Statement of Organization, Functions, and Delegations of Authority, 66308-66309 [2011-27497]
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66308
Federal Register / Vol. 76, No. 207 / Wednesday, October 26, 2011 / Notices
for studies that report on phototherapy
for treatment of chronic plaque
psoriasis, including those that describe
adverse events, as specified in the key
questions detailed below. The entire
research protocol, including the key
questions, is also available online at:
https://effectivehealthcare.AHRQ.gov/
index.cfm/search-forouides-reviews-and
-reports/?pageaction=displayproduct&
productid=793.
This notice is a request for industry
stakeholders to submit the following:
• A current product label, if
applicable (preferably an electronic PDF
file).
• Information identifying published
randomized controlled trials and
observational studies relevant to the
clinical outcomes. Please provide both a
list of citations and reprints if possible.
• Information identifying
unpublished randomized controlled
trials and observational studies relevant
to the clinical outcomes. If possible,
please provide a summary that includes
the following elements: study number,
study period, design, methodology,
indication and diagnosis, proper use
instructions, inclusion and exclusion
criteria, primary and secondary
outcomes, baseline characteristics,
number of patients screened/eligible/
enrolled/lost to withdrawn/followup/
analyzed, and effectiveness/efficacy and
safety results.
• Registered ClinicalTrials.gov
studies. Please provide a list including
the ClinicalTrials.gov identifier,
condition, and intervention.
Your contribution is very beneficial to
this program. AHRQ is not requesting
and will not consider marketing
material, health economics information,
or information on other indications.
This is a voluntary request for
information, and all costs for complying
with this request must be borne by the
submitter. In addition to your scientific
information please submit an index
document outlining the relevant
information in each file along with a
statement regarding whether or not the
submission comprises all of the
complete information available.
jlentini on DSK4TPTVN1PROD with NOTICES
Please Note: The contents of all
submissions, regardless of format, will be
available to the public upon request unless
prohibited by law.
The draft of this review will be posted
on AHRQ’s EHC program Web site and
available for public comment for a
period of 4 weeks. If you would like to
be notified when the draft is posted,
please sign up for the e-mail list at:
https://effectivehealthcare.AHRQ.gov/
index.cfm/join-the-email-list1/.
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Key Questions
Proposed Key Questions (KQs) were
posted for public comments and were
modified with consideration of the
comments received. Since controversy
surrounds the classification of psoriasis
as mild or moderate-to-severe,
moderate-to-severe disease was not
included as an explicit inclusion
criterion in the systematic search of the
literature or in the comparative
effectiveness review. As suggested in
the public comments, we will consider
when evaluating efficacy data whether
¨
patients were naıve to biologics, were
treated previously with biologics, or
were allowed drug holidays. Although a
suggestion was made to evaluate
combination therapy and to compare
harms in patients without psoriasis or
untreated controls with psoriasis, such
an evaluation falls outside the scope of
our review. We have now specified the
measures that will be used for healthrelated quality of life in KQ.
1. The Psoriasis Area and Severity
Index (PAST) score will be considered
not only as a binary outcome but as a
continuous outcome as suggested.
Although we had proposed the Psoriasis
Scalp Severity Index (PSSI) and the Nail
Psoriasis Severity Index (NAPSI) scores
as outcomes, patient-reported
improvement in scalp pruritus and
scalp pain were suggested as additional
outcomes in KQ 1; scalp pruritus and
scalp pain are not as commonly
reported in the literature and are less
likely to add extra value over the bodywide assessments. We have not listed
specific malignancies (hepatosplenic Tcell lymphoma and other lymphomas)
and infections (tuberculosis and
histoplasmosis) in KQ 2 as suggested to
be more comprehensive. Weight and
impact of neutralizing antibodies have
been added as characteristics that will
be evaluated in KQ 3. We did not move
major adverse cardiovascular events
(MACE) from final health outcomes to
harms, because this is an outcome of the
disease process rather than of
therapeutic interventions. Subgroup
analyses based on duration of followup
were discussed with the Technical
Expert Panelists (TEP).
The acronyms used in the questions
below are defined within the text and
the list under Definitions of Terms.
Question 1
In patients with chronic plaque
psoriasis, what is the comparative
effectiveness of systemic biologic agents
and systemic nonbiologic agents
(between-class comparisons) or
phototherapy when evaluating
intermediate (plaque BSA measurement,
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PAST score, Patient’s Assessment of
Global Improvement, PGA, and
individual symptom improvement) and
final health outcomes (mortality,
HRQoL [e.g., DLQI, HAQ–DI, EQ–5D]
and other patient-reported outcomes,
MACE, diabetes, and psychological
comorbidities [e.g., depression,
suicide])?
