[Federal Register Volume 74, Number 96 (Wednesday, May 20, 2009)]
[Notices]
[Pages 23721-23727]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-11687]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0546]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Electronic Data 
Collection Using MedWatch\Plus\ Portal and Rational Questionnaire

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

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 June 
19, 2009.

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: 202-395-6974, or e-mailed to <a href="/cdn-cgi/l/email-protection#d7b8bea5b688a4a2b5babea4a4beb8b997b8bab5f9b2b8a7f9b0b8a1"><span class="__cf_email__" data-cfemail="600f0912013f1315020d091313090f0e200f0d024e050f104e070f16">[email protected]</span></a>. All 
comments should be identified with the OMB control number 0910-NEW and 
title ``Electronic Data Collection Using MedWatch\Plus\ Portal and 
Rational Questionnaire.'' Also include the FDA docket number found in 
brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information 
Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-796-3794.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed

[[Page 23722]]

collection of information to OMB for review and clearance.

Electronic Data Collection Using MedWatch\Plus\ Portal and Rational 
Questionnaire

    FDA is implementing electronic data collection to improve adverse 
event reporting across the agency. FDA's current processes and systems 
for adverse event reporting vary across its centers and are not optimal 
for the efficient collection of voluntary and mandatory adverse event 
reports, product problems/consumer complaints, or errors associated 
with the use of FDA-regulated products. Current FDA reporting forms 
(Forms FDA 3500, 3500A, 1932, and 1932a) are an outgrowth of a paper 
process era and frequently result in the submission of inconsistent and 
poor quality information. In addition, the agency is limited in its 
ability to modify its paper forms to keep pace with changes in the 
types of regulated products and the information necessary to meet 
evolving standards to ensure post market safety. Further, the existing 
supporting business processes are not able to efficiently manage the 
information being provided on the paper forms. For example, the upfront 
data integrity constraints on required (vital) data limit the extent of 
reviewable information on items such as reporter identification of one 
or more subject product types (animal and human food/feed, drug--animal 
or human, device, etc.), reporter name, date of occurrence, related 
details, and followup information. Data collected on paper forms must 
be manually transcribed into an electronic format for usability and 
analysis. Furthermore, these forms are not very intuitive for a casual 
reporter (e.g., consumers of FDA-regulated products), that is, the 
paper forms lack the features available in an electronic system that 
assist a new user in understanding what information is being requested.
    FDA has launched the development and implementation of a new 
electronic system for collecting, submitting and processing adverse 
event reports and other safety information for all FDA-regulated 
products. This new system, MedWatch\Plus\ Portal, will enhance the 
current MedWatch collection system and integrate the agency's existing 
safety reporting systems into the various FDA Adverse Event Report 
Systems (FAERS). FAERS will enable FDA staff to more efficiently 
analyze thousands of safety reports and to identify potential safety 
problems earlier than would be possible using paper forms. The 
MedWatch\Plus\ Portal provides one central point-of-entry for persons 
submitting information to FDA. The agency believes that one central 
point-of-entry will better enable persons to submit their information. 
In addition, mandatory reporters will be able to use the Internet to 
access the MedWatch\Plus\ Portal to report safety concerns about 
dietary supplements, nonprescription drugs, and human and animal food, 
thus fulfilling the mandatory reporting requirements of the Dietary 
Supplement and Nonprescription Drug Consumer Protection Act (DSNDCPA) 
(Public Law 109-462) and the Food and Drug Administration Amendments 
Act of 2007 (FDAAA) (Public Law 110-85).
    The MedWatch\Plus\ Portal involves the development of a single Web-
based portal and a user-friendly data collection tool, the ``Rational 
Questionnaire,'' which will make it easy for anyone to report a safety 
problem. The Rational Questionnaire will ask users simple questions to 
help guide them to determine what information they should provide. 
Anyone will be able to use the questionnaire to submit adverse event, 
product problem/consumer complaint, and medication use error reports to 
the FDA. For example, a healthcare practitioner could report an adverse 
event; a medical device maker could report a safety concern about a 
product; a pet owner could report a problem that their pet experienced 
associated with the use of an animal drug or animal food; a parent 
could report a reaction that their child experienced associated with 
the use of a cosmetic; and a consumer could report a concern about a 
drug they are taking at home, or about a food that may have made them 
ill. The system will compile the users' responses into a standardized 
report that would be routed to the appropriate FDA organizational 
component(s) for review and analysis.
    There are several types of information that will be submitted to 
FDA via the MedWatch\Plus\ Portal and Rational Questionnaire. Some of 
the information is required to be submitted to FDA (mandatory 
reporting) and some of the information is submitted voluntarily 
(voluntary reporting). The majority of the information to be collected 
using the MedWatch\Plus\ Rational Questionnaire has been approved 
previously by OMB under the PRA. Recently, additional information 
collection has been mandated by DSNDCPA and FDAAA. A complete list of 
information collections, their current OMB approval numbers, as well as 
citations to the relevant statute, regulation or guidance information 
for each is depicted in table 1 of this document.

