Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Decision Analysis: A Risk-Tolerance Pilot Study, 38299-38301 [2012-15720]
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38299
Federal Register / Vol. 77, No. 124 / Wednesday, June 27, 2012 / Notices
participants in the study Management
Information System (MIS).
Annual Burden Estimates
previously-approved field data
collection instrument, and the current
request. Burden for all instruments is
annualized over three years.
The following table provides the
combined burden estimates for the
Annual
number of
respondents
Activity/respondent
Average
burden per
response
(minutes)
Number of
responses per
respondent
Total annual
burden hours
Collection of Field Data (Approved April 20, 2012)
Selecting Study Grantees Discussions/grantee and partner organization
staff ...........................................................................................................
50
1
60
50
30
2,105
70.2
1
10
10
351
351
2,000
1
30
2,517
2
Introductory Script and Baseline Survey (Currently Requested)
Introductory Script:
(1) Grantee staff ...................................................................................
(2) Program applicants .........................................................................
Baseline Survey:
(1) Study participants ...........................................................................
1.000
Study MIS (Currently Requested)
Study MIS:
(1) Grantee staff ...................................................................................
30
Estimated Total Annual Burden
Hours: 4,269.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Additional Information
Food and Drug Administration
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: OPRE Reports Clearance Officer.
All requests should be identified by the
title of the information collection. Email
address: OPREinfocollection@acf.
hhs.gov.
[Docket No. FDA–2011–N–0747]
srobinson on DSK4SPTVN1PROD with NOTICES
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.E0P.GOV, Attn:
Desk Officer for the Administration for
Children and Families.
Steven M. Hanmer,
Reports Clearance, Officer.
[FR Doc. 2012–15440 Filed 6–26–12; 8:45 am]
BILLING CODE 4184–37–M
19:05 Jun 26, 2012
AGENCY:
Jkt 226001
Food and Drug Administration,
HHS.
ACTION:
OMB Comment
VerDate Mar<15>2010
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Waivers of In Vivo Demonstration of
Bioequivalence of Animal Drugs in
Soluble Powder Oral Dosage Form and
Type A Medicated Articles
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Waivers of In Vivo Demonstration of
Bioequivalence of Animal Drugs in
Soluble Powder Oral Dosage Form and
Type A Medicated Articles’’ has been
approved by the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT:
Juanmanuel Vilela, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850, 301–
796–7651,
Juanmanuel.Vilela@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: On March
19, 2012, the Agency submitted a
proposed collection of information
entitled ‘‘Waivers of In Vivo
Demonstration of Bioequivalence of
Animal Drugs in Soluble Powder Oral
Dosage Form and Type A Medicated
SUMMARY:
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
2,517
Articles’’ to OMB for review and
clearance under 44 U.S.C. 3507. An
Agency may not conduct or sponsor,
and a person is not required to respond
to, a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0575. The
approval expires on June 30, 2015. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
Dated: June 20, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–15721 Filed 6–26–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0357]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Medical Device
Decision Analysis: A Risk-Tolerance
Pilot Study
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
SUMMARY:
E:\FR\FM\27JNN1.SGM
27JNN1
38300
Federal Register / Vol. 77, No. 124 / Wednesday, June 27, 2012 / Notices
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 July 27,
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–New and
title ‘‘Medical Device Decision Analysis:
A Risk-Tolerance Pilot Study.’’ 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.
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.
Medical Device Decision Analysis: A
Risk-Tolerance Pilot Study—(OMB
Control Number 0910–New)
I. Background
A recent study of obesity indicates
that 35.5 percent of men and 35.8
percent of women in America reported
being obese in 2010. This represents an
increase from 27.5 percent and 33.4
percent in 2000 for men and women,
respectively (Ref. 1). People who are
obese are more likely to suffer from
diabetes, cardiovascular disease,
respiratory and metabolic disease, and
sleep apnea, as well as other physical
and psychological disabilities. By some
estimates, as much as $140 billion were
spent in 2008 to treat obesity-related
diseases (Ref. 2). Studies have shown
that weight loss can significantly reduce
the burden of obesity-related
comorbidities (Refs. 3 and 4), and that
weight lost as a result of laparoscopic
banding or other weight-loss surgeries
positively impacts quality of life and
burden of disease (Refs. 5 through 7).
However, like any surgical procedure,
these surgeries are associated with
substantial risks, including risks of
potentially life-threatening events (Ref.
6), that patients and physicians must
weigh against any potential benefits
when making an informed treatment
decision.
