Proposed Information Collection Activity; Comment Request, 77541-77542 [2011-31871]
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Federal Register / Vol. 76, No. 239 / Tuesday, December 13, 2011 / Notices
submit the SF–425 Federal Financial
Report, which provides aggregate
expenditure and obligation data. This
proposed new data collection would
replace the current requirement for the
SF–425 with a report form that would
collect the same expenditures and
obligations data separately for each of
the four CMA program components:
refugee cash assistance, refugee medical
assistance, cash and medical assistance
administration, and services for
unaccompanied minors. This
breakdown of financial status data will
allow ORR to track program
expenditures in greater detail to
anticipate any funding issues and to
meet the requirements of ORR
regulations at CFR 400.211 to collect
these data for use in estimating future
costs of the refugee resettlement
program. ORR must implement the
methodology at CFR 400.211 each year
after receipt of its annual appropriation
to ensure that appropriated funds will
be adequate for reimbursement to States
of the costs for assistance provided to
entering refugees. The estimating
methodology prescribed in the
regulations requires the use of actual
past costs by program component. In the
event that the methodology indicates
that appropriated funds are inadequate,
ORR must take steps to reduce federal
expenses, such as by limiting the
number of months of eligibility for
Refugee Cash Assistance and Refugee
Medical Assistance. This proposed
single-page financial report will allow
ORR to collect the necessary data to
ensure that funds are adequate for the
projected need and thereby meet the
requirements of both the Refugee Act
and ORR regulations, as well as provide
the data currently required in aggregate
by the SF–425.
Respondents: State governments,
Wilson/Fish Alternative Projects.
Instrument
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
ORR Financial Status Report ..........................................................................
58
4
0.50
116
Estimated Total Annual Burden
Hours: 116
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 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. 2011–31872 Filed 12–12–11; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Proposed Projects
Title: Annual Survey of Refugees
(Form ORR–9).
Number of
respondents
Instrument
srobinson on DSK4SPTVN1PROD with NOTICES
ORR–9 Annual Survey of Refugees .............................................................
Request for Participation Letter .....................................................................
Estimated Total Annual Burden
Hours: 1,333.20.
In compliance with the requirements
of Section 506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the
Administration for Children and
VerDate Mar<15>2010
16:25 Dec 12, 2011
Jkt 226001
OMB No.: 0970–0033.
Description: The Annual Survey of
Refugees collects information on the
social and economic circumstances of a
random sample of refugees, Amerasians,
and entrants who arrived in the United
States in the five years prior to the date
of the survey. The survey focuses on the
refugees training, labor force
participation, and welfare utilization
rates. Dates are segmented by region of
origin, State of resettlement, and
number of months since arrival. From
the responses, the Office of Refugee
Resettlement reports on the economic
adjustment of refugees to the American
economy. These data are used by
Congress in its annual deliberations for
refugee admissions and funding and by
program managers in formulating
policies for the future direction of the
Refugee Resettlement Program.
Respondents: Refugees, entrants,
Amerasians, and Havana parolees.
Number of
responses per
respondent
2,000
2,000
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
PO 00000
Frm 00072
Fmt 4703
Sfmt 4703
Average
burden hours
per
response
1
1
0.63
0.04
Total burden
hours
1,253.20
80
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,
E:\FR\FM\13DEN1.SGM
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77542
Federal Register / Vol. 76, No. 239 / Tuesday, December 13, 2011 / Notices
Attn: ACF Reports Clearance Officer.
Email address: infocollection@acf.hhs.
gov. All requests should be 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. 2011–31871 Filed 12–12–11; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2011–D–0847]
Draft Guidance for Industry and Food
and Drug Administration Staff on
Humanitarian Use Device
Designations; Availability
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry and FDA staff entitled
‘‘Humanitarian Use Device (HUD)
Designations.’’ Devices are eligible for
HUD designation if they are designed to
treat or diagnose a disease or condition
that affects or is manifested in fewer
than 4,000 individuals in the United
States per year. Devices that receive
HUD designation may be eligible for
marketing approval under the
Humanitarian Device Exemption (HDE)
marketing pathway. This guidance
document is intended to assist
applicants in the preparation and
submission of HUD designation requests
and FDA reviewers in evaluating such
requests.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
srobinson on DSK4SPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
16:25 Dec 12, 2011
Jkt 226001
Submit written requests for
single copies of the draft guidance to the
Office of Orphan Products Development
(OOPD), Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 32,
rm. 5271, Silver Spring, MD 20993.
