83 FR 19785 - Medicare Program: Announcement of the Advisory Panel on Hospital Outpatient Payment (the Panel) Meeting on August 20-21, 2018
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 83, Issue 87 (May 4, 2018)
Centers for Medicare & Medicaid Services
Federal Register Volume 83, Issue 87 (May 4, 2018)
| Page Range | 19785-19787 | |
| FR Document | 2018-09532 |
[Federal Register Volume 83, Number 87 (Friday, May 4, 2018)] [Notices] [Pages 19785-19787] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-09532] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-1707-N] Medicare Program: Announcement of the Advisory Panel on Hospital Outpatient Payment (the Panel) Meeting on August 20-21, 2018 AGENCY: Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (DHHS). ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: This notice announces the annual meeting of the Advisory Panel on Hospital Outpatient Payment (the Panel) for 2018. The purpose of the Panel is to advise the Secretary of Department of Health and Human Services and the Administrator of the Centers for Medicare & Medicaid Services concerning the clinical integrity of the Ambulatory Payment Classification groups and their associated weights as well as hospital outpatient therapeutic services supervision issues. The advice provided by the Panel will be considered as we prepare the annual updates for the hospital outpatient prospective payment system. DATES: Meeting Dates: Monday, August 20, 2018, 9:30 a.m. to 5 p.m. EDT through Tuesday, August 21, 2018, 9:30 a.m. to 1 p.m. EDT. The times listed in this notice are Eastern Daylight Time (EDT) and are approximate times. Consequently, the meetings may last longer or be shorter than the times listed in this notice, but will not begin before the posted times: Meeting Information Updates: The actual meeting hours and days will be posted in the agenda. As information and updates regarding the onsite, webcast, and teleconference meeting and the agenda become available, they will be posted to our website at: http://cms.gov/Regulations-and-Guidance/Guidance/FACA/AdvisoryPanelonAmbulatoryPaymentClassificationGroups.html. Deadline for Presentations and Comments: Presentations or comments and form CMS-20017, (located at https://www.cms.gov/Medicare/CMS-Forms/CMS-Forms/downloads/cms20017.pdf) must be received by 5 p.m. EDT, Monday, July 23, 2018. Presentations and comments that are not received by the due date and time will be considered late and will not be included on the agenda. In commenting, refer to file code CMS-1707-N. Meeting Registration Timeframe: Monday, June 25, 2018, through Monday, July 30, 2018 at 5 p.m. EDT. Participants planning to attend this meeting in person must register online, during the specified timeframe at: https://www.cms.gov/apps/events/default.asp. On this web page, double click the ``Upcoming Events'' hyperlink, and then double click the ``HOP Panel'' event title link and enter the required information. Include any requests for special accommodations. Note: Participants who do not plan to attend the meeting in person should not register. No registration is required for participants who plan to participate in the meeting via webcast or teleconference. Because of staff and resource limitations, we cannot accept comments and presentations by facsimile (FAX) transmission. Deadline for Requesting Special Accommodations: Monday, July 30, 2018 at 5 p.m. EDT. ADDRESSES: Meeting Location, Webcast, and Teleconference. The meeting will be held in the Auditorium at the CMS Single Site campus, 7500 Security Boulevard, Baltimore, MD 21244. Alternately, the public may either view this meeting via a webcast or listen by teleconference. During the scheduled meeting, webcasting is accessible online at: http://cms.gov/live. Teleconference dial-in information will appear on the final meeting agenda, which will be posted on our website when available at: http://www.cms.gov/Regulations-and-Guidance/Guidance/FACA/AdvisoryPanelonAmbulatoryPaymentClassificationGroups.html. News Media. Press inquiries are handled through the CMS Press Office at (202) 690-6145. Advisory Committees' Information Lines. The phone number for the CMS Federal Advisory Committee Hotline is (410) 786-3985. Websites. For additional information on the Panel, including the Panel charter, and updates to the Panel's activities, we refer readers to view our website at: http://www.cms.gov/Regulations-and-Guidance/Guidance/FACA/AdvisoryPanelonAmbulatoryPaymentClassificationGroups.html. Information about the Panel and its membership in the Federal Advisory Committee Act database are also located at: http://facadatabase.gov/. Registration: The meeting is open to the public; but attendance is limited to the space available and registration is required. Priority will be given to those who pre-register and attendance may be limited based on the number of registrants and the space available. Persons wishing to attend this meeting, which is located on federal property, must register by following the instructions in the DATES section of this notice under ``Meeting Registration Timeframe''. A confirmation email will be sent to the registrants shortly after completing the registration process. FOR FURTHER INFORMATION CONTACT: Elise Barringer, Designated Federal Official (DFO), 410-786-9222, email at [email protected]. Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Mail Stop: C4-04-25, Baltimore, MD 21244-1850. SUPPLEMENTARY INFORMATION: I. Background The Secretary of the Department of Health and Human Services (DHHS) is required by section 1833(t)(9)(A) of the Social Security Act (the Act) and is allowed by section 222 of the Public Health Service Act (PHS Act) to consult with an expert outside panel, such as the Advisory Panel on Hospital Outpatient Payment (the Panel), regarding the clinical integrity of the Ambulatory Payment Classification (APC) groups and relative payment weights. The Panel is governed by the provisions of the Federal Advisory Committee Act (Pub. L. 92-463), as amended (5 U.S.C. Appendix 2), to set forth standards for the formation and use of advisory panels. We consider the technical advice provided by the Panel as we prepare the proposed and final rules to update the Hospital Outpatient Prospective Payment System (OPPS) for the following calendar year. II. Meeting Agenda The agenda for the August 20 through August 21, 2018 Panel meeting will provide for discussion and comment on the following topics as designated in the Panel's Charter:Addressing whether procedures within an APC group are similar both clinically and in terms of resource use. Evaluating APC group structure. Reviewing the packaging of OPPS services and costs, including the methodology and the impact on APC groups and payment. Removing procedures from the inpatient-only list for payment under the OPPS. Using single and multiple procedure claims data for Center for Medicare & Medicaid's (CMS') determination of APC group weights. [[Page 19786]] Addressing other technical issues concerning APC group structure. Recommending the appropriate supervision level (general, direct, or personal) for individual hospital outpatient therapeutic services. The Agenda will be posted on our website at: https://www.cms.gov/Regulations-and-Guidance/Guidance/FACA/AdvisoryPanelonAmbulatoryPaymentClassificationGroups.html approximately 1 week before the meeting. III. Presentations The subject matter of any presentation and comment matter must be within the scope of the Panel designated in the Charter. Any presentations or comments outside of the scope of this Panel will be returned or requested for amendment. Unrelated topics include, but are not limited to, the conversion factor, charge compression, revisions to the cost report, pass-through payments, correct coding, new technology applications (including supporting information/documentation), provider payment adjustments, supervision of hospital outpatient diagnostic services, and the types of practitioners that are permitted to supervise hospital outpatient services. The Panel may not recommend that services be designated as nonsurgical extended duration therapeutic services. The Panel may use data collected or developed by entities and organizations other than DHHS and CMS in conducting its review. We recommend organizations submit data for CMS staff and the Panel's review. All presentations are limited to 5 minutes, regardless of the number of individuals or organizations represented by a single presentation. Presenters may use their 5 minutes to represent either 1 or more agenda items. Section 508 Compliance For this meeting, we are aiming to have all presentations and comments available on our website. Materials on our website must be Section 508 compliant to ensure access to federal employees and members of the public with and without disabilities. We encourage presenters and commenters to reference the guidance on making documents Section 508 compliant as they draft their submissions, and, whenever possible, to submit their presentations and comments in a 508 compliant form. Such guidance is available at: http://www.cms.gov/Research-Statistics-Data-and-Systems/CMS-Information-Technology/Section508/508-Compliant-doc.html. We will review presentations and comments for 508 compliance and place compliant materials on our website. As resources permit, we will also convert non-compliant submissions to 508 compliant forms and offer assistance to submitters who wish to make their submissions 508 compliant. All non-508 compliant presentations and comments will be shared with the public onsite and through the webcast and made available to the public upon request. Those wishing to access such materials should contact the DFO (the DFO's address, email, and phone number are provided in the FOR FURTHER INFORMATION CONTACT section of this notice). In order to consider presentations and/or comments, we will need to receive the following: 1. An email copy of the presentation or comments sent to the DFO mailbox, [email protected] or, if unable to submit by email, a hard copy sent to the DFO at the address noted in the FOR FURTHER INFORMATION CONTACT section of this notice. 