[Federal Register Volume 73, Number 13 (Friday, January 18, 2008)]
[Rules and Regulations]
[Pages 3405-3409]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-895]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Part 488

[CMS-2278-IFC3]
RIN 0938-AP22


Revisit User Fee Program for Medicare Survey and Certification 
Activities

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Interim final rule with comment period.

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SUMMARY: This interim final rule with comment period implements the 
continuation of the revisit user fee program for Medicare Survey and 
Certification activities, in accordance with the statutory authority in 
the Continuing Appropriations Resolution entitled, ``Making further 
continuing appropriations for the fiscal year 2008, and for all other 
purposes,'' Public Law 110-137 (``Continuing Resolution'') passed by 
the Congress and signed by the President on December 14, 2007. On 
September 19, 2007, we published a final rule that established a system 
of revisit user fees applicable to health care facilities that have 
been cited for deficiencies during initial certification, 
recertification or substantiated complaint surveys and require a 
revisit to confirm that previously-identified deficiencies have been 
corrected.

DATES: Effective date: These regulations are effective January 18, 
2008, and applicable beginning December 14, 2007.
    Comment date: To be assured consideration, comments must be 
received at one of the addresses provided below, no later than 5 p.m. 
on March 18, 2008.

ADDRESSES: In commenting, please refer to file code CMS-2278-IFC3. 
Because of staff and resource limitations, we cannot accept comments by 
facsimile (FAX) transmission.
    You may submit comments in one of four ways (no duplicates, 
please):
    1. Electronically. You may submit electronic comments on specific 
issues in this regulation to http://www.cms.hhs.gov/eRulemaking. Click 
on the link ``Submit electronic comments on CMS regulations with an 
open comment period.'' (Attachments should be in Microsoft Word, 
WordPerfect, or Excel; however, we prefer Microsoft Word.)
    2. By regular mail. You may mail written comments (one original and 
two copies) to the following address ONLY: Centers for Medicare & 
Medicaid Services, Department of Health and Human Services, Attention: 
CMS-2278-IFC3, P.O. Box 8010, Baltimore, MD 21244-8016.
    Please allow sufficient time for mailed comments to be received 
before the close of the comment period.
    3. By express or overnight mail. You may send written comments (one 
original and two copies) to the following address only: Centers for 
Medicare & Medicaid Services, Department of Health and Human Services, 
Attention: CMS-2278-IFC3, Mail Stop C4-26-05, 7500 Security Boulevard, 
Baltimore, MD 21244-1850.
    4. By hand or courier. If you prefer, you may deliver (by hand or 
courier) your written comments (one original and two copies) before the 
close of the comment period to one of the following addresses. If you 
intend to deliver your comments to the Baltimore address, please call 
telephone number (410) 786-7195 in advance to schedule your arrival 
with one of our staff members. Room 445-G, Hubert H. Humphrey Building, 
200 Independence Avenue, SW., Washington, DC 20201; or 7500 Security 
Boulevard, Baltimore, MD 21244-1850. (Because access to the interior of 
the HHH Building is not readily available to persons without Federal 
Government identification, commenters are encouraged to leave their 
comments in the CMS drop slots located in the main lobby of the 
building. A stamp-in clock is available for persons wishing to retain a 
proof of filing by stamping in and retaining an extra copy of the 
comments being filed.)
    Comments mailed to the addresses indicated as appropriate for hand 
or courier delivery may be delayed and received after the comment 
period.
    For information on viewing public comments, see the beginning of 
the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: Kelley Tinsley, (410) 786-6664.

SUPPLEMENTARY INFORMATION: Submitting Comments: As the public was 
provided an opportunity to comment on the substance of the rule during 
the comment period prior to the publication of the September 19, 2007 
final rule, and as the substance of the rule is not changed by this 
interim final rule with comment period, we are accepting comments only 
to the extent that they pertain to the applicability of the new 
authority for the rule. You can assist us by referencing the file code 
CMS-2278-IFC3.
    Inspection of Public Comments: All comments received before the 
close of the comment period are available for viewing by the public, 
including any personally identifiable or confidential business 
information that is included in a comment. We post all comments 
received before the close of the comment period on the following Web 
site as soon as possible after they have been received: http://www.cms.hhs.gov/eRulemaking. Click on the link ``Electronic Comments on 
CMS

[[Page 3406]]

Regulations'' on that Web site to view public comments.
    Comments received timely will be available for public inspection as 
they are received, generally beginning approximately three weeks after 
publication of a document, at the headquarters of the Centers for 
Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, 
Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 
p.m. To schedule an appointment to view public comments, phone 1-800-
743-3951.