Send one self-addressed adhesive label
to assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Eric
Chen, Office of Orphan Products
Development, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5271, Silver Spring,
MD 20993, (301) 796–8660.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
I. Background
Food and Drug Administration
AGENCY:
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by March 12,
2012.
FDA is announcing the availability of
a draft guidance for industry and FDA
staff entitled ‘‘Humanitarian Use Device
(HUD) Designations.’’ Devices are
eligible for HUD designation if they are
designed to treat or diagnose a disease
or condition that affects or is manifested
in fewer than 4,000 individuals in the
United States per year. (See section
520(m) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C.
360j(m)); 21 CFR 814.102). This
guidance document is intended to assist
applicants in the preparation and
submission of HUD designation requests
to FDA, OOPD. This guidance is also
intended to assist FDA reviewers in the
evaluation and analysis of HUD
designation requests.
Topics addressed in this guidance
include: (1) Demonstrating in HUD
requests that the device is designed to
treat or diagnose a disease or condition
that affects or is manifested in fewer
than 4,000 individuals in the United
States per year; (2) how this
demonstration varies, depending on
whether the device is intended for
therapeutic or diagnostic purposes; (3)
how properties of the device may affect
this demonstration; and (4) delineating
a medically plausible subset of persons
with a given disease or condition.
PO 00000
Frm 00073
Fmt 4703
Sfmt 4703
Devices that receive HUD designation
may be eligible for marketing approval
under an HDE application. An HDE
application is a premarketing
application that is similar to a
premarket approval (PMA) application
in that the applicant must demonstrate
a reasonable assurance of safety, but in
an HDE application, the applicant seeks
an exemption from the PMA
requirement to demonstrate a reasonable
assurance of effectiveness. A device is
eligible for HDE approval if, among
other criteria, the probable benefit to
health from use of the device outweighs
the risk of injury or illness from its use,
taking into account the probable risks
and benefits of currently available
devices or alternative forms of
treatment. (See section 520(m) of the
FD&C Act; 21 CFR 814.104(b)(2)).
Although a HUD designation is a
prerequisite to submitting an HDE
application, it is only one of many
required elements of the application (21
CFR 814.104). Receipt of a HUD
designation does not guarantee that the
HDE marketing application will be
approved.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the Agency’s current thinking
on humanitarian use device
designations. It does not create or confer
any rights for or on any person and does
not operate to bind FDA or the public.
An alternative approach may be used if
such approach satisfies the
requirements of the applicable statutes
and regulations.
II. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR part 814,
subpart H, have been approved under
OMB control number 0910–0332.
III. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed comments.
Identify comments with the docket
number found in brackets in the
heading of this document. Received
comments may be seen in the Division
E:\FR\FM\13DEN1.SGM
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]]>Agencies
[Federal Register Volume 76, Number 239 (Tuesday, December 13, 2011)]
[Notices]
[Pages 77541-77542]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-31871]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Proposed Projects
Title: Annual Survey of Refugees (Form ORR-9).
OMB No.: 0970-0033.
Description: The Annual Survey of Refugees collects information on
the social and economic circumstances of a random sample of refugees,
Amerasians, and entrants who arrived in the United States in the five
years prior to the date of the survey. The survey focuses on the
refugees training, labor force participation, and welfare utilization
rates. Dates are segmented by region of origin, State of resettlement,
and number of months since arrival. From the responses, the Office of
Refugee Resettlement reports on the economic adjustment of refugees to
the American economy. These data are used by Congress in its annual
deliberations for refugee admissions and funding and by program
managers in formulating policies for the future direction of the
Refugee Resettlement Program.
Respondents: Refugees, entrants, Amerasians, and Havana parolees.
----------------------------------------------------------------------------------------------------------------
Number of Average
Instrument Number of responses per burden hours Total burden
respondents respondent per response hours
----------------------------------------------------------------------------------------------------------------
ORR-9 Annual Survey of Refugees................. 2,000 1 0.63 1,253.20
Request for Participation Letter................ 2,000 1 0.04 80
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 1,333.20.
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,
[[Page 77542]]
Attn: ACF Reports Clearance Officer. Email address:
infocollection@acf.hhs.gov. All requests should be 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. 2011-31871 Filed 12-12-11; 8:45 am]
BILLING CODE 4184-01-P
