordkeeping         Total hours
                                               recordkeepers   recordkeeper       records
--------------------------------------------------------------------------------------------------------------------------------------------------------
21 U.S.C. 379aa-1(e)(1))--dietary supplement           1,815              72         130,680  0.5 (30 minutes)..........................          65,340
 adverse events records.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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