Proposed Data Collections Submitted for Public Comment and Recommendations, 46825-46827 [2014-18845]
Download as PDF
<![CDATA[
mstockstill on DSK4VPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 154 / Monday, August 11, 2014 / Notices
molecular techniques. This is also true
with laboratory diagnoses of poxvirus
infections. Precise and consistent
identification of orthopoxviruses, in
particular variola viruses, is now
achievable using such molecular
techniques as real-time Polymerase
Chain Reaction (unlike earlier
techniques that may have relied on
direct virus isolation and identification).
Additionally, the U.S. Government
supports the development of other
medical products, including vaccines
and drugs, for use within the U.S. upon
verification of a smallpox case. The U.S.
Government, through the Office of the
Assistant Secretary for Preparedness
and Response (ASPR), has successfully
developed vaccine products, and is
actively engaged in the development of
several drug candidates for smallpox
therapies which require access to the
Variola virus to satisfy regulatory
requirements for product approvals.
Period of Performance: September 30,
2014 to September 29, 2015.
FOR FURTHER INFORMATION CONTACT: The
agency program contact is Julie Schafer,
who can be contacted by phone at 202–
205–1435or via email at Julie.Schafer@
hhs.gov.
SUPPLEMENTARY INFORMATION: Pursuant
to Sections 42 U.S.C. 241 and 247d–7e
(Sections 301 and 319L of the Public
Health Service Act); ASPR’s Office of
Biomedical Advanced Research and
Development Authority (BARDA) is the
program office for this award.
Justification: WHO is the only eligible
applicant; it is the only organization
that is allowed by international
agreements to address the issues
outlined in this proposal. WHO is the
directing and coordinating authority for
health within the United Nations
system. It is responsible for providing
leadership on global health matters,
shaping the health research agenda,
setting norms and standards,
articulating evidence-based policy
options, providing technical support to
countries, and monitoring and assessing
health trends. In the 21st century, health
is a shared responsibility, involving
equitable access to essential care and
collective defense against transnational
threats. States Parties to the U.N. have
agreed to international standards on
reporting public health incidents of
concern under IHR (2005). Additionally,
a majority of States Parties have also
agreed to specific work-frames for
pathogens such as smallpox under the
Biological Weapons Convention.
Since May 1999, when the 52nd
World Health Assembly (WHA) resolved
to postpone the destruction of the
Variola virus to allow for essential
VerDate Mar<15>2010
17:35 Aug 08, 2014
Jkt 232001
research (WHA 52.10), WHO has been
charged with convening a group of
experts to advise on the need for
continuing such research, to review
proposals for research involving viable
Variola virus, to review the progress of
such research, and to report to the WHA
each year. The need to support the
activities described in this project has
not changed. In fact, WHO Member
States continue to exert pressure for the
WHO Secretariat to carry out this work.
The WHO Advisory Committee on
Variola Virus Research (ACVVR) was
established in 1999 to determine what
essential research, if any, must be
carried out with live Variola virus. The
ACVVR monitored the research progress
in order to reach global consensus on
the timing for the destruction of existing
Variola virus stocks. In 2007, the WHA
requested the ACVVR undertake a
thorough review of the approved
research program with a report
presented in 2010. The results were
presented at the 64th WHA meeting in
May of 2011. The ACVVR continues to
serve a critically important function for
global public health, and to oversee
research requested specifically by the
U.S. to complete its national strategic
goals. This includes the development of
new antiviral agents, safer vaccines, and
better diagnostics, thus strengthening
our national security.
Estimated amount of award: up to
$662,500 USD.
HHS/ASPR/BARDA: $225,000
DOD: $250,000 (funds pending)
HHS/NIH/NIAID: $50,000
HHS/CDC: $87,500
HHS/OGA: $50,000
Procedures for Providing Public Input:
All written comments must be received
no later than 15 days after the posting
of this announcement. Please submit
comments via asprgrants@hhs.gov.
Date: August 4, 2014.
Nicole Lurie,
Assistant Secretary for Preparedness and
Response.
[FR Doc. 2014–18836 Filed 8–8–14; 8:45 am]
BILLING CODE 4150–37–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–14–14AQA]
Proposed Data Collections Submitted
for Public Comment and
Recommendations
The Centers for Disease Control and
Prevention (CDC), as part of its
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
46825
continuing effort to reduce public
burden, invites the general public and
other Federal agencies to take this
opportunity to comment on proposed
and/or continuing information
collections, as required by the
Paperwork Reduction Act of 1995. To
request more information on the below
proposed project or to obtain a copy of
the information collection plan and
instruments, call 404–639–7570 or send
comments to Leroy Richardson, 1600
Clifton Road, MS–D74, Atlanta, GA
30333 or send an email to omb@cdc.gov.