SUPPLEMENTARY INFORMATION: 

I. Background

    In the June 29, 2007 Federal Register (72 FR 35673), we published 
the proposed rule entitled, ``Establishment of Revisit User Fee Program 
for Medicare Survey and Certification Activities'' and provided for a 
60-day comment period. In the September 19, 2007 Federal Register (72 
FR 53628) we published the Revisit User Fee Program final rule. That 
final rule set forth final requirements and a final fee schedule for 
providers and suppliers who require a revisit survey as a result of 
deficiencies cited during an initial certification, recertification, or 
substantiated complaint survey.
    The Centers for Medicare & Medicaid Services (CMS) has in place an 
outcome-oriented survey process that is designed to ensure that 
existing Medicare-certified providers and suppliers or providers and 
suppliers seeking initial Medicare certification, meet statutory and 
regulatory requirements, conditions of participation, or conditions for 
coverage. These health and safety requirements apply to the 
environments of care and the delivery of services to residents or 
patients served by these facilities and agencies. The Secretary of the 
Department of Health and Human Services (HHS) has designated CMS to 
enforce the conditions of participation/coverage and other requirements 
of the Medicare program. The revisit user fee will be assessed for 
revisits conducted in order to determine whether deficiencies cited as 
a result of failing to satisfy federal quality of care requirements 
have been corrected.
    Pursuant to the requirements of the Continuing Appropriations 
Resolution budget bill for fiscal year (FY) 2007, the Secretary 
directed CMS to implement the revisit user fees for FY 2007 for certain 
providers and suppliers for which a revisit was required to confirm 
that previously-identified failures to meet federal quality of care 
requirements had been remedied. The fees recover the costs associated 
with the Medicare Survey and Certification program's revisit surveys. 
The primary purpose for implementing the revisit user fees is to ensure 
the continuance of CMS Survey and Certification quality assurance 
activities that improve patient care and safety. The fees became 
effective upon publication September 19, 2007, when the final rule was 
published.

II. Provisions of the Interim Final Rule

    The current Continuing Resolution, Public Law 110-137, amends 
Public Law 110-16 Division B by striking the date specified in section 
106(3) and inserting `December 21, 2007'. The current Continuing 
Resolution authorizes HHS to continue to impose revisit user fees until 
December 21, 2007, as follows:

    * * * Sec. 101. Such amounts as may be necessary, at a rate for 
operations as provided in the applicable appropriations Acts for 
fiscal year 2007 and under the authority and conditions provided in 
such Acts, for continuing projects or activities (including the 
costs of direct loans and loan guarantees) that are not otherwise 
specifically provided for in this joint resolution, that were 
conducted in fiscal year 2007, and for which appropriations, funds, 
or other authority were made available in the following 
appropriations Acts:
* * * * *
    (3) The Continuing Appropriations Resolution, 2007 (division B 
of Pub. L. 109-289, as amended by Pub. L. 110-5). (H.J. Res. 20, 
Sec.  101 (2007)).
    Sec. 106. Unless otherwise provided for in this joint resolution 
or in the applicable appropriations Act for fiscal year 2008, 
appropriations and funds made available and authority granted 
pursuant to this joint resolution shall be available until whichever 
of the following first occurs: * * *

