0645 Ss 2016

FDA Adverse Event Reporting; Electronic Submissions
OMB Control No. 0910-0645
SUPPORTING STATEMENT
A. Justification
1. Circumstances Making the Collection of Information Necessary
The FDA Safety Reporting Portal (the SRP) and the Electronic Submission Gateway (ESG) are the
agency’s electronic systems for collecting, submitting, and processing adverse event reports,
product problem reports, and other safety information for FDA-regulated products. To ensure the
safety and identify any risks, harms, or other dangers to health for all FDA-regulated human and
animal products, the agency needs to be informed whenever an adverse event, product quality
problem, or product use error occurs. This risk identification process is the first necessary step that
allows the agency to gather the information necessary to be able to evaluate the risk associated with
the product and take whatever action is necessary to mitigate or eliminate the public's exposure to
the risk.
Some adverse event reports are required to be submitted to FDA (mandatory reporting) and some
adverse event reports are submitted voluntarily (voluntary reporting). Requirements regarding
mandatory reporting of adverse events or product problems have been codified in 21 CFR parts 310,
314, 514, 600, 803 and 1271, specifically §§ 310.305, 314.80, 314.98, 314.540, 514.80, 600.80,
803.30, 803.40,803.50, 803.53, 803.56 and 1271.350(a) ( 21 CFR 310.305, 314.80, 314.98,
314.540, 514.80, 600.80, 803.30, 803.40,803.50, 803.53, 803.56 and 1271.350(a)). While adverse
event reports submitted to FDA in paper format using FDA Forms FDA 3500, 3500A, 1932, and
1932a, are approved under OMB control numbers 0910-0284 and 0910-0291, this information
collection request concerns adverse event reports filed electronically via the SRP and the ESG, and
currently approved under OMB control number 0910-0645.
We request the extension of OMB approval for the following collection of information requirements
and four rational questionnaires (RQs) available as variations of Form FDA 3800:
21 CFR 310.305, 314.80, 314.98, 314.540, 514.80, 600.80, 803.30, 803.40, 803.50, 803.53, 803.56
and 1271.350(a) -- Reporting
Requires submission of an adverse event report to FDA, sets forth the information that the report is
required to contain, the method of submission of the report, and the time within which the report
must be submitted.
The FDA Safety Reporting Portal Rational Questionnaires:
FDA currently accepts several types of adverse event reports electronically via the SRP using RQs.
We are revising the collection with regard to the RQs for dietary supplements; the RQ for tobacco
products; a new RQ that will be used for a new safety reporting program for clinical trials and/or
investigational use by the Center for Tobacco Products (CTP); and new RQs that will be used for
food, infant formula, and cosmetic adverse event reports.

