Agency Information Collection Activities: Proposed Collection; Comment Request, 46483-46484 [E6-13189]
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Federal Register / Vol. 71, No. 156 / Monday, August 14, 2006 / Notices
• Develop, monitor progress on,
report on, and periodically update
program plans in their respective areas
of responsibility.
The CEO or EEO Director may also
establish standing committees to deal
with specific issues as they arise. The
Head of each Agency office will provide
support to the individuals identified
above on an as needed basis upon
request from the EEO Director.
Adopted this 13th day of July 2006 by
Order of the Board.
Dated: August 8, 2006.
Roland E. Smith,
Secretary, Farm Credit Administration Board.
[FR Doc. E6–13306 Filed 8–11–06; 8:45 am]
A. Federal Reserve Bank of Atlanta
(Andre Anderson, Vice President) 1000
Peachtree Street, NE., Atlanta, Georgia
30309:
1. Florida Bank Group, Inc., Tampa,
Florida; to acquire 100 percent of the
voting shares of Bank of North Florida,
Jacksonville, Florida.
Board of Governors of the Federal Reserve
System, August 9, 2006.
Robert deV. Frierson,
Deputy Secretary of the Board.
[FR Doc. E6–13232 Filed 8–11–06; 8:45 am]
BILLING CODE 6210–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
FEDERAL RESERVE SYSTEM
Centers for Medicare & Medicaid
Services
Formations of, Acquisitions by, and
Mergers of Bank Holding Companies
jlentini on PROD1PC65 with NOTICES
BILLING CODE 6705–01–P
[Document Identifier: CMS–576A, CMS–
10203, CMS–R–64, CMS–3070G–I, and
CMS–304/304A]
The companies listed in this notice
have applied to the Board for approval,
pursuant to the Bank Holding Company
Act of 1956 (12 U.S.C. 1841 et seq.)
(BHC Act), Regulation Y (12 CFR part
225), and all other applicable statutes
and regulations to become a bank
holding company and/or to acquire the
assets or the ownership of, control of, or
the power to vote shares of a bank or
bank holding company and all of the
banks and nonbanking companies
owned by the bank holding company,
including the companies listed below.
The applications listed below, as well
as other related filings required by the
Board, are available for immediate
inspection at the Federal Reserve Bank
indicated. The application also will be
available for inspection at the offices of
the Board of Governors. Interested
persons may express their views in
writing on the standards enumerated in
the BHC Act (12 U.S.C. 1842(c)). If the
proposal also involves the acquisition of
a nonbanking company, the review also
includes whether the acquisition of the
nonbanking company complies with the
standards in section 4 of the BHC Act
(12 U.S.C. 1843). Unless otherwise
noted, nonbanking activities will be
conducted throughout the United States.
Additional information on all bank
holding companies may be obtained
from the National Information Center
Web site at https://www.ffiec.gov/nic/.
Unless otherwise noted, comments
regarding each of these applications
must be received at the Reserve Bank
indicated or the offices of the Board of
Governors not later than September 8,
2006.
VerDate Aug<31>2005
17:58 Aug 11, 2006
Jkt 208001
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
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’s (OPO’s)
Health Insurance Benefits Agreement
and Supporting Regulations at 42 CFR
486.301–486.348; Use: The information
provided on this form serves as a basis
for continuing the agreements with CMS
and the 58 OPOs for participation in the
Medicare and Medicaid programs and
for reimbursement of service; Form
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
46483
Number: CMS–576A (OMB#: 0938–
0512; Frequency: Reporting—Every 4
years and as needed; Affected Public:
Business or other for-profit and Not-forprofit institutions; Number of
Respondents: 58; Total Annual
Responses: 58; Total Annual Hours:
116.
2. Type of Information Collection
Request: New collection; Title of
Information Collection: Medicare Health
Outcome Survey (HOS) and supporting
regulations at 42 CFR 422.152; Use: The
Medicare Prescription Drug,
Improvement, and Modernization Act of
2003 mandates the collection, analysis
and reporting of health outcomes
information. The collection of Medicare
health outcomes information is
necessary to hold Medicare managed
care contractors accountable for the
quality of care they are delivering. This
reporting requirement allows CMS to
obtain the information necessary for the
proper oversight of the program; Form
Number: CMS–10203 (OMB#: 0938–
New; Frequency: Recordkeeping,
Reporting: Annually; Affected Public:
Individuals or Households, Business or
other for-profit and Not-for-profit
institutions; Number of Respondents:
320,040; Total Annual Responses:
320,040; Total Annual Hours: 105,613.
