83_FR_52659 83 FR 52458 - Medicare and Medicaid Program; Application from the Accreditation Association for Hospitals/Health Systems-Healthcare Facilities Accreditation Program (AAHHS-HFAP) for Approval of its Hospital Accreditation Program

83 FR 52458 - Medicare and Medicaid Program; Application from the Accreditation Association for Hospitals/Health Systems-Healthcare Facilities Accreditation Program (AAHHS-HFAP) for Approval of its Hospital Accreditation Program

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services

Federal Register Volume 83, Issue 201 (October 17, 2018)

Page Range52458-52459
FR Document2018-22546

This proposed notice acknowledges the receipt of an application from the Accreditation Association for Hospitals/Health Systems-Healthcare Facilities Accreditation Program (AAHHS-HFAP) for recognition as a national accrediting organization for hospitals that wish to participate in the Medicare or Medicaid programs.

Federal Register, Volume 83 Issue 201 (Wednesday, October 17, 2018)
[Federal Register Volume 83, Number 201 (Wednesday, October 17, 2018)]
[Notices]
[Pages 52458-52459]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-22546]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3370-PN]


Medicare and Medicaid Program; Application from the Accreditation 
Association for Hospitals/Health Systems-Healthcare Facilities 
Accreditation Program (AAHHS-HFAP) for Approval of its Hospital 
Accreditation Program

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

ACTION: Notice with request for comment.

-----------------------------------------------------------------------

SUMMARY: This proposed notice acknowledges the receipt of an 
application from the Accreditation Association for Hospitals/Health 
Systems-Healthcare Facilities Accreditation Program (AAHHS-HFAP) for 
recognition as a national accrediting organization for hospitals that 
wish to participate in the Medicare or Medicaid programs.

DATES: To be assured consideration, comments must be received at one of 
the addresses provided below, no later than 5 p.m. on November 16, 
2018.

ADDRESSES: In commenting, refer to file code CMS-3370-PN. Because of 
staff and resource limitations, we cannot accept comments by facsimile 
(FAX) transmission.
    Comments, including mass comment submissions, must be submitted in 
one of the following three ways (please choose only one of the ways 
listed):
    1. Electronically. You may submit electronic comments on this 
regulation to http://www.regulations.gov. Follow the ``Submit a 
comment'' instructions.
    2. By regular mail. You may mail written comments to the following 
address ONLY: Centers for Medicare & Medicaid Services, Department of 
Health and Human Services, Attention: CMS-3370-PN, P.O. Box 8016, 
Baltimore, MD 21244-8010.
    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 to 
the following address ONLY: Centers for Medicare & Medicaid Services, 
Department of Health and Human Services, Attention: CMS-3370-PN, Mail 
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
    For information on viewing public comments, see the beginning of 
the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: Monda Shaver, (410) 786-3410, Mary 
Ellen Palowitch, (410) 786-4496, or Renee Henry, (410) 786-7828.

SUPPLEMENTARY INFORMATION: 
    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 
website as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that website to 
view public comments.