                    Table 1-- Information Collections
------------------------------------------------------------------------
                                                 Relevant
                                                 Statute,     Mandatory
   FDA          FDA Form No.        OMB No.   Regulation or     (M) or
  Center                                         Guidance     Voluntary
                                               Information       (V)
------------------------------------------------------------------------
Center                     3500   0910-0291   MedWatch Form  V
 for                                           FDA 3500,
 Biologic                                      Voluntary
 s                                             Reporting
 Evaluati                                      Instructions
 on and
 Research/
 Center
 for Drug
 Evaluati
 on and
 Research
 (CBER/
 CDER)
------------------------------------------------------------------------
CBER/CDER                 3500A   0910-0291   21 CFR         M
                                               310.305,
                                               314.80,
                                               314.98,
                                               600.80 and
                                               1271.350
------------------------------------------------------------------------
Center                     3500   0910-0291   MedWatch Form  V
 for                                           FDA 3500,
 Devices                                       Voluntary
 and                                           Reporting
 Radiolog                                      Instructions
 ical
 Health
 (CDRH)
------------------------------------------------------------------------
CDRH                      3500A   0910-0291   21 CFR Part    M
                                               803
------------------------------------------------------------------------
Center                     3500   0910-0291   None           V
 for Food
 Safety
 and
 Applied
 Nutritio
 n
 (CFSAN)
------------------------------------------------------------------------

[[Page 23723]]

 
CFSAN\1\                  3500A   OMB         Pub. L. 109-   M
                                   approval    462; Section
                                   is in       761(b)(1) of
                                   process     the Federal
                                               Food, Drug,
                                               and Cosmetic
                                               Act (the
                                               act) (21
                                               U.S.C. 379aa-
                                               1(b)(1))
------------------------------------------------------------------------
CFSAN/                     None   This        Pub. L. 110-   M
 Center                            notice      85; Section
 for                               solicits    417 of the
 Veterina                          comments    act (21
 ry                                on this     U.S.C. 350f)
 Medicine                          proposed
 (CVM)\1\                          new
                                   collectio
                                   n
------------------------------------------------------------------------
CVM                       1932a   0910-0284   Veterinary     V
                                               Adverse Drug
                                               Reaction,
                                               Lack of
                                               Effectivenes
                                               s, or
                                               Product
                                               Defect
                                               Report Form
                                               and
                                               Instructions
------------------------------------------------------------------------
CVM                        1932   0910-0284   21 CFR 514.80  M
------------------------------------------------------------------------
CVM\1\                     None   This        Pub. L. 110-   V
                                   notice      85; Section
                                   solicits    1002 of
                                   comments    FDAAA
                                   on this
                                   proposed
                                   new
                                   collectio
                                   n
------------------------------------------------------------------------
Office of                  None   This        None           V
 Regulato                          notice
 ry                                solicits
 Affairs                           comments
 (ORA)                             on this
                                   proposed
                                   new
                                   collectio
                                   n
------------------------------------------------------------------------
\1\ New reporting requirements included in DSNDCPA and FDAAA.

