Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review, 31379-31380 [2015-13314]
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31379
Federal Register / Vol. 80, No. 105 / Tuesday, June 2, 2015 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–15–15UR]
Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) has submitted the
following information collection request
to the Office of Management and Budget
(OMB) for review and approval in
accordance with the Paperwork
Reduction Act of 1995. The notice for
the proposed information collection is
published to obtain comments from the
public and affected agencies.
Written comments and suggestions
from the public and affected agencies
concerning the proposed collection of
information are encouraged. Your
comments should address any of the
following: (a) Evaluate whether the
proposed collection of information is
necessary for the proper performance of
the functions of the agency, including
whether the information will have
practical utility; (b) Evaluate the
accuracy of the agencies estimate of the
burden of the proposed collection of
information, including the validity of
the methodology and assumptions used;
(c) Enhance the quality, utility, and
clarity of the information to be
collected; (d) Minimize the burden of
the collection of information on those
who are to respond, including through
the use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submission of
responses; and (e) Assess information
collection costs.
To request additional information on
the proposed project or to obtain a copy
of the information collection plan and
instruments, call (404) 639–7570 or
send an email to omb@cdc.gov. Written
comments and/or suggestions regarding
the items contained in this notice
should be directed to the Attention:
CDC Desk Officer, Office of Management
and Budget, Washington, DC 20503 or
by fax to (202) 395–5806. Written
comments should be received within 30
days of this notice.
Proposed Project
Enhanced Surveillance of
Coccidioidomycosis in Low- and NonEndemic States—New—National Center
for Emerging and Zoonotic Infectious
Diseases (NCEZID), Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
Coccidioidomycosis, also called
‘‘Valley fever,’’ is a nationally notifiable
fungal infection caused by inhalation of
soil-dwelling Coccidioides spp. In the
United States, coccidioidomycosis is
known to be endemic in the
southwestern states, but new evidence
suggests that the true endemic areas
may be broader than previously
recognized. Approximately 10,000
coccidioidomycosis cases are reported
in the U.S. each year to the National
Notifiable Disease Surveillance System
(NNDSS), but this system captures
limited clinical and epidemiological
information about reported cases. Most
cases occur in Arizona or California, so
the epidemiology of this disease has
been well-described for these states, but
little is known about the features of
cases in other states.
Enhanced surveillance in low- and
non-endemic states will help determine
which information is most important to
collect during routine surveillance and
will help assess the suitability of the
Council of State and Territorial
Epidemiologists (CSTE) case definition
for coccidioidomycosis in these areas.
Primary prevention strategies for
coccidioidomycosis have not yet been
proven to be effective, so public health
efforts may be best aimed at promoting
awareness of coccidioidomycosis among
healthcare providers and the general
public. Improved surveillance data are
essential for identifying such
opportunities to promote awareness
about this disease and for determining
its true public health burden.
State health department personnel in
participating low- and non-endemic
states will conduct telephone interviews
with coccidioidomycosis cases reported
during one calendar year that meet the
CSTE case definition and will record
responses on a standardized form. State
health department personnel will use
the form to collect information on
demographics, underlying medical
conditions, travel history, symptom type
and duration, healthcare-seeking
behaviors, diagnosis, treatment, and
outcomes.
OMB approval is requested for two
years. Participation is voluntary. The
total estimated annualized burden is 48
hours.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondents
Form name
State Health Department Personnel ...............
Case Report Form for Coccidioidomycosis
(Valley Fever) Enhanced Surveillance.
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2015–13161 Filed 6–1–15; 8:45 am]
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel (SEP): Initial Review
BILLING CODE 4163–18–P
Centers for Disease Control and
Prevention
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 for the initial
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17:26 Jun 01, 2015
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145
Number of
responses per
respondent
1
Average
burden per
response
(in hrs.)
20/60
review of applications in response to
Funding Opportunity Announcement,
RFA–EH–15–002, Development and
validation of laboratory procedures
using next generation sequencing
technologies to assess genes causing
severe combined immune deficiency
(SCID) in state newborn screening
laboratories.
Times and Dates: 11:00 a.m.–3:00
p.m., EDT, June 25, 2015 (CLOSED).
Place: Teleconference.
Status: The meeting will be closed to
the public in accordance with
provisions set forth in section 552b(c)(4)
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Federal Register / Vol. 80, No. 105 / Tuesday, June 2, 2015 / Notices
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 for Discussion: The meeting
will include the initial review,
discussion, and evaluation of
applications received in response to
‘‘Development and validation of
laboratory procedures using next
generation sequencing technologies to
assess genes causing severe combined
immune deficiency (SCID) in state
newborn screening laboratories’’, EH15–
002.
Contact Person for More Information:
Jane Suen, Dr.P.H., M.S., Scientific
Review Officer, CDC, 4770 Buford
Highway, NE., Mailstop F63, Atlanta,
Georgia 30341–3724, Telephone (770)
488–4281.
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 the
Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
whether the information will have
practical utility; (b) Evaluate the
accuracy of the agencies estimate of the
burden of the proposed collection of
information, including the validity of
the methodology and assumptions used;
(c) Enhance the quality, utility, and
clarity of the information to be
collected; (d) Minimize the burden of
the collection of information on those
who are to respond, including through
the use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submission of
responses; and (e) Assess information
collection costs.
