[Federal Register Volume 84, Number 103 (Wednesday, May 29, 2019)]
[Notices]
[Pages 24798-24801]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-11074]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-4131]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Food and Drug 
Administration Adverse Event Reports; Electronic Submissions

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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 June 
28, 2019.

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 [email protected]. All 
comments should be identified with the OMB control number 0910-0645. 
Also include the FDA docket number found in brackets in the heading of 
this document.

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: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance. FDA Adverse Event Reports; Electronic 
Submissions--21 CFR 310.305, 314.80, 314.98, 314.540, 329.100, 514.80, 
600.80, 1271.350, and Part 803 OMB Control Number 0910-0645--Extension

I. Background

    The Safety Reporting Portal (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

[[Page 24799]]

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, 329, 514, 600, 803, and 1271, specifically 
Sec. Sec.  [thinsp]310.305, 314.80, 314.98, 314.540, 329.100, 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, 329.100, 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 Forms FDA 3500, 3500A, 
1932, and 1932a are approved under OMB control numbers 0910-0284 and 
0910-0291, this notice solicits comments on adverse event reports filed 
electronically via the SRP and the ESG, and currently approved under 
OMB control number 0910-0645.

II. The FDA Safety Reporting Portal Rational Questionnaires

    FDA currently has OMB approval to receive several types of adverse 
event reports electronically via the SRP using rational questionnaires. 
In this notice, FDA seeks comments on the extension of OMB approval for 
the following rational questionnaires and the proposed revision of the 
existing rational questionnaire for tobacco products.

A. Reportable Food Registry Reports

    The Food and Drug Administration Amendments Act of 2007 (Pub. L. 
110-085) (FDAAA) amended the Federal Food, Drug, and Cosmetic Act (FD&C 
Act) by creating section 417 (21 U.S.C. 350f), Reportable Food Registry 
(RFR). 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.) We designed the RFR report rational questionnaire to enable us 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 
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

    Section 512(l) of the FD&C Act (21 U.S.C. 360b(l)) and Sec.  
[thinsp]514.80(b) of FDA's regulations (21 CFR 514.80(b)) 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 we obtain 
information regarding potential problems with the safety and efficacy 
of marketed approved new animal drugs as well as potential product/
manufacturing problems. Postapproval 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.
    To report adverse drug experiences and product/manufacturing 
defects using the Agency's paper forms, respondents are 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 Sec.  
[thinsp]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, however, we encourage respondents 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.

C. Animal Food Adverse Event and Product Problem Reports

    Section 1002(b) of FDAAA directed the Secretary of Health and Human 
Resources to establish an early warning and surveillance system to 
identify adulteration of the pet food supply and outbreaks of illness 
associated with pet food. We developed the Pet Food Early Warning 
System rational questionnaire as a user-friendly data collection tool, 
as well as a questionnaire for collecting voluntary adverse event 
reports associated with livestock food. 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. 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 since last OMB review.

D. Voluntary Tobacco Product Adverse Event and Product Problem Reports

    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. We collect 
voluntary adverse event reports associated with the use of tobacco 
products from interested parties such as healthcare providers, 
researchers, consumers, and other users of tobacco products. 
Information collected in voluntary adverse event reports contributes to 
FDA's Center for Tobacco Products (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 
responsibility to obtain current, timely, and policy-relevant 
information to carry out our statutory functions. CTP has been 
receiving adverse event and product problem reports through the SRP 
since January 2014. CTP has developed two voluntary rational 
questionnaires on the SRP. The first is utilized by consumers and 
concerned citizens to report tobacco product adverse event or product 
problems. A second rational questionnaire is used by tobacco product 
investigators in clinical

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trials with investigational tobacco products. Both CTP voluntary 
rational questionnaires capture tobacco-specific adverse event and 
product problem information from reporting entities such as healthcare 
providers, researchers, consumers, and other users of tobacco products.

E. Dietary Supplement Adverse Event Reports

    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 ``responsible person'') 
is required to submit to FDA a followup 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 followup 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 followup 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. The electronic submission 
data elements to report adverse events associated with dietary 
supplement products remain unchanged in this request for extension of 
OMB approval.

F. Food, Infant Formula, and Cosmetic Adverse Event Reports

    Rational questionnaires have also been developed for submitting 
adverse event reports for food, infant formula, and cosmetics. The 
electronic submission data elements to report adverse events associated 
with food, infant formula, and cosmetics products remain unchanged in 
this request for extension of OMB approval.
    In the Federal Register of November 30, 2018 (83 FR 61653), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. One general comment was received suggesting 
the associated forms could be improved but did not include specific 
problems that might have been encountered. We are appreciative of this 
comment and continually seek ways to improve the electronic reporting 
of adverse events associated with FDA-regulated products.

III. Information Collection Burden Estimate

    Description of respondents: The respondents to this 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.
    We estimate the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                             Number of
                        Activity                             FDA Form        Number of     responses per   Total annual   Average burden    Total hours
                                                              number        respondents     respondent       responses     per response
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Voluntary Adverse Event Report via the SRP (Other than              3800           1,800               1           1,800             0.6           1,080
 RFR Reports)...........................................
Mandatory Adverse Event Report via the SRP (Other than              3800           3,360               1           3,360               1           3,360
 RFR Reports)...........................................
Mandatory Adverse Event Report via the ESG (Gateway-to-             3800       3,007,000               1       3,007,000             0.6       1,804,200
 Gateway transmission)..................................
Mandatory and Voluntary RFR Reports via the SRP.........            3800           1,260               1           1,260             0.6             756
                                                         -----------------------------------------------------------------------------------------------
    Total...............................................  ..............  ..............  ..............  ..............  ..............       1,809,396
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
* 36 minutes.


[[Page 24801]]

    Our estimate of the number of respondents and the total annual 
responses in table 1, Estimated Annual Reporting Burden, is based 
primarily on mandatory and voluntary adverse event reports 
electronically submitted to the Agency. The estimated total annual 
responses are based on initial reports. Followup reports, if any, are 
not counted as new reports. Based on our experience with adverse event 
reporting, we assume it takes respondents 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. We assume it takes respondents 0.6 hour to 
submit an RFR report, whether the submission is mandatory or voluntary.
    The burden hours required to complete paper FDA reporting forms 
(Forms FDA 3500, 3500A, 1932, and 1932a) are reported under OMB control 
numbers 0910-0284 and 0910-0291. While we do not charge for the use of 
the ESG, we require 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.
    Our estimated burden for the information collection reflects an 
overall increase of 688,547 hours and a corresponding increase of 
1,145,763 responses. We attribute this adjustment to an increase in the 
number of submissions we have received over the last few years.

    Dated: May 22, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-11074 Filed 5-28-19; 8:45 am]
 BILLING CODE 4164-01-P