Disease, Disability, and Injury Prevention and Control Special Emphasis Panel: Agricultural Center Review, Program Announcement (PAR) 06-057, 9950-9951 [E7-3852]
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Federal Register / Vol. 72, No. 43 / Tuesday, March 6, 2007 / Notices
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. Written comments should
be received within 60 days of this
notice.
Proposed Project
Study to Examine Web-Based
Administration of the Youth Risk
Behavior Survey—New—National
Center for Chronic Disease Prevention
and Health Promotion (NCCDPHP),
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
The Youth Risk Behavior Survey
(YRBS) has been conducted biennially
since 1991 using paper-and-pencil
study is a survey of approximately 6000
9th- and 10th-grade students attending
schools in the United States, using the
YRBS questionnaire. In the second
study, students will be assigned
randomly to one of the following
conditions: (1) Paper-and-pencil group
administration without skip patterns, (2)
web-based group administration
without skip patterns, (3) web-based
group administration with skip patterns,
and (4) web-based individual
administration without skip patterns.
An additional 1500 9th- and 10th-grade
students assigned to condition #4 will
participate in a sub-study to assess how
incentives affect participation rates.
There are no costs to respondents
except their time to participate in the
survey and, in the case of school
administrators, to assist in school
recruitment.
questionnaires in schools. Because of
technological improvements in survey
research methods, CDC is considering
changing to Web-based administration
of the YRBS. Because YRBS is the only
national source of data for at least 10
national health objectives in Healthy
People 2010, it is critical to understand
(1) whether it is feasible to change to
web-based administration, and (2) how
a change to web-based administration,
both with and without the use of skip
patterns in the questionnaire, might
affect prevalence estimates of the
priority health risk behaviors reported
in the YRBS.
CDC is proposing two studies to
address these issues. The first study is
a survey of U.S. high school principals,
using a questionnaire designed to assess
the feasibility and burden of web-based
administration in schools. The second
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Respondents
Average
burden per
response
(in hrs.)
Number of
responses per
respondent
Total burden
(in hours)
High school students .......................................................................................
High school principals ......................................................................................
School administrators ......................................................................................
7500
600
210
1
1
1
45/60
25/60
30/60
5625
250
105
Total ..........................................................................................................
........................
........................
........................
5980
Dated: February 28, 2007.
Joan F. Karr,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E7–3851 Filed 3–5–07; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
cprice-sewell on PROD1PC67 with NOTICES
Disease, Disability, and Injury
Prevention and ControlSpecial
Emphasis Panel (SEP): The Small
Business Innovation Research (SBIR)
020, ‘‘New Laboratory Tests for
Tuberculosis and Detection of Drug
Resistance’’ and SRIB 021,
‘‘Development of Novel Information
System for Remote Tuberculosis
Control and Prevention’’
Review Administrator, Coordinating
Center for Infectious Diseases, National
Center for Immunization and
Respiratory Diseases, Office of the
Director, CDC, 1600 Clifton Road NE.,
Mailstop E05, Atlanta, GA 30333,
Telephone 404.639.6101.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both CDC
and the Agency for Toxic Substances
and Disease Registry.
Dated: February 28, 2007.
Elaine L. Baker,
Acting Director, Management Analysis and
Services Office,Centers for Disease Control
and Prevention.
[FR Doc. E7–3843 Filed 3–5–07; 8:45 am]
BILLING CODE 4163–18–P
Correction: This notice was published
in the Federal Register on February 23,
2007, Volume 72, Number 36, page
8166. The reference to the acronym
SRIB 021 in the SEP title is corrected to
read SBIR 021.
For Further Information Contact:
Felix Rogers, PhD, M.P.H., Scientific
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel: Agricultural Center
Review, Program Announcement
(PAR) 06–057
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces a meeting of the
aforementioned Special Emphasis
Panel.
