Proposed Information Collection Activity; Comment Request, 21689-21690 [E9-10703]
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21689
Federal Register / Vol. 74, No. 88 / Friday, May 8, 2009 / Notices
Emergency Shortages Data Collection
System (formerly ‘‘Emergency Medical
Device Shortages Program Survey’’)—
Section 903(d)(2) of the Federal Food,
Drug, and Cosmetic Act (OMB Control
Number 0910–0491)—Extension
Under section 903(d)(2) of the Federal
Food, Drug, and Cosmetic Act (the act)
(21 U.S.C. 393(d)(2)), the FDA
Commissioner is authorized to
implement general powers (including
conducting research) to carry out
effectively the mission of FDA.
Subsequent to the events of September
11, 2001, and as part of broader counterterrorism and emergency preparedness
activities, FDA’s Center for Devices and
Radiological Health (CDRH) began
developing operational plans and
interventions that would enable CDRH
to anticipate and respond to medical
device shortages that might arise in the
context of federally-declared disasters/
emergencies or regulatory actions. In
particular, CDRH identified the need to
acquire and maintain detailed data on
domestic inventory, manufacturing
capabilities, distribution plans and raw
material constraints for medical devices
that would be in high demand, and/or
would be vulnerable to shortages in
specific disaster/emergency situations,
or following specific regulatory actions.
Such data could support prospective
risk assessment, help inform risk
mitigation strategies, and support realtime decisionmaking by the Department
of Health and Human Services during
actual emergencies or emergency
preparedness exercises.
‘‘The Emergency Medical Device
Shortages Program Survey’’ was
developed in 2002 to support the
acquisition of such data from medical
device manufacturers. In 2004, CDRH
changed the process for the data
collection, and the electronic database
in which the data were stored and was
formally renamed the ‘‘Emergency
Shortages Data Collection System’’
(ESDCS). Recognizing that some of the
data collected may be commercially
confidential, access to ESDCS is
restricted to members of the FDA
Emergency Shortage Team (EST) and
senior management with a need-toknow. At this time, the need-to-know
senior management personnel are
limited to 5 senior managers. Further,
the data are used by this defined group
only for decisionmaking and planning
in the context of a federally-declared
disaster/emergency, an official
emergency preparedness exercise, or a
potential public health risk posed by
non-disaster-related device shortage.
The data procurement process
consists of an initial scripted telephone
call to a regulatory officer at a registered
manufacturer of one or more key
medical devices being tracked in the
emergency shortages data collection
system. In this initial call, the intent and
goals of the data collection effort are
described, and the specific data request
is made. After the initial call, one or
more additional followup calls and/or
electronic mail correspondence may be
required to verify/validate data sent
from the manufacturer, confirm receipt
and/or request additional detail.
Although the regulatory officer is the
agent who is initially contacted, they
may designate an alternate
representative within their organization
to correspond subsequently with the
CDRH EST member who is collecting or
verifying/validating the data.
Because of the dynamic nature of the
medical device industry, particularly
with respect to specific product lines,
manufacturing capabilities and raw
material/subcomponent sourcing, it is
necessary to update the data in the
ESDCS at regular intervals. This is done
on a weekly basis, but efforts are made
to limit the frequency of outreach to a
specific manufacturer to no more than
every 4 months.
The ESDCS will only include those
medical devices for which there will
likely be high demand during a specific
emergency/disaster, or for which there
are sufficiently small numbers of
manufacturers such that disruption of
manufacture or loss of one or more of
these manufacturers would create a
shortage.
