Agency Information Collection Activities; Proposed Collection; Comment Request; Evaluation of Potential Data Sources for the Sentinel Initiative, 10053-10055 [E9-4830]
Download as PDF
<![CDATA[
10053
Federal Register / Vol. 74, No. 44 / Monday, March 9, 2009 / Notices
ACTION:
Notice.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by April 8,
2009.
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–6974, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0138. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Jr., Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3793.
Reclassification Petitions for Medical
Devices—21 CFR Section 860.123 (OMB
Control Number 0910–0138)—Extension
FDA has responsibility under sections
513(e) and (f), 514(b), 515(b), and 520(l)
of the Federal Food, Drug, and Cosmetic
Act (the act) (21 U.S.C. 360c(e), and (f),
360d(b), 360e(b), and 360j(l)) and part
860 (21 CFR part 860), subpart C, to
collect data and information contained
in reclassification petitions. The
reclassification provisions of the act
allow any person to petition for
reclassification of a device from any one
of the three classes i.e, I, II, and III, to
another class. The reclassification
procedure regulation requires the
submission of specific data when a
manufacturer is petitioning for
reclassification. This includes a
‘‘Supplemental Data Sheet,’’ Form FDA
3427, and a ‘‘Classification
Questionnaire,’’ Form FDA 3429. Both
forms are a series of questions
concerning the safety and effectiveness
of the device type. Further, the
reclassification content regulation
(§ 860.123) requires the submission of
sufficient, valid scientific evidence
demonstrating that the proposed
reclassification will provide a
reasonable assurance of safety and
effectiveness of the device type for its
indications for use. Thus, the
reclassification provisions of the act
serve primarily as a vehicle for
manufacturers to seek reclassification
from a higher to a lower class, thereby
reducing the regulatory requirements
applicable to a particular device type, or
to seek reclassification from a lower to
a higher class, thereby increasing the
regulatory requirements. The
reclassification petitions requesting
classification from class III to class II or
class I, if approved, provides an
alternative route to the market in lieu of
premarket approval for class III devices
or from class I or II, to one or the other
class, which may increase requirements.
In the Federal Register of December 4,
2008 (73 FR 73938), FDA published a
60-day notice requesting public
comment on the information collection
provisions. No comments were received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR Section
No. of
Respondents
860.123
1There
6
Total Annual
Responses
1
Hours per
Response
6
Total Hours
500
3,000
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on the last 3 years, and actual
reclassification petitions received, FDA
anticipates that six petitions will be
submitted each year. The time required
to prepare and submit a reclassification
petition, including the time needed to
assemble supporting data, averages 500
hours per petition. This average is based
upon estimates by FDA administrative
and technical staff that: (1) Are familiar
with the requirements for submission of
a reclassification petition, (2) have
consulted and advised manufacturers on
these requirements, and (3) have
reviewed the documentation submitted.
dwashington3 on PROD1PC60 with NOTICES
Annual Frequency
per Response
Dated: March 2, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–4829 Filed 3–6–09; 8:45 am]
BILLING CODE 4160–01–S
VerDate Nov<24>2008
15:28 Mar 06, 2009
Jkt 217001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0098]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Evaluation of
Potential Data Sources for the Sentinel
Initiative
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
PO 00000
Frm 00075
Fmt 4703
Sfmt 4703
notice. This notice solicits comments on
the proposed information collection
through a survey designed to identify
potential data sources and/or data
environments that could participate in
the Sentinel Initiative to create a
national, electronic distributed system,
strengthening FDA’s ability to monitor
the postmarket performance of a
medical product.
DATES: Submit written or electronic
comments on the collection of
information by May 8, 2009.
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
E:\FR\FM\09MRN1.SGM
09MRN1
10054
Federal Register / Vol. 74, No. 44 / Monday, March 9, 2009 / Notices
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3794. To
obtain a copy of the draft survey
instrument contact Tomeka Arnett on
301–827–1512.
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.
Evaluation of Potential Data Sources for
the Sentinel Initiative
In September 2005, the Secretary of
Health and Human Services (the
Secretary) asked FDA to expand its
current system for monitoring medical
product performance. The Secretary
asked FDA to explore the possibility of
working in collaboration with multiple
healthcare data systems to augment
FDA’s capability of identifying and
evaluating product safety information
beyond its existing voluntary reporting
systems. Such a step would strengthen
FDA’s ability, ultimately, to monitor the
performance of a product after
marketing approval. The Secretary
recommended that FDA explore creating
a public-private collaboration as a
framework for such an effort leveraging
increasingly available large, electronic
healthcare databases and taking
advantage of emerging technologies and
building on existing systems and efforts,
rather than creating new systems.
