Agency Emergency Processing Under the Office of Management and Budget Review; MedWatch-The Food and Drug Administration Safety Information and Adverse Event Reporting Program; Proposal to Survey MedWatch Partners Organizations, 25591-25593 [E6-6461]
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25591
Federal Register / Vol. 71, No. 83 / Monday, May 1, 2006 / Notices
Survey, OMB No. 0920–0214) and other
federally sponsored surveys. The QDRL
conducts cognitive interviews, focus
groups, mini field-pretests, and
experimental research in laboratory and
field settings, both for applied
questionnaire evaluation and more basic
research on response errors in surveys.
The most common questionnaire
evaluation method is the cognitive
interview. In a cognitive interview, a
questionnaire design specialist
interviews a volunteer participant. The
interviewer administers the draft survey
questions as written, but also probes the
participant in depth about
interpretations of questions, recall
processes used to answer them, and
adequacy of response categories to
express answers, while noting points of
confusion and errors in responding.
Interviews are generally conducted in
small rounds of 10–15 interviews;
ideally, the questionnaire is re-worked
between rounds and revisions are tested
iteratively until interviews yield
relatively few new insights. When
possible, cognitive interviews are
conducted in the survey’s intended
mode of administration. For example,
when testing telephone survey
questionnaires, participants often
respond to the questions via a telephone
in a laboratory room. Under this
condition, the participant answers
without face-to-face interaction. QDRL
staff watch for response difficulties from
an observation room, and then conduct
a face-to-face debriefing with in-depth
probes. Cognitive interviewing provides
useful data on questionnaire
performance at minimal cost and
respondent burden. Similar
methodology has been adopted by other
federal agencies, as well as by academic
and commercial survey organizations.
NCHS is requesting 3 years of OMB
Clearance for the project. There are no
costs to respondents other than their
time.
ESTIMATED ANNUALIZED BURDEN
Respondents
Number of
respondents
per year
Number of
responses/
respondent
Avg. burden
response
(in hours)
Total burden
hours
2007 test volunteers ................................................................................................
500
1
1.2
600
Dated: April 25, 2006.
Joan F. Karr,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E6–6501 Filed 4–28–06; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003N–0273] (formerly 03N–
0273)
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Research Study Complaint Form
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
cchase on PROD1PC60 with NOTICES
17:38 Apr 28, 2006
Dated: April 24, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–6457 Filed 4–28–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Research Study Complaint Form’’ has
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT:
Karen L. Nelson, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1482.
SUPPLEMENTARY INFORMATION: In the
Federal Register of December 16, 2005
(70 FR 74817), the agency announced
that the proposed information collection
had been submitted to OMB for review
and clearance under 44 U.S.C. 3507. An
SUMMARY:
VerDate Aug<31>2005
agency may not conduct or sponsor, and
a person is not required to respond to,
a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0579. The
approval expires on March 31, 2009. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.fda.gov/
ohrms/dockets.
Jkt 208001
[Docket No. 2006N–0166]
Agency Emergency Processing Under
the Office of Management and Budget
Review; MedWatch—The Food and
Drug Administration Safety
Information and Adverse Event
Reporting Program; Proposal to
Survey MedWatch Partners
Organizations
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
Office of Management and Budget
(OMB) for emergency processing under
the Paperwork Reduction Act of 1995
(the PRA). This notice solicits
comments on a proposal for the
MedWatch program to deploy and
conduct a web-based customer
satisfaction survey of certain health care
professional trade and specialty
organizations that voluntarily have
chosen to participate in the FDA
MedWatch’s Partners program. The
survey will solicit information about the
utility of the FDA MedWatch safety
alerts and monthly safety labeling
changes that are posted on the
MedWatch Web site and disseminated
to partner organizations for sharing with
members of the organizations.
DATES: Fax written comments on the
collection of information by May 31,
2006. FDA is requesting approval of this
emergency processing by May 31, 2006.