1

A. Reportable Food Registry Reports - Unchanged
The Food and Drug Administration Amendments Act of 2007 (Pub. L. 110–085) (FDAAA)
amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) by creating section 417 (21
U.S.C. 350f), Reportable Food Registry (RFR or the Registry). Section 417 of the FD&C Act
defines “reportable food” as an “article of food (other than infant formula or dietary supplements)
for which there is a reasonable probability that the use of, or exposure to, such article of food will
cause serious adverse health consequences or death to humans or animals.” (See section 417(a)(2)
of the FD&C Act). The Secretary of Health and Human Services (the Secretary) has delegated to
the Commissioner of FDA the responsibility for administering the FD&C Act, including section
417. The Congressionally identified purpose of the RFR is to provide “a reliable mechanism to
track patterns of adulteration in food [which] would support efforts by [FDA] to target limited
inspection resources to protect the public health” (121 Stat. 965). We designed the RFR report RQ
to enable FDA to quickly identify, track, and remove from commerce an article of food (other than
infant formula and dietary supplements) for which there is a reasonable probability that the use of,
or exposure to, such article of food will cause serious adverse health consequences or death to
humans or animals. FDA’s Center for Food Safety and Applied Nutrition (CFSAN) uses the
information collected to help ensure that such products are quickly and efficiently removed from the
market to prevent foodborne illnesses. The data elements for RFR reports remain unchanged in this
request for extension of OMB approval.
B. Reports Concerning Experience With Approved New Animal Drugs - Unchanged
Section 512(l) of the FD&C Act (21 U.S.C. 360b(l)) and § 514.80(b) of FDA’s regulations (21 CFR
514.80) require applicants of approved new animal drug applications (NADAs) and approved
abbreviated new animal drug applications (ANADAs) to report adverse drug experiences and
product/ manufacturing defects to the Center for Veterinary Medicine (CVM). This continuous
monitoring of approved NADAs and ANADAs affords the primary means by which FDA obtains
information regarding potential problems with the safety and efficacy of marketed approved new
animal drugs as well as potential product/manufacturing problems. Post-approval marketing
surveillance is important because data previously submitted to FDA may no longer be adequate, as
animal drug effects can change over time and less apparent effects may take years to manifest.
If an applicant must report adverse drug experiences and product/ manufacturing defects and
chooses to do so using the agency’s paper forms, the applicant is required to use Form FDA 1932,
“Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product Defect Report.” Periodic drug
experience reports and special drug experience reports must be accompanied by a completed Form
FDA 2301, “Transmittal of Periodic Reports and Promotional Material for New Animal Drugs” (see
§ 514.80(d)). Form FDA 1932a, “Veterinary Adverse Drug Reaction, Lack of Effectiveness or
Product Defect Report” allows for voluntary reporting of adverse drug experiences or
product/manufacturing defects by veterinarians and the general public. Collection of information
using existing paper forms FDA 2301, 1932, and 1932a is approved under OMB control number
0910–0284.
Alternatively, an applicant may choose to report adverse drug experiences and
product/manufacturing defects electronically. The electronic submission data elements to report
adverse drug experiences and product/manufacturing defects electronically remain unchanged in
this request for extension of OMB approval.
2

C. Animal Food Adverse Event and Product Problem Reports - Unchanged
Section 1002(b) of FDAAA directed the Secretary to establish an early warning and surveillance
system to identify adulteration of the pet food supply and outbreaks of illness associated with pet
food. As part of the effort to fulfill that directive, the Secretary tasked FDA with developing the
instrument that would allow consumers to report voluntarily adverse events associated with pet
food. We developed the Pet Food Early Warning System RQ as a user-friendly data collection tool,
to make it easy for the public to report a safety problem with pet food. Subsequently, we developed
a questionnaire for collecting voluntary adverse event reports associated with livestock food from
interested parties such as livestock owners, managers, veterinary staff or other professionals, and
concerned citizens. Information collected in these voluntary adverse event reports contribute to
CVM’s ability to identify adulteration of the livestock food supply and outbreaks of illness
associated with livestock food. The Pet Food Early Warning System and the Livestock Food
Reports are designed to identify adulteration of the animal food supply and outbreaks of illness
associated with animal food to enable us to quickly identify, track, and remove from commerce
such articles of food. We use the information collected to help ensure that such products are
quickly and efficiently removed from the market to prevent foodborne illnesses. The electronic
submission data elements to report adverse events associated with animal food remain unchanged in
this request for extension of OMB approval.
D. Voluntary Tobacco Product Adverse Event and Product Problem Reports – Revision; New RQ
As noted above, we are making certain revisions to the collection, including (1) a revision to the
existing RQ utilized by consumers and concerned citizens to report tobacco product adverse event
or product problems, and (2) a proposed new RQ that will be used for a new safety reporting
program for clinical trials and/or investigational use by CTP.
FDA has broad legal authority under the FD&C Act to protect the public health, including
protecting Americans from tobacco-related death and disease by regulating the manufacture,
distribution, and marketing of tobacco products and by educating the public, especially young
people, about tobacco products and the dangers their use poses to themselves and others. The
Family Smoking Prevention and Tobacco Control Act of 2009 (Pub. L. 111–31) (Tobacco Control
Act) amended the FD&C Act by creating a new section 909 (21 U.S.C. 387i, Records and Reports
on Tobacco Products). Section 909(a) of the FD&C Act (21 U.S.C. 387i(a)) authorizes FDA to
establish regulations with respect to mandatory adverse event reports associated with the use of a
tobacco product. At this time, FDA collects voluntary adverse event reports associated with the use
of tobacco products from interested parties such as health care providers, researchers, consumers,
and other users of tobacco products. Information collected in voluntary adverse event reports will
contribute to CTP’s ability to be informed of, and assess the real consequences of, tobacco product
use.
The need for this collection of information derives from our objective to obtain current, timely, and
policy-relevant information to carry out our statutory functions. The FDA Commissioner is
authorized to undertake this collection as specified in section 1003(d)(2) of the FD&C Act (21
U.S.C. 393(d)(2)).

