Agency Information Collection Activities: Proposed Collection; Comment Request, 25175-25176 [E6-6385]
Download as PDF
<![CDATA[
Federal Register / Vol. 71, No. 82 / Friday, April 28, 2006 / Notices
Idaho, and thereby engage in
nonbanking financial and investment
advisory services, pursuant to sections
225.28(b)(6)(i) and (b)(7)(i) of Regulation
Y.
Board of Governors of the Federal Reserve
System, April 24, 2006.
Robert deV. Frierson,
Deputy Secretary of the Board.
[FR Doc. E6–6372 Filed 4–27–06; 8:45 am]
Dated: April 21, 2006.
Alvin Hall,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. E6–6417 Filed 4–27–06; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BILLING CODE 6210–01–S
Centers for Medicare & Medicaid
Services
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: CMS–216, CMS–
10191, and CMS–588]
Centers for Disease Control and
Prevention
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panels (SEP): Centers for
Autism and Developmental Disabilities
Research and Epidemiology, A Case
Cohort Study. Request for
Applications (RFA) Number DD06–003
In accordance with Section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the following meeting:
Name: Disease, Disability, and Injury
Prevention and Control Special Emphasis
Panel (SEP): Centers for Autism and
Developmental Disabilities Research and
Epidemiology (CADDRE), A Case Cohort
Study.
Time and Date: 8 a.m.–5 p.m., June 23,
2006 (Closed).
Place: Centers for Disease Control and
Prevention, 1600 Clifton Road, NE., Building
19, Room 248, Atlanta, GA 30333.
Status: The meeting will be closed to the
public in accordance with provisions set
forth in Section 552b(c) (4) and (6), Title 5
U.S.C., and the Determination of the Director,
Management Analysis and Services Office,
CDC, pursuant to Public Law 92–463.
Matters to be Discussed: To conduct expert
review of scientific and merit of research
applications: Centers for Autism and
Developmental Disabilities Research and
Epidemiology, A Case Cohort Study, RFA–
DD06–003.
jlentini on PROD1PC65 with NOTICES
FOR FURTHER INFORMATION CONTACT:
Juliana Cyril, Ph.D., Scientific Review
Administrator, CDC, 1600 Clifton Road,
NE., Mail Stop D–72, Atlanta, GA,
30333, Telephone 404.639.4897, e-mail
address: zdq4@cdc.gov.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both CDC
and the Agency for Toxic Substances
and Disease Registry.
VerDate Aug<31>2005
17:14 Apr 27, 2006
Jkt 208001
Centers for Medicare &
Medicaid Services.
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
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: Organ
Procurement Organization/
Histocompatibility Laboratory
Statement of Reimbursable Cost, Manual
Instructions and Supporting Regulations
Contained in 42 CFR 413.20 and 413.24;
Use: CMS is requesting reapproval of
Form CMS–216–94 (OMB No. 0938–
0102). The current form implements
various provisions of the Social Security
Act, including section 1881(a) which
provides Medicare coverage for endstage renal disease patients who meet
certain entitlement requirements and
kidney donors. It also implements
sections 1881(b)(2)(B) and 1861(v)(1)(A)
of the Act to determine the reasonable
costs incurred to furnish treatment for
renal patients and transplant patients.
The reasonable costs of securing and
AGENCY:
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
25175
transporting organs cannot be
determined for the fiscal year until the
Organ Procurement Organization/
Histocompatibility Laboratory files its
cost report (Form CMS–216) at year-end
and costs are verified by the Medicare
fiscal intermediary.; Form Number:
CMS–216 (OMB#: 0938–0102);
Frequency: Recordkeeping—Daily,
Reporting—Annually; Affected Public:
Business or other for-profit, Not-forprofit institutions, and the Federal
government; Number of Respondents:
108; Total Annual Responses: 108; Total
Annual Hours: 4,860.
