Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Generic Clearance for the Collection of Qualitative Feedback on FDA Service Delivery, 74790 [2011-30877]
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Federal Register / Vol. 76, No. 231 / Thursday, December 1, 2011 / Notices
should address combinations of
treatments, co-morbid conditions, and
ulcer characteristics that require an
individualized approach to treatment.
These comments led us to expand the
potential range of treatments evaluated
in the review. Because treatment goals
for patients in hospice care differ widely
from patients with pressure ulcers in
other settings (wound healing may not
be a goal of hospice care), we excluded
hospice from the list of care settings to
be reviewed. The final set of KQs is as
follows:
Final Key Questions
Question 1
In adults with pressure ulcers, what is
the comparative effectiveness of
treatment strategies for improved health
outcomes including but not limited to:
Complete wound healing, healing time,
reduced wound surface area, pain, and
prevention of serious complications of
infection?
Question 1a
Does the comparative effectiveness of
treatment strategies differ according to
features of the pressure ulcers, such as
anatomic site or severity at baseline?
Question 1b
Does the comparative effectiveness of
treatment strategies differ according to
patient characteristics, including but not
limited to: Age; race/ethnicity; body
weight; specific medical co-morbidities;
and known risk factors for pressure
ulcers, such as functional ability,
nutritional status, or incontinence?
Question 1c
Does the comparative effectiveness of
treatment strategies differ according to
patient care settings such as home,
nursing facility, or hospital, or
according to features of patient care
settings, including but not limited to
nurse/patient staffing ratio, staff
education and training in wound care,
the use of wound care teams, and home
caregiver support and training?
emcdonald on DSK5VPTVN1PROD with NOTICES
Question 2
What are the harms of treatments for
pressure ulcers?
Question 2a
Do the harms of treatment strategies
differ according to features of the
pressure ulcers, such as anatomic site or
severity at baseline?
Question 2b
Do the harms of treatment strategies
differ according to patient
characteristics, including: Age, race/
ethnicity; body weight; specific medical
VerDate Mar<15>2010
17:34 Nov 30, 2011
Jkt 226001
co-morbidities; and knows risk factors
for pressure ulcers, such as functional
ability, nutritional status, or
incontinence?
Question 2c
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0327]
Do the harms of treatment strategies
differ according to patient care settings
such as home, nursing facility, or
hospital, or according to features of
patient care settings, including but not
limited to nurse/patient staffing ratio,
staff education and training in wound
care, the use of wound care teams, and
home caregiver support and training?
The following PICOTS were identified
for each KQ and include:
Population
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Generic Clearance for the Collection of
Qualitative Feedback on FDA Service
Delivery
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Generic Clearance for the Collection of
Qualitative Feedback on FDA Service
Delivery’’ has been approved by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995.
SUMMARY:
• Adults ages 18 and older with
pressure ulcers.
Interventions
• Various treatment strategies for
pressure ulcers including but not
limited to therapies that address the
underlying contributing factors
(e.g., support surfaces and nutritional
supplements); therapies that address
local wound care (e.g., absorbent wound
dressings and biological agents);
surgical repair; and adjunctive therapies
(e.g., physical therapy).
• Combined treatment modalities
(co-interventions) will also be evaluated
(such as comparing two treatments in
combination with a single treatment).
Comparators
• Placebo or active control, usual
care, or other interventions.
Outcomes
• For effectiveness: Complete wound
healing, healing time, reduced wound
surface area, pain, and prevention of
serious complications of infection.
• For harms of treatment: Pain,
dermatologic complications, bleeding,
and infection.
Timing
• Any duration of follow-up.
Settings
• Patient care settings, such as home,
nursing facility, or hospital.
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.
On May
26, 2011, the Agency submitted a
proposed collection of information
entitled ‘‘Generic Clearance for the
Collection of Qualitative Feedback on
FDA Service Delivery’’ 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
0910–0697. The approval expires on
November 30, 2014. A copy of the
supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
SUPPLEMENTARY INFORMATION:
Dated: November 25, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–30877 Filed 11–30–11; 8:45 am]
Dated: November 16, 2011.
Carolyn M. Clancy,
AHRQ, Director.
BILLING CODE 4160–01–P
[FR Doc. 2011–30796 Filed 11–30–11; 8:45 am]
BILLING CODE 4160–90–M
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]]>Agencies
[Federal Register Volume 76, Number 231 (Thursday, December 1, 2011)]
[Notices]
[Page 74790]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-30877]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0327]
Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Generic Clearance for the Collection
of Qualitative Feedback on FDA Service Delivery
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
collection of information entitled ``Generic Clearance for the
Collection of Qualitative Feedback on FDA Service Delivery'' 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 Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B,
Rockville, MD 20850, (301) 796-3794, Jonnalynn.Capezzuto@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: On May 26, 2011, the Agency submitted a
proposed collection of information entitled ``Generic Clearance for the
Collection of Qualitative Feedback on FDA Service Delivery'' 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 0910-0697. The approval expires on November 30, 2014. A
copy of the supporting statement for this information collection is
available on the Internet at https://www.reginfo.gov/public/do/PRAMain.
Dated: November 25, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-30877 Filed 11-30-11; 8:45 am]
BILLING CODE 4160-01-P