3. Type of Information Collection
Request: Extension of a currently
approved information collection; Title
of Information Collection: Indirect
Medical Education (IME) and
Supporting Regulations 42 CFR 412.105;
Direct Graduate Medical Education
(GME) and Supporting Regulations in 42
CFR 413.75–413.73; Use: The collection
of information on interns and residents
(IR) is needed to properly calculate
Medicare program payments to
hospitals that incur indirect and direct
costs for medical education. The
agency’s Intern and Resident
Information System (IRIS) and similar
contractor systems use the information
for producing reports of duplicate fulltime equivalent IR counts for IME and
GME. The contractors also use this
information to ensure that hospitals are
properly reimbursed for IME and GME,
and help eliminate duplicate reporting
of IR counts which inflate payments.
The collection of this information
affects 1,215 hospitals which participate
in approved medical education
programs; Form Number: CMS–R–64
(OMB#: 0938–0456); Frequency:
Recordkeeping and Reporting—
Annually; Affected Public: Not-for-profit
and Business or other for-profit
institutions; Number of Respondents:
1,215; Total Annual Responses: 1,215;
Total Annual Hours: 2,430.
E:\FR\FM\14AUN1.SGM
14AUN1
jlentini on PROD1PC65 with NOTICES
46484
Federal Register / Vol. 71, No. 156 / Monday, August 14, 2006 / Notices
4. Type of Information Collection
Request: Extension of a currently
approved information collection; Title
of Information Collection: Intermediate
Care Facility for the Mentally Retarded
or Persons with Related Conditions ICF/
MR Survey Report Form and Supporting
Regulations at 42 CFR 442.30, 483.410,
483.420, 483.440, 483.50, and 483.460;
Use: The survey forms are needed to
ensure provider compliance. In order to
participate in the Medicaid program as
an ICF/MR, providers must meet
Federal standards. The survey report
form is used to record providers’ level
of compliance with the individual
standard requirements and report it to
the Federal government; Form Number:
CMS–3070G–I (OMB#: 0938–0062);
Frequency: Recordkeeping and
Reporting—Annually; Affected Public:
Business or other for-profit and Not-forprofit institutions; Number of
Respondents: 6,428; Total Annual
Responses: 6,428; Total Annual Hours:
19,284.
5. Type of Information Collection
Request: Extension of a currently
approved information collection; Title
of Information Collection:
Reconciliation of State Invoice and Prior
Quarter Adjustment Statement; Use:
Section 1927 of the Social Security Act
requires drug labelers to enter into and
have in effect a rebate agreement with
CMS for States to receive funding for
drugs dispensed to Medicaid recipients.
Drug manufacturers must complete and
submit to States the CMS–304 form to
explain any rebate payment adjustments
for the current quarter, and complete
and submit the CMS–304A form to
States to explain rebate payment
adjustments to any prior quarters. Both
forms are used to reconcile drug rebate
payments made by manufacturers with
the States’ invoices of rebates due; Form
Number: CMS–304/304A (OMB#: 0938–
0676); Frequency: Recordkeeping and
Reporting—Quarterly; Affected Public:
Business or other for-profit; Number of
Respondents: 550; Total Annual
Responses: 3,740; Total Annual Hours:
139,480.
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS’s 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
VerDate Aug<31>2005
17:58 Aug 11, 2006
Jkt 208001
proposed information collections must
be received at the address below, no
later than 5 p.m. on October 13, 2006.
CMS, Office of Strategic Operations
and Regulatory Affairs, Division of
Regulations Development—A,
Attention: Melissa Musotto, Room C4–
26–05, 7500 Security Boulevard,
Baltimore, Maryland 21244–1850.
