[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]]

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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.

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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: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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 
http://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 http://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: http://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 http://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, [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, 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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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\
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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)--                     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
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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