Submission for OMB Review; Comment Request, 20356-20357 [2011-8663]
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20356
Federal Register / Vol. 76, No. 70 / Tuesday, April 12, 2011 / Notices
Dated: March 31, 2011.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2011–8654 Filed 4–11–11; 8:45 am]
Submission for OMB Review;
Comment Request
BILLING CODE 4163–18–P
Administration for Children and
Families
Title: State Plan for Child Support
under IV–D of the Social Security Act.
OMB No.: 0970–0017.
Description: The Office of Child
Support Enforcement has approved a
IV–D State plan for each State. Federal
regulations require States to amend their
State plans only when necessary to
reflect new or revised Federal statutes or
regulations or material change in any
State law, organization, policy, or IV–D
agency operations. The requirement for
submission of a State plan and plan
amendments for the Child Support
Enforcement program is found in
sections 452, 454, and 466 of the Social
Security Act.
Respondents: State IV–D Agencies.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
State Plan ........................................................................................................
OCSE–21–U4 ..................................................................................................
Estimated Total Annual Burden
Hours: 324.
Additional Information: Copies of the
proposed collection may be obtained 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. All requests
should be identified by the title of the
information collection. E-mail 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,
E-mail:
OIRA_SUBMISSION@OMB.EOP.GOV,
Attn: Desk Officer for the
Administration for Children and
Families.
Robert Sargis,
Reports Clearance Officer.
srobinson on DSKHWCL6B1PROD with NOTICES
[FR Doc. 2011–8666 Filed 4–11–11; 8:45 am]
BILLING CODE 4184–01–P
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18:00 Apr 11, 2011
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54
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: Statewide Automated Child
Welfare Information System (SACWIS)
Assessment Review Guide (SARG).
OMB No.: 0970–0159.
Description: For HHS to fulfill its
obligation to effectively serve the
nation’s Adoption and Foster Care
populations, and to report meaningful
and reliable information to Congress
about the extent of problems facing
these children and the effectiveness of
assistance provided to this population,
the agency must have access to timely
and accurate information about child
welfare service populations and child
welfare services. Section 476(b)of the
Social Security Act requires that States
submit statistical reports for child
welfare populations, and Section 479 of
the Act details State responsibilities to
report specific information related to
child abuse and neglect. CFR 1355.52
provides funding authority for statewide
automated child welfare information
systems (SACWIS) that meet Federal
requirements for child welfare data
collection. If a State chooses to
implement a SACWIS, that system
serves as the primary data source for
Federal reporting. Currently, states use
their SACWIS to support their efforts to
meet the following Federal reporting
requirements related to child welfare:
the Adoption and Foster Care Analysis
and Reporting System (AFCARS)
required by section 479(b)(2) of the
Social Security Act; the National Child
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
8
8
Average
burden hours
per response
0.50
0.25
Total burden
hours
216
108
Abuse and Neglect Data System
(NCANDS); Child Abuse Prevention and
Treatment Act (CAPTA); and the Chafee
Independent Living Program’s National
Youth in Transition Database (NYTD).
These systems also support state efforts
to provide the information to conduct
the Child and Family Service Reviews.
Currently, forty-two States and the
District of Columbia have developed, or
are developing, a SACWIS with Federal
financial participation.
45 CFR 1355.55 provides for
continuing review, assessment and
inspection of SACWIS. The purpose of
this review is to determine whether the
system, as described in the approved
Advance Planning Document has been
adequately completed and conforms to
applicable regulations and policies.
To initiate a review, States complete
and submit the SACWIS Assessment
Review Guide (SARG) and other system
documentation when they have
completed system development and the
system is operational statewide. The
SARG template provides a format for
State description of system
functionality, operation, and outputs
such as reports. The additional
materials submitted as part of this
process, such as system design
documentation, are typically readily
available to the State as a result of good
project management practices.