Dated: August 3, 2006.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. E6–13189 Filed 8–11–06; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 1997D–0318] (formerly Docket
No. 97D–0318)
Draft Guidance for Industry on an
Amendment Involving Donor Deferral
for Transfusion in France Since 1980
to ‘‘Guidance for Industry: Revised
Preventive Measures to Reduce the
Possible Risk of Transmission of
Creutzfeldt-Jakob Disease (CJD) and
Variant Creutzfeldt-Jakob Disease
(vCJD) by Blood and Blood Products’’;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft document entitled
‘‘Guidance for Industry: Amendment
(Donor Deferral for Transfusion in
France Since 1980) to ‘Guidance for
Industry: Revised Preventive Measures
to Reduce the Possible Risk of
Transmission of Creutzfeldt-Jakob
Disease (CJD) and Variant CreutzfeldtJakob Disease (vCJD) by Blood and
Blood Products,’’’ dated August 2006.
The draft guidance document, when
finalized, is intended to amend FDA’s
‘‘Guidance for Industry: Revised
Preventive Measures to Reduce the
Possible Risk of Transmission of
Creutzfeldt-Jakob Disease (CJD) and
Variant Creutzfeldt-Jakob Disease (vCJD)
by Blood and Blood Products’’ dated
January 2002. This draft guidance,
which is a level I guidance document,
would add to the January 2002 guidance
a donor deferral recommendation for
donors who have received a transfusion
of blood or blood components in France
since 1980. After we review comments
received on this draft guidance, we
intend to incorporate this donor deferral
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
recommendation and reissue the revised
January 2002 guidance as a level II
guidance document for immediate
implementation.
DATES: Submit written or electronic
comments on the draft guidance by
October 13, 2006 to ensure their
adequate consideration in preparation of
the revisions to the 2002 guidance.
General comments on agency guidance
documents are welcome at any time.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Office of Communication, Training, and
Manufacturers Assistance (HFM–40),
Center for Biologics Evaluation and
Research (CBER), Food and Drug
Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852–1448.
Send one self-addressed adhesive label
to assist the office in processing your
requests. The draft guidance may also be
obtained by mail by calling CBER at 1–
800–835–4709 or 301–827–1800. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
Submit written comments on the draft
guidance to the Division of Dockets
Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT:
Brenda R. Friend, Center for Biologics
Evaluation and Research (HFM–17),
Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville,
MD 20852–1448, 301–827–6210.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft document entitled ‘‘Guidance for
Industry: Amendment (Donor Deferral
for Transfusion in France Since 1980) to
‘Guidance for Industry: Revised
Preventive Measures to Reduce the
Possible Risk of Transmission of
Creutzfeldt-Jakob Disease (CJD) and
Variant Creutzfeldt-Jakob Disease (vCJD)
by Blood and Blood Products’’’ dated
August 2006 (Draft Guidance). The Draft
Guidance is intended to amend FDA’s
‘‘Guidance for Industry: Revised
Preventive Measures to Reduce the
Possible Risk of Transmission of
Creutzfeldt-Jakob Disease (CJD) and
Variant Creutzfeldt-Jakob Disease (vCJD)
by Blood and Blood Products’’ (CJD/
vCJD Guidance), dated January 2002, by
adding a donor deferral
recommendation for donors who have
received a transfusion of blood or blood
components in France since 1980. After
we review comments received on this
Draft Guidance, we intend to
E:\FR\FM\14AUN1.SGM
14AUN1
]]>Agencies
[Federal Register Volume 71, Number 156 (Monday, August 14, 2006)]
[Notices]
[Pages 46483-46484]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-13189]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-576A, CMS-10203, CMS-R-64, CMS-3070G-I, and
CMS-304/304A]
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 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's (OPO's) Health Insurance Benefits Agreement and
Supporting Regulations at 42 CFR 486.301-486.348; Use: The information
provided on this form serves as a basis for continuing the agreements
with CMS and the 58 OPOs for participation in the Medicare and Medicaid
programs and for reimbursement of service; Form Number: CMS-576A
(OMB: 0938-0512; Frequency: Reporting--Every 4 years and as
needed; Affected Public: Business or other for-profit and Not-for-
profit institutions; Number of Respondents: 58; Total Annual Responses:
58; Total Annual Hours: 116.