Question 2
In patients with chronic plaque
psoriasis, what is the comparative safety
of systemic biologic agents and systemic
nonbiologic agents (between-class
comparisons) or phototherapy
(hepatotoxicity [e.g., AST, ALT],
nephrotoxicity [e.g., SCr, GFR],
hematologic toxicity [e.g., TCP, anemia,
neutropenia], hypertension, alteration in
metabolic parameters [e.g., glucose,
lipids, weight, BMI, thyroid function],
injection site reaction, malignancy,
infection, and study withdrawal)?
Question 3
In patients with chronic plaque
psoriasis treated with systemic biologic
therapy, systemic nonbiologic therapy,
or phototherapy, which patient or
disease characteristics (e.g., age, gender,
race, weight, smoking status, psoriasis
severity, presence or absence of
concomitant psoriatic arthritis, disease
duration, baseline disease severity,
affected BSA, disease location, number
and type of previous treatments, failure
of previous treatments and presence of
neutralizing antibodies) affect
intermediate and final outcomes?
Details regarding the specific
therapies considered in each class of
interventions and comparators can be
found in Tables 1–5. There are no
specific requirements in terms of
followup period that will be evaluated
in these key questions. The setting will
include inpatient, outpatient and home
therapy.
Dated: October 14, 2011.
Carolyn M. Clancy,
Director, AHRQ.
[FR Doc. 2011–27563 Filed 10–25–11; 8:45 am]
BILLING CODE 4160–90–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Statement of Organization, Functions,
and Delegations of Authority
Part C (Centers for Disease Control
and Prevention) of the Statement of
Organization, Functions, and
Delegations of Authority of the
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Federal Register / Vol. 76, No. 207 / Wednesday, October 26, 2011 / Notices
Department of Health and Human
Services (45 FR 67772–76, dated
October 14, 1980, and corrected at 45 FR
69296, October 20, 1980, as amended
most recently at 76 FR 50223—50224,
dated August 12, 2011) is amended to
reflect the reorganization of the Office of
Public Health Preparedness and
Response, Centers for Disease Control
and Prevention.
Section C–B, Organization and
Functions, is hereby amended as
follows:
After item (7) in the functional
statement for the Office of Public Health
Preparedness and Response (CG),
Division of Strategic National Stockpile
(CGE), Office of the Director (CGE1),
insert the following: And (8) provides
leadership, guidance, and technical
assistance to state, tribal and local
territories for healthcare preparedness
and emergency response and for the
integration of preparedness planning
across the public health, healthcare, and
emergency management sectors.
Dated: October 14, 2011.
Sherri A. Berger,
Chief Operating Officer, Centers for Disease
Control and Prevention.
[FR Doc. 2011–27497 Filed 10–25–11; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare and Medicaid
Services
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 4434, Silver Spring,
MD 20993–0002, 301–796–6579.
SUPPLEMENTARY INFORMATION: In FR Doc.
2011–25907, appearing on page 62808
in the Federal Register of Tuesday,
October 11, 2011, the following
corrections are made:
1. On page 62808, in the third
column, under the heading ‘‘A. Parallel
Review Proposal,’’ the Web site address
‘‘https://www.parallel-review.fda.gov’’ is
corrected to read ‘‘https://www.fda.gov/
parallel-review’’.
2. On page 62809, in the second
column, under the heading ‘‘B.
Appropriate Candidates,’’ the e-mail
address ‘‘parallel-review@fda.gov’’ is
corrected to read ‘‘parallelreview@fda.hhs.gov’’.
3. On page 62809, in the third
column, under the heading ‘‘1.
Nomination,’’ the Web site address
‘‘https://www.parallel-review.fda.gov’’ is
corrected to read ‘‘https://www.fda.gov/
parallel-review’’.
Dated: October 17, 2011.
Jacquelyn Y. White,
Director, Office of Strategic Operations and
Regulatory Affairs. Centers for Medicare &
Medicaid Services.
Dated: October 19, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy,
Food and Drug Administration.
[FR Doc. 2011–27694 Filed 10–25–11; 8:45 am]
BILLING CODE 4160–01–P
[CMS–3180–N2]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0308]
Administration for Children and
Families
Pilot Program for Parallel Review of
Medical Products; Correction
Food and Drug Administration,
Centers for Medicare and Medicaid
Services, HHS.
ACTION: Notice; correction.
