Emergency Clearance: Public Information Collection Requirements Submitted to the Office of Management and Budget (OMB), 10976-10977 [06-1921]
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10976
Federal Register / Vol. 71, No. 42 / Friday, March 3, 2006 / Notices
proposing that the expiration date of the
last lot sold must be reported to CMS
once at the end of utilization of the NDC
or when there are no sales for three
consecutive quarters.
On November 21, 2005, we published
an interim final rule (70 FR 70478)
stating that, during the first three years
of the Part B Drug Competitive
Acquisition Program (CAP), sales and
price concessions associated with units
administered to a beneficiary by a
participating CAP vendor are excluded
from the ASP units and price. We
propose to collect the number of CAP
units excluded from the ASP
calculation. Frequency: Recordkeeping
and Reporting—Quarterly; Affected
Public: Business or other for-profit;
Number of Respondents: 120; Total
Annual Responses: 480; Total Annual
Hours: 17,760.
2. 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/
PaperworkReductionActof1995, or e-
VerDate Aug<31>2005
16:43 Mar 02, 2006
Jkt 208001
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.
Written comments and
recommendations for the proposed
information collections must be mailed
within 30 days of this notice directly to
the OMB desk officer: OMB Human
Resources and Housing Branch,
Attention: Carolyn Lovett, New
Executive Office Building, Room 10235,
Washington, DC 20503.
Dated: February 23, 2006.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. 06–1920 Filed 3–2–06; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare and Medicaid
Services
[Document Identifier: CMS–10185]
Emergency Clearance: Public
Information Collection Requirements
Submitted to the Office of Management
and Budget (OMB)
Centers 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
AGENCY:
PO 00000
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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. CMS does not have
sufficient time to complete the normal
PRA clearance process. We request this
Paperwork Reduction Act clearance
under an emergency approval process to
meet the statutorily-mandated reporting
requirement under the Medicare
Prescription Drug, Improvement, and
Modernization Act of 2003 (MMA) and
to accommodate the operational
schedule for the bidding process for
prospective and renewing Part D
Sponsors. In order to uphold the MMA
reporting requirement in conjunction
with the bid deadline for contract year
2007, key preceding events must occur.
If these events do not occur, prospective
and renewing Part D Sponsors will be
unable to adjust their bids to reflect
compliance with these reporting
requirements. Inaccuracies in Part D
bids will cause many adverse
consequences to Part D Sponsors, their
enrolled Medicare beneficiaries, and
CMS.
1. Type of Information Collection
Request: New Collection; Title of
Information Collection: Medicare Part D
Reporting Requirements; Use: Data
collected via Medicare Part D Reporting
Requirements 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. Data will be validated,
analyzed, and utilized for trend
reporting by CMS. If outliers or other
data anomalies are detected, CMS will
work in collaboration with other CMS
divisions for follow-up and resolution.
Form Number: CMS–10185 (OMB
#0938–New); Frequency: Reporting:
Quarterly and Semi-annually; Affected
Public: Business or other for-profit;
Number of Respondents: 3,203; Total
Annual Responses: 12,812; Total
Annual Hours: 102,496.
CMS is requesting OMB review and
approval of these collections by April
14, 2006, with a 180-day approval
period. Written comments and
recommendations will be considered
from the public if received by the
individuals designated below by April
3, 2006.
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS’ Web site
E:\FR\FM\03MRN1.SGM
03MRN1
10977
Federal Register / Vol. 71, No. 42 / Friday, March 3, 2006 / Notices
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.
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 April 14, 2006:
Centers for Medicare and Medicaid
Services, Office of Strategic
Operations and Regulatory Affairs,
Room C4–26–05, 7500 Security
Boulevard, Baltimore, MD 21244–
1850, Attn: Bonnie L Harkless,
and,
OMB Human Resources and Housing
Branch, Attention: Carolyn Lovett,
New Executive Office Building, Room
10235, Washington, DC 20503.
Dated: February 23, 2006.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. 06–1921 Filed 3–2–06; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0427]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Filing Objections
and Requests for a Hearing on a
Regulation or Order
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 April 3,
2006.
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 written
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:
Jonna Capezzuto, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–4659.
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.
