Proposed Information Collection Activity; Comment Request, 38209-38210 [2015-16285]
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38209
Federal Register / Vol. 80, No. 127 / Thursday, July 2, 2015 / Notices
requests on the behalf of both
collaborating agencies. Data for the
study is collected from the following
three major sources: Baseline forms,
follow-up surveys (at 6, 12, and 30
months after study entry), and
implementation research and site visits.
Data collection for all but one STED site
has been reviewed and approved by
OMB (see OMB #0970–0413). This
notice is specific to the request for
approval of the contact information
form and baseline information form for
the new STED site. These forms will
collect important demographic and
other information from all study
participants in this site prior to the
point of random assignment. These data
will be important for describing the
study sample and for estimating
program effects for particular groups of
interest.
Respondents: Study participants in
the treatment and control groups at one
additional STED site.
ANNUAL BURDEN ESTIMATES—NEW INSTRUMENTS
Total
number of
respondents
Instrument
Annual
number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Annual burden
hours
Participant contact information form ....................................
Participant baseline information form ..................................
4,002
4,002
1,334
1,334
1
1
.08
.25
107
334
Total ..............................................................................
........................
........................
........................
........................
441
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. Email 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, Email:
OIRA_SUBMISSION@OMB.EOP.GOV,
Attn: Desk Officer for the
Administration for Children and
Families.
Karl Koerper,
OPRE Reports Clearance Officer.
[FR Doc. 2015–16283 Filed 7–1–15; 8:45 am]
BILLING CODE 4184–09–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Proposed Projects
Title: Refugee Data Submission
System for Formula Funds Allocations.
OMB No.: 0970–0043.
Description: The Refugee Data
Submission System for Allocation of
Formula Funds is designed to satisfy the
statutory requirements of the
Immigration and Nationity Act (INA).
Section 412(a)(3) of the Act requires that
the Director of the Office of Refugee
Resettlement (ORR) make a periodic
assessment of the needs of refugees for
assistance and services and the
resources available to meet those needs.
This assessment includes compiling and
maintaining data on 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 in each State, taking
into account secondary migration. In
order to meet these statutory
requirements, ORR requires each State
to submit disaggregated individual
records containing certain data elements
for eligible populations. ORR uses the
information collected through the Web
site to determine secondary migration
for the purposes of formula funds
allocation to States. The submission of
individual records via the Refugee Data
Submission System for Allocation of
Formula Funds is a 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
Web site are also compiled and
analyzed for inclusion in ORR’s Annual
Report to Congress.
Respondents: States, Wilson/Fish
Alternative Projects, and the District of
Columbia.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
Refugee Data Submission for Formula Funds Allocations .............................
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Instrument
50
1
20
1,000
Estimated Total Annual Burden
Hours: 1,000.
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
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21:16 Jul 01, 2015
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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
PO 00000
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Fmt 4703
Sfmt 4703
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
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Federal Register / Vol. 80, No. 127 / Thursday, July 2, 2015 / Notices
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
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. 2015–16285 Filed 7–1–15; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–0001]
New Methods To Predict the
Immunogenicity of Therapeutic
Coagulation Proteins; Public
Workshop
AGENCY:
Food and Drug Administration,
HHS.
asabaliauskas on DSK5VPTVN1PROD with NOTICES
ACTION:
Notice of public workshop.
The Food and Drug Administration
(FDA) is announcing a public workshop
entitled: ‘‘New Methods to Predict the
Immunogenicity of Therapeutic
Coagulation Proteins’’. The purpose of
the public workshop is to discuss recent
scientific progress in identifying the
genetic determinants for an unwanted
immune response to therapeutic
coagulation proteins (immunogenicity),
and to identify and discuss potential
new methods to predict such
immunogenicity. Immunogenicity
results in the development of antibodies
that target the therapeutic protein and
can affect the safety and efficacy of the
biological product. The workshop has
been planned in partnership with the
National Heart, Lung and Blood
Institute, National Institutes of Health
(NIH), the National Hemophilia
Foundation, and the Plasma Protein
Therapeutics Association. The
workshop will include presentations
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21:16 Jul 01, 2015
Jkt 235001
and panel discussions by experts from
academic institutions, industry, and
government Agencies.
Date and Time: The public workshop
will be held on September 17, 2015,
from 8:30 a.m. to 5 p.m. and on
September 18, 2015, from 8:30 a.m. to
12 p.m.
Location: The public workshop will
be held at the Ruth Kirschstein
Auditorium, Natcher Conference Center,
Bldg. 45, National Institutes of Health
Campus, 9000 Rockville Pike, Bethesda,
MD 20892. The entrance for the public
workshop participants (non-NIH
employees) is through the NIH Gateway
Center located adjacent to the Medical
Center Metro, where routine security
check procedures will be performed.
