Submission for OMB Review; Comment Request, 53160-53161 [2015-21727]
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53160
Federal Register / Vol. 80, No. 170 / Wednesday, September 2, 2015 / Notices
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
Youth Outcome Survey ...................................................................................
Data File ..........................................................................................................
20,667
52
Estimated Total Annual Burden
Hours: 202,630.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Additional Information
Administration for Children and
Families
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,
Email: OIRA_SUBMISSION@
OMB.EOP.GOV. Attn: Desk Officer for
the Administration for Children and
Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2015–21728 Filed 9–1–15; 8:45 am]
BILLING CODE 4184–01–P
Number of
responses per
respondent
Submission for OMB Review;
Comment Request
Title: Refugee Data Submission
System for Formula Funds Allocations
OMB No.: 0970–0043.
Description: The information
collection of Refugee Data Submission
System for Formula Funds Allocations
replaces the ORR–11 Refugee State of
Origin Report and is designed to satisfy
the statutory requirements of the
Immigration and Nationality Act (INA).
Section 412(a)(3)of the Act requires the
Director of the Office of Refugee
Resettlement (ORR) to make a periodic
assessment, based on refugee population
and other relevant factors, of the relative
needs of refugees for assistance and
services and the resources available to
meet those needs. This includes
compiling and maintaining data on the
secondary migration of refugees within
the United States after arrival. Further,
INA 412(c)(1)(B)states that formula
funds shall be allocated based on the
total number of refugees, taking into
account secondary migration.
In order to meet the statutory
requirements, ORR requires each state to
submit disaggregated individual records
containing certain data elements for
eligible refugee populations. This
revised collection differs from the ORR–
11 Refugee State-of-Origin Report
process, whereby states submitted the
ORR–11 form containing aggregate data
on the number of refugees and entrants
served whose ‘‘area numbers’’ (the first
three digits of the social security
number) fell into each of several
Average
burden hours
per response
1
2
0.50
1,849
Total burden
hours
10,334
192,296
designated numerical ranges. ORR used
the information on the ORR–11 to
measure secondary migration for the
purposes of formula funds allocation to
states. The revision is proposed due to
the realization that:
(1) The Social Security
Administration states that the first three
digits of social security numbers (area
number) should not be used for any
other purpose than as an individual
identifier for book-keeping purposes.
(2) It is possible for individuals to
apply for social security numbers from
any social security office, not just offices
in the state in which they were born or
first resided. This is particularly likely
in metropolitan statistical areas where
individuals may live in one of several
states (e.g., the Washington
Metropolitan Area). In these cases, the
area number of the social security
number may be unreliable as a measure
of refugees’ state of initial resettlement.
(3) In recent years, the Social Security
Administration has begun to issue social
security numbers whose area number is
not connected to any specific state.
The submission of individual records
via the Refugee Data Submission System
for Formula Funds Allocations Web site
is a more reliable and secure process for
collecting data for the purposes of
tracking secondary migration and
allocating formula funds. Data
submitted by the States via the secure
Web site are compiled and analyzed by
the ORR statistician for the purpose of
refugee secondary services formula
funds allocation. The statistician also
prepares a summary report, which is
included in ORR’s Annual Report to
Congress.
Respondents: States and the District
of Columbia.
ANNUAL BURDEN ESTIMATES
mstockstill on DSK4VPTVN1PROD with NOTICES
Instrument
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
Refugee Data Submission for Formula Funds Allocations .............................
50
1
20
1,000
Estimated Total Annual Burden
Hours: 1,000.
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19:04 Sep 01, 2015
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Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
PO 00000
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Fmt 4703
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Children and Families, Office of
Planning, Research and Evaluation, 370
L’Enfant Promenade SW., Washington,
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02SEN1
Federal Register / Vol. 80, No. 170 / Wednesday, September 2, 2015 / Notices
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,
Email: OIRA_SUBMISSION@
OMB.EOP.GOV, Attn: Desk Officer for
the Administration for Children and
Families.
Robert Sargis,
Reports Clearance Officer.
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0164]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Guidance for
Industry on Safety Labeling Changes—
Implementation of Section 505(o)(4) of
the Federal Food, Drug, and Cosmetic
Act
Food and Drug Administration,
HHS.
ACTION:
Notice.
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
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the requirement to make safety related
labeling changes based upon new safety
information that becomes available after
the drug or biological product is
approved under the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) or the
Public Health Service Act (PHS Act.)
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
19:04 Sep 01, 2015
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.
ADDRESSES:
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on: (1) Whether the proposed
collection of information is necessary
for the proper performance of FDA’s
functions, including whether the
information will have practical utility;
(2) the accuracy of FDA’s estimate of the
burden of the proposed collection of
information, including the validity of
the methodology and assumptions used;
(3) ways to enhance the quality, utility,
and clarity of the information to be
collected; and (4) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques,
when appropriate, and other forms of
information technology.
SUPPLEMENTARY INFORMATION:
[FR Doc. 2015–21727 Filed 9–1–15; 8:45 am]
AGENCY:
Submit either electronic or
written comments on the collection of
information by November 2, 2015.
