Proposed Information Collection Activity; Comment Request, 64391-64392 [2014-25684]
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64391
Federal Register / Vol. 79, No. 209 / Wednesday, October 29, 2014 / Notices
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
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: 21,838.
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
Planning, Research and Evaluation, 370
L’Enfant Promenade SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. All requests should be
identified by the title of the information
collection. Email address:
infocollection@acf.hhs.gov.
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
and 60 days after publication of this
document in the Federal Register.
Therefore, a comment is best assured of
having its full effect if OMB receives it
within 30 days of publication. Written
comments and recommendations for the
proposed information collection should
be sent directly to the following: Office
of Management and Budget, Paperwork
Reduction Project, Fax: 202–395–7285,
Number of
responses per
respondent
2
13
13
13
1
Email: OIRA_SUBMISSION@
OMB.EOP.GOV, Attn: Desk Officer for
the Administration for Children and
Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2014–25644 Filed 10–28–14; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Proposed Projects
Title: Intergovernmental Reference
Guide (IRG).
OMB No.: 0970–0209.
Description: The Intergovernmental
Reference Guide (IRG) is a centralized
1
1
1
1
1
Average
burden hours
per response
90
120
1,186
300
780
Total
burden hours
180
1,560
15,418
3,900
780
and automated repository of state and
tribal profiles, which contains highlevel descriptions of each state and
tribe’s child support enforcement (CSE)
program. These profiles provide state
and tribal CSE agencies, and foreign
countries with an effective and efficient
method for updating and accessing
information needed to process
intergovernmental child support cases.
The IRG information collection
activities are authorized by: (1) 42
U.S.C. 652(a)(7), which requires OCSE
to provide technical assistance to state
child support enforcement agencies to
help them establish effective systems for
collecting child and spousal support; (2)
42 U.S.C. 666(f), which requires states to
enact the Uniform Interstate Family
Support Act; and (3) 45 CFR 303.7,
which requires state child support
agencies to provide services in
intergovernmental cases.
Respondents: All state and tribal CSE
agencies.
ANNUAL BURDEN ESTIMATES
Number of
respondents
mstockstill on DSK4VPTVN1PROD with NOTICES
Instrument
Intergovernmental Referral Guide: State Profile Guidance—(States and Territories) .........................................................................................................
Intergovernmental Referral Guide: Tribal Profile Guidance ............................
Estimated Total Annual Burden
Hours: 615.60.
In compliance with the requirements
of Section 506(c)(2)(A) of the Paperwork
VerDate Sep<11>2014
16:21 Oct 28, 2014
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54
60
Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
PO 00000
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Number of
responses per
respondent
18
18
Average
burden hours
per response
0.30
0.30
Total burden
hours
291.60
324.00
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
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64392
Federal Register / Vol. 79, No. 209 / Wednesday, October 29, 2014 / Notices
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 370 L’Enfant
Promenade SW., Washington, DC 20447,
Attn: ACF Reports Clearance Officer.
Email 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.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2014–25684 Filed 10–28–14; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0231]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Adverse
Experience Reporting for Licensed
Biological Products; and General
Records
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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 November
28, 2014.
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:
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
16:21 Oct 28, 2014
Jkt 235001
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0308. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Adverse Experience Reporting for
Licensed Biological Products; and
General Records—21 CFR Part 600—
(OMB Control Number 0910–0308)—
Extension
Under the Public Health Service
(PHS) Act (42 U.S.C. 262), FDA may
only approve a biologics license
application for a biological product that
is safe, pure, and potent. When a
biological product is approved and
enters the market, the product is
introduced to a larger patient
population in settings different from
clinical trials. New information
generated during the postmarketing
period offers further insight into the
benefits and risks of the product, and
evaluation of this information is
important to insure its safe use. FDA
issued the Adverse Experience
Reporting (AER) requirements in part
600 (21 CFR part 600) to enable FDA to
take actions necessary for the protection
of the public health in response to
reports of adverse experiences related to
licensed biological products.1
The primary purpose of FDA’s AER
system is to identify potentially serious
safety problems with licensed biological
products. Although the premarket
approval process is meant to disclose a
general safety profile of a biological
product’s comparatively common
adverse effects, the larger and more
diverse patient populations exposed to
the licensed biological product provides
the opportunity to collect information
on rare, latent, and long-term effects. In
addition, production and/or distribution
problems have contaminated biological
products in the past. AER reports are
obtained from a variety of sources,
including manufacturers, patients,
1 Please note that throughout the regulations
referenced in relation to these information
collections, licensed biological products refers to
biologics licensed under any provision of section
351 of the PHS Act.
