Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Continuous Marketing Applications: Pilot 2-Scientific Feedback and Interactions During Development of Fast Track Products Under the Prescription Drug User Fee Act, 41819-41821 [E6-11643]
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Federal Register / Vol. 71, No. 141 / Monday, July 24, 2006 / Notices
Description of Respondents:
Businesses or other for-profit
organizations.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
21 CFR Section
101.93
2,500
1There
Dated: July 17, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–11642 Filed 7–21–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N–0278]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Guidance for
Industry on Continuous Marketing
Applications: Pilot 2—Scientific
Feedback and Interactions During
Development of Fast Track Products
Under the Prescription Drug User Fee
Act
AGENCY:
Food and Drug Administration,
HHS.
sroberts on PROD1PC70 with NOTICES
Total Annual
Responses
1
Hours per
Respondent
2,500
Total Hours
.75
1,875
are no capital costs or operating and maintenance costs associated with this collection of information.
The agency believes that there will be
minimal burden on the industry to
generate information to meet the
requirements of section 403 of the act in
submitting information regarding
section 403(r)(6) of the act statements on
labels or in labeling of dietary
supplements. The agency is requesting
only information that is immediately
available to the manufacturer, packer, or
distributor of the dietary supplement
that bears such a statement on its label
or in its labeling. This estimate is based
on the average number of notification
submissions received by the agency in
the preceding 12 months.
ACTION:
Annual Frequency
per Response
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
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notice. This notice solicits comments on
the information collection contained in
the guidance for industry on Continuous
Marketing Applications: Pilot 2—
Scientific Feedback and Interactions
During Development of Fast Track
Products Under the Prescription Drug
User Fee Act.
DATES: Submit written or electronic
comments on the collection of
information by September 22, 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
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Berbakos, Office of
Management Programs (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
1482.
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
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
SUPPLEMENTARY INFORMATION:
PO 00000
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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.
Guidance for Industry on Continuous
Marketing Applications: Pilot 2—
Scientific Feedback and Interactions
During Development of Fast Track
Products Under the Prescription Drug
User Fee Act—(OMB Control Number
0910–0518)— Extension
FDA is requesting OMB approval
under the PRA (44 U.S.C. 3507) for the
reporting and recordkeeping
requirements contained in the guidance
for industry entitled ‘‘Continuous
Marketing Applications (CMA): Pilot
2—Scientific Feedback and Interactions
During Development of Fast Track
Products Under PDUFA.’’ This guidance
discusses how the agency will
implement a pilot program for frequent
scientific feedback and interactions
between FDA and applicants during the
investigational phase of the
development of certain Fast Track drug
and biological products. Applicants are
asked to apply to participate in the Pilot
2 program.
In conjunction with the June 2002
reauthorization of the Prescription Drug
User Fee Act of 1992 (PDUFA), FDA
agreed to meet specific performance
goals (PDUFA Goals). The PDUFA Goals
include two pilot programs to explore
the CMA concept. The CMA concept
builds on the current practice of
interaction between FDA and applicants
during drug development and
application review and proposes
opportunities for improvement. Under
E:\FR\FM\24JYN1.SGM
24JYN1
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Federal Register / Vol. 71, No. 141 / Monday, July 24, 2006 / Notices
the CMA pilot program, Pilot 2, certain
drug and biologic products that have
been designated as Fast Track (i.e.,
products intended to treat a serious and/
or life-threatening disease for which
there is an unmet medical need) are
eligible to participate in the program.
Pilot 2 is an exploratory program that
allows FDA to evaluate the impact of
frequent scientific feedback and
interactions with applicants during the
investigational new drug application
(IND) phase. Under the pilot program, a
maximum of 1 Fast Track product per
review division in FDA’s Center for
Drug Evaluation and Research (CDER)
and Center for Biologics Evaluation and
Research (CBER) is selected to
participate. This guidance provides
information regarding the selection of
participant applications for Pilot 2, the
formation of agreements between FDA
and applicants on the IND
communication process, and other
procedural aspects of Pilot 2. FDA began
accepting applications for participation
in Pilot 2 on October 1, 2003.
The guidance describes 1 collection of
information: Applicants who would like
to participate in Pilot 2 must submit an
application (Pilot 2 application)
containing certain information outlined
in the guidance. The purpose of the
Pilot 2 application is for the applicants
to describe how their designated Fast
Track product would benefit from
enhanced communications between
FDA and the applicant during the
product development process.
