President's Committee for People With Intellectual Disabilities; Notice of Meeting, 59294-59295 [E7-20617]
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Federal Register / Vol. 72, No. 202 / Friday, October 19, 2007 / Notices
2. Type of Information Collection
Request: New collection; Title of
Information Collection: Testing of
Revised OASIS Instrument for Home
Health Quality Measures & Data
Analysis; Use: Medicare-certified home
health agencies (HHAs) must meet the
Conditions of Participation (COPs) as set
forth at 42 CFR Part 484 and 488. Since
1999, the COPs have mandated that
HHAs use the ‘‘Outcome and
Assessment Information Set’’ (OASIS)
data set when evaluating adult, nonmaternity patients receiving skilled
services. The OASIS is a patientspecific, comprehensive assessment that
identifies each patient’s need for home
care and that meets the patient’s
medical, nursing, rehabilitative, social
and discharge planning needs.
Since OASIS data collection was
mandated in 1999, CMS has been
systematically collecting input on ways
to improve the OASIS instrument and
reduce the burden of the collection
effort. In 2002, CMS introduced the
‘‘reduced-burden’’ OASIS that was a
product of the Secretary’s Regulatory
Reform Advisory Committee to help
guide HHS’ broader efforts to streamline
unnecessarily burdensome or inefficient
regulations that interfere with the
quality of health care. Since the 2002
revision, CMS has continued to solicit
input on potential refinements and
enhancements of the OASIS instrument
from HHAs, industry associations,
consumer representatives, researchers
and other stakeholders.
Abt Associates and their
subcontractor UCHSC were awarded a
contract by CMS in September 2006 to
continue the process of refining the
OASIS data set, as well as for the testing
of the instrument and analysis of the
impact of proposed changes. Under this
contract, researchers from Abt
Associates, University of Colorado
Health Sciences Center (UCHSC), and
Case Western Reserve University have
assisted CMS in carrying out the
revisions based on the input described
in the previous section. Changes to the
OASIS instrument include the following
removal and revision of items:
• Elimination of 7 original OASIS
items not required for payment, quality
or risk adjustment;
• Replacement of 44 original OASIS
items with items that are revised and/
or simplified to respond to industry
concerns by increasing clarity and userfriendliness, and/or reducing
complexity and burden (e.g., removal of
‘‘prior status’’ assessment for all
Activity of Daily Living (ADL) and
Instrumental Activity of Daily Living
(IADL) items).
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The revised OASIS also includes the
addition of the following process items
to support evidence-based practices:
• A total of 7 process items to be
collected only at Start of Care/
Resumption of Care, 4 of which are to
be asked seasonally (e.g.; flu vaccine);
• A total of 10 process items to be
collected only at Follow-up, Transfer or
Discharge, either seasonally or on a
small subpopulation;
• A total of 13 process items to be
collected at all OASIS time points, 6 of
which are to be collected on a small
subpopulation.
We estimate the elimination,
simplification and revision of existing
OASIS items will have a burden impact
equivalent to the complete elimination
of 19 items. Since many of the process
items will be collected only on small
subpopulations or during specific
months of the year, we estimate the
impact of the addition of these items on
burden to be equivalent to the addition
of 20 items. Therefore, total impact of
proposed OASIS revisions, including
the elimination, revision and addition of
items, changes the estimated burden of
the OASIS very little while
incorporating process measures needed
to support evidence-based practices
across the post-acute care spectrum.
As a result of comments received
during the 60-day comment period from
the notice that published July 27, 2007
(72 FR 41328), we revised the
information collection. The revisions
include clarified language, corrected
time point guidance, improved
alignment with items in the CARE tool,
improved skip patterns that allow
clinicians to bypass questions not
relevant to patients, and the addition of
response options that allow clinicians to
document patient improvement. It is the
opinion of CMS that these revisions
have resulted in an improved tool that
addresses many of the concerns
expressed by commenters, with no
increase in burden. Form Number:
CMS–10238 (OMB#: 0938–NEW);
Frequency: Reporting: One-time;
Affected Public: Private Sector—
Business or other for-profit and Not-forprofit institutions; Number of
Respondents: 11; Total Annual
Responses: 11; Total Annual Hours:
173.58. 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
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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 19, 2007.