ADDRESSES: OMB is still experiencing
significant delays in the regular mail,
including first class and express mail,
and messenger deliveries are not being
accepted. To ensure that comments on
the information collection are received,
OMB recommends that comments be
faxed to the Office of Information and
Regulatory Affairs, OMB, Attn: Fumie
Yokota, Desk Officer for FDA, Fax: 202–
395–6974.
FOR FURTHER INFORMATION CONTACT:
Karen Nelson, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1482.
SUPPLEMENTARY INFORMATION: FDA has
requested emergency processing of this
E:\FR\FM\01MYN1.SGM
01MYN1
25592
Federal Register / Vol. 71, No. 83 / Monday, May 1, 2006 / Notices
proposed collection of information
under section 3507(j) of the PRA (44
U.S.C. 3507(j)) and 5 CFR 1320.13. This
information is needed immediately so
that the agency can effectively assess
and re-evaluate its FDA MedWatch risk
communication efforts in drug safety as
part of a broader center level (the Center
for Drug Evaluation and Research
(CDER)) reorganization action to
enhance its risk communication
activities for CDER-regulated products,
and address public expectations for
timely dissemination of clinically useful
safety information to both providers and
their patients at the point of care.
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.
MedWatch—The FDA Safety
Information and Adverse Event
Reporting Program; Proposal to Survey
MedWatch Partners Organizations
The MedWatch Partners program is an
FDA outreach effort directed at health
care provider professional
organizations. The effort facilitates the
timely dissemination of clinically
important new safety information on the
drugs, devices, and other human
medical care products regulated by FDA
and prescribed, dispensed, or used by
the membership of these professional
societies. In voluntarily agreeing to
work with FDA MedWatch, these
partner organizations disseminate this
important safety information to their
members and their members’ patients so
that medical products necessary to
efforts to improve a patient’s health may
be used more safely and reduce the risk
of harm.
Risk communication is one of the
essential elements in the risk
management paradigm accepted as a
framework within CDER since described
in the ‘‘Report to the FDA
Commissioner from the Task Force on
Risk Management’’ in May 1999. As an
agency that regulates a broad range of
clinical medical products—drugs,
therapeutic biologics, blood products,
medical devices, and dietary
supplements—FDA’s public health
mission includes the timely
dissemination of new safety information
identified during post-marketing
surveillance activities. This information
includes class 1 recalls, public health
advisories, notice of counterfeit drug
product, and labeling changes such as
new black box warnings or
contraindications to drug product use.
In recent years, there has been a public
commitment to actively disseminating
this new safety information, both to
health care providers and their patients,
and to leveraging this risk
communication activity by developing
partnerships and alliances with nongovernmental organizations. This
commitment was explicitly identified as
an objective in the strategic plan for
‘‘Improving Patient Safety’’ of former
Commissioner of Food and Drugs, Mark
McClellan. That objective states that
FDA will ‘‘take appropriate actions to
communicate risks and correct problems
associated with medical products’’ and
‘‘will identify new ways to inform
physicians, pharmacists, nurses, and
patients about the safety of FDAregulated products.’’
The MedWatch program is currently
located in the Office of Drug Safety,
CDER. MedWatch disseminates safety
information on FDA-regulated medical
products to both health care
professional and consumer/patient
audiences. MedWatch maintains a
comprehensive Web site at https://
www.fda.gov/medwatch for this
purpose. The FDA MedWatch program
has about 120 Partner organizations that
represent clinical care providers
(doctors, nurses, pharmacists, etc.). As a
‘‘Partner,’’ the organization has agreed
to support the goals of the MedWatch
program: Participating in the
dissemination of FDA-approved safety
information and promoting the
voluntary reporting to FDA of adverse
events. In order to communicate quickly
with MedWatch Partner organizations, a
listserve, supported by the National
Institutes of Health, is maintained, with
contacts for each MedWatch Partner
group. Partner organizations have
voluntarily agreed to receive these FDA
MedWatch safety alerts and monthly
safety labeling changes. Each
organization receives e-mail notification
of two types of FDA MedWatch safety
information at the time it is added to the
MedWatch Web site—safety alerts for
individual products and, once a month,
a listing of the 30 to 60 drugs that have
had safety labeling changes for that
month.
