Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Event Pilot Program for Medical Products, 39535-39537 [2010-16807]
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39535
Federal Register / Vol. 75, No. 131 / Friday, July 9, 2010 / Notices
Dated: July 2, 2010.
Carol Walker,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. 2010–16739 Filed 7–8–10; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection:
Comment Request
In compliance with the requirement
for opportunity for public comment on
proposed data collection projects
(section 3506(c)(2)(A) of Title 44, United
States Code, as amended by the
Paperwork Reduction Act of 1995, Pub.
L. 104–13), the Health Resources and
Services Administration (HRSA)
publishes periodic summaries of
proposed projects being developed for
submission to the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and draft instruments, call the
HRSA Reports Clearance Officer on
(301) 443–1129.
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology.
Proposed Project: Bureau of Primary
Health Care (BPHC) Uniform Data
System (OMB Clearance No. 0915–
0193—Revision)
The Uniform Data System (UDS)
contains the annual reporting
requirements for the cluster of primary
care grantees funded by the Health
Resources and Services Administration
(HRSA). The UDS includes reporting
requirements for grantees of the
following primary care programs:
Community Health Centers, Migrant
Health Centers, Health Care for the
Homeless, Public Housing Primary Care,
and other grantees under Section 330.
The authorizing statute is section 330 of
Number of
respondents
Type of report
the Public Health Service Act, as
amended.
HRSA collects data in the UDS which
are used to ensure compliance with
legislative mandates and to report to
Congress and policymakers on program
accomplishments. To meet these
objectives, BPHC requires a core set of
data collected annually that is
appropriate for monitoring and
evaluating performance and reporting
on annual trends. The UDS will be
revised in several ways. Certain data
elements are added for staffing and
utilization and for diagnoses, services,
and tests. Specifications for current
clinical measures are revised to align
with those of national standard setting
organizations. Revenue sources are
updated to include new federal revenue
sources. A limited number of clinical
measures will be added consistent with
identified national priorities.
These new measures are included in
the UDS data collection request in order
to allow advance time for health centers
to change data collection systems. These
changes reflect an increase in burden of
18,224 hours over the previous
information collection request in 2009.
The burden is increased due to a greater
number of respondents and reporting of
the new measures.
Estimates of annualized reporting
burden are as follows:
Responses
per respondent
Hours per
response
Total burden
hours
Universal report ...............................................................................................
Grant report .....................................................................................................
1,181
328
1
1
68
18
80,308
5,904
Total ..........................................................................................................
1,181
........................
........................
86,212
E-mail comments to
paperwork@hrsa.gov or mail the HRSA
Reports Clearance Officer, Room 10–33,
Parklawn Building, 5600 Fishers Lane,
Rockville, MD 20857. Written comments
should be received within 60 days of
this notice.
Dated: July 2, 2010.
Sahira Rafiullah,
Director, Division of Policy Information and
Coordination.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0316]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Adverse Event
Pilot Program for Medical Products
AGENCY:
wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
[FR Doc. 2010–16821 Filed 7–8–10; 8:45 am]
BILLING CODE 4165–15–P
ACTION:
Food and Drug Administration,
HHS.
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
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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 continuation of a pilot project to
evaluate the electronic collection of the
3500A Form for adverse events related
to the use of medical products to obtain
data from user facilities participating in
the Medical Product Safety Network
(MedSun). Additionally, the electronic
form will include hospital profile
information and several other questions
related to the use of medical products.
It will no longer contain the page called
Device-Safety Exchange (DS–X)
(formerly called M-Den), which was a
moderated site where MedSun members
shared information with each other.
This will be replaced by a page where
questions about possible emerging
E:\FR\FM\09JYN1.SGM
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39536
Federal Register / Vol. 75, No. 131 / Friday, July 9, 2010 / Notices
signals will be asked of the MedSun
sites.
DATES: Submit either electronic or
written comments on the collection of
information by September 7, 2010.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. 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:
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: 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.
