80 FR 38209 - Proposed Information Collection Activity; Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families Federal Register Volume 80, Issue 127 (July 2, 2015)
Administration for Children and Families
Federal Register Volume 80, Issue 127 (July 2, 2015)
| Page Range | 38209-38210 | |
| FR Document | 2015-16285 |
[Federal Register Volume 80, Number 127 (Thursday, July 2, 2015)] [Notices] [Pages 38209-38210] From the Federal Register Online [www.thefederalregister.org] [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
![Federal Register / Vol. 80, No. 127 / Thursday, July 2, 2015 / Notices 38209
requests on the behalf of both OMB (see OMB #0970–0413). This will be important for describing the
collaborating agencies. Data for the notice is specific to the request for study sample and for estimating
study is collected from the following approval of the contact information program effects for particular groups of
three major sources: Baseline forms, form and baseline information form for interest.
follow-up surveys (at 6, 12, and 30 the new STED site. These forms will Respondents: Study participants in
months after study entry), and collect important demographic and
the treatment and control groups at one
implementation research and site visits. other information from all study
additional STED site.
Data collection for all but one STED site participants in this site prior to the
has been reviewed and approved by point of random assignment. These data
ANNUAL BURDEN ESTIMATES—NEW INSTRUMENTS
Total Annual Number of Average Annual burden
Instrument number of number of responses per burden hours hours
respondents respondents respondent per response
Participant contact information form .................................... 4,002 1,334 1 .08 107
Participant baseline information form .................................. 4,002 1,334 1 .25 334
Total .............................................................................. ........................ ........................ ........................ ........................ 441
Additional Information: Copies of the Administration for Children and resources available to meet those needs.
proposed collection may be obtained by Families. This assessment includes compiling and
writing to the Administration for maintaining data on secondary
Karl Koerper,
Children and Families, Office of migration of refugees within the United
OPRE Reports Clearance Officer. States after arrival. Further, INA
Planning, Research and Evaluation, 370
[FR Doc. 2015–16283 Filed 7–1–15; 8:45 am] 412(c)(1)(B) states that formula funds
L’Enfant Promenade SW., Washington,
DC 20447, Attn: OPRE Reports BILLING CODE 4184–09–P shall be allocated based on the total
Clearance Officer. All requests should number of refugees in each State, taking
be identified by the title of the into account secondary migration. In
DEPARTMENT OF HEALTH AND order to meet these statutory
information collection. Email address: HUMAN SERVICES
OPREinfocollection@acf.hhs.gov. requirements, ORR requires each State
Administration for Children and to submit disaggregated individual
OMB Comment: OMB is required to records containing certain data elements
make a decision concerning the Families
for eligible populations. ORR uses the
collection of information between 30 Proposed Information Collection information collected through the Web
and 60 days after publication of this Activity; Comment Request site to determine secondary migration
document in the Federal Register. for the purposes of formula funds
Therefore, a comment is best assured of Proposed Projects allocation to States. The submission of
having its full effect if OMB receives it Title: Refugee Data Submission individual records via the Refugee Data
within 30 days of publication. Written System for Formula Funds Allocations. Submission System for Allocation of
comments and recommendations for the OMB No.: 0970–0043. Formula Funds is a reliable and secure
proposed information collection should Description: The Refugee Data process for collecting data for the
be sent directly to the following: Office Submission System for Allocation of purposes of tracking secondary
of Management and Budget, Paperwork Formula Funds is designed to satisfy the migration and allocating formula funds.
Reduction Project, Email: statutory requirements of the Data submitted by the States via the
OIRA_SUBMISSION@OMB.EOP.GOV, Immigration and Nationity Act (INA). Web site are also compiled and
Attn: Desk Officer for the Section 412(a)(3) of the Act requires that analyzed for inclusion in ORR’s Annual
the Director of the Office of Refugee Report to Congress.
Resettlement (ORR) make a periodic Respondents: States, Wilson/Fish
assessment of the needs of refugees for Alternative Projects, and the District of
assistance and services and the Columbia.
ANNUAL BURDEN ESTIMATES
Number of Average
Number of Total burden
Instrument responses per burden hours
respondents hours
respondent per response
Refugee Data Submission for Formula Funds Allocations ............................. 50 1 20 1,000
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Estimated Total Annual Burden on the specific aspects of the Families, Office of Planning, Research
Hours: 1,000. information collection described above. and Evaluation, 370 L’Enfant
In compliance with the requirements Copies of the proposed collection of Promenade SW., Washington, DC 20447,
of section 506(c)(2)(A) of the Paperwork information can be obtained and Attn: ACF Reports Clearance Officer.