Please visit the following Web site for
location, parking, security, and travel
information: https://www.nih.gov/about/
visitor/index.htm. Please visit the
following Web site for information on
the Natcher Conference Center: https://
www.genome.gov/11007522.
Contact Person: Freddy Barnes,
Center for Biologics Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993, 240–
402–6943, William.Barnes@fda.hhs.gov.
For questions email:
CBERPublicEvents@fda.hhs.gov (Subject
line: FDA MPICPDT Workshop).
Registration: Please visit the following
Web site to register for the workshop by
August 27, 2015: https://
methodspredictimmunogenicity.
eventbrite.com. There is no registration
fee for the public workshop. Early
registration is recommended because
seating is limited. Registration on the
day of the public workshop will be
provided on a space available basis
beginning at 8:15 a.m.
If you need special accommodations
due to a disability, please contact
Freddy Barnes (see Contact Person) at
least 7 days in advance.
Supplementary Information: The
development of unwanted immune
responses to therapeutic coagulation
protein products may affect both
product efficacy and patient safety. In
the case of replacement coagulation
protein therapies, the inhibitory antidrug antibodies also interact with the
endogenous protein and may result in
serious adverse events in patients. Both
product and patient specific factors may
affect the immunogenicity of
therapeutic coagulation protein
products. There are currently several
initiatives underway to assess the
genetic basis for developing unwanted
immune responses to coagulation
protein products in individuals with
hemophilia, which will result in the
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Fmt 4703
Sfmt 9990
accumulation of large data sets over the
next few years. The workshop aims to
address what patients, healthcare
professionals and regulators may do
with this information to improve patient
outcomes.
In addition, an unprecedented
number of new engineered recombinant
coagulation proteins are in
development. This workshop will
discuss the state-of-the art with respect
to leveraging scientific progress to
predict the immunogenicity of protein
amino acid sequences that do not exist
in nature, and whether there is a need
for novel strategies in the design and
conduct of clinical trials for these
products.
The first day of the workshop will
include presentations and panel
discussions on the following topics: (1)
Overview of the current understanding
of genetic factors that affect
immunogenicity of therapeutic
coagulation proteins; (2) recent
advances in immunology relevant to
immunogenicity; (3) emerging
computational, in vitro and ex vivo
tools to predict the immunogenicity of
therapeutic coagulation proteins and
how these tools may be evaluated in a
clinical setting; and (4) initiatives to
determine the genetic factors that affect
immunogenicity of coagulation protein
products in individuals with
hemophilia and strategies to optimize
the outcome data.
The second day of the workshop will
include presentations and panel
discussions on the following topics: (1)
Challenges related to the development
of novel recombinant coagulation
protein products; (2) a round-table
discussion and question and answer
session; and (3) workshop summary.
Transcripts: Please be advised that as
soon as possible after a transcript of this
public workshop will be available, it
will be accessible at: https://
www.fda.gov/BiologicsBloodVaccines/
NewsEvents/WorkshopsMeetings
Conferences/ucm438035.htm.
Transcripts of the public workshop may
also be requested in writing from the
Division of Freedom of Information
(ELEM–1029), Food and Drug
Administration, 12420 Parklawn Dr.,
Rockville, MD 20857.
Dated: June 29, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–16365 Filed 7–1–15; 8:45 am]
BILLING CODE 4164–01–P
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]]>Agencies
[Federal Register Volume 80, Number 127 (Thursday, July 2, 2015)]
[Notices]
[Pages 38209-38210]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-16285]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Proposed Projects
Title: Refugee Data Submission System for Formula Funds
Allocations.
OMB No.: 0970-0043.
Description: The Refugee Data Submission System for Allocation of
Formula Funds is designed to satisfy the statutory requirements of the
Immigration and Nationity Act (INA). Section 412(a)(3) of the Act
requires that the Director of the Office of Refugee Resettlement (ORR)
make a periodic assessment of the needs of refugees for assistance and
services and the resources available to meet those needs. This
assessment includes compiling and maintaining data on 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 in each State, taking into account
secondary migration. In order to meet these statutory requirements, ORR
requires each State to submit disaggregated individual records
containing certain data elements for eligible populations. ORR uses the
information collected through the Web site to determine secondary
migration for the purposes of formula funds allocation to States. The
submission of individual records via the Refugee Data Submission System
for Allocation of Formula Funds is a 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 Web site
are also compiled and analyzed for inclusion in ORR's Annual Report to
Congress.
Respondents: States, Wilson/Fish Alternative Projects, 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.
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
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
[[Page 38210]]
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 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. 2015-16285 Filed 7-1-15; 8:45 am]
BILLING CODE 4184-01-P
