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, 2068-2070 [2012-503]
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2068
Federal Register / Vol. 77, No. 9 / Friday, January 13, 2012 / Notices
contact Jean Close at (410) 786–2804 or
Melissa Musotto at (410) 786–6962. For
all other issues call (410) 786–1326.)
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS’ Web Site
address at https://www.cms.hhs.gov/
PaperworkReductionActof1995, or
Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov, or call the
Reports Clearance Office on (410) 786–
1326.
In commenting on the proposed
information collections please reference
the document identifier or OMB control
number. To be assured consideration,
comments and recommendations must
be submitted in one of the following
ways by March 13, 2012:
1. Electronically. You may submit
your comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) accepting comments.
2. By regular mail. You may mail
written comments to the following
address: CMS, Office of Strategic
Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: Document Identifier/OMB
Control Number CMS–R–306 (0938–
0833), Room C4–26–05, 7500 Security
Boulevard, Baltimore, Maryland 21244–
1850.
Dated: January 6, 2012.
Martique Jones,
Director, Regulations Development Group,
Division B, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2012–593 Filed 1–12–12; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
OMB No.: 0970–0311.
Description: Section 453(j)(3) of the
Social Security Act (the Act) allows for
matching between the National
Directory of New Hires (maintained by
the Federal Office of Child Support
Enforcement (OCSE) and State TANF
Agencies for purposes of carrying out
responsibilities under programs funded
under part A of Title IV of the Act. To
assist OCSE and the Office of Family
Assistance (OFA) in measuring savings
to the TANF program attributable to the
use of NDNH data matches, the State
TANF Agencies have agreed to provide
OCSE with a written description of the
performance outputs and outcomes
attributable to the State TANF Agency’s
use of NDNH match results. This
information will help OCSE
demonstrate how the NDNH supports
the OCSE’s mission and strategic goals.
Respondents: State TANF Agencies.
Submission for OMB Review;
Comment Request
Title: Temporary Assistance for Needy
Families/National Directory of New
Hires Match Results Report.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
TANF/NDNH Match Results Report ................................................................
mstockstill on DSK4VPTVN1PROD with NOTICES
Instrument
12
4
0.17
8.16
Estimated Total Annual Burden
Hours: 8.16.
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, Fax: (202)
395–7285, Email:
OIRA_SUBMISSION@OMB.EOP.GOV,
Attn: Desk Officer for the
VerDate Mar<15>2010
15:46 Jan 12, 2012
Jkt 226001
Administration for Children and
Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2012–568 Filed 1–12–12; 8:45 am]
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.
Fax written comments on the
collection of information by February
13, 2012.
BILLING CODE 4184–01–P
DATES:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
ADDRESSES:
Food and Drug Administration
[Docket No. FDA–2011–N–0755]
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.
The Food and Drug
Administration (FDA) is announcing
SUMMARY:
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
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) 395–7285, or emailed to
oira_submission@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:
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.
E:\FR\FM\13JAN1.SGM
13JAN1
Federal Register / Vol. 77, No. 9 / Friday, January 13, 2012 / Notices
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
mstockstill on DSK4VPTVN1PROD with NOTICES
SUPPLEMENTARY INFORMATION:
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 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. There are approximately 24,000
establishments that are electronically
registered as of September 2011.
Section 222 of FDAAA amends
sections 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 to 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.
The estimates in table 1 of this
document are based on FDA’s
experience, data from the device
VerDate Mar<15>2010
15:46 Jan 12, 2012
Jkt 226001
registration and listing database, and
our estimates of the time needed to
complete the previously required forms.
We estimate that the time needed to
enter registration and listing
information electronically using FDA
Form 3673 will not differ significantly
from the time needed to fill in the paper
forms (FDA Forms 2891, 2891a, and
2892) that previously were used for this
purpose because the information
required is essentially identical.
In addition, under section 224 of
FDAAA, device establishment owner/
operators, for whom registering and
listing by electronic means is not
reasonable, may request a waiver from
the Secretary. Because a device
establishment’s owner/operator is
required to register and list, they would
need only to have access to a computer,
Internet, and an email address for
registration and listing by electronic
means, the Agency did not anticipate
receipt of a large number of requests for
waivers. From the October through
December 2007 timeframe, FDA
received fewer than 10 requests for
waivers for the requirement to submit
registration and listing information
electronically. As data for more than
16,000 establishments were received
electronically for the same period, these
requests amount to less than 1 percent
of the total number of establishments
that have responded. The number of
waiver requests received through fiscal
year 2011 has remained consistently
less than 1 percent.