    (3) December 21, 2007.
    As directed by the Secretary, in the September 19, 2007 Federal 
Register (72 FR 53628), we established the revisit user fee program for 
revisit surveys. We put forth in regulation the relevant definitions, 
criteria for determining the fees, the fee schedule, procedures for the 
collection of fees, the reconsideration process, enforcement and 
regulatory language addressing enrollment and billing privileges, and 
provider agreements. In the September 19, 2007 final rule, cost 
projections were based on FY 2006 actual data and were expected to 
amount to $37.3 million for FY 2007. These calculations were included 
in section IV of the final rule (72 FR 53642).
    We stated in the final rule that, ``if authority for the revisit 
user fee is continued, we will use the current fee schedule in [the 
final rule] for the assessment of such fees until such time as a new 
fee schedule notice is proposed and published in final form.'' (72 FR 
53628). The current Continuing Resolution continues the authority of 
the FY 2007 Continuing Resolution from December 14, 2007 through 
December 21, 2007. Accordingly, the revisit fees will continue to be 
assessed for the entire time period authorized by the current 
Continuing Resolution.

III. Response to Comments

    Because of the large number of public comments we normally receive 
on Federal Register documents, we are not always able to acknowledge or 
respond to all of them individually. We will consider all comments we 
receive by the date and time specified in the DATES section of this 
preamble, and, when we proceed with a subsequent document, we will 
respond to the comments in the preamble to that document.

IV. Waiver of Proposed Rulemaking and Delay in Effective Date

    We ordinarily publish a notice of proposed rulemaking in the 
Federal Register and invite public comment on the proposed rule in 
accordance with 5 U.S.C. 553(b) of the Administrative Procedure Act 
(APA). The notice of proposed rulemaking includes a reference to the 
legal authority under which the rule is proposed, and the terms and 
substance of the proposed rule or a description of the subjects and 
issues involved. This procedure can be waived, however, if an agency 
finds good cause that a notice-and-comment procedure is impracticable, 
unnecessary, or contrary to the public interest and incorporates a 
statement of the finding and its reasons in the rule issued. We find 
that the notice-and-comment procedure is unnecessary in this 
circumstance because providers and suppliers have already been provided 
notice and an opportunity to comment on the substance of this rule. 
This interim final rule with comment merely updates the Congressional 
authority under which the rule operates.
    Therefore, we find good cause to waive the notice of proposed 
rulemaking and to issue this final rule on an interim basis. We are 
providing a 60-day public comment period.
    We ordinarily provide a 30-day delay in the effective date of the 
provisions of a rule in accordance with the Administrative Procedure 
Act (APA), 5 U.S.C. 553(d). However, the delay in the effective date 
may be waived as, in pertinent part, ``provided by the agency for good 
cause found and published with the rule.'' 5 U.S.C. 553(d)(3). The 
Secretary finds that good cause exists to waive the 30-day effective 
date delay.

[[Page 3407]]

    The good cause exception to the 30-day effective date delay 
provision of section 553(d) of the APA is read to be broader than the 
good cause exception to the notice and comment provision of section 
553(b) of the APA.
    The legislative history of the APA indicates that the purpose for 
deferring the effectiveness of a rule under section 553(d) was to 
``afford persons affected a reasonable time to prepare for the 
effective date of a rule or rules or to take other action which the 
issuance may prompt.'' S. Rep. No. 752, 79th Cong., 1st Sess. 15 
(1946); H.R. Rep. No. 1980, 79th Cong. 2d Sess. 25 (1946). In this 
case, affected parties do not need time to adjust their behavior before 
this rule takes effect. This rule merely updates the authority under 
which the revisit fee is assessed and does not provide any additional 
requirements for the affected parties. Moreover, with or without a 
revisit fee, a provider or supplier must be found to have corrected 
significant deficiencies in order to avoid termination. Additionally, 
the application of a fee for the revisit does not place appreciable 
administrative burdens on the affected providers or suppliers. We do 
not expect appreciable cost to State survey agencies because we are 
undertaking the billing and collection of the revisit user fee.
    We identified in the September 19, 2007 final rule the immediacy of 
this revisit user fee program and the specific statutory requirement 
contained limited in the Continuing Resolution that required us to 
implement the revisit user fee program in FY 2007. Accordingly, 
providers and suppliers have been on notice for some time that these 
fees will be imposed, and do not need additional time to be prepared to 
comply with the requirements of this regulation. We believe that given 
the short timeframe that we have to collect fees before the statutory 
authority of the current Continuing Resolution expires, there is good 
cause to waive the 30-day effective date.

