Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic Submission of Food and Drug Administration Adverse Event Reports and Other Safety Information Using the Electronic Submission Gateway and the Safety Reporting Portal, 56847-56851 [2012-22659]
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Federal Register / Vol. 77, No. 179 / Friday, September 14, 2012 / Notices
Clinical Laboratory Improvement
Amendments Waiver Applications—
(OMB Control Number 0910–0598)—
Extension
Congress passed the Clinical
Laboratory Improvement Amendments
(CLIA) (Pub. L. 100–578) in 1988 to
establish quality standards for all
laboratory testing. The purpose was to
ensure the accuracy, reliability, and
timeliness of patient test results
regardless of where the test took place.
CLIA requires that clinical laboratories
obtain a certificate from the Secretary of
Health and Human Services (the
Secretary), before accepting materials
derived from the human body for
laboratory tests (42 U.S.C. 263a(b)).
Laboratories that perform only tests that
are ‘‘simple’’ and that have an
‘‘insignificant risk of an erroneous
result’’ may obtain a certificate of
waiver (42 U.S.C. 263a(d)(2)). The
Secretary has delegated to FDA the
authority to determine whether
particular tests (waived tests) are
‘‘simple’’ and have ‘‘an insignificant risk
of an erroneous result’’ under CLIA (69
FR 22849, April 27, 2004).
On January 30, 2008, FDA published
a guidance document entitled
‘‘Guidance for Industry and FDA Staff:
Recommendations for Clinical
Laboratory Improvement Amendments
of 1988 (CLIA) Waiver Applications for
Manufacturers of In Vitro Diagnostic
Devices’’ (https://www.fda.gov/Medical
Devices/DeviceRegulationandGuidance/
GuidanceDocuments/ucm079632.htm).
This guidance document describes
recommendations for device
manufacturers submitting to FDA an
application for determination that a
cleared or approved device meets this
CLIA standard (CLIA waiver
application). The guidance recommends
that CLIA waiver applications include a
description of the features of the device
that make it ‘‘simple’’; a report
describing a hazard analysis that
identifies potential sources of error,
including a summary of the design and
results of flex studies and conclusions
drawn from the flex studies; a
description of fail-safe and failure alert
mechanisms and a description of the
studies validating these mechanisms; a
description of clinical tests that
demonstrate the accuracy of the test in
the hands of intended operators; and
statistical analyses of clinical study
results.
The total number of reporting and
recordkeeping hours is 143,200 hours.
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FDA bases the burden on an Agency
analysis of premarket submissions with
clinical trials similar to the waived
laboratory tests. Based on previous
years’ experience with CLIA waiver
applications, FDA expects 40
manufacturers to submit one CLIA
waiver application per year. The time
required to prepare and submit a waiver
application, including the time needed
to assemble supporting data, averages
780 hours per waiver application for a
total of 31,200 hours for reporting.
Based on previous years’ experience
with CLIA waiver applications, FDA
expects that each manufacturer will
spend 2,800 hours creating and
maintaining the record for a total of
112,000 hours. The total operating and
maintenance cost associated with the
waiver application is estimated at
$66,200. The cost consists of specimen
collection for the clinical study
(estimated $23,500); laboratory supplies,
reference testing and study oversight
(estimated $26,700); shipping and office
supplies (estimated $6,000); and
educational materials, including quick
reference instructions (estimated
$10,000).
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Total operating
and maintenance costs
CLIA waiver application ...........................
40
1
40
780
31,200
$66,200
1
There are no capital costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN
Activity
Number of
recordkeepers
Number of records
per recordkeeper
Total annual
records
Average burden
per recordkeeping
Total hours
CLIA waiver records ..............................
40
1
40
2,800
112,000
Dated: August 30, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–22660 Filed 9–13–12; 8:45 am]
Food and Drug Administration
[Docket No. FDA–2012–N–0921]
BILLING CODE 4160–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Electronic
Submission of Food and Drug
Administration Adverse Event Reports
and Other Safety Information Using the
Electronic Submission Gateway and
the Safety Reporting Portal
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
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Notice.
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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 use of the FDA Electronic
Submission Gateway (ESG) and the
Safety Reporting Portal (the SRP) to
collect adverse event reports and other
SUMMARY:
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Federal Register / Vol. 77, No. 179 / Friday, September 14, 2012 / Notices
safety information for FDA-regulated
products.
when appropriate, and other forms of
information technology.
Submit either electronic or
written comments on the collection of
information by November 13, 2012.
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:
Domini Bean, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400T, Rockville, MD 20850,
domini.bean@fda.hhs.gov.
II. Electronic Submission of Food and
Drug Administration Adverse Event
Reports and Other Safety Information
Using the Electronic Submission
Gateway and the Safety Reporting
Portal—21 CFR 310.305, 314.80, 314.98,
314.540, 514.80, 600.80, 1271.350 and
Part 803 (OMB Control Number 0910–
0645)—Revision
The SRP (formerly referred to as the
MedWatchPlus Portal and Rational
Questionnaire) and the ESG are the
Agency’s electronic systems for
collecting, submitting, and processing
adverse event reports and other safety
information for FDA-regulated products.
To ensure the safety and identify any
risks, harms, or other dangers to health
for all FDA-regulated human and animal
products, the Agency needs to be
informed whenever an adverse event,
product quality problem, or product use
error occurs. This risk identification
process is the first necessary step that
allows the Agency to gather the
information necessary to be able to
evaluate the risk associated with the
product and take whatever action is
necessary to mitigate or eliminate the
public’s exposure to the risk.
