Emergency Clearance: Public Information Collection Requirements Submitted to the Office of Management and Budget (OMB), 58708-58709 [05-20229]
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58708
Federal Register / Vol. 70, No. 194 / Friday, October 7, 2005 / Notices
Annual Responses: 125,000; Total
Annual Hours: 62,500.
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.
To be assured consideration,
comments and recommendations for the
proposed information collections must
be received by the OMB Desk Officer at
the address below, no later than 5 p.m.
on November 7, 2005.
OMB Human Resources and Housing
Branch, Attention: CMS Desk Officer,
New Executive Office Building, Room
10235, Washington, DC 20503.
Dated: September 29, 2005.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. 05–20101 Filed 10–6–05; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–1557 and CMS–
1880/1882 and CMS 10142]
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
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.
AGENCY:
VerDate Aug<31>2005
18:27 Oct 06, 2005
Jkt 208001
1. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Survey Report
Form Clinical Laboratory Improvement
Amendments (CLIA) and supporting
regulations under 42 CFR 493.1–
493.2001; Form Number: CMS–1557
(OMB#: 0938–0544); Use: This form is
used by the State agency to determine
a laboratory’s compliance with CLIA.
This information is needed for a
laboratory’s CLIA certification and
recertification; Frequency:
Recordkeeping and Reporting—
Biennially; Affected Public: Business or
other for-profit, Not-for-profit
institutions, Federal, State, Local or
Tribal Government; Number of
Respondents: 25,000; Total Annual
Responses: 12,500; Total Annual Hours:
6,250.
2. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: The Request for
Certification as a Supplier of Portable XRay Services and Portable X-Ray Survey
Report Form under the Medicare and
Medicaid Program—Portable X-Ray
Survey Report and Supporting
Regulations under 42 CFR 486.100–
486.110; Form Number: CMS–1880/
1882 (OMB#: 0938–0027); Use: The
Medicare program requires portable Xray suppliers to be surveyed for health
and safety standards. The CMS–1882 is
the survey form that records survey
results. The CMS–1880 is used by the
surveyor to determine if a portable X-ray
applicant meets the eligibility
requirements. This information serves
as a screen for the State survey agency
to determine if the portable X-ray
supplier has the basic capabilities to
participate in the Medicare program.
CMS will use this information to make
certification decisions; Frequency:
Reporting—On occasion; Affected
Public: Business or other for-profit;
Number of Respondents: 655; Total
Annual Responses: 98; Total Annual
Hours: 172.
3. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Bid Pricing Tool
(BPT) for Medicare Advantage and
Prescription Drug Plans (PDP) contained
in 42 Code of Federal Regulation (CFR):
422.250, 422.252, 422.254, 422.256,
422.258, 422.262, 422.264, 422.266,
422.270, 422.300, 422.304, 422.306,
422.308, 422.310, 422.312, 422.314,
422.316, 422.318, 422.320, 422.322,
422.324, 423.251, 423.258, 423.265,
423.272, 423.279, 423.286, 423.293,
423.301, 423.308, 423.315, 423.322,
423.329, 423.336, 423.343, 423.346,
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
423.350 ; Form Number: CMS–10142
(OMB#: 0938–0944); Use: Under the
Medicare Modernization Act, Medicare
Advantage Organizations (MAO) and
Prescription Drug Plans (PDP) are
required to submit an actuarial pricing
bid to CMS for approval. The BPT
software is used by MAOs and PDPs to
price their plan benefit package. The
BPT software is used by CMS to review
and approve the plan pricing proposed
by each organization; Frequency:
Reporting ‘‘ On occasion, Annually and
As required by new legislation; Affected
Public: Business or other for-profit and
not-for-profit institutions; Number of
Respondents: 350; Total Annual
Responses: 350; Total Annual Hours:
12,050.
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 December 6, 2005.
CMS, Office of Strategic Operations
and Regulatory Affairs, Division of
Regulations Development, Attention:
Melissa Musotto, Room C4–26–05, 7500
Security Boulevard, Baltimore,
Maryland 21244–1850.
Dated: September 30, 2005.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. 05–20228 Filed 10–6–05; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10171]
Emergency Clearance: Public
Information Collection Requirements
Submitted to the Office of Management
and Budget (OMB)
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), Department of Health
AGENCY:
E:\FR\FM\07OCN1.SGM
07OCN1
Federal Register / Vol. 70, No. 194 / Friday, October 7, 2005 / Notices
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 normal
procedures are likely to cause a
statutory deadline to be missed which
may result in public harm.
Section 1860D–23 and 1860D–24 of
the Social Security Act, added by the
Medicare Prescription Drug,
Improvement and Modernization Act of
2003 (MMA), requires the Secretary to
establish requirements for prescription
drug plans to ensure the effective
coordination between Part D plans,
State pharmaceutical assistance
programs and other payers. These
requirements have been codified into
the Code of Federal Regulations at 42
CFR 423.464.
Part D sponsors will be responsible
for making system changes related to
enrollment file sharing, claims
processing and payment, reconciliation
and tracking of the true out-of-pocket
expenditures of beneficiaries prior to
the implementation of Part D (January 1,
2006). System changes must also be
implemented by State pharmaceutical
assistance programs so that they may
provide additional drug benefits at the
pharmacy to Part D beneficiaries. In
addition to making system changes,
these changes must be tested, which
will require additional time prior to
VerDate Aug<31>2005
19:29 Oct 06, 2005
Jkt 208001
January 1, 2006. Failure to make system
changes may result in the delay in the
implementation of the program and may
result in a direct harm to beneficiaries
since delays or mistakes in claims
processing may result in beneficiaries
not receiving their medications, or being
unable to pay for medications out-ofpocket until the system issue is
resolved.
