Agency Information Collection Activities; Proposed Collection; Comment Request; Notice of Participation, 55918-55919 [2011-23105]
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55918
Federal Register / Vol. 76, No. 175 / Friday, September 9, 2011 / Notices
152) (collectively, the ‘‘Affordable Care
Act’’), ‘‘Preservation of Resident Cap
Positions from Closed Hospitals.’’
Specifically, section 5506 of the
Affordable Care Act authorizes the
Secretary to redistribute residency cap
slots after a hospital that trained
residents in an approved medical
residency program(s) closes. St.
Vincent’s Medical Center’s official date
of termination of the Medicare provider
agreement and date of closure is October
31, 2010. The published notice,
announcing the hospital closure and
initiating the application process to
preserve St. Vincent’s resident cap
positions stated that the application
deadline was September 28, 2011. The
date of September 28, 2011, was chosen
since the procedure described in the
November 24, 2010 Federal Register (75
FR 72215) for initiating an application
process specifies that the application
deadline would be 4 months after
issuance of the notice to the public (that
is, September 28, 2011, is 4 months after
May 31, 2011).
Specifically, section 5506 of the
Affordable Care Act instructs the
Secretary to increase the FTE resident
caps for other hospitals based upon the
FTE resident positions in teaching
hospitals that closed ‘‘on or after a date
that is 2 years before the date of
enactment’’ (that is, March 23, 2008). In
the November 24, 2010 Federal Register
(75 FR 72215), we stated that hospitals
wishing to apply for FTE resident cap
slots from teaching hospitals that closed
between March 23, 2008 and through
and including August 3, 2010, must
submit applications to CMS by April 1,
2011. We further stated that for any
teaching hospital closures occurring
after August 3, 2010, separate notice
would be made announcing the closure
and initiating an application process for
those slots and a future application
deadline. The first application process
with the application deadline of April 1,
2011, spanned over a 2-year timeframe
(covering all hospital closures between
March 28, 2008 and through and
including August 3, 2010), and involved
15 closed teaching hospitals, generating
a very large number of applications and
slots to be redistributed. The closure of
St. Vincent’s Medical Center occurred
on October 31, 2010, and the notice
announcing the closure and initiating
the application process was published
on May 31, 2011, establishing the
September 28, 2011 application
deadline. Thus, the application period
CMS initiated for the preservation of
FTE resident slots due to the closure of
St. Vincent’s Medical Center overlaps
with the period during which CMS is
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16:58 Sep 08, 2011
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processing and reviewing the
applications received under the first
expansive section 5506 application
process, and issuing final
determinations to hospitals that may
receive increases to their FTE resident
caps. Moreover, we note that St.
Vincent’s Medical Center is located in
the same CBSA as 3 (of the 15) hospitals
that closed between March 23, 2008
through August 3, 2010, and many of
the hospitals wishing to apply for slots
from St. Vincent’s Medical Center have
indicated that it would be helpful to
receive the results of their applications
submitted under the first section 5506
process in order to make informed
decisions regarding the number of slots
for which to apply from St. Vincent’s
Medical Center under this separate
application process. CMS does not have
a specific deadline by which to issue
final determinations to hospitals that
receive slots under section 5506 of the
Affordable Care Act under the initial
expansive application process, yet we
understand the concerns of these
hospitals and believe it is appropriate,
in this case, to extend the application
deadline for FTE resident slots from St.
Vincent’s Medical Center. Accordingly,
we are extending the application
deadline for FTE resident slots from St.
Vincent’s Medical Center from
September 28, 2011 to December 1,
2011. We will consider applications
received no later than 5 p.m. (e.s.t)
December 1, 2011. Applications must be
received, not postmarked, by this date.
We continue to refer readers to
https://www.cms.gov/
AcuteInpatientPPS/06_dgme.asp#
TopOfPage to download a copy of the
CMS Evaluation Form 5506, which is
the application form that hospitals are
to use to apply for slots under section
5506 of the Affordable Care Act. In
addition, readers can access this Web
site for a copy of the CY 2011 OPPS
November 24, 2010 final rule, for an
explanation of the policy and
procedures for applying for slots and the
redistribution of the slots under sections
1886(h)(4)(H)(vi) and 1886(d)(5)(B)(v) of
the Social Security Act, as provided by
section 5506 of the Affordable Care Act.
The mailing addresses for the CMS New
York Regional Office and the CMS
Central Office are included in this
application form.
(Catalog of Federal Domestic Assistance
Program No. 93.773, Medicare—Hospital
Insurance; and Program No. 93.774,
Medicare—Supplementary Medical
Insurance Program)
PO 00000
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Dated: September 1, 2011.
Donald M. Berwick,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 2011–23120 Filed 9–8–11; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0624]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Notice of
Participation
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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
reporting requirements for filing a
notice of participation with FDA.