2. Form CMS-20017 with complete contact information that includes name, address, phone number, and email addresses for all presenters and commenters and a contact person that can answer any questions, and provide revisions that are requested, for the presentation. Presenters and commenters must clearly explain the actions that they are requesting CMS to take in the appropriate section of the form. A presenter's or commenter's relationship with the organization that they represent must also be clearly listed. The form is now available through the CMS Forms website at: https://www.cms.gov/Medicare/CMS-Forms/CMS-Forms/downloads/cms20017.pdf. We encourage presenters to make efforts to ensure that their presentations and comments are 508 compliant. IV. Oral Comments In addition to formal oral presentations (limited to 5 minutes total per presentation), there will be an opportunity during the meeting for public oral comments (limited to 1 minute for each individual) and a total of 3 minutes per organization. V. Panel Recommendations and Discussions The Panel's recommendations at any Panel meeting generally are not final until they have been reviewed and approved by the Panel on the last day of the meeting, before the final adjournment. These recommendations will be posted to our website after the meeting. VI. Security, Building, and Parking Guidelines The meeting is open to the public, but attendance is limited to the space available. Persons wishing to attend this meeting must register by contacting the DFO at the address listed in the ADDRESSES section of this notice or by telephone at the number listed in the FOR FURTHER INFORMATION CONTACT section of this notice by the date specified in the DATES section of this notice. This meeting will be held in a Federal government building; therefore, Federal security measures are applicable. We recommend that confirmed registrants arrive reasonably early, but no earlier than 45 minutes prior to the start of the meeting, to allow additional time to clear security. Security measures include the following: Presentation of government-issued photographic identification to the Federal Protective Service or Guard Service personnel. Inspection of vehicle's interior and exterior (this includes engine and trunk inspection) at the entrance to the grounds. Parking permits and instructions will be issued after the vehicle inspection. Inspection, via metal detector or other applicable means of all persons brought entering the building. We note that all items brought into CMS, whether personal or for the purpose of presentation or to support a presentation, are subject to inspection. We cannot assume responsibility for coordinating the receipt, transfer, transport, storage, set-up, safety, or timely arrival of any personal belongings or items used for presentation or to support a presentation. Note: Individuals who are not registered in advance will not be permitted to enter the building and will be unable to attend the meeting. The public may not enter the building earlier than 45 minutes prior to the convening of the meeting. All visitors must be escorted in areas other than the lower and first floor levels in the Central Building. VII. 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. 3501 et seq.). [[Page 19787]] Dated: April 23, 2018. Seema Verma, Administrator, Centers for Medicare & Medicaid Services. [FR Doc. 2018-09532 Filed 5-3-18; 8:45 am] BILLING CODE 4120-01-P
![Federal Register / Vol. 83, No. 87 / Friday, May 4, 2018 / Notices 19785
[FR Doc. 2018–09430 Filed 5–3–18; 8:45 a.m.] received by the due date and time will the space available and registration is
BILLING CODE 4120–01–C be considered late and will not be required. Priority will be given to those
included on the agenda. In commenting, who pre-register and attendance may be
refer to file code CMS–1707–N. limited based on the number of
DEPARTMENT OF HEALTH AND Meeting Registration Timeframe: registrants and the space available.
HUMAN SERVICES Monday, June 25, 2018, through Persons wishing to attend this
Monday, July 30, 2018 at 5 p.m. EDT. meeting, which is located on federal
Centers for Medicare & Medicaid Participants planning to attend this property, must register by following the
Services meeting in person must register online, instructions in the DATES section of this
[CMS–1707–N]
during the specified timeframe at: notice under ‘‘Meeting Registration
https://www.cms.gov/apps/events/ Timeframe’’. A confirmation email will
Medicare Program: Announcement of default.asp. On this web page, double be sent to the registrants shortly after
the Advisory Panel on Hospital click the ‘‘Upcoming Events’’ hyperlink, completing the registration process.