3

FDA’s CTP has been receiving adverse event and product problem reports through the Safety
Reporting Portal since January 2014, when the Safety Reporting Portal for tobacco products first
became available to the public. CTP also receives adverse event and product problem reports via
paper forms, as approved under OMB control number 0910-0291. The original questionnaire
evolved with input from a National Institutes of Health team of human-factors experts, from other
regulatory agencies, and with extensive input from consumer advocacy groups and the general
public. The revised CTP questionnaire along with the proposed new Investigator questionnaire
build on the foundation of the original RQ to make the report’s data more useful, analyzable, and
specific. The changes from the original to the new questionnaire are made in an effort to make the
questions more understandable and specific. In some instances, alterations were made to the list of
values to choose from by the end user in order to include values more pertinent to CTP’s current
and future data collection needs. In other instances, questions were added that will provide FDA
with more specific, analyzable information. In still other instances, questions were removed
altogether in an effort to streamline the questionnaire and make it more user-friendly. All changes
were made with the goal of providing FDA more pertinent information while minimizing the
burden on the reporter. Finally, we note that users who are unable to submit reports using the
electronic system will still be able to provide their information by paper form (by mail or fax) or
telephone.
The new RQ will be used by tobacco product investigators in clinical trials with investigational
tobacco products. In addition to the information collected by the existing RQ for tobacco products,
the new RQ will collect identifying information specific to the clinical trial or investigational
product such as clinical protocol numbers or other identifying features to pinpoint under which test
or protocol the adverse event occurred.
Both CTP voluntary will capture tobacco-specific adverse event and product problem information
from voluntary reporting entities such as health care providers, researchers, consumers, and other
users of tobacco products. To carry out its responsibilities, FDA needs to be informed when an
adverse event, product problem, or error with use is suspected or identified. When FDA receives
tobacco-specific adverse event and product problem information, it will use the information to
assess and evaluate the risk associated with the product, and then FDA will take whatever action is
necessary to reduce, mitigate, or eliminate the public’s exposure to the risk through regulatory and
public health interventions.
E. Dietary Supplement Adverse Event Reports– Revision
The Dietary Supplement and Nonprescription Drug Consumer Protection Act (DSNDCPA) (Pub.
L. 109–462, 120 Stat. 3469) amended the FD&C Act with respect to serious adverse event reporting
and recordkeeping for dietary supplements and nonprescription 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 (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

4

“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.
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. The guidance document
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,” 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.
Reporting of serious adverse events for dietary supplements to FDA serves as an early warning sign
of potential public health issues associated with such products. 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 provides a reliable mechanism to track patterns of
adulteration in food that supports efforts by FDA to target limited inspection resources to protect the
public health. FDA uses the information collected to help ensure that such products are quickly and
efficiently removed from the market to prevent foodborne illnesses.
Paper mandatory dietary supplement adverse event reports are submitted to FDA on the MedWatch
form, Form FDA 3500A, and paper voluntary reports are submitted on Form FDA 3500. Forms
FDA 3500 and 3500A are available as fillable pdf forms. Dietary supplement adverse event reports
may be electronically submitted to the agency via the SRP. This method of submission is
voluntary. A manufacturer, packer, or distributor of a dietary supplement who is unable to or
chooses not to submit reports using the electronic system will still be able to provide their
information by paper MedWatch form, Form FDA 3500A (by mail or fax). There is no change to
the mandatory information previously required on the MedWatch form. CFSAN is making
available the option to submit the same information via electronic means. However, we are adding
a new voluntary question on the mandatory report RQ and a new voluntary question on the
voluntary report RQ. The text of the new questions is provided in table 1. Finally, we are changing
the following data elements from a text box method of response to an individual question and
answer method: Race and known allergies.
Table 1. – Proposed New Questions on the Dietary Supplement Rational Questionnaire
Text of new question
Is response mandatory or voluntary?
Voluntary, and only displayed if the
Mandatory Report -In the Contact Information
section, we propose to add, “Please provide contact person filling out the report is reporting on
information for you, the person who is filling out
behalf of a responsible person, such as a
this report.”
contractor, and has not created an account
on the SRP.
Voluntary.
Voluntary Report - In the Product Information
section, we propose to request the ingredients of the
suspect and concomitant product(s), as provided on
the label of the product(s).

