Agency Information Collection Activities: Proposed Collection; Comment Request, 76288-76289 [05-24301]
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76288
Federal Register / Vol. 70, No. 246 / Friday, December 23, 2005 / Notices
the Consolidated Health Informatics
(CHI) initiative.
FOR FURTHER INFORMATION CONTACT:
Cheryl Ford, (410) 786–7415.
SUPPLEMENTARY INFORMATION:
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I. Background
The Consolidated Health Informatics
(CHI) initiative began in October 2001 as
one of 24 E-Government initiatives
included in the President’s Management
Agenda (PMA). The CHI initiative is a
collaborative effort to adopt Federal
government-wide health information
interoperability standards to be
implemented by Federal agencies in
order to enable the Federal government
to exchange electronic health
information.
On May 6, 2004, the Secretary of the
Department of Health and Human
Services (HHS) announced the adoption
by HHS, the Department of Defense, the
Department of Veterans Affairs, the
Office of Management and Budget, and
other participating Federal partners of
15 healthcare messaging and vocabulary
standards recommended by the CHI
initiative (https://www.hhs.gov/news/
press/2004pres/20040506.html). The
adoption of these standards
supplemented the first 5 standards
adopted on March 21, 2003 (https://
www.hhs.gov/news/press/2003pres/
20030321a.html), thereby completing
the initial CHI portfolio.
The portfolio of 20 adopted standards
will be used by all Federal agencies in
implementing new, and to the extent
possible, in modifying existing health
information technology systems, as well
as related business processes.
II. CHI Adopted Standards
As a result of work completed in
furtherance of CHI, the 20 clinical
standards that have been adopted for
use by all Federal agencies as they
develop and implement new
information technology systems are as
follows:
1. Laboratory Results Names.
Standard: Logical Observation
Identifiers Names and Codes (LOINC).
2. Messaging Standards. Includes:
Scheduling, medical record/image
management, patient administration,
observation reporting, financial
management, public health notification,
and patient care. Standard: Health Level
Seven (HL7) Version 2.3 and greater.
3. Messaging Standards. Includes:
Retail pharmacy transactions. Standard:
National Council for Prescription Drug
Programs (NCPDP) SCRIPT.
4. Messaging Standards. Includes:
Device-device connectivity. Standard:
Institute of Electrical and Electronics
Engineers, Inc. TM 1073.
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5. Messaging Standards. Includes:
Image information to workstations.
Standard: Digital Imaging and
Communications in Medicine
(DICOM).
6. Demographics. Standard: HL7
Version 2.4 and greater.
7. Lab Result Contents. Standard:
Systematized Nomenclature of Medicine
Clinical Terms (SNOMED CT).
8. Units of Measure. Standard: HL7
Version 2.X+.
9. Immunizations. Standard: HL7
Version 2.3.1, specifically the Vaccines
Administered (CVX) and Manufacturers
of Vaccines (MVX) external code sets
maintained by the Centers for Disease
Control and Prevention’s (CDC) National
Immunization Program (NIP).
10. Medications. Standards: Federal
Drug Terminologies: (Sub-domain:
Standard Adopted):
• Active Ingredient: FDA Established
Names & Unique Ingredient Identifier
(UNII) codes.
• Manufactured Dosage Form: FDA/
CDER Data Standards Manual.
• Drug Product: FDA’s National Drug
Codes (NDC).
• Medication Package: FDA
Standards Manual.
• Label Section Headers: LOINC
Clinical Structured Product Labeling
(SPL).
• Special Populations: HL7 Version
2.4 and greater.
• Drug Classifications: The
Department of Veterans Affairs’
National Drug File Reference
Terminology (NDF–RT) for mechanism
of action and physiologic effect.
• Clinical Drug: the National Library
of Medicine’s RxNorm.
11. Interventions/Procedures (Part A):
Lab Test Order Names. Standard:
LOINC.
12. Interventions/Procedures (Part B):
Non-laboratory. Standard: SNOMED
CT.
13. Anatomy. Standards: SNOMED
CT and the National Cancer Institute’s
(NCI) Thesaurus.
14. Diagnosis/Problem Lists.
Standard: SNOMED CT.
15. Nursing. Standard: SNOMED CT.
16. Financial/Payment. Standard:
HIPAA Transactions and Code Sets.
17. Genes. Standard: Human Genome
Nomenclature.
18. Clinical Encounters. Standard:
HL7 Version 2.4 and greater.
19. Text-Based Reports. Standards:
HL7 and Clinical Document
Architecture (CDA) Version 1.0–2000
Chemicals.
20. Chemicals. Standard:
Environmental Protection Agency’s
Substance Registry System.
Specific details of these CHI standards
can be obtained from the domain-
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specific full reports available for
download at: https://www.hhs.gov/
healthit/chi.html.
III. Collection of Information
Requirements
This notice does not impose
information collection and
recordkeeping requirements regulated
by the Paperwork Reduction Act of
1995; that is, it does not require
obtaining facts or opinions or answers to
questions by or for a Federal agency.
