Emergency Clearance: Public Information Collection Requirements Submitted to the Office of Management and Budget (OMB), 61292-61293 [05-21101]
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61292
Federal Register / Vol. 70, No. 203 / Friday, October 21, 2005 / Notices
approved collection; Title of
Information Collection: Request for
Retirement Benefit Information (BBA
‘97); Form Number: CMS–R–285
(OMB#: 0938–0769); Use: The Request
for Retirement Benefit Information form
is used to obtain retirement benefit
information from beneficiaries that
purchase Medicare Part A coverage. The
Social Security Administration (SSA)
will use this information to determine if
a beneficiary meets the requirements to
qualify for a Medicare Part A premium
reduction.; Frequency: Reporting—On
occasion; Affected Public: State, Local
or Tribal Government; Number of
Respondents: 1500; Total Annual
Responses: 1500; Total Annual Hours:
375.
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS’l 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 December 20, 2005.
CMS, Office of Strategic Operations and
Regulatory Affairs, Division of
Regulations Development, Attention:
Bonnie L Harkless, Room C4–26–05,
7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
Dated: October 13, 2005.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. 05–20962 Filed 10–20–05; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare and Medicaid
Services
[Document Identifier: CMS–10133]
Emergency Clearance: Public
Information Collection Requirements
Submitted to the Office of Management
and Budget (OMB)
Center for Medicare and
Medicaid Services.
In compliance with the requirement
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Centers for Medicare and Medicaid
AGENCY:
VerDate Aug<31>2005
15:13 Oct 20, 2005
Jkt 208001
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 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.
We are, however, requesting an
emergency review of the information
collection referenced below. In
compliance with the requirement of
section 3506(c)(2)(A) of the Paperwork
Reduction Act of 1995, we have
submitted to the Office of Management
and Budget (OMB) the following
requirements for emergency review. We
are requesting an emergency review
because the collection of this
information is needed before the
expiration of the normal time limits
under OMB’s regulations at 5 CFR Part
1320. This is necessary to ensure
compliance with an initiative of the
Administration. We cannot reasonably
comply with the normal clearance
procedures because the use of normal
clearance procedures will jeopardize
program implementation by a statutorily
mandated deadline and could
contribute to impaired beneficiary
access to Part B drugs.
Section 303(d) of the MMA provides
an alternative payment methodology for
Part B drugs that are not paid on a cost
or prospective payment basis. In
particular, Section 303(d) of the MMA
amends Title XVIII of the Social
Security Act (the Act) by adding a new
section 1847B, which establishes a
competitive acquisition program for the
acquisition of and payment for Part B
covered drugs and biologicals furnished
on or after January 1, 2006. Beginning in
2006, physicians will have a choice
between acquiring and billing for Part B
covered drugs under the Average Sales
Price (ASP) drug payment methodology
or electing to receive these drugs from
vendors/suppliers selected for the
Competitive Acquisition Program (CAP),
through a competitive bidding process.
The provisions for this new payment
system are described in the proposed
rule (42 CFR Part 414 Subpart K)
published March 4, 2005 (70 FR 10746),
the interim final rule published July 6,
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
2005 (70 FR 39022), and a final rule that
is expected to be published in
November 2005.
1. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Competitive
Acquisition Program for Medicare Part B
Drugs: Vendor Application and Bid
Form; Use: The CAP Vendor
Application and Bid Form is a
collection tool which will be used by
potential vendors to provide
information related to the characteristics
of their company and to submit their bid
prices for CAP drugs. The information
collected on the CAP Vendor
Application and Bid Form will be used
by CMS during the bidding evaluation
process to evaluate the vendors bid
prices, their credentials, experience and
to assess their ability to provide quality
service to physicians and beneficiaries.
Competitive bidding is seen as a means
of using the dynamics of the
marketplace to provide incentives for
suppliers to provide reasonably priced
products and services of high quality in
an efficient manner. The CAP’s
objectives include providing an
alternative method for physicians to
obtain Part B drugs to administer to
Medicare beneficiaries and reducing
drug acquisition and billing burdens for
physicians; Form Number: CMS–10133
(OMB#: 0938–0955); Frequency:
Reporting—Other, during enrollment;
Affected Public: Business or other forprofit; Number of Respondents: 12;
Total Annual Responses: 12; Total
Annual Hours: 480.
CMS is requesting OMB review and
approval of this collection by November
1, 2005, with a 180-day approval period.
Written comments and
recommendations will be considered
from the public if received by the
individuals designated below by
October 28, 2005.
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access the 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.