Times and Dates: 8 a.m.–5 p.m., April 10,
2007 (Closed). 8 a.m.–12 p.m., April 11, 2007
(Closed).
Place: Renaissance Hotel, 107 6th Street,
Pittsburgh, PA 15222, telephone (412) 562–
1200.
Status: The meeting will be closed to the
public in accordance with provisions set
forth in section 552b(c)(4) and (6), Title 5
U.S.C., and the Determination of the Director,
Management Analysis and Services Office,
CDC, pursuant to Public Law 92–463.
Matters to be Discussed: The meeting will
include the review, discussion, and
evaluation of research grant applications in
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Federal Register / Vol. 72, No. 43 / Tuesday, March 6, 2007 / Notices
response to PAR 06–057, ‘‘Agricultural
Center Review.’’
For Further Information Contact: Stephen
Olenchock, Scientific Review Administrator,
1095 Willowdale Road, Morgantown, WV
26506, telephone (304) 285–6271.
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register notices
pertaining to announcements of meetings and
other committee management activities, for
both CDC and the Agency for Toxic
Substances and Disease Registry.
Elaine L. Baker,
Acting Director, Management Analysis and
Services Office, Centers for Disease Control
and Prevention.
[FR Doc. E7–3852 Filed 3–5–07; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2001D–0432]
Guidance for Industry on Orally
Inhaled and Intranasal Corticosteroids:
Evaluation of the Effects on Growth in
Children; Availability
AGENCY:
Food and Drug Administration,
HHS.
cprice-sewell on PROD1PC67 with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
entitled ‘‘Orally Inhaled and Intranasal
Corticosteroids: Evaluation of the Effects
on Growth in Children.’’ This guidance
provides recommendations regarding
the design, conduct, and evaluation of
clinical trials to assess the effects of
orally inhaled and intranasal
corticosteroids on growth in children.
For this class of drug products,
measurement of growth is considered a
sensitive surrogate of, and an important
sentinel for, the potential to cause
systemic effects. Growth studies
designed and carried out following the
recommendations in this guidance can
provide adequate and well-controlled
data that are consistent among drug
products and can be included in
product labeling. This guidance
finalizes the draft guidance published
on November 6, 2001.
DATES: Submit written or electronic
comments on agency guidances at any
time.
Submit written requests for
single copies of this guidance to the
Division of Drug Information (HFD–
240), Center for Drug Evaluation and
Research, Food and Drug
Administration, 5600 Fishers Lane,
ADDRESSES:
VerDate Aug<31>2005
15:35 Mar 05, 2007
Jkt 211001
Rockville, MD 20857. Send one selfaddressed adhesive label to assist that
office in processing your requests.
Submit written comments on the
guidance to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.fda.gov/dockets/ecomments. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
FOR FURTHER INFORMATION CONTACT:
Peter Starke, Center for Drug Evaluation
and Research (HFD–7), Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, rm. 3300, Silver Spring,
MD 20993–0002, 301–796–2300.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for industry entitled ‘‘Orally
Inhaled and Intranasal Corticosteroids:
Evaluation of the Effects on Growth in
Children.’’ This guidance provides
recommendations for the design,
conduct, and evaluation of clinical
studies to assess the effects of orally
inhaled and intranasal corticosteroids
on linear growth (‘‘growth study’’). The
guidance was developed by the Division
of Pulmonary and Allergy Products in
consultation with the Division of
Metabolism and Endocrinology
Products and the Office of Biostatistics
to encourage the collection of evidence
that can consistently and accurately
describe the effects of intranasal and
orally inhaled corticosteroids on growth
velocity in children.