I. Background

    Under the Medicare program, eligible beneficiaries may receive 
covered services from a hospital, provided that certain requirements 
are met. Section 1861(e) of the Social Security Act (the Act), 
establishes distinct criteria for facilities seeking designation as a 
hospital. Regulations concerning provider agreements are at 42 CFR part 
489 and those pertaining to activities relating to the survey and 
certification of facilities are at 42 CFR part 488. The regulations at 
42 CFR part 482 specify the minimum conditions that a hospital must 
meet to participate in the Medicare program.
    Generally, to enter into an agreement, a hospital must first be 
certified by a state survey agency as complying with the conditions or 
requirements set forth in part 482 of our regulations. Thereafter, the 
hospital is subject to regular surveys by a state survey agency to 
determine whether it continues to meet these requirements. There is an 
alternative; however, to surveys by state agencies.
    Section 1865(a)(1) of the Act provides that, if a provider entity 
demonstrates through accreditation by an approved national accrediting 
organization that all applicable Medicare conditions are met or 
exceeded, we may deem those provider entities as having met the 
requirements. Accreditation by an accrediting organization is voluntary 
and is not required for Medicare participation.
    If an accrediting organization is recognized by the Secretary of 
the Department of Health and Human Services (the Secretary) as having 
standards for accreditation that meet or exceed Medicare requirements, 
any provider entity accredited by the national accrediting body's 
approved program may be deemed to meet the Medicare conditions. A 
national accrediting organization applying for approval of its 
accreditation program under part 488, subpart A, must provide the 
Centers for Medicare and Medicaid Services (CMS) with reasonable 
assurance that the accrediting organization requires the accredited 
provider entities to meet requirements that are at least as stringent 
as the Medicare conditions. Our regulations concerning the approval of 
accrediting organizations are set forth at Sec.  488.5. The regulations 
at Sec.  488.5(e)(2)(i) require accrediting organizations to reapply 
for continued approval of its accreditation program every 6 years or 
sooner as determined by CMS.

II. Provisions of the Proposed Notice

A. Approval of Deeming Organizations

    Section 1865(a)(2) of the Act and our regulations at Sec.  488.5 
require that our

[[Page 52459]]

findings concerning review and approval of a national accrediting 
organization's requirements consider, among other factors, the applying 
accrediting organization's requirements for accreditation; survey 
procedures; resources for conducting required surveys; capacity to 
furnish information for use in enforcement activities; monitoring 
procedures for provider entities found not in compliance with the 
conditions or requirements; and ability to provide us with the 
necessary data for validation.
    Section 1865(a)(3)(A) of the Act further requires that we publish, 
within 60 days of receipt of an organization's complete application, a 
notice identifying the national accrediting body making the request, 
describing the nature of the request, and providing at least a 30-day 
public comment period. We have 210 days from the receipt of a complete 
application to publish notice of approval or denial of the application.
    The purpose of this proposed notice is to inform the public of 
AAHHS-HFAP's request for approval of its hospital accreditation 
program. This notice also solicits public comment on whether AAHHS-
HFAP's requirements meet or exceed the Medicare conditions of 
participation (CoPs) for hospitals.

B. Evaluation of Deeming Authority Request

    AAHHS-HFAP submitted all the necessary materials to enable us to 
make a determination concerning its request for continued approval of 
its hospital accreditation program. This application was determined to 
be complete on August 17, 2018. Under section 1865(a)(2) of the Act and 
our regulations at Sec.  488.5 (Application and re-application 
procedures for national accrediting organizations), our review and 
evaluation of AAHHS-HFAP will be conducted in accordance with, but not 
necessarily limited to, the following factors:
     The equivalency of AAHHS-HFAP's standards for hospitals as 
compared with CMS' hospital CoPs.
     AAHHS-HFAP's survey process to determine the following:
    ++ The composition of the survey team, surveyor qualifications, and 
the ability of the organization to provide continuing surveyor 
training.
    ++ The comparability of AAHHS-HFAP's processes to those of state 
agencies, including survey frequency, and the ability to investigate 
and respond appropriately to complaints against accredited facilities.
    ++ AAHHS-HFAP's processes and procedures for monitoring a hospital 
found out of compliance with the AAHHS-HFAP's program requirements. 
These monitoring procedures are used only when the AAHHS-HFAP 
identifies noncompliance. If noncompliance is identified through 
validation reviews or complaint surveys, the state survey agency 
monitors corrections as specified at Sec.  488.9(c).
    ++ AAHHS-HFAP's capacity to report deficiencies to the surveyed 
facilities and respond to the facility's plan of correction in a timely 
manner.
    ++ AAHHS-HFAP's capacity to provide CMS with electronic data and 
reports necessary for effective validation and assessment of the 
organization's survey process.
    ++ The adequacy of AAHHS-HFAP's staff and other resources, and its 
financial viability.
    ++ AAHHS-HFAP's capacity to adequately fund required surveys.
    ++ AAHHS-HFAP's policies with respect to whether surveys are 
announced or unannounced, to assure that surveys are unannounced.
    ++ AAHHS-HFAP's agreement to provide CMS with a copy of the most 
current accreditation survey together with any other information 
related to the survey as we may require (including corrective action 
plans).

