[Federal Register: June 24, 2010 (Volume 75, Number 121)]
[Notices]
[Page 36092-36097]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24jn10-48]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0273]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Medical Devices: Current Good Manufacturing Practice
Quality System Regulations
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
[[Page 36093]]
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 recordkeeping requirements
related to the medical devices current good manufacturing practice
(CGMP) quality system (QS) regulation (CGMP/QS regulation).
DATES: Submit either electronic or written comments on the collection
of information by August 23, 2010.
ADDRESSES: Submit electronic comments on the collection of information
to http://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 20857, 301-796-5156 email:
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.
Medical Devices: Current Good Manufacturing Practice Quality System
Regulations--21 CFR Part 820 (OMB Control Number 0910-0073)--Extension
Under section 520(f) of the Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 360j(f)), the Secretary of the Department of
Health and Human Services has the authority to prescribe regulations
requiring that the methods used in, and the facilities and controls
used for, the manufacture, pre-production design validation (including
a process to assess the performance of a device but not including an
evaluation of the safety and effectiveness of a device), packing,
storage, and installation of a device conform to CGMP, as described in
such regulations, to assure that the device will be safe and effective
and otherwise in compliance with the act.
The CGMP/QS regulation implementing authority provided by this
statutory provision is found under part 820 (21 CFR part 820) and sets
forth basic CGMP requirements governing the design, manufacture,
packing, labeling, storage, installation, and servicing of all finished
medical devices intended for human use. The authority for this
regulation is covered under sections 501, 502, 510, 513, 514, 515, 518,
519, 520, 522, 701, 704, 801, and 803 of the act (21 U.S.C. 351, 352,
360, 360c, 360d, 360e, 360h, 360i, 360j, 360l, 371, 374, 381, and 383).
The CGMP/QS regulation includes requirements for purchasing and service
controls, clarifies recordkeeping requirements for device failure and
complaint investigations, clarifies requirements for verifying/
validating production processes and process or product changes, and
clarifies requirements for product acceptance activities quality data
evaluations and corrections of nonconforming product/quality problems.
Requirements are compatible with specifications in the
international standards ``ISO 9001: Quality Systems Model for Quality
Assurance in Design/Development, Production, Installation, and
Servicing.'' The CGMP/QS information collections will assist FDA
inspections of manufacturers for compliance with QS requirements
encompassing design, production, installation, and servicing processes.
Section 820.20(a) through (e) requires management with executive
responsibility to establish, maintain, and/or review the following
topics: (1) The quality policy, (2) the organizational structure, (3)
the quality plan, and (4) the quality system procedures of the
organization.
Section 820.22 requires the conduct and documentation of QS audits
and reaudits.
Section 820.25(b) requires the establishment of procedures to
identify training needs and documentation of such training.
Section 820.30(a)(1) and (b) through (j), requires in respective
order, the establishment, maintenance, and/or documentation of the
following topics: (1) Procedures to control design of class III and
class II devices and certain class I devices as listed therein; (2)
plans for design and development activities and updates; (3) procedures
identifying, documenting, and approving design input requirements; (4)
procedures defining design output, including acceptance criteria, and
documentation of approved records; (5) procedures for formal review of
design results and documentation of results in the design history file
(DHF); (6) procedures for verifying device design and documentation of
results and approvals in the DHF; (7) procedures for validating device
design, including documentation of results in the DHF; (8) procedures
for translating device design into production specifications; (9)
procedures for documenting, verifying, and validating approved design
changes before implementation of changes; and (10) the records and
references constituting the DHF for each type of device.
Section 820.40 requires manufacturers to establish and maintain
procedures controlling approval and distribution of required documents
and document changes.
Section 820.40(a) and (b) requires the establishment and
maintenance of procedures for the review, approval, issuance, and
documentation of required records (documents) and changes to those
records.
Section 820.50(a)(1), (a)(2), (a)(3), and (b) requires the
establishment and maintenance of procedures and requirements to ensure
service and product quality, records of acceptable suppliers, and
purchasing data
[[Page 36094]]
describing specified requirements for products and services.
Sections 820.60 and 820.65 require, respectively, the establishment
and maintenance of procedures for identifying all products from receipt
to distribution and for using control numbers to track surgical
implants and life-sustaining or supporting devices and their
components.