Some adverse event reports are
required to be submitted to FDA
(mandatory reporting) and some adverse
event reports are submitted voluntarily
(voluntary reporting). Requirements
regarding mandatory reporting of
adverse events or product problems
have been codified in 21 CFR parts 310,
314, 514, 600, 803 and 1271, specifically
§§ 310.305, 314.80, 314.98, 314.540,
514.80, 600.80, 803.30, 803.40, 803.50,
803.53, 803.56 and 1271.350(a) (21 CFR
310.305, 314.80, 314.98, 314.540,
514.80, 600.80, 803.30, 803.40, 803.50,
803.53, 803.56 and 1271.350(a)). Many
of the adverse event reports submitted
to FDA are currently filed in paper
format using FDA Forms FDA 3500,
3500A, 1932, and 1932a, approved
under OMB control numbers 0910–0284
and 0910–0291. This notice solicits
comments on adverse event reports filed
electronically via the SRP and the ESG,
approved under OMB control number
0910–0645.
DATES:
SUPPLEMENTARY INFORMATION:
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I. Background
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,
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III. The FDA Safety Reporting Portal
Rational Questionnaires
FDA currently has OMB approval to
receive three types of adverse event
reports electronically via the SRP using
rational questionnaires. In this notice,
FDA seeks comments on the extension
of OMB approval for the existing three
rational questionnaires, as well as
comments on a proposed fourth rational
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questionnaire that will be used for a
new safety reporting program being
launched by the Center for Tobacco
Products (CTP).
A. Reportable Food Registry Reports
The Food and Drug Administration
Amendments Act of 2007 (Pub. L. 110–
085) (FDAAA) amended the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act) by creating a new section
417 (21 U.S.C. 350f), Reportable Food
Registry (RFR or the Registry). Section
417 of the FD&C Act defines ‘‘reportable
food’’ as an ‘‘article of food (other than
infant formula or dietary supplements)
for which there is a reasonable
probability that the use of, or exposure
to, such article of food will cause
serious adverse health consequences or
death to humans or animals.’’ (See
section 417(a)(2) of the FD&C Act). The
Secretary of Health and Human Services
(the Secretary) has delegated to the
Commissioner of FDA the responsibility
for administering the FD&C Act,
including section 417. To further the
development of the RFR, section 417 of
the FD&C Act required FDA to establish
an electronic portal by which instances
of reportable food (‘‘RFR reports’’) must
be submitted to FDA by responsible
parties and may be submitted by public
health officials. A ‘‘responsible party’’ is
the person who submits the registration
under section 415(a) of the FD&C Act
(21 U.S.C. 350d) for a food facility that
is required to register under section
415(a), at which such article of food is
manufactured, processed, packed, or
held. The RFR electronic portal was
established in 2009 as part of the
MedWatchPlus Portal, now the SRP, and
approved under OMB control number
0910–0645.
The Congressionally identified
purpose of the RFR is to provide ‘‘a
reliable mechanism to track patterns of
adulteration in food [which] would
support efforts by the Food and Drug
Administration to target limited
inspection resources to protect the
public health’’ (121 Stat. 965). The RFR
reports are designed to enable FDA to
quickly identify, track, and remove from
commerce an article of food (other than
infant formula and dietary supplements)
for which there is a reasonable
probability that the use of, or exposure
to, such article of food will cause
serious adverse health consequences or
death to humans or animals. FDA uses
the information collected to help ensure
that such products are quickly and
efficiently removed from the market to
prevent foodborne illnesses.
On January 4, 2011, the President
signed into law the FDA Food Safety
Modernization Act (Pub. L. 111–353)
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(the legislation or FSMA). Section 211
of the legislation amended section 417
of the FD&C Act to require FDA to
collect additional information in the
Agency’s RFR reports:
(1) A description of the article of food;
(2) Affected product identification
codes, such as Universal Product Code,
Stock Keeping Unit, or lot or batch
numbers sufficient for the consumer to
identify the article of food;
(3) Contact information for the
responsible party; and
(4) Any other information the
Secretary determines is necessary to
enable a consumer to accurately identify
whether such consumer is in possession
of the reportable food.
Section 211 of FSMA also amended
section 417 of the FD&C Act to require
FDA to generate one-page notices from
RFR reports to post on www.fda.gov for
grocery stores to display to consumers
when a reportable food has been sold.
The amendment made by section 211 of
FSMA took effect June 4, 2012, 18
months after the date of enactment. To
comply with this statutory deadline,
FDA initially obtained OMB approval of
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the additional collection of information
requirements under the emergency
processing provisions of the PRA under
OMB control number 0910–0709. The
new data improves the RFR’s
effectiveness in carrying out its purpose
of tracking patterns of adulteration in
food and supporting FDA’s efforts to
target limited inspection resources to
protect the public health.
Table 1 of this document, entitled
‘‘New Data Elements for RFR Reports,’’
presents the new data elements aded by
FDA to RFR Reports on June 4, 2012.
TABLE 1—NEW DATA ELEMENTS FOR RFR REPORTS
Field text
Mandatory or optional input
Reason this food is reportable (agent) .............................
What did your investigation identify as the root cause of
the problem (if you were required to conduct an investigation under section 417(d)(1)(B) of the FD&C Act)?
How did you determine which products/lots/batches
were affected?
To the best of your knowledge, has all of the reportable
food been removed from commerce?
What corrective actions have been taken to prevent future occurrences?
Product Commodity Type .................................................
Manufacturing/Production Date(s) ....................................
Use-by dates, if any, or approximate Shelf Life ...............
Was product treated to reduce microorganisms ..............
Microbial Reduction Treatment Details .............................
Mandatory ..........................
Mandatory ..........................
Section 417(e)(4) of the FD&C Act.
Section 417(e)(5) of the FD&C Act.
Mandatory ..........................
Section 417(e)(4) and (5) of the FD&C Act.
Mandatory ..........................
Section 417(e)(6) of the FD&C Act.
Mandatory
Mandatory
Mandatory
Mandatory
Mandatory
Is a Bacterial Isolate Available for collection?
