Agency Information Collection Activities: Proposed Collection; Comment Request, 54823-54824 [E9-25572]
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Federal Register / Vol. 74, No. 204 / Friday, October 23, 2009 / Notices
allowed for presentation by on-site
registrants may be less than that for preregistered speakers and will be
determined by the number of persons
who register at the meeting.
Persons registering to make oral
comments are asked, if possible, to send
a copy of their statement to the
Executive Secretary for the BSC (see
ADDRESSES above) by December 2, 2009,
to enable review by the BSC prior to the
meeting. Written statements can
supplement and may expand the oral
presentation. If registering on-site and
reading from written text, please bring
40 copies of the statement for
distribution to the BSC and NTP staff
and to supplement the record.
Background Information on the NTP
Board of Scientific Counselors
The BSC is a technical advisory body
comprised of scientists from the public
and private sectors that provides
primary scientific oversight to the NTP.
Specifically, the BSC advises the NTP
on matters of scientific program content,
both present and future, and conducts
periodic review of the program for the
purpose of determining and advising on
the scientific merit of its activities and
their overall scientific quality. Its
members are selected from recognized
authorities knowledgeable in fields such
as toxicology, pharmacology, pathology,
biochemistry, epidemiology, risk
assessment, carcinogenesis,
mutagenesis, molecular biology,
behavioral toxicology, neurotoxicology,
immunotoxicology, reproductive
toxicology or teratology, and
biostatistics. Members serve overlapping
terms of up to four years. BSC meetings
are held annually or biannually.
Dated: October 16, 2009.
John R. Bucher,
Associate Director, National Toxicology
Program.
[FR Doc. E9–25587 Filed 10–22–09; 8:45 am]
BILLING CODE P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
CPrice-Sewell on DSKGBLS3C1PROD with NOTICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–R–284 and
CMS–10190]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
AGENCY: Centers for Medicare &
Medicaid Services.
In compliance with the requirement
of section 3506(c)(2)(A) of the
VerDate Nov<24>2008
15:24 Oct 22, 2009
Jkt 220001
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: Extension without change of a
currently approved collection; Title of
Information Collection: Medicaid
Statistical Information System; Use:
State data are reported by the Federally
mandated electronic process, known as
(MSIS) Medical Statistical Information
System. These data are the basis of
actuarial forecasts for Medicaid service
utilization and costs; of analysis and
cost savings estimates required for
legislative initiatives relating to
Medicaid and for responding to requests
for information from CMS components,
the Department, Congress and other
customers; Form Number: CMS–R–284
(OMB#: 0938–0345); Frequency:
Reporting—Quarterly; Affected Public:
State, Local, or Tribal Governments;
Number of Respondents: 51; Total
Annual Responses: 204; Total Annual
Hours: 2,040. (For policy questions
regarding this collection contact Denise
Franz 410–786–6117. For all other
issues call 410–786–1326.)
2. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: State Plan
Preprints to Implement Sections 6083,
6036, 6041, 6042, 6043 and 6044 of the
Deficit Reduction Act (DRA) of 1995;
Use: These preprints allow States the
opportunity and flexibility to request
changes in benefit packages, cost
sharing, non-emergency medical
transportation services, etc.; Form
Number: CMS–10190 (OMB#: 0938–
0993); Frequency: Reporting—Once and
Occasionally; Affected Public: State,
Local, or Tribal Governments; Number
of Respondents: 56; Total Annual
Responses: 16; Total Annual Hours:
699. (For policy questions regarding this
collection contact Fran Crystal at 410–
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54823
786–1195. 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 November 23, 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: October 16, 2009.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. E9–25573 Filed 10–22–09; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–R–64]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
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) 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
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54824
Federal Register / Vol. 74, No. 204 / Friday, October 23, 2009 / Notices
minimize the information collection
burden.
1. Type of Information Collection
Request: Extension of the currently
approved collection; Title of
Information Collection: Indirect Medical
Education (IME) and Supporting
Regulations at 42 CFR 412.105; Direct
Graduate Medical Education (GME) and
Supporting Regulations at 42 CFR
413.75 through 413.83; Use: The
information collected on interns and
residents (IRs) is used by the Medicare
Part A fiscal intermediaries (FI) and Part
A Medicare Administrative Contractors
(MAC) to verify the number of IRs used
in the calculation of Medicare program
payments for indirect medical education
(IME) as well as direct graduate medical
education (GME). The IR data collected
from the hospitals is processed through
computers at FIs/MACs to identify any
duplicated time based upon the
accumulated time of each individual
that worked at one or more hospitals.