In July 1998, the Pulmonary and
Allergy Drugs Advisory Committee and
the Metabolic and Endocrine Drugs
Advisory Committee were jointly
convened to discuss the implications of
findings in previous clinical studies that
indicated that inhaled corticosteroids
can, as a class of drug products, affect
linear growth in pediatric patients. The
joint committee concluded that data
were sufficient to justify inclusion of a
precautionary statement in the labeling
for this class of drug products, but the
data were inadequate to precisely
determine the decrement in growth
velocity resulting from the use of these
drug products. Members of the joint
committee recommended that
companies filing new drug applications
for all newly approved corticosteroid
products conduct further studies, as
post-approval phase 4 commitments, to
assess the effects of nasally and orally
inhaled corticosteroids on growth
velocity in prepubertal children. On
November 6, 2001 (66 FR 56109), FDA
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9951
published for comment in the Federal
Register a draft of this guidance.
Comments received from industry,
professional societies, and consumer
groups on the draft guidance have been
taken into consideration in finalizing
this guidance. Changes are based on
thorough review of all comments
received, growth studies submitted
since publication of the draft guidance,
and previously submitted growth data.
Changes or updates were made to all
sections of the guidance, and are briefly
summarized here.
A new overview section and updated
background and data analysis sections
include a more thorough discussion of
the objective of and the appropriate
statistical comparisons for a growth
study. These changes will affect future
labeling for such studies.
Recommendations for sample size
calculations and primary and secondary
‘‘sensitivity’’ analyses have been
reviewed and modified based on review
of growth studies submitted since
publication of the draft guidance as well
as previously submitted data. The
general study recommendations and
protocol design sections include a
discussion of the appropriate patient
populations to be studied and
modifications to recommendations for
the inclusion and exclusion criteria,
assessments of adherence, and spacer
use.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance represents the
agency’s current thinking on the
evaluation of the effects of orally
inhaled and intranasal corticosteroids
on growth in children. It does not create
or confer any rights for or on any person
and does not operate to bind FDA or the
public. An alternative approach may be
used if such approach satisfies the
requirements of the applicable statutes
and regulations.
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments on the draft guidance. Submit
a single copy of electronic comments or
two paper copies of any mailed
comments, except that individuals may
submit one paper copy. Comments are
to be identified with the docket number
found in brackets in the heading of this
document. The draft guidance and
received comments may be seen in the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
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]]>Agencies
[Federal Register Volume 72, Number 43 (Tuesday, March 6, 2007)]
[Notices]
[Pages 9950-9951]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-3852]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Disease, Disability, and Injury Prevention and Control Special
Emphasis Panel: Agricultural Center Review, Program Announcement (PAR)
06-057
In accordance with section 10(a)(2) of the Federal Advisory
Committee Act (Pub. L. 92-463), the Centers for Disease Control and
Prevention (CDC) announces a meeting of the aforementioned Special
Emphasis Panel.
Times and Dates: 8 a.m.-5 p.m., April 10, 2007 (Closed). 8 a.m.-
12 p.m., April 11, 2007 (Closed).
Place: Renaissance Hotel, 107 6th Street, Pittsburgh, PA 15222,
telephone (412) 562-1200.
Status: The meeting will be closed to the public in accordance
with provisions set forth in section 552b(c)(4) and (6), Title 5
U.S.C., and the Determination of the Director, Management Analysis
and Services Office, CDC, pursuant to Public Law 92-463.
Matters to be Discussed: The meeting will include the review,
discussion, and evaluation of research grant applications in
[[Page 9951]]
response to PAR 06-057, ``Agricultural Center Review.''
For Further Information Contact: Stephen Olenchock, Scientific
Review Administrator, 1095 Willowdale Road, Morgantown, WV 26506,
telephone (304) 285-6271.
The Director, Management Analysis and Services Office, has been
delegated the authority to sign Federal Register notices pertaining
to announcements of meetings and other committee management
activities, for both CDC and the Agency for Toxic Substances and
Disease Registry.
Elaine L. Baker,
Acting Director, Management Analysis and Services Office, Centers for
Disease Control and Prevention.
[FR Doc. E7-3852 Filed 3-5-07; 8:45 am]
BILLING CODE 4163-18-P