Consequently, it need not be reviewed
by the Office of Management and
Budget under 44 U.S.C. 35.
IV. Impact Statement
We have chosen to explain the impact
we foresee this notice having on the
public as follows: There are indirect
impacts for Federal contractors or
potential contractors who may be
involved in health information
technology design, development, or
evaluation. The Federal government
will require all future health
information technology system
acquisitions to be based on CHI
standards when applicable, whether
system development occurs within the
Agency or through the use of contractor
services.
Authority: The E-Government Act of 2002
(Pub. L. 107–347) (H.R. 2458)
Dated: September 13, 2005.
Mark B. McClellan,
Administrator, Centers for Medicare &
Medicaid Services.
Approved: August 25, 2005.
Michael O. Leavitt,
Secretary.
[FR Doc. 05–24289 Filed 12–22–05; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10170]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid Services, HHS.
In compliance with the requirement
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Centers for Medicare & Medicaid
Services (CMS) is publishing the
following summary of proposed
collections for public comment.
Interested persons are invited to send
comments regarding this burden
AGENCY:
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Federal Register / Vol. 70, No. 246 / Friday, December 23, 2005 / Notices
estimate or any other aspect of this
collection of information, including any
of the following subjects: (1) The
necessity and utility of the proposed
information collection for the proper
performance of the agency’s functions;
(2) the accuracy of the estimated
burden; (3) ways to enhance the quality,
utility, and clarity of the information to
be collected; and (4) the use of
automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
1. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Retiree Drug
Subsidy (RDS) Payment Request and
Instructions; Form Number: CMS–10170
(OMB#: 0938–0977); Use: Under section
1860D–22 of the Social Security Act
(Act), added by the Medicare
Prescription Drug, Improvement and
Modernization Act of 2003, plan
sponsors (employers, unions) who offer
prescription drug coverage to their
qualified covered retirees are eligible to
receive a 28 percent tax-free subsidy for
allowable drug costs. To receive the
subsidy, plan sponsors must submit
required prescription cost data. CMS
has contracted with an outside vendor
(ViPS) to assist in the administration of
the retiree drug subsidy (RDS) program;
this effort is called the RDS Center. Plan
sponsors will request subsidy payments
on-line by logging on to the RDS secure
Web site. Cost data required for each
payment request may be entered into
the RDS secure Web site, or uploaded to
the RDS Center mainframe. Once the
plan sponsor submits the payment
request, the RDS Center will process the
request to determine if payment is due
and the amount of the payment.
Frequency: Recordkeeping and
Reporting—Monthly, Quarterly and
Annually; Affected Public: Not-for-profit
institutions, Business or other for-profit,
Federal Government, State, Local, or
Tribal Government; Number of
Respondents: 6,000; Total Annual
Responses: 6,000; Total Annual Hours:
222,000.
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS’ Web site
address at https://www.cms.hhs.gov/
regulations/pra/, or E-mail your request,
including your address, phone number,
OMB number, and CMS document
identifier, to Paperwork@cms.hhs.gov,
or call the Reports Clearance Office on
(410) 786–1326.
To be assured consideration,
comments and recommendations for the
proposed information collections must
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be received at the address below, no
later than 5 p.m. on February 21, 2006.
CMS, Office of Strategic Operations and
Regulatory Affairs, Division of
Regulations Development—C, Attention:
Bonnie L Harkless, Room C4–26–05,
7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
Dated: December 13, 2005.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. 05–24301 Filed 12–22–05; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS R–193 and CMS–
2567]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Centers for Medicare &
Medicaid Services, HHS.
In compliance with the requirement
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Centers for Medicare & Medicaid
Services (CMS), Department of Health
and Human Services, is publishing the
following summary of proposed
collections for public comment.
Interested persons are invited to send
comments regarding this burden
estimate or any other aspect of this
collection of information, including any
of the following subjects: (1) The
necessity and utility of the proposed
information collection for the proper
performance of the Agency’s function;
(2) the accuracy of the estimated
burden; (3) ways to enhance the quality,
utility, and clarity of the information to
be collected; and (4) the use of
automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
1. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Important
Message from Medicare Title XVII
Section 1866(a)(1)(M), 42 CFR Sections
466.78, 489.20, and 489.27; Form
Number: CMS–R–193 (OMB#: 0938–
0692); Use: Hospitals participating in
the Medicare program are required to
distribute the ‘‘Important Message From
Medicare’’ to all Medicare beneficiaries
(including those enrolled in a Medicare
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76289
managed care health plan). Hospitals
must distribute this notice at or about
the same time of a Medicare
beneficiary’s admission or during the
course of his or her hospital stay.