The information collected in the
SACWIS Assessment Review Guide will
allow Federal reviewers to determine if
the State’s SACWIS meets the
requirements for title IV–E Federal
Financial Participation (FFP) defined at
45 CFR 1355.50, and that systems meet
the goals and objectives of the approved
Advance Planning Documents (APD)
and conforms to the schedule, budget,
E:\FR\FM\12APN1.SGM
12APN1
20357
Federal Register / Vol. 76, No. 70 / Tuesday, April 12, 2011 / Notices
and other conditions of their approved
APDs. Additionally, other States may be
able to use the documentation provided
as part of their preparation for the
review process of their own system
development efforts.
Respondents: Title IV–E Agencies.
ANNUAL BURDEN ESTIMATES
SACWIS Assessment Review Guide ..............................................................
Estimated Total Annual Burden
Hours: 750.
Additional Information: Copies of the
proposed collection may be obtained 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. All requests
should be identified by the title of the
information collection. E-mail 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,
E-mail:
OIRA_SUBMISSION@OMB.EOP.GOV,
Attn: Desk Officer for the
Administration for Children and
Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2011–8663 Filed 4–11–11; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
srobinson on DSKHWCL6B1PROD with NOTICES
[Docket No. FDA–2009–P–0256]
Determination That KEFLEX
(Cephalexin) Capsule, Equivalent to
333 Milligrams Base, Was Not
Withdrawn From Sale for Reasons of
Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
that KEFLEX (cephalexin) capsule,
SUMMARY:
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18:00 Apr 11, 2011
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Number of
responses per
respondent
Number of
respondents
Instrument
3
equivalent to (EQ) 333 milligrams (mg)
base, was not withdrawn from sale for
reasons of safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for cephalexin
capsule, EQ 333 mg base, if all other
legal and regulatory requirements are
met.
FOR FURTHER INFORMATION CONTACT:
Patrick Raulerson, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6368,
Silver Spring, MD 20993–0002, 301–
796–3522.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products approved
under an ANDA procedure. ANDA
applicants must, with certain
exceptions, show that the drug for
which they are seeking approval
contains the same active ingredient in
the same strength and dosage form as
the ‘‘listed drug,’’ which is a version of
the drug that was previously approved.
ANDA applicants do not have to repeat
the extensive clinical testing otherwise
necessary to gain approval of a new
drug application (NDA). The only
clinical data required in an ANDA are
data to show that the drug that is the
subject of the ANDA is bioequivalent to
the listed drug.
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is known generally as the
‘‘Orange Book.’’ Under FDA regulations,
a drug is removed from the list if the
Agency withdraws or suspends
approval of the drug’s NDA or ANDA
for reasons of safety or effectiveness or
if FDA determines that the listed drug
was withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162).
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
1
Average
burden hours
per response
250
Total burden
hours
750
Under § 314.161(a)(1) (21 CFR
314.161(a)(1)), the Agency must
determine whether a listed drug was
withdrawn from sale for reasons of
safety or effectiveness before an ANDA
that refers to that listed drug may be
approved. FDA may not approve an
ANDA that does not refer to a listed
drug.
KEFLEX (cephalexin) capsule, EQ 333
mg base, is the subject of NDA 050405
held by Victory Pharma, Inc., and the
333-mg strength was approved on May
12, 2006. KEFLEX is a cephalosporin
antibiotic indicated for the treatment of
respiratory tract infections caused by
Streptococcus pneumoniae and S.
pyogenes, as well as certain other
infections caused by susceptible strains
of certain designated micro-organisms
as described in the product labeling.
KEFLEX (cephalexin) capsule, EQ 333
mg base, has never been marketed. In
previous instances (see 72 FR 9763,
March 5, 2007; 61 FR 25497, May 21,
1996), the Agency has determined that,
for purposes of §§ 314.161 and 314.162,
never marketing an approved drug
product is equivalent to withdrawing
the drug from sale.
