Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food and Drug Administration Adverse Event Reports; Electronic Submissions
| Published date | 29 May 2019 |
| Citation | 84 FR 24798 |
| Record Number | 2019-11074 |
| Section | Notices |
| Court | Food And Drug Administration,Health And Human Services Department |
Federal Register, Volume 84 Issue 103 (Wednesday, May 29, 2019)
[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
[[Page 24800]]
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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity FDA Form Number of responses per Total annual Average burden Total hours
number respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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