Comments submitted in response to
this notice will be summarized and/or
included in the request for Office of
Management and Budget (OMB)
approval. Comments are invited on: (a)
Whether the proposed collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) ways to enhance the
quality, utility, and clarity of the
information to be collected; (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; and (e) estimates of capital
or start-up costs and costs of operation,
maintenance, and purchase of services
to provide information. Burden means
the total time, effort, or financial
resources expended by persons to
generate, maintain, retain, disclose or
provide information to or for a Federal
agency. This includes the time needed
to review instructions; to develop,
acquire, install and utilize technology
and systems for the purpose of
collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information, to search
data sources, to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. Written comments should
be received within 60 days of this
notice.
Proposed Project
The Enhanced STD surveillance
Network (eSSuN)—New—Division of
STD Prevention (DSTDP), National
Center for HIV/AIDS, Viral Hepatitis,
STD, and TB prevention (NCHHSTP),
Centers for Disease Control and
Prevention (CDC).
E:\FR\FM\11AUN1.SGM
11AUN1
46826
Federal Register / Vol. 79, No. 154 / Monday, August 11, 2014 / Notices
Background and Brief Description
The Enhanced STD Surveillance
Network (eSSuN) project is an active
STD sentinel surveillance network
comprised of 10 surveillance sites
including Baltimore City Health
Department, California Department of
Public Health, Florida Department of
Health, Massachusetts Department of
Public Health, Minnesota Department of
Health, Multnomah County Health
Department, New York City Department
of Health & Mental Hygiene,
Philadelphia Department of Public
Health, San Francisco Department of
Public Health, and Washington State
Department of Health.
The enhanced STD Surveillance
Network is a sentinel surveillance
initiative designed to collect
longitudinal data of a magnitude
sufficient to detect trends and changes
over time in the clinical and
demographic characteristics of persons
presenting for care in STD and family
planning/reproductive health clinical
facilities and those being diagnosed and
reported with gonorrhea in funded
jurisdictions. Data collection activities
will be ongoing and continuous and will
take five years to complete to establish
annual trends, allowing for accretion of
a sufficient number of investigated cases
or patient visits to detect statistically
meaningful differences between
population sub groups.
While routine STD surveillance
activities are ongoing in all states and
jurisdictions through the National
Notifiable Disease Surveillance System,
these data do not include the patient
populations and specific clinical data
elements and behavioral data proposed
for collection in eSSuN. No other
sources of information currently
collected by, or available to, CDC
answer the specific questions eSSuN is
designed to answer.
A similar data collection
infrastructure, the STD Surveillance
Network (OMB No. 0920–0842), expires
on September 30th, 2015. However,
funding for this cooperative agreement
ended in September 29th, 2013 and the
protocols have been retired. The
enhanced STD network is not a
continuation of SSuN, instead, it is a
new initiative to collect different kinds
of data in different jurisdictions and to
respond to different national objectives.
The objectives of the eSSuN Project
are (1) provide a dataset of
supplemental information on case
reports of STDs of interest; (2) provide
geographic information on case reports
of STDs of interest for investigating
social determinants of STDs; (3) monitor
screening coverage for chlamydial
infection among young women in
sentinel clinical settings; (4) monitor
STD screening, incidence, prevalence,
epidemiologic and health care access
trends in populations of interest such as
men-who-have-sex-with men (MSM),
young people and persons diagnosed
with gonorrhea; (5) monitor STD
treatment and prevention services
practices; (6) monitor selected adverse
health outcomes of STDs; (7) evaluate
and enhance local and state STD
surveillance capacity; (8) enhance local
STD-specific health information
technology and epidemiologic capacity,
and, (9) establish a core of exemplary
state, tribal, territorial, county and/or
city health department STD surveillance
programs employing innovative
approaches to STD surveillance.
This project collects data using two
surveillance strategies; (1) enhanced
surveillance in participating STD and
Family planning/reproductive health
clinics and (2) enhanced gonorrhea
surveillance on a random sample of
persons diagnosed with gonorrhea in
participating jurisdictions of these 10
local and state health departments.