The FDA MedWatch program, in
order to implement this safety
information dissemination process
effectively, needs to evaluate
satisfaction of these customer groups so
that FDA MedWatch can improve the
dissemination process and content of
this safety information and increase its
use and application to direct patient
care and to the public’s health.
The purpose of the survey is to fulfill
phase one of Executive Order 12862,
‘‘Setting Customer Service Standards,’’
which directs agencies to continually
reform their management practices and
operations to provide service to the
public that matches or exceeds the best
service available in the private sector.
There is no duplication of effort. The
MedWatch program is the only one
planning to perform this survey. By
actively gathering this survey
information from MedWatch partner
customers, the agency will achieve a
better understanding customer
satisfaction with this program, and be
able to direct limited resources to
produce an improved program that is
most useful to both health care provider
customers and, secondarily, their
patients.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN 1
cchase on PROD1PC60 with NOTICES
No. of
Respondents
Partner Organizations
1There
Annual Frequency
per Response
120
Total Annual
Responses
1
Hours per
Response
120
Total Hours
.5
60
are no capital costs or operating and maintenance costs associated with this collection of information.
This burden estimate of total hours
was developed by using: (1) The number
VerDate Aug<31>2005
17:38 Apr 28, 2006
Jkt 208001
of known MedWatch partner health care
organizations, (2) the number of times
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
the survey will be deployed, and (3) the
expected time to complete the response
E:\FR\FM\01MYN1.SGM
01MYN1
Federal Register / Vol. 71, No. 83 / Monday, May 1, 2006 / Notices
based on internal pilot testing of the
survey instrument at the agency.
Dated: April 24, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–6461 Filed 4–28–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Research Review Subcommittee of the
Vaccines and Related Biological
Products Advisory Committee; Notice
of Meeting
AGENCY:
Food and Drug Administration,
HHS.
cchase on PROD1PC60 with NOTICES
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). At least one portion of the
meeting will be closed to the public.
Name of the Subcommittee: Research
Review Subcommittee of the Vaccines
and Related Biological Products
Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on May 19, 2006, from 8 a.m. to
4:30 p.m.
Location: Hilton Hotel, Washington
DC North/Gaithersburg, 620 Perry
Pkwy., Gaithersburg, MD 20877.
Contact Person: Christine Walsh or
Denise Royster, Center for Biologics
Evaluation and Research (HFM–71),
Food and Drug Administration, 1401
Rockville Pike, Rockville, MD 20852,
301–827–0314, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area), code
3014512391. Please call the Information
Line for up-to-date information on this
meeting.
Agenda: On May 19, 2006, the
subcommittee will listen to
presentations about the research
program at the Office of Vaccines
Research and Review (OVRR), Center for
Biologics Evaluation and Research
(CBER). The program is intended to
provide dynamic, responsive, cutting
edge research to contribute to OVRR’s
regulatory mission and facilitate
development of safe and effective
biological products. The subcommittee
will discuss the program and make
recommendations to the Vaccines and
Related Biological Products Advisory
VerDate Aug<31>2005
18:29 Apr 28, 2006
Jkt 208001
Committee at a future open meeting of
the full committee. Information
regarding CBER’s scientific program is
outlined in its Strategic Plan of 2004
and is available to the public on the
Internet at: https://www.fda.gov/cber/
inside/mission.htm. Information
regarding FDA’s Critical Path to New
Medical Products is available to the
public on the Internet at: https://
www.fda.gov/oc/initiatives/
criticalpath/.
Procedure: On May 19, 2006, from 8
a.m. to 1 p.m., the meeting is open to
the public. Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person by May 12, 2006. Oral
presentations from the public will be
scheduled between approximately 12
p.m. to 1 p.m. Time allotted for each
presentation may be limited. Those
desiring to make formal oral
presentations should notify the contact
person before May 12, 2006, and submit
a brief statement of the general nature of
the evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation.
Closed Committee Deliberations: On
May 19, 2006, from 2 p.m. to 4:30 p.m.,
the meeting will be closed to the public.