Based on information taken from our
databases, FDA estimates that there are
21,254 owner/operators who
collectively register a total of 24,000
device establishments. The number of
respondents listed for section 222 of
FDAAA in table 1 of this document is
21,254, which corresponds to the
number of owner/operators who
annually register. In addition, FDA
estimates that 3,504 owner/operators are
initial importers who must register their
establishments but who, under FDA’s
existing regulations, are not required to
list their devices unless they initiate or
develop the specifications for the
devices or repackage or relabel the
devices. The number of respondents
included in table 1 of this document for
section 223 of FDAAA is 17,750, which
corresponds to the number of owner/
operators who annually list one or more
devices (21,254 ¥ 3,504 = 17,750).
To calculate the burden estimate for
waiver requests under section 224 of
FDAAA, we assume as stated
previously, that less than 1 percent of
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
2069
the 24,000 total device establishments
would request waivers from FDA. This
means the total number of waiver
requests would probably not exceed 14
requests (24,000 x 0.0006). We also
estimate that the one-time burden on
these establishments would be an hour
of time for a mid-level manager to draft,
approve, and mail a letter. In addition,
FDA estimates the total number of
establishments will increase by 2,162
new establishments each year. Of the
2,162 new registrants each year, we
assume that less than 1 percent (i.e., 1)
of these will also request waivers each
year. The total, therefore, is 14 waiver
requests, which could increase by only
one additional request each year.
Based on the number of owner
operators of foreign establishments
reflected in our current database,
approximately 8,067 owner operators
will spend an hour annually identifying
the name, address, telephone and fax
numbers, email address, and registration
number, if any has been assigned, of any
importer of the establishment’s devices
that is known to the foreign
establishment.
Also based on the current number of
owner/operators in the FDA database,
we estimate that approximately 1,305
owner operators will spend .25 hours
each year to identify changes in their
U.S. agent’s name, address, or phone
number to FDA.
The burden estimate for
recordkeeping requirements under
section 222 of FDAAA in table 2 of this
document complies with the
requirement that owners or operators
keep a list of officers, directors, and
partners for each establishment. Owners
or operators will need to provide this
information only upon request from
FDA. However, it is assumed that some
effort will need to be expended for
keeping such lists current.
The burden estimate for the
recordkeeping requirements under
section 223 of FDAAA in table 2 of this
document reflect other recordkeeping
requirements for devices listed with
FDA and the requirement to provide
these records upon request from FDA.
These estimates are based on FDA
experience.
In the Federal Register of November
3, 2011 (76 FR 68195), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\13JAN1.SGM
13JAN1
2070
Federal Register / Vol. 77, No. 9 / Friday, January 13, 2012 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
FDAAA Section of the 2007 amendments
FDA form No.
Total hours
222 3 .........................................................
222 2 .........................................................
222 3 .........................................................
222 3 .........................................................
223 3 .........................................................
224 (waiver request) 2 ..............................
224 (waiver request) 3 ..............................
3673
3673
3673
3673
3673
3673
3673
21,254
2,162
8,067
1,305
17,750
14
1
1
1
1
1
1
1
1
21,254
2,162
8,067
1,305
17,750
14
1
0.75
0.50
1
0.25
1
1
2
15,941
1,081
8,067
326
17,750
14
2
Total ..................................................
........................
........................
........................
........................
........................
43,181
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
burden.
3 Annual recurring burden.
2 One-time
TABLE 2—ESTIMATED AVERAGE ANNUAL RECORDKEEPING BURDEN1
Number of
recordkeepers
FDAAA Section of the 2007 amendments
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
222 2 .....................................................................................
223 2 .....................................................................................
23,806
11,746
1
4
23,806
46,984
0.25
0.5
5,952
23,492
Total ..............................................................................
........................
........................
........................
........................
29,444
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
2 Recurring burden.
Dated: January 9, 2012.
