0635 Supporting Statement 2016

Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the
Dietary Supplement and Nonprescription Drug Consumer Protection Act
OMB Control No. 0910-0635
SUPPORTING STATEMENT

A. Justification
1. Circumstances Making the Collection of Information Necessary
The Dietary Supplement and Nonprescription Drug Consumer Protection Act (the DSNDCPA)
(Public Law 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 FDA 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 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, FDA 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), FDA 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
FDA’s recommendation on records maintenance and access for serious and non-serious adverse
event reports and related documents.
FDA is requesting OMB approval of the information collection provisions in the guidance and
the following statutory citations:

21 U.S.C. 379aa-1(b)(1) – Reporting
Serious adverse event reports for dietary supplements – 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 submit to FDA any serious adverse event report it
receives regarding use of dietary supplements in the United States.
21 U.S.C. 379aa-1(c)(2) – Reporting
Follow-up reports of new medical information – Section 761(c)(2) of the FD&C Act (21 U.S.C.
379aa-1(c)(2)) requires the responsible party to submit to FDA a follow-up report of any new
medical information received within one year of the initial report.
21 U.S.C. 379aa-1(e)(1) -- Recordkeeping
Maintenance of records of dietary supplement adverse events – Section 761(e)(1) of the FD&C
Act (21 U.S.C. 379aa-1(e)(1)) requires that responsible persons maintain for six years records
related to dietary supplement adverse event reports they receive, whether or not the adverse
event is serious.

2. Purpose and Use of the Information Collection
The FDA will receive the information as required by the DSNDCPA with respect to serious
adverse event reporting for dietary supplements. The reporting and recordkeeping requirements
for serious adverse events related to dietary supplements are important for public health reasons.
Reporting of serious adverse events to FDA will serve as an early warning sign of potential
public health issues associated with dietary supplements. Without notification of all serious
adverse events associated with dietary supplements, FDA would be unable to investigate and
follow up promptly, which in turn could cause delays in alerting the public when safety problems
are found. In addition, the information received will provide a reliable mechanism to track
patterns of adulteration in food that would support efforts by FDA to target limited inspection
resources to protect the public health.
Description of Respondents: Respondents are businesses engaged in the manufacture, packing,
or distribution of dietary supplements marketed in the United States. Respondents are from the
private sector (for-profit businesses).

3. Use of Improved Information Technology and Burden Reduction
Adverse event reports for dietary supplements may be submitted to FDA electronically via the
FDA Safety Reporting Portal (the SRP). FDA estimates about seventy-five percent (75%) of the
dietary supplement adverse event reports will be submitted electronically.

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4. Efforts to Identify Duplication and Use of Similar Information
FDA is aware of no duplicative reporting requirements to those found in the DSNDCPA. The
manufacturer, packer, or distributor of a dietary supplement is required by statute to use a
MedWatch form when submitting a serious adverse event report to FDA. The statute permits but
does not require FDA to modify the MedWatch form for dietary supplement serious adverse
event reporting. The agency has determined that MedWatch Form 3500A (approved under OMB
Control No. 0910-02911), the form used for mandatory reporting of adverse events for other
FDA-regulated products, is also the most appropriate MedWatch form currently available for
mandatory reporting of dietary supplement serious adverse events.

5. Impact on Small Businesses or Other Small Entities
FDA estimates that eighty percent (80%) of respondents are small businesses. Because the
information collection requirements are mandated by the DSNDCPA, there is no statutory
exception for small businesses. However, FDA aids small businesses in complying with its
requirements through the agency’s Regional Small Business Representatives and through the
scientific and administrative staffs within the agency. FDA has provided a Small Business
Guide on the agency’s website at http://www.fda.gov/oc/industry/.