The meeting will be closed to permit
discussion where disclosure would
constitute a clearly unwarranted
invasion of personal privacy (5 U.S.C.
552b(c)(6) and to permit discussion and
review of trade secret and/or
confidential information (5 U.S.C.
552b(c)(4). The subcommittee will
discuss internal research programs in
the Office of Vaccines Research and
Review, CBER.
Persons attending FDA’s advisory
committee meetings are advised that the
agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Christine
Walsh or Denise Royster at least 7 days
in advance of the meeting.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
25593
Dated: April 21, 2006.
Jason Brodsky,
Acting Associate Commissioner for External
Relations.
[FR Doc. E6–6508 Filed 4–28–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Vaccines and Related Biological
Products Advisory Committee; Notice
of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Vaccines and
Related Biological Products Advisory
Committee.
General Function of the Committee:
To provide advice and
recommendations to the agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on May 18, 2006, from 9 a.m. to
4:45 p.m.
Location: Hilton Hotel, Washington
DC North/Gaithersburg, 620 Perry
Pkwy., Gaithersburg, MD 20877.
Contact Person: Christine Walsh or
Denise Royster, Center for Biologics
Evaluation and Research (HFM–71),
Food and Drug Administration, 1401
Rockville Pike, Rockville, MD 20852,
301–827–0314, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area), code
3014512391. Please call the Information
Line for up-to-date information on this
meeting.
Agenda: The committee will hear
presentations and make
recommendations on the safety and
efficacy of GARDASIL (Human
Papillomavirus [Types 6,11,16,18]
Recombinant Vaccine) manufactured by
Merck.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person by May 11, 2006. Oral
presentations from the public will be
scheduled between approximately 1:30
p.m. and 2:30 p.m. Time allotted for
each presentation may be limited. Those
desiring to make formal oral
E:\FR\FM\01MYN1.SGM
01MYN1
]]>Agencies
[Federal Register Volume 71, Number 83 (Monday, May 1, 2006)]
[Notices]
[Pages 25591-25593]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-6461]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N-0166]
Agency Emergency Processing Under the Office of Management and
Budget Review; MedWatch--The Food and Drug Administration Safety
Information and Adverse Event Reporting Program; Proposal to Survey
MedWatch Partners Organizations
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for emergency processing under the
Paperwork Reduction Act of 1995 (the PRA). This notice solicits
comments on a proposal for the MedWatch program to deploy and conduct a
web-based customer satisfaction survey of certain health care
professional trade and specialty organizations that voluntarily have
chosen to participate in the FDA MedWatch's Partners program. The
survey will solicit information about the utility of the FDA MedWatch
safety alerts and monthly safety labeling changes that are posted on
the MedWatch Web site and disseminated to partner organizations for
sharing with members of the organizations.
DATES: Fax written comments on the collection of information by May 31,
2006. FDA is requesting approval of this emergency processing by May
31, 2006.
ADDRESSES: OMB is still experiencing significant delays in the regular
mail, including first class and express mail, and messenger deliveries
are not being accepted. To ensure that comments on the information
collection are received, OMB recommends that comments be faxed to the
Office of Information and Regulatory Affairs, OMB, Attn: Fumie Yokota,
Desk Officer for FDA, Fax: 202-395-6974.
FOR FURTHER INFORMATION CONTACT: Karen Nelson, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-1482.
SUPPLEMENTARY INFORMATION: FDA has requested emergency processing of
this
[[Page 25592]]
proposed collection of information under section 3507(j) of the PRA (44
U.S.C. 3507(j)) and 5 CFR 1320.13. This information is needed
immediately so that the agency can effectively assess and re-evaluate
its FDA MedWatch risk communication efforts in drug safety as part of a
broader center level (the Center for Drug Evaluation and Research
(CDER)) reorganization action to enhance its risk communication
activities for CDER-regulated products, and address public expectations
for timely dissemination of clinically useful safety information to
both providers and their patients at the point of care.
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.
