[Federal Register Volume 78, Number 11 (Wednesday, January 16, 2013)]
[Notices]
[Pages 3433-3437]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-00761]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0921]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Electronic Submission 
of Food and Drug Administration Adverse Event Reports and Other Safety 
Information Using the Electronic Submission Gateway and the Safety 
Reporting Portal

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) 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 (the PRA).

DATES: Fax written comments on the collection of information by 
February 15, 2013.

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 Information 
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400T, 
Rockville, MD 20850, [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.

Electronic Submission of Food and Drug Administration Adverse Event 
Reports and Other Safety Information Using the Electronic Submission 
Gateway and the Safety Reporting Portal--21 CFR 310.305, 314.80, 
314.98, 314.540, 514.80, 600.80, 1271.350 and Part 803 (OMB Control 
Number 0910-0645)--Revision

    The FDA Safety Reporting Portal (the SRP) (formerly referred to as 
the MedWatch\Plus\ Portal and Rational Questionnaire) and the 
Electronic Submission Gateway (ESG) are the Agency's electronic systems 
for collecting, submitting, and processing adverse event 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 Sec. Sec.  
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)). Many of the adverse event reports submitted to FDA are 
currently filed in paper format using FDA Forms FDA 3500, 3500A, 1932, 
and 1932a, 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, approved under OMB control 
number 0910-0645.

I. The FDA Safety Reporting Portal Rational Questionnaires

    FDA currently has OMB approval to receive three types of adverse 
event reports electronically via the SRP using rational questionnaires. 
FDA sought comments on the extension of OMB approval for the existing 
three rational questionnaires, as well as comments on a proposed fourth 
rational questionnaire that will be used for a new safety reporting 
program being launched by the Center for Tobacco Products (CTP).

A. Reportable Food Registry Reports

    The Food and Drug Administration Amendments Act of 2007 (Pub. L. 
110-85) (FDAAA) amended the Federal Food, Drug, and Cosmetic Act (the 
FD&C Act) by creating a new 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

[[Page 3434]]

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. To further the development of the RFR, section 
417 of the FD&C Act required FDA to establish an electronic portal by 
which instances of reportable food (``RFR reports'') must be submitted 
to FDA by responsible parties and may be submitted by public health 
officials. A ``responsible party'' is the person who submits the 
registration under section 415(a) of the FD&C Act (21 U.S.C. 350d) for 
a food facility that is required to register under section 415(a), at 
which such article of food is manufactured, processed, packed, or held. 
The RFR electronic portal was established in 2009 as part of the 
MedWatch\Plus\ Portal, now the SRP, and approved under OMB control 
number 0910-0645.
    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 the Food and Drug Administration to target 
limited inspection resources to protect the public health'' (121 Stat. 
965). The RFR reports are designed 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 uses the information collected to help ensure that such 
products are quickly and efficiently removed from the market to prevent 
foodborne illnesses.
    On January 4, 2011, the President signed into law the FDA Food 
Safety Modernization Act (Pub. L. 111-353) (the legislation or FSMA). 
Section 211 of the legislation amended section 417 of the FD&C Act to 
require FDA to collect additional information in the Agency's RFR 
reports: (1) A description of the article of food; (2) affected product 
identification codes, such as universal product code (UPC), stock 
keeping unit, or lot or batch numbers sufficient for the consumer to 
identify the article of food; (3) contact information for the 
responsible party; and (4) any other information the Secretary 
determines is necessary to enable a consumer to accurately identify 
whether such consumer is in possession of the reportable food.
    Section 211 of FSMA also amended section 417 of the FD&C Act to 
require FDA to generate one-page notices from RFR reports to post on 
www.fda.gov for grocery stores to display to consumers when a 
reportable food has been sold. The amendment made by section 211 of 
FSMA took effect June 4, 2012, 18 months after the date of enactment. 
To comply with this statutory deadline, FDA initially obtained OMB 
approval of the additional collection of information requirements under 
the emergency processing provisions of the PRA under OMB control number 
0910-0709. The new data improves the RFR's effectiveness in carrying 
out its purpose of tracking patterns of adulteration in food and 
supporting FDA's efforts to target limited inspection resources to 
protect the public health.
    Table 1 of this document, entitled ``New Data Elements for RFR 
Reports,'' presents the new data elements added by FDA to RFR Reports 
on June 4, 2012.