In 2006, the Institute of Medicine
(IOM) issued a report entitled ‘‘The
Future of Drug Safety—Promoting and
Protecting the Health of the Public.’’1
Among other suggestions, this IOM
report recommended FDA identify ways
to access other health-related databases
and create a public-private partnership
to support safety and efficacy studies.
In 2007, Congress enacted the Food
and Drug Administration Amendments
Act of 20072 (FDAAA). Section 905 of
FDAAA calls for the Secretary to
develop methods to obtain access to
disparate data sources and to establish
an active postmarket risk identification
and analysis system that links and
analyzes healthcare data from multiple
sources. The law sets a goal of access to
data from 25 million patients by July 1,
2010, and 100 million patients by July
1, 2012. The law also requires FDA to
work closely with partners from public,
academic, and private entities. FDA
views the Sentinel Initiative as a
mechanism through which this mandate
can be carried out.
Consistent with FDA’s mission to
protect and promote the public health,
FDA is embarking on the Sentinel
Initiative to create a national, electronic
distributed system, strengthening FDA’s
ability to monitor the post-market
performance of a product. As currently
envisioned, the Sentinel Initiative will
enable FDA to capitalize on the
capabilities of multiple, existing data
systems (e.g. electronic health record
systems and medical claims databases)
to augment the agency’s current
surveillance capabilities. The proposed
system will enable queries of distributed
data sources quickly and securely for
relevant product safety information.
Data will continue to be managed by its
owners, and only data of organizations
who agree to participate in this system
will be included. Operations will adhere
to strict privacy and security safeguards.
The success of this Initiative will
depend largely on the content, quality,
searchability, and responsiveness of
participating data sources and/or data
environments. It is essential that FDA
understand the strengths and limitations
of potential data sources that might be
included in the Sentinel Initiative. This
survey will be used to collect
information from potentially
participating data sources and/or
environments. The data we are seeking
will describe the characteristics of the
data available, not personally
identifiable information. The findings
will help FDA plan for this proposed
system and for future work related to
the Sentinel Initiative.
This survey will collect information
on the scope, content, structure, quality,
and timeliness of data; patient
population(s), duration of follow up,
and capture of care across all settings;
availability, experience, and interest of
investigators with knowledge of the data
in using it for post-market product
safety surveillance as well as plans for
further data source enhancements;
availability, experience, and interest of
investigators with knowledge of the data
in participating in a distributed data
system; and barriers that exist to
including each data source in the
Sentinel Initiative.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
Activity
dwashington3 on PROD1PC60 with NOTICES
Data Source and/or Environment
Survey
1There
Annual Frequency
per Response
250
Total Annual
Responses
1
Hours per
Response
250
Total Hours
24.5
6,125
are no capital costs or operating and maintenance costs associated with this collection of information.
1 Institute of Medicine, ‘‘The Future of Drug
Safety—Promoting and Protecting the Health of the
Public,’’ September 22, 2006, https://www.iom.
edu/. (FDA has verified the Web site address, but
VerDate Nov<24>2008
15:28 Mar 06, 2009
Jkt 217001
FDA is not responsible for any subsequent changes
to the Web site after this document publishes in the
Federal Register.)
PO 00000
Frm 00076
Fmt 4703
Sfmt 4703
2 Food and Drug Administration Amendments
Act of 2007, Public Law 110–85, was signed into
law in September 2007. See Title IX, Section 905.
E:\FR\FM\09MRN1.SGM
09MRN1
Federal Register / Vol. 74, No. 44 / Monday, March 9, 2009 / Notices
FDA estimates that approximately 250
respondents will participate in this
voluntary survey. These respondents
will consist mostly of other Federal
agencies, health plan data sources,
health information exchanges, large
multi-specialty medical groups and
academic medical centers, large hospital
systems, pharmacies, medical societies,
consumer-oriented Web sites,
commercial data sets, research
networks, lab data, and registries.
Each respondent will extend
approximately 24.5 hours to complete 1
survey for a total of 6,125 hours (250 x
1 x 24.5 = 6,125).
Dated: February 27, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–4830 Filed 3–6–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–E–0164]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; ALTABAX OINTMENT
AGENCY:
Food and Drug Administration,
HHS.
dwashington3 on PROD1PC60 with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for
ALTABAX OINTMENT and is
publishing this notice of that
determination as required by law. FDA
has made the determination because of
the submission of an application to the
Director of Patents and Trademarks,
Department of Commerce, for the
extension of a patent which claims that
human drug product.