FDA’s regulation at § 312.23 (21 CFR
312.23) states that information provided
to the agency as part of an IND must be
submitted in triplicate and with an
appropriate cover form. Form FDA 1571
must accompany submissions under
INDs. 21 CFR part 312 and FDA Form
1571 have a valid OMB control number:
OMB control number 0910–0014, which
expires May 31, 2009.
In the guidance document, CDER and
CBER ask that a Pilot 2 application be
submitted as an amendment to the
application for the underlying product
under the requirements of § 312.23;
therefore, Pilot 2 applications should be
submitted to the agency in triplicate
with Form FDA 1571. The agency
recommends that a Pilot 2 application
be submitted in this manner for two
reasons: (1) To ensure that each Pilot 2
application is kept in the administrative
file with the entire underlying
application, and (2) to ensure that
pertinent information about the Pilot 2
application is entered into the
appropriate tracking databases. Use of
the information in the agency’s tracking
databases enables the agency to monitor
progress on activities.
Under the guidance, the agency asks
applicants to include the following
information in the Pilot 2 application:
• Cover letter prominently labeled
‘‘Pilot 2 application;’’
• IND number;
• Date of Fast Track designation;
• Date of the end-of-phase 1 meeting,
or equivalent meeting, and summary of
the outcome;
• A timeline of milestones from the
drug or biological product development
program, including projected date of
new drug application (NDA)/biologics
license application (BLA) submissions;
• Overview of the proposed product
development program for a specified
disease and indication(s), providing
information about each of the review
disciplines (e.g., chemistry/
manufacturing/controls, pharmacology/
toxicology, clinical, clinical
pharmacology and biopharmaceutics);
• Rationale for interest in
participating in Pilot 2, specifying the
ways in which development of the
subject drug or biological product
would be improved by frequent
scientific feedback and interactions with
FDA and the potential for such
communication to benefit public health
by improving the efficiency of the
product development program; and
• Draft agreement for proposed
feedback and interactions with FDA.
This information is used by the
agency to determine which Fast Track
products are eligible for participation in
Pilot 2. Participation in this pilot
program is voluntary.
Based on the number of Pilot 2
applications submitted to CDER and
CBER during fiscal year 2004 and 2005,
we estimate that the number of
applications received annually for Pilot
2 is 7 for products regulated by CDER
and 1 for products regulated by CBER.
FDA anticipates that approximately 7
applicants (respondents) will submit
these Pilot 2 applications annually to
CDER and approximately 1 applicant
(respondent) will submit these Pilot 2
applications annually to CBER. The
hours per response, which is the
estimated number of hours that a
respondent would spend preparing the
information to be submitted in a Pilot 2
application in accordance with the
guidance, is estimated to be
approximately 80 hours. Based on
FDA’s experience, we expect it will take
respondents this amount of time to
obtain and draft the information to be
submitted with a Pilot 2 application.
Therefore, the agency estimates that
applicants use approximately 640 hours
annually to submit the Pilot 2
applications.
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
Pilot 2 Application
No. of
Responses per
Response
No. of
Respondents
Total Responses
Hours per
Response
Total Hours
CDER
7
1
7
80
560
CBER
1
1
1
80
80
Total
sroberts on PROD1PC70 with NOTICES
1There
640
are no capital costs or operating and maintenance costs associated with this collection of information.
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41821
Federal Register / Vol. 71, No. 141 / Monday, July 24, 2006 / Notices
Dated: July 17, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–11643 Filed 7–21–06; 8:45 am]
BILLING CODE 4160–01–S
FDA Public Health Notification
(formerly known as Safety Alert/Public
Health Advisory) Readership Survey
(OMB Control Number 0910–0341)—
Extension.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0486]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Food and Drug
Administration Public Health
Notification (formerly known as Safety
Alert/Public Health Advisory)
Readership Survey
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
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 August 23,
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:
Denver Presley, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1472
Section 705(b) of the Federal Food,
Drug, and Cosmetic Act (the act) (21
U.S.C. 375(b)) authorizes FDA to
disseminate information concerning
imminent danger to public health by
any regulated product. The Center for
Devices and Radiological Health (CDRH)
communicates these risks to user
communities through two publications:
(1) The Public Health Notification
(PHN) and (2) the Preliminary Public
Health Notification (PPHN). The PHN is
published when CDRH has information
or a message to convey to health care
practitioners that they would want to
know in order to make informed clinical
decisions about the use of a device or
device type, and that information may
not be readily available to the affected
target audience in the health care
community, and CDRH can make
recommendations that will help the
health care practitioner mitigate or
avoid the risk.