Reduction Act of 1995, the comments may be forwarded by writing Email address: infocollection@
Administration for Children and to the Administration for Children and acf.hhs.gov. All requests should be
Families is soliciting public comment
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![38210 Federal Register / Vol. 80, No. 127 / Thursday, July 2, 2015 / Notices
identified by the title of the information and panel discussions by experts from accumulation of large data sets over the
collection. academic institutions, industry, and next few years. The workshop aims to
The Department specifically requests government Agencies. address what patients, healthcare
comments on: (a) Whether the proposed Date and Time: The public workshop professionals and regulators may do
collection of information is necessary will be held on September 17, 2015, with this information to improve patient
for the proper performance of the from 8:30 a.m. to 5 p.m. and on outcomes.
functions of the agency, including September 18, 2015, from 8:30 a.m. to
12 p.m. In addition, an unprecedented
whether the information shall have
practical utility; (b) the accuracy of the Location: The public workshop will number of new engineered recombinant
agency’s estimate of the burden of the be held at the Ruth Kirschstein coagulation proteins are in
proposed collection of information; (c) Auditorium, Natcher Conference Center, development. This workshop will
the quality, utility, and clarity of the Bldg. 45, National Institutes of Health discuss the state-of-the art with respect
information to be collected; and (d) Campus, 9000 Rockville Pike, Bethesda, to leveraging scientific progress to
ways to minimize the burden MD 20892. The entrance for the public predict the immunogenicity of protein
information to be collected; and (d) workshop participants (non-NIH amino acid sequences that do not exist
ways to minimize the burden of the employees) is through the NIH Gateway in nature, and whether there is a need
collection of information on Center located adjacent to the Medical for novel strategies in the design and
respondents, including through the use Center Metro, where routine security conduct of clinical trials for these
of automated collection techniques or check procedures will be performed. products.
other forms of information technology. Please visit the following Web site for
location, parking, security, and travel The first day of the workshop will
Consideration will be given to include presentations and panel
comments and suggestions submitted information: http://www.nih.gov/about/
visitor/index.htm. Please visit the discussions on the following topics: (1)
within 60 days of this publication. Overview of the current understanding
following Web site for information on
Robert Sargis, the Natcher Conference Center: http:// of genetic factors that affect
Reports Clearance Officer. www.genome.gov/11007522. immunogenicity of therapeutic
[FR Doc. 2015–16285 Filed 7–1–15; 8:45 am] Contact Person: Freddy Barnes, coagulation proteins; (2) recent
BILLING CODE 4184–01–P Center for Biologics Evaluation and advances in immunology relevant to
Research, Food and Drug immunogenicity; (3) emerging
Administration, 10903 New Hampshire computational, in vitro and ex vivo
DEPARTMENT OF HEALTH AND Ave., Silver Spring, MD 20993, 240– tools to predict the immunogenicity of
HUMAN SERVICES 402–6943, William.Barnes@fda.hhs.gov. therapeutic coagulation proteins and
For questions email: how these tools may be evaluated in a
Food and Drug Administration CBERPublicEvents@fda.hhs.gov (Subject clinical setting; and (4) initiatives to
[Docket No. FDA–2015–N–0001]
line: FDA MPICPDT Workshop). determine the genetic factors that affect
Registration: Please visit the following
immunogenicity of coagulation protein
New Methods To Predict the Web site to register for the workshop by
August 27, 2015: http:// products in individuals with
Immunogenicity of Therapeutic hemophilia and strategies to optimize
Coagulation Proteins; Public methodspredictimmunogenicity.
eventbrite.com. There is no registration the outcome data.
Workshop
fee for the public workshop. Early The second day of the workshop will
AGENCY: Food and Drug Administration, registration is recommended because include presentations and panel
HHS. seating is limited. Registration on the discussions on the following topics: (1)
ACTION: Notice of public workshop. day of the public workshop will be Challenges related to the development
provided on a space available basis of novel recombinant coagulation
The Food and Drug Administration beginning at 8:15 a.m. protein products; (2) a round-table
(FDA) is announcing a public workshop If you need special accommodations discussion and question and answer
entitled: ‘‘New Methods to Predict the due to a disability, please contact session; and (3) workshop summary.
Immunogenicity of Therapeutic Freddy Barnes (see Contact Person) at
Coagulation Proteins’’. The purpose of least 7 days in advance. Transcripts: Please be advised that as
the public workshop is to discuss recent Supplementary Information: The soon as possible after a transcript of this
scientific progress in identifying the development of unwanted immune public workshop will be available, it
genetic determinants for an unwanted responses to therapeutic coagulation will be accessible at: http://
immune response to therapeutic protein products may affect both www.fda.gov/BiologicsBloodVaccines/
coagulation proteins (immunogenicity), product efficacy and patient safety. In NewsEvents/WorkshopsMeetings
and to identify and discuss potential the case of replacement coagulation Conferences/ucm438035.htm.
new methods to predict such protein therapies, the inhibitory anti- Transcripts of the public workshop may
immunogenicity. Immunogenicity drug antibodies also interact with the also be requested in writing from the
results in the development of antibodies endogenous protein and may result in Division of Freedom of Information
that target the therapeutic protein and serious adverse events in patients. Both (ELEM–1029), Food and Drug
can affect the safety and efficacy of the product and patient specific factors may
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Administration, 12420 Parklawn Dr.,
biological product. The workshop has affect the immunogenicity of Rockville, MD 20857.
been planned in partnership with the therapeutic coagulation protein
Dated: June 29, 2015.
National Heart, Lung and Blood products. There are currently several
Institute, National Institutes of Health initiatives underway to assess the Leslie Kux,
(NIH), the National Hemophilia genetic basis for developing unwanted Associate Commissioner for Policy.
Foundation, and the Plasma Protein immune responses to coagulation [FR Doc. 2015–16365 Filed 7–1–15; 8:45 am]
Therapeutics Association. The protein products in individuals with BILLING CODE 4164–01–P
workshop will include presentations hemophilia, which will result in the
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Document Created: 2015-12-15 13:15:03
Document Modified: 2015-12-15 13:15:03
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| FR Citation | 80 FR 38209 |
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