V. Collection of Information Requirements

    This document does not impose information collection and 
recordkeeping requirements. Consequently, it need not be reviewed by 
the Office of Management and Budget under the authority of the 
Paperwork Reduction Act of 1995.

VI. Regulatory Impact Analysis

A. Overall Impact

    We have examined the impacts of this rule as required by Executive 
Order 12866 (September 1993, Regulatory Planning and Review), the 
Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), 
section 1102(b) of the Social Security Act, the Unfunded Mandates 
Reform Act of 1995 (Pub. L. 104-4), and Executive Order 13132.
    Executive Order 12866 (as amended by Executive Order 13258, which 
merely reassigns responsibility of duties) directs agencies to assess 
all costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, distributive impacts, and equity). A 
regulatory impact analysis (RIA) must be prepared for major rules with 
economically significant effects ($100 million or more in any one 
year). This rule is not a major rule. The aggregate costs will total 
approximately $37.3 million in any one year.
    The RFA requires agencies to analyze options for regulatory relief 
of small businesses. For purposes of the RFA, small entities include 
small businesses, nonprofit organizations, and small governmental 
jurisdictions. Individuals and States are not included in the 
definition of a small entity. Small businesses are small entities, 
either by nonprofit status or by having revenues of $6.5 million to 
$31.9 million or less in any one year for purposes of the RFA. The 
September 19, 2007 final rule provided an analysis on the impact of 
small entities (72 FR 53642-3). The analysis published in the final 
rule remains valid. Since this interim final rule with comment merely 
updates the Congressional authority under which the rule operates, we 
have determined that this rule will not have a significant impact on 
small entities based on the overall effect on revenues.
    Section 1102(b) of the Act requires us to prepare a regulatory 
impact analysis if a rule may have a significant impact on the 
operations of a substantial number of small rural hospitals. This 
analysis must conform to the provisions of section 604 of the RFA. For 
purposes of section 1102(b) of the Act, we define a small rural 
hospital as a hospital that is located outside of a Metropolitan 
statistical Area (superseded by Core Based Statistical Areas) and has 
fewer than 100 beds. This rule affects those small rural hospitals that 
have been cited for a deficiency based on noncompliance with required 
conditions of participation and for which a revisit is needed to ensure 
that the deficiency has been corrected. We identified in the September 
19, 2007 final rule that for the effective period of that rule that 
less than 3 percent of all hospitals may be assessed a revisit user fee 
and that less than 1 percent of those hospitals would be rural 
hospitals (72 FR 53643). The analysis published in the final rule 
remains valid. Since this interim final rule with comment merely 
updates the Congressional authority under which the rule operates, we 
maintain that this rule will not have a significant impact on small 
rural hospitals.
    Section 202 of the Unfunded Mandates Reform Act of 1995 also 
requires that agencies assess anticipated costs and benefits before 
issuing any rule whose mandates require spending in any one year of 
$100 million in 1995 dollars, updated annually for inflation. That 
threshold level is currently approximately $120 million. This interim 
final rule with comment will have no mandated effect on State, local, 
or tribal governments and the impact on the private sector is estimated 
to be less than $120 million and will only effect those Medicare 
providers or suppliers for which a revisit user fee is assessed based 
on the need to conduct a revisit survey to ensure deficient practices 
that were cited have been corrected.
    Executive Order 13132 establishes certain requirements that an 
agency must meet when it promulgates a proposed rule (and subsequent 
final rule) that imposes substantial direct requirement costs on State 
and local governments, preempts State law, or otherwise has Federalism 
implications. This interim final rule with comment will not 
substantially affect State or local governments. This rule establishes 
user fees for providers and suppliers for which CMS has identified 
deficient practices and requires a revisit to assure that corrections 
have been made. Therefore, we have determined that this interim final 
rule with comment will not have a significant effect on the rights, 
roles, and responsibilities of State or local governments.

