Submission for OMB Review; Comment Request, 40373-40374 [2011-16974]
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40373
Federal Register / Vol. 76, No. 131 / Friday, July 8, 2011 / Notices
ANNUAL BURDEN ESTIMATES—Continued
Number of
responses per
respondent
Number of
respondents
Instrument
Average
burden hours
per response
Total burden
hours
Home Visitor Interview .................................................................................
Primary Caregiver/Home Visitor Child Rating .............................................
Family Service Tracking ..............................................................................
Child Direct Assessment .............................................................................
Parent-Child Interaction ...............................................................................
270
450
450
774
774
1
3.2
166
1
1
.25
.333
.125
1
.25
68
480
9,360
774
194
Estimated Total Annual Burden Hours .................................................
........................
..........................
..........................
12,460
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: OPRE Reports Clearance
Officer. All requests should be
identified by the title of the information
collection.
E-mail address:
OPREinfocollection@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: 202–395–6974,
Attn: Desk Officer for the
Administration for Children and
Families.
Dated: July 1, 2011.
Steven M. Hanmer,
Reports Clearance Officer.
[FR Doc. 2011–16976 Filed 7–7–11; 8:45 am]
BILLING CODE 4184–03–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: Evaluation of Adolescent
Pregnancy Prevention Approaches—
First Follow-up Data Collection.
OMB No.: ICRAS: 0970–0360.
Description: The Office of Adolescent
Health (OAH), Office of the Assistant
Secretary for Health (OASH), U.S.
Department of Health and Human
Services (HHS), is overseeing and
coordinating adolescent pregnancy
prevention evaluation efforts as part of
the Teen Pregnancy Prevention
Initiative. OAH is working
collaboratively with the Office of the
Assistant Secretary for Planning and
Evaluation (ASPE), the Centers for
Disease Control and Prevention (CDC),
and the Administration for Children and
Families (ACF) on adolescent pregnancy
prevention evaluation activities.
The Evaluation of Adolescent
Pregnancy Prevention Approaches
(PPA) is one of these efforts. PPA is a
random assignment evaluation which
will expand available evidence on
effective ways to reduce teen pregnancy.
The evaluation will document and test
a range of pregnancy prevention
approaches in up to eight program sites.
The findings from the evaluation will be
of interest to the general public, to
policy-makers, and to organizations
interested in teen pregnancy prevention.
This request for comment follows on
a 60-Day Federal Register Public
Comment Request Notice, published on
Monday, July 12, 2010, pp. 39695–
39696, with the document identifier of
OS–0990–New.
This proposed information collection
activity focuses on collecting follow-up
data from a self-administered
questionnaire which will be analyzed to
determine program effects. Through a
survey instrument, respondents will be
asked to answer questions about
demographics and risk and protective
factors related to teen pregnancy.
Respondents: The data will be
collected through private, selfadministered questionnaires completed
by study participants, i.e. adolescents
assigned to a select school or
community teen pregnancy prevention
program or to a control group. Surveys
will be distributed and collected by
trained professional staff.
ANNUAL BURDEN ESTIMATES
Annual
number of
respondents
Instrument
Number of responses per
respondent
Average burden hours per
response
Total annual
burden hours
430
306
1
1
.5
.6
215
184
Estimated Total Annual Burden Hours .....................................................
mstockstill on DSK4VPTVN1PROD with NOTICES
Chicago Public Schools/Health Teacher .........................................................
Oklahoma Institute of Child Advocacy/Power Through Choices .....................
........................
........................
........................
399
Additional Information
Copies of the proposed collection may
be obtained by writing to the
Administration for Children and
Families, Office of Planning, Research
VerDate Mar<15>2010
17:52 Jul 07, 2011
Jkt 223001
and Evaluation, 370 L’Enfant
Promenade, SW., Washington, DC
20447, Attn: OPRE Reports Clearance
Officer. All requests should be
identified by the title of the information
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
collection. E-mail address:
OPREinfocollection@acf.hhs.gov.
OMB Comment
OMB is required to make a decision
concerning the collection of information
E:\FR\FM\08JYN1.SGM
08JYN1
40374
Federal Register / Vol. 76, No. 131 / Friday, July 8, 2011 / Notices
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: 202–395–6974,
Attn: Desk Officer for the
Administration for Children and
Families.
Dated: July 1, 2011.
Steven Hanmer,
OPRE Reports Clearance Officer.
[FR Doc. 2011–16974 Filed 7–7–11; 8:45 am]
BILLING CODE 4150–30–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0237]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Applications for
Food and Drug Administration
Approval to Market a New Drug;
Postmarketing Reports; Reporting
Information About Authorized Generic
Drugs
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 August 8,
2011.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
SUMMARY:
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0646. 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, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850,
301–796–3792,
Elizabeth.Berbakos@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.
Applications for Food and Drug
Administration Approval to Market a
New Drug; Postmarketing Reports;
Reporting Information About
Authorized Generic Drugs—(OMB
Control Number 0910–0646)—Extension
In the Federal Register of July 28,
2009 (74 FR 37163), FDA published a
final rule that required the holder of a
new drug application (NDA) to notify
the Agency if an authorized generic
drug is marketed by clearly including
this information in annual reports in an
easily accessible place and by sending a
copy of the relevant portion of the
annual reports to a central contact point.
We took this action as part of our
implementation of the Food and Drug
Administration Amendments Act,
which requires that FDA publish a list
of all authorized generic drugs included
in an annual report after January 1,
1999, and that the Agency update the
list quarterly. We initially published
this list on June 27, 2008, on the
Internet and notified relevant Federal
Agencies that the list was published,
and we will continue to update it.