               Table 1--New Data Elements for RFR Reports
------------------------------------------------------------------------
                                   Mandatory or         Authority if
          Field text              optional input         mandatory
------------------------------------------------------------------------
Reason this food is reportable  Mandatory........  Section 417(e)(4) of
 (agent).                                           the FD&C Act.
What did your investigation     Mandatory........  Section 417(e)(5) of
 identify as the root cause of                      the FD&C Act.
 the problem (if you were
 required to conduct an
 investigation under section
 417(d)(1)(B) of the FD&C
 Act)?
How did you determine which     Mandatory........  Section 417(e)(4) and
 products/lots/batches were                         (5) of the FD&C Act.
 affected?
To the best of your knowledge,  Mandatory........  Section 417(e)(6) of
 has all of the reportable                          the FD&C Act.
 food been removed from
 commerce?
What corrective actions have    Optional.........
 been taken to prevent future
 occurrences?
Product commodity type........  Mandatory........  Section 417(e)(3) of
                                                    the FD&C Act.
Manufacturing/production        Mandatory........  Section 417(e)(3) and
 date(s).                                           (4) of the FD&C Act.
Use-by dates, if any, or        Mandatory........  Section 417(e)(7) of
 approximate shelf life.                            the FD&C Act.
Was product treated to reduce   Mandatory (but     Section 417(e)(3) and
 microorganisms?                 conditional).      (4) of the FD&C Act.
Microbial reduction treatment   Mandatory (but     Section 417(e)(3) and
 details.                        conditional).      (4) of the FD&C Act
                                                    (Conditional for
                                                    microbial hazards
                                                    only and only after
                                                    ``yes'' answer to
                                                    ``Was product
                                                    treated to reduce
                                                    microorganisms?'').
Is a bacterial isolate          Mandatory (but     Section 417(e)(4) of
 available for collection?       conditional).      the FD&C Act
                                                    (Conditional for
                                                    microbial hazards
                                                    only.)
Animal species intended for...  Mandatory........  Section 417(e)(3) and
                                                    (4) of the FD&C Act.
Life stage of animal intended   Mandatory........  Section 417(e)(3) and
 for.                                               (4) of the FD&C Act.
Have you notified all           Optional.........
 immediate previous sources of
 this reportable food?
Have you notified all           Mandatory........  Section 417(e)(6) of
 immediate subsequent                               the FD&C Act.
 recipients of this reportable
 food?
------------------------------------------------------------------------

    In this request for extension of OMB approval, FDA is combining the 
burden hours associated with OMB control number 0910-0709 with the 
burden hours approved under this OMB control number (0910-0645).

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.  
514.80(b)) require applicants of approved new animal drug

[[Page 3435]]

applications (NADAs) and approved abbreviated new animal drug 
applications (ANADAs) to report adverse drug experiences and product/
manufacturing defects.
    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. 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.
    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 
Sec.  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. 
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. 
Collection of this information electronically was approved in 2010 
under OMB control number 0910-0645. 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. Pet Food Early Warning System

    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.
    FDA developed the Pet Food Early Warning System rational 
questionnaire as a user-friendly data collection tool, to make it easy 
for the public to report a safety problem with pet food. The Pet Food 
Early Warning System is designed to identify adulteration of the pet 
food supply and outbreaks of illness associated with pet food to enable 
FDA to quickly identify, track and remove from commerce such articles 
of food. FDA uses the information collected to help ensure that such 
products are quickly and efficiently removed from the market to prevent 
foodborne illnesses. In 2010, OMB approved the Pet Food Early Warning 
System component of the SRP under OMB control number 0910-0645, and FDA 
launched the rational questionnaire by which consumers may 
electronically report adverse events associated with pet food. The 
electronic submission data elements to report adverse events associated 
with pet food remain unchanged in this request for extension of OMB 
approval.

D. Voluntary Tobacco Product Adverse Event and Product Problem Reports

    As noted, this notice seeks comments on a proposed fourth rational 
questionnaire that will be used for a new safety reporting program 
being launched by the CTP to collect voluntary tobacco product adverse 
event and product problem reports.
    FDA has broad legal authority under the FD&C Act to protect the 
public health. CTP's mission is to protect 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 is proposing to collect 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)).
    CTP currently receives adverse event and product problem reports 
primarily via paper MedWatch forms, approved under OMB control number 
0910-0291. MedWatch forms, although recently updated with field labels 
and descriptions to better clarify for reporters the range of 
reportable products, including tobacco products, do not specifically 
include questions relevant for the analysis of adverse events or 
product problems related to tobacco products. The proposed voluntary 
tobacco product adverse event and product problem rational 
questionnaire will include these specific questions. The 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. FDA is also 
working with the FDA Internet team to follow the Department of Health 
and Human Services Internet guidelines for Web design. FDA has and will 
continue to reach out to professional organizations and community 
interest groups to collect feedback during the user acceptance testing. 
The rational questionnaire will provide the user with detailed 
navigation instructions to include drop-down menus, lists of values, 
controlled vocabularies, and mouse over help where possible. In 
addition, CTP will issue guidance for the rational questionnaire. 
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 proposed voluntary tobacco product adverse event and product 
problem rational questionnaire requests the following information:
Introductory Information About the Submission
     Whether the submission is a new report, or a followup or 
amendment to a previously transmitted report.
Information About the Sender and the Affected Person
     Unless the sender wishes to remain anonymous, the name of 
and contact information for the person sending the report; and
     Unless the affected person wishes to remain anonymous, the 
name, contact