6. Consequences of Collecting the Information Less Frequently
Data collection occurs occasionally. The DSNDCPA requires that serious adverse event reports
received through the address or phone number on the label of a dietary supplement, as well as
follow-up reports of new medical information received by the responsible person within one year
after the initial report, be submitted to FDA no later than 15 business days after the report is
received by the responsible person. FDA believes that prompt, mandatory reporting is consistent
with the Congressional intent of the DSNDCPA and important for public health reasons.
Delayed or less frequent reporting of serious adverse events to FDA would diminish the
effectiveness of adverse event reporting as an early warning sign of possible safety problems
with dietary supplements. Without notification of all serious adverse events associated with
dietary supplements, FDA is unable to investigate and follow-up promptly, which in turn could
cause delays in alerting the public when safety problems are found.

7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
The DSNDCPA requires that serious adverse event reports, as well as follow-up reports of new
medical information received by the responsible person within one year after the initial report, be
submitted to FDA no later than 15 business days after the report is received by the responsible
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Burden for the instant collection, 0910-0635, represents a subset of adverse event reporting associated with the
underlying guidance “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.” We have counted this burden separately from the burden approved under 0910-0291 but
we are currently considering combining these collections.

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person. As a result, reporting information to FDA may occur more frequently than on a quarterly
basis. Also, section 761(e)(1) of the FD&C Act requires that responsible persons maintain for
records related to dietary supplement adverse event reports they receive for six years, whether or
not the adverse event is serious. This collection of information does not involve submission of
more than an original and 2 copies, the use of statistical methods, pledges of confidentiality by
FDA not supported by authority established in statute or regulation, or require the disclosure of
trade secrets or other confidential information.

8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside
the Agency
In accordance with 5 CFR 1320.8(d), FDA published a 60-day notice for public comment in the
Federal Register of October 21, 2015 (80 FR 63797). No comments were received.

9. Explanation of Any Payment or Gift to Respondents
FDA does not provide any payments or gifts to respondents.

10. Assurance of Confidentiality Provided to Respondents
Section 761(f)(2) of the FD&C Act (21 U.S.C. 379aa-1(f)(2)) provides that a serious adverse
event report submitted to FDA, including any new medical information submitted, shall be
considered a record about an individual under section 552a of title 5, United States Code
(commonly referred to as the “Privacy Act of 1974”) and a medical or similar file the disclosure
of which would constitute a violation of section 552 of such title 5 (commonly referred to as the
“Freedom of Information Act”), and shall not be publicly disclosed unless all personally
identifiable information is redacted.

11. Justification for Sensitive Questions
This information collection does not contain questions that are of a personally sensitive nature.

12. Estimates of Annualized Burden Hours and Costs
We estimate the burden for this information collection as follows:

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12a. Annualized Hour Burden Estimate
Reporting
Table 1 – Estimated Annual Reporting Burden1
21 U.S.C. Section

21 U.S.C. 379aa1(b)(1)- serious
adverse event
reports for dietary
supplements
21 U.S.C. 379aa1(c)(2) – follow-up
reports of new
medical information
TOTAL

No. of
Respondents

No. of Responses
per Respondent

Total
Annual
Responses

Avg. Burden
per
Response

Total
Hours

170

17

2,890

2

5,780

42

17

714

1

714

6,494

1

There are no capital costs or operating and maintenance costs associated with the collection of information.

This estimate is based on FDA’s 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 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 takes
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
(approved under OMB Control No. 0910-0291). 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 25 percent of serious
adverse event reports related to dietary supplements will require a follow-up report, 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.
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Recordkeeping
Table 2 – Estimated Annual Recordkeeping Burden1
21 U.S.C. Section

No. of
Recordkeepers

No. of Records
per Recordkeeper

1,700

74

21 U.S.C. 379aa1(e)(1)- dietary
supplement
adverse events
records
TOTAL

Total
Annual
Records

125,800

Avg. Burden
per
Recordkeeping

0.5
(30 mins.)