C. Notice Upon Completion of Evaluation

    Upon completion of our evaluation, including evaluation of public 
comments received as a result of this notice, we will publish a final 
notice in the Federal Register announcing the result of our evaluation.

III. Collection of Information Requirements

    This document does not impose information collection requirements, 
that is, reporting, recordkeeping or third-party disclosure 
requirements. Consequently, there is no need for review by the Office 
of Management and Budget under the authority of the Paperwork Reduction 
Act of 1995 (44 U.S.C. Chapter 35).

IV. Response to Comments

    Because of the large number of public comments we normally receive 
on Federal Register documents, we are not able to acknowledge or 
respond to 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.

    Dated: October 10, 2018.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2018-22546 Filed 10-16-18; 8:45 am]
 BILLING CODE 4120-01-P



                                               52458                     Federal Register / Vol. 83, No. 201 / Wednesday, October 17, 2018 / Notices

                                               proposed rule (and subsequent final                     application from the Accreditation                    services from a hospital, provided that
                                               rule) that imposes substantial direct                   Association for Hospitals/Health                      certain requirements are met. Section
                                               requirement costs on state and local                    Systems-Healthcare Facilities                         1861(e) of the Social Security Act (the
                                               governments, preempts state law, or                     Accreditation Program (AAHHS–HFAP)                    Act), establishes distinct criteria for
                                               otherwise has Federalism implications.                  for recognition as a national accrediting             facilities seeking designation as a
                                               This notice will not have a substantial                 organization for hospitals that wish to               hospital. Regulations concerning
                                               direct effect on state or local                         participate in the Medicare or Medicaid               provider agreements are at 42 CFR part
                                               governments, preempt state law, or                      programs.                                             489 and those pertaining to activities
                                               otherwise have Federalism implications.                 DATES: To be assured consideration,                   relating to the survey and certification
                                                  Executive Order 13771, titled                        comments must be received at one of                   of facilities are at 42 CFR part 488. The
                                               ‘‘Reducing Regulation and Controlling                   the addresses provided below, no later                regulations at 42 CFR part 482 specify
                                               Regulatory Costs,’’ was issued on                       than 5 p.m. on November 16, 2018.                     the minimum conditions that a hospital
                                               January 30, 2017 (82 FR 9339, February                  ADDRESSES: In commenting, refer to file               must meet to participate in the Medicare
                                               3, 2017). It has been determined that                   code CMS–3370–PN. Because of staff                    program.
                                               this notice is a transfer notice that does              and resource limitations, we cannot                      Generally, to enter into an agreement,
                                               not impose more than de minimis costs                   accept comments by facsimile (FAX)                    a hospital must first be certified by a
                                               and thus is not a regulatory action for                 transmission.                                         state survey agency as complying with
                                               the purposes of E.O. 13771.                                Comments, including mass comment                   the conditions or requirements set forth
                                                  Consistent with the Congressional                    submissions, must be submitted in one                 in part 482 of our regulations.
                                               Review Act provisions of the Small                      of the following three ways (please                   Thereafter, the hospital is subject to
                                               Business Regulatory Enforcement                         choose only one of the ways listed):                  regular surveys by a state survey agency
                                               Fairness Act of 1996 (5 U.S.C. 801 et                      1. Electronically. You may submit                  to determine whether it continues to
                                               seq.), this notice has been transmitted to              electronic comments on this regulation                meet these requirements. There is an
                                               the Congress and the Comptroller                        to http://www.regulations.gov. Follow                 alternative; however, to surveys by state
                                               General for review.                                     the ‘‘Submit a comment’’ instructions.                agencies.
                                                  In accordance with the provisions of                    2. By regular mail. You may mail                      Section 1865(a)(1) of the Act provides
                                               Executive Order 12866, this notice was                  written comments to the following                     that, if a provider entity demonstrates
                                               reviewed by the Office of Management                    address ONLY: Centers for Medicare &                  through accreditation by an approved
                                               and Budget.                                             Medicaid Services, Department of                      national accrediting organization that all
                                                  Although this notice does not                        Health and Human Services, Attention:                 applicable Medicare conditions are met
                                               constitute a substantive rule, we                       CMS–3370–PN, P.O. Box 8016,                           or exceeded, we may deem those
                                               nevertheless prepared this Impact                       Baltimore, MD 21244–8010.                             provider entities as having met the
                                               Analysis in the interest of ensuring that                  Please allow sufficient time for mailed            requirements. Accreditation by an
                                               the impacts of this notice are fully                    comments to be received before the                    accrediting organization is voluntary
