Agency Forms Undergoing Paperwork Reduction Act Review, 75722-75723 [E8-29402]
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75722
Federal Register / Vol. 73, No. 240 / Friday, December 12, 2008 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of
respondents
Average
burden per
response
(in hours)
Total Burden
(in hours)
Type of respondent
Data collection mechanism
Private Sector Partners ...................................
Focus group ...................................................
Web-based survey .........................................
Interview .........................................................
Focus group ...................................................
32
120
120
48
1
30/60
1
1
32
60
120
48
Total .........................................................
.........................................................................
........................
........................
415
Dated: December 5, 2008.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E8–29399 Filed 12–11–08; 8:45 am]
Landmines—New—National Center for
Environmental Health (NCEH), Centers
for Disease Control and Prevention
(CDC).
BILLING CODE 4163–18–P
The purpose of this project is to
conduct focus groups and an
observational baseline survey that
assesses the effectiveness of
Humanitarian Mine Action (landmine
and unexploded ordnance clearance,
also known as de-mining) upon the
economic, social and mental well being
of impacted communities.
This work will be conducted by the
Harvard Humanitarian Initiative, a
center of Harvard University, under a
cooperative agreement with CDC. The
study will examine the impact that
individuals and communities in these
locations suffer when living in an area
with landmines and unexploded
ordnance (UXO). Individuals and
communities also suffer from the lack of
use of all land resources as well as the
trauma of injured or killed family
members.
This research on the impact of
demining is necessary because
landmines and UXO continue to
negatively impact civilian populations.
For example, it has been estimated that
each year landmines and unexploded
ordnance lead to the injury and death of
24,000 persons worldwide,
predominately civilians. At the same
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–09–07AB]
Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) publishes a list of
information collection requests under
review by the Office of Management and
Budget (OMB) in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
requests, call the CDC Reports Clearance
Officer at (404) 639–5960 or send an email to omb@cdc.gov. Send written
comments to CDC Desk Officer, Office of
Management and Budget, Washington,
DC or by fax to (202) 395–6974. Written
comments should be received within 30
days of this notice.
Proposed Project
Measuring the Psychological Impact
on Communities Affected by
Background and Brief Description
time, it is estimated that civilians
account for 35% to 65% of war-related
deaths and injuries. The use of
landmines and UXO is ongoing, and
therefore this issue merits continued
attention.
Up to this point, however, little if any
of the international response to
landmines has studied the economic,
social, and mental impact upon a
community. Instead the focus has been
their physical impact in terms of
numbers of injured and killed. There are
no statistics nor is there research that
can accurately capture these alternative
measures of impact.
There now exists an opportunity for
further research that will benefit the
general public as well as the
organizations and governments working
with persons impacted by landmines
and UXO. The proposed work will
allow CDC to continue its commitment
to reduce the negative health impact
posed by landmines and unexploded
ordnance, both for U.S. and non-U.S.based populations. Approximately 1,264
respondents will come from the
Lebanon area. The estimates of
annualized burden hours for the
household surveys and the focus groups
are shown in the table below.
There are no costs to respondents
except their time to participate in the
survey. The total estimated annualized
burden hours are 1,328.
ESTIMATED ANNUALIZED BURDEN
Number of
respondents
Type of respondents
jlentini on PROD1PC65 with NOTICES
Household Survey—Cluster munitions ........................................................................................
Household Survey Control—Remote landmines .........................................................................
Focus Group—Cluster munitions ................................................................................................
Focus Group Control—Remote landmines .................................................................................
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600
600
32
32
12DEN1
Number of
responses per
respondent
1
1
1
1
Average
burden per
response
(in hrs)
1
1
2
2
75723
Federal Register / Vol. 73, No. 240 / Friday, December 12, 2008 / Notices
Dated: December 2, 2008.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E8–29402 Filed 12–11–08; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0499]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Implementation of
Sections 222, 223, and 224 of the Food
and Drug Administration Amendments
Act of 2007
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by January 12,
2009.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–6974, or e-mailed to
oira_submissions@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0625. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Jr., Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3793.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Implementation of Sections 222, 223,
and 224 of the Food and Drug
Administration Amendments Act of
2007 (OMB Control Number 0910–
0625)—Extension
Sections 222, 223, and 224 of the
Food and Drug Administration
Amendments Act of 2007 (FDAAA),
which were in effect on October 1, 2007,
require that device establishment
registrations and listings under section
510 of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C.
360), (including the submission of
updated information), be submitted to
the Secretary by electronic means,
unless the Secretary grants a request for
waiver of the requirement because the
use of electronic means is not
reasonable for the person requesting the
waiver. FDA expects 20,000 to 30,000
device establishments to begin
registering electronically at that time.
Section 222 of FDAAA amends
section 510(b) of the FD&C Act to
require domestic establishments to
register annually during the period
beginning October 1 and ending
December 31 of each year. Section 222
of FDAAA also amends section 510(i)(1)
of the FD&C Act to require foreign
establishments to register immediately
upon first engaging in one of the
covered device activities described
under the statute, and in addition, they
must also register annually during the
time period beginning October 1 and
ending December 31 of each year.