With the assistance of advisory
panels, FDA determines the acceptable
risk threshold of a medical intervention
against its effectiveness as demonstrated
in clinical evidence. In addition,
individual patients and patientadvocacy groups anecdotally express
their opinions about their needs and
tolerance for risks to FDA through
letters and public testimonies during
advisory panel meetings. To evaluate
the scientific validity of systematically
eliciting patient perspectives on
outcomes associated with weight-loss
devices, the Agency requests approval
of a pilot survey to quantify obesity
patients’ benefit-risk preferences.
The choice-format preferenceelicitation survey will ask obese
individuals (with a body mass index of
30 kg/m2 or above) to evaluate a series
of choices between pairs of hypothetical
medical devices. Each hypothetical
device will be defined by the amount
and duration of weight loss, side effects,
risks associated with hypothetical
weight-loss devices, and the effect of the
device on weight-related comorbidities.
The survey was developed using
findings from a literature review of the
outcomes associated with weight-loss
devices, interviews with obesity
patients, and expert opinion.
An invitation to the online survey
will be sent to a sample of 1,000 obese
adults in the United States. Among the
adults who receive the invitation, about
600 are expected to complete the
consent form and about 450 are
expected to qualify for the study and
complete the survey in full. In addition
to the choice-format questions, the
survey also will collect information on
respondent demographics, disease
history, and weight-management
history. There is no cost to respondents
other than about 25 minutes of their
time.
Final results will provide an estimate
of the maximum levels of various
treatment-related risks that obesity
patients would be willing to accept to
achieve specific levels of weight loss or
improvements in weight-related
diseases. These results will be used to
investigate the viability of choice-format
surveys as a way to quantify patients’
risk tolerance for the therapeutic
benefits of weight-loss devices.
In the Federal Register of April 19,
2012 (77 FR 23484), 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:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Survey
instrument
Number of
respondents
Number of
responses
per
respondent
Total annual
responses
Average
burden per
response
Survey invitation ...................................................................
Consent form .......................................................................
Full survey ............................................................................
Total ..............................................................................
1,000
700
450
........................
1
1
1
........................
1,000
700
450
........................
0.03
0.03
0.42
........................
srobinson on DSK4SPTVN1PROD with NOTICES
1 There
Total hours
30
21
189
240
are no capital costs or operating and maintenance costs associated with this collection of information.
II. References
The following references are on
display in the Division of Dockets
Management (see ADDRESSES) and may
be seen by interested persons between 9
a.m. and 4 p.m., Monday through
Friday.
1. Ogden, C.L., M.D. Carroll, B.K. Kit,
and K.M. Flegal, ‘‘Prevalence of Obesity
VerDate Mar<15>2010
19:05 Jun 26, 2012
Jkt 226001
and Trends in Body Mass Index Among
U.S. Children and Adolescents, 1999–
2010,’’ Journal of the American Medical
Association, vol. 307, no. 5, pp. 483–
490, 2012.
2. Finkelstein, E.A., J.G. Trogdon, J.W.
Cohen, and W. Dietz, ‘‘Annual Medical
Spending Attributable to Obesity: Payerand Service-Specific Estimates,’’ Health
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
Affairs, vol. 28, no. 5, pp. w822–w831,
2009.
3. Dhabuwala, A., R.J. Cannan, and
R.S. Stubbs, ‘‘Improvement in
Comorbidities Following Weight Loss
From Gastric Bypass Surgery,’’ Obesity
Surgery, vol. 10, pp. 428–435, 2000.
¨ ¨
4. Sjostrom, L., A. Lindroos, M.
Peltonen, et al., ‘‘Lifestyle, Diabetes, and
E:\FR\FM\27JNN1.SGM
27JNN1
38301
Federal Register / Vol. 77, No. 124 / Wednesday, June 27, 2012 / Notices
Cardiovascular Risk Factors 10 Years
After Bariatric Surgery,’’ The New
England Journal of Medicine, vol. 351,
no. 26, pp. 2683–2693, 2004.
5. Dixon, J.B., M.E. Dixon, and P.E.
O’Brien, ‘‘Quality of Life After Lap-Band
Placement: Influence of Time, Weight
Loss, and Comorbidities,’’ Obesity
Research, vol. 9, no. 11, pp. 713–721,
2001.
6. Buchwald, H., Y. Avidor, E.
Braunwald et al., ‘‘Bariatric Surgery: A
Systematic Review and Meta-Analysis,’’
Journal of the American Medical
Association, vol. 292, no. 14, pp. 1724–
1728, 2004.
7. Dixon, J.B., M.J. Hayden, G.W.
Lambert, et al., ‘‘Raised CRP Levels in
Obese Patients: Symptoms of
Depression Have an Independent
Positive Association,’’ Obesity, vol. 16,
no. 9, pp. 2010–2015, 2008.