Lachman Consultant Services, Inc.,
submitted a citizen petition dated May
29, 2009 (Docket No. FDA–2009–P–
0256), under 21 CFR 10.30, requesting
that the Agency determine whether
KEFLEX (cephalexin) capsule, EQ 333
mg base, was withdrawn from sale for
reasons of safety or effectiveness. After
considering the citizen petition and
reviewing Agency records, FDA has
determined under § 314.161 that
KEFLEX (cephalexin) capsule, EQ 333
mg base, was not withdrawn for reasons
of safety or effectiveness. The petitioner
has identified no data or other
information suggesting that KEFLEX
(cephalexin) capsule, EQ 333 mg base,
was withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of KEFLEX
(cephalexin) capsule, EQ 333 mg base,
from sale. We have also independently
evaluated relevant literature and data
for possible postmarketing adverse
events. We have found no information
E:\FR\FM\12APN1.SGM
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[Federal Register Volume 76, Number 70 (Tuesday, April 12, 2011)]
[Notices]
[Pages 20356-20357]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-8663]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review; Comment Request
Title: Statewide Automated Child Welfare Information System
(SACWIS) Assessment Review Guide (SARG).
OMB No.: 0970-0159.
Description: For HHS to fulfill its obligation to effectively serve
the nation's Adoption and Foster Care populations, and to report
meaningful and reliable information to Congress about the extent of
problems facing these children and the effectiveness of assistance
provided to this population, the agency must have access to timely and
accurate information about child welfare service populations and child
welfare services. Section 476(b)of the Social Security Act requires
that States submit statistical reports for child welfare populations,
and Section 479 of the Act details State responsibilities to report
specific information related to child abuse and neglect. CFR 1355.52
provides funding authority for statewide automated child welfare
information systems (SACWIS) that meet Federal requirements for child
welfare data collection. If a State chooses to implement a SACWIS, that
system serves as the primary data source for Federal reporting.
Currently, states use their SACWIS to support their efforts to meet the
following Federal reporting requirements related to child welfare: the
Adoption and Foster Care Analysis and Reporting System (AFCARS)
required by section 479(b)(2) of the Social Security Act; the National
Child Abuse and Neglect Data System (NCANDS); Child Abuse Prevention
and Treatment Act (CAPTA); and the Chafee Independent Living Program's
National Youth in Transition Database (NYTD). These systems also
support state efforts to provide the information to conduct the Child
and Family Service Reviews. Currently, forty-two States and the
District of Columbia have developed, or are developing, a SACWIS with
Federal financial participation.
45 CFR 1355.55 provides for continuing review, assessment and
inspection of SACWIS. The purpose of this review is to determine
whether the system, as described in the approved Advance Planning
Document has been adequately completed and conforms to applicable
regulations and policies.
To initiate a review, States complete and submit the SACWIS
Assessment Review Guide (SARG) and other system documentation when they
have completed system development and the system is operational
statewide. The SARG template provides a format for State description of
system functionality, operation, and outputs such as reports. The
additional materials submitted as part of this process, such as system
design documentation, are typically readily available to the State as a
result of good project management practices.
The information collected in the SACWIS Assessment Review Guide
will allow Federal reviewers to determine if the State's SACWIS meets
the requirements for title IV-E Federal Financial Participation (FFP)
defined at 45 CFR 1355.50, and that systems meet the goals and
objectives of the approved Advance Planning Documents (APD) and
conforms to the schedule, budget,
[[Page 20357]]
and other conditions of their approved APDs. Additionally, other States
may be able to use the documentation provided as part of their
preparation for the review process of their own system development
efforts.
Respondents: Title IV-E Agencies.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
SACWIS Assessment Review Guide.................. 3 1 250 750
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 750.
Additional Information: Copies of the proposed collection may be
obtained 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. All requests should be identified by the title of the
information collection. E-mail 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, E-mail: OIRA_SUBMISSION@OMB.EOP.GOV, Attn: Desk Officer for the
Administration for Children and Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2011-8663 Filed 4-11-11; 8:45 am]
BILLING CODE 4184-01-P
