Submission for OMB Review; Comment Request, 21563-21564 [2012-8512]
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21563
Federal Register / Vol. 77, No. 69 / Tuesday, April 10, 2012 / Notices
ESTIMATED ANNUALIZED BURDEN TABLE—Continued
Number of
respondents
Average
burden/
response
(in hours)
Number
responses/
respondent
Total response
burden
(in hours)
Data collection task
Instrument/form name
In person focus groups (public health professionals).
Screener ...............................
140
1
10/60
23.3
Focus Group .........................
Confidentiality Agreement ....
Screener ...............................
70
70
168
1
1
1
1.5
5/60
10/60
105
6
28
Focus Group .........................
Confidentiality Agreement ....
Screener ...............................
42
42
126
1
1
1
1.5
5/60
10/60
63
3.5
21
Focus Group .........................
Confidentiality Agreement ....
Screener ...............................
42
42
84
1
1
1
1.5
5/60
10/60
63
3.5
14
Focus Group .........................
Confidentiality Agreement ....
Screener ...............................
42
42
160
1
1
1
1.5
5/60
10/60
63
3.5
27
Usability Test ........................
Confidentiality Agreement ....
Screener ...............................
40
40
200
1
1
1
1.5
5/60
10/60
60
3.3
33.3
Web-test ...............................
Confidentiality Agreement ....
Screener ...............................
Card Sort ..............................
Confidentiality Agreement ....
Screener ...............................
Card Sort ..............................
Confidentiality Agreement ....
Screener ...............................
Web-test ...............................
Confidentiality Agreement ....
50
50
120
30
30
400
100
100
0
115
115
1
1
1
1
1
1
1
1
0
1
1
1
5/60
10/60
1.5
5/60
10/60
.5
5/60
0
1
5/60
50
4.2
20
45
2.5
67
50
8.3
0
115
9.6
...............................................
........................
........................
........................
1329.1
Remote focus groups (consumers with limited health literacy and/or Spanish speakers).
Remote focus
mediaries).
groups
(health
inter-
Remote focus groups (public health professionals).
In person usability and prototype testing of
materials (print and Web).
Remote usability, prototype and concept
testing.
In person card sorting ...................................
Web-based card sorting ...............................
Web-based message testing ........................
TOTAL ...................................................
Keith A. Tucker,
Office of the Secretary, Paperwork Reduction
Act Reports Clearance Officer.
[FR Doc. 2012–8518 Filed 4–9–12; 8:45 am]
BILLING CODE 4150–32–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
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.
srobinson on DSK4SPTVN1PROD with NOTICES
ANNUAL BURDEN ESTIMATES
ORR–9 Annual Survey of Refugees ...............................................
Request for Participation Letter .......................................................
VerDate Mar<15>2010
16:26 Apr 09, 2012
Jkt 226001
Number of
responses
per respondent
Number of
respondents
Instrument
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Fmt 4703
2,000
2,000
Sfmt 4703
E:\FR\FM\10APN1.SGM
Average burden
hours
per response
1
1
10APN1
0.63
0.04
Total burden
hours
1,253.20
80
21564
Federal Register / Vol. 77, No. 69 / Tuesday, April 10, 2012 / Notices
Estimated Total Annual Burden
Hours: 1,333.20.
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: 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, Email:
OIRA_SUBMISSION@OMB.EOP.GOV.
Attn: Desk Officer for the
Administration for Children and
Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2012–8512 Filed 4–9–12; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0306]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Administrative
Detention and Banned Medical Devices
AGENCY:
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
srobinson on DSK4SPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
16:26 Apr 09, 2012
Jkt 226001
notice. This notice solicits comments on
information collection for
administrative detention and banned
medical devices.
DATES: Submit either electronic or
written comments on the collection of
information by June 11, 2012.
ADDRESSES: 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.
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
5156, Daniel.Gittleson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: 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 these topics: (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,
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
when appropriate, and other forms of
information technology.
Administrative Detention and Banned
Medical Devices—(OMB Control
Number 0910–0114)—Extension
FDA has the statutory authority under
section 304(g) of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) (21
U.S.C. 334(g)) to detain during
established inspections devices that are
believed to be adulterated or
misbranded. Section 800.55 (21 CFR
800.55), on administrative detention,
includes among other things, certain
reporting requirements and
recordkeeping requirements. Under
§ 800.55(g), an applicant of a detention
order must show documentation of
ownership if devices are detained at a
place other than that of the appellant.
Under § 800.55(k), the owner or other
responsible person must supply records
about how the devices may have
become adulterated or misbranded, in
addition to records of distribution of the
detained devices. These recordkeeping
requirements for administrative
detentions permit FDA to trace devices
for which the detention period expired
before a seizure is accomplished or
injunctive relief is obtained.
FDA also has the statutory authority
under section 516 of the FD&C Act (21
U.S.C. 360f) to ban devices that present
substantial deception or an
unreasonable and substantial risk of
illness or injury. Section 895.21 (21 CFR
895.21), on banned devices, contains
certain reporting requirements. Section
895.21(d) describes the procedures for
banning a device when the
Commissioner of Food and Drugs (the
Commissioner) decides to initiate such
a proceeding. Under 21 CFR 895.22, a
manufacturer, distributor, or importer of
a device may be required to submit to
FDA all relevant and available data and
information to enable the Commissioner
to determine whether the device
presents substantial deception,
unreasonable and substantial risk of
illness or injury, or unreasonable, direct,
and substantial danger to the health of
individuals.
During the past several years, there
has been an average of less than one
new administrative detention action per
year. Each administrative detention will
have varying amounts of data and
information that must be maintained.
FDA’s estimate of the burden under the
administrative detention provision is
based on FDA’s discussion with one of
three firms whose devices had been
detained.
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\10APN1.SGM
10APN1
]]>Agencies
[Federal Register Volume 77, Number 69 (Tuesday, April 10, 2012)]
[Notices]
[Pages 21563-21564]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-8512]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review; Comment Request
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.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total burden
respondents respondent 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
----------------------------------------------------------------------------------------------------------------
[[Page 21564]]
Estimated Total Annual Burden Hours: 1,333.20.
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: 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, Email: OIRA_SUBMISSION@OMB.EOP.GOV.
Attn: Desk Officer for the Administration for Children and
Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2012-8512 Filed 4-9-12; 8:45 am]
BILLING CODE 4184-01-P