During the past several years, FDA
has been reviewing annual reports it has
received under § 314.81(b)(2) (21 CFR
314.81(b)(2)) to discern whether an
authorized generic drug is being
marketed by the NDA holder. Based on
information learned from this review
and based on the number of annual
reports the Agency currently receives
under § 314.81(b)(2), we estimate that
we will receive approximately 400
annual reports containing the
information required under
§ 314.81(b)(2)(ii)(b), for authorized
generic drugs that were marketed during
the time period covered by an annual
report submitted after January 1, 1999.
Based on the number of sponsors that
currently submit annual reports, we
estimate that approximately 60 sponsors
will submit these 400 annual reports
with authorized generics. As indicated
in table 1 of this document, we are
estimating that the same number of
annual reports will be submitted each
year from the same number of sponsors
containing the information required
under § 314.81(b)(2)(ii)(b), and that the
same number of copies of that portion
of each annual report containing the
authorized generic drug information
will be submitted from the same number
of sponsors. Concerning the hours per
response, based on our estimate of 40
hours to prepare each annual report
currently submitted under
§ 314.81(b)(2), we estimate that sponsors
will need approximately 1 hour to
prepare the information required under
§ 314.81(b)(2)(ii)(b) for each authorized
generic drug that was marketed during
the time period covered by an annual
report submitted after January 1, 1999;
approximately 15 minutes to prepare
the information required under
§ 314.81(b)(2)(ii)(b) for each subsequent
annual report; and approximately 3
minutes to submit to FDA a copy of that
portion of each annual report containing
the authorized generic drug information.
In the Federal Register of April 13,
2011 (76 FR 20677), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
mstockstill on DSK4VPTVN1PROD with NOTICES
21 CFR 314.81(b)(2)(ii)(b)
Authorized generic drug information on first marketed
generics in an annual report ............................................
Authorized generic drug information submitted in each
subsequent annual report ................................................
The submission of a copy of that portion of each annual
report containing authorized generic drug information ....
VerDate Mar<15>2010
17:52 Jul 07, 2011
Jkt 223001
PO 00000
Frm 00053
Number of
reponses per
respondent
Total annual
responses
Average
burden per
response (in
hours) 2
Total hours
60
400
1
400
60
6.7
400
15/60
100
60
Fmt 4703
6.7
6.7
400
3/60
20
Sfmt 4703
E:\FR\FM\08JYN1.SGM
08JYN1
]]>Agencies
[Federal Register Volume 76, Number 131 (Friday, July 8, 2011)]
[Notices]
[Pages 40373-40374]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-16974]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review; Comment Request
Title: Evaluation of Adolescent Pregnancy Prevention Approaches--
First Follow-up Data Collection.
OMB No.: ICRAS: 0970-0360.
Description: The Office of Adolescent Health (OAH), Office of the
Assistant Secretary for Health (OASH), U.S. Department of Health and
Human Services (HHS), is overseeing and coordinating adolescent
pregnancy prevention evaluation efforts as part of the Teen Pregnancy
Prevention Initiative. OAH is working collaboratively with the Office
of the Assistant Secretary for Planning and Evaluation (ASPE), the
Centers for Disease Control and Prevention (CDC), and the
Administration for Children and Families (ACF) on adolescent pregnancy
prevention evaluation activities.
The Evaluation of Adolescent Pregnancy Prevention Approaches (PPA)
is one of these efforts. PPA is a random assignment evaluation which
will expand available evidence on effective ways to reduce teen
pregnancy. The evaluation will document and test a range of pregnancy
prevention approaches in up to eight program sites. The findings from
the evaluation will be of interest to the general public, to policy-
makers, and to organizations interested in teen pregnancy prevention.
This request for comment follows on a 60-Day Federal Register
Public Comment Request Notice, published on Monday, July 12, 2010, pp.
39695-39696, with the document identifier of OS-0990-New.
This proposed information collection activity focuses on collecting
follow-up data from a self-administered questionnaire which will be
analyzed to determine program effects. Through a survey instrument,
respondents will be asked to answer questions about demographics and
risk and protective factors related to teen pregnancy.
Respondents: The data will be collected through private, self-
administered questionnaires completed by study participants, i.e.
adolescents assigned to a select school or community teen pregnancy
prevention program or to a control group. Surveys will be distributed
and collected by trained professional staff.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Annual number Number of Average burden
Instrument of responses per hours per Total annual
respondents respondent response burden hours
----------------------------------------------------------------------------------------------------------------
Chicago Public Schools/Health Teacher........... 430 1 .5 215
Oklahoma Institute of Child Advocacy/Power 306 1 .6 184
Through Choices................................
---------------------------------------------------------------
Estimated Total Annual Burden Hours......... .............. .............. .............. 399
----------------------------------------------------------------------------------------------------------------
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: OPRE Reports Clearance Officer. All requests should be identified
by the title of the information collection. E-mail address:
OPREinfocollection@acf.hhs.gov.
OMB Comment
OMB is required to make a decision concerning the collection of
information
[[Page 40374]]
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: 202-395-6974, Attn: Desk
Officer for the Administration for Children and Families.
Dated: July 1, 2011.
Steven Hanmer,
OPRE Reports Clearance Officer.
[FR Doc. 2011-16974 Filed 7-7-11; 8:45 am]
BILLING CODE 4150-30-M