In the Federal Register of December
19, 2008 (73 FR 77718), 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
No. of
Respondents
Section of the Act
903(d)(2)
hsrobinson on PROD1PC76 with NOTICES
1There
Annual Frequency
per
Response
125
Total Annual
Responses
3
Hours per
Response
375
Total Hours
0.5
188
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA based the burden estimates in
Table 1 of this document on past
experience with direct contact with the
medical device manufacturers, and
anticipated changes in the medical
device manufacturing patterns for the
specific devices being monitored. FDA
estimates that approximately 125
manufacturers would be contacted by
telephone and/or electronic mail 3 times
per year to either obtain primary data or
to verify/validate data. Because the data
being requested represent data elements
that are monitored or tracked by
manufacturers as part of routine
inventory management activities, it is
anticipated that for most manufacturers,
the estimated time required of
manufacturers to complete the data
VerDate Nov<24>2008
17:51 May 07, 2009
Jkt 217001
request will not exceed 30 minutes per
request cycle.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: May 4, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–10816 Filed 5–7–09; 8:45 am]
Administration for Children and
Families
BILLING CODE 4160–01–S
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Fmt 4703
Proposed Information Collection
Activity; Comment Request
Proposed Projects
Title: Title IV–E Foster Care Eligibility
Review and Child and Family Service
Reviews; Final Rule.
OMB No.: 0970–0214.
Description: The following five
separate activities are associated with
this information collection: Foster Care
Eligibility Review (FCER) Program
Improvement Plan; Child and Family
Services Reviews (CFSR) State agency
Sfmt 4703
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08MYN1
21690
Federal Register / Vol. 74, No. 88 / Friday, May 8, 2009 / Notices
Statewide Assessment; CFSR On-site
Review; CFSR Program Improvement
Plan; and Anti-Discrimination
Enforcement Corrective Action Plan.
The collection of information for review
of Federal payments to States for foster
care maintenance payments (45 CFR
1356.71(i)) is authorized by title IV–E of
the Social Security Act (the Act), section
474 [42 U.S.C. 674]. The Foster Care
Eligibility Reviews (FCER) ensure that
States claim title IV–E funds only on
behalf of title IV–E eligible children.
The collection of information for review
of State child and family services
programs (45 CFR 1355.33(b), 1355.33(c)
and 1355.35(a)) is to determine whether
such programs are in substantial
conformity with State plan requirements
under parts B and E of the Act and is
authorized by section 1123(a) [42 U.S.C
1320a–1a] of the Act. The CFSR looks at
the outcomes related to safety,
permanency and well-being of children
served by the child welfare system and
at seven systemic factors that support
the outcomes. Section 474(d) of the Act
[42 U.S.C 674] deploys enforcement
provisions (45 CFR 1355.38(b) and (c))
for the requirements at section
4371(a)(18) [42 U.S.C 671], which
prohibit the delay or denial of foster and
adoptive placements based on the race,
color, or national origin of any of the
individuals involved. The enforcement
provisions include the execution and
completion of corrective action plans
when a State is in violation of section
471(a)(18) of the Act. The information
collection is needed: (1) To ensure
compliance with title IV–E foster care
eligibility requirements; (2) to monitor
State plan requirements under titles IV–
B and IV–E of the Act, as required by
Federal statute; and (3) to enforce the
title IV–E anti-discrimination
requirements through State corrective
action plans. The resultant information
will allow ACF to determine if States
are in compliance with State plan
requirements and are achieving desired
outcomes for children and families, help
ensure that claims by States for title IV–
E funds are made only on behalf of title
IV–E eligible children, and require
States to revise applicable statutes,
rules, policies and procedures, and
provide proper training to staff, through
the development and implementation of
corrective action plans. These reviews
not only address compliance with
eligibility requirements but also assist
States in enhancing the capacities to
serve children and families. In
computing the number of burden hours
for this information collection, ACF
based the annual burden estimates on
ACF’s and States’ experiences in
conducting reviews and developing
program improvement plans.
Respondents: State Title IV–B and
Title IV–E Agencies.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
hsrobinson on PROD1PC76 with NOTICES
45
45
45
45
45
CFR
CFR
CFR
CFR
CFR
1356.7 (i) Program Improvement Plan (FCER) .................................
1366.33 (b) Statewide Assessment (CFSR) ......................................
1355.33 (c) On-site Review (CFSR) ..................................................
1355.35 (a) Program Improvement Plan (CFSR) ..............................
1355.38 (b) and (c) Corrective Action ...............................................
Estimated Total Annual Burden
Hours: 22,860
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
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
VerDate Nov<24>2008
17:51 May 07, 2009
Jkt 217001
7
13
13
13
1
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: May 5, 2009.
Janean Chambers,
Reports Clearance Officer.