DATES:
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Fmt 4703
Sfmt 4703
53161
Guidance for Industry on Safety
Labeling Changes—Implementation of
Section 505(o)(4) of the Federal Food,
Drug, and Cosmetic Act (OMB Control
Number 0910–0734)—Extension
Section 505(o)(4) of the FD&C Act (21
U.S.C. 355(o)(4)) authorizes FDA to
require, and if necessary, order labeling
changes if FDA becomes aware of new
safety information that FDA believes
should be included in the labeling of
certain prescription drug and biological
products approved under section 505 of
the FD&C Act or section 351 of the PHS
Act (42 U.S.C. 262). Section 505(o)(4) of
the FD&C Act applies to prescription
drug products with an approved new
drug application (NDA) under section
505(b) of the FD&C Act, biological
products with an approved biologics
license application under section 351 of
the PHS Act, or prescription drug
products with an approved abbreviated
new drug application under section
505(j) of the FD&C Act if the reference
listed drug with an approved NDA is
not currently marketed. Section
505(o)(4) imposes timeframes for
application holders to submit and FDA
staff to review such changes, and gives
FDA new enforcement tools to bring
about timely and appropriate labeling
changes. The guidance provides
information on the implementation of
the new provisions, including a
description of the types of safety
labeling changes that ordinarily might
be required under the new legislation,
how FDA plans to determine what
constitutes new safety information, the
procedures involved in requiring safety
labeling changes, and enforcement of
the requirements for safety labeling
changes.
FDA requires safety labeling changes
by sending a notification letter to the
application holder. Under section
505(o)(4)(B), the application holder
must respond to FDA’s notification by
submitting a labeling supplement or
notifying FDA that the applicant does
not believe the labeling change is
warranted and submitting a statement
detailing the reasons why the
application holder does not believe a
change is warranted (a rebuttal
statement).
Based on FDA’s experience to date
with safety labeling changes
requirements under section 505(o)(4),
we estimate that approximately 42
application holders will elect to submit
approximately one rebuttal statement
each year and that each rebuttal
statement will take approximately 6
hours to prepare.
In addition, in the guidance, FDA
states that new labeling prepared in
E:\FR\FM\02SEN1.SGM
02SEN1
]]>Agencies
[Federal Register Volume 80, Number 170 (Wednesday, September 2, 2015)]
[Notices]
[Pages 53160-53161]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-21727]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review; Comment Request
Title: Refugee Data Submission System for Formula Funds Allocations
OMB No.: 0970-0043.
Description: The information collection of Refugee Data Submission
System for Formula Funds Allocations replaces the ORR-11 Refugee State
of Origin Report and is designed to satisfy the statutory requirements
of the Immigration and Nationality Act (INA). Section 412(a)(3)of the
Act requires the Director of the Office of Refugee Resettlement (ORR)
to make a periodic assessment, based on refugee population and other
relevant factors, of the relative needs of refugees for assistance and
services and the resources available to meet those needs. This includes
compiling and maintaining data on the secondary migration of refugees
within the United States after arrival. Further, INA 412(c)(1)(B)states
that formula funds shall be allocated based on the total number of
refugees, taking into account secondary migration.
In order to meet the statutory requirements, ORR requires each
state to submit disaggregated individual records containing certain
data elements for eligible refugee populations. This revised collection
differs from the ORR-11 Refugee State-of-Origin Report process, whereby
states submitted the ORR-11 form containing aggregate data on the
number of refugees and entrants served whose ``area numbers'' (the
first three digits of the social security number) fell into each of
several designated numerical ranges. ORR used the information on the
ORR-11 to measure secondary migration for the purposes of formula funds
allocation to states. The revision is proposed due to the realization
that:
(1) The Social Security Administration states that the first three
digits of social security numbers (area number) should not be used for
any other purpose than as an individual identifier for book-keeping
purposes.
(2) It is possible for individuals to apply for social security
numbers from any social security office, not just offices in the state
in which they were born or first resided. This is particularly likely
in metropolitan statistical areas where individuals may live in one of
several states (e.g., the Washington Metropolitan Area). In these
cases, the area number of the social security number may be unreliable
as a measure of refugees' state of initial resettlement.
(3) In recent years, the Social Security Administration has begun
to issue social security numbers whose area number is not connected to
any specific state.
The submission of individual records via the Refugee Data
Submission System for Formula Funds Allocations Web site is a more
reliable and secure process for collecting data for the purposes of
tracking secondary migration and allocating formula funds. Data
submitted by the States via the secure Web site are compiled and
analyzed by the ORR statistician for the purpose of refugee secondary
services formula funds allocation. The statistician also prepares a
summary report, which is included in ORR's Annual Report to Congress.
Respondents: States and the District of Columbia.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
Refugee Data Submission for Formula Funds 50 1 20 1,000
Allocations................................
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 1,000.
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,
[[Page 53161]]
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, Email: OIRA_SUBMISSION@OMB.EOP.GOV, Attn: Desk Officer for the
Administration for Children and Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2015-21727 Filed 9-1-15; 8:45 am]
BILLING CODE 4184-01-P