David Dorsey,
Acting Associate Commissioner for Policy and
Planning.
[FR Doc. 2012–503 Filed 1–12–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0589]
Anneri Izurieta: Debarment Order
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is issuing an
order under the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) debarring
Anneri Izurieta for a period of 30 years
from importing articles of food or
offering such articles for importation
into the United States. FDA bases this
order on a finding that Ms. Izurieta was
convicted of six felony counts under
Federal law for conduct relating to the
importation into the United States of an
article of food. Ms. Izurieta was given
notice of the proposed debarment and
an opportunity to request a hearing
within the timeframe prescribed by
regulation. As of November 4, 2011 (30
days after receipt of the notice), Ms.
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
15:46 Jan 12, 2012
Jkt 226001
Izurieta had not responded. Ms.
Izurieta’s failure to respond constitutes
a waiver of her right to a hearing
concerning this action.
DATES: This order is effective January
13, 2012.
ADDRESSES: Submit applications for
termination of debarment to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT:
Kenny Shade, Office of Regulatory
Affairs, Food and Drug Administration,
12420 Parklawn Dr., Rockville, MD
20857, (301) 796–4640.
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(b)(1)(C) of the FD&C Act
(21 U.S.C. 335a(b)(1)(C)) permits FDA to
debar an individual from importing an
article of food or offering such an article
for import into the United States if FDA
finds, as required by section
306(b)(3)(A) of the FD&C Act, that the
individual has been convicted of a
felony for conduct relating to the
importation into the United States of
any food.
On May 11, 2011, in the U.S. District
Court for the Southern District of
Florida, Ms. Izurieta was convicted of
one count of conspiracy to smuggle
goods into the United States, in
violation of 18 U.S.C. 371, and five
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
counts of smuggling goods into the
United States, in violation of 18 U.S.C.
545. The U.S. District Court for the
Southern District of Florida entered
judgment against Ms. Izurieta on July
29, 2011.
FDA’s finding that debarment is
appropriate is based on the felony
convictions referenced herein for
conduct relating to the importation into
the United States of any food. The
factual basis for these convictions is as
follows: On or about April 18, 2007, and
continuing through on or about
December 23, 2010, in violation of 18
U.S.C. 371, Ms. Izurieta knowingly, and
with the intent to further the object of
the conspiracy, conspired with others to
commit an offense against the United
States to fraudulently and knowingly
import and bring into the United States
merchandise contrary to law in
violation of 18 U.S.C. 545. Specifically,
Ms. Izurieta conspired to distribute and
sell imported dairy products that FDA
had detained after receiving notice from
FDA that the dairy products were
suspected to be adulterated.
While serving as president and
director of Naver Trading, Ms. Izurieta
caused dairy products and other food to
be imported from Honduras and
Nicaragua. Despite a request from FDA
to disclose the location of shipments of
dairy products after learning that FDA
had slated specific shipments for
examination due to concerns of
adulteration with Escherichia coli,
E:\FR\FM\13JAN1.SGM
13JAN1
]]>Agencies
[Federal Register Volume 77, Number 9 (Friday, January 13, 2012)]
[Notices]
[Pages 2068-2070]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-503]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0755]
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
February 13, 2012.
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) 395-7285, or emailed to oira_submission@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: 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.
[[Page 2069]]
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 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. There are approximately 24,000 establishments that are
electronically registered as of September 2011.
Section 222 of FDAAA amends sections 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 to 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.
The estimates in table 1 of this document are based on FDA's
experience, data from the device registration and listing database, and
our estimates of the time needed to complete the previously required
forms. We estimate that the time needed to enter registration and
listing information electronically using FDA Form 3673 will not differ
significantly from the time needed to fill in the paper forms (FDA
Forms 2891, 2891a, and 2892) that previously were used for this purpose
because the information required is essentially identical.
In addition, under section 224 of FDAAA, device establishment
owner/operators, for whom registering and listing by electronic means
is not reasonable, may request a waiver from the Secretary. Because a
device establishment's owner/operator is required to register and list,
they would need only to have access to a computer, Internet, and an
email address for registration and listing by electronic means, the
Agency did not anticipate receipt of a large number of requests for
waivers. From the October through December 2007 timeframe, FDA received
fewer than 10 requests for waivers for the requirement to submit
registration and listing information electronically. As data for more
than 16,000 establishments were received electronically for the same
period, these requests amount to less than 1 percent of the total
number of establishments that have responded. The number of waiver
requests received through fiscal year 2011 has remained consistently
less than 1 percent.
