Proposed Information Collection Activity; Comment Request, 46835-46836 [2014-18903]
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Federal Register / Vol. 79, No. 154 / Monday, August 11, 2014 / Notices
Order No. 001 are identified in
Attachment J.1(a) Schedule of
Deliverables of the 11th SOW. Further,
as indicated in Sections G.22 and G.29,
the Contracting Officer will use the
Contractor Performance Assessment
Reporting System (CPARS) criteria in
performing evaluations: Quality,
Schedule/Timeliness, Cost/Price
Control, Business Relations,
Management, and Small Business.
Performance on the evaluation criteria
defined in Attachment J–1(b) will be
considered for assessment of the Quality
sub-factor for the CPARS assessment.
If we choose, we may notify the QIN–
QIO of the intention not to renew the
QIN–QIO contract, and inform the QIN–
QIO of the QIN–QIO’s rights under the
current statute. Any failure at one or
more of the annual or 54th month
evaluations for any Task may result in
the QIN–QIO receiving an adverse
performance evaluation. Further, failure
may impact on the QIN–QIO’s ability to
continue similar work in or eligibility
for future QIO Program awards.
We reserve the right at any point,
prior to the notification of our intention
not to continue the option for a Task
and/or to renew the contract, to revise
measures or adjust the expected
minimum thresholds for satisfactory
performance or remove criteria from a
Task evaluation protocol for any reason,
including, but not limited to, data
gathered based on experience with the
amount of improvement achieved
during the contract cycle or in pilot
projects currently in progress,
information gathered through evaluation
of the QIN–QIO performance overall, or
any unforeseen circumstances. Further,
in accordance with standard contract
procedures, we reserve the right at any
time to discontinue all or part of one or
more tasks for one or more states or
territories in the QIN area or any other
part of this contract regardless of QIN–
QIO performance on the Task.
mstockstill on DSK4VPTVN1PROD with NOTICES
Rounding Rules
The rounding of results to assess the
minimum performance criteria
indicated in Section J, Attachment J.1(b)
uses the following rules.
1. Interim Calculations
We will not round the interim results
of calculations used to produce results.
(For example, we will not round the
results from steps used to calculate the
criteria or result). For example, we will
not first round baseline and remeasurement rates for the calculation of
relative improvement.
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2. Percentages/Proportions/Rates
Use conventional rounding ‘‘round
half up.’’ For example, to round from
the hundredth to the tenth digit, round
using the tie-break rule of ‘‘half-up.’’
5.45 will become 5.5 whereas 5.44 will
become 5.4. Apply conventional
rounding to one digit beyond that used
to specify the criteria (for example, for
whole numbers, to the tenths place). For
example, for a criterion expressed as 5
percent, 4.46 percent rounds to 4.5
percent and 4.44 percent rounds to 4.4
percent.
3. Integers
For discrete numbers of units required
for improvement, round to the more
favorable (typically lower) integer with
a minimum of one. We note that this
method is applied selectively to special
cases as indicated in Section J,
Attachment J.1(b). This method is more
than a rounding rule. We calculate a
minimum performance target using the
minimum performance criteria and the
size of the re-measurement criteria. For
example, for a minimum criteria of 95
percent and a re-measurement
denominator of 10, 10 × 0.95 = 9.5,
which is rounded down (the more
favorable direction) to 9. For this
example, if CMS specified use of the
integer rounding rule for this measure,
the minimum performance criteria of 95
percent would be met by achieving at
least 9 cases given a re-measurement
denominator count of size 10. If we do
not specifically indicate that the integer
rounding rule applied to this measure,
the percentage rounding rule would be
used.
III. Collection of Information
Requirements
This document does not impose
information collection and
recordkeeping requirements.
Consequently, it need not be reviewed
by the Office of Management and
Budget under the authority of the
Paperwork Reduction Act of 1995.
IV. Response to Comments
Because of the large number of public
comments we normally receive on
Federal Register documents, we are not
able to acknowledge or respond to them
individually. We will consider all
comments we receive by the date and
time specified in the DATES section of
this preamble, and, when we proceed
with a subsequent document, we will
respond to the comments in the
preamble to that document.
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46835
VI. Regulatory Impact Statement
In accordance with the provisions of
Executive Order 12866, this notice was
not reviewed by the Office of
Management and Budget.
Dated: June 3, 2014.
Marilyn Tavenner,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 2014–18901 Filed 8–8–14; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Proposed Projects:
Title: Annual Report/ACF 204 (State
MOE)—1 collection.
OMB No.: 0970–0248.
Description: The Administration for
Children and Families (ACF) is
requesting a three-year extension of the
ACF–204 (Annual MOE Report). The
report is used to collect descriptive
program characteristics information on
the programs operated by States and
Territories in association with their
Temporary Assistance for Needy
Families (TANF) programs. All State
and Territory expenditures claimed
toward States and Territories MOE
requirements must be appropriate, i.e.,
meet all applicable MOE requirements.