B. Impact on Providers/Suppliers

    There is no change on the impact on providers and suppliers with 
the publication of this interim final rule with comment. The impact 
remains as discussed in the final rule (72 FR 53643).
Final Fee Schedule for Onsite and Offsite Revisit Surveys
    The FY 2007 fee schedule published on September 19, 2007 (72 FR 
53647) in the final rule will be retained. As noted in the final rule, 
the published fee schedule will be used by CMS for the assessment of 
fees until a new fee schedule is proposed and published in final form. 
The calculations used to

[[Page 3408]]

determine the fee as identified in the final rule will be the same (72 
FR 53645-6). We will continue to assess a flat fee based on provider or 
supplier type and type of revisit survey conducted. Table A below 
identifies the final fee schedule.

                      Table A.--Final Fee Schedule
------------------------------------------------------------------------
                                                       Fee        Fee
                                                     assessed   assessed
                                                       per        per
                     Facility                        offsite     onsite
                                                     revisit    revisit
                                                      survey     survey
------------------------------------------------------------------------
SNF & NF..........................................       $168     $2,072
Hospitals.........................................        168      2,554
HHA...............................................        168      1,613
Hospice...........................................        168      1,736
ASC...............................................        168      1,669
RHC...............................................        168        851
ESRD..............................................        168      1,490
------------------------------------------------------------------------

Costs for All Revisit User Fees Assessed
    We anticipated that the combined costs for all providers and 
suppliers for all revisit surveys in FY 2007 would total approximately 
$37.3 million on an annual basis, with onsite revisit surveys amounting 
to approximately $34.6 million and offsite revisit surveys totaling 
approximately $2.7 million. (72 FR 53645). However, actual fees 
assessed in FY 2007 were much less than this amount, since CMS did not 
charge for revisits that occurred prior to publication of the final 
regulation. Since we continue to operate under this same estimate for 
FY 07, we provide below monthly estimates of the impact for the period 
of the current Continuing Resolution in Tables B and C. For the period 
of the current Continuing Resolution, we will use the FY 2007 fee 
schedule established in the final rule for the assessment of fees until 
a new fee schedule notice is proposed and published as final.
    In Table B below, we provide the projected costs for the period of 
this current Continuing Resolution based on the fee schedule of the 
final rule. We expect the combined costs for all providers and 
suppliers for all onsite revisit surveys for the period of this current 
Continuing Resolution to total approximately $665,000. We first 
multiplied the total number of onsite revisit surveys in one year by 
the expected revisit user fees assessed per revisits as finalized in 
Table A above, estimated by provider or supplier, to obtain the annual 
cost of revisit surveys. We then divided this number by 52 to obtain 
the weekly cost per provider or supplier of onsite revisit surveys to 
obtain the total costs for onsite revisit surveys for the period of the 
current Continuing Resolution (roughly 1 week). We then totaled all 
providers and suppliers to achieve the total costs for all onsite 
revisit surveys for the period of this current Continuing Resolution.

                            Table B.--Onsite Revisit Surveys--Estimated Weekly Costs
----------------------------------------------------------------------------------------------------------------
                                                          Fee assessed per
                                       Number of onsite    onsite revisit    Number of onsite  Monthly costs for
              Facility                 revisit surveys    surveys  (hrs x    revisit surveys     onsite revisit
                                          (FY 2006)            $112)        est. for 1 week *      surveys **
----------------------------------------------------------------------------------------------------------------
SNF & NF............................             14,288             $2,072                275           $569,321
Hospitals...........................                575              2,554                 11             28,241
HHA.................................              1,068              1,613                 21             33,128
Hospice.............................                256              1,736                  5              8,546
ASC.................................                 95              1,669                  2              3,049
RHC.................................                149                851                  3              2,438
ESRD................................                698              1,490                 13             20,000
                                     ---------------------------------------------------------------------------
    Total...........................             17,129  .................                330           664,723
----------------------------------------------------------------------------------------------------------------
* Estimated total numbers of onsite revisit surveys per week were rounded up after dividing yearly survey totals
  from FY 2006 actual data by 52.
** Weekly costs may differ from the multiple of weekly revisits and fee per revisit due to rounding.