                                               understood.                                             close of the comment period.                          and is not required for Medicare
                                                 Dated: October 3, 2018.                                  3. By express or overnight mail. You               participation.
                                               Seema Verma,                                            may send written comments to the                         If an accrediting organization is
                                               Administrator, Centers for Medicare &                   following address ONLY: Centers for                   recognized by the Secretary of the
                                               Medicaid Services.                                      Medicare & Medicaid Services,                         Department of Health and Human
                                                 Dated: October 11, 2018.                              Department of Health and Human                        Services (the Secretary) as having
                                                                                                       Services, Attention: CMS–3370–PN,                     standards for accreditation that meet or
                                               Alex M. Azar II,
                                                                                                       Mail Stop C4–26–05, 7500 Security                     exceed Medicare requirements, any
                                               Secretary, Department of Health and Human
                                                                                                       Boulevard, Baltimore, MD 21244–1850.                  provider entity accredited by the
                                               Services.
                                                                                                          For information on viewing public                  national accrediting body’s approved
                                               [FR Doc. 2018–22529 Filed 10–12–18; 11:15 am]
                                                                                                       comments, see the beginning of the                    program may be deemed to meet the
                                               BILLING CODE 4120–01–P                                  SUPPLEMENTARY INFORMATION section.
                                                                                                                                                             Medicare conditions. A national
                                                                                                       FOR FURTHER INFORMATION CONTACT:                      accrediting organization applying for
                                               DEPARTMENT OF HEALTH AND                                Monda Shaver, (410) 786–3410, Mary                    approval of its accreditation program
                                               HUMAN SERVICES                                          Ellen Palowitch, (410) 786–4496, or                   under part 488, subpart A, must provide
                                                                                                       Renee Henry, (410) 786–7828.                          the Centers for Medicare and Medicaid
                                               Centers for Medicare & Medicaid                         SUPPLEMENTARY INFORMATION:                            Services (CMS) with reasonable
                                               Services                                                   Inspection of Public Comments: All                 assurance that the accrediting
                                                                                                       comments received before the close of                 organization requires the accredited
                                               [CMS–3370–PN]                                           the comment period are available for                  provider entities to meet requirements
                                               Medicare and Medicaid Program;                          viewing by the public, including any                  that are at least as stringent as the
                                                                                                       personally identifiable or confidential               Medicare conditions. Our regulations
                                               Application from the Accreditation
                                                                                                       business information that is included in              concerning the approval of accrediting
                                               Association for Hospitals/Health
                                                                                                       a comment. We post all comments                       organizations are set forth at § 488.5.
                                               Systems-Healthcare Facilities
                                                                                                       received before the close of the                      The regulations at § 488.5(e)(2)(i)
                                               Accreditation Program (AAHHS–HFAP)
                                                                                                       comment period on the following                       require accrediting organizations to
                                               for Approval of its Hospital
                                                                                                       website as soon as possible after they                reapply for continued approval of its
                                               Accreditation Program
                                                                                                       have been received: http://
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                                                                                                                                                             accreditation program every 6 years or
                                               AGENCY: Centers for Medicare &                          www.regulations.gov. Follow the search                sooner as determined by CMS.
                                               Medicaid Services (CMS), HHS.                           instructions on that website to view
                                               ACTION: Notice with request for                         public comments.                                      II. Provisions of the Proposed Notice
                                               comment.                                                I. Background                                         A. Approval of Deeming Organizations
                                               SUMMARY: This proposed notice                              Under the Medicare program, eligible                 Section 1865(a)(2) of the Act and our
                                               acknowledges the receipt of an                          beneficiaries may receive covered                     regulations at § 488.5 require that our