2. Type of Information Collection Request: New collection; Title of
Information Collection: Medicare Health Outcome Survey (HOS) and
supporting regulations at 42 CFR 422.152; Use: The Medicare
Prescription Drug, Improvement, and Modernization Act of 2003 mandates
the collection, analysis and reporting of health outcomes information.
The collection of Medicare health outcomes information is necessary to
hold Medicare managed care contractors accountable for the quality of
care they are delivering. This reporting requirement allows CMS to
obtain the information necessary for the proper oversight of the
program; Form Number: CMS-10203 (OMB: 0938-New; Frequency:
Recordkeeping, Reporting: Annually; Affected Public: Individuals or
Households, Business or other for-profit and Not-for-profit
institutions; Number of Respondents: 320,040; Total Annual Responses:
320,040; Total Annual Hours: 105,613.
3. Type of Information Collection Request: Extension of a currently
approved information collection; Title of Information Collection:
Indirect Medical Education (IME) and Supporting Regulations 42 CFR
412.105; Direct Graduate Medical Education (GME) and Supporting
Regulations in 42 CFR 413.75-413.73; Use: The collection of information
on interns and residents (IR) is needed to properly calculate Medicare
program payments to hospitals that incur indirect and direct costs for
medical education. The agency's Intern and Resident Information System
(IRIS) and similar contractor systems use the information for producing
reports of duplicate full-time equivalent IR counts for IME and GME.
The contractors also use this information to ensure that hospitals are
properly reimbursed for IME and GME, and help eliminate duplicate
reporting of IR counts which inflate payments. The collection of this
information affects 1,215 hospitals which participate in approved
medical education programs; Form Number: CMS-R-64 (OMB: 0938-
0456); Frequency: Recordkeeping and Reporting--Annually; Affected
Public: Not-for-profit and Business or other for-profit institutions;
Number of Respondents: 1,215; Total Annual Responses: 1,215; Total
Annual Hours: 2,430.
[[Page 46484]]
4. Type of Information Collection Request: Extension of a currently
approved information collection; Title of Information Collection:
Intermediate Care Facility for the Mentally Retarded or Persons with
Related Conditions ICF/MR Survey Report Form and Supporting Regulations
at 42 CFR 442.30, 483.410, 483.420, 483.440, 483.50, and 483.460; Use:
The survey forms are needed to ensure provider compliance. In order to
participate in the Medicaid program as an ICF/MR, providers must meet
Federal standards. The survey report form is used to record providers'
level of compliance with the individual standard requirements and
report it to the Federal government; Form Number: CMS-3070G-I
(OMB: 0938-0062); Frequency: Recordkeeping and Reporting--
Annually; Affected Public: Business or other for-profit and Not-for-
profit institutions; Number of Respondents: 6,428; Total Annual
Responses: 6,428; Total Annual Hours: 19,284.
5. Type of Information Collection Request: Extension of a currently
approved information collection; Title of Information Collection:
Reconciliation of State Invoice and Prior Quarter Adjustment Statement;
Use: Section 1927 of the Social Security Act requires drug labelers to
enter into and have in effect a rebate agreement with CMS for States to
receive funding for drugs dispensed to Medicaid recipients. Drug
manufacturers must complete and submit to States the CMS-304 form to
explain any rebate payment adjustments for the current quarter, and
complete and submit the CMS-304A form to States to explain rebate
payment adjustments to any prior quarters. Both forms are used to
reconcile drug rebate payments made by manufacturers with the States'
invoices of rebates due; Form Number: CMS-304/304A (OMB: 0938-
0676); Frequency: Recordkeeping and Reporting--Quarterly; Affected
Public: Business or other for-profit; Number of Respondents: 550; Total
Annual Responses: 3,740; Total Annual Hours: 139,480.
To obtain copies of the supporting statement and any related forms
for the proposed paperwork collections referenced above, access CMS's
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 October 13, 2006.
CMS, Office of Strategic Operations and Regulatory Affairs,
Division of Regulations Development--A, Attention: Melissa Musotto,
Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland 21244-1850.
Dated: August 3, 2006.
Michelle Shortt,
Director, Regulations Development Group, Office of Strategic Operations
and Regulatory Affairs.
[FR Doc. E6-13189 Filed 8-11-06; 8:45 am]
BILLING CODE 4120-01-P
