Proposed Information Collection Activity; Comment Request, 60051-60052 [2011-24967]
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Federal Register / Vol. 76, No. 188 / Wednesday, September 28, 2011 / Notices
Demonstration grant. The program
supports the movement of Medicaid
beneficiaries with disabling and chronic
conditions from institutions into the
community. The award expands already
funded tasks related to quality technical
assistance provided to State grantees.
DATES: Effective Date: The program
expansion is effective on the date of
award (before September 30, 2011
through April 15, 2013).
FOR FURTHER INFORMATION CONTACT:
Anita Yuskauskas, (410) 786–0268.
Arun Natarajan, (410) 786–7455.
SUPPLEMENTARY INFORMATION:
sroberts on DSK5SPTVN1PROD with NOTICES
I. Background
The need for additional funds is the
result of an increase in the number of
Money Follows the Person (MFP) State
Grantees through the Patient Protection
and Affordable Care Act (Affordable
Care Act) (Pub. L. 111–148, enacted on
March 23, 2010). Fifteen additional
States received new MFP funds in
January, 2011 under the Affordable Care
Act. The increase in the number of
States and programs resulting from the
Affordable Care Act place more demand
on the need for technical assistance to
States developing and implementing
quality improvement strategies,
particularly given the complexity and
vulnerability of the populations being
served in MFP and the Congress’
commitment to the Grant Program’s
success. The expansion was not
calculated in the original National
Quality Enterprise (NQE) budget
because at the time of the original
award, the Affordable Care Act money
was not included in CMS’ budget
allocation.
The additional resources are
necessary to assure the success of the
individual placements, specifically, by
facilitating sufficient quality
mechanisms to address the unique
needs of the populations with disabling
and chronic conditions. These are the
most vulnerable populations and a lack
of quality and oversight mechanisms in
place, may place individuals at risk.
II. Provisions of the Notice
We solicited a proposal from
Thomson Reuters Healthcare to expand
the National Home and CommunityBased Services (HCBS) Quality
Enterprise beyond the grant’s present
scope. The expansion was created by
section 2403 of the Affordable Care Act,
which amended section 6071 of the
Deficit Reduction Act of 2005, the
Money Follows the Person Rebalancing
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18:20 Sep 27, 2011
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Demonstration. The provision expanded
previous legislation to support State and
CMS efforts to improve quality in a
‘‘rebalanced’’ long-term support system,
and to demonstrate the ongoing benefits
from and need for an effective HCBS QI
Enterprise. The grant offered $1.2
million over 2 years through a program
expansion supplement.
We requested that the Thomson
Reuters Healthcare submit an
abbreviated application addressing the
expansion of the existing grant. The
Grantee provided an updated quality
technical assistance model and work
plan focused on the following four
major goals:
• Development of a process
demonstrating consistency between the
Grantee and CMS, and across all
Grantee staff and subcontractors for
providing technical assistance (Project
Management, 1.1).
• The provision of technical
assistance to states related to quality in
home and community-based services
programs (Technical Assistance, 2.1b).
• The provision of technical
assistance to CMS staff related to the
oversight of quality in HCBS programs
(Technical Assistance, 2.1c).
• The ongoing development and
maintenance of a national HCBS quality
web-based technical assistance site and
quality TA manuscripts (Technical
Assistance, 2.1d and e).
As part of the application, based on
the four major goals listed above, the
Grantee submitted a 3 page project
narrative describing the activities, and
an accompanying budget revision,
related to Grant #1LICMS030329/01,
entitled ‘‘The National HCBS Quality
Enterprise: Assisting States to Achieve
Enhanced Quality in a Rebalanced
Environment’’.
The documents included the
following:
• Cover Letter—The letter included
the current project director’s name and
a brief summary of the proposed project,
submitted and signed by the authorized
representative for this grant.
• SF–424a (Budget Information—Non
Construction Programs)—The applicant
provided the total costs for the
remainder of the project for $1.2
million, with a break out of those costs
in Section B ‘‘Budget Categories’’ of the
SF–424a form. The costs proposed were
for the additional costs only (not the
cumulative total costs of the entire
grant).
• Detailed Budget Narrative—The
applicant provided a detailed
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60051
breakdown of the aggregate numbers for
the budget recorded on the Standard
Form 424a ‘‘Budget Information—Non
Constructions Programs,’’ including
allocations for each major set of
activities or proposed tasks. The
proposed budget justification clearly
described each cost element in the
related budget category.
• Project Narrative—The project
narrative (approximately 3 pages in
length) provided a concise and complete
description of the proposed project. It
contained the information necessary for
CMS to fully understand the additional
work of the project. It covered all
aspects of the project requirements (see
criteria for writing the project
narrative—four major goals).
Authority: Section 6071 Deficit Reduction
Act of 2005.
Dated: September 20, 2011.
