Agency Information Collection Activities; Proposed Collection; Comment Request; Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002, 54570-54571 [E9-25395]
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54570
Federal Register / Vol. 74, No. 203 / Thursday, October 22, 2009 / Notices
TRANSACTION GRANTED EARLY TERMINATION—Continued
ET date
Trans No.
20090690
03–SEP–09 ............................................................
20090401
04–SEP–09 ............................................................
20090697
20090702
20090704
FOR FURTHER INFORMATION CONTACT:
Sandra M. Peay, Contact Representative,
or Renee Hallman, Contact
Representative, Federal Trade
Commission, Premerger Notification
Office, Bureau of Competition, Room H–
303, Washington, DC 20580, (202) 326–
3100.
By direction of the Commission.
Donald S. Clark,
Secretary.
[FR Doc. E9–25377 Filed 10–21–09; 8:45 am]
BILLING CODE 6750–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0474]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Inspection by
Accredited Persons Program Under
the Medical Device User Fee and
Modernization Act of 2002
AGENCY:
Food and Drug Administration,
HHS.
dcolon on DSK2BSOYB1PROD with NOTICES
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
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Tilton Energy LLC.
Griffith Energy LLC.
Dynegy Arlington Valley, LLC.
Rocky Road Power, LLC.
General Motors Company.
Delphi Corporation.
DIP Holdco LLP.
Fidelity National Information Services, Inc.
Metavante Technologies, Inc.
Metavante Technologies, Inc.
Electric Power Development Co., Ltd.
General Electric Company.
Birchwood Power Partners, L.P.
Joe and Marlene Ricketts Grandchildren’s Trust.
Tribune Company.
Chicago Baseball Holdings, LLC.
STG III, L.P.
MSC.Software Corporation.
MSC.Software Corporation.
public comment in response to the
notice. This notice solicits comments on
the publication of the criteria FDA
intends to use to accredit third parties
to conduct inspections of eligible
manufacturers of class II or class III
medical devices.
DATES: Submit written or electronic
comments on the collection of
information by December 21, 2009.
ADDRESSES: Submit electronic
comments on the collection of
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,
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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.
Inspection by Accredited Persons
Program Under the Medical Device
User Fee and Modernization Act of
2002; FD&C Act, Section 704(g) (OMB
Control Number 0910–0510)—Extension
The Medical Device User Fee and
Modernization Act of 2002 (MDUFMA)
(Public Law 107–250) was signed into
law on October 26, 2002. Section 201 of
MDUFMA adds a new paragraph ‘‘g’’ to
section 704 of the Federal, Food, Drug,
and Cosmetic Act (the FD&C Act) (21
U.S.C. 374), directing FDA to accredit
third parties (accredited persons (APs)
to conduct inspections of eligible
manufacturers of class II or class III
devices. This is a voluntary program.
E:\FR\FM\22OCN1.SGM
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54571
Federal Register / Vol. 74, No. 203 / Thursday, October 22, 2009 / Notices
FDA has a guidance document that
provides information for those
interested in participating in this
program. The guidance is entitled
‘‘Implementation of the Inspection by
Accredited Persons Program Under the
Medical Device User Fee and
Modernization Act of 2002;
Accreditation Criteria.’’
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
FD&C Act
Section:
No. of
Respondents
704(g)
1 There
Annual Frequency
per Response
3
Total Annual
Responses
1
3
Total Hours
80
240
are no capital costs or operating and maintenance costs associated with this collection of information
FDA based these estimates on
conversations with industry, trade
association representatives, and internal
FDA estimates. Once an organization is
accredited, it will not be required to
reapply.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: October 7, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–25395 Filed 10–21–09; 8:45 am]
RIN 0938–AP48
BILLING CODE 4160–01–S
National Institutes of Health
Notice of Establishment
Pursuant to the Federal Advisory
Committee Act, as amended (5 U.S.C.
Appendix 2), the Director, National
Institutes of Health (NIH), announces
the establishment of the
Interdisciplinary Molecular Sciences
and Training Integrated Review Group,
(IRG).
The IRG shall advise the Director,
National Institutes of Health (NIH), and
the Director, Center for Scientific
Review (CSR), on the scientific and
technical merit of applications for
grants-in-aid for research, research
training or research-related grants and
cooperative agreements, or contract
proposals relating to scientific areas
relevant to biological chemistry,
biophysics and cell biology, drug
discovery and development, devices
and detection systems, biomaterials,
delivery systems and nanotechnology,
computational biology, imaging and
data mining, genes, genomes and
genetics, environmental monitoring, and
basic translational oncology.
Duration of this committee will be
continuing with no specified end date.
Dated: October 9, 2009.
Francis S. Collins,
Director, National Institutes of Health.