Receiving this information will provide
all Medicare beneficiaries with some
ability to participate and/or initiate
discussions concerning actions that may
affect their Medicare coverage, payment,
and appeal rights in response to a
hospital’s or Medicare managed care
plan’s notification that their care will no
longer continue; Frequency:
Recordkeeping and Reporting—Other:
Distribution; Affected Public:
Individuals or Households, Business or
other for-profit, Not-for-profit
institutions, Federal, State, Local or
Tribal Government; Number of
Respondents: 6,051; Total Annual
Responses: 12,500,000; Total Annual
Hours: 208,333.
2. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Statement of
Deficiencies and Plan of Correction
contained under 42 CFR 488.18, 488.26,
and 488.28; Form Number: CMS–2567
(OMB#: 0938–0391); Use: Section
1864(a) of the Social Security Act
requires that the Secretary use State
survey agencies to conduct surveys. The
surveys are used to determine if health
care facilities meet Medicare, Medicaid,
and Clinical Laboratory Improvement
Amendments (CLIA) participation
requirements. The Statement of
Deficiencies and Plan of Correction
form, is used to record each deficiency
discovered during an inspection.
Providers, suppliers and CLIA
laboratories also utilize this form to
outline a corrective action plan for each
deficiency. The States and CMS regional
offices use this form to document and
certify compliance, and to disclose
information to the public; Frequency:
Recordkeeping, Third party disclosure
and Reporting—Annually and
Biennially; Affected Public: Business or
other for-profit, Not-for-profit
institutions, Federal, State, Local or
Tribal Government; Number of
Respondents: 60,000; Total Annual
Responses: 60,000; Total Annual Hours:
120,000.
To obtain copies of the supporting
statement and any related forms for
these paperwork collections referenced
above, access CMS Web site address at
https://www.cms.hhs.gov/regulations/
pra/, or e-mail your request, including
your address, phone number, OMB
number, and CMS document identifier,
to Paperwork@cms.hhs.gov, or call the
Reports Clearance Office on (410) 786–
1326.
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]]>Agencies
[Federal Register Volume 70, Number 246 (Friday, December 23, 2005)]
[Notices]
[Pages 76288-76289]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-24301]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-10170]
Agency Information Collection Activities: Proposed Collection;
Comment Request
AGENCY: Centers for Medicare & Medicaid Services, HHS.
In compliance with the requirement of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid
Services (CMS) is publishing the following summary of proposed
collections for public comment. Interested persons are invited to send
comments regarding this burden
[[Page 76289]]
estimate or any other aspect of this collection of information,
including any of the following subjects: (1) The necessity and utility
of the proposed information collection for the proper performance of
the agency's functions; (2) the accuracy of the estimated burden; (3)
ways to enhance the quality, utility, and clarity of the information to
be collected; and (4) the use of automated collection techniques or
other forms of information technology to minimize the information
collection burden.
1. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Retiree Drug
Subsidy (RDS) Payment Request and Instructions; Form Number: CMS-10170
(OMB: 0938-0977); Use: Under section 1860D-22 of the Social
Security Act (Act), added by the Medicare Prescription Drug,
Improvement and Modernization Act of 2003, plan sponsors (employers,
unions) who offer prescription drug coverage to their qualified covered
retirees are eligible to receive a 28 percent tax-free subsidy for
allowable drug costs. To receive the subsidy, plan sponsors must submit
required prescription cost data. CMS has contracted with an outside
vendor (ViPS) to assist in the administration of the retiree drug
subsidy (RDS) program; this effort is called the RDS Center. Plan
sponsors will request subsidy payments on-line by logging on to the RDS
secure Web site. Cost data required for each payment request may be
entered into the RDS secure Web site, or uploaded to the RDS Center
mainframe. Once the plan sponsor submits the payment request, the RDS
Center will process the request to determine if payment is due and the
amount of the payment. Frequency: Recordkeeping and Reporting--Monthly,
Quarterly and Annually; Affected Public: Not-for-profit institutions,
Business or other for-profit, Federal Government, State, Local, or
Tribal Government; Number of Respondents: 6,000; Total Annual
Responses: 6,000; Total Annual Hours: 222,000.
To obtain copies of the supporting statement and any related forms
for the proposed paperwork collections referenced above, access CMS'
Web site address at https://www.cms.hhs.gov/regulations/pra/, or E-mail
your request, including your address, phone number, OMB number, and CMS
document identifier, to Paperwork@cms.hhs.gov, or call the Reports
Clearance Office on (410) 786-1326.
To be assured consideration, comments and recommendations for the
proposed information collections must be received at the address below,
no later than 5 p.m. on February 21, 2006. CMS, Office of Strategic
Operations and Regulatory Affairs, Division of Regulations
Development--C, Attention: Bonnie L Harkless, Room C4-26-05, 7500
Security Boulevard, Baltimore, Maryland 21244-1850.
Dated: December 13, 2005.
Michelle Shortt,
Director, Regulations Development Group, Office of Strategic Operations
and Regulatory Affairs.
[FR Doc. 05-24301 Filed 12-22-05; 8:45 am]
BILLING CODE 4120-01-P