2. Type of Information Collection
Request: New Collection; Title of
Information Collection: Medicare Part D
Audit Guide, Version 1.0 and
Supporting Regulation contained in 42
CFR Section 423.505; Use: 42 CFR
section 423.505 provides CMS the
regulatory authority to audit, evaluate,
or inspect any Part D sponsors’
performance related to the law in the
areas of medication therapy
management, drug utilization
management, formulary, and grievances
and appeals. The information collected
will be an integral resource for
oversight, monitoring, compliance, and
auditing activities necessary to ensure
quality provision of the Medicare
Prescription Drug Benefit to
beneficiaries.; Form Number: CMS–
10191 (OMB#: 0938-New); Frequency:
Recordkeeping and Reporting—
Annually; Affected Public: Business or
other for-profit; Number of
Respondents: 564; Total Annual
Responses: 564; Total Annual Hours:
54,144.
3. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Electronic
Funds Transfer Authorization
Agreement; Use: Section 1815(a) of the
Social Security Act provides the
authority for the Secretary of Health and
Human Services to pay providers/
suppliers of Medicare services at such
time or times as the Secretary
determines appropriate (but no less
frequently than monthly). Under
Medicare, CMS, acting for the Secretary,
contracts with fiscal intermediaries and
carriers to pay claims submitted by
providers/suppliers who furnish
services to Medicare beneficiaries.
Under CMS’ payment policy, Medicare
providers/suppliers have the option of
receiving payments electronically. Form
number CMS–588 authorizes the use of
electronic fund transfers (EFTs).; Form
Number: CMS–588 (OMB#: 0938–0626);
Frequency: Recordkeeping and
Reporting—On occasion; Affected
Public: Business or other for-profit, Not-
E:\FR\FM\28APN1.SGM
28APN1
25176
Federal Register / Vol. 71, No. 82 / Friday, April 28, 2006 / Notices
for-profit institutions, and State, Local
or Tribal governments; Number of
Respondents: 100,000; Total Annual
Responses: 100,000; Total Annual
Hours: 100,000.
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/
PaperworkReductionActof1995, or email 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 June 27, 2006.
CMS, Office of Strategic Operations
and Regulatory Affairs, Division of
Regulations Development—B, Attention:
William N. Parham, III, Room C4–26–
05, 7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
Dated: April 24, 2006.
Michelle Shortt,
Acting Director, Regulations Development
Group, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. E6–6385 Filed 4–27–06; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–3171–N; and 0938–ZA91]
Medicare Program; Calendar Year 2006
Review of the Appropriateness of
Payment Amounts for New Technology
Intraocular Lenses (NTIOLs) Furnished
by Ambulatory Surgical Centers
(ASCs) and Correction
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice.
jlentini on PROD1PC65 with NOTICES
AGENCY:
SUMMARY: This notice solicits interested
parties to submit requests for review of
the appropriateness of the payment
amount for a particular intraocular lens
furnished by an ambulatory surgical
center. Also, this notice corrects
typographical errors in the notice with
public comment period that appeared in
the September 30, 2005 Federal Register
entitled ‘‘Medicare Program; Calendar
Year 2005 Review of the
Appropriateness of Payment Amounts
for New Technology Intraocular Lenses
(NTIOLs) Furnished by Ambulatory
VerDate Aug<31>2005
17:14 Apr 27, 2006
Jkt 208001
Surgical Centers (ASCs)’’ (70 FR 57297),
and in the final notice that appeared in
the January 27, 2006 Federal Register
entitled ‘‘Medicare Program; Approval
of Adjustment in Payment Amounts for
New Technology Intraocular Lenses
Furnished by Ambulatory Surgical
Centers’’ (71 FR 4586).
DATES: Requests for review must be
received at the address provided no
later than 5 p.m. on May 30, 2006.
ADDRESSES: Mail requests for review
(one original and three copies) to the
Centers for Medicare & Medicaid
Services, Department of Health and
Human Services, Attention: Michael
Lyman, Mailstop C1–09–06, 7500
Security Blvd., Baltimore, Maryland
21244–1850.