Adverse Event Pilot Program for
Medical Products—21 U.S.C. 360(i)
(OMB Control Number 0910–0471)—
Extension
Under section 519 of the Federal
Food, Drug, and Cosmetic Act (the act)
(21 U.S.C. 360(i)), FDA is authorized to
require: Manufacturers to report medical
device related deaths, serious injuries,
and malfunctions; and user facilities to
report device-related deaths directly to
manufacturers and FDA, and to report
serious injuries to the manufacturer.
Section 213 of the FDA Modernization
Act of 1997 (FDAMA), amended section
519(b) of the act relating to mandatory
reporting by user facilities of deaths and
serious injuries and serious illnesses
associated with the use of medical
devices. This amendment legislated the
replacement of universal user facility
reporting by a system that is limited to
a ‘‘* * * subset of user facilities that
constitutes a representative profile of
user reports’’ for device related deaths
and serious injuries. This amendment is
reflected in section 519(b)(5)(A) of the
act. The current universal reporting
system remains in place during the pilot
stages of the new program, and until
FDA implements the new national
system by regulation. This legislation
provides FDA with the opportunity to
design and implement a national
surveillance network, composed of welltrained clinical facilities, to provide
high quality data on medical devices in
clinical use. This system is called
MedSun.
FDA is continuing to conduct a pilot
of the MedSun system before the agency
issues a regulation to change from
universal mandatory reporting for
medical device user facilities to
reporting by a representative sample of
facilities. This data collection has been
ongoing since February 20, 2002, and
this notice is for continuation of this
data collection.
FDA is seeking OMB clearance to
continue to use electronic data
collection to obtain the information on
the 3500A Form related to medical
devices and tissue products from the
user facilities participating in MedSun,
to obtain a demographic profile of the
facilities, and to pilot additional
questions which will permit FDA to
better understand the cause of reported
adverse events. During the pilot
program, participants will be asked to
complete an annual outcome measures
form, as a Customer/Partner Service
Survey (approved under OMB control
number 0910–0360) to aid FDA in
evaluating the effectiveness of the
program. Participation in this pilot is
voluntary and currently includes 400
facilities. The use of an interactive
electronic data collection system is
easier and more efficient for the
participating user facilities to use than
the alternative paper system.
In addition to collecting data on the
electronic adverse event report form,
MedSun also is proposing to collect
additional information from
participating sites about reported
problems emerging from the MedSun
Network hospitals. This data collection
is also voluntary, and will be collected
on the same Web site as the report
information. This will replace the
Device-Safety Exchange (DS–X). The
burden to respond to these questions
will take the same time as that used for
DS–X, 30 minutes.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
Activity
No. of Respondents
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total
Facilities participating in the
electronic reporting of adverse events programs
400
15
6,000
.75
4,500
Facilities responding to emerging signal questions (not
used by all sites)
300
10
3,000
.50
1,500
Total
1There
6,000
are no capital costs or operating and maintenance costs associated with this collection of information.
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Federal Register / Vol. 75, No. 131 / Friday, July 9, 2010 / Notices
The total burden hours for MedSun
and emerging signal questions equals
6,000 hours (4,500 for MedSun and
1,500 for emerging signals).
The burden estimate for the electronic
reporting of adverse events is based on
the number of facilities currently
participating in MedSun (400). FDA
estimates an average of 15 reports per
site annually. This estimate is based on
MedSun working to promote reporting
in general from the sites, as well as
promoting reporting from specific parts
of the hospitals, such as the pediatric
intensive care units, electrophysiology
laboratories, and the hospital
laboratories.
The burden estimate for the emerging
signal portion of MedSun is based on
the assumption that not all sites will use
this part of the software each time
questions are asked, because not all sites
will use the device in question.
Dated: July 1, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–16807 Filed 7–8–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0101]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Human Cells,
Tissues, and Cellular and TissueBased Products: Establishment
Registration and Listing; Form FDA
3356; Eligibility Determination for
Donors; and Current Good Tissue
Practice
AGENCY:
Food and Drug Administration,
HHS.
wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
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 August 9,
2010.
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 e-mailed to
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15:17 Jul 08, 2010
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oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0543. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Berbakos, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850, 301–
796–3792,
Elizabeth.Berbakos@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.
