Proposed Information Collection Activity; Comment Request, 42675-42676 [E9-20175]
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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]
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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
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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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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
42676
Federal Register / Vol. 74, No. 162 / Monday, August 24, 2009 / Notices
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. E-mail address:
infocollection@acf.hhs.gov. All requests
should be identified by the title of the
information collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: August 18, 2009.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. E9–20175 Filed 8–21–09; 8:45 am]
Proposed Project: HRSA/Bureau of
Primary Health Care Capital
Improvement Program Application
Electronic Health Records (EHR)
Readiness Checklist (OMB No. 0915–
0325)—Extension
The American Recovery and
Reinvestment Act (ARRA) provides $1.5
billion in grants to support
BILLING CODE 4184–01–P
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Periodically, the Health Resources
and Services Administration (HRSA)
publishes abstracts of information
collection requests under review by the
Office of Management and Budget
(OMB), in compliance with the
Paperwork Reduction Act of 1995 (44
U.S.C. Chapter 35). To request a copy of
the clearance requests submitted to
OMB for review, e-mail
paperwork@hrsa.gov or call the HRSA
Reports Clearance Office on (301)-443–
1129.
The following request has been
submitted to the Office of Management
and Budget for review under the
Paperwork Reduction Act of 1995:
Number of
respondents
Form
Responses per
respondent
‘‘construction, renovation and
equipment’’, and ‘‘the acquisition of
health information technology systems,
for health centers including health
center controlled networks receiving
operating grants under section 330’’ of
the Public Health Service (PHS) Act, as
amended (42 U.S.C. 254b). HRSA is
requesting extension of the approval of
the Electronic Health Records (EHR)
Readiness Checklist portion of the
application where applicants must
provide information to demonstrate
readiness for electronic health records if
they propose to use funds for electronic
health record (EHR) related purchases.
Of the $1.5 billion, HRSA will award
approximately $850 million, through
limited competition grants, for one-time
Capital Improvement Program (CIP)
grant funding in fiscal year (FY) 2009 to
support existing section 330 funded
health centers. Funding under this
opportunity will address pressing
capital improvement needs in health
centers, such as construction, repair,
renovation, and equipment purchases,
including health information technology
systems. Applicants must provide
information using the EHR Readiness
Checklist that demonstrates
comprehensive planning and readiness
for implementing EHRs.
The estimated annual burden is as
follows:
Total responses
Hours per
response
Total burden
hours
EHR Readiness Checklist ................................
568
1
568
.25
142
Total ..........................................................
568
............................
568
............................
142
Written comments and
recommendations concerning the
proposed information collection should
be sent within 30 days of this notice to
the desk officer for HRSA, either by email to OIRA_submission@omb.eop.gov
or by fax to 202–395–6974. Please direct
all correspondence to the ‘‘attention of
the desk officer for HRSA.’’
Dated: August 18, 2009.
Alexandra Huttinger,
Director, Division of Policy Review and
Coordination.
[FR Doc. E9–20306 Filed 8–21–09; 8:45 am]
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15:04 Aug 21, 2009
Food and Drug Administration
[Docket No. FDA–2009–N–0345]
Agency Information Collection
Activities: Proposed Collection;
Comment Request; Internet Survey on
Barriers to Food Label Use
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
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information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the Internet Survey on Barriers to Food
Label Use.
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:
Daniel Gittleson, Office of Information
Management (HFA–710), Food and Drug
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[Federal Register Volume 74, Number 162 (Monday, August 24, 2009)]
[Notices]
[Pages 42675-42676]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-20175]
-----------------------------------------------------------------------
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 Average
Number of responses burden Total
Instrument respondents per hours per burden
respondent response hours
----------------------------------------------------------------------------------------------------------------
ORR-3....................................................... 15 63 0.25 236.25
ORR-4....................................................... 15 63 0.30 283.50
----------------------------------------------------------------------------------------------------------------
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 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 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
[[Page 42676]]
L'Enfant Promenade, SW., Washington, DC 20447, Attn: ACF Reports
Clearance Officer. E-mail address: infocollection@acf.hhs.gov. All
requests should be identified by the title of the information
collection.
The Department specifically requests comments on: (a) Whether the
proposed collection of information is necessary for the proper
performance of the functions of the agency, including whether the
information shall have practical utility; (b) the accuracy of the
agency's estimate of the burden of the proposed collection of
information; (c) the quality, utility, and clarity of the information
to be collected; and (d) ways to minimize the burden of the collection
of information on respondents, including through the use of automated
collection techniques or other forms of information technology.
Consideration will be given to comments and suggestions submitted
within 60 days of this publication.
Dated: August 18, 2009.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. E9-20175 Filed 8-21-09; 8:45 am]
BILLING CODE 4184-01-P