Mandatory (but conditional)
Animal Species Intended for ............................................
Life Stage of Animal Intended for .....................................
Have you notified all immediate previous sources of this
reportable food?
Have you notified all immediate subsequent recipients of
this reportable food?
Mandatory ..........................
Mandatory ..........................
Optional ..............................
In this request for extension of OMB
approval, FDA is combining the burden
hours associated with OMB control
number 0910–0709 with the burden
hours approved under this OMB control
number (0910–0645).
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B. Reports Concerning Experience With
Approved New Animal Drugs
Section 512(l) of the FD&C Act (21
U.S.C. 360b(l)) and § 514.80(b) of FDA’s
regulations (21 CFR 514.80) require
applicants of approved new animal drug
applications (NADAs) and approved
abbreviated new animal drug
applications (ANADAs) to report
adverse drug experiences and product/
manufacturing defects.
This continuous monitoring of
approved NADAs and ANADAs affords
the primary means by which FDA
obtains information regarding potential
problems with the safety and efficacy of
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Authority if mandatory
Optional. .............................
..........................
..........................
..........................
(but conditional)
(but conditional)
Mandatory ..........................
Section 417(e)(3) of the FD&C Act.
Section 417(e)(3) and (4) of the FD&C Act.
Section 417(e)(7) of the FD&C Act.
Section 417(e)(3) and (4) of the FD&C Act.
Section 417(e)(3) and (4) of the FD&C Act (Conditional
for microbial hazards only and only after ‘‘yes’’ answer to ‘‘was product treated to reduce microorganisms?’’)
Section 417(e)(4) of the FD&C Act (Conditional for microbial hazards only.)
Section 417(e)(3) and (4) of the FD&C Act.
Section 417(e)(3) and (4) of the FD&C Act.
Section 417(e)(6) of the FD&C Act.
marketed approved new animal drugs as
well as potential product/manufacturing
problems. Post-approval marketing
surveillance is important because data
previously submitted to FDA may no
longer be adequate, as animal drug
effects can change over time and less
apparent effects may take years to
manifest.
If an applicant must report adverse
drug experiences and product/
manufacturing defects and chooses to
do so using the Agency’s paper forms,
the applicant is required to use Form
FDA 1932, ‘‘Veterinary Adverse Drug
Reaction, Lack of Effectiveness, Product
Defect Report.’’ Periodic drug
experience reports and special drug
experience reports must be
accompanied by a completed Form FDA
2301, ‘‘Transmittal of Periodic Reports
and Promotional Material for New
Animal Drugs’’ (see § 514.80(d)). Form
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FDA 1932a, ‘‘Veterinary Adverse Drug
Reaction, Lack of Effectiveness or
Product Defect Report’’ allows for
voluntary reporting of adverse drug
experiences or product/manufacturing
defects. Collection of information using
existing paper forms FDA 2301, 1932,
and 1932a is approved under OMB
control number 0910–0284.
Alternatively, an applicant may choose
to report adverse drug experiences and
product/manufacturing defects
electronically. Collection of this
information electronically was approved
in 2010 under OMB control number
0910–0645. The electronic submission
data elements to report adverse drug
experiences and product/manufacturing
defects electronically remain unchanged
in this request for extension of OMB
approval.
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C. Pet Food Early Warning System
Section 1002(b) of FDAAA directed
the Secretary to establish an early
warning and surveillance system to
identify adulteration of the pet food
supply and outbreaks of illness
associated with pet food. As part of the
effort to fulfill that directive, the
Secretary tasked FDA with developing
the instrument that would allow
consumers to report voluntarily adverse
events associated with pet food.
FDA developed the Pet Food Early
Warning System rational questionnaire
as a user-friendly data collection tool, to
make it easy for the public to report a
safety problem with pet food. The Pet
Food Early Warning System is designed
to identify adulteration of the pet food
supply and outbreaks of illness
associated with pet food to enable FDA
to quickly identify, track, and remove
from commerce such articles of food.
FDA uses the information collected to
help ensure that such products are
quickly and efficiently removed from
the market to prevent foodborne
illnesses. In 2010, OMB approved the
Pet Food Early Warning System
component of the SRP under OMB
control number 0910–0645, and FDA
launched the rational questionnaire by
which consumers may electronically
report adverse events associated with
pet food. The electronic submission data
elements to report adverse events
associated with pet food remain
unchanged in this request for extension
of OMB approval.
D. Voluntary Tobacco Product Adverse
Event and Product Problem Reports
As noted, this notice seeks comments
on a proposed fourth rational
questionnaire that will be used for a
new safety reporting program being
launched by the FDA Center for
Tobacco Products (CTP) to collect
voluntary tobacco product adverse event
and product problem reports.
FDA has broad legal authority under
the FD&C Act to protect the public
health. CTP’s mission is to protect
Americans from tobacco-related death
and disease by regulating the
manufacture, distribution, and
marketing of tobacco products and by
educating the public, especially young
people, about tobacco products and the
dangers their use poses to themselves
and others. The Family Smoking
Prevention and Tobacco Control Act of
2009 (Pub. L. 111–31) (Tobacco Control
Act) amended the FD&C Act by creating
a new section 909 (21 U.S.C. 387i,
Records and Reports on Tobacco
Products). Section 909(a) of the FD&C
Act (21 U.S.C. 387i(a)) authorizes FDA
to establish regulations with respect to
mandatory adverse event reports
associated with the use of a tobacco
product. At this time, FDA is proposing
to collect voluntary adverse event
reports associated with the use of
tobacco products from interested parties
such as health care providers,
researchers, consumers, and other users
of tobacco products. Information
collected in voluntary adverse event
reports will contribute to CTP’s ability
to be informed of, and assess the real
consequences of, tobacco product use.