For the clinic-based surveillance,
participating sites have developed
common protocols stipulating which
data elements would be collected,
including demographic, clinical, risk
and sexual behaviors. The specified data
elements are abstracted from existing
electronic medical records for (1) all
patient visits to participating STD
clinics and (2) for all female patient
visits aged 15–44 years of age to
participating family planning/
reproductive health clinics. Data are deidentified and recoded by health
departments and then are transmitted to
CDC through secure file transport
mechanisms on an every two month
basis. Each eSSuN site will spend 16
hours to transmit the data to CDC every
two months. At CDC, data will be
aggregated with data from all
participating sites in a common
language and formatted for analysis.
For the population-based
surveillance, a random sample of
individuals reported with gonorrhea
residing within participating
jurisdictions are interviewed using
locally designed interview templates.
Enhanced data collection includes
detailed information on demographic
characteristics, behavioral risk factors
and clinical history of persons with
gonorrhea. Each of the 10 sites will
interview a minimum of 250 persons or
2.5% of total morbidity if annual GC
cases exceed 10,000 cases and each
interview is expected to take about 10
minutes per person. Data for the
population-based component will be
collected through telephoneadministered or in-person interviews
conducted by trained interviewers in
the 10 eSSuN sites.
The survey results will be entered
into the existing information systems at
each health department and sent to CDC
through secure file transport
mechanisms on an every two month
basis.
This information is being collected to
(1) enhance and improve STD
surveillance data, (2) inform a more
comprehensive understanding of tends
and determinants of STDs of interest, (3)
monitor public health program impact
and (4) provide a more robust evidence
base for directing public health action in
the US.
Participation is voluntary. There is no
cost to the respondents other than their
time.
ESTIMATE OF ANNUALIZED BURDEN
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
(hours)
Total burden
hours
mstockstill on DSK4VPTVN1PROD with NOTICES
Type of respondent
Form name
Data manager at clinic (Electronic transmittal of
clinical variables in clinic databases).
Data manager at each of the 10 local/state
health department.
Gonorrhea cases sampled ...................................
Record Abstraction .......
33
6
3
594
Record Abstraction .......
10
12
16
1920
3,225
1
10/60
538
Total ...............................................................
.......................................
........................
........................
........................
3,050
VerDate Mar<15>2010
17:35 Aug 08, 2014
Jkt 232001
Telephone/in-person
interview.
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
E:\FR\FM\11AUN1.SGM
11AUN1
46827
Federal Register / Vol. 79, No. 154 / Monday, August 11, 2014 / Notices
LeRoy 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.
[FR Doc. 2014–18845 Filed 8–8–14; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–14–14ARJ]
Proposed Data Collections Submitted
for Public Comment and
Recommendations
The Centers for Disease Control and
Prevention (CDC), as part of its
continuing effort to reduce public
burden, invites the general public and
other Federal agencies to take this
opportunity to comment on proposed
and/or continuing information
collections, as required by the
Paperwork Reduction Act of 1995. To
request more information on the below
proposed project or to obtain a copy of
the information collection plan and
instruments, call 404–639–7570 or send
comments to Leroy Richardson, 1600
Clifton Road, MS–D74, Atlanta, GA
30333 or send an email to omb@cdc.gov.
Comments submitted in response to
this notice will be summarized and/or
included in the request for Office of
Management and Budget (OMB)
approval. Comments are invited on: (a)
Whether the proposed collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) ways to enhance the
quality, utility, and clarity of the
information to be collected; (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; and (e) estimates of capital
or start-up costs and costs of operation,
maintenance, and purchase of services
to provide information. Burden means
the total time, effort, or financial
resources expended by persons to
generate, maintain, retain, disclose or
provide information to or for a Federal
agency. This includes the time needed
to review instructions; to develop,
acquire, install and utilize technology
and systems for the purpose of
collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information, to search
data sources, to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. Written comments should
be received within 60 days of this
notice.
guidelines for its use. Because
approximately 50,000 new HIV
infections continue to occur each year,
with rates of HIV infection increasing
most rapidly for young MSM and
because severe disparities in HIV
infection continue among AfricanAmerican men and women,
incorporation of PrEP into HIV
prevention is important. However, as a
prevention tool in very early stages of
introduction and use, there is much we
need to learn about how to implement
PrEP in a real-world setting.
CDC is requesting OMB approval to
collect data over a 3-year period that
will be used to conduct research among
clinicians about their knowledge,
attitudes, and practices related to a new
intervention (PrEP) over the period of its
initial introduction in their clinics. The
knowledge gained will be used to refine
measurement instruments and methods
(for example, identify modifications to
questions in the current surveys that are
unclear to participants), develop
training and educational resources and
tools for use by CDC/DHAP (Division of
HIV/AIDS Prevention)-funded partners,
and other organizations supporting
delivery of PrEP in clinical settings.