OMB Human Resources and Housing
Branch, Attention: Katherine Astrich,
New Executive Office Building, Room
10235, Washington, DC 20503, Fax
Number: (202) 395–6974.
Dated: October 11, 2007.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. E7–20649 Filed 10–18–07; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
President’s Committee for People With
Intellectual Disabilities; Notice of
Meeting
AGENCY: President’s Committee for
People With Intellectual Disabilities
(PCPID).
ACTION: Notice of quarterly meeting.
Thursday, November 15, 2007,
from 2 p.m.–4 p.m. EST. The meeting
will be conducted via conference call
and will be open to the public using the
dial-in information provided below.
ADDRESSES: The conference call may be
accessed on the date and time indicated
by dialing 888–989–6481, passcode:
PCPID.
Agenda: PCPID will meet to formulate
an action plan and timeline for
completion of the 2008 Report to the
President.
FOR FURTHER INFORMATION CONTACT:
Sally D. Atwater, Executive Director,
President’s Committee for People With
Intellectual Disabilities, The Aerospace
Center, Second Floor, West, 370
L’Enfant Promenade, SW., Washington,
DC 20447. Telephone: 202–619–0634,
fax: 202–205–9591. E-mail:
satwater@acf.hhs.gov.
SUPPLEMENTARY INFORMATION: PCPID
acts in an advisory capacity to the
President and the Secretary of Health
and Human Services on a broad range
of topics relating to programs, services
and supports for persons with
intellectual disabilities. PCPID, by
Executive Order, is responsible for
evaluating the adequacy of current
DATES:
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Federal Register / Vol. 72, No. 202 / Friday, October 19, 2007 / Notices
practices in programs, services and
supports for persons with intellectual
disabilities, and for reviewing legislative
proposals that impact the quality of life
experienced by citizens with
intellectual disabilities and their
families.
Dated: October 15, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–20632 Filed 10–18–07; 8:45 am]
Dated: October 3, 2007.
Sally D. Atwater,
Executive Director, President’s Committee for
People With Intellectual Disabilities.
[FR Doc. E7–20617 Filed 10–18–07; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Information
Program on Clinical Trials for Serious
or Life-Threatening Diseases:
Maintaining a Data Bank
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Guide to Minimize Food Safety
Hazards for Fresh-Cut Fruits and
Vegetables
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Guide to Minimize Food Safety
Hazards for Fresh-Cut Fruits and
Vegetables’’ has been approved by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
4659.
In the
Federal Register of March 13, 2007 (72
FR 11364), the agency announced that
the proposed information collection had
been submitted to OMB for review and
clearance under 44 U.S.C. 3507. An
agency may not conduct or sponsor, and
a person is not required to respond to,
a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0609. The
approval expires on October 31, 2010. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.fda.gov/
ohrms/dockets.
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SUPPLEMENTARY INFORMATION:
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Food and Drug Administration
[Docket No. 2007N–0182]
AGENCY:
[Docket No. 2006D–0079]
AGENCY:
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Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: 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.
DATES: Fax written comments on the
collection of information by November
19, 2007.
ADDRESSES: 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:
202–395–6974, or e-mailed to
baguilar@omb.eop.gov. All comments
should be identified with the OMB
control number 0910–0459. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
4659.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Information Program on Clinical Trials
for Serious or Life-Threatening
Diseases: Maintaining a Data Bank—
(OMB Control Number 0910–0459)—
Extension
In the Federal Register of March 18,
2002 (67 FR 12022), FDA issued a
guidance to industry on
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59295
recommendations for investigational
new drug application (IND) sponsors on
submitting information about clinical
trials for serious or life-threatening
diseases to a Clinical Trials Data Bank
developed by the National Library of
Medicine (NLM), National Institutes of
Health (NIH). This information is
especially important for patients and
their families seeking opportunities to
participate in clinical trials of new drug
treatments for serious or life-threatening
diseases. The guidance describes three
collections of information: Mandatory
submissions, voluntary submissions,
and certifications.