    The single portal and a harmonized, Web-based format for submitting 
safety information will greatly enhance the ability of FDA to protect 
the public health. FDA will analyze electronic adverse event and safety 
reports for all marketed products and track safety signals throughout 
the life cycle of FDA-regulated products. FDA intends to review the 
information the agency receives to ensure that the submitters comply 
with the criteria established by the Federal Food, Drug, and Cosmetic 
Act (the act), where required.
    Description of respondents: The respondents to this collection of 
information include all persons submitting mandatory or voluntary 
information electronically to FDA via the MedWatch\Plus\ Portal and 
Rational Questionnaire.
    FDA expects that all of its centers and ORA will be utilizing the 
electronic reporting capabilities of MedWatch\Plus\ Portal by Fiscal 
Year 2011. Thus, FDA has prepared its estimate of the annual reporting 
burden on the basis that the majority of all submissions will be 
submitted electronically.
    In accordance with 5 CFR 1320.8(d), in the Federal Register of 
October 23, 2008 (73 FR 63153), FDA published a 60-day notice 
requesting public comment on the proposed information collection. FDA 
received five letters in response to the four specified aspects of the 
collection of information, each containing one or more comments.
    (Comment 1) Several comments commended FDA for implementing 
electronic data collection to improve adverse event reporting and 
expected the new format to greatly improve the agency's ability to 
utilize adverse event, product problem/consumer complaints, and 
medication use error reports submitted to FDA.
    (Response) FDA agrees. As discussed previously in this document, 
the new system will enhance the current MedWatch collection system and 
integrate the Agency's existing adverse event reporting systems. This 
will enable FDA staff to more efficiently analyze thousands of safety 
reports and to identify potential safety problems earlier than would be 
possible using paper forms.
    (Comment 2) One comment recommended that FDA continue to allow the 
submission of adverse event reports via paper. Another comment 
requested that FDA allow for a paper based contingency in the event 
that the MedWatch\Plus\ system becomes unavailable.
    (Response) FDA agrees. The agency is not eliminating paper, or 
telephone reporting. We will continue to support and accept reports 
submitted to us by mail, fax or telephone including when the system is 
unavailable.
    (Comment 3) One comment stated that FDA should recognize that the 
major component of the reporting burden is in the assembly of data, not 
in the transmission of data. The comment suggested that the submission 
of mandatory data to the MedWatch system will take 1 hour per initial 
report and from one-half hour to 3 hours for supplemental reports.
    (Response) FDA agrees that the assembly of data is a major 
component of the reporting burden. However, the agency notes that the 
comment did not provide any data to support the burden hour figures set 
forth. Thus, FDA has not changed the burden hour estimates in tables 1 
and 2 of this document.
    (Comment 4) Several comments suggested that FDA consider using 
pilot programs in the different stages of developing the system. One 
comment suggested using a pilot with the proposed questionnaire. 
Another comment asked FDA to consider developing a pilot project with 
electronic medical record software vendors to assess the functionality 
and determine the impact on the practitioner's time to complete the 
submission. A third comment offered to provide the assistance of its 
professional association members to assess the functionality of the 
MedWatch\Plus\ portal and rational questionnaire.
    (Response) FDA agrees. The agency intends to utilize internal and 
external early adopters for user acceptance testing that will include a 
test site environment for beta testing prior to implementation of the 
portal. However, the integration of electronic medical record software 
is not in scope for the planned releases of MedWatch\Plus\ portal and 
rational questionnaire.
    (Comment 5) One comment expressed concern that those wanting to use 
the Web portal would not be able to find it.

[[Page 23724]]