5

The reporting and recordkeeping requirements for dietary supplement adverse event reports and the
recommendations of the guidance are approved under OMB control number 0910-0635. Burden
hours are also reported under OMB control number 0910-0291 reflecting the submission of dietary
supplement adverse event reports on the paper MedWatch form, Form FDA 3500A.
F. Food, Infant Formula, and Cosmetic Adverse Event Reports – New RQ
We are planning new RQ functionality that will be used for food, infant formula, and cosmetic
adverse event reports. Currently, voluntary adverse event reports for such products are submitted
on Form FDA 3500, which is available as a fillable pdf form. However, we have not developed
RQs by which these reports may be electronically submitted to us via the SRP. In addition,
MedWatch forms, although recently updated with field labels and descriptions to better clarify for
reporters the range of reportable products, do not specifically include questions relevant for the
analysis of adverse events related to food, infant formula, and cosmetics. The food, infant formula,
and cosmetics RQ functionality will operate in a manner similar to the dietary supplement RQ and
will include specific questions relevant for the analysis of adverse events related to food, infant
formula, and cosmetics.
Table 2. -- New Questions on the Proposed Food, Infant Formula, and Cosmetics Rational
Questionnaires for Both Suspect and Concomitant Products
Text of new question
Is response mandatory or voluntary?
For food products:
Voluntary.
“Is this a medical food?”
“If so, what was the diagnosis or reason for use?”
“How was the product prepared?”
For infant formula products:
Voluntary.
“What form of the product was used: Concentrate,
powder or ready to serve?”
Is this a specialized infant formula?”
“If so, what was the diagnosis or reason for use?”
“How was the product prepared?”
“What type of water was used to prepare the
formula?”
For cosmetic products:
Voluntary.
“Do you have existing skin conditions?”
“How soon did symptoms develop after using the
product?
“Did the intensity of the reaction get worse with
time?
“Where did the reaction develop?”
“What treatments were sought for this adverse
event?”
“What ingredient do you suspect caused the adverse
event?”
“Has the problem resolved?”
“Does the product label contain a warning or
caution statement?”

6

2. Purpose and Use of the Information Collection
The information collected is used by FDA to assess potential public health issues, evaluate the risk,
if any, associated with the regulated product, and take whatever action is necessary to reduce,
mitigate, or eliminate the public's exposure to the risk. In addition, the information received
provides a reliable mechanism to track patterns of adulteration in FDA-regulated products and
supports efforts by FDA to target limited inspection resources to protect the public health. Without
notification of all adverse events associated with products it regulates, 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. The need for this collection of information derives from our objective to
obtain current, timely, and policy-relevant information to carry out our statutory functions.
Description of Respondents: Respondents to the collection of information include all persons
submitting mandatory or voluntary adverse event reports electronically to FDA via the ESG or the
SRP regarding FDA-regulated products. Respondents include, unless otherwise exempt, individuals
and households, the private sector (including for-profit businesses, not-for-profit institutions and
farms), state local or tribal governments, as well as the Federal government.
3. Use of Improved Information Technology and Burden Reduction
This information collection supports electronic submission of adverse event reports and other safety
information submitted via the SRP and ESG to FDA. Thus, one hundred percent (100%) of the
respondents will use electronic means to submit the information.
4. Efforts to Identify Duplication and Use of Similar Information
There is no duplication of reporting in this information collection as a result of the mandatory
adverse event reporting required by statute or regulation. To the best of FDA’s knowledge, no other
Federal government agency is engaged in the collection of this information. In the event that we
receive a report on a product that is not under FDA’s jurisdiction, the report will be forwarded to the
as appropriate. For example, adverse event reports submitted for biologic products used for animals
will be forwarded to the U.S. Department of Agriculture.
5. Impact on Small Businesses or Other Small Entities
FDA estimates that fifty percent (50%) of respondents are small businesses, however the SRP is
available to all users through the Internet, without requiring the use of special software. FDA aids
small businesses in complying with its requirements through the agency’s Regional Small Business
Representatives and through its scientific and administrative staffs. 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. Original adverse event and safety reports are submitted once
and cannot, therefore, be collected less frequently.

