Agency Forms Undergoing Paperwork Reduction Act Review, 42796-42797 [2014-17328]
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42796
Federal Register / Vol. 79, No. 141 / Wednesday, July 23, 2014 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–14–14VS]
mstockstill on DSK4VPTVN1PROD 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
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
Developmental Studies to Improve the
National Health Care Surveys—New—
National Center for Health Statistics
(NCHS), Centers for Disease Control and
Prevention (CDC).
VerDate Mar<15>2010
17:33 Jul 22, 2014
Jkt 232001
Background and Brief Description
Section 306 of the Public Health
Service (PHS) Act (42 U.S.C. 242k), as
amended, authorizes the Secretary of
Health and Human Services (DHHS),
acting through the Division of Health
Care Statistics (DHCS) within NCHS,
shall collect statistics on the extent and
nature of illness and disability of the
population of the United States.
The DHCS conducts the National
Health Care Surveys, a family of
nationally representative surveys of
encounters and health care providers in
inpatient, outpatient, and long-term care
settings. This information collection
request (ICR) is for a new generic
clearance to conduct developmental
studies to improve this family of
surveys. This three year clearance
period will include studies to evaluate
and improve upon existing survey
design and operations, as well as to
examine the feasibility of, and address
challenges that may arise with, future
expansions of the National Health Care
Surveys.
Specifically, this request covers
developmental research with the
following aims: (1) To explore ways to
refine and improve upon existing survey
designs and procedures; and (2) to
explore and evaluate proposed survey
designs and alternative approaches to
data collection. The goal of these
research studies is to further enhance
DHCS existing and future data
collection protocols to increase research
capacity and improve health care data
quality for the purpose of monitoring
public health and well-being at the
national, state and local levels, thereby
informing health policy decisionmaking process. The information
collected through this generic ICR will
not be used to make generalizable
statements about the population of
interest or to inform public policy;
however, methodological findings may
be reported.
This generic clearance would include
studies conducted in person, via the
telephone or internet, and by postal or
electronic mail. Methods covered would
include qualitative (e.g., usability
testing, focus groups, ethnographic
studies, and respondent debriefing
questionnaires) and/or quantitative (e.g.,
pilot tests, pre-tests and split sample
experiments) research methodologies.
Examples of studies to improve existing
survey designs and procedures may
include evaluation of incentive
approaches to improve recruitment and
increase participation rates; testing of
new survey items to obtain additional
data on providers, patients, and their
encounters while minimizing
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
misinterpretation and human error in
data collection; testing data collection in
panel surveys; triangulating and
validating survey responses from
multiple data sources; assessment of the
feasibility of data retrieval; and
development of protocols that will
locate, identify, and collect accurate
survey data in the least labor-intensive
and burdensome manner at the sampled
practice site.
To explore and evaluate proposed
survey designs and alternative
approaches to collecting data, especially
with the nationwide adoption of
electronic health records, studies may
expand the evaluation of data extraction
of electronic health records and
submission via continuity of care
documentation to small/mid-size/large
medical providers and hospital
networks, managed care health plans,
prison-hospitals, and other inpatient,
outpatient, and long-term care settings
that are currently either in-scope or outof-scope of the National Health Care
Surveys. Research on feasibility, data
quality and respondent burden also may
be carried out in the context of
developing new surveys of health care
providers and establishments that are
currently out-of-scope of the National
Health Care Surveys.
Specific motivations for conducting
developmental studies include: (1)
Within the National Ambulatory
Medical Care Survey (NAMCS) (OMB
No. 0920–0234), new clinical groups
may be expanded to include dentists,
psychologists, podiatrists, chiropractors,
optometrists), mid-level providers (e.g.,
physician assistants, advanced practice
nurses, nurse practitioners, certified
nurse midwives) and allied-health
professionals (e.g., certified nursing
aides, medical assistants, radiology
technicians, laboratory technicians,
pharmacists, dieticians/nutritionists).
Current sampling frames such as those
from the American Medical Association
may be obtained and studied, as well as
frames that are not currently in use by
NAMCS, such as state and
organizational listings of other licensed
providers. (2) Within the National Study
of Long-Term Care Providers (OMB No.
0920–0912), additional new frames may
be sought and evaluated and data items
from home care agencies, long-term care
hospitals, and facilities exclusively
serving individuals with intellectual/
developmental disability may be tested.
Similarly, data may be obtained from
lists compiled by states and other
organizations. Data about the facilities
as well as residents and their visits will
be investigated. (3) In the inpatient and
outpatient care settings, the National
Hospital Care Survey (NHCS) (OMB No.