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Frm 00036
Fmt 4703
Sfmt 4703
physicians, foreign regulatory agencies,
and clinical investigators. Identification
of new and unexpected safety issues
through the analysis of the data in AERS
contributes directly to increased public
health protection. For example,
evaluation of these safety issues enables
FDA to take focused regulatory action.
Such action may include, but is not
limited to, important changes to the
product’s labeling (such as adding a
new warning), coordination with
manufacturers to ensure adequate
corrective action is taken, and removal
of a biological product from the market
when necessary.
Section 600.80(c)(1) requires licensed
manufacturers or any person whose
name appears on the label of a licensed
biological product to report each
adverse experience that is both serious
and unexpected, whether foreign or
domestic, as soon as possible but in no
case later than 15 calendar days of
initial receipt of the information by the
licensed manufacturer. These reports
are known as postmarketing 15-day
Alert reports. This section also requires
licensed manufacturers to submit any
follow-up reports within 15 calendar
days of receipt of new information or as
requested by FDA, and if additional
information is not obtainable, to
maintain records of the unsuccessful
steps taken to seek additional
information. In addition, this section
requires a person who submits an
adverse action report to the licensed
manufacturer, rather than FDA, to
maintain a record of this action.
Section 600.80(e) requires licensed
manufacturers to submit a 15-day Alert
report for an adverse experience
obtained from a postmarketing clinical
study only if the licensed manufacturer
concludes that there is a reasonable
possibility that the product caused the
adverse experience. Section 600.80(c)(2)
requires licensed manufacturers to
report each adverse experience not
reported in a postmarketing 15-day
Alert report at quarterly intervals, for 3
years from the date of issuance of the
biologics license, and then at annual
intervals. The majority of these periodic
reports are submitted annually since a
large percentage of currently licensed
biological products have been licensed
longer than 3 years. Section 600.80(i)
requires licensed manufacturers to
maintain for a period of 10 years records
of all adverse experiences known to the
licensed manufacturer, including raw
data and any correspondence relating to
the adverse experiences. Section 600.81
requires licensed manufacturers to
submit, at an interval of every 6 months,
information about the quantity of the
product distributed under the biologics
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[Federal Register Volume 79, Number 209 (Wednesday, October 29, 2014)]
[Notices]
[Pages 64391-64392]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-25684]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Proposed Projects
Title: Intergovernmental Reference Guide (IRG).
OMB No.: 0970-0209.
Description: The Intergovernmental Reference Guide (IRG) is a
centralized and automated repository of state and tribal profiles,
which contains high-level descriptions of each state and tribe's child
support enforcement (CSE) program. These profiles provide state and
tribal CSE agencies, and foreign countries with an effective and
efficient method for updating and accessing information needed to
process intergovernmental child support cases.
The IRG information collection activities are authorized by: (1) 42
U.S.C. 652(a)(7), which requires OCSE to provide technical assistance
to state child support enforcement agencies to help them establish
effective systems for collecting child and spousal support; (2) 42
U.S.C. 666(f), which requires states to enact the Uniform Interstate
Family Support Act; and (3) 45 CFR 303.7, which requires state child
support agencies to provide services in intergovernmental cases.
Respondents: All state and tribal CSE agencies.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average
Instrument Number of responses per burden hours Total burden
respondents respondent per response hours
----------------------------------------------------------------------------------------------------------------
Intergovernmental Referral Guide: State Profile 54 18 0.30 291.60
Guidance--(States and Territories).............
Intergovernmental Referral Guide: Tribal Profile 60 18 0.30 324.00
Guidance.......................................
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 615.60.
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
[[Page 64392]]
to the Administration for Children and Families, Office of Planning,
Research and Evaluation, 370 L'Enfant Promenade SW., Washington, DC
20447, Attn: ACF Reports Clearance Officer. Email 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.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2014-25684 Filed 10-28-14; 8:45 am]
BILLING CODE 4184-01-P