Human Cells, Tissues, and Cellular and
Tissue-Based Products: Establishment
Registration and Listing; Form FDA
3356; Eligibility Determination for
Donors; and Current Good Tissue
Practice—(OMB Control Number 0910–
0543)—Extension
Under section 361 of the Public
Health Service Act (the PHS Act) (42
U.S.C. 264), FDA may issue and enforce
regulations necessary to prevent the
introduction, transmission, or spread of
communicable diseases between the
States or possessions or from foreign
countries into the States. As derivatives
of the human body, all human cells,
tissues, and cellular and tissue-based
products (HCT/Ps) pose some risk of
carrying pathogens that could
potentially infect recipients or handlers.
FDA has issued regulations related to
HCT/Ps involving establishment
registration and listing using Form FDA
3356, eligibility determination for
donors, and current good tissue practice
(CGTP).
A. Establishment Registration and
Listing; Form FDA 3356
The regulations in part 1271 (21 CFR
part 1271) require domestic and foreign
establishments that recover, process,
store, label, package, or distribute an
HCT/P described in § 1271.10(a), or that
perform screening or testing of the cell
or tissue donor to register with FDA
(§ 1271.10(b)(1)) and submit a list of
each HCT/P manufactured
(§ 1271.10(b)). Section 1271.21(a)
requires an establishment to follow
certain procedures for initial registration
and listing of HCT/Ps, and § 1271.25(a)
and (b) identifies the required initial
registration and HCT/P listing
information.
Section 1271.21(b), in brief, requires
an annual update of the establishment
registration. Section 1271.21(c)(ii)
requires establishments to submit
PO 00000
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Fmt 4703
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39537
HCT/P listing updates when an HCT/P
is changed as described in § 1271.25(c).
Section 1271.25(c) identifies the
required HCT/P listing update
information. Section 1271.26 requires
establishments to submit an amendment
if ownership or location of the
establishment changes. FDA requires
the use of a registration and listing form
(Form FDA 3356: Establishment
Registration and Listing for Human
Cells, Tissues, and Cellular and TissueBased Products (HCT/Ps)) to submit the
required information (§§ 1271.10,
1271.21, 1271.25, and 1271.26). To
further facilitate the ease and speed of
submissions, electronic submission is
accepted (https://www.fda.gov/Biologics
BloodVaccines/GuidanceCompliance
RegulatoryInformation/Establishment
Registration/TissueEstablishment
Registration/default.htm).
B. Eligibility Determination for Donors
In brief, FDA requires certain HCT/P
establishments described in § 1271.1(b)
to determine donor eligibility based on
donor screening and testing for relevant
communicable diseases agents and
diseases, except as provided under
§ 1271.90. The documented
determination of a donor’s eligibility is
made by a responsible person defined in
§ 1271.3(t) and is based on the results of
required donor screening, which
includes a donor medical history
interview (defined in § 1271.3(n)) and
testing (§ 1271.50(a)). Certain records
must accompany an HCT/P once the
donor-eligibility determination has been
made (§ 1271.55(a)). This requirement
applies both to an HCT/P from a donor
who is determined to be eligible as well
as to an HCT/P from a donor who is
determined to be ineligible or where the
donor-eligibility determination is not
complete if there is a documented
urgent medical need (§ 1271.60). Once
the donor-eligibility determination has
been made, the HCT/P must be
accompanied by a summary of records
used to make the donor-eligibility
determination (§ 1271.55(b)) and a
statement whether, based on the results
of the screening and testing, the donor
is determined to be eligible or ineligible
(§ 1271.55(a)(2)).
Records used in determining the
eligibility of a donor, i.e., results and
interpretations of testing for relevant
communicable disease agents, the
donor-eligibility determination, the
name and address of the testing
laboratory or laboratories, and the name
of the responsible person (defined in
§ 1271.3(t)) who made the donoreligibility determination and the date of
the determination, must be maintained
(§ 1271.55(d)(1)). If any information on
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]]>Agencies
[Federal Register Volume 75, Number 131 (Friday, July 9, 2010)]
[Notices]
[Pages 39535-39537]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-16807]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0316]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Adverse Event Pilot Program for Medical Products
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 continuation of a pilot
project to evaluate the electronic collection of the 3500A Form for
adverse events related to the use of medical products to obtain data
from user facilities participating in the Medical Product Safety
Network (MedSun). Additionally, the electronic form will include
hospital profile information and several other questions related to the
use of medical products. It will no longer contain the page called
Device-Safety Exchange (DS-X) (formerly called M-Den), which was a
moderated site where MedSun members shared information with each other.
