Agency Information Collection Activities; Proposed Collection; Comment Request; FDA Public Health Notification Readership Survey (formerly known as “Safety Alert/Public Health Advisory Readership Survey”), 42674-42675 [E9-20247]
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42674
Federal Register / Vol. 74, No. 162 / Monday, August 24, 2009 / Notices
awareness on resource availability. List
the measurable variables and data
elements that you believe need to be
defined and captured in order to
effectively support regional delivery of
care. Also include any suggestions as to
which common data elements, at a
minimum, should be included within a
standardized data language to facilitate,
encourage, and improve the support and
integration of the various state resource
tracking mechanisms.
D. Opportunities and challenges in
regionalized care delivery. Please share
your opinions on the potential benefits,
obstacles, drawbacks, and consequences
(both intended and unintended) of
regionalized healthcare models,
providing specific evidence where
feasible. If possible, elaborate on the
effects regionalization may produce on
providers’ financial viability, patient
access to care, healthcare service
utilization rates, disaster preparedness
efforts, and response capabilities.
E. Evaluation of regionalized care
delivery systems. Please provide
comments on how regionalized care
systems can be objectively assessed and
evaluated, including suggestions on
appropriate measures of programmatic
success or failure and opinions on
which data sources could be used to
establish compliance with regional
performance benchmarks. Where
possible, also list measurable ways to
assess regionalization’s impact with
regard to health outcomes, including
factors such as morbidity and mortality,
time-to-care, condition-specific
treatment, quality of care, patient safety,
etc.
F. Adaptation of regionalization to
emergency medical care. Given the legal
requirement to screen and stabilize ED
patients, the need for time-sensitive,
high-quality care in emergency settings,
and the diversity of patient populations
and geographic locations, please
provide insights or commentary on how
the concept of regionalization could be
adapted and/or customized to fit the
unique aspects of emergency medical
care.
G. Additional information. Please
provide any additional opinions,
suggestions, or comments as to how the
ECCC and the Emergency Care
Enterprise can shape demonstration
projects of regionalized, coordinated,
and accountable systems of emergency
care to effectively utilize limited
resources, facilitate information
management and flow, increase the
efficiency and effectiveness of the
emergency healthcare delivery system,
and enhance the overall quality of care
provided.
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15:04 Aug 21, 2009
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Please indicate which type of
institution or organization you are
primarily affiliated with (using the
following categories):
• Academia;
• Small Business;
• Healthcare Facility;
• Trauma or EMSS region;
• Federal Government;
• State Government;
• Healthcare Professional;
• Patient Advocacy Group;
• Other (briefly define).
This request for information is for
planning purposes only and shall not be
interpreted as a solicitation for
applications or as an obligation on the
part of the government. The government
will not pay for the preparation of any
information submitted or for the
government’s use of that information.
Dated: August 14, 2009.
Nicole Lurie,
Assistant Secretary for Preparedness and
Response, Rear Admiral, U.S. Public Health
Service.
[FR Doc. E9–20162 Filed 8–21–09; 8:45 am]
BILLING CODE 4150–37–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0360]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; FDA Public Health
Notification Readership Survey
(formerly known as ‘‘Safety Alert/
Public Health Advisory Readership
Survey’’)
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
FDA Public Health Notification
Readership Survey.
DATES: Submit written or electronic
comments on the collection of
information by October 23, 2009.
ADDRESSES: Submit electronic
comments on the collection of
PO 00000
Frm 00031
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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:
Denver Presley, Jr., Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3793.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
FDA Public Health Notification
Readership Survey (formerly known as
Safety Alert/Public Health Advisory
Readership Survey) (PHS Act, Section
1701 (a)(4)); OMB Control Number
0910–0341–Extension
Section 705(b) of the Federal Food,
Drug, and Cosmetic Act (the act) (21
E:\FR\FM\24AUN1.SGM
24AUN1
42675
Federal Register / Vol. 74, No. 162 / Monday, August 24, 2009 / Notices
U.S.C. 375(b)) authorizes FDA to
disseminate information concerning
imminent danger to public health by
any regulated product. The Center for
Devices and Radiological Health
(CDRH), communicates these risks to
user communities through two
publications: (1) The Public Health
Notification (PHN) and (2) the
Preliminary Public Health Notification
(PPHN). The PHN is published when
CDRH has information or a message to
convey to health care practitioners that
they would want to know in order to
make informed clinical decisions about
the use of a device or device type, and
that information may not be readily
available to the affected target audience
in the health care community. CDRH
can make recommendations that will
help the health care practitioner
mitigate or avoid the risk.
The PPHN is also published when
CDRH has information to convey to
health care practitioners that they
would want to know in order to make
informed clinical decisions about the
use of a device or device type. However,
two additional conditions exist that
make the use of this type of notification
preferable: (1) CDRH’s understanding of
the problem, its cause(s), and the scope
of the risk that is still evolving, so that
in order to minimize the risk, the center
believes that health care practitioners
needs the information they can provide,
however incomplete, as soon as possible
and (2) the problem is actively being
investigated by the center, private
industry, another agency or some other
reliable entity, so that the center expects
to be able to update the PPHN when
definitive new information becomes
available. Notifications are sent to
organizations affected by risks discussed
in the notification, such as hospitals,
nursing homes, hospices, home health
care agencies, retail pharmacies, and
other health care providers. Through a
process for identifying and addressing
postmarket safety issues related to
regulated products, CDRH determines
when to publish notifications.
Section 1701(a)(4) of the Public
Health Service Act (42 U.S.C.
300u(a)(4)), authorizes FDA to conduct
research relating to health information.
FDA seeks to evaluate the clarity,
timeliness and impact of safety alerts
and public health advisories by
surveying a sample of recipients.
