[Federal Register Volume 73, Number 206 (Thursday, October 23, 2008)]
[Notices]
[Pages 63153-63157]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-25211]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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 an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on the use of MedWatch\Plus\ Portal and 
Rational Questionnaire to collect electronically all adverse event, 
consumer complaint/product problem and medication use error data 
submitted to FDA.

DATES: Submit written or electronic comments on the collection of 
information by December 22, 2008.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the 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: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information before 
submitting the collection to OMB for approval. To comply with this 
requirement, FDA is publishing notice of the proposed collection of 
information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Electronic Data Collection Using MedWatch\Plus\ Portal and Rational 
Questionnaire--21 CFR 310.305, 314.80, 314.98, 514.80, 600.80, 1271.350 
and Part 803

    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

[[Page 63154]]

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 follow-up 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) 
(Pub. L. 109-462) and the Food and Drug Administration Amendments Act 
of 2007 (FDAAA) (Pub. L. 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 Paperwork Reduction Act. 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,
                                                                              Regulation or     Mandatory (M) or
             FDA Center                  FDA Form No.         OMB No.            Guidance        Voluntary (V)
                                                                               Information
----------------------------------------------------------------------------------------------------------------
CBER/CDER                                          3500           0910-029  MedWatch Form FDA                  V
                                                                              3500, Voluntary
                                                                                    Reporting
                                                                                Instructions.
----------------------------------------------------------------------------------------------------------------
CBER/CDER                                         3500A          0910-0291    21 CFR 310.305,                  M
                                                                              314.80, 314.98,
                                                                                   600.80 and
                                                                                    1271.350.
----------------------------------------------------------------------------------------------------------------
CDRH                                               3500          0910-0291  MedWatch Form FDA                  V
                                                                              3500, Voluntary
                                                                                    Reporting
                                                                                Instructions.
----------------------------------------------------------------------------------------------------------------
CDRH                                              3500A          0910-0291    21 CFR Part 803                  M
----------------------------------------------------------------------------------------------------------------
CFSAN                                              3500          0910-0291               None                  V
----------------------------------------------------------------------------------------------------------------
CFSAN\*\                                          3500A    OMB approval is   Pub. L. 109-462;                  M
                                                               in process.  Section 761(b)(1)
                                                                               of the Federal
                                                                              Food, Drug, and
                                                                            Cosmetic Act (the
                                                                              act) (21 U.S.C.
                                                                              379aa-1(b)(1)).
----------------------------------------------------------------------------------------------------------------

[[Page 63155]]

 
CFSAN/CVM\*\                                       None        This notice    Pub. L. 110-85;                  M
                                                         solicits comments     Section 417 of
                                                          on this proposed        the Act (21
                                                           new collection.    U.S.C. 350(f)).
----------------------------------------------------------------------------------------------------------------
CVM                                               1932a          0910-0284         Veterinary                  V
                                                                                 Adverse Drug
                                                                            Reaction, Lack of
                                                                            Effectiveness, or
                                                                               Product Defect
                                                                              Report Form and
                                                                                Instructions.
----------------------------------------------------------------------------------------------------------------
CVM                                                1932          0910-0284      21 CFR 514.80                  M
----------------------------------------------------------------------------------------------------------------
CVM\*\                                             None        This notice    Pub. L. 110-85;                  V
                                                         solicits comments    Section 1002 of
                                                          on this proposed             FDAAA.
                                                           new collection.
----------------------------------------------------------------------------------------------------------------
ORA                                                None        This notice               None                  V
                                                         solicits comments
                                                          on this proposed
                                                           new collection.
----------------------------------------------------------------------------------------------------------------
\*\ 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 the Office of Regulatory 
Affairs (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.
    FDA estimates the burden of this information collection as follows:

                                                     Table 2.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              No. 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 using MedWatch\Plus\ Rational                          645                   199            128,403                1.0            128,403
 Questionnaire\2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Mandatory View using direct Gateway-to-Gateway                      2,578                 199.2            513,613                0.6            308,168
 transmission\2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reportable Food (human and animal) Mandatory View                   1,200                     1              1,200                0.6                720
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reportable Food (human and animal) Voluntary View                   1,200                     1              1,200                0.6                720
--------------------------------------------------------------------------------------------------------------------------------------------------------
Early Warning Recall Voluntary View                                   540                     1                540                0.6                324
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total                                                                                                                                            460,874
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

[[Page 63156]]

 
\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 0.60 hours. Current reporting estimates indicate that approximately 80% of the Mandatory Reports would be submitted via a Gateway-to-
  Gateway transmission and 20% 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. 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 of 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 (Pub. L. 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 the 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 
the 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 the 
FDA, the optional questions may aid in fully understanding the problem 
and may eliminate the need for extensive follow up 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 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. Follow-up 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).
    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

[[Page 63157]]

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 0.60 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 the 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).
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://www.regulations.gov.

    Dated: October 16, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-25211 Filed 10-22-08; 8:45 am]
BILLING CODE 4160-01-S