Section 820.70(a)(1) through (a)(5), (b) through (e), (g)(1)
through (g)(3), (h), and (i) requires the establishment, maintenance,
and/or documentation of the following topics: (1) Process control
procedures; (2) procedures for verifying or validating changes to
specification, method, process, or procedure; (3) procedures to control
environmental conditions and inspection result records; (4)
requirements for personnel hygiene; (5) procedures for preventing
contamination of equipment and products; (6) equipment adjustment,
cleaning, and maintenance schedules; (7) equipment inspection records;
(8) equipment tolerance postings, procedures for utilizing
manufacturing materials expected to have an adverse effect on product
quality; and (9) validation protocols and validation records for
computer software and software changes.
Sections 820.72(a), (b)(1), and (b)(2) and 820.75(a) through (c)
require, respectively, the establishment, maintenance, and/or
documentation of the following topics: (1) Equipment calibration and
inspection procedures; (2) national, international or in-house
calibration standards; (3) records that identify calibrated equipment
and next calibration dates; (4) validation procedures and validation
results for processes not verifiable by inspections and tests; (5)
procedures for keeping validated processes within specified limits; (6)
records for monitoring and controlling validated processes; and (7)
records of the results of revalidation where necessitated by process
changes or deviations.
Sections 820.80(a) through (e) and 820.86, respectively, require
the establishment, maintenance, and/or documentation of the following
topics: (1) Procedures for incoming acceptance by inspection, test, or
other verification; (2) procedures for ensuring that in-process
products meet specified requirements and the control of product until
inspection and tests are completed; (3) procedures for, and records
that show, incoming acceptance or rejection is conducted by
inspections, tests or other verifications; (4) procedures for, and
records that show, finished devices meet acceptance criteria and are
not distributed until device master record (DMR) activities are
completed; (5) records in the device history record (DHR) showing
acceptance dates, results, and equipment used; and (6) the acceptance/
rejection identification of products from receipt to installation and
servicing.
Sections 820.90(a), (b)(1), and (b)(2) and 820.100 require,
respectively, the establishment, maintenance and/or documentation of
the following topics: (1) Procedures for identifying, recording,
evaluating, and disposing of nonconforming product; (2) procedures for
reviewing and recording concessions made for, and disposition of,
nonconforming product; (3) procedures for reworking products,
evaluating possible adverse rework effect and recording results in the
DHR; (4) procedures and requirements for corrective and preventive
actions, including analysis, investigation, identification and review
of data, records, causes, and results; and (5) records for all
corrective and preventive action activities.
Section 820.100(a)(1) through (a)(7) states that procedures and
requirements shall be established and maintained for corrective/
preventive actions, including the following: (1) Analysis of data from
process, work, quality, servicing records; investigation of
nonconformance causes; (2) identification of corrections and their
effectiveness; (3) recording of changes made; and (4) appropriate
distribution and managerial review of corrective and preventive action
information.
Section 820.120 states that manufacturers shall establish/maintain
procedures to control labeling storage/application; and examination/
release for storage and use, and document those procedures.
Sections 820.120(b) and (d), 820.130, 820.140, 820.150(a) and (b),
820.160(a) and (b), and 820.170(a) and (b), respectively, require the
establishment, maintenance, and/or documentation of following topics:
(1) Procedures for controlling and recording the storage, examination,
release, and use of labeling; (2) the filing of labels/labeling used in
the DHR; (3) procedures for controlling product storage areas and
receipt/dispatch authorizations; (4) procedures controlling the release
of products for distribution; (5) distribution records that identify
consignee, product, date, and control numbers; and (6) instructions,
inspection and test procedures that are made available, and the
recording of results for devices requiring installation.
Sections 820.180(b) and (c), 820.181(a) through (e), 820.184(a)
through (f), and 820.186 require, respectively, the maintenance of
records that are: (1) Retained at prescribed site(s), made readily
available and accessible to FDA and retained for the device's life
expectancy or for 2 years; (2) contained or referenced in a DMR
consisting of device, process, quality assurance, packaging and
labeling, and installation, maintenance, and servicing specifications
and procedures; (3) contained in a DHR and demonstrate the manufacture
of each unit, lot, or batch of product in conformance with DMR and
regulatory requirements, include manufacturing and distribution dates,
quantities, acceptance documents, labels and labeling, control numbers;
and (4) contained in a quality system record (QSR), consisting of
references, documents, procedures, and activities not specific to
particular devices.
Sections 820.198(a) through (c) and 820.200(a) through (d),
respectively, require the establishment, maintenance, and/or
documentation of the following topics: (1) Complaint files and
procedures for receiving, reviewing and evaluating complaints; (2)
complaint investigation records identifying the device, complainant,
and relationship of the device to the incident; (3) complaint records
that are reasonably accessible to the manufacturing site or at
prescribed sites; (4) procedures for performing and verifying that
device servicing requirements are met and that service reports
involving complaints are processed as complaints; and (5) service
reports that record the device, service activity, and test and
inspection data.
