Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Request for Samples and Protocols, 37080-37082 [06-5805]
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Federal Register / Vol. 71, No. 125 / Thursday, June 29, 2006 / Notices
of their qualifications (in particular,
those that address the required
qualifications, outlined above) and the
current expertise needs of the Task
Force. It is anticipated that 2
individuals will be invited to serve on
the Task Force beginning in January,
2007. AHRQ will retain and consider for
future vacancies the nominations of
those not selected during this cycle.
Submit your response to:
Helen Burstin, MD MPH, ATTN:
USPSTF Nominations, Center for
Primary Care, Prevention, and Clinical
Partnerships, Agency for Healthcare
Research and Quality, 540 Gaither Road,
Rockville, Maryland 20850.
ADDRESSES:
Nomination Submissions
Nominations may submitted in
writing or electronically, but must
include (1) the applicant’s current
curriculum vitae, and (2) a letter
explaining how this individual meets
the qualification requirements and how
he/she would contribute to the Task
Force. The letter should also attest to
the nominee’s willingness to serve as a
member of the Task Force.
AHRQ will later ask persons under
serious consideration for membership to
provide detailed information that will
permit evaluation of possible significant
conflicts of interest. Such information
will concern matters such as financial
holdings, consultancies, and research
grants or contracts.
Nomination Selection
Nominations for the Task Force will
be selected on the basis of qualifications
as outlined above (see qualification
requirements) and the current expertise
needs of the Task Force.
jlentini on PROD1PC65 with NOTICES
Arrangement for Public Inspection
Nominations and applications are
kept on file at the Center for Primary
Care, Prevention and Clinical
Partnerships, and are available for
review during business hours. AHRQ
does not reply to individual responses,
but considers all nominations in
selecting members. Information
regarded as private and personal, such
as a nominee’s social security number,
home and internet addresses, home
telephone and fax numbers, or names of
family members will not be disclosed to
the public. This is in accord with
agency confidentiality policies and
Department regulations (45 CFR 5.67).
FOR FURTHER INFORMATION CONTACT:
Therese Miller at
therese.miller@ahrq.hhs.gov.
SUPPLEMENTARY INFORMATION:
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Background
Under Title IX of the Public Health
Service Act, AHRQ is charged with
enhancing the quality, appropriateness,
and effectiveness of health care services
and access to such services. AHRQ
accomplishes these goals through
scientific research and promotion of
improvements in clinical practice,
including prevention of diseases and
other health conditions, and
improvements in the organization,
financing, and delivery of health care
services (42 U.S.C. 299–299c–7 as
amended).
The Task Force is an independent
expert panel, first established in 1984
under the auspices of the U.S. Public
Health Service, Currently, the USPSTF,
under AHRQ’s authorizing legislation
(see in particular, 42 U.S.C. 299b–4(a)),
is convened at the call of the Director of
AHRQ. The Task Force is charged with
rigorously evaluating the effectiveness,
cost-effectiveness and appropriateness
of clinical preventive services and
formulating or updating
recommendations for primary are
clinicians regarding the appropriate
provision of preventive services. The
USPSTF transitioned to a standing Task
Force in 2001. Current Task Force
recommendations and associated
evidence reviews are available on the
Internet (https://
www.preventiveservices.ahrq.gov).
Dated: June 22, 2006.
Carolyn M. Clancy,
Director.
[FR Doc. 06–5782 Filed 6–28–06; 8:45 am]
BILLING CODE 4160–90–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Statement of Organization, Functions,
and Delegations of Authority
Part C (Centers for Disease Control
and Prevention) of the Statement of
Organization, Functions, and
Delegations of Authority of the
Department of Health and Human
Services (45 FR 67772–76, dated
October 14, 1980, and corrected at 45 FR
69296, October 20, 1980, as amended
most recently at 71 FR 32349–32350,
dated June 5, 2006) is amended to
reflect the reorganization of the Office of
the Chief Science Officer, Office of the
Director, Centers for Disease Control
and Prevention.