Dated: June 22, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–15720 Filed 6–26–12; 8:45 am]
BILLING CODE 4160–01–P
Food and Drug Administration
[Docket No. FDA–2012–N–0369]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Regulations Under
the Federal Import Milk Act
Food and Drug Administration,
HHS.
ACTION:
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 0910–0212. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400T, Rockville, MD 20850, 301–796–
5733, domini.bean@fda.hhs.gov.
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.
Regulations Under the Federal Import
Milk Act—21 CFR Part 1210 (OMB
Control Number 0910–0212)—Extension
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
Fax written comments on the
collection of information by July 27,
2012.
DATES:
Notice.
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.
SUMMARY:
Under Federal Import Milk Act
(FIMA) (21 U.S.C. 141–149), milk or
cream may be imported into the United
States only by the holder of a valid
import milk permit (21 U.S.C. 141).
Before such permit is issued: (1) All
cows from which import milk or cream
is produced must be physically
examined and found healthy; (2) if the
milk or cream is imported raw, all such
cows must pass a tuberculin test; (3) the
dairy farm and each plant in which the
milk or cream is processed or handled
must be inspected and found to meet
certain sanitary requirements; (4)
bacterial counts of the milk at the time
of importation must not exceed
specified limits; and (5) the temperature
of the milk or cream at time of
importation must not exceed 50 °F (21
U.S.C. 142).
FDA’s regulations in part 1210 (21
CFR part 1210) implement the
provisions of FIMA. Sections 1210.11
and 1210.14 require reports on the
sanitary conditions of, respectively,
dairy farms and plants producing milk
and/or cream to be shipped to the
United States. Section 1210.12 requires
reports on the physical examination of
herds, while § 1210.13 requires the
reporting of tuberculin testing of the
herds. In addition, the regulations in
part 1210 require that dairy farmers and
plants maintain pasteurization records
(§ 1210.15) and that each container of
milk or cream imported into the United
States bear a tag with the product type,
permit number, and shipper’s name and
address (§ 1210.22). Section 1210.20
requires that an application for a permit
to ship or transport milk or cream into
the United States be made by the actual
shipper. Section 1210.23 allows permits
to be granted based on certificates from
accredited officials.
In the Federal Register of April 20,
2012 (77 FR 23732), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. FDA received one letter in
response to the notice. The letter
contained one relevant comment, while
additional comments were outside the
scope of the four collection of
information topics on which the notice
solicits comments and will not be
discussed in this document.
(Comment 1) One comment suggested
that ‘‘huge bureaucratic expenses
created by the usa [sic] for 2 forms’’ for
taxpayers.
(Response) While FDA appreciates the
comment, the commenter did not
specify which two forms might create an
undue expense for taxpayers. Each form
relating to this information collection
request is necessary for the proper
performance of FDA’s functions. FDA
has examined each form related to this
information collection request to assure
its efficiency.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
srobinson on DSK4SPTVN1PROD with NOTICES
21 CFR
Section
1210.11
1210.12
1210.13
1210.14
1210.20
1210.23
....
....
....
....
....
....
VerDate Mar<15>2010
FDA
FDA
FDA
FDA
FDA
FDA
1996/Sanitary inspection of dairy farms
1995/Physical examination of cows ......
1994/Tuberculin test ..............................
1997/Sanitary inspections of plants ......
1993/Application for permit ...................
1815/Permits granted on certificates ....
19:05 Jun 26, 2012
Jkt 226001
Number of
responses
per
respondent
Number of
respondents
Form No.
PO 00000
Frm 00035
2
1
1
2
2
2
Fmt 4703
Sfmt 4703
Total annual
responses
200
1
1
1
1
1
E:\FR\FM\27JNN1.SGM
400
1
1
2
2
2
27JNN1
Average
burden per
response
1.5
0.5
0.5
2
0.5
0.5
Total hours
600
0.5
0.5
4
1
1
]]>Agencies
[Federal Register Volume 77, Number 124 (Wednesday, June 27, 2012)]
[Notices]
[Pages 38299-38301]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-15720]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0357]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Medical Device
Decision Analysis: A Risk-Tolerance Pilot Study
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
[[Page 38300]]
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 July
27, 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-New and
title ``Medical Device Decision Analysis: A Risk-Tolerance Pilot
Study.'' 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.
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.
Medical Device Decision Analysis: A Risk-Tolerance Pilot Study--(OMB
Control Number 0910-New)
I. Background
A recent study of obesity indicates that 35.5 percent of men and
35.8 percent of women in America reported being obese in 2010. This
represents an increase from 27.5 percent and 33.4 percent in 2000 for
men and women, respectively (Ref. 1). People who are obese are more
likely to suffer from diabetes, cardiovascular disease, respiratory and
metabolic disease, and sleep apnea, as well as other physical and
psychological disabilities. By some estimates, as much as $140 billion
were spent in 2008 to treat obesity-related diseases (Ref. 2). Studies
have shown that weight loss can significantly reduce the burden of
obesity-related comorbidities (Refs. 3 and 4), and that weight lost as
a result of laparoscopic banding or other weight-loss surgeries
positively impacts quality of life and burden of disease (Refs. 5
through 7). However, like any surgical procedure, these surgeries are
associated with substantial risks, including risks of potentially life-
threatening events (Ref. 6), that patients and physicians must weigh
against any potential benefits when making an informed treatment
decision.