ADDRESSES: Submit written comments
and petitions to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51,
rm. 6222, Silver Spring, MD 20993–
0002, 301–796–3602.
SUPPLEMENTARY INFORMATION: The Drug
Price Competition and Patent Term
Restoration Act of 1984 (Public Law 98–
417) and the Generic Animal Drug and
Patent Term Restoration Act (Public
VerDate Nov<24>2008
15:28 Mar 06, 2009
Jkt 217001
Law 100–670) generally provide that a
patent may be extended for a period of
up to 5 years so long as the patented
item (human drug product, animal drug
product, medical device, food additive,
or color additive) was subject to
regulatory review by FDA before the
item was marketed. Under these acts, a
product’s regulatory review period
forms the basis for determining the
amount of extension an applicant may
receive.
A regulatory review period consists of
two periods of time: A testing phase and
an approval phase. For human drug
products, the testing phase begins when
the exemption to permit the clinical
investigations of the human drug
product becomes effective and runs
until the approval phase begins. The
approval phase starts with the initial
submission of an application to market
the human drug product and continues
until FDA grants permission to market
the drug product. Although only a
portion of a regulatory review period
may count toward the actual amount of
extension that the Director of Patents
and Trademarks may award (for
example, half the testing phase must be
subtracted as well as any time that may
have occurred before the patent was
issued), FDA’s determination of the
length of a regulatory review period for
a human drug product will include all
of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
FDA recently approved for marketing
the human drug product ALTABAX
OINTMENT (retapamulin). ALTABAX
OINTMENT is indicated for the topical
treatment of impetigo due to
Staphylococcus aureus (methicillinsusceptible isolates only) or
Streptococcus pyogenes in patients aged
9 months or older. Subsequent to this
approval, the Patent and Trademark
Office received a patent term restoration
application for ALTABAX OINTMENT
(U.S. Patent No. RE39,128E) from
SmithKline Beecham P.L.C., and
SmithKline Beecham Corp., and the
Patent and Trademark Office requested
FDA’s assistance in determining this
patent’s eligibility for patent term
restoration. In a letter dated April 28,
2008, FDA advised the Patent and
Trademark Office that this human drug
product had undergone a regulatory
review period and that the approval of
ALTABAX OINTMENT represented the
first permitted commercial marketing or
use of the product. Thereafter, the
Patent and Trademark Office requested
that FDA determine the product’s
regulatory review period.
FDA has determined that the
applicable regulatory review period for
ALTABAX OINTMENT is 1,602 days.
PO 00000
Frm 00077
Fmt 4703
Sfmt 4703
10055
Of this time, 1,297 days occurred during
the testing phase of the regulatory
review period, while 305 days occurred
during the approval phase. These
periods of time were derived from the
following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (the act) (21 U.S.C.
355(i)) became effective: November 24,
2002. FDA has verified the applicant’s
claim that the date the investigational
new drug application became effective
was on November 24, 2002.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the act: June 12, 2006. FDA
has verified the applicant’s claim that
the new drug application (NDA) for
ALTABAX OINTMENT (NDA 22–055)
was initially submitted on June 12,
2006.
3. The date the application was
approved: April 12, 2007. FDA has
verified the applicant’s claim that NDA
22–055 was approved on April 12, 2007.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the U.S. Patent and
Trademark Office applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its application for patent extension,
this applicant seeks 833 days of patent
term extension.
Anyone with knowledge that any of
the dates as published are incorrect may
submit to the Division of Dockets
Management (see ADDRESSES) written or
electronic comments and ask for a
redetermination by May 8, 2009.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
September 8, 2009. To meet its burden,
the petition must contain sufficient facts
to merit an FDA investigation. (See H.
Rept. 857, part 1, 98th Cong., 2d sess.,
pp. 41–42, 1984.) Petitions should be in
the format specified in 21 CFR 10.30.
Comments and petitions should be
submitted to the Division of Dockets
Management. Three copies of any
mailed information are to be submitted,
except that individuals may submit one
copy. Comments are to be identified
with the docket number found in
brackets in the heading of this
document. Comments and petitions may
be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
E:\FR\FM\09MRN1.SGM
09MRN1
]]>Agencies
[Federal Register Volume 74, Number 44 (Monday, March 9, 2009)]
[Notices]
[Pages 10053-10055]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-4830]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0098]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Evaluation of Potential Data Sources for the Sentinel
Initiative
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 proposed information collection through
a survey designed to identify potential data sources and/or data
environments that could participate in the Sentinel Initiative to
create a national, electronic distributed system, strengthening FDA's
ability to monitor the postmarket performance of a medical product.