To request additional information on
the proposed project or to obtain a copy
of the information collection plan and
instruments, call (404) 639–7570 or
send an email to omb@cdc.gov. Written
comments and/or suggestions regarding
the items contained in this notice
should be directed to the Attention:
CDC Desk Officer, Office of Management
and Budget, Washington, DC 20503 or
by fax to (202) 395–5806. Written
comments should be received within 30
days of this notice.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
Proposed Project
Birth Defects Study To Evaluate
Pregnancy exposureS (BD–STEPS)
(formerly titled The National Birth
Defects Prevention Study (NBDPS)),
(OMB 0920–0010, Expiration 01/31/
2017)—Revision—National Center on
Birth Defects and Developmental
Disabilities (NCBDDD), Centers for
Disease Control and Prevention (CDC).
[FR Doc. 2015–13314 Filed 6–1–15; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–15–0010]
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) has submitted the
following information collection request
to the Office of Management and Budget
(OMB) for review and approval in
accordance with the Paperwork
Reduction Act of 1995. The notice for
the proposed information collection is
published to obtain comments from the
public and affected agencies.
Written comments and suggestions
from the public and affected agencies
concerning the proposed collection of
information are encouraged. Your
comments should address any of the
following: (a) Evaluate whether the
proposed collection of information is
necessary for the proper performance of
the functions of the agency, including
VerDate Sep<11>2014
17:26 Jun 01, 2015
Jkt 235001
Background and Brief Description
CDC has been monitoring the
occurrence of serious birth defects and
genetic diseases in Atlanta since 1967
through the Metropolitan Atlanta
Congenital Defects Program (MACDP).
The MACDP is a population-based
surveillance system for birth defects
currently covering three counties in
Metropolitan Atlanta.
Since 1997, CDC has funded casecontrol studies of major birth defects
that utilize existing birth defect
surveillance registries (including
MACDP) to identify cases and study
birth defects causes in participating
states/municipalities across the United
States.
The current study, BD–STEPS, is a
case-control study that is similar to the
previous CDC-funded birth defects casecontrol study, NBDPS, which stopped
interviewing participants in 2013. As
with NBDPS, BD–STEPS control infants
are randomly selected from birth
certificates or birth hospital records;
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mothers of case and control infants are
interviewed using a computer-assisted
telephone interview.
The results from NBDPS have
improved understanding of the causes
of birth defects. Over 200 articles have
been written in professional journals
using the data from NBDPS, and BD–
STEPS data will soon be added to
NBDPS data for analysis. The current
BD–STEPS revision is a change in
proposed data collection. Specifically,
the study will not ask BD–STEPS
participants to participate in saliva
collection as originally planned, but we
will add an opportunity for some
participants to respond to an online
questionnaire, and we will also ask
some participants for permission to
retrieve newborn bloodspots.
The BD–STEPS interview takes
approximately forty-five minutes to
complete. A maximum of 275
interviews are planned per year per
center, 200 cases and 75 controls. With
seven centers planned, the maximum
interview burden for all centers
combined would be approximately
1,444 hours. Mothers in five of the
seven BD–STEPS Centers will also be
asked to provide consent for the study
to access previously collected infant
bloodspots. It takes approximately 15
minutes to read, sign and return the
informed consent for retrieval of
bloodspots. For approximately one fifth
of participants, some medical records
review will be conducted. The medical
records release form will take
participants approximately 15 minutes
to read, sign and return. In addition, it
will take approximately 30 minutes for
each medical record reviewer to
conduct the review and send the
medical record. Finally, the newly
planned online questionnaire will be
offered to approximately one third of
participants who report certain
occupations during the telephone
interview; these participants will be
asked to complete additional
occupational questions via a Web site
which will take approximately 20
minutes to answer.
Information gathered from both the
interviews and the Deoxyribonucleic
acid specimens has been and will
continue to be used to study
independent genetic and environmental
factors as well as gene-environment
interactions for a broad range of
carefully classified birth defects.
This request is submitted to revise the
previously estimated burden details and
to request OMB clearance for three
additional years. The total estimated
annual burden hours are 2,290.
There are no costs to the respondents
other than their time.
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]]>Agencies
[Federal Register Volume 80, Number 105 (Tuesday, June 2, 2015)]
[Notices]
[Pages 31379-31380]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-13314]
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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 (SEP): Initial Review
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 for the initial review of
applications in response to Funding Opportunity Announcement, RFA-EH-
15-002, Development and validation of laboratory procedures using next
generation sequencing technologies to assess genes causing severe
combined immune deficiency (SCID) in state newborn screening
laboratories.
Times and Dates: 11:00 a.m.-3:00 p.m., EDT, June 25, 2015 (CLOSED).
Place: Teleconference.
Status: The meeting will be closed to the public in accordance with
provisions set forth in section 552b(c)(4)
[[Page 31380]]
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 for Discussion: The meeting will include the initial
review, discussion, and evaluation of applications received in response
to ``Development and validation of laboratory procedures using next
generation sequencing technologies to assess genes causing severe
combined immune deficiency (SCID) in state newborn screening
laboratories'', EH15-002.
Contact Person for More Information: Jane Suen, Dr.P.H., M.S.,
Scientific Review Officer, CDC, 4770 Buford Highway, NE., Mailstop F63,
Atlanta, Georgia 30341-3724, Telephone (770) 488-4281.
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 the Centers for Disease Control and Prevention and the Agency
for Toxic Substances and Disease Registry.
Elaine L. Baker,
Director, Management Analysis and Services Office, Centers for Disease
Control and Prevention.
[FR Doc. 2015-13314 Filed 6-1-15; 8:45 am]
BILLING CODE 4163-18-P