E:\FR\FM\23JYN1.SGM
23JYN1
42797
Federal Register / Vol. 79, No. 141 / Wednesday, July 23, 2014 / Notices
0920–0212) and the National Hospital
Ambulatory Medical Care Survey
(NHAMCS) (OMB No. 0920–0278) may
investigate the addition of facility and
patient information especially as it
relates to insurance and electronic
medical records.
Discussion is underway with the
DHHS Office of Minority Health on the
possibility of conducting a study to
collect data on the awareness, adoption
and implementation of the Enhanced
National Standards on Culturally and
Linguistically Appropriate Services
(CLAS) in physician offices. The study
may be preceded by a feasibility study.
The National Health Care Surveys
collect critical, accurate data that are
used to produce reliable national
estimates—and in recent years, statelevel estimates—of clinical services and
of the providers who delivered those
services in inpatient, outpatient,
ambulatory, and long-term care settings.
The data from these surveys are used by
providers, policy makers and
researchers to address important topics
of interest, including the quality and
disparities of care among populations,
epidemiology of medical conditions,
diffusion of technologies, effects of
policies and practice guidelines, and
changes in health care over time.
Research studies need to be conducted
to improve existing and proposed
survey design and procedures of the
National Health Care Surveys, as well as
to evaluate alternative data collection
approaches particularly due to the
expansion of electronic health record
use, and to develop new sample frames
of currently out-of-scope providers and
settings of care. There is no cost to
respondents other than their time to
participate. Average burdens are
designed to cover 15–40 min interviews
as well as 90 minute focus groups,
longer on-site visits, and situations
where organizations may be preparing
electronic data files. The total estimated
annualized burden is 7,085 hours.
ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondents
Health Care Providers and Business entities
Health Care Providers,State/local government
agencies, and business entities.
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. 2014–17328 Filed 7–22–14; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–1009]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Information
Request Regarding pH of Smokeless
Tobacco Products
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information and to allow 60 days for
public comment in response to the
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
17:33 Jul 22, 2014
Jkt 232001
Number of
respondents
Form name
Interviews, surveys,
ments (in person,
electronic mail).
Interviews, surveys,
ments (in person,
electronic mail).
6,667
1
1
focus groups, experiphone, internet, postal/
167
1
2.5
Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
SUPPLEMENTARY INFORMATION:
Frm 00043
Average
burden per
response
(in hours)
focus groups, experiphone, internet, postal/
notice. This notice solicits comments on
the collection of information regarding
pH of smokeless tobacco products.
DATES: Submit either electronic or
written comments on the collection of
information by September 22, 2014.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
PO 00000
Number of
responses per
respondent
Fmt 4703
Sfmt 4703
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
E:\FR\FM\23JYN1.SGM
23JYN1
]]>Agencies
[Federal Register Volume 79, Number 141 (Wednesday, July 23, 2014)]
[Notices]
[Pages 42796-42797]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-17328]
[[Page 42796]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-14-14VS]
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
Developmental Studies to Improve the National Health Care Surveys--
New--National Center for Health Statistics (NCHS), Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
Section 306 of the Public Health Service (PHS) Act (42 U.S.C.
242k), as amended, authorizes the Secretary of Health and Human
Services (DHHS), acting through the Division of Health Care Statistics
(DHCS) within NCHS, shall collect statistics on the extent and nature
of illness and disability of the population of the United States.
The DHCS conducts the National Health Care Surveys, a family of
nationally representative surveys of encounters and health care
providers in inpatient, outpatient, and long-term care settings. This
information collection request (ICR) is for a new generic clearance to
conduct developmental studies to improve this family of surveys. This
three year clearance period will include studies to evaluate and
improve upon existing survey design and operations, as well as to
examine the feasibility of, and address challenges that may arise with,
future expansions of the National Health Care Surveys.
Specifically, this request covers developmental research with the
following aims: (1) To explore ways to refine and improve upon existing
survey designs and procedures; and (2) to explore and evaluate proposed
survey designs and alternative approaches to data collection. The goal
of these research studies is to further enhance DHCS existing and
future data collection protocols to increase research capacity and
improve health care data quality for the purpose of monitoring public
health and well-being at the national, state and local levels, thereby
informing health policy decision-making process. The information
collected through this generic ICR will not be used to make
generalizable statements about the population of interest or to inform
public policy; however, methodological findings may be reported.
This generic clearance would include studies conducted in person,
via the telephone or internet, and by postal or electronic mail.