The project will be conducted in
clinics in each of four cities (Houston,
Newark, Chicago, and Philadelphia)
where PrEP has recently become
available through a local community
health center.
Once per year for 3 years, CDC will
conduct an online survey of clinicians
at participating clinics to collect data on
the demographics of the respondents
and their knowledge, attitudes,
practices, and organizational factors
related to PrEP and its delivery in their
clinics. Surveys will be administered
through an online survey Web site.
There are no costs to respondents
other than their time.
Proposed Project
Clinic Context Matters Study–New–
National Center for HIV/AIDS, Viral
Hepatitis, STD, and TB Prevention
(NCHHSTP), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
The daily use of specific antiretroviral
medications by persons without HIV
infection, but at high risk of sexual or
injection exposure to HIV, has been
shown to be a safe and effective HIV
prevention method. The Food and Drug
Administration approved the use of
Truvada® for preexposure prophylaxis
(PrEP) in July 2012 and CDC has issued
Public Health Service clinical practice
ESTIMATED ANNUALIZED BURDEN HOURS
Form name
Clinician .............................................
Average hours
per response
Total
response burden hours)
175
1
30/60
88
........................
........................
........................
88
Clinician Consent and Interview ......
Total ...........................................
mstockstill on DSK4VPTVN1PROD with NOTICES
Number of
responses per
respondent
Number of
respondents
Type of respondent
...........................................................
Leroy 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.
[FR Doc. 2014–18940 Filed 8–8–14; 8:45 am]
BILLING CODE 4163–18–P
VerDate Mar<15>2010
17:35 Aug 08, 2014
Jkt 232001
PO 00000
Frm 00059
Fmt 4703
Sfmt 9990
E:\FR\FM\11AUN1.SGM
11AUN1
]]>Agencies
[Federal Register Volume 79, Number 154 (Monday, August 11, 2014)]
[Notices]
[Pages 46825-46827]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-18845]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-14-14AQA]
Proposed Data Collections Submitted for Public Comment and
Recommendations
The Centers for Disease Control and Prevention (CDC), as part of
its continuing effort to reduce public burden, invites the general
public and other Federal agencies to take this opportunity to comment
on proposed and/or continuing information collections, as required by
the Paperwork Reduction Act of 1995. To request more information on the
below proposed project or to obtain a copy of the information
collection plan and instruments, call 404-639-7570 or send comments to
Leroy Richardson, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send
an email to omb@cdc.gov.
Comments submitted in response to this notice will be summarized
and/or included in the request for Office of Management and Budget
(OMB) approval. Comments are invited on: (a) Whether the proposed
collection of information is necessary for the proper performance of
the functions of the agency, including whether the information shall
have practical utility; (b) the accuracy of the agency's estimate of
the burden of the proposed collection of information; (c) ways to
enhance the quality, utility, and clarity of the information to be
collected; (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; and (e)
estimates of capital or start-up costs and costs of operation,
maintenance, and purchase of services to provide information. Burden
means the total time, effort, or financial resources expended by
persons to generate, maintain, retain, disclose or provide information
to or for a Federal agency. This includes the time needed to review
instructions; to develop, acquire, install and utilize technology and
systems for the purpose of collecting, validating and verifying
information, processing and maintaining information, and disclosing and
providing information; to train personnel and to be able to respond to
a collection of information, to search data sources, to complete and
review the collection of information; and to transmit or otherwise
disclose the information. Written comments should be received within 60
days of this notice.
Proposed Project
The Enhanced STD surveillance Network (eSSuN)--New--Division of STD
Prevention (DSTDP), National Center for HIV/AIDS, Viral Hepatitis, STD,
and TB prevention (NCHHSTP), Centers for Disease Control and Prevention
(CDC).
[[Page 46826]]
Background and Brief Description
The Enhanced STD Surveillance Network (eSSuN) project is an active
STD sentinel surveillance network comprised of 10 surveillance sites
including Baltimore City Health Department, California Department of
Public Health, Florida Department of Health, Massachusetts Department
of Public Health, Minnesota Department of Health, Multnomah County
Health Department, New York City Department of Health & Mental Hygiene,
Philadelphia Department of Public Health, San Francisco Department of
Public Health, and Washington State Department of Health.