Another comment suggested that FDA initiate a public education campaign 
to ensure potential users are aware of the new system and use the new 
system correctly.
    (Response) FDA agrees and is working with National Institutes of 
Health and the FDA Internet teams to follow the HHS Internet guidelines 
for Web design. We expect that the link to the MedWatch\Plus\ portal 
and rational questionnaire will be prominently displayed on the FDA 
home page. FDA also intends to reach out to our industry stakeholders, 
as well as professional organizations and community interest groups. 
The rational questionnaire will provide the user with detailed 
navigation instructions to include drop-down menus, lists of values and 
controlled vocabularies where possible. In addition, FDA will issue 
guidance and technical documents for the iterative releases of the 
rational questionnaire. The FDA intends to provide a phased approach. 
The first release will include Reportable Food Reports. Early Warning 
Pet Food Recall and adverse event reports for veterinary drug products 
will follow. Other product reports (CFSAN, CVM, CDER, CBER and CDRH) 
will be rolled out in later releases.
    (Comment 6) One comment suggested that FDA include a means by which 
adverse events associated with other products could be reported using 
the MedWatch\Plus\ portal and rational questionnaire, including: 
devices used in animals, compounded drugs for animals, and biologics 
used in animals.
    (Response) FDA agrees that individuals should be able to report 
adverse events associated with devices used in animals and adverse 
reactions associated with compounded drugs for animals. For example, 
when the MedWatch\Plus\ portal is operational, reporters will be able 
to use the animal adverse event view of the rational questionnaire to 
submit these reports. Furthermore, adverse event reports submitted 
through the portal for biologic products used for animals will be 
forwarded to the U.S. Department of Agriculture.
    (Comment 7) One comment suggested that the Naranjo scale be 
incorporated into the rational questionnaire.
    (Response) FDA disagrees. The Naranjo scale is a causality 
assessment tool. FDA does not plan to require assessment of causality 
by reporters who already suspect a product-event association and have 
made the decision to report by accessing the MedWatch\Plus\ portal.
    (Comment 8) One comment suggested that FDA should adjust its 
business processes to effectively leverage and appropriately respond to 
rapidly changing data in terms of number of reports, varying quality, 
and potential impact to signal detection.
    (Response) FDA agrees. The rational questionnaire will facilitate 
the collection of consistent, complete, accurate information and 
produce a structured report utilizing the HL7-ICSR data exchange 
message. The agency will continue to support the submission of 
``batched'' adverse event reports through the FDA electronic submission 
gateway. FDA is moving toward the use of the HL7-ICSR message exchange; 
however, acceptable, alternative data exchange message formats (e.g., 
E2BM, E2BR) will be supported for a period of time that has not been 
yet been determined.
    (Comment 9) One comment suggested that the MedWatch\Plus\ portal 
and rational questionnaire should document who submits the information 
and stated that the type of submitter (e.g., pharmacist, physician, 
patient) provides a good indication of the accuracy of and the reasons 
behind the information provided.
    (Response) FDA agrees that information describing the type of 
submitter is useful. The rational questionnaire reporting views will be 
created to include questions describing who the reporter is, the type 
of report (adverse event, product problem/consumer complaint or product 
use error), whether the reporting is mandatory, and identify the 
suspect product. From that information, the agency can infer the type 
of submitter as follows: General citizen, health care professional, and 
whether or not the reporter is a mandatory or voluntary reporter.
    (Comment 10) One comment recommended that FDA obtain contact 
information from all individuals who submit adverse event reports, 
arguing that false reports could be submitted more readily if 
individual contact submission is not required for report submission. 
The comment also noted that such information would allow FDA to follow 
up with individuals and verify reported information in the event that 
FDA had questions or concerns regarding an individual report.
    (Response) FDA is encouraging all users to provide contact 
information in all reports which both verifies the source of the report 
and allows FDA to conduct any needed followup. However, FDA will accept 
voluntary reports submitted by anonymous sources. Only mandatory 
reporters will be required to include their contact information.
    (Comment 11) One comment urged FDA to consider how duplicate 
reporting through different mechanisms will be reduced or eliminated.
    (Response) FDA agrees. We have a system requirement that addresses 
our abilities to assess and link duplicate reports to minimize the 
problem of duplicate reporting. In addition, the Web portal will allow 
followup information as well as attachments to be entered and linked to 
a previously submitted report.
    (Comment 12) One comment suggested that FDA should incorporate the 
Alternative Summary Report (ASR) methodology in MedWatch\Plus\.
    (Response) FDA is considering including summary reporting (ASRs) in 
future releases of the rational questionnaire, but the exact mechanism 
has not been determined.
    (Comment 13) The rational questionnaire should not have 
supplemental questions, which are not required by the agency's 
regulations at 21 CFR Part 803.
    (Response) The rational questionnaire will include the information 
mandated by regulation, legislation or otherwise deemed necessary by 
the agency for a complete report. Reporters will not be required to 
submit information in response to optional questions.
    (Comment 14) One comment recommended that a single acknowledgement 
bearing the MDR report number and the official time receipt stamp be 
transmitted to the sender within one hour of the MDR submission. 
Another comment noted that the FDA 3500A form is the evidentiary record 
of the MDR. The comment went on to express concern about how the 
MedWatch\Plus\ system would acknowledge the submission of the adverse 
event report in the required timeframe.
    (Response) FDA agrees. The reporter will receive an electronic 
response with an acknowledgement containing a unique FDA identification 
number, which the reporter can save and print. The acknowledgement 
receipt will be generated immediately by the MedWatch\Plus\ system. The 
reporter may also print and save an electronic copy of their report. If 
the reporter creates an account, the reporter will have access, for an 
undetermined finite period of time, to both their in-process and 
previously submitted reports using the MedWatch\Plus\ system. However, 
FDA notes that voluntary reporters who report anonymously will not 
receive such a response because we will not have their email address, 
but they will be able to print and save an electronic copy of their 
report.