    We expect the combined costs for all providers and suppliers for 
all offsite revisit surveys to total $52,905 for the period of the 
current Continuing Resolution. In Table C below, we first estimated by 
provider or supplier the number of offsite revisit surveys expected for 
an entire fiscal year, and multiplied this number by the expected 
revisit user fee of $168 per offsite revisit survey to obtain the 
annual cost of surveys. We then divided this number by 52 to obtain the 
weekly cost of offsite revisit surveys to obtain the total costs for 
offsite revisit surveys for the period of the current Continuing 
Resolution (roughly 1 week).

                            Table C.--Offsite Revisit Surveys--Estimated Weekly Costs
----------------------------------------------------------------------------------------------------------------
                                                         Fee assessed  per
                                      Number of offsite   offsite  revisit  Number of offsite   Weekly costs for
              Facility                  revisit surveys   survey  ($112 x     revisit surveys   offsite revisit
                                          (FY 2006)           1.5 hrs)      est. for 1 week *      surveys **
----------------------------------------------------------------------------------------------------------------
SNF & NF............................             15,138               $168                291            $48,907
Hospitals...........................                278                168                  5                898
HHA.................................                517                168                 10              1,670
Hospice.............................                 51                168                  1                168
ASC.................................                 93                168                  2                300
RHC.................................                 67                168                  1                216
ESRD................................                231                168                  4                746
                                     ---------------------------------------------------------------------------
    Total...........................             16,375  .................                314            52,905
----------------------------------------------------------------------------------------------------------------
* Estimated total numbers of offsite revisit surveys per week were rounded up after dividing yearly survey
  totals from FY 2006 actual data by 52.
** Weekly costs may differ from the multiple of weekly revisits and fee per revisit due to rounding.


[[Page 3409]]

    As shown in Table D below, we provide the aggregate costs expected 
as projected for the entire FY 2007, as well as the costs we would 
expect to offset for the period of the current Continuing Resolution.

 Table D.--Total Costs Combined for All Revisits Surveys per Fiscal Year
                             & Period of CR
------------------------------------------------------------------------
                                         FY 2007         Period of CR *
------------------------------------------------------------------------
Onsite Revisit Surveys............        $34,565,760           $664,723
Offsite Revisit Surveys...........          2,751,000             52,905
                                   -------------------------------------
    Total Costs All Revisits......         37,316,760           717,628
------------------------------------------------------------------------
* CR period's costs are based on CR period revisit surveys rounded up to
  the nearest whole number as shown in Table B & C.

E. Alternatives Considered

    We considered a number of alternatives to the revisit user fee 
program. Such alternatives were discussed in the final rule published 
on September 19, 2007 (72 FR 53647). We affirm the continuing validity 
of that analysis. The current Continuing Resolution provides CMS with 
the authority to continue projects or activities as was otherwise 
provided for in FY 2007, and as such CMS is required to publish an 
interim final rule with comment. This interim final rule with comment 
merely updates the Congressional authority under which the rule 
operates.
    In accordance with Executive Order 12866, this rule was not 
reviewed by the Office of Management and Budget.

List of Subjects in 42 CFR Part 488

    Administrative practice and procedure, Health facilities, Medicare, 
Reporting and recording requirements.

0
For the reasons set forth in the preamble, the Centers for Medicare & 
Medicaid Services amends 42 CFR chapter IV, part 488 as set forth 
below:

PART 488--SURVEY, CERTIFICATION, AND ENFORCEMENT PROCEDURES

0
1. The authority citation for part 488 is revised to read as follows:

    Authority: Secs. 1102 and 1871 of the Social Security Act, 
unless otherwise noted (42 U.S.C. 1302 and 1395(hh)); Continuing 
Resolution Pub. L. 110-137 H.J. Res. 69.


(Catalog of Federal Domestic Assistance Program No. 93.778, Medical 
Assistance Program)

(Catalog of Federal Domestic Assistance Program No. 93.773, 
Medicare--Hospital Insurance; and Program No. 93.774, Medicare--
Supplementary Medical Insurance Program)

    Dated: January 4, 2008.
Kerry Weems,
Acting Administrator, Centers for Medicare & Medicaid Services.
    Approved: January 15, 2008.
Michael O. Leavitt,
Secretary.
[FR Doc. E8-895 Filed 1-17-08; 8:45 am]
BILLING CODE 4120-01-P