The need for this collection of
information derives from our objective
to obtain current, timely, and policyrelevant information to carry out our
statutory functions. The FDA
Commissioner is authorized to
undertake this collection as specified in
section 1003(d)(2) of the FD&C Act (21
U.S.C. 393(d)(2)).
CTP currently receives adverse event
and product problem reports primarily
via paper MedWatch forms, approved
under OMB control number 0910–0291.
MedWatch forms, although recently
updated with field labels and
descriptions to better clarify for
reporters the range of reportable
products, including tobacco products,
do not specifically include questions
relevant for the analysis of adverse
events or product problems related to
tobacco products. The proposed
voluntary tobacco product adverse event
and product problem rational
questionnaire will include these specific
questions. The questionnaire evolved
with input from a National Institutes of
Health team of human-factors experts,
from other regulatory Agencies, and
with extensive input from consumer
advocacy groups and the general public.
FDA is also working with the FDA
Internet team to follow the HHS Internet
guidelines for Web design. FDA has and
will continue to reach out to
professional organizations and
community interest groups to collect
feedback during the user acceptance
testing. The rational questionnaire will
provide the user with detailed
navigation instructions to include dropdown menus, lists of values, controlled
vocabularies, and mouse over help
where possible. In addition, CTP will
issue guidance for the rational
questionnaire. Finally, we note that
users who are unable to submit reports
using the electronic system will still be
able to provide their information by
paper form (by mail or fax) or telephone.
The rational questionnaire will
capture tobacco-specific adverse event
and product problem information from
voluntary reporting entities such as
health care providers, researchers,
consumers, and other users of tobacco
products. To carry out its
responsibilities, FDA needs to be
informed when an adverse event,
product problem, or error with use is
suspected or identified. When FDA
receives tobacco-specific adverse event
and product problem information, it
will use the information to assess and
evaluate the risk associated with the
product, and then FDA will take
whatever action is necessary to reduce,
mitigate, or eliminate the public’s
exposure to the risk through regulatory
and public health interventions.
IV. Information Collection Burden
Estimate
Description of respondents: The
respondents to this collection of
information include all persons
submitting mandatory or voluntary
adverse event reports electronically to
FDA via the ESG or the SRP.
FDA estimates the burden of this
collection of information as follows:
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
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Activity
FDA Form No.
Voluntary Adverse Event Report via
the SRP (Other than RFR Reports).
Mandatory Adverse Event Report via
the SRP (Other than RFR Reports).
Mandatory Adverse Event Report via
the
ESG
(Gateway-to-Gateway
transmission).
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Number of
respondents
Number of
responses per
respondent
Total annual
responses
3800
1,513
1
1,513
3800
636
1
636
3800
1,491,228
1
1,491,228
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Average burden
per response
Total hours
0.6 (36 minutes)
908
1.0 ......................
636
0.6 (36 minutes)
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TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Activity
FDA Form No.
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Mandatory and Voluntary RFR Reports via the SRP.
3800
1,413
1
1,413
Total .............................................
........................
........................
........................
........................
1
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Average burden
per response
Total hours
0.6 (36 minutes)
............................
848
897,129
There are no capital costs or operating and maintenance costs associated with this collection of information.
The Agency’s estimate of the number
of respondents and the total annual
responses in table 2, Estimated Annual
Reporting Burden, is based primarily on
mandatory and voluntary adverse event
reports electronically submitted to the
Agency. The estimated total annual
responses are based on initial reports.
Follow-up reports, if any, are not
counted as new reports. Based on its
experience with adverse event
reporting, FDA estimates that it will
take a respondent 0.6 hour to submit a
voluntary adverse event report via the
SRP, 1.0 hour to submit a mandatory
adverse event report via the SRP, and
0.6 hour to submit a mandatory adverse
event report via the ESG (gateway-togateway transmission). Both mandatory
and voluntary RFR reports must be
submitted via the SRP. FDA estimates
that it will take a respondent 0.6 hour
to submit a RFR report, whether the
submission is mandatory or voluntary.
Voluntary adverse event reports
submitted via the SRP (other than RFR
Reports) include reports associated with
pet food (the Pet Food Early Warning
System) and the new tobacco product
adverse event and product problem
reports. CVM received 845 pet food
adverse event reports in 2010; 1,293
reports in 2011; and 471 reports in the
first 4 months of 2012; and estimates
that for the full 12 months of 2012 it
will receive 1,413 reports. Based on this
experience, CVM estimates that it will
receive, on average, 1,413 pet food
reports annually over the next 3 years.
CTP estimates that it will receive
approximately 100 voluntary tobacco
product adverse event and product
problem reports annually, after
implementation of electronic reporting.
CTP received 27 reports in 2010, 30
reports in 2011, and 22 reports in the
first half of 2012, and estimates that for
the full 12 months of 2012 it will
receive over 40 reports. Based on this
experience and an expectation that
reporting will increase once electronic
reporting is launched, CTP estimates
that it will receive, on average, 100
voluntary adverse event and product
problem reports annually over the next
3 years. Thus, FDA estimates that over
VerDate Mar<15>2010
16:39 Sep 13, 2012
Jkt 226001
the next 3 years it will receive annually
1,513 voluntary adverse event reports
submitted via the SRP, with a burden of
907.8 hours, rounded to 908 hours, as
reported in table 2, row 1 (1,413 + 100
= 1,513).
Mandatory adverse event reports
submitted via the SRP (other than RFR
Reports) include reports of adverse
animal drug experiences and product/
manufacturing defects associated with
approved NADAs and ANADAs. CVM
received 144 such adverse event reports
in 2010, 537 reports in 2011, and 212
reports in the first 4 months of 2012,
and estimates that for the full 12 months
of 2012 it will receive 636 reports.
