Agency Information Collection Activities: Submission for OMB Review; Comment Request, 9819-9820 [E9-4791]
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Federal Register / Vol. 74, No. 43 / Friday, March 6, 2009 / Notices
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[FR Doc. E9–4888 Filed 3–4–09; 4:15 pm]
BILLING CODE 6712–01–P
FEDERAL MARITIME COMMISSION
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AGENCY HOLDING THE MEETING:
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Maritime Commission.
TIME AND DATE:
March 11, 2009–10 a.m.
PLACE: 800 North Capitol Street, NW.,
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STATUS: A portion of the meeting will
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MATTERS TO BE CONSIDERED:
Open Session
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CONTACT PERSON FOR MORE INFORMATION:
mstockstill on PROD1PC66 with NOTICES
Karen V. Gregory, Secretary, (202) 523–
5725.
Karen V. Gregory,
Secretary.
[FR Doc. E9–4949 Filed 3–4–09; 4:15 pm]
BILLING CODE 6730–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10110, CMS–R–
250, CMS–R–144/CMS–368 and CMS–668B]
Agency Information Collection
Activities: Submission for OMB
Review; 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), 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 function;
(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: Revision of a currently
approved collection; Title of
Information Collection: Manufacturer
Submission of Average Sales Price
(ASP) Data for Medicare Part B Drugs
and Biologicals; Use: Section 1847A of
the Social Security Act requires that the
Medicare Part B payment amounts for
covered drugs and biologicals not paid
on a cost or prospective payment basis
be based upon manufacturers’ average
sales price data submitted to CMS. CMS
will utilize the ASP data to determine
the Medicare Part B drug payment
amounts. Form Number: CMS–10110
(OMB# 0938–0921); Frequency:
Quarterly; Affected Public: Business or
other for-profits; Number of
Respondents: 180; Total Annual
Responses: 720; Total Annual Hours:
28,800. (For policy questions regarding
this collection contact Catherine Jansto
at 410–786–7762. For all other issues
call 410–786–1326.)
2. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: MPAF Data and
Supporting Regulations in 42 CFR
413.337, 413.343, 424.32 and 483.20;
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
9819
Use: Resident assessment information
that Skilled Nursing Facilities (SNFs)
are required to submit is described
under section 42 CFR 413.343 and
483.20. The manner necessary to
administer the payment rate
methodology is described under section
42 CFR 413.337. An assessment form
comprised of a subset of resident
assessment information has been
developed for use by SNFs to satisfy
Medicare payment requirements, in lieu
of a full Minimum Data Set. The
associated burden is the time the SNF
staff is required to complete the
Medicare PPS Assessment Form
(MPAF), SNF staff time to encode, and
SNF staff time spent in transmitting the
data. Form Number: CMS–R–250
(OMB# 0938–0739); Frequency:
Occasionally; Affected Public: Business
or other for-profits and not-for-profit
institutions, State, Local, or Tribal
Governments, and Federal Government;
Number of Respondents: 15,039; Total
Annual Responses: 3,834,945; Total
Annual Hours: 2,704,764. (For policy
questions regarding this collection
contact Julie Stankivic at 410–786–5725.
For all other issues call 410–786–1326.)
3. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: State Medicaid
Drug Rebate; Use: Section 1927 of the
Social Security Act requires each State
Medicaid agency to report quarterly
prescription drug utilization
information to drug manufacturers and
to CMS. As part of this information, the
State Medicaid agencies are required to
report the total Medicaid rebate amount
they claim they are owed by each drug
manufacturer for each covered
prescription drug product each quarter.
Form Number: CMS–R–144 and CMS–
368 (OMB# 0938–0582); Frequency:
Quarterly; Affected Public: State, Local
or Tribal Governments; Number of
Respondents: 51; Total Annual
Responses: 204; Total Annual Hours:
9,389. (For policy questions regarding
this collection contact Dusty Kerhart at
410–786–3273. For all other issues call
410–786–1326.)
4. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Post Clinical
Laboratory Survey Questionnaire and
Supporting Regulations in 42 CFR
493.1771, 493.1773, and 493.1777; Use:
This form is used by the State agency to
determine a laboratory’s compliance
with the Clinical Laboratory
Improvement Amendments of 1988
(CLIA). This information is needed for
a laboratory’s CLIA certification and
recertification. Form Number: CMS–
E:\FR\FM\06MRN1.SGM
06MRN1
9820
Federal Register / Vol. 74, No. 43 / Friday, March 6, 2009 / Notices
668B (OMB# 0938–0653); Frequency:
Biennially; Affected Public: Business or
other for-profits and not-for-profit
institutions. State, Local, or Tribal
Government, Federal Government;
Number of Respondents: 21,000; Total
Annual Responses: 10,500; Total
Annual Hours: 2,625. (For policy
questions regarding this collection
contact Kathleen Todd at 410–786–
3385. For all other issues call 410–786–
1326.)
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 by the OMB desk officer at
the address below, no later than 5 p.m.
on April 6, 2009.
OMB, Office of Information and
Regulatory Affairs, Attention: CMS Desk
Officer, Fax Number: (202) 395–6974,
E-mail: OIRA_submission@omb.eop.gov.
Dated: February 27, 2009.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. E9–4791 Filed 3–5–09; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10165]
mstockstill on PROD1PC66 with NOTICES
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
VerDate Nov<24>2008
16:20 Mar 05, 2009
Jkt 217001
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: Revision of a currently
approved collection; Title of
Information Collection: Electronic
Health Records (EHR) Demonstration
Web Enabled Application for Phase II;
Use: The goal of the Electronic Health
Record (EHR) demonstration is to foster
the implementation and adoption of
EHRs and Health Information
Technology (HIT) more broadly as
effective vehicles improve the quality of
care provided and transform the way
medicine is practiced and delivered.
Adoption of HIT has the potential to
provide significant savings to the
Medicare program and improve the
quality of care rendered to Medicare
beneficiaries. This demonstration is
designed to leverage the combined
forces of private and public payers to
drive physician practices to widespread
adoption and use of EHRs. The
demonstration is being implemented in
two phases. Over 800 applications were
received, via a manual (paper) process,
from interested practices in the four
Phase I sites. Because of the greater
number of sites and projected applicants
for Phase II, CMS has Web enabled the
application. This is expected to make it
easier for practices to complete the
application accurately and completely,
submit it in a timely manner, and allow
CMS to process the applications more
efficiently and effectively. Form
Number: CMS–10165(OMB#: 0938–
0936–0965); Frequency: Reporting—
Once; Affected Public: Business or other
for-profit and not-for-profit institutions;
Number of Respondents: 1,600; Total
Annual Responses: 1,600; Total Annual
Hours: 347. (For policy questions
regarding this collection contact Jody
Blatt at 410–786–6921. For all other
issues call 410–786–1326.)
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS’ Web Site
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.
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
In commenting on the proposed
information collections please reference
the document identifier or OMB control
number. To be assured consideration,
comments and recommendations must
be submitted in one of the following
ways by May 5, 2009:
1. Electronically. You may submit
your comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) accepting comments.
2. By Regular Mail. You may mail
written comments to the following
address: CMS, Office of Strategic
Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: Document Identifier/OMB
Control Number lll, Room C4–26–
05, 7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
Dated: February 27, 2009.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. E9–4807 Filed 3–5–09; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0097]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Request for
Samples and Protocols
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the information collection requirements
relating to the regulations which state
that protocols for samples of biological
products must be submitted to the
agency.
DATES: Submit written or electronic
comments on the collection of
information by May 5, 2009.