Outpatient Payment (the Panel) and then double click the ‘‘HOP Panel’’
FOR FURTHER INFORMATION CONTACT:
Meeting on August 20–21, 2018 event title link and enter the required
Elise Barringer, Designated Federal
information. Include any requests for
AGENCY: Centers for Medicare & Official (DFO), 410–786–9222, email at
special accommodations.
Medicaid Services (CMS), Department APCPanel@cms.hhs.gov. Centers for
Note: Participants who do not plan to Medicare & Medicaid Services, 7500
of Health and Human Services (DHHS). attend the meeting in person should not
ACTION: Notice.
Security Boulevard, Mail Stop: C4–04–
register. No registration is required for
participants who plan to participate in the
25, Baltimore, MD 21244–1850.
SUMMARY: This notice announces the meeting via webcast or teleconference. SUPPLEMENTARY INFORMATION:
annual meeting of the Advisory Panel
Because of staff and resource I. Background
on Hospital Outpatient Payment (the
limitations, we cannot accept comments
Panel) for 2018. The purpose of the The Secretary of the Department of
and presentations by facsimile (FAX)
Panel is to advise the Secretary of Health and Human Services (DHHS) is
transmission.
Department of Health and Human Deadline for Requesting Special required by section 1833(t)(9)(A) of the
Services and the Administrator of the Accommodations: Monday, July 30, Social Security Act (the Act) and is
Centers for Medicare & Medicaid 2018 at 5 p.m. EDT. allowed by section 222 of the Public
Services concerning the clinical Health Service Act (PHS Act) to consult
ADDRESSES:
integrity of the Ambulatory Payment Meeting Location, Webcast, and with an expert outside panel, such as
Classification groups and their Teleconference. the Advisory Panel on Hospital
associated weights as well as hospital The meeting will be held in the Outpatient Payment (the Panel),
outpatient therapeutic services Auditorium at the CMS Single Site regarding the clinical integrity of the
supervision issues. The advice provided campus, 7500 Security Boulevard, Ambulatory Payment Classification
by the Panel will be considered as we Baltimore, MD 21244. Alternately, the (APC) groups and relative payment
prepare the annual updates for the public may either view this meeting via weights. The Panel is governed by the
hospital outpatient prospective payment a webcast or listen by teleconference. provisions of the Federal Advisory
system. During the scheduled meeting, Committee Act (Pub. L. 92–463), as
DATES: webcasting is accessible online at: amended (5 U.S.C. Appendix 2), to set
Meeting Dates: Monday, August 20, http://cms.gov/live. Teleconference dial- forth standards for the formation and
2018, 9:30 a.m. to 5 p.m. EDT through in information will appear on the final use of advisory panels. We consider the
Tuesday, August 21, 2018, 9:30 a.m. to meeting agenda, which will be posted technical advice provided by the Panel
1 p.m. EDT. on our website when available at: http:// as we prepare the proposed and final
The times listed in this notice are www.cms.gov/Regulations-and- rules to update the Hospital Outpatient
Eastern Daylight Time (EDT) and are Guidance/Guidance/FACA/ Prospective Payment System (OPPS) for
approximate times. Consequently, the AdvisoryPanelonAmbulatoryPayment the following calendar year.
meetings may last longer or be shorter ClassificationGroups.html. II. Meeting Agenda
than the times listed in this notice, but News Media. Press inquiries are
will not begin before the posted times: handled through the CMS Press Office The agenda for the August 20 through
Meeting Information Updates: The at (202) 690–6145. August 21, 2018 Panel meeting will
actual meeting hours and days will be Advisory Committees’ Information provide for discussion and comment on
posted in the agenda. As information Lines. The phone number for the CMS the following topics as designated in the
and updates regarding the onsite, Federal Advisory Committee Hotline is Panel’s Charter:
webcast, and teleconference meeting (410) 786–3985. • Addressing whether procedures
and the agenda become available, they Websites. For additional information within an APC group are similar both
will be posted to our website at: http:// on the Panel, including the Panel clinically and in terms of resource use.
cms.gov/Regulations-and-Guidance/ charter, and updates to the Panel’s • Evaluating APC group structure.