[[Page 23725]]

    (Comment 15) One comment asked that FDA engage stakeholders in a 
public consultation process and asked FDA to subject a draft of the 
rational questionnaire to a public consultation period to permit 
manufacturers, patients, and other stakeholders to comment prior to 
finalizing a questionnaire for production use.
    (Response) FDA agrees. We plan to use internal and external 
stakeholders in user acceptance testing. Additionally, the agency 
intends to hold two public meetings for Reportable Foods and give 
presentations on the Web-based portal and the rational questionnaire at 
professional organization and industry meetings.
    (Comment 16) One comment suggested that FDA make the electronic 
collection tool user friendly and asked that the questionnaire be made 
accessible and intuitive for a broad population to use, with easy to 
understand data entry instructions and a user-friendly interface that 
requires limited computer or technical expertise to complete. Another 
comment stated that the effectiveness of the rational questionnaire 
would depend on the length of time required for the user to complete 
the adverse event report.
    (Response) FDA agrees that the rational questionnaire should be 
user friendly. We are taking every available step in developing this 
tool to ensure that it is user-friendly and accessible for public use 
while minimizing user time. Such steps include utilizing both internal 
and external expertise with Web-techniques and leveraging current 
technology. The agency is following HHS Web standards in developing the 
portal and rational questionnaire and plans to collect feedback during 
the user acceptance testing.
    (Comment 17) Another comment suggested that questions on the 
rational questionnaire should be prioritized to capture the most 
important questions and information first in a shorter period of time. 
Another comment suggested that FDA should use an electronic approach 
that will ensure that reporters only see and fill out those fields 
relevant to the event that they are reporting.
    (Response) FDA agrees that the questions should be prioritized. The 
rational questionnaire is designed to request the mandatory information 
first, then present the optional questions. In addition, the specific 
reporting situations will use a tree-branching logic approach. The 
reporter will be provided only those fields necessary to providing a 
full report and they will not see questions that are not needed, which 
helps in prioritizing the information.
    (Comment 18) One comment suggested that FDA create an intelligent 
questionnaire that aligns with the reporter's knowledge base and 
experience. Another comment requested that FDA provide an advanced 
method of submitting information using the rational questionnaire that 
would allow individuals familiar with the system to more quickly and 
efficiently input the information.
    (Response) FDA agrees. FDA is aware that persons familiar with the 
reporting process do not want to be led through the questionnaire 
because they know what information they want to report. The agency is 
planning future releases of the rational questionnaire with an ``Expert 
Reporter'' mode for those who are familiar with the information and 
frequent reporters. FDA notes that if a user chooses to establish an 
account with FDA, the system will be designed so that when the user 
properly signs in, the system will pre-populate the point-of-contact 
information. In addition, when a report is submitted, a user will be 
able to retain and save unique identifying information which can be 
used to access a previously filed report for additional followup 
reporting.
    (Comment 19) One comment suggested that FDA ensure that the 
MedWatch\Plus\ portal is interoperable with software that institutions 
currently use to document suspected adverse drug events internally.
    (Response) The MedWatch\Plus\ portal is available to all users 
through the Internet, without requiring the use of special software. 
The portal will also allow submission of attachments to reports in 
commonly-used file formats, such as Microsoft Word, Excel and Adobe. 
The agency intends to publish guidance that will provide a list of 
acceptable file types. In the event that a user would like to submit an 
attachment that is in an unacceptable file type, the agency intends to 
communicate with the user via a message providing instructions for file 
types we will accept and contact information for a help desk providing 
IT support and additional assistance to the public. The current 
MedWatch\Plus\ portal and rational questionnaire project scope does not 
include the integration with electronic medical record software, but 
may be considered in the future as medical software systems mature and 
are increasingly utilized.
    (Comment 20) One comment asked FDA to ensure interoperability 
utilizing HL7 or other appropriate standards. Another comment asked FDA 
to utilize international consensus standards in electronic case 
reporting.
    (Response) FDA agrees. The MedWatch\Plus\ rational questionnaire 
will produce an HL7-ICSR data exchange message and the portal will 
accept HL7-ICSR compliant exchange messages that are formatted outside 
the rational questionnaire. As noted previously in this document, the 
agency will continue to support the submission of `batched' adverse 
event reports through the FDA electronic submission gateway. FDA is 
moving toward the use of the HL7-ICSR message exchange; however, 
acceptable, alternative data exchange message formats (e.g., E2BM, 
E2BR) will be supported for a period of time that has not been yet been 
determined. We intend to use structured and controlled vocabularies and 
terminologies where they exist.
    FDA estimates the burden of this collection of information as 
follows:

                                  Table 2--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                       Number of       Annual Frequency     Total Annual        Hours per
   FDA Activity       Respondents       per  Response        Responses           Response         Total Hours
----------------------------------------------------------------------------------------------------------------
Voluntary View                37,565                  1             37,565                0.6             22,539
----------------------------------------------------------------------------------------------------------------
Mandatory View                   645                199            128,403                1.0            128,403
 using
 MedWatch\Plus\
 Rational
 Questionnaire\2\
----------------------------------------------------------------------------------------------------------------
Mandatory View                 2,578              199.2            513,613                0.6            308,168
 using direct
 Gateway-to-
 Gateway
 transmission\2\
----------------------------------------------------------------------------------------------------------------

[[Page 23726]]

 
Reportable Food                1,200                  1              1,200                0.6                720
 (human and
 animal)
 Mandatory View
----------------------------------------------------------------------------------------------------------------
Reportable Food                1,200                  1              1,200                0.6                720
 (human and
 animal)
 Voluntary View
----------------------------------------------------------------------------------------------------------------
Early Warning                    540                  1                540                0.6                324
 Recall Voluntary
 View
----------------------------------------------------------------------------------------------------------------
Total                                                                                                    460,874
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ The reporter may choose to use the MedWatch\Plus\ Rational Questionnaire or a direct Gateway-to-Gateway
  transmission to submit a Mandatory report. FDA believes that these are different reporting burdens for these
  two types of transmission of information. The reporting burden for use of the MedWatch\Plus\ Rational
  Questionnaire Mandatory View is estimated to be 1 hour. The reporting burden for a direct Gateway-to-Gateway
  transmission is estimated to be 0.6 hours. Current reporting estimates indicate that approximately 80 percent
  of the Mandatory Reports would be submitted via a Gateway-to-Gateway transmission and 20 percent of reports
  would be received via the MedWatch\Plus\ Rational Questionnaire in the future. The Mandatory View reporting
  burden estimates reflect this calculation.