AGENCY:
The Food and Drug
Administration (FDA) and the Centers
for Medicare and Medicaid Services
(CMS) are correcting a notice that
appeared in the Federal Register of
October 11, 2011 (76 FR 62808). The
document announced a pilot program
for sponsors of innovative device
technologies to participate in a program
of parallel FDA–CMS review. The
document was published with an
incorrect Web page address and an
incorrect email address. This document
corrects those errors.
FOR FURTHER INFORMATION CONTACT: Jean
Olson, Center for Devices and
jlentini on DSK4TPTVN1PROD with NOTICES
SUMMARY:
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Proposed Information Collection
Activity; Comment Request
Title: Affordable Care Act Tribal
Maternal, Infant and Early Childhood
Home Visiting Program Annual Report.
OMB No.: New.
Description
Section 511(h)(2)(A) of Title V of the
Social Security Act, as added by Section
2951 of the Patient Protection and
Affordable Care Act of 2010 (Pub. L.
111–148, Affordable Care Act or ACA),
authorizes the Secretary of HHS to
award grants to Indian Tribes (or a
consortium of Indian Tribes), Tribal
Organizations, or Urban Indian
Organizations to conduct an early
childhood home visiting program.
The legislation sets aside 3 percent of
the total ACA Maternal, Infant, and
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66309
Early Childhood Home Visiting Program
appropriation (authorized in Section
511(j)) for grants to Tribal entities and
requires that the Tribal grants, to the
greatest extent practicable, be consistent
with the requirements of the Maternal,
Infant, and Early Childhood Home
Visiting Program grants to States and
territories (authorized in Section
511(c)), and include (1) Conducting a
needs assessment similar to the
assessment required for all States under
the legislation and (2) establishing
quantifiable, measurable 3- and 5-year
benchmarks consistent with the
legislation.
The Administration for Children and
Families, Office of Child Care, in
collaboration with the Health Resources
and Services Administration, Maternal
and Child Health Bureau, has awarded
grants for the Tribal Maternal, Infant,
and Early Childhood Home Visiting
Program (Tribal Home Visiting). The
Tribal Home Visiting grant awards
support 5-year cooperative agreements
to conduct community needs
assessments, plan for and implement (in
accordance with an Implementation
Plan submitted at the end of Year 1)
high-quality, culturally-relevant,
evidence-based and promising home
visiting programs in at-risk Tribal
communities, and participate in
research and evaluation activities to
build the knowledge base on home
visiting among Native populations.
In the Affordable Care Act Tribal
Maternal, Infant, and Early Childhood
Home Visiting Program Needs
Assessment and Plan for Responding to
Identified Needs (‘‘Implementation Plan
Guidance’’) (OMB Control No. 0970–
0389, Expiration Date 6/30/14), grantees
were notified that in Years 2–5 of their
grant they must comply with the
requirement for submission of an
Annual Report to the Secretary
regarding the program and activities
carried out under the program.
This Report Shall Address the Following
Home Visiting Program Goals and
Objectives.
Implementation of Home Visiting
Program in Targeted Community(ies).
Progress toward Meeting Legislatively
Mandated Benchmark Requirements.
Research and Evaluation Update.
Home Visiting Program Continuous
Quality Improvement (CQI) Efforts.
Administration of Home Visiting
Program.
Technical Assistance Needs.
Respondents
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]]>Agencies
[Federal Register Volume 76, Number 207 (Wednesday, October 26, 2011)]
[Notices]
[Pages 66308-66309]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-27497]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Statement of Organization, Functions, and Delegations of
Authority
Part C (Centers for Disease Control and Prevention) of the
Statement of Organization, Functions, and Delegations of Authority of
the
[[Page 66309]]
Department of Health and Human Services (45 FR 67772-76, dated October
14, 1980, and corrected at 45 FR 69296, October 20, 1980, as amended
most recently at 76 FR 50223--50224, dated August 12, 2011) is amended
to reflect the reorganization of the Office of Public Health
Preparedness and Response, Centers for Disease Control and Prevention.
Section C-B, Organization and Functions, is hereby amended as
follows:
After item (7) in the functional statement for the Office of Public
Health Preparedness and Response (CG), Division of Strategic National
Stockpile (CGE), Office of the Director (CGE1), insert the following:
And (8) provides leadership, guidance, and technical assistance to
state, tribal and local territories for healthcare preparedness and
emergency response and for the integration of preparedness planning
across the public health, healthcare, and emergency management sectors.
Dated: October 14, 2011.
Sherri A. Berger,
Chief Operating Officer, Centers for Disease Control and Prevention.
[FR Doc. 2011-27497 Filed 10-25-11; 8:45 am]
BILLING CODE 4163-18-P