Daniel F. Kane,
Chief Grants Management Officer, Office of
Acquisition and Grants Management, Centers
for Medicare & Medicaid Services.
[FR Doc. 2011–24986 Filed 9–27–11; 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: State Council on Developmental
Disabilities Program Performance
Report.
OMB No.: 0980–0172.
Description: A Developmental
Disabilities Council Program
Performance Report is required by
federal statute. Each State
Developmental Disabilities Council
must submit an annual report for the
preceding fiscal year of activities and
accomplishments. Information provided
in the Program Performance Report will
be used (1) in the preparation of the
biennial Report to the President, the
Congress, and the National Council on
Disabilities and (2) to provide a national
perspective on program
accomplishments and continuing
challenges. This information will also
be used to comply with requirements in
the Government Performance and
Results Act of 1993.
Respondents: State Governments.
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60052
Federal Register / Vol. 76, No. 188 / Wednesday, September 28, 2011 / Notices
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
State Council on Developmental Disabilities Program Performance Report ..
55
Estimated Total Annual Burden
Hours: 7,590.
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. E-mail 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
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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Robert Sargis,
Reports Clearance Officer.
FOR FURTHER INFORMATION CONTACT:
[FR Doc. 2011–24967 Filed 9–27–11; 8:45 am]
sroberts on DSK5SPTVN1PROD with NOTICES
BILLING CODE 4184–01–P
Food and Drug Administration
[Docket No. FDA–2011–N–0362]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Current Good
Manufacturing Practice Regulations for
Finished Pharmaceuticals
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
SUMMARY:
Fax written comments on the
collection of information by October 28,
2011.
DATES:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0139. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
Juanmanuel Vilela, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850, 301–
796–7651,
juanmanuel.vilela@fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
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Number of
responses per
respondent
1
Average
burden hours
per response
138
Total burden
hours
7,590
Current Good Manufacturing Practice
Regulations for Finished
Pharmaceuticals—21CFR Parts 210 and
211 (OMB Control No. 0910–0139)—
Extension
Under Section 501(a)(2)(B) of the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 351(a)(2)(B)),
a drug is adulterated if the methods
used in, or the facilities or controls used
for, its manufacture, processing,
packing, or holding do not conform to
or are not operated or administered in
conformity with Current Good
Manufacturing Practices (CGMPs) to
ensure that such drug meets the
requirements of the FD&C Act as to
safety, and has the identity and strength,
and meets the quality and purity
characteristics, which it purports or is
represented to possess.
The FDA has the authority under
Section 701(a) of the FD&C Act
(21 U.S.C. 371(a)) to issue regulations
for the efficient enforcement of the
FD&C Act regarding CGMP procedures
for manufacturing, processing, and
holding drugs and drug products. The
CGMP regulations help ensure that drug
products meet the statutory
requirements for safety and have their
purported or represented identity,
strength, quality, and purity
characteristics. The information
collection requirements in the CGMP
regulations provide FDA with the
necessary information to perform its
duty to protect public health and safety.
CGMP requirements establish
accountability in the manufacturing and
processing of drug products, provide for
meaningful FDA inspections, and
enable manufacturers to improve the
quality of drug products over time. The
CGMP recordkeeping requirements also
serve preventive and remedial purposes
and provide crucial information if it is
necessary to recall a drug product.
The general requirements for
recordkeeping under part 211 (21 CFR
part 211) are set forth in § 211.180. Any
production, control, or distribution
record associated with a batch and
required to be maintained in
compliance with part 211 must be
retained for at least one year after the
expiration date of the batch and, for
certain OTC drugs, three years after
distribution of the batch (§ 211.180(a)).
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[Federal Register Volume 76, Number 188 (Wednesday, September 28, 2011)]
[Notices]
[Pages 60051-60052]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-24967]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Proposed Projects
Title: State Council on Developmental Disabilities Program
Performance Report.
OMB No.: 0980-0172.
Description: A Developmental Disabilities Council Program
Performance Report is required by federal statute. Each State
Developmental Disabilities Council must submit an annual report for the
preceding fiscal year of activities and accomplishments. Information
provided in the Program Performance Report will be used (1) in the
preparation of the biennial Report to the President, the Congress, and
the National Council on Disabilities and (2) to provide a national
perspective on program accomplishments and continuing challenges. This
information will also be used to comply with requirements in the
Government Performance and Results Act of 1993.
Respondents: State Governments.
[[Page 60052]]
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average
Instrument Number of responses per burden hours Total burden
respondents respondent per response hours
----------------------------------------------------------------------------------------------------------------
State Council on Developmental Disabilities 55 1 138 7,590
Program Performance Report.....................
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 7,590.
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. E-mail
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 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. 2011-24967 Filed 9-27-11; 8:45 am]
BILLING CODE 4184-01-P