Based on this experience, CVM
estimates that it will receive, on average,
636 reports of adverse drug experiences
and product/manufacturing defects
associated with approved NADAs and
ANADAs annually over the next 3 years.
Thus, FDA estimates that over the next
3 years it will receive annually 636
mandatory adverse event reports
submitted via the SRP, with a burden of
636 hours, as reported in table 2, row 2.
Adverse event reports submitted via
the ESG include reports of adverse
experiences related to drugs, biological
products, and medical devices, as well
as, adverse animal drug experiences and
product/manufacturing defects
associated with approved NADAs and
ANADAs. FDA received 586,229 such
adverse event reports in 2010; 850,161
reports in 2011; and 497,076 reports in
the first 4 months of 2012; and estimates
that for the full 12 months of 2012 it
will receive 1,491,228 reports. Based on
this experience, FDA estimates that it
will receive, on average, 1,491,228
adverse event reports submitted via the
ESG, with a burden of 894,736.8 hours,
rounded to 894,737 hours, as reported
in table 2, row 3.
FDA estimates that over the next 3
years it will receive annually 1,413
mandatory and voluntary RFR Reports
submitted via the SRP, as reported in
table 2, row 4. CFSAN received 845
such adverse event reports in 2010;
1,293 reports in 2011; and 471 reports
in the first 4 months of 2012; and
estimates that for the full 12 months of
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
2012 it will receive 1,413 reports. Based
on this experience, CFSAN estimates
that it will receive, on average, 1,413
mandatory and voluntary RFR Reports
submitted via the SRP annually over the
next 3 years, with a burden of 847.8
hours, rounded to 848 hours, as
reported in table 2, row 4.
The burden hours required to
complete paper FDA reporting forms
(Forms FDA 3500, 3500A, 1932, and
1932a) are reported under OMB control
numbers 0910–0284 and 0910–0291.
While FDA does not charge for the
use of the ESG, FDA requires
respondents to obtain a public key
infrastructure certificate in order to set
up the account. This can be obtained inhouse or outsourced by purchasing a
public key certificate that is valid for 1
year to 3 years. The certificate typically
costs from $20 to $30.
Dated: August 29, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–22659 Filed 9–13–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–D–0369 (formerly
Docket 2007D–0168)]
Draft and Revised Draft Guidances for
Industry Describing Product-Specific
Bioequivalence Recommendations;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of additional draft and
revised draft product-specific
bioequivalence (BE) recommendations.
The recommendations provide productspecific guidance on the design of BE
studies to support abbreviated new drug
applications (ANDAs). In the Federal
Register of June 11, 2010, FDA
announced the availability of a guidance
SUMMARY:
E:\FR\FM\14SEN1.SGM
14SEN1
]]>Agencies
[Federal Register Volume 77, Number 179 (Friday, September 14, 2012)]
[Notices]
[Pages 56847-56851]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-22659]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0921]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Electronic Submission of Food and Drug Administration
Adverse Event Reports and Other Safety Information Using the Electronic
Submission Gateway and the Safety Reporting Portal
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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 use of the FDA Electronic
Submission Gateway (ESG) and the Safety Reporting Portal (the SRP) to
collect adverse event reports and other
[[Page 56848]]
safety information for FDA-regulated products.
DATES: Submit either electronic or written comments on the collection
of information by November 13, 2012.
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: Domini Bean, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400T,
Rockville, MD 20850, domini.bean@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
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.
II. Electronic Submission of Food and Drug Administration Adverse Event
Reports and Other Safety Information Using the Electronic Submission
Gateway and the Safety Reporting Portal--21 CFR 310.305, 314.80,
314.98, 314.540, 514.80, 600.80, 1271.350 and Part 803 (OMB Control
Number 0910-0645)--Revision
The SRP (formerly referred to as the MedWatch\Plus\ Portal and
Rational Questionnaire) and the ESG are the Agency's electronic systems
for collecting, submitting, and processing adverse event reports and
other safety information for FDA-regulated products. To ensure the
safety and identify any risks, harms, or other dangers to health for
all FDA-regulated human and animal products, the Agency needs to be
informed whenever an adverse event, product quality problem, or product
use error occurs. This risk identification process is the first
necessary step that allows the Agency to gather the information
necessary to be able to evaluate the risk associated with the product
and take whatever action is necessary to mitigate or eliminate the
public's exposure to the risk.
Some adverse event reports are required to be submitted to FDA
(mandatory reporting) and some adverse event reports are submitted
voluntarily (voluntary reporting). Requirements regarding mandatory
reporting of adverse events or product problems have been codified in
21 CFR parts 310, 314, 514, 600, 803 and 1271, specifically Sec. Sec.
310.305, 314.80, 314.98, 314.540, 514.80, 600.80, 803.30, 803.40,
803.50, 803.53, 803.56 and 1271.350(a) (21 CFR 310.305, 314.80, 314.98,
314.540, 514.80, 600.80, 803.30, 803.40, 803.50, 803.53, 803.56 and
1271.350(a)). Many of the adverse event reports submitted to FDA are
currently filed in paper format using FDA Forms FDA 3500, 3500A, 1932,
and 1932a, approved under OMB control numbers 0910-0284 and 0910-0291.
This notice solicits comments on adverse event reports filed
electronically via the SRP and the ESG, approved under OMB control
number 0910-0645.
III. The FDA Safety Reporting Portal Rational Questionnaires
FDA currently has OMB approval to receive three types of adverse
event reports electronically via the SRP using rational questionnaires.
In this notice, FDA seeks comments on the extension of OMB approval for
the existing three rational questionnaires, as well as comments on a
proposed fourth rational questionnaire that will be used for a new
safety reporting program being launched by the Center for Tobacco
Products (CTP).
A. Reportable Food Registry Reports
The Food and Drug Administration Amendments Act of 2007 (Pub. L.