The identification of duplicate IRs is
necessary to ensure that no IR is
counted more than once.
The FIs/MACs use the information
collected on IRs to help ensure that all
program payments for IME and GME are
based upon an accurate number of FTE–
IRs, determined in accordance with
Medicare regulations. The IR data
submitted by the hospitals are used by
the FIs/MACs during their audits of the
providers’ cost reports. The audit
procedures help assure that the
information reported was correct, and
that IRs who should not have been
reported by the hospitals (or portions of
the IRs’ time) are not included in the
FTE count. The FIs/MACs also use
reports of duplicate IRs to prevent
improper payment for IME and GME.
Form Number: CMS–R–64 (OMB#:
0938–0456); Frequency: Reporting—
Yearly; Affected Public: Business or
other for-profit and Not-for-profit
institutions; Number of Respondents:
1,190; Total Annual Responses: 1,190;
Total Annual Hours: 2,380. (For policy
questions regarding this collection
contact Milton Jacobson at 410–786–
7553. 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.
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15:24 Oct 22, 2009
Jkt 220001
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 December 22, 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: October 16, 2009.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. E9–25572 Filed 10–22–09; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0480]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Investigational
Device Exemptions Reports and
Records
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
Investigational Device Exemptions
Reports and Records.
DATES: Submit written or electronic
comments on the collection of
information by December 22, 2009.
ADDRESSES: Submit electronic
comments on the collection of
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information to https://www.
regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Jr., Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3793.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Investigational Device Exemptions
Reports and Records—21 CFR Part 812
(OMB Control Number 0910–0078)—
Extension
Section 520(g) of the Federal Food,
Drug, and Cosmetic Act (the act) (21
U.S.C. 360j(g)) establishes the statutory
authority to collect information
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Agencies
[Federal Register Volume 74, Number 204 (Friday, October 23, 2009)]
[Notices]
[Pages 54823-54824]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-25572]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-R-64]
Agency Information Collection Activities: Proposed Collection;
Comment Request
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) 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
[[Page 54824]]
minimize the information collection burden.
1. Type of Information Collection Request: Extension of the
currently approved collection; Title of Information Collection:
Indirect Medical Education (IME) and Supporting Regulations at 42 CFR
412.105; Direct Graduate Medical Education (GME) and Supporting
Regulations at 42 CFR 413.75 through 413.83; Use: The information
collected on interns and residents (IRs) is used by the Medicare Part A
fiscal intermediaries (FI) and Part A Medicare Administrative
Contractors (MAC) to verify the number of IRs used in the calculation
of Medicare program payments for indirect medical education (IME) as
well as direct graduate medical education (GME). The IR data collected
from the hospitals is processed through computers at FIs/MACs to
identify any duplicated time based upon the accumulated time of each
individual that worked at one or more hospitals. The identification of
duplicate IRs is necessary to ensure that no IR is counted more than
once.
The FIs/MACs use the information collected on IRs to help ensure
that all program payments for IME and GME are based upon an accurate
number of FTE-IRs, determined in accordance with Medicare regulations.
The IR data submitted by the hospitals are used by the FIs/MACs during
their audits of the providers' cost reports. The audit procedures help
assure that the information reported was correct, and that IRs who
should not have been reported by the hospitals (or portions of the IRs'
time) are not included in the FTE count. The FIs/MACs also use reports
of duplicate IRs to prevent improper payment for IME and GME. Form
Number: CMS-R-64 (OMB: 0938-0456); Frequency: Reporting--
Yearly; Affected Public: Business or other for-profit and Not-for-
profit institutions; Number of Respondents: 1,190; Total Annual
Responses: 1,190; Total Annual Hours: 2,380. (For policy questions
regarding this collection contact Milton Jacobson at 410-786-7553. 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 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 December 22, 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: October 16, 2009.
Michelle Shortt,
Director, Regulations Development Group, Office of Strategic Operations
and Regulatory Affairs.
[FR Doc. E9-25572 Filed 10-22-09; 8:45 am]
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