[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 [email protected]. 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