Further, section 223 of FDAAA amends
section 510(j)(2) of the FD&C Act to
require establishments list their devices
with FDA annually, during the time
period beginning October 1 and ending
December 31 of each year.
Under FDAAA, device establishment
owners and operators are required to
keep their registration and device listing
information up-to-date using the
agency’s new electronic system. Owners
and operators of new device
establishments must use the electronic
system to create new accounts, new
registration records, and new device
listings. Section 224 of FDAAA amends
section 510(p) of the FD&C Act by
allowing an affected person to request a
waiver from the requirement to register
electronically when the ‘‘use of
electronic means’’ is not reasonable for
the person.
In the Federal Register of October 1,
2008 (73 FR 57106), FDA published a
60-day notice requesting public
comment on the information collection
provisions. No comments were received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
Section of
the 2007
Amendments
FDA Form No.
No. of
Respondents
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
3673
2,600
1
2,704
0.5
1,352
2232
3673
24,382
1
24,382
0.25
6,095
2242
29,370
1
29,370
0.75
22,028
2243
2,600
1
2,600
0.5
1,300
224 (waiver
request)2
20
1
20
1
20
224 (waiver
request)3
jlentini on PROD1PC65 with NOTICES
2222
1
1
1
1
1
Total Hours
30,796
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
time burden.
3 Annual increase in burden.
2 One
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12DEN1
]]>Agencies
[Federal Register Volume 73, Number 240 (Friday, December 12, 2008)]
[Notices]
[Pages 75722-75723]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-29402]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-09-07AB]
Agency Forms Undergoing Paperwork Reduction Act Review
The Centers for Disease Control and Prevention (CDC) publishes a
list of information collection requests under review by the Office of
Management and Budget (OMB) in compliance with the Paperwork Reduction
Act (44 U.S.C. Chapter 35). To request a copy of these requests, call
the CDC Reports Clearance Officer at (404) 639-5960 or send an e-mail
to omb@cdc.gov. Send written comments to CDC Desk Officer, Office of
Management and Budget, Washington, DC or by fax to (202) 395-6974.
Written comments should be received within 30 days of this notice.
Proposed Project
Measuring the Psychological Impact on Communities Affected by
Landmines--New--National Center for Environmental Health (NCEH),
Centers for Disease Control and Prevention (CDC).
Background and Brief Description
The purpose of this project is to conduct focus groups and an
observational baseline survey that assesses the effectiveness of
Humanitarian Mine Action (landmine and unexploded ordnance clearance,
also known as de-mining) upon the economic, social and mental well
being of impacted communities.
This work will be conducted by the Harvard Humanitarian Initiative,
a center of Harvard University, under a cooperative agreement with CDC.
The study will examine the impact that individuals and communities in
these locations suffer when living in an area with landmines and
unexploded ordnance (UXO). Individuals and communities also suffer from
the lack of use of all land resources as well as the trauma of injured
or killed family members.
This research on the impact of demining is necessary because
landmines and UXO continue to negatively impact civilian populations.
For example, it has been estimated that each year landmines and
unexploded ordnance lead to the injury and death of 24,000 persons
worldwide, predominately civilians. At the same time, it is estimated
that civilians account for 35% to 65% of war-related deaths and
injuries. The use of landmines and UXO is ongoing, and therefore this
issue merits continued attention.
Up to this point, however, little if any of the international
response to landmines has studied the economic, social, and mental
impact upon a community. Instead the focus has been their physical
impact in terms of numbers of injured and killed. There are no
statistics nor is there research that can accurately capture these
alternative measures of impact.
There now exists an opportunity for further research that will
benefit the general public as well as the organizations and governments
working with persons impacted by landmines and UXO. The proposed work
will allow CDC to continue its commitment to reduce the negative health
impact posed by landmines and unexploded ordnance, both for U.S. and
non-U.S.-based populations. Approximately 1,264 respondents will come
from the Lebanon area. The estimates of annualized burden hours for the
household surveys and the focus groups are shown in the table below.
There are no costs to respondents except their time to participate
in the survey. The total estimated annualized burden hours are 1,328.
Estimated Annualized Burden
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondents Number of responses per per response
respondents respondent (in hrs)
----------------------------------------------------------------------------------------------------------------
Household Survey--Cluster munitions............................. 600 1 1
Household Survey Control--Remote landmines...................... 600 1 1
Focus Group--Cluster munitions.................................. 32 1 2
Focus Group Control--Remote landmines........................... 32 1 2
----------------------------------------------------------------------------------------------------------------
[[Page 75723]]
Dated: December 2, 2008.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for Disease Control and
Prevention.
[FR Doc. E8-29402 Filed 12-11-08; 8:45 am]
BILLING CODE 4163-18-P