Interested persons are invited to send
comments regarding the burden or any
other aspect of these collections of
information requirements. However, as
noted above, comments on these
information collection and
recordkeeping requirements must be
mailed to the designees referenced
below by October 28, 2005:
E:\FR\FM\21OCN1.SGM
21OCN1
Federal Register / Vol. 70, No. 203 / Friday, October 21, 2005 / Notices
Centers for Medicare and Medicaid
Services, Office of Strategic Operations
and Regulatory Affairs, Room C4–26–05,
7500 Security Boulevard, Baltimore, MD
21244–1850, Fax Number: (410) 786–
5267, Attn: William N. Parham, III and,
OMB Human Resources and Housing
Branch, Attention: CMS Desk Officer,
New Executive Office Building, Room
10235, Washington, DC 20503.
Dated: October 17, 2005.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. 05–21101 Filed 10–20–05; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Science Board to the Food and Drug
Administration; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Science Board to
FDA.
General Function of the Committee:
The Board shall provide advice
primarily to the agency’s Senior Science
Advisor and, as needed, to the
Commissioner of Food and Drugs and
other appropriate officials on specific
complex and technical issues as well as
emerging issues within the scientific
community in industry and academia.
Additionally, the Board will provide
advice to the agency on keeping pace
with technical and scientific evolutions
in the fields of regulatory science, on
formulating an appropriate research
agenda, and on upgrading its scientific
and research facilities to keep pace with
these changes. It will also provide the
means for critical review of agencysponsored intramural and extramural
scientific research programs.
Date and Time: The meeting will be
held on November 4, 2005, from 8:30
a.m. to 4 p.m.
Location: Washington Room, Holiday
Inn Bethesda, 8120 Wisconsin Ave.,
Bethesda, MD.
Contact Person: Jan Johannessen,
Office of the Commissioner (HF–33),
Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,
301–827–6687, jjohannessen@fda.gov,
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15:13 Oct 20, 2005
Jkt 208001
or FDA Advisory Committee
Information Line, 1–800–741–8138
(301–443–0572 in the Washington, DC
area), code 3014512603. Please call the
Information Line for up-to-date
information on this meeting.
Agenda: The Science Board will hear
about and discuss the following topics:
(1) An update on activities of the Drug
Safety Oversight Board, (2) the agency’s
Bioresearch Monitoring Initiative, and
(3) the Board’s science peer review
activities, including presentation of the
Board’s peer review of the Office of
Regulatory Affairs’ pesticide monitoring
program.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person by October 28, 2005. Oral
presentations from the public will be
scheduled between approximately 12:30
p.m. and 1:30 p.m. Time allotted for
each presentation may be limited. Those
desiring to make formal oral
presentations should notify the contact
person before October 28, 2005, and
submit a brief statement of the general
nature of the evidence or arguments
they wish to present, the names and
addresses of proposed participants, and
an indication of the approximate time
requested to make their presentation.
Persons attending FDA’s advisory
committee meetings are advised that the
agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Jan
Johannessen at least 7 days in advance
of the meeting.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: October 14, 2005.
Jason Brodsky,
Acting Associate Commissioner for External
Relations.
[FR Doc. 05–21036 Filed 10–20–05; 8:45 am]
BILLING CODE 4160–01–S
PO 00000
61293
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Statement of Organization, Functions
and Delegations of Authority
This notice amends Part R of the
Statement of Organization Functions
and Delegations of Authority of the
Department of Health and Human
Services (HHS), Health Resources and
Services Administration (HRSA) as
amended at (60 FR 56605, November 6,
1995; amended at 67 FR 46519, July 15,
2002; 68 FR 787–793, January 7, 2003,
and 68 FR 64357–64358, November 13,
2003; and last amended at 69 FR 56433–
56434, September 21, 2004).
This notice reflects changes to the
organization and functions of the Office
of Communications (RA6) and the
Office of Information Technology (RAG)
both in the Office of the Administrator
(RA): Specifically, it moves the Audio
Visual technology support function
from the Office of Information
Technology to the Office of
Communications.
Chapter RA—Office of the
Administrator
Section RA–10, Organization
The Office of the Administrator (OA)
is headed by the Administrator, Health
Resources and Services Administration,
who reports directly to the Secretary.
The OA includes the following
components:
(1) Immediate Office of the
Administrator (RA);
(2) Office of Equal Opportunity and
Civil Rights (RA2);
(3) Office of Planning and Evaluation
(RA5);
(4) Office of Communications (RA6);
(5) Office of Minority Health and
Health Disparities (RA9);
(6) Office of Legislation (RAE);
(7) Office of International Health
Affairs (RAH); and
(8) Office of Information Technology
(RAG).