FOR FURTHER INFORMATION CONTACT:
Michael Lyman, (410) 786–6938.
SUPPLEMENTARY INFORMATION:
I. Background
A. Statutory Requirements
On October 31, 1994, the Social
Security Act Amendments of 1994
(SSAA 1994) (Pub. L. 103–432) were
enacted. Section 141(b)(1) of SSAA 1994
required the Secretary of the
Department of Health and Human
Services to develop and implement a
process under which interested parties
may request a review of the
appropriateness of the payment amount
for intraocular lenses (IOLs) furnished
by ambulatory surgical centers (ASCs)
under section 1833(i)(2)(A)(iii) of the
Social Security Act (the Act) on the
basis that those lenses constitute a class
of new technology intraocular lenses
(NTIOLs).
On June 16, 1999, the Centers for
Medicare & Medicaid Services (CMS)
(then known as the Health Care
Financing Administration), published a
final rule in the Federal Register
entitled ‘‘Adjustment in Payment
Amounts for New Technology
Intraocular Lenses Furnished by
Ambulatory Surgical Centers’’ (64 FR
32198) which added subpart F to 42
CFR part 416. The June 16, 1999 final
rule established a process for adjusting
payment amounts for NTIOLs furnished
by ambulatory surgical centers (ASCs);
defined the terms relevant to the
process; and established an initial flat
rate payment adjustment of $50 for IOLs
that we determine are NTIOLs. The
payment adjustment applies for a 5-year
period that begins when we recognize a
payment adjustment for the first IOL in
a new class of technology, as explained
below. Any subsequent IOL request that
we review and approve with the same
characteristics as the first IOL
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
recognized for a payment adjustment
will receive the adjustment for the
remainder of the 5-year period
established by the first recognized
NTIOL. After July 16, 2002, we have the
option of changing the $50 adjustment
amount through proposed and final
rulemaking. We have opted not to
change the adjustment amount for
calendar year 2006 (CY 06).
B. CMS Review Process for Establishing
Classes of New Technology Intraocular
Lenses (NTIOLs)
We will classify an IOL as a NTIOL if
the lens meets the definition of a ‘‘new
technology IOL’’ in 42 CFR 416.180,
which incorporates section 141(b)(2) of
SSAA 1994. Under that section, a ‘‘new
technology IOL’’ is defined as ‘‘an IOL
that CMS determines has been approved
by the Food and Drug Administration
(FDA) for use in labeling and
advertising the IOL’s claims of specific
clinical advantages and superiority over
existing IOLs with regard to reduced
risk of intraoperative or postoperative
complication or trauma, accelerated
postoperative recovery, reduced
induced astigmatism, improved
postoperative visual acuity, more stable
postoperative vision, or other
comparable clinical advantages.’’ Thus,
an IOL must first be an FDA approved
IOL before we can designate that IOL as
an NTIOL.
We evaluate requests for the
designation of an IOL as an NTIOL by
doing the following:
(1) Publishing a public notice in the
Federal Register that identifies the
requirements and deadline for
submitting a request for a review of the
appropriateness of the payment amount
for an IOL.
(2) Processing requests to review the
appropriateness of the payment amount
for an IOL.
(3) Compiling a list of the requests we
receive that identify the IOL
manufacturer, IOL model number under
review, name of the requester, and a
summary of the request for review of the
appropriateness of the IOL payment
amount.
(4) Publishing an annual notice in the
Federal Register that lists the requests
and provides the public with 30 days to
submit comments on the IOLs for which
a review was requested.