Guidance/FACA/AdvisoryPanelon activities, we refer readers to view our • Reviewing the packaging of OPPS
AmbulatoryPaymentClassification website at: http://www.cms.gov/ services and costs, including the
Groups.html. Regulations-and-Guidance/Guidance/ methodology and the impact on APC
Deadline for Presentations and FACA/AdvisoryPanelonAmbulatory groups and payment.
amozie on DSK3GDR082PROD with NOTICES
Comments: Presentations or comments PaymentClassificationGroups.html. • Removing procedures from the
and form CMS–20017, (located at Information about the Panel and its inpatient-only list for payment under
https://www.cms.gov/Medicare/CMS- membership in the Federal Advisory the OPPS.
Forms/CMS-Forms/downloads/ Committee Act database are also located • Using single and multiple
cms20017.pdf) must be received by 5 at: http://facadatabase.gov/. procedure claims data for Center for
p.m. EDT, Monday, July 23, 2018. Registration: The meeting is open to Medicare & Medicaid’s (CMS’)
Presentations and comments that are not the public; but attendance is limited to determination of APC group weights.
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![Federal Register / Vol. 83, No. 87 / Friday, May 4, 2018 / Notices 19787
Dated: April 23, 2018. incorrect docket number. This SUMMARY: The Food and Drug
Seema Verma, document corrects that error. Administration (FDA or Agency) is
Administrator, Centers for Medicare & FOR FURTHER INFORMATION CONTACT: Lisa withdrawing approval of three
Medicaid Services. Granger, Office of Policy and Planning, abbreviated new drug applications
[FR Doc. 2018–09532 Filed 5–3–18; 8:45 am] Food and Drug Administration, 10903 (ANDAs) held by Sun Pharmaceutical
BILLING CODE 4120–01–P New Hampshire Ave., Bldg. 32, Rm. Industries, Ltd., c/o Sun Pharmaceutical
3330, Silver Spring, MD 20993–0002, Industries, Inc. (Sun Pharmaceutical).
301–796–9115. These drug products are no longer
DEPARTMENT OF HEALTH AND SUPPLEMENTARY INFORMATION: In the marketed, and Sun Pharmaceutical has
HUMAN SERVICES Federal Register of Tuesday, April 9, requested that the approval of the
2018 (83 FR 15152), in FR Doc. 2018– applications be withdrawn.
Food and Drug Administration 07147, on page 15152, the following DATES: Approval is withdrawn as of
[Docket Nos. FDA–2011–N–0075; FDA– correction is made: June 4, 2018.
2011–N–0015; FDA–2011–N–0076; FDA– 1. On page 15152, in the second
2017–N–0932; FDA–2016–N–4487; FDA– column, in the first line of the list of FOR FURTHER INFORMATION CONTACT:
2014–N–0345; FDA–2013–N–0523; FDA– docket numbers, ‘‘FDA–2014–N–0075’’ Trang Tran, Center for Drug Evaluation
2017–N–2428; FDA–2008–N–0312; and is corrected to read ‘‘FDA–2011–N– and Research, Food and Drug
FDA–2014–N–1072]
0075.’’ Administration, 10903 New Hampshire
Agency Information Collection Dated: April 30, 2018. Ave., Bldg. 75, Rm. 1671, Silver Spring,
Activities; Announcement of Office of Leslie Kux, MD 20993–0002, 240–402–7945,
Management and Budget Approvals; Associate Commissioner for Policy. Trang.Tran@fda.hhs.gov.
Correction [FR Doc. 2018–09437 Filed 5–3–18; 8:45 am] SUPPLEMENTARY INFORMATION: Sun
AGENCY: Food and Drug Administration, BILLING CODE 4164–01–P Pharmaceutical has informed FDA that
HHS. these drug products are no longer
ACTION: Notice; correction. marketed and requested that FDA
DEPARTMENT OF HEALTH AND withdraw approval of the applications.