The PPHN is also published when
CDRH has information to convey to
health care practitioners that they
would want to know in order to make
informed clinical decisions about the
use of a device or device type. However,
two additional conditions exist that
make the use of this type of notification
preferable. First, CDRH’s understanding
of the problem, its cause(s), and the
scope of the risk is still evolving, and in
order to minimize the risk, the center
believes that health care practitioners
need the information they have,
however incomplete, as soon as
possible. Second, the problem is being
actively investigated by the center, the
industry, another agency, or some other
reliable entity, so that the center expects
to be able to update the PPHN when
definitive new information becomes
available.
Notifications are sent to organizations
affected by the risks discussed in the
notification, such as hospitals, nursing
homes, hospices, home health care
agencies, retail pharmacies, and other
health care providers. Through a
process for identifying and addressing
postmarket safety issues related to
regulated products, CDRH determines
when to publish notifications.
Section 1701(a)(4) of the Public
Health Service Act (42 U.S.C.
300u(a)(4)) authorizes FDA to conduct
research relating to health information.
FDA seeks to evaluate the clarity,
timeliness, and impact of safety alerts
and public health advisories by
surveying a sample of recipients.
Subjects will receive a questionnaire to
be completed and returned to FDA. The
information to be collected will address
how clearly notifications for reducing
risk are explained, the timeliness of the
information, and whether the reader has
taken any action to eliminate or reduce
risk as a result of information in the
alert. Subjects will also be asked
whether they wish to receive future
notifications electronically, as well as
how the PHN program might be
improved.
The information collected will be
used to shape FDA’s editorial policy for
the PHN and PPHN. Understanding how
target audiences view these publications
will aid in deciding what changes
should be considered in their content,
format, and method of dissemination.
In the Federal Register of December
22,2005 (70 FR 76054), FDA published
a 60-day notice requesting public
comment on the information collection
provisions. No comments were received
in response to that notice.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
Annual Frequency
per Response
No. of Respondents
308
sroberts on PROD1PC70 with NOTICES
1There
Total Annual
Responses
3
Hours per
Response
924
Total Hours
.17
157
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on the history of the PHN
program, it is estimated that an average
of three collections will be conducted a
year. The total burden of response time
is estimated at 10 minutes per survey.
This was derived by CDRH staff
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completing the survey and through
discussions with the contacts in trade
organizations.
PO 00000
Dated: July 17, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–11644 Filed 7–21–06; 8:45 am]
BILLING CODE 4160–01–S
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]]>Agencies
[Federal Register Volume 71, Number 141 (Monday, July 24, 2006)]
[Notices]
[Pages 41819-41821]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-11643]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N-0278]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Guidance for Industry on Continuous Marketing
Applications: Pilot 2--Scientific Feedback and Interactions During
Development of Fast Track Products Under the Prescription Drug User Fee
Act
AGENCY: Food and Drug Administration, HHS.
ACTION: 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 the information collection
contained in the guidance for industry on Continuous Marketing
Applications: Pilot 2--Scientific Feedback and Interactions During
Development of Fast Track Products Under the Prescription Drug User Fee
Act.
DATES: Submit written or electronic comments on the collection of
information by September 22, 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 docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of
Management Programs (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-1482.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in 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.
Guidance for Industry on Continuous Marketing Applications: Pilot 2--
Scientific Feedback and Interactions During Development of Fast Track
Products Under the Prescription Drug User Fee Act--(OMB Control Number
0910-0518)-- Extension
FDA is requesting OMB approval under the PRA (44 U.S.C. 3507) for
the reporting and recordkeeping requirements contained in the guidance
for industry entitled ``Continuous Marketing Applications (CMA): Pilot
2--Scientific Feedback and Interactions During Development of Fast
Track Products Under PDUFA.'' This guidance discusses how the agency
will implement a pilot program for frequent scientific feedback and
interactions between FDA and applicants during the investigational
phase of the development of certain Fast Track drug and biological
products. Applicants are asked to apply to participate in the Pilot 2
program.