With the assistance of advisory panels, FDA determines the
acceptable risk threshold of a medical intervention against its
effectiveness as demonstrated in clinical evidence. In addition,
individual patients and patient-advocacy groups anecdotally express
their opinions about their needs and tolerance for risks to FDA through
letters and public testimonies during advisory panel meetings. To
evaluate the scientific validity of systematically eliciting patient
perspectives on outcomes associated with weight-loss devices, the
Agency requests approval of a pilot survey to quantify obesity
patients' benefit-risk preferences.
The choice-format preference-elicitation survey will ask obese
individuals (with a body mass index of 30 kg/m\2\ or above) to evaluate
a series of choices between pairs of hypothetical medical devices. Each
hypothetical device will be defined by the amount and duration of
weight loss, side effects, risks associated with hypothetical weight-
loss devices, and the effect of the device on weight-related
comorbidities. The survey was developed using findings from a
literature review of the outcomes associated with weight-loss devices,
interviews with obesity patients, and expert opinion.
An invitation to the online survey will be sent to a sample of
1,000 obese adults in the United States. Among the adults who receive
the invitation, about 600 are expected to complete the consent form and
about 450 are expected to qualify for the study and complete the survey
in full. In addition to the choice-format questions, the survey also
will collect information on respondent demographics, disease history,
and weight-management history. There is no cost to respondents other
than about 25 minutes of their time.
Final results will provide an estimate of the maximum levels of
various treatment-related risks that obesity patients would be willing
to accept to achieve specific levels of weight loss or improvements in
weight-related diseases. These results will be used to investigate the
viability of choice-format surveys as a way to quantify patients' risk
tolerance for the therapeutic benefits of weight-loss devices.
In the Federal Register of April 19, 2012 (77 FR 23484), 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:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
Survey instrument Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
Survey invitation............... 1,000 1 1,000 0.03 30
Consent form.................... 700 1 700 0.03 21
Full survey..................... 450 1 450 0.42 189
Total....................... .............. .............. .............. .............. 240
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
II. References
The following references are on display in the Division of Dockets
Management (see ADDRESSES) and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday through Friday.
1. Ogden, C.L., M.D. Carroll, B.K. Kit, and K.M. Flegal,
``Prevalence of Obesity and Trends in Body Mass Index Among U.S.
Children and Adolescents, 1999-2010,'' Journal of the American Medical
Association, vol. 307, no. 5, pp. 483-490, 2012.
2. Finkelstein, E.A., J.G. Trogdon, J.W. Cohen, and W. Dietz,
``Annual Medical Spending Attributable to Obesity: Payer- and Service-
Specific Estimates,'' Health Affairs, vol. 28, no. 5, pp. w822-w831,
2009.
3. Dhabuwala, A., R.J. Cannan, and R.S. Stubbs, ``Improvement in
Comorbidities Following Weight Loss From Gastric Bypass Surgery,''
Obesity Surgery, vol. 10, pp. 428-435, 2000.
4. Sj[ouml]str[ouml]m, L., A. Lindroos, M. Peltonen, et al.,
``Lifestyle, Diabetes, and
[[Page 38301]]
Cardiovascular Risk Factors 10 Years After Bariatric Surgery,'' The New
England Journal of Medicine, vol. 351, no. 26, pp. 2683-2693, 2004.
5. Dixon, J.B., M.E. Dixon, and P.E. O'Brien, ``Quality of Life
After Lap-Band Placement: Influence of Time, Weight Loss, and
Comorbidities,'' Obesity Research, vol. 9, no. 11, pp. 713-721, 2001.
6. Buchwald, H., Y. Avidor, E. Braunwald et al., ``Bariatric
Surgery: A Systematic Review and Meta-Analysis,'' Journal of the
American Medical Association, vol. 292, no. 14, pp. 1724-1728, 2004.
7. Dixon, J.B., M.J. Hayden, G.W. Lambert, et al., ``Raised CRP
Levels in Obese Patients: Symptoms of Depression Have an Independent
Positive Association,'' Obesity, vol. 16, no. 9, pp. 2010-2015, 2008.
Dated: June 22, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-15720 Filed 6-26-12; 8:45 am]
BILLING CODE 4160-01-P