DATES: Submit either electronic or
written comments on the collection of
information by November 8, 2011.
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: Ila
S. Mizrachi, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., P150–
400B, Rockville, MD 20850, 301–796–
7726, Ila.Mizrachi@fda.hhs.gov.
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
SUMMARY:
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Federal Register / Vol. 76, No. 175 / Friday, September 9, 2011 / Notices
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.
Notice of Participation—21 CFR 12.45
(OMB Control Number 0910–0191)—
Extension
Section 12.45 (21 CFR 12.45), issued
under section 701 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 371),
sets forth the format and procedures for
any interested person to file a petition
to participate in a formal evidentiary
hearing, either personally or through a
representative. Section 12.45 requires
that any person filing a notice of
participation state their specific interest
in the proceedings, including the
specific issues of fact about which the
person desires to be heard. This section
also requires that the notice include a
statement that the person will present
testimony at the hearing and will
comply with specific requirements in 21
CFR 12.85, or, in the case of a hearing
before a Public Board of Inquiry,
concerning disclosure of data and
information by participants (21 CFR
13.25). In accordance with § 12.45(e),
the presiding officer may omit a
participant’s appearance.
The presiding officer and other
participants will use the collected
information in a hearing to identify
specific interests to be presented. This
preliminary information serves to
expedite the prehearing conference and
commits participation.
The respondents are individuals or
households, State or local governments,
not-for-profit institutions and
businesses, or other for-profit groups
and institutions.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
12.45 ....................................................................................
1 There
Number of
responses per
respondent
Number of
respondents
21 CFR section
4
1
Food and Drug Administration
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
revisions to Form FDA 3500 and Form
FDA 3500A, and proposed consumer
version of Form FDA 3500 (known as
the MedWatch reporting form) used in
the FDA Medical Products Reporting
Program.
[Docket No. FDA–2011–N–0608]
DATES:
Agency Information Collection
Activities; Proposed Collection;
Comment Request; MedWatch: The
Food and Drug Administration Medical
Products Reporting Program
ADDRESSES:
Dated: September 2, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–23105 Filed 9–8–11; 8:45 am]
BILLING CODE 4160–01–P
mstockstill on DSK4VPTVN1PROD with NOTICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration,
HHS.
ACTION:
4
Total hours
3
12
are no capital costs or operating and maintenance costs associated with this collection of information.
The burden estimates for this
collection of information are based on
Agency records and experience over the
past 3 years.
AGENCY:
Average
burden per
response
Total annual
responses
Notice.
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
SUMMARY:
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16:58 Sep 08, 2011
Jkt 223001
Submit either electronic or
written comments on the collection of
information by November 8, 2011.
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.
PO 00000
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Fmt 4703
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FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
3794,
Jonnalynn.capezzuto@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
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
E:\FR\FM\09SEN1.SGM
09SEN1
]]>Agencies
[Federal Register Volume 76, Number 175 (Friday, September 9, 2011)]
[Notices]
[Pages 55918-55919]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-23105]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0624]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Notice of Participation
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 reporting requirements for
filing a notice of participation with FDA.
DATES: Submit either electronic or written comments on the collection
of information by November 8, 2011.
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: Ila S. Mizrachi, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., P150-400B,
Rockville, MD 20850, 301-796-7726, Ila.Mizrachi@fda.hhs.gov.
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
[[Page 55919]]
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.
Notice of Participation--21 CFR 12.45 (OMB Control Number 0910-0191)--
Extension
Section 12.45 (21 CFR 12.45), issued under section 701 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371), sets forth the
format and procedures for any interested person to file a petition to
participate in a formal evidentiary hearing, either personally or
through a representative. Section 12.45 requires that any person filing
a notice of participation state their specific interest in the
proceedings, including the specific issues of fact about which the
person desires to be heard. This section also requires that the notice
include a statement that the person will present testimony at the
hearing and will comply with specific requirements in 21 CFR 12.85, or,
in the case of a hearing before a Public Board of Inquiry, concerning
disclosure of data and information by participants (21 CFR 13.25). In
accordance with Sec. 12.45(e), the presiding officer may omit a
participant's appearance.
The presiding officer and other participants will use the collected
information in a hearing to identify specific interests to be
presented. This preliminary information serves to expedite the
prehearing conference and commits participation.
The respondents are individuals or households, State or local
governments, not-for-profit institutions and businesses, or other for-
profit groups and institutions.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
21 CFR section Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
12.45........................... 4 1 4 3 12
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The burden estimates for this collection of information are based
on Agency records and experience over the past 3 years.
Dated: September 2, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-23105 Filed 9-8-11; 8:45 am]
BILLING CODE 4160-01-P