110-085) (FDAAA) amended the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) by creating a new section 417 (21 U.S.C. 350f), Reportable
Food Registry (RFR or the Registry). Section 417 of the FD&C Act
defines ``reportable food'' as an ``article of food (other than infant
formula or dietary supplements) for which there is a reasonable
probability that the use of, or exposure to, such article of food will
cause serious adverse health consequences or death to humans or
animals.'' (See section 417(a)(2) of the FD&C Act). The Secretary of
Health and Human Services (the Secretary) has delegated to the
Commissioner of FDA the responsibility for administering the FD&C Act,
including section 417. To further the development of the RFR, section
417 of the FD&C Act required FDA to establish an electronic portal by
which instances of reportable food (``RFR reports'') must be submitted
to FDA by responsible parties and may be submitted by public health
officials. A ``responsible party'' is the person who submits the
registration under section 415(a) of the FD&C Act (21 U.S.C. 350d) for
a food facility that is required to register under section 415(a), at
which such article of food is manufactured, processed, packed, or held.
The RFR electronic portal was established in 2009 as part of the
MedWatch\Plus\ Portal, now the SRP, and approved under OMB control
number 0910-0645.
The Congressionally identified purpose of the RFR is to provide ``a
reliable mechanism to track patterns of adulteration in food [which]
would support efforts by the Food and Drug Administration to target
limited inspection resources to protect the public health'' (121 Stat.
965). The RFR reports are designed to enable FDA to quickly identify,
track, and remove from commerce an article of food (other than infant
formula and dietary supplements) for which there is a reasonable
probability that the use of, or exposure to, such article of food will
cause serious adverse health consequences or death to humans or
animals. FDA uses the information collected to help ensure that such
products are quickly and efficiently removed from the market to prevent
foodborne illnesses.
On January 4, 2011, the President signed into law the FDA Food
Safety Modernization Act (Pub. L. 111-353)
[[Page 56849]]
(the legislation or FSMA). Section 211 of the legislation amended
section 417 of the FD&C Act to require FDA to collect additional
information in the Agency's RFR reports:
(1) A description of the article of food;
(2) Affected product identification codes, such as Universal
Product Code, Stock Keeping Unit, or lot or batch numbers sufficient
for the consumer to identify the article of food;
(3) Contact information for the responsible party; and
(4) Any other information the Secretary determines is necessary to
enable a consumer to accurately identify whether such consumer is in
possession of the reportable food.
Section 211 of FSMA also amended section 417 of the FD&C Act to
require FDA to generate one-page notices from RFR reports to post on
www.fda.gov for grocery stores to display to consumers when a
reportable food has been sold. The amendment made by section 211 of
FSMA took effect June 4, 2012, 18 months after the date of enactment.
To comply with this statutory deadline, FDA initially obtained OMB
approval of the additional collection of information requirements under
the emergency processing provisions of the PRA under OMB control number
0910-0709. The new data improves the RFR's effectiveness in carrying
out its purpose of tracking patterns of adulteration in food and
supporting FDA's efforts to target limited inspection resources to
protect the public health.
Table 1 of this document, entitled ``New Data Elements for RFR
Reports,'' presents the new data elements aded by FDA to RFR Reports on
June 4, 2012.
Table 1--New Data Elements for RFR Reports
------------------------------------------------------------------------
Mandatory or Authority if
Field text optional input mandatory
------------------------------------------------------------------------
Reason this food is reportable Mandatory........ Section 417(e)(4) of
(agent). the FD&C Act.
What did your investigation Mandatory........ Section 417(e)(5) of
identify as the root cause of the FD&C Act.
the problem (if you were
required to conduct an
investigation under section
417(d)(1)(B) of the FD&C
Act)?
How did you determine which Mandatory........ Section 417(e)(4) and
products/lots/batches were (5) of the FD&C Act.
affected?
To the best of your knowledge, Mandatory........ Section 417(e)(6) of
has all of the reportable the FD&C Act.
food been removed from
commerce?
What corrective actions have Optional......... .....................
been taken to prevent future
occurrences?
Product Commodity Type........ Mandatory........ Section 417(e)(3) of
the FD&C Act.
Manufacturing/Production Mandatory........ Section 417(e)(3) and
Date(s). (4) of the FD&C Act.
Use-by dates, if any, or Mandatory........ Section 417(e)(7) of
approximate Shelf Life. the FD&C Act.
Was product treated to reduce Mandatory (but Section 417(e)(3) and
microorganisms. conditional). (4) of the FD&C Act.
Microbial Reduction Treatment Mandatory (but Section 417(e)(3) and
Details. conditional). (4) of the FD&C Act
(Conditional for
microbial hazards
only and only after
``yes'' answer to
``was product
treated to reduce
microorganisms?'')
Is a Bacterial Isolate Mandatory (but Section 417(e)(4) of
Available for collection? conditional). the FD&C Act
(Conditional for
microbial hazards
only.)
Animal Species Intended for... Mandatory........ Section 417(e)(3) and
(4) of the FD&C Act.
Life Stage of Animal Intended Mandatory........ Section 417(e)(3) and
for. (4) of the FD&C Act.
Have you notified all Optional......... .....................
immediate previous sources of
this reportable food?
Have you notified all Mandatory........ Section 417(e)(6) of
immediate subsequent the FD&C Act.
recipients of this reportable
food?
------------------------------------------------------------------------
In this request for extension of OMB approval, FDA is combining the
burden hours associated with OMB control number 0910-0709 with the
burden hours approved under this OMB control number (0910-0645).
B. Reports Concerning Experience With Approved New Animal Drugs
Section 512(l) of the FD&C Act (21 U.S.C. 360b(l)) and Sec.