The Annual MOE Report provides the
ability to learn about and to monitor the
nature of State and Territory
expenditures used to meet States and
Territories MOE requirements, and it is
an important source of information
about the different ways that States and
Territories are using their resources to
help families attain and maintain selfsufficiency. In addition, the report is
used to obtain State and Territory
program characteristics for ACFs annual
report to Congress, and the report serves
as a useful resource to use in
Congressional hearings about how
TANF programs are evolving, in
assessing State the Territory MOE
expenditures, and in assessing the need
for legislative changes.
Respondents: The 50 States of the
United States, the District of Columbia,
Guam, Puerto Rico, and the Virgin
Islands.
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Federal Register / Vol. 79, No. 154 / Monday, August 11, 2014 / Notices
ANNUAL BURDEN ESTIMATES
Instrument
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
ACF–204 ..........................................................................................................
54
1
118
6,372
Estimated Total Annual Burden
Hours: 6,372
In compliance with the requirements
of Section 506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 370 L’Enfant
Promenade SW., Washington, DC 20447,
Attn: ACF Reports Clearance Officer.
Email address: infocollection@
acf.hhs.gov. All requests should be
identified by the title of the information
collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
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BILLING CODE 4184–01–P
17:35 Aug 08, 2014
Food and Drug Administration
[Docket No. FDA–2014–N–1076]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Guidance for
Industry on Formal Dispute
Resolution: Scientific and Technical
Issues Related to Pharmaceutical
Current Good Manufacturing Practice
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
the proposed collection of information
resulting from the guidance to
manufacturers of veterinary and human
drugs, including human biological drug
products, on how to resolve disputes of
scientific and technical issues relating
to current good manufacturing practice
(CGMP).
DATES: Submit either electronic or
written comments on the collection of
information by October 10, 2014.
SUMMARY:
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: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
ADDRESSES:
[FR Doc. 2014–18903 Filed 8–8–14; 8:45 am]
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Spring, MD 20993–0002; PRAStaff@
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
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.
Guidance for Industry on Formal
Dispute Resolution: Scientific and
Technical Issues Related to
Pharmaceutical Current Good
Manufacturing Practice (OMB Control
Number 0910–0563)—Extension
The guidance is intended to provide
information to manufacturers of
veterinary and human drugs, including
human biological drug products, on
how to resolve disputes of scientific and
technical issues relating to CGMP.
Disputes related to scientific and
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Agencies
[Federal Register Volume 79, Number 154 (Monday, August 11, 2014)]
[Notices]
[Pages 46835-46836]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-18903]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Proposed Projects:
Title: Annual Report/ACF 204 (State MOE)--1 collection.
OMB No.: 0970-0248.
Description: The Administration for Children and Families (ACF) is
requesting a three-year extension of the ACF-204 (Annual MOE Report).
The report is used to collect descriptive program characteristics
information on the programs operated by States and Territories in
association with their Temporary Assistance for Needy Families (TANF)
programs. All State and Territory expenditures claimed toward States
and Territories MOE requirements must be appropriate, i.e., meet all
applicable MOE requirements. The Annual MOE Report provides the ability
to learn about and to monitor the nature of State and Territory
expenditures used to meet States and Territories MOE requirements, and
it is an important source of information about the different ways that
States and Territories are using their resources to help families
attain and maintain self-sufficiency. In addition, the report is used
to obtain State and Territory program characteristics for ACFs annual
report to Congress, and the report serves as a useful resource to use
in Congressional hearings about how TANF programs are evolving, in
assessing State the Territory MOE expenditures, and in assessing the
need for legislative changes.
Respondents: The 50 States of the United States, the District of
Columbia, Guam, Puerto Rico, and the Virgin Islands.
[[Page 46836]]
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
ACF-204..................................... 54 1 118 6,372
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 6,372
In compliance with the requirements of Section 506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the Administration for Children and
Families is soliciting public comment on the specific aspects of the
information collection described above. Copies of the proposed
collection of information can be obtained and comments may be forwarded
by writing to the Administration for Children and Families, Office of
Planning, Research and Evaluation, 370 L'Enfant Promenade SW.,
Washington, DC 20447, Attn: ACF Reports Clearance Officer. Email
address: infocollection@acf.hhs.gov. All requests should be identified
by the title of the information collection.
The Department specifically requests comments on: (a) Whether the
proposed collection of information is necessary for the proper
performance of the functions of the agency, including whether the
information shall have practical utility; (b) the accuracy of the
agency's estimate of the burden of the proposed collection of
information; (c) the quality, utility, and clarity of the information
to be collected; and (d) ways to minimize the burden of the collection
of information on respondents, including through the use of automated
collection techniques or other forms of information technology.
Consideration will be given to comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2014-18903 Filed 8-8-14; 8:45 am]
BILLING CODE 4184-01-P