[FR Doc. E9–25374 Filed 10–21–09; 8:45 am]
BILLING CODE 4140–01–M
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Centers for Medicare & Medicaid
Services
[CMS–8039–N]
Medicare Program; Medicare Part B
Monthly Actuarial Rates, Premium
Rate, and Annual Deductible
Beginning January 1, 2010
AGENCY: Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
dcolon on DSK2BSOYB1PROD with NOTICES
Hours per
Response
SUMMARY: This notice announces the
monthly actuarial rates for aged (age 65
and over) and disabled (under age 65)
beneficiaries enrolled in Part B of the
Medicare Supplementary Medical
Insurance (SMI) program beginning
January 1, 2010. In addition, this notice
announces the monthly premium for
aged and disabled beneficiaries as well
as the income-related monthly
adjustment amounts to be paid by
beneficiaries with modified adjusted
gross income above certain threshold
amounts. The monthly actuarial rates
for 2010 are $221.00 for aged enrollees
and $270.40 for disabled enrollees. The
standard monthly Part B premium rate
for 2010 is $110.50, which is equal to
50 percent of the monthly actuarial rate
for aged enrollees or roughly 25 percent
of the expected average total cost of Part
B coverage for aged enrollees. (The 2009
standard premium rate was $96.40.) The
Part B deductible for 2010 is $155.00 for
all Part B beneficiaries. A beneficiary
who has to pay an income-related
monthly adjustment may have to pay a
total monthly premium of roughly 35,
50, 65 or 80 percent of the total cost of
Part B coverage.
DATES: Effective Date: January 1, 2010.
FOR FURTHER INFORMATION CONTACT: M.
Kent Clemens, (410) 786–6391.
SUPPLEMENTARY INFORMATION:
I. Background
Part B is the voluntary portion of the
Medicare program that pays all or part
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of the costs for physicians’ services,
outpatient hospital services, certain
home health services, services furnished
by rural health clinics, ambulatory
surgical centers, comprehensive
outpatient rehabilitation facilities, and
certain other medical and health
services not covered by Medicare Part
A, Hospital Insurance. Medicare Part B
is available to individuals who are
entitled to Medicare Part A, as well as
to U.S. residents who have attained age
65 and are citizens, and aliens who were
lawfully admitted for permanent
residence and have resided in the
United States for 5 consecutive years.
Part B requires enrollment and payment
of monthly premiums, as provided for
in 42 CFR part 407, subpart B, and part
408, respectively. Part B costs are met
by payments from the Part B account of
the Supplementary Medical Insurance
Trust Fund, which is funded by the
premiums paid by all enrollees and
general revenues of the Federal
Government.
The Secretary of the Department of
Health and Human Services (the
Secretary) is required by section 1839 of
the Social Security Act (the Act) to
announce the Part B monthly actuarial
rates for aged and disabled beneficiaries
as well as the monthly Part B premium.
The Part B annual deductible is
included because its determination is
directly linked to the aged actuarial rate.
The monthly actuarial rates for aged
and disabled enrollees are used to
determine the correct amount of general
revenue financing per beneficiary each
month. These rates, according to
actuarial estimates, will initially equal,
respectively, one-half the expected
average monthly cost of Part B for each
aged enrollee (age 65 or over) and onehalf the expected average monthly cost
of Part B for each disabled enrollee
(under age 65). The actuarial rates are
then adjusted to include any margin
necessary to maintain an adequate
contingency reserve in the Part B
account of the Supplementary Medical
Insurance Trust Fund.
The Part B deductible to be paid by
enrollees is also announced. Prior to the
E:\FR\FM\22OCN1.SGM
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]]>Agencies
[Federal Register Volume 74, Number 203 (Thursday, October 22, 2009)]
[Notices]
[Pages 54570-54571]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-25395]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0474]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Inspection by Accredited Persons Program Under the
Medical Device User Fee and Modernization Act of 2002
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 publication of the
criteria FDA intends to use to accredit third parties to conduct
inspections of eligible manufacturers of class II or class III medical
devices.
DATES: Submit written or electronic comments on the collection of
information by December 21, 2009.
ADDRESSES: Submit electronic comments on the collection of 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.
Inspection by Accredited Persons Program Under the Medical Device
User Fee and Modernization Act of 2002; FD&C Act, Section 704(g) (OMB
Control Number 0910-0510)--Extension
The Medical Device User Fee and Modernization Act of 2002 (MDUFMA)
(Public Law 107-250) was signed into law on October 26, 2002. Section
201 of MDUFMA adds a new paragraph ``g'' to section 704 of the Federal,
Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 374), directing
FDA to accredit third parties (accredited persons (APs) to conduct
inspections of eligible manufacturers of class II or class III devices.
This is a voluntary program.
[[Page 54571]]
FDA has a guidance document that provides information for those
interested in participating in this program. The guidance is entitled
``Implementation of the Inspection by Accredited Persons Program Under
the Medical Device User Fee and Modernization Act of 2002;
Accreditation Criteria.''
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
FD&C Act No. of Annual Frequency Total Annual Hours per
Section : Respondents per Response Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
704(g) 3 1 3 80 240
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information
FDA based these estimates on conversations with industry, trade
association representatives, and internal FDA estimates. Once an
organization is accredited, it will not be required to reapply.
Dated: October 7, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-25395 Filed 10-21-09; 8:45 am]
BILLING CODE 4160-01-S