The enhanced STD Surveillance Network is a sentinel surveillance
initiative designed to collect longitudinal data of a magnitude
sufficient to detect trends and changes over time in the clinical and
demographic characteristics of persons presenting for care in STD and
family planning/reproductive health clinical facilities and those being
diagnosed and reported with gonorrhea in funded jurisdictions. Data
collection activities will be ongoing and continuous and will take five
years to complete to establish annual trends, allowing for accretion of
a sufficient number of investigated cases or patient visits to detect
statistically meaningful differences between population sub groups.
While routine STD surveillance activities are ongoing in all states
and jurisdictions through the National Notifiable Disease Surveillance
System, these data do not include the patient populations and specific
clinical data elements and behavioral data proposed for collection in
eSSuN. No other sources of information currently collected by, or
available to, CDC answer the specific questions eSSuN is designed to
answer.
A similar data collection infrastructure, the STD Surveillance
Network (OMB No. 0920-0842), expires on September 30th, 2015. However,
funding for this cooperative agreement ended in September 29th, 2013
and the protocols have been retired. The enhanced STD network is not a
continuation of SSuN, instead, it is a new initiative to collect
different kinds of data in different jurisdictions and to respond to
different national objectives.
The objectives of the eSSuN Project are (1) provide a dataset of
supplemental information on case reports of STDs of interest; (2)
provide geographic information on case reports of STDs of interest for
investigating social determinants of STDs; (3) monitor screening
coverage for chlamydial infection among young women in sentinel
clinical settings; (4) monitor STD screening, incidence, prevalence,
epidemiologic and health care access trends in populations of interest
such as men-who-have-sex-with men (MSM), young people and persons
diagnosed with gonorrhea; (5) monitor STD treatment and prevention
services practices; (6) monitor selected adverse health outcomes of
STDs; (7) evaluate and enhance local and state STD surveillance
capacity; (8) enhance local STD-specific health information technology
and epidemiologic capacity, and, (9) establish a core of exemplary
state, tribal, territorial, county and/or city health department STD
surveillance programs employing innovative approaches to STD
surveillance.
This project collects data using two surveillance strategies; (1)
enhanced surveillance in participating STD and Family planning/
reproductive health clinics and (2) enhanced gonorrhea surveillance on
a random sample of persons diagnosed with gonorrhea in participating
jurisdictions of these 10 local and state health departments.
For the clinic-based surveillance, participating sites have
developed common protocols stipulating which data elements would be
collected, including demographic, clinical, risk and sexual behaviors.
The specified data elements are abstracted from existing electronic
medical records for (1) all patient visits to participating STD clinics
and (2) for all female patient visits aged 15-44 years of age to
participating family planning/reproductive health clinics. Data are de-
identified and recoded by health departments and then are transmitted
to CDC through secure file transport mechanisms on an every two month
basis. Each eSSuN site will spend 16 hours to transmit the data to CDC
every two months. At CDC, data will be aggregated with data from all
participating sites in a common language and formatted for analysis.
For the population-based surveillance, a random sample of
individuals reported with gonorrhea residing within participating
jurisdictions are interviewed using locally designed interview
templates.
Enhanced data collection includes detailed information on
demographic characteristics, behavioral risk factors and clinical
history of persons with gonorrhea. Each of the 10 sites will interview
a minimum of 250 persons or 2.5% of total morbidity if annual GC cases
exceed 10,000 cases and each interview is expected to take about 10
minutes per person. Data for the population-based component will be
collected through telephone-administered or in-person interviews
conducted by trained interviewers in the 10 eSSuN sites.
The survey results will be entered into the existing information
systems at each health department and sent to CDC through secure file
transport mechanisms on an every two month basis.
This information is being collected to (1) enhance and improve STD
surveillance data, (2) inform a more comprehensive understanding of
tends and determinants of STDs of interest, (3) monitor public health
program impact and (4) provide a more robust evidence base for
directing public health action in the US.
Participation is voluntary. There is no cost to the respondents
other than their time.
Estimate of Annualized Burden
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per Total burden
Type of respondent Form name respondents responses per response hours
respondent (hours)
----------------------------------------------------------------------------------------------------------------
Data manager at clinic Record 33 6 3 594
(Electronic transmittal of Abstraction.
clinical variables in clinic
databases).
Data manager at each of the 10 Record 10 12 16 1920
local/state health department. Abstraction.
Gonorrhea cases sampled....... Telephone/in- 3,225 1 10/60 538
person
interview.
---------------------------------------------------------------
Total..................... ................ .............. .............. .............. 3,050
----------------------------------------------------------------------------------------------------------------
[[Page 46827]]
LeRoy 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.
[FR Doc. 2014-18845 Filed 8-8-14; 8:45 am]
BILLING CODE 4163-18-P