MedWatch--The FDA Safety Information and Adverse Event Reporting
Program; Proposal to Survey MedWatch Partners Organizations
The MedWatch Partners program is an FDA outreach effort directed at
health care provider professional organizations. The effort facilitates
the timely dissemination of clinically important new safety information
on the drugs, devices, and other human medical care products regulated
by FDA and prescribed, dispensed, or used by the membership of these
professional societies. In voluntarily agreeing to work with FDA
MedWatch, these partner organizations disseminate this important safety
information to their members and their members' patients so that
medical products necessary to efforts to improve a patient's health may
be used more safely and reduce the risk of harm.
Risk communication is one of the essential elements in the risk
management paradigm accepted as a framework within CDER since described
in the ``Report to the FDA Commissioner from the Task Force on Risk
Management'' in May 1999. As an agency that regulates a broad range of
clinical medical products--drugs, therapeutic biologics, blood
products, medical devices, and dietary supplements--FDA's public health
mission includes the timely dissemination of new safety information
identified during post-marketing surveillance activities. This
information includes class 1 recalls, public health advisories, notice
of counterfeit drug product, and labeling changes such as new black box
warnings or contraindications to drug product use. In recent years,
there has been a public commitment to actively disseminating this new
safety information, both to health care providers and their patients,
and to leveraging this risk communication activity by developing
partnerships and alliances with non-governmental organizations. This
commitment was explicitly identified as an objective in the strategic
plan for ``Improving Patient Safety'' of former Commissioner of Food
and Drugs, Mark McClellan. That objective states that FDA will ``take
appropriate actions to communicate risks and correct problems
associated with medical products'' and ``will identify new ways to
inform physicians, pharmacists, nurses, and patients about the safety
of FDA-regulated products.''
The MedWatch program is currently located in the Office of Drug
Safety, CDER. MedWatch disseminates safety information on FDA-regulated
medical products to both health care professional and consumer/patient
audiences. MedWatch maintains a comprehensive Web site at https://
www.fda.gov/medwatch for this purpose. The FDA MedWatch program has
about 120 Partner organizations that represent clinical care providers
(doctors, nurses, pharmacists, etc.). As a ``Partner,'' the
organization has agreed to support the goals of the MedWatch program:
Participating in the dissemination of FDA-approved safety information
and promoting the voluntary reporting to FDA of adverse events. In
order to communicate quickly with MedWatch Partner organizations, a
listserve, supported by the National Institutes of Health, is
maintained, with contacts for each MedWatch Partner group. Partner
organizations have voluntarily agreed to receive these FDA MedWatch
safety alerts and monthly safety labeling changes. Each organization
receives e-mail notification of two types of FDA MedWatch safety
information at the time it is added to the MedWatch Web site--safety
alerts for individual products and, once a month, a listing of the 30
to 60 drugs that have had safety labeling changes for that month.
The FDA MedWatch program, in order to implement this safety
information dissemination process effectively, needs to evaluate
satisfaction of these customer groups so that FDA MedWatch can improve
the dissemination process and content of this safety information and
increase its use and application to direct patient care and to the
public's health.
The purpose of the survey is to fulfill phase one of Executive
Order 12862, ``Setting Customer Service Standards,'' which directs
agencies to continually reform their management practices and
operations to provide service to the public that matches or exceeds the
best service available in the private sector. There is no duplication
of effort. The MedWatch program is the only one planning to perform
this survey. By actively gathering this survey information from
MedWatch partner customers, the agency will achieve a better
understanding customer satisfaction with this program, and be able to
direct limited resources to produce an improved program that is most
useful to both health care provider customers and, secondarily, their
patients.
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
Respondents per Response Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Partner Organizations 120 1 120 .5 60
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
This burden estimate of total hours was developed by using: (1) The
number of known MedWatch partner health care organizations, (2) the
number of times the survey will be deployed, and (3) the expected time
to complete the response
[[Page 25593]]
based on internal pilot testing of the survey instrument at the agency.
Dated: April 24, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-6461 Filed 4-28-06; 8:45 am]
BILLING CODE 4160-01-S