CMS is requesting OMB review and
approval of this collection by November
8, 2005, with a 180-day approval period.
Written comments and
recommendations will be accepted from
the public if received by the individuals
designated below by November 7, 2005.
Type of Information Collection
Request: New Collection; Title of
Information Collection: Coordination of
Benefits between Part D Plans and Other
Prescription Coverage Providers; Use:
This information is necessary to assist
with coordination of prescription drug
benefits provided to the Medicare
beneficiary at the pharmacy; Form
Number: CMS–10171 (OMB#: 0938–
NEW); Frequency: On occasion and
monthly; Affected Public: Business or
other for-profit, Federal, State, Local
and Tribal Government; Number of
Respondents: 56,320; Total Annual
Responses: 2,153,767,270; Total Annual
Hours: 1,017,914.
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 at
(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
received by the designees referenced
below by November 7, 2005: Centers for
Medicare & Medicaid Services, Office of
Strategic Operations and Regulatory
Affairs, Room C4–26–05, 7500 Security
Boulevard, Baltimore, MD 21244–1850,
Attn: Melissa Musotto, CMS–10171.
and, OMB Human Resources and
Housing Branch, Attention: CMS Desk
Officer, New Executive Office Building,
Room 10235, Washington, DC 20503.
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
58709
Dated: September 30, 2005.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. 05–20229 Filed 10–6–05; 8:45 am]
BILLING CODE 4120–03–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0178]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Regulations Under the Federal Import
Milk Act
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by November
7, 2005.
ADDRESSES: OMB is still experiencing
significant delays in the regular mail,
including first class and express mail,
and messenger deliveries are not being
accepted. To ensure that comments on
the information collection are received,
OMB recommends that comments be
faxed to the Office of Information and
Regulatory Affairs, OMB, Attn: Fumie
Yokota, Desk Officer for FDA, FAX:
202–395–6974.
FOR FURTHER INFORMATION CONTACT:
Peggy Robbins, Office of Management
Programs (HFA 250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1223.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Under the regulations implementing
the Federal Import Milk Act (FIMA) (21
U.S.C. 141–149), milk or cream may be
imported into the United States only by
the holder of a valid import milk permit.
Before such permit is issued: (1) All
cows from which import milk or cream
is produced must be physically
examined and found healthy; (2) if the
milk or cream is imported raw, all such
cows must pass a tuberculin test; (3) the
dairy farm and each plant in which the
E:\FR\FM\07OCN1.SGM
07OCN1
Agencies
[Federal Register Volume 70, Number 194 (Friday, October 7, 2005)]
[Notices]
[Pages 58708-58709]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-20229]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-10171]
Emergency Clearance: Public Information Collection Requirements
Submitted to the Office of Management and Budget (OMB)
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), Department of Health
[[Page 58709]]
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 normal procedures are likely to cause
a statutory deadline to be missed which may result in public harm.
Section 1860D-23 and 1860D-24 of the Social Security Act, added by
the Medicare Prescription Drug, Improvement and Modernization Act of
2003 (MMA), requires the Secretary to establish requirements for
prescription drug plans to ensure the effective coordination between
Part D plans, State pharmaceutical assistance programs and other
payers. These requirements have been codified into the Code of Federal
Regulations at 42 CFR 423.464.
Part D sponsors will be responsible for making system changes
related to enrollment file sharing, claims processing and payment,
reconciliation and tracking of the true out-of-pocket expenditures of
beneficiaries prior to the implementation of Part D (January 1, 2006).
System changes must also be implemented by State pharmaceutical
assistance programs so that they may provide additional drug benefits
at the pharmacy to Part D beneficiaries. In addition to making system
changes, these changes must be tested, which will require additional
time prior to January 1, 2006. Failure to make system changes may
result in the delay in the implementation of the program and may result
in a direct harm to beneficiaries since delays or mistakes in claims
processing may result in beneficiaries not receiving their medications,
or being unable to pay for medications out-of-pocket until the system
issue is resolved.
CMS is requesting OMB review and approval of this collection by
November 8, 2005, with a 180-day approval period. Written comments and
recommendations will be accepted from the public if received by the
individuals designated below by November 7, 2005.
Type of Information Collection Request: New Collection; Title of
Information Collection: Coordination of Benefits between Part D Plans
and Other Prescription Coverage Providers; Use: This information is
necessary to assist with coordination of prescription drug benefits
provided to the Medicare beneficiary at the pharmacy; Form Number: CMS-
10171 (OMB: 0938-NEW); Frequency: On occasion and monthly;
Affected Public: Business or other for-profit, Federal, State, Local
and Tribal Government; Number of Respondents: 56,320; Total Annual
Responses: 2,153,767,270; Total Annual Hours: 1,017,914.
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 at (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 received by the
designees referenced below by November 7, 2005: Centers for Medicare &
Medicaid Services, Office of Strategic Operations and Regulatory
Affairs, Room C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-
1850, Attn: Melissa Musotto, CMS-10171. and, OMB Human Resources and
Housing Branch, Attention: CMS Desk Officer, New Executive Office
Building, Room 10235, Washington, DC 20503.
Dated: September 30, 2005.
Michelle Shortt,
Director, Regulations Development Group, Office of Strategic Operations
and Regulatory Affairs.
[FR Doc. 05-20229 Filed 10-6-05; 8:45 am]
BILLING CODE 4120-03-P