Agency Information Collection Activities: Proposed Collection; Comment Request, 76034 [E8-29543]
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76034
Federal Register / Vol. 73, No. 241 / Monday, December 15, 2008 / Notices
the address below, no later than 5 p.m.
on January 14, 2009.
OMB, Office of Information and
Regulatory Affairs, Attention: CMS
Desk Officer, New Executive Office
Building, Room 10235, Washington,
DC 20503, Fax Number: (202) 395–
6974.
Date: December 5, 2008.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. E8–29542 Filed 12–12–08; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10110, CMS–R–
250 and CMS–668B]
pwalker on PROD1PC71 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
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: 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
VerDate Aug<31>2005
20:00 Dec 12, 2008
Jkt 217001
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.
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
Governments; Number of Respondents:
15,039; Total Annual Responses:
3,834,945; Total Annual Hours:
2,704,764.
3. 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–
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.
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/
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
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.
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 February 13, 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 ll, Room C4–26–05,
7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
Dated: December 5, 2008.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. E8–29543 Filed 12–12–08; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0602]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Experimental
Study of the Impact of Coupons
Embedded in Direct-to-Consumer
Prescription Drug Print
Advertisements on Consumer
Perceptions of Product Risks and
Benefits
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 and to allow 60 days for
E:\FR\FM\15DEN1.SGM
15DEN1
Agencies
[Federal Register Volume 73, Number 241 (Monday, December 15, 2008)]
[Notices]
[Page 76034]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-29543]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-10110, CMS-R-250 and CMS-668B]
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: 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.
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 Governments; Number of Respondents: 15,039; Total Annual
Responses: 3,834,945; Total Annual Hours: 2,704,764.
3. 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-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.
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 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.
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 February 13, 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 ----, Room C4-26-05, 7500 Security Boulevard, Baltimore,
Maryland 21244-1850.
Dated: December 5, 2008.
Michelle Shortt,
Director, Regulations Development Group, Office of Strategic Operations
and Regulatory Affairs.
[FR Doc. E8-29543 Filed 12-12-08; 8:45 am]
BILLING CODE 4120-01-P