Based on information taken from our databases, FDA estimates that
there are 21,254 owner/operators who collectively register a total of
24,000 device establishments. The number of respondents listed for
section 222 of FDAAA in table 1 of this document is 21,254, which
corresponds to the number of owner/operators who annually register. In
addition, FDA estimates that 3,504 owner/operators are initial
importers who must register their establishments but who, under FDA's
existing regulations, are not required to list their devices unless
they initiate or develop the specifications for the devices or
repackage or relabel the devices. The number of respondents included in
table 1 of this document for section 223 of FDAAA is 17,750, which
corresponds to the number of owner/operators who annually list one or
more devices (21,254 - 3,504 = 17,750).
To calculate the burden estimate for waiver requests under section
224 of FDAAA, we assume as stated previously, that less than 1 percent
of the 24,000 total device establishments would request waivers from
FDA. This means the total number of waiver requests would probably not
exceed 14 requests (24,000 x 0.0006). We also estimate that the one-
time burden on these establishments would be an hour of time for a mid-
level manager to draft, approve, and mail a letter. In addition, FDA
estimates the total number of establishments will increase by 2,162 new
establishments each year. Of the 2,162 new registrants each year, we
assume that less than 1 percent (i.e., 1) of these will also request
waivers each year. The total, therefore, is 14 waiver requests, which
could increase by only one additional request each year.
Based on the number of owner operators of foreign establishments
reflected in our current database, approximately 8,067 owner operators
will spend an hour annually identifying the name, address, telephone
and fax numbers, email address, and registration number, if any has
been assigned, of any importer of the establishment's devices that is
known to the foreign establishment.
Also based on the current number of owner/operators in the FDA
database, we estimate that approximately 1,305 owner operators will
spend .25 hours each year to identify changes in their U.S. agent's
name, address, or phone number to FDA.
The burden estimate for recordkeeping requirements under section
222 of FDAAA in table 2 of this document complies with the requirement
that owners or operators keep a list of officers, directors, and
partners for each establishment. Owners or operators will need to
provide this information only upon request from FDA. However, it is
assumed that some effort will need to be expended for keeping such
lists current.
The burden estimate for the recordkeeping requirements under
section 223 of FDAAA in table 2 of this document reflect other
recordkeeping requirements for devices listed with FDA and the
requirement to provide these records upon request from FDA. These
estimates are based on FDA experience.
In the Federal Register of November 3, 2011 (76 FR 68195), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
[[Page 2070]]
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average
FDAAA Section of the 2007 amendments FDA form No. Number of responses per Total annual burden per Total hours
respondents respondent responses response
--------------------------------------------------------------------------------------------------------------------------------------------------------
222 \3\.................................................. 3673 21,254 1 21,254 0.75 15,941
222 \2\.................................................. 3673 2,162 1 2,162 0.50 1,081
222 \3\.................................................. 3673 8,067 1 8,067 1 8,067
222 \3\.................................................. 3673 1,305 1 1,305 0.25 326
223 \3\.................................................. 3673 17,750 1 17,750 1 17,750
224 (waiver request) \2\................................. 3673 14 1 14 1 14
224 (waiver request) \3\................................. 3673 1 1 1 2 2
----------------------------------------------------------------------------------------------
Total................................................ .............. .............. .............. .............. ............. 43,181
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ One-time burden.
\3\ Annual recurring burden.
Table 2--Estimated Average Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
Number of Average
FDAAA Section of the 2007 Number of records per Total annual burden per Total hours
amendments recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
222 \2\.......................... 23,806 1 23,806 0.25 5,952
223 \2\.......................... 11,746 4 46,984 0.5 23,492
------------------------------------------------------------------------------
Total........................ .............. .............. .............. ............. 29,444
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Recurring burden.
Dated: January 9, 2012.
David Dorsey,
Acting Associate Commissioner for Policy and Planning.
[FR Doc. 2012-503 Filed 1-12-12; 8:45 am]
BILLING CODE 4160-01-P