Methods covered would include qualitative (e.g., usability testing,
focus groups, ethnographic studies, and respondent debriefing
questionnaires) and/or quantitative (e.g., pilot tests, pre-tests and
split sample experiments) research methodologies. Examples of studies
to improve existing survey designs and procedures may include
evaluation of incentive approaches to improve recruitment and increase
participation rates; testing of new survey items to obtain additional
data on providers, patients, and their encounters while minimizing
misinterpretation and human error in data collection; testing data
collection in panel surveys; triangulating and validating survey
responses from multiple data sources; assessment of the feasibility of
data retrieval; and development of protocols that will locate,
identify, and collect accurate survey data in the least labor-intensive
and burdensome manner at the sampled practice site.
To explore and evaluate proposed survey designs and alternative
approaches to collecting data, especially with the nationwide adoption
of electronic health records, studies may expand the evaluation of data
extraction of electronic health records and submission via continuity
of care documentation to small/mid-size/large medical providers and
hospital networks, managed care health plans, prison-hospitals, and
other inpatient, outpatient, and long-term care settings that are
currently either in-scope or out-of-scope of the National Health Care
Surveys. Research on feasibility, data quality and respondent burden
also may be carried out in the context of developing new surveys of
health care providers and establishments that are currently out-of-
scope of the National Health Care Surveys.
Specific motivations for conducting developmental studies include:
(1) Within the National Ambulatory Medical Care Survey (NAMCS) (OMB No.
0920-0234), new clinical groups may be expanded to include dentists,
psychologists, podiatrists, chiropractors, optometrists), mid-level
providers (e.g., physician assistants, advanced practice nurses, nurse
practitioners, certified nurse midwives) and allied-health
professionals (e.g., certified nursing aides, medical assistants,
radiology technicians, laboratory technicians, pharmacists, dieticians/
nutritionists). Current sampling frames such as those from the American
Medical Association may be obtained and studied, as well as frames that
are not currently in use by NAMCS, such as state and organizational
listings of other licensed providers. (2) Within the National Study of
Long-Term Care Providers (OMB No. 0920-0912), additional new frames may
be sought and evaluated and data items from home care agencies, long-
term care hospitals, and facilities exclusively serving individuals
with intellectual/developmental disability may be tested. Similarly,
data may be obtained from lists compiled by states and other
organizations. Data about the facilities as well as residents and their
visits will be investigated. (3) In the inpatient and outpatient care
settings, the National Hospital Care Survey (NHCS) (OMB No.
[[Page 42797]]
0920-0212) and the National Hospital Ambulatory Medical Care Survey
(NHAMCS) (OMB No. 0920-0278) may investigate the addition of facility
and patient information especially as it relates to insurance and
electronic medical records.
Discussion is underway with the DHHS Office of Minority Health on
the possibility of conducting a study to collect data on the awareness,
adoption and implementation of the Enhanced National Standards on
Culturally and Linguistically Appropriate Services (CLAS) in physician
offices. The study may be preceded by a feasibility study.
The National Health Care Surveys collect critical, accurate data
that are used to produce reliable national estimates--and in recent
years, state-level estimates--of clinical services and of the providers
who delivered those services in inpatient, outpatient, ambulatory, and
long-term care settings. The data from these surveys are used by
providers, policy makers and researchers to address important topics of
interest, including the quality and disparities of care among
populations, epidemiology of medical conditions, diffusion of
technologies, effects of policies and practice guidelines, and changes
in health care over time. Research studies need to be conducted to
improve existing and proposed survey design and procedures of the
National Health Care Surveys, as well as to evaluate alternative data
collection approaches particularly due to the expansion of electronic
health record use, and to develop new sample frames of currently out-
of-scope providers and settings of care. There is no cost to
respondents other than their time to participate. Average burdens are
designed to cover 15-40 min interviews as well as 90 minute focus
groups, longer on-site visits, and situations where organizations may
be preparing electronic data files. The total estimated annualized
burden is 7,085 hours.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondents Form name Number of responses per per response
respondents respondent (in hours)
----------------------------------------------------------------------------------------------------------------
Health Care Providers and Business Interviews, surveys, 6,667 1 1
entities. focus groups,
experiments (in person,
phone, internet, postal/
electronic mail).
Health Care Providers,State/local Interviews, surveys, 167 1 2.5
government agencies, and business focus groups,
entities. experiments (in person,
phone, internet, postal/
electronic mail).
----------------------------------------------------------------------------------------------------------------
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. 2014-17328 Filed 7-22-14; 8:45 am]
BILLING CODE 4163-18-P