Section C–B, Organization and
Functions, is hereby amended as
follows:
PO 00000
Frm 00049
Fmt 4703
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Revise the functional statement for
the Office of the Chief Science Officer
(CAS), as follows:
After item (12), insert the following
item: (13) provides oversight, training,
monitoring, and quality assurance in the
use of animals in research.
Delete item (10) of the functional
statement for the Scientific Resources
Program (CVCE), National Center for
Infectious Diseases (CVC), and
renumber the remaining items
accordingly.
Dated: June 22, 2006.
William H. Gimson,
Chief Operating Officer, Centers for Disease
Control and Prevention (CDC).
[FR Doc. 06–5785 Filed 6–28–06; 8:45 am]
BILLING CODE 4160–18–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N–0021]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Request for
Samples and Protocols
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 July 31,
2006.
ADDRESSES: OMB is still experiencing
significant delays in the regular mail,
including first class and express mail,
and messenger deliveries are not being
accepted. 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.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–4659.
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.
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Federal Register / Vol. 71, No. 125 / Thursday, June 29, 2006 / Notices
Request for Samples and Protocols —
(OMB Control Number 0910–0206) —
Extension
Under section 351 of the Public
Health Service Act (42 U.S.C. 262), FDA
has the responsibility to issue
regulations that prescribe standards
designed to ensure that the biologics
licenses for such products are only
issued when a product meets the
prescribed standards. Under § 610.2 (21
CFR 610.2), FDA may at any time
require manufacturers of licensed
biological products to submit to FDA
samples of any lot along with the
protocols showing the results of
applicable tests prior to marketing the
lot of the product. In addition to § 610.2,
there are other regulations that require
the submission of samples and protocols
for specific licensed biological products:
§ 660.6 (21 CFR 660.6) (Antibody to
Hepatitis B Surface Antigen), 660.36 (21
CFR 660.36) (Reagent Red Blood Cells),
and 660.46 (21 CFR 660.46)(Hepatitis B
Surface Antigen).
Section 660.6(a) provides
requirements for the frequency of
submission of samples from each lot of
Antibody to Hepatitis B Surface Antigen
product, and § 660.6(b) provides the
requirements for the submission of a
protocol containing specific information
along with each required sample. For
§ 660.6 products subject to official
release by FDA, one sample from each
filling of each lot is required to be
submitted along with a protocol
consisting of a summary of the history
of manufacture of the product,
including all results of each test for
which test results are requested by the
Center for Biologics Evaluation and
Research (CBER). After official release is
no longer required, one sample along
with a protocol is required to be
submitted at an interval of 90 days. In
addition, samples, which must be
accompanied by a protocol, may at any
time be required to be submitted to FDA
if continued evaluation is deemed
necessary.
Section 660.36(a) requires, after each
routine establishment inspection by
FDA, the submission of samples from a
lot of final Reagent Red Blood Cell
product along with a protocol
containing specific information. Section
660.36(a)(2) requires that a protocol
contain information including, but not
limited to, manufacturing records, test
records, and test results. Section
660.36(b) requires a copy of the
antigenic constitution matrix specifying
the antigens present or absent to be
submitted to FDA at the time of initial
distribution of each lot.
Section 660.46(a) provides
requirements for the frequency of
submission of samples from each lot of
Hepatitis B Surface Antigen product,
and § 660.46(b) provides the
requirements for the submission of a
protocol containing specific information
along with each required sample. For
§ 660.46 products subject to official
release by FDA, one sample from each
filling of each lot is required to be
submitted along with a protocol
consisting of a summary of the history
of manufacture of the product,
including all results of each test for
which test results are requested by
CBER. After notification of official
release is received, one sample along
with a protocol is required to be
submitted at an interval of 90 days. In
addition, samples, which must be
accompanied by a protocol, may at any
time be required to be submitted to FDA
if continued evaluation is deemed
necessary.