Section 820.250 requires the establishment and maintenance of
procedures to identify valid statistical techniques necessary to verify
process and product acceptability; and sampling plans, when used, which
are written and based on valid statistical rationale; and procedures
for ensuring adequate sampling methods. The CGMP/QS regulation amends
and revises the CGMP requirements for medical devices set out under
part 820. The regulation adds design and purchasing controls; modifies
previous critical device requirements; revises previous validation and
other requirements; and harmonizes device CGMP requirements with QS
specifications in the international standard ``ISO 9001: Quality
Systems Model for Quality Assurance in Design/Development, Production,
Installation, and Servicing.'' The rule does not apply to manufacturers
of components or parts of finished devices, nor to manufacturers of
human blood and blood components subject to 21 CFR part 606. With
respect to devices classified in class I, design control requirements
apply only to class
[[Page 36095]]
I devices listed in Sec. 820.30(a)(2) of the regulation. The rule
imposes burden upon: (1) Finished device manufacturer firms, which are
subject to all recordkeeping requirements; (2) finished device contract
manufacturers, specification developers; and (3) repacker, relabelers,
and contract sterilizer firms, which are subject only to requirements
applicable to their activities. In addition, remanufacturers of
hospital single-use devices (SUDs) will now be considered to have the
same requirements as manufacturers in regard to this regulation. The
establishment, maintenance and/or documentation of procedures, records,
and data required by this regulation will assist FDA in determining
whether firms are in compliance with CGMP requirements, which are
intended to ensure that devices meet their design, production,
labeling, installation, and servicing specifications and, thus are
safe, effective and suitable for their intended purpose. In particular,
compliance with CGMP design control requirements should decrease the
number of design-related device failures that have resulted in deaths
and serious injuries.
The CGMP/QS regulation applies to approximately 8,924 respondents.
These recordkeepers consist of 8,945 original respondents and an
estimated 18 hospitals that remanufacture or reuse SUDs. They include
manufacturers, subject to all requirements and contract manufacturers,
specification developers, repackers, relabelers, and contract
sterilizers, subject only to requirements applicable to their
activities. Hospital remanufacturers of SUDs are now defined to be
manufacturers under guidelines issued by FDA's Center for Devices and
Radiological Health (CDRH), Office of Surveillance and Biometrics.
Respondents to this collection have no reporting activities, but must
make required records available for review or copying during FDA
inspection. The regulation contains additional recordkeeping
requirements in such areas as design control, purchasing, installation,
and information relating to the remanufacture of SUDs. The estimates
for this burden are derived from those incremental tasks that were
determined when the new CGMP/QS regulation became final as well as
those carryover requirements. The carryover requirements are based on
decisions made by the agency on July 16, 1992, under OMB Control Number
0910-0073, which still provides valid base line data.
FDA estimates the burden for this collection of information as
follows:
Table 1.--Estimated Annual Recordkeeping Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total Operating
21 CFR Section No. of Annual Frequency per Total Annual Hours Per and Maintenance Total Hours
Recordkeepers Recordkeeping Records Record Costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
820.20(a) 8,924 1 8,924 7 ................ 62,468
--------------------------------------------------------------------------------------------------------------------------------------------------------
820.20(b) 8,924 1 8,924 4 ................ 35,696
--------------------------------------------------------------------------------------------------------------------------------------------------------
820.20(c) 8,924 1 8,924 6 ................ 53,544
--------------------------------------------------------------------------------------------------------------------------------------------------------
820.20(d) 8,924 1 8,924 10 ................ 89,240
--------------------------------------------------------------------------------------------------------------------------------------------------------
820.20(e) 8,924 1 8,924 10 ................ 89,240
--------------------------------------------------------------------------------------------------------------------------------------------------------
820.22 8,924 1 8,924 33 ................ 294,492
--------------------------------------------------------------------------------------------------------------------------------------------------------
820.25(b) 8,924 1 8,924 13 ................ 116,012
--------------------------------------------------------------------------------------------------------------------------------------------------------
820.30(a)(1) 8,924 1 8,924 2 ................ 17,848
--------------------------------------------------------------------------------------------------------------------------------------------------------
820.30(b) 8,924 1 8,924 6 ................ 53,544
--------------------------------------------------------------------------------------------------------------------------------------------------------
820.30(c) 8,924 1 8,924 2 ................ 17,848
--------------------------------------------------------------------------------------------------------------------------------------------------------
820.30(d) 8,924 1 8,924 2 ................ 17,848
--------------------------------------------------------------------------------------------------------------------------------------------------------