Filing Objections and Requests for a
Hearing on a Regulation or Order
—(OMB Control Number 0910–0184)—
Extension
Under part 12 (21 CFR part 12),
§ 12.22, issued under section 701(e)(2)
of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 371(e)(2)), sets forth the
instructions for filing objections and
requests for a hearing on a regulation or
order under § 12.20(d). Objections and
requests must be submitted within the
time specified in § 12.20(e). Each
objection for which a hearing has been
requested must be separately numbered
and specify the provision of the
regulation or the proposed order. In
addition, each objection must include a
detailed description and analysis of the
factual information and any other
document, with some exceptions,
supporting the objection. Failure to
include this information constitutes a
waiver of the right to a hearing on that
objection. FDA uses the description and
analysis to determine whether a hearing
request is justified. The description and
analysis may be used only for the
purpose of determining whether a
hearing has been justified under § 12.24
and do not limit the evidence that may
be presented if a hearing is granted.
Respondents to this information
collection are those parties that may be
adversely affected by an order or
regulation.
In the Federal Register of November
16, 2005 (70 FR 69577), FDA published
a 60-day notice requesting public
comment on the information collection
provisions. No comments were received.
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR Section
No. of
Respondents
12.22
1There
Annual Frequency
per Response
10
Total Annual
Responses
1
10
Total Hours
20
200
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: February 24, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–3020 Filed 3–2–06; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BILLING CODE 4160–01–S
wwhite on PROD1PC61 with NOTICES
Hours per
Response
Peripheral and Central Nervous
System Drugs Advisory Committee;
Notice of Meeting
Food and Drug Administration
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
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PO 00000
Notice.
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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: Peripheral and
Central Nervous System Drugs Advisory
Committee.
General Function of the Committee:
To provide advice and
recommendations to the agency on
FDA’s regulatory issues.
E:\FR\FM\03MRN1.SGM
03MRN1
Agencies
[Federal Register Volume 71, Number 42 (Friday, March 3, 2006)]
[Notices]
[Pages 10976-10977]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-1921]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare and Medicaid Services
[Document Identifier: CMS-10185]
Emergency Clearance: Public Information Collection Requirements
Submitted to the Office of Management and Budget (OMB)
AGENCY: Centers 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. CMS does not have sufficient time to complete the
normal PRA clearance process. We request this Paperwork Reduction Act
clearance under an emergency approval process to meet the statutorily-
mandated reporting requirement under the Medicare Prescription Drug,
Improvement, and Modernization Act of 2003 (MMA) and to accommodate the
operational schedule for the bidding process for prospective and
renewing Part D Sponsors. In order to uphold the MMA reporting
requirement in conjunction with the bid deadline for contract year
2007, key preceding events must occur. If these events do not occur,
prospective and renewing Part D Sponsors will be unable to adjust their
bids to reflect compliance with these reporting requirements.
Inaccuracies in Part D bids will cause many adverse consequences to
Part D Sponsors, their enrolled Medicare beneficiaries, and CMS.
1. Type of Information Collection Request: New Collection; Title of
Information Collection: Medicare Part D Reporting Requirements; Use:
Data collected via Medicare Part D Reporting Requirements 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. Data will be validated,
analyzed, and utilized for trend reporting by CMS. If outliers or other
data anomalies are detected, CMS will work in collaboration with other
CMS divisions for follow-up and resolution. Form Number: CMS-10185 (OMB
0938-New); Frequency: Reporting: Quarterly and Semi-annually;
Affected Public: Business or other for-profit; Number of Respondents:
3,203; Total Annual Responses: 12,812; Total Annual Hours: 102,496.
CMS is requesting OMB review and approval of these collections by
April 14, 2006, with a 180-day approval period. Written comments and
recommendations will be considered from the public if received by the
individuals designated below by April 3, 2006.
To obtain copies of the supporting statement and any related forms
for the proposed paperwork collections referenced above, access CMS'
Web site
[[Page 10977]]
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.
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 April 14, 2006:
Centers for Medicare and Medicaid Services, Office of Strategic
Operations and Regulatory Affairs, Room C4-26-05, 7500 Security
Boulevard, Baltimore, MD 21244-1850, Attn: Bonnie L Harkless,
and,
OMB Human Resources and Housing Branch, Attention: Carolyn Lovett, New
Executive Office Building, Room 10235, Washington, DC 20503.
Dated: February 23, 2006.
Michelle Shortt,
Director, Regulations Development Group, Office of Strategic Operations
and Regulatory Affairs.
[FR Doc. 06-1921 Filed 3-2-06; 8:45 am]
BILLING CODE 4120-01-P