(5) Reviewing the information
submitted with the applicant’s request
for review, and confirming the FDA
labeling for the IOL model under
review. We also review the available
evidence relevant to FDA’s labeling
approval as to whether or not the IOL
model submitted represents a new class
E:\FR\FM\28APN1.SGM
28APN1
]]>Agencies
[Federal Register Volume 71, Number 82 (Friday, April 28, 2006)]
[Notices]
[Pages 25175-25176]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-6385]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-216, CMS-10191, and CMS-588]
Agency Information Collection Activities: Proposed Collection;
Comment Request
AGENCY: Centers for Medicare & Medicaid Services.
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 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: Organ Procurement
Organization/Histocompatibility Laboratory Statement of Reimbursable
Cost, Manual Instructions and Supporting Regulations Contained in 42
CFR 413.20 and 413.24; Use: CMS is requesting reapproval of Form CMS-
216-94 (OMB No. 0938-0102). The current form implements various
provisions of the Social Security Act, including section 1881(a) which
provides Medicare coverage for end-stage renal disease patients who
meet certain entitlement requirements and kidney donors. It also
implements sections 1881(b)(2)(B) and 1861(v)(1)(A) of the Act to
determine the reasonable costs incurred to furnish treatment for renal
patients and transplant patients. The reasonable costs of securing and
transporting organs cannot be determined for the fiscal year until the
Organ Procurement Organization/Histocompatibility Laboratory files its
cost report (Form CMS-216) at year-end and costs are verified by the
Medicare fiscal intermediary.; Form Number: CMS-216 (OMB:
0938-0102); Frequency: Recordkeeping--Daily, Reporting--Annually;
Affected Public: Business or other for-profit, Not-for-profit
institutions, and the Federal government; Number of Respondents: 108;
Total Annual Responses: 108; Total Annual Hours: 4,860.
2. Type of Information Collection Request: New Collection; Title of
Information Collection: Medicare Part D Audit Guide, Version 1.0 and
Supporting Regulation contained in 42 CFR Section 423.505; Use: 42 CFR
section 423.505 provides CMS the regulatory authority to audit,
evaluate, or inspect any Part D sponsors' performance related to the
law in the areas of medication therapy management, drug utilization
management, formulary, and grievances and appeals. The information
collected will be an integral resource for oversight, monitoring,
compliance, and auditing activities necessary to ensure quality
provision of the Medicare Prescription Drug Benefit to beneficiaries.;
Form Number: CMS-10191 (OMB: 0938-New); Frequency:
Recordkeeping and Reporting--Annually; Affected Public: Business or
other for-profit; Number of Respondents: 564; Total Annual Responses:
564; Total Annual Hours: 54,144.
3. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Electronic Funds
Transfer Authorization Agreement; Use: Section 1815(a) of the Social
Security Act provides the authority for the Secretary of Health and
Human Services to pay providers/suppliers of Medicare services at such
time or times as the Secretary determines appropriate (but no less
frequently than monthly). Under Medicare, CMS, acting for the
Secretary, contracts with fiscal intermediaries and carriers to pay
claims submitted by providers/suppliers who furnish services to
Medicare beneficiaries. Under CMS' payment policy, Medicare providers/
suppliers have the option of receiving payments electronically. Form
number CMS-588 authorizes the use of electronic fund transfers (EFTs).;
Form Number: CMS-588 (OMB: 0938-0626); Frequency:
Recordkeeping and Reporting--On occasion; Affected Public: Business or
other for-profit, Not-
[[Page 25176]]
for-profit institutions, and State, Local or Tribal governments; Number
of Respondents: 100,000; Total Annual Responses: 100,000; Total Annual
Hours: 100,000.
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/PaperworkReductionActof1995,
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 June 27, 2006.
CMS, Office of Strategic Operations and Regulatory Affairs,
Division of Regulations Development--B, Attention: William N. Parham,
III, Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland 21244-
1850.
Dated: April 24, 2006.
Michelle Shortt,
Acting Director, Regulations Development Group, Office of Strategic
Operations and Regulatory Affairs.
[FR Doc. E6-6385 Filed 4-27-06; 8:45 am]
BILLING CODE 4120-01-P