820.30(e) 8,924 1 8,924 23 ................ 205,252
--------------------------------------------------------------------------------------------------------------------------------------------------------
820.30(f) 8,924 1 8,924 37 ................ 330,188
--------------------------------------------------------------------------------------------------------------------------------------------------------
820.30(g) 8,924 1 8,924 37 ................ 330,188
--------------------------------------------------------------------------------------------------------------------------------------------------------
820.30(h) 8,924 1 8,924 3 ................ 26,772
--------------------------------------------------------------------------------------------------------------------------------------------------------
820.30(i) 8,924 1 8,924 17 ................ 151,708
--------------------------------------------------------------------------------------------------------------------------------------------------------
820.30(j) 8,924 1 8,924 3 ................ 26,772
--------------------------------------------------------------------------------------------------------------------------------------------------------
820.40 8,924 1 8,924 9 ................ 80,316
--------------------------------------------------------------------------------------------------------------------------------------------------------
820.40(a) and (b) 8,924 1 8,924 2 ................ 17,848
--------------------------------------------------------------------------------------------------------------------------------------------------------
820.50(a)(1) through (a)(3) 8,924 1 8,924 22 1,300,805 196,328
--------------------------------------------------------------------------------------------------------------------------------------------------------
820.50(b) 8,924 1 8,924 6 ................ 53,544
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 36096]]
820.6 8,924 1 8,924 1 ................ 8,924
--------------------------------------------------------------------------------------------------------------------------------------------------------
820.65 8,924 1 8,924 1 ................ 8,924
--------------------------------------------------------------------------------------------------------------------------------------------------------
820.70(a)(1) through (a)(5) 8,924 1 8,924 2 ................ 17,848
--------------------------------------------------------------------------------------------------------------------------------------------------------
820.70(b) and (c) 8,924 1 8,924 2 ................ 17,848
--------------------------------------------------------------------------------------------------------------------------------------------------------
820.70(d) 8,924 1 8,924 3 ................ 26,772
--------------------------------------------------------------------------------------------------------------------------------------------------------
820.70(e) 8,924 1 8,924 2 ................ 17,848
--------------------------------------------------------------------------------------------------------------------------------------------------------
820.70(g)(1) through (g)(3) 8,924 1 8,924 1 ................ 8,924
--------------------------------------------------------------------------------------------------------------------------------------------------------
820.70(h) 8,924 1 8,924 2 ................ 17,848
--------------------------------------------------------------------------------------------------------------------------------------------------------
820.70(i) 8,924 1 8,924 8 ................ 71,392
--------------------------------------------------------------------------------------------------------------------------------------------------------
820.72(a) 8,924 1 8,924 5 ................ 44,620
--------------------------------------------------------------------------------------------------------------------------------------------------------
820.72(b)(1) and (b)(2) 8,924 1 8,924 1 ................ 8,924
--------------------------------------------------------------------------------------------------------------------------------------------------------
820.75(a) 8,924 1 8,924 3 ................ 26,772
--------------------------------------------------------------------------------------------------------------------------------------------------------
820.75(b) 8,924 1 8,924 1 ................ 8,924
--------------------------------------------------------------------------------------------------------------------------------------------------------
820.75(c) 8,924 1 8,924 1 ................ 8,924
--------------------------------------------------------------------------------------------------------------------------------------------------------
820.80(a) through (e) 8,924 1 8,924 5 ................ 44,620
--------------------------------------------------------------------------------------------------------------------------------------------------------
820.86 8,924 1 8,924 1 ................ 8,924
--------------------------------------------------------------------------------------------------------------------------------------------------------
820.90(a) 8,924 1 8,924 5 ................ 44,620
--------------------------------------------------------------------------------------------------------------------------------------------------------
820.90(b)(1) and (b)(2) 8,924 1 8,924 5 ................ 44,620
--------------------------------------------------------------------------------------------------------------------------------------------------------
820.100(a)(1) through (a)(7) 8,924 1 8,924 12 ................ 107,088
--------------------------------------------------------------------------------------------------------------------------------------------------------
820.100(b) 8,924 1 8,924 1 ................ 8,924
--------------------------------------------------------------------------------------------------------------------------------------------------------