Samples and protocols are required by
FDA to help ensure the product meets
the criteria for lot release that have been
determined to be necessary by FDA. In
cases of certain biological products (e.g.,
Albumin, Plasma Protein Fraction, and
specified biotechnology and specified
synthetic biological products) that are
known to have lot-to-lot consistency,
official lot release is not normally
required. However, submissions of
samples and protocols of these products
may still be required for surveillance,
licensing, and export purposes, or in the
event that FDA obtains information that
the manufacturing process may not
result in consistent quality of the
product.
The following burden estimate is for
the protocols that are required to be
submitted with each sample. The
collection of samples is not a collection
of information under 5 CFR
1320.3(h)(2). Respondents to the
collection of information under § 610.2
are manufacturers of licensed biological
products. Respondents to the collection
of information under § 660.6(b),
660.36(a)(2) and (b), and 660.46(b) are
manufacturers of the specific products
referenced previously in this document.
The estimated number of respondents
for each regulation is based on the
annual number of manufacturers that
submitted samples and protocols for
biological products including
submissions for lot release, surveillance,
licensing, or export. Based on
information obtained from FDA’s
database system, approximately 70
manufacturer’s submitted samples and
protocols in fiscal year (FY) 2005, under
the regulations cited previously in this
document. FDA estimates that 65
manufacturers submitted protocols
under § 610.2, and 4 manufacturers
submitted protocols under the
regulations (§§ 660.6 and 660.46) for the
other specific products. FDA received
no submissions under § 660.36, however
FDA is using the estimate of one
protocol submission in the event one is
submitted in the future.
The estimated total annual responses
are based on FDA’s final actions
completed in FY 2005, which totaled
4,930, for the various submission
requirements of samples and protocols
for the licensed biological products. The
rate of final actions is not expected to
change significantly in the next few
years. The hours per response are based
on information provided by industry.
The burden estimates provided by
industry ranged from 1 to 5.5 hours.
Under § 610.2, the hours per response
are based on the average of these
estimates and rounded to 3 hours.
Under the remaining regulations, the
hours per response are based on the
higher end of the estimate (rounded to
5 or 6 hours) since more information is
generally required to be submitted in
the protocol than under § 610.2.
In the Federal Register of January 24,
2006 (71 FR 3856), FDA published a 60day 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
jlentini on PROD1PC65 with NOTICES
21 CFR Section
No. of
Respondents
610.2
Total Annual
Responses
Hours per
Respondent
Total Hours
65
17:03 Jun 28, 2006
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PO 00000
74.1
4,816
3
14,448
3
660.6(b)
VerDate Aug<31>2005
Annual Frequency
per Response
26
78
5
390
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Federal Register / Vol. 71, No. 125 / Thursday, June 29, 2006 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued
No. of
Respondents
21 CFR Section
Annual Frequency
per Response
Total Annual
Responses
Hours per
Respondent
Total Hours
660.36(a)(2) and (b)
1
1
1
6
6
660.46(b)
1
35
35
5
175
Total
70
1There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: June 23, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 06–5805 Filed 6–28–06; 8:45 am]
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1472.
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. 2006N–0247]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Medical Device
User Fee Cover Sheet
AGENCY:
Food and Drug Administration,
HHS.
jlentini on PROD1PC65 with NOTICES
Notice.
SUMMARY: 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
notice. This notice solicits comments on
Form FDA 3601 entitled ‘‘Medical
Device User Fee Cover Sheet’’ which
must be submitted along with certain
medical device product applications,
supplements, and fee payment of those
applications.
DATES: Submit written or electronic
comments on the collection of
information by August 28, 2006.
ADDRESSES: Submit electronic
comments on the collection of
information to: https://www.fda.gov/
dockets/ecomments. 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
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17:03 Jun 28, 2006
Jkt 208001
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,
when appropriate, and other forms of
information technology.