    The term ``Voluntary View'' refers to the MedWatch\Plus\ Rational 
Questionnaire as it appears to a respondent submitting a voluntary 
report. The term ``Mandatory View'' refers to the Gateway-to-Gateway 
and the MedWatch\Plus\ Rational Questionnaire as it appears to a 
respondent submitting a mandatory report. The estimated number of 
responses and hours per response for the voluntary view and the 
mandatory view are based on FDA's experience and the average number of 
voluntary reports and mandatory reports submitted to FDA in 2007 (and 
in the case of mandatory dietary supplement reports, those submitted to 
FDA from January 1, 2008, to April 15, 2008) via the existing methods 
of submission, including paper submission. The term, ``Reportable Food 
(human and animal) Mandatory View'' refers to the MedWatch\Plus\ 
Rational Questionnaire as it appears to a respondent submitting a 
mandatory report under section 417 of the act (21 U.S.C. 350f). The 
term, ``Reportable Food (human and animal) Voluntary View'' refers to 
the MedWatch\Plus\ Rational Questionnaire as it appears to the 
respondent submitting a voluntary report under section 417 of the act. 
The estimated number of responses and hours per response for the 
reportable food (human and animal) mandatory and voluntary views are 
based on FDA's experience with reports recently submitted to FDA that 
would be considered ``Reportable Food'' reports in the future. The 
term, ``Early Warning Recall Voluntary View,'' refers to the 
MedWatch\Plus\ Rational Questionnaire as it appears to a respondent 
submitting a mandatory report under FDAAA Section 1002 of the act 
(Public Law 110-85). The estimated number of responses and hours per 
response for the early warning recall voluntary view are based on FDA's 
experience with reports recently submitted to FDA that would be 
considered ``Early Warning Recall'' reports in the future.
    In an effort to meet the needs of all reporters, the Rational 
Questionnaire will allow for the submission of a report by completing 
certain minimum data elements. Both mandatory and voluntary reporters 
will see and be provided the opportunity to submit additional optional 
information. A reporter can answer one, a few, or all of the optional 
questions. Reporters are strongly encouraged to submit as much optional 
information as possible. This will help to ensure FDA has sufficient 
information to identify products and problems, and enhance their 
ability to address these problems.
    The optional questions serve a purpose for both the reporter and 
FDA. The reporter may believe that additional information is needed for 
FDA to fully understand the event/problem and the optional questions 
provide an opportunity to provide such information. For FDA, the 
optional questions may aid in fully understanding the problem and may 
eliminate the need for extensive followup with the reporter. Because 
reporters can choose to answer none, one, a few, or all of the optional 
questions, we estimated the maximum time needed to submit a safety 
report online for both voluntary and mandatory reporters in the hours 
per response column in table 2 of this document.
    The agency's estimate of the number of respondents and the total 
annual responses in table 2 of this document is based on the mandatory 
and voluntary reports submitted to the centers and ORA. The estimated 
total annual responses in table 2 are based on initial reports. 
Followup reports, if any, are not counted as new reports. FDA estimates 
that it will receive 37,565 voluntary reports [23,033 (CBER/CDER) + 
4,369 (CDRH) + 5,000 (CFSAN) + 163 (CVM) + 5,000 (ORA) = 37,565]. FDA 
estimates that it will receive 642,016 mandatory reports [459,121 
(CBER/CDER) + 146,274 (CDRH) + 856 (CFSAN) + 35,765 (CVM) + 0 (ORA) = 
642,016].
    FDA received 23,033 voluntary reports to CBER/CDER during 2007. 
Based on this experience, FDA estimates that CBER and CDER, 
collectively, will receive 23,033 voluntary reports annually from 
23,033 users of the electronic reporting system. FDA estimates the 
reporting burden for a voluntary report to be 0.6 hours, for a total 
burden of 13,820 hours (23,033 reports x 0.6 hours = 13,819.8 hours).
    FDA received 459,121 mandatory reports to CBER/CDER during 2007. 
Based on this experience, FDA estimates that CBER and CDER, 
collectively, will receive 459,121 mandatory reports annually from 600 
users of the electronic reporting system. FDA estimates the maximum 
reporting burden for a mandatory report to be 1 hour, for a total 
burden of 459,121 hours (459,121 reports x 1 hour) or a minimum burden 
of 312,202 hours with ((459,121 reports x 80% x 0.60 hour) + (459,121 
reports x 20% x 1 hour) = 312,202.28 hours).
    FDA received 4,369 voluntary reports to CDRH during 2007. Based on 
this experience, FDA estimates that CDRH will receive 4,369 voluntary 
reports annually from 4,369 users of the electronic reporting system. 
FDA estimates the reporting burden for a voluntary report to be 0.6 
hours, for a total burden of 2,621 hours (4,369 reports x 0.6 hours = 
2,621.4 hours).