This will be replaced by a page where questions about possible emerging
[[Page 39536]]
signals will be asked of the MedSun sites.
DATES: Submit either electronic or written comments on the collection
of information by September 7, 2010.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. 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: 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: 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.
Adverse Event Pilot Program for Medical Products--21 U.S.C. 360(i) (OMB
Control Number 0910-0471)--Extension
Under section 519 of the Federal Food, Drug, and Cosmetic Act (the
act) (21 U.S.C. 360(i)), FDA is authorized to require: Manufacturers to
report medical device related deaths, serious injuries, and
malfunctions; and user facilities to report device-related deaths
directly to manufacturers and FDA, and to report serious injuries to
the manufacturer. Section 213 of the FDA Modernization Act of 1997
(FDAMA), amended section 519(b) of the act relating to mandatory
reporting by user facilities of deaths and serious injuries and serious
illnesses associated with the use of medical devices. This amendment
legislated the replacement of universal user facility reporting by a
system that is limited to a ``* * * subset of user facilities that
constitutes a representative profile of user reports'' for device
related deaths and serious injuries. This amendment is reflected in
section 519(b)(5)(A) of the act. The current universal reporting system
remains in place during the pilot stages of the new program, and until
FDA implements the new national system by regulation. This legislation
provides FDA with the opportunity to design and implement a national
surveillance network, composed of well-trained clinical facilities, to
provide high quality data on medical devices in clinical use. This
system is called MedSun.
FDA is continuing to conduct a pilot of the MedSun system before
the agency issues a regulation to change from universal mandatory
reporting for medical device user facilities to reporting by a
representative sample of facilities. This data collection has been
ongoing since February 20, 2002, and this notice is for continuation of
this data collection.
FDA is seeking OMB clearance to continue to use electronic data
collection to obtain the information on the 3500A Form related to
medical devices and tissue products from the user facilities
participating in MedSun, to obtain a demographic profile of the
facilities, and to pilot additional questions which will permit FDA to
better understand the cause of reported adverse events. During the
pilot program, participants will be asked to complete an annual outcome
measures form, as a Customer/Partner Service Survey (approved under OMB
control number 0910-0360) to aid FDA in evaluating the effectiveness of
the program. Participation in this pilot is voluntary and currently
includes 400 facilities. The use of an interactive electronic data
collection system is easier and more efficient for the participating
user facilities to use than the alternative paper system.
In addition to collecting data on the electronic adverse event
report form, MedSun also is proposing to collect additional information
from participating sites about reported problems emerging from the
MedSun Network hospitals. This data collection is also voluntary, and
will be collected on the same Web site as the report information. This
will replace the Device-Safety Exchange (DS-X). The burden to respond
to these questions will take the same time as that used for DS-X, 30
minutes.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual Frequency Total Annual Hours per
Activity No. of Respondents per Response Responses Response Total
--------------------------------------------------------------------------------------------------------------------------------------------------------
Facilities participating in the electronic 400 15 6,000 .75 4,500
reporting of adverse events programs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Facilities responding to emerging signal questions 300 10 3,000 .50 1,500
(not used by all sites)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total .................. .................... .................. .................. 6,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 39537]]
The total burden hours for MedSun and emerging signal questions
equals 6,000 hours (4,500 for MedSun and 1,500 for emerging signals).
The burden estimate for the electronic reporting of adverse events
is based on the number of facilities currently participating in MedSun
(400). FDA estimates an average of 15 reports per site annually. This
estimate is based on MedSun working to promote reporting in general
from the sites, as well as promoting reporting from specific parts of
the hospitals, such as the pediatric intensive care units,
electrophysiology laboratories, and the hospital laboratories.
The burden estimate for the emerging signal portion of MedSun is
based on the assumption that not all sites will use this part of the
software each time questions are asked, because not all sites will use
the device in question.
Dated: July 1, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-16807 Filed 7-8-10; 8:45 am]
BILLING CODE 4160-01-S