SUPPLEMENTARY INFORMATION:
Food and Drug Administration
ACTION:
15,019
PO 00000
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Medical Device User Fee Cover Sheet;
Form FDA 3601 (OMB Control Number
0910–0511)—Extension
The Federal Food, Drug, and Cosmetic
Act (the act), as amended by the
Medical Device User Fee and
Modernization Act of 2002 (MDUFMA)
(Public Law 107–250), authorizes FDA
to collect user fees for certain medical
device applications. Under this
authority, companies pay a fee for
certain new medical device applications
or supplements submitted to the agency
for review. Because the submission of
user fees concurrently with applications
and supplements is required, the review
of an application cannot begin until the
fee is submitted. Form FDA 3601, the
‘‘Medical Device User Fee Cover Sheet’’,
is designed to provide the minimum
necessary information to determine
whether a fee is required for review of
an application, to determine the amount
of the fee required, and to account for
and track user fees. The form provides
a cross-reference of the fees submitted
for an application with the actual
application by using a unique number
tracking system. The information
collected is used by FDA’s Center for
Devices and Radiological Health (CDRH)
and the Center for Biologics Evaluation
and Research (CBER) to initiate the
administrative screening of new medical
device applications and supplemental
applications.
According to FDA’s database system,
there are an estimated 4,600
manufacturers of products subject to
MDUFMA. However, not all
manufacturers will have any cover sheet
submissions in a given year and some
may have multiple cover sheet
submissions. The total number of
annual responses is based on the
number of cover sheet submissions
received by FDA in fiscal year 2005.
CDRH received 4,436 annual responses
that included the following
submissions: 43 premarket approval
applications (PMAs), 4,071 premarket
notifications, 22 modular premarket
applications, 1 product development
protocol, 1 premarket report, 15 panel
track supplements, 174 real-time
supplements, and 109 180–day
E:\FR\FM\29JNN1.SGM
29JNN1
]]>Agencies
[Federal Register Volume 71, Number 125 (Thursday, June 29, 2006)]
[Notices]
[Pages 37080-37082]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-5805]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N-0021]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Request for Samples
and Protocols
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 July
31, 2006.
ADDRESSES: OMB is still experiencing significant delays in the regular
mail, including first class and express mail, and messenger deliveries
are not being accepted. 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.
FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-4659.
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.
[[Page 37081]]
Request for Samples and Protocols -- (OMB Control Number 0910-0206) --
Extension
Under section 351 of the Public Health Service Act (42 U.S.C. 262),
FDA has the responsibility to issue regulations that prescribe
standards designed to ensure that the biologics licenses for such
products are only issued when a product meets the prescribed standards.
Under Sec. 610.2 (21 CFR 610.2), FDA may at any time require
manufacturers of licensed biological products to submit to FDA samples
of any lot along with the protocols showing the results of applicable
tests prior to marketing the lot of the product. In addition to Sec.
610.2, there are other regulations that require the submission of
samples and protocols for specific licensed biological products: Sec.
660.6 (21 CFR 660.6) (Antibody to Hepatitis B Surface Antigen), 660.36
(21 CFR 660.36) (Reagent Red Blood Cells), and 660.46 (21 CFR
660.46)(Hepatitis B Surface Antigen).
Section 660.6(a) provides requirements for the frequency of
submission of samples from each lot of Antibody to Hepatitis B Surface
Antigen product, and Sec. 660.6(b) provides the requirements for the
submission of a protocol containing specific information along with
each required sample. For Sec. 660.6 products subject to official
release by FDA, one sample from each filling of each lot is required to
be submitted along with a protocol consisting of a summary of the
history of manufacture of the product, including all results of each
test for which test results are requested by the Center for Biologics
Evaluation and Research (CBER). After official release is no longer
required, one sample along with a protocol is required to be submitted
at an interval of 90 days. In addition, samples, which must be
accompanied by a protocol, may at any time be required to be submitted
to FDA if continued evaluation is deemed necessary.