In conjunction with the June 2002 reauthorization of the
Prescription Drug User Fee Act of 1992 (PDUFA), FDA agreed to meet
specific performance goals (PDUFA Goals). The PDUFA Goals include two
pilot programs to explore the CMA concept. The CMA concept builds on
the current practice of interaction between FDA and applicants during
drug development and application review and proposes opportunities for
improvement. Under
[[Page 41820]]
the CMA pilot program, Pilot 2, certain drug and biologic products that
have been designated as Fast Track (i.e., products intended to treat a
serious and/or life-threatening disease for which there is an unmet
medical need) are eligible to participate in the program. Pilot 2 is an
exploratory program that allows FDA to evaluate the impact of frequent
scientific feedback and interactions with applicants during the
investigational new drug application (IND) phase. Under the pilot
program, a maximum of 1 Fast Track product per review division in FDA's
Center for Drug Evaluation and Research (CDER) and Center for Biologics
Evaluation and Research (CBER) is selected to participate. This
guidance provides information regarding the selection of participant
applications for Pilot 2, the formation of agreements between FDA and
applicants on the IND communication process, and other procedural
aspects of Pilot 2. FDA began accepting applications for participation
in Pilot 2 on October 1, 2003.
The guidance describes 1 collection of information: Applicants who
would like to participate in Pilot 2 must submit an application (Pilot
2 application) containing certain information outlined in the guidance.
The purpose of the Pilot 2 application is for the applicants to
describe how their designated Fast Track product would benefit from
enhanced communications between FDA and the applicant during the
product development process.
FDA's regulation at Sec. 312.23 (21 CFR 312.23) states that
information provided to the agency as part of an IND must be submitted
in triplicate and with an appropriate cover form. Form FDA 1571 must
accompany submissions under INDs. 21 CFR part 312 and FDA Form 1571
have a valid OMB control number: OMB control number 0910-0014, which
expires May 31, 2009.
In the guidance document, CDER and CBER ask that a Pilot 2
application be submitted as an amendment to the application for the
underlying product under the requirements of Sec. 312.23; therefore,
Pilot 2 applications should be submitted to the agency in triplicate
with Form FDA 1571. The agency recommends that a Pilot 2 application be
submitted in this manner for two reasons: (1) To ensure that each Pilot
2 application is kept in the administrative file with the entire
underlying application, and (2) to ensure that pertinent information
about the Pilot 2 application is entered into the appropriate tracking
databases. Use of the information in the agency's tracking databases
enables the agency to monitor progress on activities.
Under the guidance, the agency asks applicants to include the
following information in the Pilot 2 application:
Cover letter prominently labeled ``Pilot 2 application;''
IND number;
Date of Fast Track designation;
Date of the end-of-phase 1 meeting, or equivalent meeting,
and summary of the outcome;
A timeline of milestones from the drug or biological
product development program, including projected date of new drug
application (NDA)/biologics license application (BLA) submissions;
Overview of the proposed product development program for a
specified disease and indication(s), providing information about each
of the review disciplines (e.g., chemistry/manufacturing/controls,
pharmacology/toxicology, clinical, clinical pharmacology and
biopharmaceutics);
Rationale for interest in participating in Pilot 2,
specifying the ways in which development of the subject drug or
biological product would be improved by frequent scientific feedback
and interactions with FDA and the potential for such communication to
benefit public health by improving the efficiency of the product
development program; and
Draft agreement for proposed feedback and interactions
with FDA.
This information is used by the agency to determine which Fast
Track products are eligible for participation in Pilot 2. Participation
in this pilot program is voluntary.
Based on the number of Pilot 2 applications submitted to CDER and
CBER during fiscal year 2004 and 2005, we estimate that the number of
applications received annually for Pilot 2 is 7 for products regulated
by CDER and 1 for products regulated by CBER. FDA anticipates that
approximately 7 applicants (respondents) will submit these Pilot 2
applications annually to CDER and approximately 1 applicant
(respondent) will submit these Pilot 2 applications annually to CBER.
The hours per response, which is the estimated number of hours that a
respondent would spend preparing the information to be submitted in a
Pilot 2 application in accordance with the guidance, is estimated to be
approximately 80 hours. Based on FDA's experience, we expect it will
take respondents this amount of time to obtain and draft the
information to be submitted with a Pilot 2 application. Therefore, the
agency estimates that applicants use approximately 640 hours annually
to submit the Pilot 2 applications.
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of No. of Responses Hours per
Pilot 2 Application Respondents per Response Total Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
CDER 7 1 7 80 560
--------------------------------------------------------------------------------------------------------------------------------------------------------
CBER 1 1 1 80 80
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 640
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 41821]]
Dated: July 17, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-11643 Filed 7-21-06; 8:45 am]
BILLING CODE 4160-01-S