820.120(b) 8,924 1 8,924 1 ................ 8,924
--------------------------------------------------------------------------------------------------------------------------------------------------------
820.120(d) 8,924 1 8,924 1 ................ 8,924
--------------------------------------------------------------------------------------------------------------------------------------------------------
820.130 8,924 1 8,924 1 ................ 8,924
--------------------------------------------------------------------------------------------------------------------------------------------------------
820.140 8,924 1 8,924 6 ................ 53,544
--------------------------------------------------------------------------------------------------------------------------------------------------------
820.150(a) and (b) 8,924 1 8,924 6 ................ 53,544
--------------------------------------------------------------------------------------------------------------------------------------------------------
820.160(a) and (b) 8,924 1 8,924 1 ................ 8,924
--------------------------------------------------------------------------------------------------------------------------------------------------------
820.170(a) and (b) 8,924 1 8,924 2 ................ 17,848
--------------------------------------------------------------------------------------------------------------------------------------------------------
820.180(b) and (c) 8,924 1 8,924 2 ................ 17,848
--------------------------------------------------------------------------------------------------------------------------------------------------------
820.181(a) through (e) 8,924 1 8,924 1 ................ 8,924
--------------------------------------------------------------------------------------------------------------------------------------------------------
820.184(a) through (f) 8,924 1 8,924 1 ................ 8,924
--------------------------------------------------------------------------------------------------------------------------------------------------------
820.186 8,924 1 8,924 1 ................ 8,924
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 36097]]
820.198(a) through (c) 8,924 1 8,924 5 ................ 44,620
--------------------------------------------------------------------------------------------------------------------------------------------------------
820.200(a) and (d) 8,924 1 8,924 3 ................ 26,772
--------------------------------------------------------------------------------------------------------------------------------------------------------
820.25 8,924 1 8,924 1 ................ 8,924
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total ................ .................... ................ ................ 1,300,805 3,105,552
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs associated with this collection of information.
Explanation of Recordkeeping Burden Estimate
FDA estimates respondents will have a total annual recordkeeping
burden of approximately 3,105,552 hours. This figure also consists of
approximately 143,052 hours spent on a startup basis by 734 new firms.
Burden (labor) hour and cost estimates were originally developed
under FDA contract by Eastern Research Group, Inc. (ERG) in 1996 when
the CGMP/QS regulation became final. Additional factors considered in
deriving estimates included the following:
Establishment type: Query has been made of CDRH's
registration/listing data bank and the current count was 7,748 domestic
firms subject to CGMPs. It was also calculated that each year, the
number of new domestic firms subject to CGMPs is 734. The average
amount of firms therefore subject to CGMPs over the 3 years is
therefore 8,924 and this figure has been used to calculate the total
burden. Because the total number of registered firms is not static, the
number of respondents will fluctuate from year to year resulting in
slight changes to the overall burden.
During the last report it was estimated that this number
was 8,963. When the last set of numbers was calculated, FDA was still
using a paper based system to register and list firms. On October 1,
2007, FDA switched to an electronic system for registration and
listing. Also at that time the Food and Drug Administration Amendments
Act of 2007 instituted an establishment registration fee for some types
of facilities. FDA believes that during the FY 2008 annual registration
cycle, establishments that had previously registered but were not
required to do so, removed themselves from inventory of active
establishments. FDA believes that the current figures reported by the
electronic system more accurately reflect the inventory of registered
establishments.
Potentially affected establishments: Except for
manufacturers, not every type of firm is subject to every CGMP/QS
requirement. For example, all are subject to Quality Policy (Sec.
820.20(a)), Document Control (Sec. 820.40), and other requirements,
whereas only manufacturers and specification developers are subject to
Subpart C, Design Controls. The type of firm subject to each
requirement was identified by the ERG.
FDA estimated the burden hours (and costs) for the
previous CGMP regulation in 1992. That estimate was submitted to OMB on
May 4, 1992, under OMB Paperwork Reduction Act Control Number 0910-
0073. It was approved by OMB on July 16, 1992, and expired on June 30,
1995. The methodology used is different than that used by ERG in
estimating incremental tasks when the new CGMP/QS became final rule.
Nevertheless, the agency believes its 1992 estimate adequately
represents labor hours (and costs) needed to comply with previous CGMP
requirements carried over into the new CGMP/QS regulation. The 1992
estimate used 9,289 respondents (rather than 8,924 respondents), which
compensates for differences in methodology.
Dated: June 18, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-15338 Filed 6-23-10; 8:45 am]
BILLING CODE 4160-01-S