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                                                                         Federal Register / Vol. 83, No. 201 / Wednesday, October 17, 2018 / Notices                                                52459

                                               findings concerning review and                          AAHHS–HFAP’s program requirements.                      Dated: October 10, 2018.
                                               approval of a national accrediting                      These monitoring procedures are used                  Seema Verma,
                                               organization’s requirements consider,                   only when the AAHHS–HFAP identifies                   Administrator, Centers for Medicare &
                                               among other factors, the applying                       noncompliance. If noncompliance is                    Medicaid Services.
                                               accrediting organization’s requirements                 identified through validation reviews or              [FR Doc. 2018–22546 Filed 10–16–18; 8:45 am]
                                               for accreditation; survey procedures;                   complaint surveys, the state survey                   BILLING CODE 4120–01–P
                                               resources for conducting required                       agency monitors corrections as specified
                                               surveys; capacity to furnish information                at § 488.9(c).
                                               for use in enforcement activities;                         ++ AAHHS–HFAP’s capacity to                        DEPARTMENT OF HEALTH AND
                                               monitoring procedures for provider                      report deficiencies to the surveyed                   HUMAN SERVICES
                                               entities found not in compliance with                   facilities and respond to the facility’s
                                               the conditions or requirements; and                     plan of correction in a timely manner.                Centers for Medicare & Medicaid
                                               ability to provide us with the necessary                                                                      Services
                                               data for validation.                                       ++ AAHHS–HFAP’s capacity to
                                                                                                       provide CMS with electronic data and                  [CMS–8068–N]
                                                  Section 1865(a)(3)(A) of the Act
                                               further requires that we publish, within                reports necessary for effective validation            RIN 0938–AT33
                                               60 days of receipt of an organization’s                 and assessment of the organization’s
                                               complete application, a notice                          survey process.                                       Medicare Program; CY 2019 Inpatient
                                               identifying the national accrediting                       ++ The adequacy of AAHHS–HFAP’s                    Hospital Deductible and Hospital and
                                               body making the request, describing the                 staff and other resources, and its                    Extended Care Services Coinsurance
                                               nature of the request, and providing at                 financial viability.                                  Amounts
                                               least a 30-day public comment period.                      ++ AAHHS–HFAP’s capacity to                        AGENCY: Centers for Medicare &
                                               We have 210 days from the receipt of a                  adequately fund required surveys.                     Medicaid Services (CMS), HHS.
                                               complete application to publish notice                                                                        ACTION: Notice.
                                                                                                          ++ AAHHS–HFAP’s policies with
                                               of approval or denial of the application.
                                                  The purpose of this proposed notice                  respect to whether surveys are
                                                                                                                                                             SUMMARY:   This notice announces the
                                               is to inform the public of AAHHS–                       announced or unannounced, to assure
                                                                                                                                                             inpatient hospital deductible and the
                                               HFAP’s request for approval of its                      that surveys are unannounced.
                                                                                                                                                             hospital and extended care services
                                               hospital accreditation program. This                       ++ AAHHS–HFAP’s agreement to                       coinsurance amounts for services
                                               notice also solicits public comment on                  provide CMS with a copy of the most                   furnished in calendar year (CY) 2019
                                               whether AAHHS–HFAP’s requirements                       current accreditation survey together                 under Medicare’s Hospital Insurance
                                               meet or exceed the Medicare conditions                  with any other information related to                 Program (Medicare Part A). The
                                               of participation (CoPs) for hospitals.                  the survey as we may require (including               Medicare statute specifies the formulae
                                                                                                       corrective action plans).                             used to determine these amounts. For
                                               B. Evaluation of Deeming Authority
                                               Request                                                 C. Notice Upon Completion of                          CY 2019, the inpatient hospital
                                                                                                       Evaluation                                            deductible will be $1,364. The daily