Section RA–20, Functions
Delete the functional statements for
the Office of Communications (RA6)
and the Office of Information
Technology (RAG) in their entirety and
replace it with the following:
Office of Communication (RA6)
Provides leadership and general
policy and program direction for, and
conducts and coordinates
communications and public affairs
activities of the Agency; Specifically, (1)
Frm 00050
Fmt 4703
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E:\FR\FM\21OCN1.SGM
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Agencies
[Federal Register Volume 70, Number 203 (Friday, October 21, 2005)]
[Notices]
[Pages 61292-61293]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-21101]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare and Medicaid Services
[Document Identifier: CMS-10133]
Emergency Clearance: Public Information Collection Requirements
Submitted to the Office of Management and Budget (OMB)
AGENCY: Center for Medicare and Medicaid Services.
In compliance with the requirement of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the Centers for Medicare and 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 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.
We are, however, requesting an emergency review of the information
collection referenced below. In compliance with the requirement of
section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, we have
submitted to the Office of Management and Budget (OMB) the following
requirements for emergency review. We are requesting an emergency
review because the collection of this information is needed before the
expiration of the normal time limits under OMB's regulations at 5 CFR
Part 1320. This is necessary to ensure compliance with an initiative of
the Administration. We cannot reasonably comply with the normal
clearance procedures because the use of normal clearance procedures
will jeopardize program implementation by a statutorily mandated
deadline and could contribute to impaired beneficiary access to Part B
drugs.
Section 303(d) of the MMA provides an alternative payment
methodology for Part B drugs that are not paid on a cost or prospective
payment basis. In particular, Section 303(d) of the MMA amends Title
XVIII of the Social Security Act (the Act) by adding a new section
1847B, which establishes a competitive acquisition program for the
acquisition of and payment for Part B covered drugs and biologicals
furnished on or after January 1, 2006. Beginning in 2006, physicians
will have a choice between acquiring and billing for Part B covered
drugs under the Average Sales Price (ASP) drug payment methodology or
electing to receive these drugs from vendors/suppliers selected for the
Competitive Acquisition Program (CAP), through a competitive bidding
process. The provisions for this new payment system are described in
the proposed rule (42 CFR Part 414 Subpart K) published March 4, 2005
(70 FR 10746), the interim final rule published July 6, 2005 (70 FR
39022), and a final rule that is expected to be published in November
2005.
1. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Competitive
Acquisition Program for Medicare Part B Drugs: Vendor Application and
Bid Form; Use: The CAP Vendor Application and Bid Form is a collection
tool which will be used by potential vendors to provide information
related to the characteristics of their company and to submit their bid
prices for CAP drugs. The information collected on the CAP Vendor
Application and Bid Form will be used by CMS during the bidding
evaluation process to evaluate the vendors bid prices, their
credentials, experience and to assess their ability to provide quality
service to physicians and beneficiaries. Competitive bidding is seen as
a means of using the dynamics of the marketplace to provide incentives
for suppliers to provide reasonably priced products and services of
high quality in an efficient manner. The CAP's objectives include
providing an alternative method for physicians to obtain Part B drugs
to administer to Medicare beneficiaries and reducing drug acquisition
and billing burdens for physicians; Form Number: CMS-10133
(OMB: 0938-0955); Frequency: Reporting--Other, during
enrollment; Affected Public: Business or other for-profit; Number of
Respondents: 12; Total Annual Responses: 12; Total Annual Hours: 480.
CMS is requesting OMB review and approval of this collection by
November 1, 2005, with a 180-day approval period. Written comments and
recommendations will be considered from the public if received by the
individuals designated below by October 28, 2005.
To obtain copies of the supporting statement and any related forms
for the proposed paperwork collections referenced above, access the 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.
Interested persons are invited to send comments regarding the
burden or any other aspect of these collections of information
requirements. However, as noted above, comments on these information
collection and recordkeeping requirements must be mailed to the
designees referenced below by October 28, 2005:
[[Page 61293]]
Centers for Medicare and Medicaid Services, Office of Strategic
Operations and Regulatory Affairs, Room C4-26-05, 7500 Security
Boulevard, Baltimore, MD 21244-1850, Fax Number: (410) 786-5267, Attn:
William N. Parham, III and, OMB Human Resources and Housing Branch,
Attention: CMS Desk Officer, New Executive Office Building, Room 10235,
Washington, DC 20503.
Dated: October 17, 2005.
Michelle Shortt,
Director, Regulations Development Group, Office of Strategic Operations
and Regulatory Affairs.
[FR Doc. 05-21101 Filed 10-20-05; 8:45 am]
BILLING CODE 4120-01-P