[[Page 3436]]

information, and demographic information for the person who experienced 
the adverse event.
Details of Any Attachments
     The type of attachment and a description of it.
Tobacco Product Details
     Information about the product that is the subject of the 
report, such as the brand name, product name, UPC, and a description of 
the tobacco product or component;
     Information about the product or component purchase date 
and location; and
     Information about the manufacturer of the product or 
component.
Problem Summary
     Information about the product problem or adverse event, 
such as the date and duration of the problem or adverse event, a 
description of the use of the product, a description of the product 
problem or adverse event, and a description of the main symptoms or 
health problems.
     Information about the medical treatment received by the 
affected person, such as whether the person was taken to an emergency 
facility, a description of any medical testing or treatment performed, 
and the results of any tests;
     Information about any similar product problems or adverse 
events previously had by the affected person; and
     In the event of death, the date of death and the reported 
cause of death.
Other Products Used
     Information about the affected person's use of other 
tobacco products, alcohol, prescription medications, over-the-counter 
medications, vitamins, or dietary supplements.
    The rational questionnaire 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.
    In the Federal Register of September 14, 2012 (77 FR 56847), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.

II. 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.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 2--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                             Number of                        Average
                        Activity                           FDA Form No.      Number of     responses per   Total annual     burden per      Total hours
                                                                            respondents     respondent       responses       response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Voluntary Adverse Event Report via the SRP (Other than              3800           1,513               1           1,513             0.6             908
 RFR Reports)...........................................                                                                    (36 minutes)
Mandatory Adverse Event Report via the SRP (Other than              3800             636               1             636               1             636
 RFR Reports)...........................................
Mandatory Adverse Event Report via the ESG (Gateway-to-             3800       1,491,228               1       1,491,228             0.6         894,737
 Gateway transmission)..................................                                                                    (36 minutes)
Mandatory and Voluntary RFR Reports via the SRP.........            3800           1,413               1           1,413             0.6             848
                                                                                                                            (36 minutes)
                                                         -----------------------------------------------------------------------------------------------
    Total...............................................  ..............  ..............  ..............  ..............  ..............         897,129
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 2, 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 its experience with adverse event 
reporting, FDA estimates that it will take 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 that it will take 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. The Center for Veterinary Medicine (CVM) 
received 845 pet food adverse event reports in 2010; 1,293 reports in 
2011; and 471 reports in the first 4 months of 2012, and estimates that 
for the full 12 months of 2012 it will receive 1,413 reports. Based on 
this experience, CVM estimates that it will receive, on average, 1,413 
pet food reports annually over the next 3 years. CTP estimates that it 
will receive approximately 100 voluntary tobacco product adverse event 
and product problem reports annually, after implementation of 
electronic reporting. CTP received 27 reports in 2010, 30 reports in 
2011, and 22 reports in the first half of 2012, and estimates that for 
the full 12 months of 2012 it will receive over 40 reports. Based on 
this experience and an expectation that reporting will increase once 
electronic

[[Page 3437]]

reporting is launched, CTP estimates that it will receive, on average, 
100 voluntary adverse event and product problem reports annually over 
the next 3 years. Thus, FDA estimates that over the next 3 years it 
will receive annually 1,513 voluntary adverse event reports submitted 
via the SRP, with a burden of 907.8 hours, rounded to 908 hours, as 
reported in table 2, row 1 (1,413 + 100 = 1,513).
    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. CVM received 144 such adverse event reports in 2010, 537 
reports in 2011, and 212 reports in the first four months of 2012, and 
estimates that for the full 12 months of 2012 it will receive 636 
reports. Based on this experience, CVM estimates that it will receive, 
on average, 636 reports of adverse drug experiences and product/
manufacturing defects associated with approved NADAs and ANADAs 
annually over the next 3 years. Thus, FDA estimates that over the next 
3 years it will receive annually 636 mandatory adverse event reports 
submitted via the SRP, with a burden of 636 hours, as reported in table 
2, row 2.
    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. FDA 
received 586,229 such adverse event reports in 2010; 850,161 reports in 
2011; and 497,076 reports in the first 4 months of 2012; and estimates 
that for the full 12 months of 2012 it will receive 1,491,228 reports. 
Based on this experience, FDA estimates that it will receive, on 
average, 1,491,228 adverse event reports submitted via the ESG, with a 
burden of 894,736.8 hours, rounded to 894,737 hours, as reported in 
table 2, row 3.
    FDA estimates that over the next 3 years it will receive annually 
1,413 mandatory and voluntary RFR Reports submitted via the SRP, as 
reported in table 2, row 4. The Center for Food Safety and Applied 
Nutrition (CFSAN) received 845 such adverse event reports in 2010; 
1,293 reports in 2011; and 471 reports in the first four months of 
2012; and estimates that for the full 12 months of 2012 it will receive 
1,413 reports. Based on this experience, CFSAN estimates that it will 
receive, on average, 1,413 mandatory and voluntary RFR Reports 
submitted via the SRP annually over the next 3 years, with a burden of 
847.8 hours, rounded to 848 hours, as reported in table 2, row 4.
    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 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.

    Dated: January 10, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-00761 Filed 1-15-13; 8:45 am]
BILLING CODE 4160-01-P