514.80(b) of FDA's regulations (21 CFR 514.80) require applicants of
approved new animal drug applications (NADAs) and approved abbreviated
new animal drug applications (ANADAs) to report adverse drug
experiences and product/manufacturing defects.
This continuous monitoring of approved NADAs and ANADAs affords the
primary means by which FDA obtains information regarding potential
problems with the safety and efficacy of marketed approved new animal
drugs as well as potential product/manufacturing problems. Post-
approval marketing surveillance is important because data previously
submitted to FDA may no longer be adequate, as animal drug effects can
change over time and less apparent effects may take years to manifest.
If an applicant must report adverse drug experiences and product/
manufacturing defects and chooses to do so using the Agency's paper
forms, the applicant is required to use Form FDA 1932, ``Veterinary
Adverse Drug Reaction, Lack of Effectiveness, Product Defect Report.''
Periodic drug experience reports and special drug experience reports
must be accompanied by a completed Form FDA 2301, ``Transmittal of
Periodic Reports and Promotional Material for New Animal Drugs'' (see
Sec. 514.80(d)). Form FDA 1932a, ``Veterinary Adverse Drug Reaction,
Lack of Effectiveness or Product Defect Report'' allows for voluntary
reporting of adverse drug experiences or product/manufacturing defects.
Collection of information using existing paper forms FDA 2301, 1932,
and 1932a is approved under OMB control number 0910-0284.
Alternatively, an applicant may choose to report adverse drug
experiences and product/manufacturing defects electronically.
Collection of this information electronically was approved in 2010
under OMB control number 0910-0645. The electronic submission data
elements to report adverse drug experiences and product/manufacturing
defects electronically remain unchanged in this request for extension
of OMB approval.
[[Page 56850]]
C. Pet Food Early Warning System
Section 1002(b) of FDAAA directed the Secretary to establish an
early warning and surveillance system to identify adulteration of the
pet food supply and outbreaks of illness associated with pet food. As
part of the effort to fulfill that directive, the Secretary tasked FDA
with developing the instrument that would allow consumers to report
voluntarily adverse events associated with pet food.
FDA developed the Pet Food Early Warning System rational
questionnaire as a user-friendly data collection tool, to make it easy
for the public to report a safety problem with pet food. The Pet Food
Early Warning System is designed to identify adulteration of the pet
food supply and outbreaks of illness associated with pet food to enable
FDA to quickly identify, track, and remove from commerce such articles
of food. FDA uses the information collected to help ensure that such
products are quickly and efficiently removed from the market to prevent
foodborne illnesses. In 2010, OMB approved the Pet Food Early Warning
System component of the SRP under OMB control number 0910-0645, and FDA
launched the rational questionnaire by which consumers may
electronically report adverse events associated with pet food. The
electronic submission data elements to report adverse events associated
with pet food remain unchanged in this request for extension of OMB
approval.
D. Voluntary Tobacco Product Adverse Event and Product Problem Reports
As noted, this notice seeks comments on a proposed fourth rational
questionnaire that will be used for a new safety reporting program
being launched by the FDA Center for Tobacco Products (CTP) to collect
voluntary tobacco product adverse event and product problem reports.
FDA has broad legal authority under the FD&C Act to protect the
public health. CTP's mission is to protect Americans from tobacco-
related death and disease by regulating the manufacture, distribution,
and marketing of tobacco products and by educating the public,
especially young people, about tobacco products and the dangers their
use poses to themselves and others. The Family Smoking Prevention and
Tobacco Control Act of 2009 (Pub. L. 111-31) (Tobacco Control Act)
amended the FD&C Act by creating a new section 909 (21 U.S.C. 387i,
Records and Reports on Tobacco Products). Section 909(a) of the FD&C
Act (21 U.S.C. 387i(a)) authorizes FDA to establish regulations with
respect to mandatory adverse event reports associated with the use of a
tobacco product. At this time, FDA is proposing to collect voluntary
adverse event reports associated with the use of tobacco products from
interested parties such as health care providers, researchers,
consumers, and other users of tobacco products. Information collected
in voluntary adverse event reports will contribute to CTP's ability to
be informed of, and assess the real consequences of, tobacco product
use. The need for this collection of information derives from our
objective to obtain current, timely, and policy-relevant information to
carry out our statutory functions. The FDA Commissioner is authorized
to undertake this collection as specified in section 1003(d)(2) of the
FD&C Act (21 U.S.C. 393(d)(2)).
CTP currently receives adverse event and product problem reports
primarily via paper MedWatch forms, approved under OMB control number
0910-0291. MedWatch forms, although recently updated with field labels
and descriptions to better clarify for reporters the range of
reportable products, including tobacco products, do not specifically
include questions relevant for the analysis of adverse events or
product problems related to tobacco products. The proposed voluntary
tobacco product adverse event and product problem rational
questionnaire will include these specific questions. The questionnaire
evolved with input from a National Institutes of Health team of human-
factors experts, from other regulatory Agencies, and with extensive
input from consumer advocacy groups and the general public. FDA is also
working with the FDA Internet team to follow the HHS Internet
guidelines for Web design. FDA has and will continue to reach out to
professional organizations and community interest groups to collect
feedback during the user acceptance testing. The rational questionnaire
will provide the user with detailed navigation instructions to include
drop-down menus, lists of values, controlled vocabularies, and mouse
over help where possible. In addition, CTP will issue guidance for the
rational questionnaire. Finally, we note that users who are unable to
submit reports using the electronic system will still be able to
provide their information by paper form (by mail or fax) or telephone.
The rational questionnaire will capture tobacco-specific adverse
event and product problem information from voluntary reporting entities
such as health care providers, researchers, consumers, and other users
of tobacco products. To carry out its responsibilities, FDA needs to be
informed when an adverse event, product problem, or error with use is
suspected or identified. When FDA receives tobacco-specific adverse
event and product problem information, it will use the information to
assess and evaluate the risk associated with the product, and then FDA
will take whatever action is necessary to reduce, mitigate, or
eliminate the public's exposure to the risk through regulatory and
public health interventions.
