Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic Data Collection Using MedWatchPlus, 63153-63157 [E8-25211]
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Federal Register / Vol. 73, No. 206 / Thursday, October 23, 2008 / Notices
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
Community-Based Abstinence Education Program Announcement Performance Progress Report/Program Narrative ....................................................
Community-Based Abstinence Education Program—Program-Specific Performance Measure .......................................................................................
Estimated Total Annual Burden
Hours: 516,000
Additional Information
Copies of the proposed collection may
be obtained by writing to the
Administration for Children and
Families, Office of Administration,
Office of Information Services, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. All requests should be
identified by the title of the information
collection. E-mail address:
infocollection@acf.hhs.gov.
OMB Comment
OMB is required to make a decision
concerning the collection of information
between 30 and 60 days after
publication of this document in the
Federal Register. Therefore, a comment
is best assured of having its full effect
if OMB receives it within 30 days of
publication. Written comments and
recommendations for the proposed
information collection should be sent
directly to the following: Office of
Management and Budget, Paperwork
Reduction Project, Fax: 202–395–6974,
Attn: Desk Officer for the
Administration for Children and
Families.
Dated: October 20, 2008.
Janean Chambers,
Reports Clearance Officer.
[FR Doc. E8–25285 Filed 10–22–08; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
dwashington3 on PRODPC61 with NOTICES
[Docket No. FDA–2008–N–0546]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Electronic Data
Collection Using MedWatchPlus Portal
and Rational Questionnaire
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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Average
burden hours
per response
Total burden
hours
60
2
50
6,000
1,000,000
3
0.17
510,000
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 MedWatchPlus 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 https://
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
PO 00000
Number of
responses per
respondent
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
MedWatchPlus 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
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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 FDAregulated products. This new system,
MedWatchPlus 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
MedWatchPlus Portal provides one
central point-of-entry for persons
submitting information to FDA. The
agency believes that one central pointof-entry will better enable persons to
submit their information. In addition,
mandatory reporters will be able to use
the Internet to access the MedWatchPlus
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 MedWatchPlus 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
MedWatchPlus 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
MedWatchPlus 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
FDA Center
FDA Form No.
OMB No.
Relevant Statute,
Regulation or
Guidance Information
Mandatory (M) or
Voluntary (V)
3500
0910–029
MedWatch Form
FDA 3500,
Voluntary
Reporting
Instructions.
V
CBER/CDER
3500A
0910–0291
21 CFR 310.305,
314.80, 314.98,
600.80 and
1271.350.
M
CDRH
3500
0910–0291
MedWatch Form
FDA 3500,
Voluntary
Reporting
Instructions.
V
CDRH
3500A
0910–0291
21 CFR Part 803
M
CFSAN
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CBER/CDER
3500
0910–0291
None
V
CFSAN*
3500A
OMB approval is
in process.
Pub. L. 109–462;
Section 761(b)(1)
of the Federal
Food, Drug, and
Cosmetic Act (the
act) (21 U.S.C.
379aa–1(b)(1)).
M
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63155
TABLE 1.—INFORMATION COLLECTIONS—Continued
OMB No.
Relevant Statute,
Regulation or
Guidance Information
None
This notice solicits
comments on this
proposed new
collection.
Pub. L. 110–85;
Section 417 of the
Act (21 U.S.C.
350(f)).
M
CVM
1932a
0910–0284
Veterinary
Adverse Drug
Reaction, Lack of
Effectiveness, or
Product Defect
Report Form and
Instructions.
V
CVM
1932
0910–0284
21 CFR 514.80
M
CVM*
None
This notice solicits
comments on this
proposed new
collection.
Pub. L. 110–85;
Section 1002 of
FDAAA.
V
ORA
None
This notice solicits
comments on this
proposed new
collection.
None
V
FDA Center
FDA Form No.
CFSAN/CVM*
* New
Mandatory (M) or
Voluntary (V)
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 FDAregulated 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 MedWatchPlus 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 MedWatchPlus 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 BURDEN1
No. of
Respondents
FDA Activity
Voluntary View
Annual Frequency
per Response
Total Annual
Responses
Hours Per
Response
Total Hours
37,565
1
37,565
0.6
22,539
645
199
128,403
1.0
128,403
Mandatory View using direct
Gateway-to-Gateway transmission2
2,578
199.2
513,613
0.6
308,168
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
540
1
540
0.6
324
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Mandatory View using
MedWatchPlus Rational Questionnaire2
Early Warning Recall Voluntary
View
Total
1 There
460,874
are no capital costs or operating and maintenance costs associated with this collection of information.
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2 The reporter may choose to use the MedWatchPlus 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 MedWatchPlus 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 MedWatchPlus Rational Questionnaire in the future. The Mandatory View reporting burden estimates reflect this calculation.
The term ‘‘Voluntary View’’ refers to
the MedWatchPlus Rational
Questionnaire as it appears to a
respondent submitting a voluntary
report. The term ‘‘Mandatory View’’
refers to the Gateway-to-Gateway and
the MedWatchPlus 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 MedWatchPlus 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
MedWatchPlus 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 MedWatchPlus 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
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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
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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
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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,
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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
https://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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0544]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Record Retention
Requirements for the Soy Protein and
Risk of Coronary Heart Disease Health
Claim
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, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the record retention requirement of the
soy protein/coronary heart disease
health claim.
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 https://
PO 00000
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63157
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,
including each proposed extension of an
existing 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.
Record Retention Requirements for the
Soy Protein and Risk of Coronary Heart
Disease Health Claim—21 CFR
101.82(c)(2)(ii)(B) (OMB Control
Number 0910–0428)—Extension
Section 403(r)(3)(A)(i) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
343(r)(3)(A)(i)) provides for the use of
food label statements characterizing a
E:\FR\FM\23OCN1.SGM
23OCN1
]]>Agencies
[Federal Register Volume 73, Number 206 (Thursday, October 23, 2008)]
[Notices]
[Pages 63153-63157]
From the Federal Register Online via the Government Printing 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 https://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 https://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