7

7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
Due to the nature of adverse event reporting, this information collection involves more than
quarterly submission of information to the agency and written responses to the agency in less than
30 days. The specific reporting timeframes required by statute are summarized below:
Name of Report:
Reportable Food
Registry Reports

Reports Concerning
Experience With
Approved New
Animal Drugs

Animal Food
Adverse Event and
Product Problem
Reports
Voluntary Tobacco
Product Adverse
Event and Product
Problem Reports and
Investigator Reports
Dietary Supplement
Adverse Event
Reports

Food, Infant Formula
and Cosmetic
Adverse Event
Reports

Table 3.—Required Timeframes for Submitting Reports
Reporting Timeframe:
Under section 417(d)(1) of the FD&C Act, a responsible party is required to submit a
reportable food registry report to FDA as soon as practicable, but in no case later than 24 hours
after determining that the food is an “article of food (other than infant formula or dietary
supplements) for which there is a reasonable probability that the use of, or exposure to, such
article of food will cause serious adverse health consequences or death to humans or animals.”
(See section 417(a)(2))
Pursuant to 21 CFR 514.80(b)(1), the applicant is required to submit product and
manufacturing defects that may result in serious adverse drug events are to be reported within 3
working days of first becoming aware that a defect may exist. Pursuant to 21 CFR
514.80(b)(2)(i)-(ii), the applicant is required to submit initial and follow-up reports within 15
working days. Pursuant to 21 CFR 514.80(b)(3), the non-applicant is required to report adverse
drug experiences to the applicant within 3 working days of first receiving the information or if
reported to FDA within 15 working days.
These are voluntary reports. There is no required timeframe for submission.

These are voluntary reports. There is no required timeframe for submission.

Mandatory reports - Serious adverse event reports received through the address or phone
number on the label of a dietary supplement, as well as all follow-up reports of new medical
information received by the responsible person within one year after the initial report, must be
submitted to FDA no later than 15 business days after the report is received by the responsible
person. Section 761(c)(1)-(2) of the FD&C Act (21 U.S.C. 379aa-1(c)(1)-(2)).
Voluntary reports - There is no required timeframe for submission of a voluntary report.
These are voluntary reports. There is no required timeframe for submission.

Short timeframes for reporting are necessary so that FDA is informed as soon as possible of any
serious problems with products it regulates. Delayed or less frequent reporting of some serious
adverse events to FDA would diminish the effectiveness of adverse event reporting as an early
warning sign of possible safety problems with FDA-regulated products. Without notification of all
serious adverse events, 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.
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