DATES: Submit written or electronic comments on the collection of
information by May 8, 2009.
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
[[Page 10054]]
Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-796-3794. To obtain a copy of the draft survey
instrument contact Tomeka Arnett on 301-827-1512.
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.
Evaluation of Potential Data Sources for the Sentinel Initiative
In September 2005, the Secretary of Health and Human Services (the
Secretary) asked FDA to expand its current system for monitoring
medical product performance. The Secretary asked FDA to explore the
possibility of working in collaboration with multiple healthcare data
systems to augment FDA's capability of identifying and evaluating
product safety information beyond its existing voluntary reporting
systems. Such a step would strengthen FDA's ability, ultimately, to
monitor the performance of a product after marketing approval. The
Secretary recommended that FDA explore creating a public-private
collaboration as a framework for such an effort leveraging increasingly
available large, electronic healthcare databases and taking advantage
of emerging technologies and building on existing systems and efforts,
rather than creating new systems.
In 2006, the Institute of Medicine (IOM) issued a report entitled
``The Future of Drug Safety--Promoting and Protecting the Health of the
Public.''\1\ Among other suggestions, this IOM report recommended FDA
identify ways to access other health-related databases and create a
public-private partnership to support safety and efficacy studies.
---------------------------------------------------------------------------
\1\ Institute of Medicine, ``The Future of Drug Safety--
Promoting and Protecting the Health of the Public,'' September 22,
2006, https://www.iom. edu/. (FDA has verified the Web site address,
but FDA is not responsible for any subsequent changes to the Web
site after this document publishes in the Federal Register.)
---------------------------------------------------------------------------
In 2007, Congress enacted the Food and Drug Administration
Amendments Act of 2007\2\ (FDAAA). Section 905 of FDAAA calls for the
Secretary to develop methods to obtain access to disparate data sources
and to establish an active postmarket risk identification and analysis
system that links and analyzes healthcare data from multiple sources.
The law sets a goal of access to data from 25 million patients by July
1, 2010, and 100 million patients by July 1, 2012. The law also
requires FDA to work closely with partners from public, academic, and
private entities. FDA views the Sentinel Initiative as a mechanism
through which this mandate can be carried out.
---------------------------------------------------------------------------
\2\ Food and Drug Administration Amendments Act of 2007, Public
Law 110-85, was signed into law in September 2007. See Title IX,
Section 905.
---------------------------------------------------------------------------
Consistent with FDA's mission to protect and promote the public
health, FDA is embarking on the Sentinel Initiative to create a
national, electronic distributed system, strengthening FDA's ability to
monitor the post-market performance of a product. As currently
envisioned, the Sentinel Initiative will enable FDA to capitalize on
the capabilities of multiple, existing data systems (e.g. electronic
health record systems and medical claims databases) to augment the
agency's current surveillance capabilities. The proposed system will
enable queries of distributed data sources quickly and securely for
relevant product safety information. Data will continue to be managed
by its owners, and only data of organizations who agree to participate
in this system will be included. Operations will adhere to strict
privacy and security safeguards.
The success of this Initiative will depend largely on the content,
quality, searchability, and responsiveness of participating data
sources and/or data environments. It is essential that FDA understand
the strengths and limitations of potential data sources that might be
included in the Sentinel Initiative. This survey will be used to
collect information from potentially participating data sources and/or
environments. The data we are seeking will describe the characteristics
of the data available, not personally identifiable information. The
findings will help FDA plan for this proposed system and for future
work related to the Sentinel Initiative.
This survey will collect information on the scope, content,
structure, quality, and timeliness of data; patient population(s),
duration of follow up, and capture of care across all settings;
availability, experience, and interest of investigators with knowledge
of the data in using it for post-market product safety surveillance as
well as plans for further data source enhancements; availability,
experience, and interest of investigators with knowledge of the data in
participating in a distributed data system; and barriers that exist to
including each data source in the Sentinel Initiative.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
Activity Respondents per Response Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
Data Source 250 1 250 24.5 6,125
and/or
Environment
Survey
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 10055]]
FDA estimates that approximately 250 respondents will participate
in this voluntary survey. These respondents will consist mostly of
other Federal agencies, health plan data sources, health information
exchanges, large multi-specialty medical groups and academic medical
centers, large hospital systems, pharmacies, medical societies,
consumer-oriented Web sites, commercial data sets, research networks,
lab data, and registries.
Each respondent will extend approximately 24.5 hours to complete 1
survey for a total of 6,125 hours (250 x 1 x 24.5 = 6,125).
Dated: February 27, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-4830 Filed 3-6-09; 8:45 am]
BILLING CODE 4160-01-S