IV. Information Collection Burden Estimate
Description of respondents: The respondents to this collection of
information include all persons submitting mandatory or voluntary
adverse event reports electronically to FDA via the ESG or the SRP.
FDA estimates the burden of this collection of information as
follows:
Table 2--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity FDA Form No. Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Voluntary Adverse Event Report via the 3800 1,513 1 1,513 0.6 (36 minutes)............... 908
SRP (Other than RFR Reports).
Mandatory Adverse Event Report via the 3800 636 1 636 1.0............................ 636
SRP (Other than RFR Reports).
Mandatory Adverse Event Report via the 3800 1,491,228 1 1,491,228 0.6 (36 minutes)............... 894,737
ESG (Gateway-to-Gateway transmission).
[[Page 56851]]
Mandatory and Voluntary RFR Reports via 3800 1,413 1 1,413 0.6 (36 minutes)............... 848
the SRP.
----------------------------------------------------------------------------------------------------------------
Total.............................. .............. .............. .............. .............. ............................... 897,129
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
The Agency's estimate of the number of respondents and the total
annual responses in table 2, Estimated Annual Reporting Burden, is
based primarily on mandatory and voluntary adverse event reports
electronically submitted to the Agency. The estimated total annual
responses are based on initial reports. Follow-up reports, if any, are
not counted as new reports. Based on its experience with adverse event
reporting, FDA estimates that it will take a respondent 0.6 hour to
submit a voluntary adverse event report via the SRP, 1.0 hour to submit
a mandatory adverse event report via the SRP, and 0.6 hour to submit a
mandatory adverse event report via the ESG (gateway-to-gateway
transmission). Both mandatory and voluntary RFR reports must be
submitted via the SRP. FDA estimates that it will take a respondent 0.6
hour to submit a RFR report, whether the submission is mandatory or
voluntary.
Voluntary adverse event reports submitted via the SRP (other than
RFR Reports) include reports associated with pet food (the Pet Food
Early Warning System) and the new tobacco product adverse event and
product problem reports. CVM received 845 pet food adverse event
reports in 2010; 1,293 reports in 2011; and 471 reports in the first 4
months of 2012; and estimates that for the full 12 months of 2012 it
will receive 1,413 reports. Based on this experience, CVM estimates
that it will receive, on average, 1,413 pet food reports annually over
the next 3 years. CTP estimates that it will receive approximately 100
voluntary tobacco product adverse event and product problem reports
annually, after implementation of electronic reporting. CTP received 27
reports in 2010, 30 reports in 2011, and 22 reports in the first half
of 2012, and estimates that for the full 12 months of 2012 it will
receive over 40 reports. Based on this experience and an expectation
that reporting will increase once electronic reporting is launched, CTP
estimates that it will receive, on average, 100 voluntary adverse event
and product problem reports annually over the next 3 years. Thus, FDA
estimates that over the next 3 years it will receive annually 1,513
voluntary adverse event reports submitted via the SRP, with a burden of
907.8 hours, rounded to 908 hours, as reported in table 2, row 1 (1,413
+ 100 = 1,513).
Mandatory adverse event reports submitted via the SRP (other than
RFR Reports) include reports of adverse animal drug experiences and
product/manufacturing defects associated with approved NADAs and
ANADAs. CVM received 144 such adverse event reports in 2010, 537
reports in 2011, and 212 reports in the first 4 months of 2012, and
estimates that for the full 12 months of 2012 it will receive 636
reports. Based on this experience, CVM estimates that it will receive,
on average, 636 reports of adverse drug experiences and product/
manufacturing defects associated with approved NADAs and ANADAs
annually over the next 3 years. Thus, FDA estimates that over the next
3 years it will receive annually 636 mandatory adverse event reports
submitted via the SRP, with a burden of 636 hours, as reported in table
2, row 2.
Adverse event reports submitted via the ESG include reports of
adverse experiences related to drugs, biological products, and medical
devices, as well as, adverse animal drug experiences and product/
manufacturing defects associated with approved NADAs and ANADAs. FDA
received 586,229 such adverse event reports in 2010; 850,161 reports in
2011; and 497,076 reports in the first 4 months of 2012; and estimates
that for the full 12 months of 2012 it will receive 1,491,228 reports.
Based on this experience, FDA estimates that it will receive, on
average, 1,491,228 adverse event reports submitted via the ESG, with a
burden of 894,736.8 hours, rounded to 894,737 hours, as reported in
table 2, row 3.
FDA estimates that over the next 3 years it will receive annually
1,413 mandatory and voluntary RFR Reports submitted via the SRP, as
reported in table 2, row 4. CFSAN received 845 such adverse event
reports in 2010; 1,293 reports in 2011; and 471 reports in the first 4
months of 2012; and estimates that for the full 12 months of 2012 it
will receive 1,413 reports. Based on this experience, CFSAN estimates
that it will receive, on average, 1,413 mandatory and voluntary RFR
Reports submitted via the SRP annually over the next 3 years, with a
burden of 847.8 hours, rounded to 848 hours, as reported in table 2,
row 4.
The burden hours required to complete paper FDA reporting forms
(Forms FDA 3500, 3500A, 1932, and 1932a) are reported under OMB control
numbers 0910-0284 and 0910-0291.
While FDA does not charge for the use of the ESG, FDA requires
respondents to obtain a public key infrastructure certificate in order
to set up the account. This can be obtained in-house or outsourced by
purchasing a public key certificate that is valid for 1 year to 3
years. The certificate typically costs from $20 to $30.
Dated: August 29, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-22659 Filed 9-13-12; 8:45 am]
BILLING CODE 4160-01-P