8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the
Agency
In accordance with 5 CFR 1320.8(d), in the Federal Register of November 18, 2015 (80 FR 72071)
FDA published a 60-day notice requesting public comment on the proposed revision of this
information collection. 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
The HIPAA Privacy Rule recognizes the legitimate need for public health authorities and others
responsible for ensuring public health and safety to have access to protected health information to
carry out their public health mission. [DISCLOSURES FOR PUBLIC HEALTH ACTIVITIES, 45
CFR 164.512(b)] The Rule also recognizes that public health reports made by covered entities are
an important means of identifying threats to the health and safety of the public at large, as well as
individuals. Accordingly, the Rule permits covered entities to disclose protected health information
without authorization for specified public health purposes. Covered entities may disclose protected
health information to a person subject to FDA jurisdiction, for public health purposes related to the
quality, safety or effectiveness of an FDA-regulated product or activity for which that person has
responsibility. Examples of purposes or activities for which such disclosures may be made include,
but are not limited to:
 Collecting or reporting adverse events (including similar reports regarding food and dietary
supplements), product defects or problems (including problems regarding use or labeling),
or biological product deviations;
 Tracking FDA-regulated products;
 Enabling product recalls, repairs, replacement or look back (which includes locating and
notifying individuals who received recalled or withdrawn products or products that are the
subject of look back); and
 Conducting post-marketing surveillance.
The “person” subject to the jurisdiction of the FDA does not have to be a specific individual.
Rather, it can be an individual or an entity, such as a partnership, corporation, or association.
Release of information submitted to FDA in voluntary adverse experience reports is governed by 21
CFR 20.63(f), which prohibits FDA and a manufacturer in possession of such reports from releasing
to the public the names of patients, individual reporters, health care practitioners, hospitals, and any
geographic identifiers.
FDA provides no assurance of confidentiality to responsible persons who voluntarily decide, or are
required, to submit a RFR report to FDA. Under section 417(h) of the FD&C Act, a record in the
Reportable Food Registry is subject to a request under the Freedom of Information Act (FOIA) (5
U.S.C. 552), except that FDA registration numbers are protected from disclosure as provided by
section 415(a)(4) of the FD&C Act. In addition, confidential commercial information is protected
from disclosure under FOIA under sections 552(a) and (b) (5 U.S.C. 552(a) and (b)), and by part 20
9

of the agency’s regulations (21 CFR part 20). To the extent 21 CFR 20.64 applies, FDA will honor
the confidentiality of any data in investigation records compiled for law enforcement purposes.
The RQ and the voluntary paper report forms (e.g., Form FDA 3500, Form FDA 1932a) used by
healthcare professionals and consumers to report directly to the FDA informs the reporter that their
identity, including self-reporters, will be shared with the manufacturer of the product unless they
indicate otherwise during the completion of the RQ report view or checking box G5 on the Form
FDA 3500 or the box on the top left on Form FDA 1932a. This limited disclosure will not trigger
release of such information under FOIA.
With regard to Reports Concerning Experience with Approved New Animal Drugs, confidentiality
of the information submitted under these reporting requirements is protected under 21 CFR 514.11
and under 21 CFR part 20. The unauthorized use or disclosure of trade secrets required in
applications is specifically prohibited under Section 310(j) of the Act. Further, under the terms of
the Freedom of Information Act, the veterinarian's name, address, and phone number, and the
owner's name, etc., reported on Form FDA 1932 cannot be made available to a public request.
11. Justification for Sensitive Questions
This information collection does not contain questions of a sensitive nature (e.g., those regarding
sexual behavior and attitudes, religious beliefs, etc).
12. Estimates of Annualized Burden Hours and Costs
12a. Annualized Hour Burden Estimate
FDA estimates the burden of this collection of information as follows:
Table 4.--Estimated Annual Reporting Burden1
Activity

FDA
Form
No.
3800

No. of
Respondents

No. of
Responses per
Respondent
1

Total
Annual
Responses
1,786

Average
Burden per
Response
0.6
(36 minutes)

Total
Hours

Voluntary Adverse Event
1,786
1,072
Report via the SRP (Other
than RFR Reports).
Mandatory Adverse Event
3800
636
1
636
1
636
Report via the SRP (Other
than RFR Reports).
Mandatory Adverse Event
3800
1,864,035
1
1,864,035
0.6 1,118,421
Report via the ESG
(36 minutes)
(Gateway-to-Gateway
transmission).
Mandatory and Voluntary
3800
1,200
1
1,200
0.6
720
RFR Reports via the SRP.
(36 minutes)
Total
1,120,849
1
There are no capital costs or operating and maintenance costs associated with this collection of information.