                                                  AAHHS–HFAP submitted all the                                                                               coinsurance amounts for CY 2019 will
                                               necessary materials to enable us to make                  Upon completion of our evaluation,                  be: $341 for the 61st through 90th day
                                               a determination concerning its request                  including evaluation of public                        of hospitalization in a benefit period;
                                               for continued approval of its hospital                  comments received as a result of this                 $682 for lifetime reserve days; and
                                               accreditation program. This application                 notice, we will publish a final notice in             $170.50 for the 21st through 100th day
                                               was determined to be complete on                        the Federal Register announcing the                   of extended care services in a skilled
                                               August 17, 2018. Under section                          result of our evaluation.                             nursing facility in a benefit period.
                                               1865(a)(2) of the Act and our regulations                                                                     DATES: Effective Date: This notice is
                                               at § 488.5 (Application and re-                         III. Collection of Information
                                                                                                       Requirements                                          effective on January 1, 2019.
                                               application procedures for national
                                                                                                                                                             FOR FURTHER INFORMATION CONTACT:
                                               accrediting organizations), our review                    This document does not impose
                                               and evaluation of AAHHS–HFAP will                                                                             Yaminee Thaker, (410) 786–7921 for
                                                                                                       information collection requirements,                  general information. Gregory J. Savord,
                                               be conducted in accordance with, but                    that is, reporting, recordkeeping or
                                               not necessarily limited to, the following                                                                     (410) 786–1521 for case-mix analysis.
                                                                                                       third-party disclosure requirements.                  SUPPLEMENTARY INFORMATION:
                                               factors:                                                Consequently, there is no need for
                                                  • The equivalency of AAHHS–                                                                                I. Background
                                                                                                       review by the Office of Management and
                                               HFAP’s standards for hospitals as
                                                                                                       Budget under the authority of the                        Section 1813 of the Social Security
                                               compared with CMS’ hospital CoPs.
                                                  • AAHHS–HFAP’s survey process to                     Paperwork Reduction Act of 1995 (44                   Act (the Act) provides for an inpatient
                                               determine the following:                                U.S.C. Chapter 35).                                   hospital deductible to be subtracted
                                                  ++ The composition of the survey                     IV. Response to Comments                              from the amount payable by Medicare
                                               team, surveyor qualifications, and the                                                                        for inpatient hospital services furnished
                                               ability of the organization to provide                    Because of the large number of public               to a beneficiary. It also provides for
                                               continuing surveyor training.                           comments we normally receive on                       certain coinsurance amounts to be
                                                  ++ The comparability of AAHHS–                       Federal Register documents, we are not                subtracted from the amounts payable by
                                               HFAP’s processes to those of state                      able to acknowledge or respond to them                Medicare for inpatient hospital and
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                                               agencies, including survey frequency,                   individually. We will consider all                    extended care services. Section
                                               and the ability to investigate and                      comments we receive by the date and                   1813(b)(2) of the Act requires the
                                               respond appropriately to complaints                     time specified in the DATES section of                Secretary of the Department of Health
                                               against accredited facilities.                          this preamble, and, when we proceed                   and Human Services (the Secretary) to
                                                  ++ AAHHS–HFAP’s processes and                        with a subsequent document, we will                   determine and publish each year the
                                               procedures for monitoring a hospital                    respond to the comments in the                        amount of the inpatient hospital
                                               found out of compliance with the                        preamble to that document.                            deductible and the hospital and


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Document Created: 2018-10-17 01:48:21
Document Modified: 2018-10-17 01:48:21
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice with request for comment.
DatesTo be assured consideration, comments must be received at one of
ContactMonda Shaver, (410) 786-3410, Mary Ellen Palowitch, (410) 786-4496, or Renee Henry, (410) 786-7828.
FR Citation83 FR 52458 

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