Total
Hours

62,900

62,900

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There are no capital costs or operating costs associated with the 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.
12b. Annualized Cost Burden Estimate
Reporting Cost Burden Estimate
The total annual hour cost burden to respondents is approximately $671,427.90 per year. FDA
estimates that the average hourly wage for an employee to prepare and submit an adverse event
report and follow-up medical information would be equivalent to a GS-14/Step-1 level in the
locality pay area of Washington-Baltimore in 2016, which is $52.17/hour. Doubling this wage to
account for overhead costs, FDA estimates the average hourly cost to respondents to be
$104.34/hour. Thus, the overall estimated cost incurred by the respondents is $671,427.90
(6,435 burden hours x $104.34/hour = $671,427.90).

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Recordkeeping Cost Burden Estimate
FDA estimates the recordkeeping hour burden costs to be about $52.17 ($104.34 x 0.5 hours) per
record kept. This estimate is based upon the records being kept by an employee making a salary
equivalent to a GS-14/Step 1 level in the locality pay area of Washington-Baltimore in 2016,
which is $52.17/hour. Doubling this wage to account for overhead costs, FDA estimates the
average hourly cost to recordkeepers to be $104.34/hour. Thus, the overall estimated cost
incurred by recordkeepers is $6,562,986 ($52.17 per record x 125,800 records).
13. Estimates of Other Total Annual Cost Burden to Respondents and Record Keepers
There are no capital costs or operating and maintenance costs associated with this collection.

14. Annualized Cost to the Federal Government
The initial evaluation of a dietary supplement adverse event includes reviewing the case,
reviewing related literature, writing a summary of the case, and providing an opinion about the
association between the product(s) and the adverse event(s) and documenting the clinical review
into the CFSAN Adverse Event Report System (CAERS) database. This task takes between 1-2
hours. A more in-depth analysis of an adverse event(s) such as looking for adverse event
patterns, or signal detection of an adverse event(s) being associated with a product and then
rewriting summarized reports to supervisors, could take between 40 to 60 hours or much longer
depending on the number of cases needed to be analyzed, complexity of the cases and related
literature research. Therefore, we estimate that on average it takes 1.5 hours for an initial
evaluation. The cost of each evaluation is about $203.49 (1.5 hours x $135.66 per hour). This
estimate is based upon the evaluation being done by an employee making a salary equivalent to a
GS-14-10 level in the locality pay area of Washington-Baltimore in 2016, which is $67.83/hour.
Doubling this wage to account for overhead costs, FDA estimates the average hourly cost to the
Federal Government to be $135.66/hour.
The in-depth analysis of each adverse event we estimate takes an average of 50 hours. The cost
of each in-depth analysis is about $6,783 (50 hours x $135.66 per hour). This estimate is based
upon the analysis being done by an employee making a salary equivalent to a GS-14-10 level in
the locality pay area of Washington-Baltimore in 2016, which is $67.83/hour. Doubling this
wage to account for overhead costs, we estimate the average hourly cost to the Federal
Government to be $135.66/hour.
Estimating that FDA will receive 2,860 serious adverse event reports annually, the total annual
cost to the Federal Government for the initial evaluation and in-depth analysis of all reports is
approximately $19,399,380 ($6,749 x 2,860).
15. Explanation for Program Changes or Adjustments
This information collection reflects agency adjustments. Also, the agency notes minor
calculation errors in its published notices but has corrected them in this supporting statement.
While there is a decrease in annual reports from 10,200 to 3,604 (a decrease of 6,596) with a

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corresponding decrease in hourly burden from 18,360 to 6,494 (a decrease of 11,866 hours),
there is an increase in annual records from 118,400 to 125,800 (an increase of 7,400) with a
corresponding increase in hourly burden from 59,200 to 62,900 (an increase of 3,700 hours).
The decrease in reporting reflects that fewer adverse event reports have been received and
consequently there are fewer follow-up reports. At the same time, the increase in recordkeeping
is attributable to an increase in the estimated number of respondents.
16. Plans for Tabulation and Publication and Project Time Schedule
We are not publishing any information received as a result of this information collection.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
We are not seeking approval to not display the expiration date for OMB approval of the
information collection.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

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