[[Page 23727]]

    FDA received 146,274 mandatory reports to CDRH during 2007. Based 
on this experience, FDA estimates that CDRH will receive 146,274 
mandatory reports annually from 1,665 users of the electronic reporting 
system (a group comprised of facilities, importers, and manufacturers). 
FDA estimates the maximum reporting burden for a mandatory report to be 
1 hour, for a total burden of 146,274 hours (146,274 reports x 1 hour = 
146,274 hours) or a minimum burden of 99,466 hours with ((146,274 
reports x 80% x 0.60 hour) + (146,274 reports x 20% x 1 hour) = 
99,466.32 hours). FDA received 5,000 voluntary reports to CFSAN during 
2007. Based on this experience, FDA estimates that CFSAN will receive 
5,000 voluntary reports annually from 5,000 users of the electronic 
reporting system. FDA estimates the reporting burden for a voluntary 
report to be 0.6 hours, for a total burden of 3,000 hours (5,000 
reports x 0.6 hours = 3,000 hours).
    FDA received 214 mandatory dietary supplement reports to CFSAN from 
January 1, 2008, to April 15, 2008. Based on this experience, FDA 
estimates that CFSAN will receive 856 mandatory reports annually from 
150 users of the electronic reporting system. FDA estimates the maximum 
reporting burden for a mandatory report to be 1 hour, for a total 
burden of 856 hours (856 reports x 1 hour = 856 hours) or a minimum 
burden of 582 hours with ((856 reports x 80% x 0.60 hour) + (856 
reports x 20% x 1 hour) = 582.08 hours).
    FDA received 163 voluntary reports to CVM during 2007. Based on 
this experience, FDA estimates that CVM will receive 163 voluntary 
reports annually from 163 users of the electronic reporting system. FDA 
estimates the reporting burden for a voluntary report to be 0.6 hours 
for a total burden of 98 hours (163 reports x 0.6 hours = 97.8 hours).
    FDA received 35,765 mandatory reports to CVM during 2007. Based on 
this experience, FDA estimates that CVM will receive 35,765 mandatory 
reports annually from 808 users of the electronic reporting system. FDA 
estimates the maximum reporting burden for a mandatory report to be 1 
hour, for a total burden of 35,765 hours (35,765 reports x 1 hour = 
35,765 hours) or a minimum burden of 24,320 hours with ((35,765 reports 
x 80% x 0.6 hour) + (35,765 reports x 20% x 1 hour) = 24,320.20 hours).
    FDA received 5,000 voluntary reports to ORA during 2007. Based on 
this experience, FDA estimates that ORA will receive 5,000 voluntary 
reports annually from 5,000 users of the electronic reporting system. 
FDA estimates the reporting burden for a voluntary report to be 0.6 
hours, for a total burden of 3,000 hours (5,000 reports x 0.6 hours = 
3,000 hours). ORA does not receive mandatory reports.
    FDAAA, Section 1005, the Reportable Food Registry, established new 
electronic mandatory and voluntary reporting requirements for instances 
of ``reportable'' food, meaning an article of food (other than infant 
formula) 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 received 625 voluntary 
food complaints leading to adverse events from January 1, 2008, to June 
30, 2008, and there were 206 and 182 Class 1 Recalls for human food in 
Fiscal Years 2006 and 2007, respectively. Based on these experiences, 
FDA estimates that FDA could receive 200 to 1,200 ``reportable'' food 
reports annually from 200 to 1,200 mandatory and voluntary users of the 
electronic reporting system. FDA will utilize the upper-bound estimate 
of 1,200 for these calculations. FDA estimates the reporting burden for 
a mandatory ``reportable'' food report to be 0.6 hours, for a total 
burden of 720 hours (1,200 reports x 0.6 hours = 720 hours). FDA 
estimates the reporting burden for a voluntary ``reportable'' food 
report to be 0.6 hours, for a total burden of 720 hours (1,200 reports 
x 0.6 hours = 720 hours).
    FDAAA, Section 1002, Early Warning Recall, mandated FDA establish a 
system to receive voluntary pet food complaint reports and provide an 
Early Warning Recall system for the public. FDA received 270 voluntary 
pet food reports from January 1, 2008, to June 30, 2008. FDA received 
10,740 and 99 pet food complaints in FY 2007 and 2006, respectively. 
Based on these experiences, FDA estimates that FDA could receive 540 
voluntary pet food reports annually from 540 users of the electronic 
reporting system. FDA estimates the reporting burden for a voluntary 
``Early Warning Recall'' report to be 0.6 hours, for a total burden of 
324 hours (540 reports x 0.6 hours = 324 hours).

    Dated: May 13, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-11687 Filed 5-19-09; 8:45 am]
BILLING CODE 4160-01-S


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