E:\FR\FM\06MRN1.SGM
06MRN1
]]>Agencies
[Federal Register Volume 74, Number 43 (Friday, March 6, 2009)]
[Notices]
[Pages 9819-9820]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-4791]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-10110, CMS-R-250, CMS-R-144/CMS-368 and CMS-
668B]
Agency Information Collection Activities: Submission for OMB
Review; 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), 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 function; (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: Revision of a currently
approved collection; Title of Information Collection: Manufacturer
Submission of Average Sales Price (ASP) Data for Medicare Part B Drugs
and Biologicals; Use: Section 1847A of the Social Security Act requires
that the Medicare Part B payment amounts for covered drugs and
biologicals not paid on a cost or prospective payment basis be based
upon manufacturers' average sales price data submitted to CMS. CMS will
utilize the ASP data to determine the Medicare Part B drug payment
amounts. Form Number: CMS-10110 (OMB 0938-0921); Frequency:
Quarterly; Affected Public: Business or other for-profits; Number of
Respondents: 180; Total Annual Responses: 720; Total Annual Hours:
28,800. (For policy questions regarding this collection contact
Catherine Jansto at 410-786-7762. For all other issues call 410-786-
1326.)
2. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: MPAF Data and
Supporting Regulations in 42 CFR 413.337, 413.343, 424.32 and 483.20;
Use: Resident assessment information that Skilled Nursing Facilities
(SNFs) are required to submit is described under section 42 CFR 413.343
and 483.20. The manner necessary to administer the payment rate
methodology is described under section 42 CFR 413.337. An assessment
form comprised of a subset of resident assessment information has been
developed for use by SNFs to satisfy Medicare payment requirements, in
lieu of a full Minimum Data Set. The associated burden is the time the
SNF staff is required to complete the Medicare PPS Assessment Form
(MPAF), SNF staff time to encode, and SNF staff time spent in
transmitting the data. Form Number: CMS-R-250 (OMB 0938-0739);
Frequency: Occasionally; Affected Public: Business or other for-profits
and not-for-profit institutions, State, Local, or Tribal Governments,
and Federal Government; Number of Respondents: 15,039; Total Annual
Responses: 3,834,945; Total Annual Hours: 2,704,764. (For policy
questions regarding this collection contact Julie Stankivic at 410-786-
5725. For all other issues call 410-786-1326.)
3. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: State Medicaid
Drug Rebate; Use: Section 1927 of the Social Security Act requires each
State Medicaid agency to report quarterly prescription drug utilization
information to drug manufacturers and to CMS. As part of this
information, the State Medicaid agencies are required to report the
total Medicaid rebate amount they claim they are owed by each drug
manufacturer for each covered prescription drug product each quarter.
Form Number: CMS-R-144 and CMS-368 (OMB 0938-0582); Frequency:
Quarterly; Affected Public: State, Local or Tribal Governments; Number
of Respondents: 51; Total Annual Responses: 204; Total Annual Hours:
9,389. (For policy questions regarding this collection contact Dusty
Kerhart at 410-786-3273. For all other issues call 410-786-1326.)
4. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Post Clinical
Laboratory Survey Questionnaire and Supporting Regulations in 42 CFR
493.1771, 493.1773, and 493.1777; Use: This form is used by the State
agency to determine a laboratory's compliance with the Clinical
Laboratory Improvement Amendments of 1988 (CLIA). This information is
needed for a laboratory's CLIA certification and recertification. Form
Number: CMS-
[[Page 9820]]
668B (OMB 0938-0653); Frequency: Biennially; Affected Public:
Business or other for-profits and not-for-profit institutions. State,
Local, or Tribal Government, Federal Government; Number of Respondents:
21,000; Total Annual Responses: 10,500; Total Annual Hours: 2,625. (For
policy questions regarding this collection contact Kathleen Todd at
410-786-3385. For all other issues call 410-786-1326.)
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 by the OMB desk
officer at the address below, no later than 5 p.m. on April 6, 2009.
OMB, Office of Information and Regulatory Affairs, Attention: CMS
Desk Officer, Fax Number: (202) 395-6974, E-mail: OIRA_
submission@omb.eop.gov.
Dated: February 27, 2009.
Michelle Shortt,
Director, Regulations Development Group, Office of Strategic Operations
and Regulatory Affairs.
[FR Doc. E9-4791 Filed 3-5-09; 8:45 am]
BILLING CODE 4120-01-P