SUMMARY: The Food and Drug HUMAN SERVICES Sun Pharmaceutical has also waived its
Administration is correcting a notice opportunity for a hearing and requested
entitled ‘‘Agency Information Collection Food and Drug Administration withdrawal of approval under a Consent
Activities; Announcement of Office of [Docket No. FDA–2018–N–1534] Decree of Permanent Injunction (Decree)
Management and Budget Approvals’’ entered in United States v. Ranbaxy
that appeared in the Federal Register of Sun Pharmaceutical Industries, Ltd.; Laboratories, Ltd. et al., JFM 12–250 (D.
April 9, 2018. The document announced Withdrawal of Approval of Three Md.) on January 26, 2012. The Decree
a list of information collections that Abbreviated New Drug Applications specifies that Sun Pharmaceutical must
have been approved by the Office of AGENCY: Food and Drug Administration, never submit another application to
Management and Budget (OMB) under HHS. FDA for these withdrawn drugs and
the Paperwork Reduction Act of 1995. must never transfer these ANDAs to a
ACTION: Notice.
The document was published with an third party.
Application No. Drug Applicant
ANDA 065174 ......... Clarithromycin Tablets USP, 250 milligrams (mg) and 500 Sun Pharmaceutical Industries, Ltd., c/o Sun Pharma-
mg. ceutical Industries, Inc., 2 Independence Way, Princeton,
NJ 08540.
ANDA 065382 ......... Clarithromycin for Oral Suspension USP, 125 mg/5 milli- Do.
liters (mL) and 250 mg/5 mL.
ANDA 075747 ......... Ciprofloxacin Tablets USP, Equivalent to (EQ) 250 mg Do.
base, EQ 500 mg base, and EQ 750 mg base.
Therefore, approval of the DEPARTMENT OF HEALTH AND holders of the applications notified the
applications listed in the above table, HUMAN SERVICES Agency in writing that the drug
and all amendments and supplements products were no longer marketed and
thereto, is hereby withdrawn as of June Food and Drug Administration requested that the approval of the
4, 2018. Introduction or delivery for [Docket No. FDA–2018–N–1564] applications be withdrawn.
introduction into interstate commerce of DATES: Approval is withdrawn as of
products without approved new drug Ferndale Laboratories, Inc., et al.; June 4, 2018.
applications violates section 301(a) and Withdrawal of Approval of Nine FOR FURTHER INFORMATION CONTACT:
(d) of the Federal Food, Drug, and Abbreviated New Drug Applications Trang Tran, Center for Drug Evaluation
Cosmetic Act (21 U.S.C. 331(a) and (d)). AGENCY: Food and Drug Administration, and Research, Food and Drug
HHS. Administration, 10903 New Hampshire
Dated: May 1, 2018.
amozie on DSK3GDR082PROD with NOTICES
Ave., Bldg. 75, Rm. 1671, Silver Spring,
Leslie Kux, ACTION: Notice.
MD 20993–0002, 240–402–7945,
Associate Commissioner for Policy. SUMMARY: The Food and Drug Trang.Tran@fda.hhs.gov.
[FR Doc. 2018–09533 Filed 5–3–18; 8:45 am] Administration (FDA or Agency) is SUPPLEMENTARY INFORMATION: The
BILLING CODE 4164–01–P withdrawing approval of nine holders of the applications listed in the
abbreviated new drug applications table have informed FDA that these drug
(ANDAs) from multiple applicants. The products are no longer marketed and
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Document Created: 2018-11-02 09:51:52
Document Modified: 2018-11-02 09:51:52
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Meeting Dates: Monday, August 20, 2018, 9:30 a.m. to 5 p.m. EDT through Tuesday, August 21, 2018, 9:30 a.m. to 1 p.m. EDT. | |
| Contact | Elise Barringer, Designated Federal Official (DFO), 410-786-9222, email at [email protected] Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Mail Stop: C4-04-25, Baltimore, MD 21244-1850. | |
| FR Citation | 83 FR 19785 |
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