Section 660.36(a) requires, after each routine establishment
inspection by FDA, the submission of samples from a lot of final
Reagent Red Blood Cell product along with a protocol containing
specific information. Section 660.36(a)(2) requires that a protocol
contain information including, but not limited to, manufacturing
records, test records, and test results. Section 660.36(b) requires a
copy of the antigenic constitution matrix specifying the antigens
present or absent to be submitted to FDA at the time of initial
distribution of each lot.
Section 660.46(a) provides requirements for the frequency of
submission of samples from each lot of Hepatitis B Surface Antigen
product, and Sec. 660.46(b) provides the requirements for the
submission of a protocol containing specific information along with
each required sample. For Sec. 660.46 products subject to official
release by FDA, one sample from each filling of each lot is required to
be submitted along with a protocol consisting of a summary of the
history of manufacture of the product, including all results of each
test for which test results are requested by CBER. After notification
of official release is received, one sample along with a protocol is
required to be submitted at an interval of 90 days. In addition,
samples, which must be accompanied by a protocol, may at any time be
required to be submitted to FDA if continued evaluation is deemed
necessary.
Samples and protocols are required by FDA to help ensure the
product meets the criteria for lot release that have been determined to
be necessary by FDA. In cases of certain biological products (e.g.,
Albumin, Plasma Protein Fraction, and specified biotechnology and
specified synthetic biological products) that are known to have lot-to-
lot consistency, official lot release is not normally required.
However, submissions of samples and protocols of these products may
still be required for surveillance, licensing, and export purposes, or
in the event that FDA obtains information that the manufacturing
process may not result in consistent quality of the product.
The following burden estimate is for the protocols that are
required to be submitted with each sample. The collection of samples is
not a collection of information under 5 CFR 1320.3(h)(2). Respondents
to the collection of information under Sec. 610.2 are manufacturers of
licensed biological products. Respondents to the collection of
information under Sec. 660.6(b), 660.36(a)(2) and (b), and 660.46(b)
are manufacturers of the specific products referenced previously in
this document. The estimated number of respondents for each regulation
is based on the annual number of manufacturers that submitted samples
and protocols for biological products including submissions for lot
release, surveillance, licensing, or export. Based on information
obtained from FDA's database system, approximately 70 manufacturer's
submitted samples and protocols in fiscal year (FY) 2005, under the
regulations cited previously in this document. FDA estimates that 65
manufacturers submitted protocols under Sec. 610.2, and 4
manufacturers submitted protocols under the regulations (Sec. Sec.
660.6 and 660.46) for the other specific products. FDA received no
submissions under Sec. 660.36, however FDA is using the estimate of
one protocol submission in the event one is submitted in the future.
The estimated total annual responses are based on FDA's final
actions completed in FY 2005, which totaled 4,930, for the various
submission requirements of samples and protocols for the licensed
biological products. The rate of final actions is not expected to
change significantly in the next few years. The hours per response are
based on information provided by industry. The burden estimates
provided by industry ranged from 1 to 5.5 hours. Under Sec. 610.2, the
hours per response are based on the average of these estimates and
rounded to 3 hours. Under the remaining regulations, the hours per
response are based on the higher end of the estimate (rounded to 5 or 6
hours) since more information is generally required to be submitted in
the protocol than under Sec. 610.2.
In the Federal Register of January 24, 2006 (71 FR 3856), 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 Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
21 CFR Section Respondents per Response Responses Respondent Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
610.2 65 74.1 4,816 3 14,448
--------------------------------------------------------------------------------------------------------------------------------------------------------
660.6(b) 3 26 78 5 390
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 37082]]
660.36(a)(2) and (b) 1 1 1 6 6
--------------------------------------------------------------------------------------------------------------------------------------------------------
660.46(b) 1 35 35 5 175
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 70 .................... ................. ................. 15,019
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: June 23, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 06-5805 Filed 6-28-06; 8:45 am]
BILLING CODE 4160-01-S