Mandatory Submissions
Section 113 of the Food and Drug
Administration Modernization Act
(FDAMA) of 1997 (the Modernization
Act) (Public Law 105–115) requires that
sponsors shall submit information to the
Clinical Trials Data Bank when the
clinical trial: (1) Involves a treatment for
a serious or life-threatening disease and
(2) is intended to assess the
effectiveness of the treatment. The
guidance discusses how sponsors can
fulfill the requirements of section 113 of
the Modernization Act. Specifically,
sponsors should provide: (1)
Information about clinical trials, both
federally and privately funded, of
experimental treatments (drugs,
including biological products) for
patients with serious or life-threatening
diseases; (2) a description of the
purpose of the experimental drug; (3)
patient eligibility criteria; (4) the
location of clinical trial sites; and (5) a
point of contact for patients wanting to
enroll in the trial.
Senate 1789, ‘‘Best Pharmaceuticals
for Children Act’’ (Public Law 107–109)
(BPCA), established a new requirement
for the Clinical Trials Data Bank
mandated by section 113 of FDAMA.
Information submitted to the data bank
must now include ‘‘a description of
whether and through what procedure,
the manufacturer or sponsor of the
investigation of a new drug will respond
to requests for protocol exception, with
appropriate safeguards, for singlepatient and expanded protocol use of
the new drug, particularly in children.’’
The guidance was updated on January
27, 2004, to include a discussion of how
sponsors can fulfill the BPCA
requirements.
As part of the resubmission process
for OMB approval, this information
collection request (ICR) has been revised
to include the burden associated with
new requirements imposed by the
Centers for Medicare and Medicaid
Services (CMS). On September 19, 2000,
the Health Care Financing
Administration (now CMS)
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]]>Agencies
[Federal Register Volume 72, Number 202 (Friday, October 19, 2007)]
[Notices]
[Pages 59294-59295]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-20617]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
President's Committee for People With Intellectual Disabilities;
Notice of Meeting
AGENCY: President's Committee for People With Intellectual Disabilities
(PCPID).
ACTION: Notice of quarterly meeting.
-----------------------------------------------------------------------
DATES: Thursday, November 15, 2007, from 2 p.m.-4 p.m. EST. The meeting
will be conducted via conference call and will be open to the public
using the dial-in information provided below.
ADDRESSES: The conference call may be accessed on the date and time
indicated by dialing 888-989-6481, passcode: PCPID.
Agenda: PCPID will meet to formulate an action plan and timeline
for completion of the 2008 Report to the President.
FOR FURTHER INFORMATION CONTACT: Sally D. Atwater, Executive Director,
President's Committee for People With Intellectual Disabilities, The
Aerospace Center, Second Floor, West, 370 L'Enfant Promenade, SW.,
Washington, DC 20447. Telephone: 202-619-0634, fax: 202-205-9591. E-
mail: satwater@acf.hhs.gov.
SUPPLEMENTARY INFORMATION: PCPID acts in an advisory capacity to the
President and the Secretary of Health and Human Services on a broad
range of topics relating to programs, services and supports for persons
with intellectual disabilities. PCPID, by Executive Order, is
responsible for evaluating the adequacy of current
[[Page 59295]]
practices in programs, services and supports for persons with
intellectual disabilities, and for reviewing legislative proposals that
impact the quality of life experienced by citizens with intellectual
disabilities and their families.
Dated: October 3, 2007.
Sally D. Atwater,
Executive Director, President's Committee for People With Intellectual
Disabilities.
[FR Doc. E7-20617 Filed 10-18-07; 8:45 am]
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