[FR Doc. E9–10703 Filed 5–7–09; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0030]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Investigational
New Drug Regulations
AGENCY:
Food and Drug Administration,
HHS.
PO 00000
Frm 00072
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
Average
burden hours
per response
1
1
1
1
1
ACTION:
90
240
1,170
240
780
Total burden
hours
630
3,120
15,210
3,120
780
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 review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by June 8,
2009.
ADDRESSES: 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
oiralsubmission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0014. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Berbakos, Office of
Information Management (HFA–710),
Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,
301–796–3792.
E:\FR\FM\08MYN1.SGM
08MYN1
]]>Agencies
[Federal Register Volume 74, Number 88 (Friday, May 8, 2009)]
[Notices]
[Pages 21689-21690]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-10703]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Proposed Projects
Title: Title IV-E Foster Care Eligibility Review and Child and
Family Service Reviews; Final Rule.
OMB No.: 0970-0214.
Description: The following five separate activities are associated
with this information collection: Foster Care Eligibility Review (FCER)
Program Improvement Plan; Child and Family Services Reviews (CFSR)
State agency
[[Page 21690]]
Statewide Assessment; CFSR On-site Review; CFSR Program Improvement
Plan; and Anti-Discrimination Enforcement Corrective Action Plan. The
collection of information for review of Federal payments to States for
foster care maintenance payments (45 CFR 1356.71(i)) is authorized by
title IV-E of the Social Security Act (the Act), section 474 [42 U.S.C.
674]. The Foster Care Eligibility Reviews (FCER) ensure that States
claim title IV-E funds only on behalf of title IV-E eligible children.
The collection of information for review of State child and family
services programs (45 CFR 1355.33(b), 1355.33(c) and 1355.35(a)) is to
determine whether such programs are in substantial conformity with
State plan requirements under parts B and E of the Act and is
authorized by section 1123(a) [42 U.S.C 1320a-1a] of the Act. The CFSR
looks at the outcomes related to safety, permanency and well-being of
children served by the child welfare system and at seven systemic
factors that support the outcomes. Section 474(d) of the Act [42 U.S.C
674] deploys enforcement provisions (45 CFR 1355.38(b) and (c)) for the
requirements at section 4371(a)(18) [42 U.S.C 671], which prohibit the
delay or denial of foster and adoptive placements based on the race,
color, or national origin of any of the individuals involved. The
enforcement provisions include the execution and completion of
corrective action plans when a State is in violation of section
471(a)(18) of the Act. The information collection is needed: (1) To
ensure compliance with title IV-E foster care eligibility requirements;
(2) to monitor State plan requirements under titles IV-B and IV-E of
the Act, as required by Federal statute; and (3) to enforce the title
IV-E anti-discrimination requirements through State corrective action
plans. The resultant information will allow ACF to determine if States
are in compliance with State plan requirements and are achieving
desired outcomes for children and families, help ensure that claims by
States for title IV-E funds are made only on behalf of title IV-E
eligible children, and require States to revise applicable statutes,
rules, policies and procedures, and provide proper training to staff,
through the development and implementation of corrective action plans.
These reviews not only address compliance with eligibility requirements
but also assist States in enhancing the capacities to serve children
and families. In computing the number of burden hours for this
information collection, ACF based the annual burden estimates on ACF's
and States' experiences in conducting reviews and developing program
improvement plans.
Respondents: State Title IV-B and Title IV-E Agencies.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
45 CFR 1356.7 (i) Program Improvement Plan 7 1 90 630
(FCER).........................................
45 CFR 1366.33 (b) Statewide Assessment (CFSR).. 13 1 240 3,120
45 CFR 1355.33 (c) On-site Review (CFSR)........ 13 1 1,170 15,210
45 CFR 1355.35 (a) Program Improvement Plan 13 1 240 3,120
(CFSR).........................................
45 CFR 1355.38 (b) and (c) Corrective Action.... 1 1 780 780
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 22,860
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 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: May 5, 2009.
Janean Chambers,
Reports Clearance Officer.
[FR Doc. E9-10703 Filed 5-7-09; 8:45 am]
BILLING CODE 4184-01-P