Subjects will receive a questionnaire to
be completed and returned to FDA. The
information to be collected will address
how clearly notifications for reducing
risks are explained, the timeliness of the
information and whether the reader has
taken any action to eliminate or reduce
risk as a result of the information in the
alert. Subjects will also be asked
whether they wish to receive future
notifications electronically, as well as
how the PHN program might be
improved.
The information collected will be
used to shape FDA’s editorial policy for
the PHN and PPHN. Understanding how
target audiences view these publications
will aid in deciding what changes
should be considered in their content
and format, and method of
dissemination.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
PHS Act
No. of
Respondents
Section 1701(a)(4)
1 There
Annual Frequency
per Response
308
Total Annual
Responses
3
Hours per
Response
924
Total Hours
.17
157
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on the history of the PHN
program, it is estimated that an average
of three collections will be conducted a
year. The total burden of response time
is estimated at 10 minutes per survey.
This was derived by CDRH staff
completing the survey and through
discussions with the contacts in trade
organizations.
Dated: August 17, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–20247 Filed 8–21–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Proposed Projects
Title: Refugee Unaccompanied Minor
Placement Report & Minor Progress
Reports; ORR–3 and ORR–4.
OMB No.: 0970–0034.
Description: The two reports collect
information necessary to administer the
Unaccompanied Refugee Minor (URM)
program. The ORR–3 (Placement
Report) is submitted to the Office of
Refugee Resettlement (ORR) by the State
agency at initial placement and
whenever there is a change in the
child’s status, including termination
from the program. The ORR–4 (Progress
Report) is submitted annually and
records the child’s progress toward the
goals listed in the child’s case plan.
Respondents: State governments.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
Number of
responses
per respondent
erowe on DSK5CLS3C1PROD with NOTICES
15
15
Estimated Total Annual Burden
Hours: 519.75
In compliance with the requirements
of Section 506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Administration,
Office of Information Services, 370
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15:04 Aug 21, 2009
Jkt 217001
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E:\FR\FM\24AUN1.SGM
24AUN1
0.25
0.30
Total
burden
hours
ORR–3 .............................................................................................................................
ORR–4 .............................................................................................................................
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
63
63
Average
burden
hours per
response
236.25
283.50
Agencies
[Federal Register Volume 74, Number 162 (Monday, August 24, 2009)]
[Notices]
[Pages 42674-42675]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-20247]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0360]
Agency Information Collection Activities; Proposed Collection;
Comment Request; FDA Public Health Notification Readership Survey
(formerly known as ``Safety Alert/Public Health Advisory Readership
Survey'')
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 FDA Public Health Notification
Readership Survey.
DATES: Submit written or electronic comments on the collection of
information by October 23, 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: Denver Presley, Jr., Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-796-3793.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
FDA Public Health Notification Readership Survey (formerly known as
Safety Alert/Public Health Advisory Readership Survey) (PHS Act,
Section 1701 (a)(4)); OMB Control Number 0910-0341-Extension
Section 705(b) of the Federal Food, Drug, and Cosmetic Act (the
act) (21
[[Page 42675]]
U.S.C. 375(b)) authorizes FDA to disseminate information concerning
imminent danger to public health by any regulated product. The Center
for Devices and Radiological Health (CDRH), communicates these risks to
user communities through two publications: (1) The Public Health
Notification (PHN) and (2) the Preliminary Public Health Notification
(PPHN). The PHN is published when CDRH has information or a message to
convey to health care practitioners that they would want to know in
order to make informed clinical decisions about the use of a device or
device type, and that information may not be readily available to the
affected target audience in the health care community. CDRH can make
recommendations that will help the health care practitioner mitigate or
avoid the risk.
The PPHN is also published when CDRH has information to convey to
health care practitioners that they would want to know in order to make
informed clinical decisions about the use of a device or device type.
However, two additional conditions exist that make the use of this type
of notification preferable: (1) CDRH's understanding of the problem,
its cause(s), and the scope of the risk that is still evolving, so that
in order to minimize the risk, the center believes that health care
practitioners needs the information they can provide, however
incomplete, as soon as possible and (2) the problem is actively being
investigated by the center, private industry, another agency or some
other reliable entity, so that the center expects to be able to update
the PPHN when definitive new information becomes available.
Notifications are sent to organizations affected by risks discussed in
the notification, such as hospitals, nursing homes, hospices, home
health care agencies, retail pharmacies, and other health care
providers. Through a process for identifying and addressing postmarket
safety issues related to regulated products, CDRH determines when to
publish notifications.
Section 1701(a)(4) of the Public Health Service Act (42 U.S.C.
300u(a)(4)), authorizes FDA to conduct research relating to health
information. FDA seeks to evaluate the clarity, timeliness and impact
of safety alerts and public health advisories by surveying a sample of
recipients. Subjects will receive a questionnaire to be completed and
returned to FDA. The information to be collected will address how
clearly notifications for reducing risks are explained, the timeliness
of the information and whether the reader has taken any action to
eliminate or reduce risk as a result of the information in the alert.
Subjects will also be asked whether they wish to receive future
notifications electronically, as well as how the PHN program might be
improved.
The information collected will be used to shape FDA's editorial
policy for the PHN and PPHN. Understanding how target audiences view
these publications will aid in deciding what changes should be
considered in their content and format, and method of dissemination.
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
PHS Act Respondents per Response Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
Section 308 3 924 .17 157
1701(a)(4)
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Based on the history of the PHN program, it is estimated that an
average of three collections will be conducted a year. The total burden
of response time is estimated at 10 minutes per survey. This was
derived by CDRH staff completing the survey and through discussions
with the contacts in trade organizations.
Dated: August 17, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-20247 Filed 8-21-09; 8:45 am]
BILLING CODE 4160-01-S