The agency’s estimate of the number of respondents and the total annual responses in table 4,
Estimated Annual Reporting Burden, is based on mandatory and voluntary adverse event reports
electronically submitted to the agency. The estimated total annual responses are based on initial
10

reports. Follow-up reports, if any, are not counted as new reports. Based on its experience with
adverse event reporting, FDA estimates it takes a respondent 0.6 hour to submit a voluntary adverse
event report via the SRP, 1 hour to submit a mandatory adverse event report via the SRP, and 0.6
hour to submit a mandatory adverse event report via the ESG (gateway-to-gateway transmission).
Both mandatory and voluntary RFR reports must be submitted via the SRP. FDA estimates it takes
a respondent 0.6 hour to submit a RFR report, whether the submission is mandatory or voluntary.
Voluntary adverse event reports submitted via the SRP (other than RFR Reports) include reports
associated with pet food (the Pet Food Early Warning System) and the new tobacco product adverse
event and product problem reports.
Mandatory adverse event reports submitted via the SRP (other than RFR Reports) include reports of
adverse animal drug experiences and product/manufacturing defects associated with approved
NADAs and ANADAs.
Adverse event reports submitted via the ESG include reports of adverse experiences related to
drugs, biological products, and medical devices, as well as, adverse animal drug experiences and
product/manufacturing defects associated with approved NADAs and ANADAs.
Burden associated with paper FDA reporting forms (Forms FDA 3500, 3500A, 1932, and 1932a) is
reported under OMB control numbers 0910-0284 and 0910-0291. While FDA does not charge for
the use of the ESG, FDA requires respondents to obtain a public key infrastructure certificate in
order to set up the account. This can be obtained in-house or outsourced by purchasing a public key
certificate that is valid for 1 year to 3 years. The certificate typically costs from $20 to $30.
12b. Annualized Cost Burden Estimate
The annual hour cost burden to respondents is approximately $82,046,146 per year. FDA estimates
that the average hourly wage for the employee preparing and submitting the report would be
equivalent to a GS-12/Step-1 level in the locality pay area of Washington-Baltimore in 2015,
approximately $36.60/hour. Doubling this wage to account for overhead costs, FDA estimates the
average hourly cost to respondents to be $73.20/hour. Thus, the overall estimated cost incurred by
the respondents is $82,046,146 (1,120,849 burden hours x $73.20/hr = $82,046,146).
13. Estimates of Other Total Annual Costs to Respondents and/or Recordkeepers/Capital
Costs
There are no capital, start-up, operating or maintenance costs associated with this information
collection.
14. Annualized Cost to the Federal Government
FDA’s internal assessment estimates that the cost for processing an electronic submission is $19.00
per report. The total annual responses (table 4) are estimated at 1,867,657 reports per year. Thus,
$19.00 x 1,867,657 reports = $35,485,483 per year.

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15. Explanation for Program Changes or Adjustments
The collection of information reflects revisions and adjustments, as explained below.
IC#1: This collection represents voluntary reporting using electronic FDA Form 3800 via the
Safety Reporting Portal. We have increased our estimate by 273 responses and 164 hours to reflect
additional reporting for Foods RQ, Infant Formula RQ, and tobacco product investigators RQ.
IC#2: This collection represents mandatory reporting using electronic FDA Form 3800 via the
Safety Reporting Portal. This collection remains unchanged.
IC#3: This collection represents mandatory reporting using electronic FDA Form 3800 via the
Electronic Submission Gateway. We have increased our estimate by 372,807 responses and
223,684 hours as the number of submissions continues to grow. We attribute the increase to the
system’s ability to more firms utilizing this reporting mechanism.
IC#4: This collection represents mandatory and voluntary reportable food registry (RFR) reports
submitted using electronic FDA Form 3800 via the Safety Reporting Portal. This collection
remains unchanged.
16. Plans for Tabulation and Publication and Project Time Schedule
No comprehensive statistical reporting, tabulation, or publication of the data are planned. However,
we do plan to post redacted, publically available adverse event data on the FDA website that can be
used by others for informational and analytic purposes.
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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