Agency Forms Undergoing Paperwork Reduction Act Review, 76992-76994 [2015-31226]
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76992
Federal Register / Vol. 80, No. 238 / Friday, December 11, 2015 / Notices
completeness of the evidence in the
systematic reviews may also address
this issue.
The proposed project does not
duplicate other available sources of this
information. Available study registries
and databases may not be complete to
sufficiently inform the Program’s
research.
The purpose of SEADS requests is not
to collect generalizable data, but to
supplement the published and grey
literature searches EPC investigators are
conducting. Furthermore, considering
the evidence and data included in
responses collected from industry
stakeholders, an assessment pertaining
to the completeness of the evidencebase will be produced. This, AHRQ
believes, will increase the value of
AHRQ’s research reviews to end users
and potentially provide stakeholders a
better understanding of how their
submissions are used.
Estimated Annual Respondent Burden
Exhibit 1 presents estimates of the
reporting burden hours for the data
collection efforts. Time estimates are
based on pilot testing of materials and
what can reasonably be requested of
respondents. The number of
respondents listed in ‘‘Number of
respondents per SEADS request’’ of
Exhibit 1 reflects a projected 80%
response rate.
Online Submission Form: A form for
submitting scientific evidence and data
related to medical interventions
sponsored by organizations and
individuals such as pharmaceutical
companies and independent
researchers. The form has three required
fields: The organization’s name, the
intervention in question, and whether
the information they provide is all the
information they know to exist. They
may upload documents and they are
also provided a data entry form if they
wish to offer greater details on their
studies.
An Optional Data Entry Form is
available as an alternative to the Online
Submission form. The time
requirements for response would be
same as the Online Submission Form.
EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
per SEADS
request
Form name
Number of
responses per
respondent
Hours per
response
Total burden
hours per
SEADS
Online Submission Form (OSF) ......................................................................
70
1
15/60
17.5
Total ..........................................................................................................
70
1
15/60
17.5
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of
SEADS
requests
Form name
Total burden
hours per
SEADS
Average
hourly wage
rate *
Total cost
burden
OSF ..................................................................................................................
70
17.5
a $55.48
$970.90
Total ..........................................................................................................
70
17.5
55.48
970.90
* Occupational Employment Statistics, May 2014 National Occupational Employment and Wage Estimates United States, U.S. Department of
Labor, Bureau of Labor Statistics. https://www.bls.gov/oes/current/oes_nat.htm#b29-0000.
a Based on the mean wages for Public Relations and Fundraising Managers, 11–2031, the occupational group most likely tasked with completing the OSF.
jstallworth on DSK7TPTVN1PROD with NOTICES
Request for Comments
In accordance with the Paperwork
Reduction Act, comments on AHRQ’s
information collection are requested
with regard to any of the following: (a)
Whether the proposed collection of
information is necessary for the proper
performance of AHRQ health care
research and health care information
dissemination functions, including
whether the information will have
practical utility; (b) the accuracy of
AHRQ’s estimate of burden (including
hours and costs) of the proposed
collection(s) of information; (c) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(d) ways to minimize the burden of the
collection of information upon the
respondents, including the use of
automated collection techniques or
other forms of information technology.
Comments submitted in response to
this notice will be summarized and
VerDate Sep<11>2014
14:55 Dec 10, 2015
Jkt 238001
included in the Agency’s subsequent
request for OMB approval of the
proposed information collection. All
comments will become a matter of
public record.
Sharon Arnold,
Deputy Director.
[FR Doc. 2015–31159 Filed 12–10–15; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–16–0950]
Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) has submitted the
following information collection request
PO 00000
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Fmt 4703
Sfmt 4703
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
E:\FR\FM\11DEN1.SGM
11DEN1
76993
Federal Register / Vol. 80, No. 238 / Friday, December 11, 2015 / Notices
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. Direct
written comments and/or suggestions
regarding the items contained in this
notice 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
The National Health and Nutrition
Examination Survey (NHANES), (OMB
No. 0920–0950, expires 11/30/2016)—
Revision—National Center for Health
Statistics (NCHS), Centers for Disease
Control and Prevention (CDC).
jstallworth on DSK7TPTVN1PROD with NOTICES
Background and Brief Description
Section 306 of the Public Health
Service (PHS) Act (42 U.S.C. 242k), as
amended, authorizes that the Secretary
of Health and Human Services (DHHS),
acting through NCHS, shall collect
statistics on the extent and nature of
illness and disability; environmental,
social and other health hazards; and
determinants of health of the population
of the United States.
The National Health and Nutrition
Examination Surveys (NHANES) have
been conducted periodically between
1970 and 1994, and continuously since
1999 by the National Center for Health
Statistics, CDC. Annually,
approximately 14,410 respondents
participate in some aspect of the full
survey. Up to 3,500 additional persons
might participate in tests of procedures,
special studies, or methodological
studies (Table 1). Participation in
NHANES is completely voluntary and
confidential. A three-year approval is
requested.
NHANES programs produce
descriptive statistics which measure the
health and nutrition status of the
general population. Through the use of
physical examinations, laboratory tests,
and interviews NHANES studies the
relationship between diet, nutrition and
health in a representative sample of the
United States. NHANES monitors the
prevalence of chronic conditions and
risk factors. NHANES data are used to
produce national reference data on
height, weight, and nutrient levels in
the blood. Results from more recent
NHANES can be compared to findings
reported from previous surveys to
monitor changes in the health of the
U.S. population over time. NCHS
collects personal identification
information. Participant level data items
will include basic demographic
information, name, address, social
security number, Medicare number and
participant health information to allow
for linkages to other data sources such
as the National Death Index and data
from the Centers for Medicare and
Medicaid Services (CMS).
A variety of agencies sponsor data
collection components on NHANES. To
keep burden down, NCHS cycles in and
out various components. The 2015–2016
NHANES physical examination
includes the following components:
Oral glucose tolerance test (ages 12 and
older), anthropometry (all ages), 24-hour
dietary recall (all ages), physician’s
examination (all ages, blood pressure is
collected here), oral health examination
(ages 1 and older), hearing (ages 20–59),
dual X-ray absorptiometry (total body
composition ages 6–59 and
osteoporosis, vertebral fractures and
aortic calcification ages 40 and older).
While at the examination center
additional interview questions are asked
(6 and older), a second 24-hour dietary
recall (all ages) is scheduled to be
conducted by phone 3–10 days later,
and an appointment is made to return
to the MEC to begin a 24-hour urine
collection (one-half sample of ages 20–
69). In 2014, a 24-hour urine collection
was added to the NHANES protocol to
better understand sodium intake and
provide a population baseline for use in
monitoring trends in sodium intake in
the future. In 2015, FDA is scheduled to
implement a plan to promote broad,
gradual reduction of added sodium in
the food supply. One half of those
successfully completing the initial
collection will be asked to complete a
second 24-hour urine. After completing
the 24-hour urine participants are asked
to provide 2 home urine collections
(first morning and an evening) and mail
them back. The urines collected in the
morning and evening will be compared
to the 24-hour urine collection.
NHANES also plans to conduct a
waist circumference methodology study.
The study population will be NHANES
participants aged 20 and over who
participate in the body measurements
component in the Mobile Examination
Center (MEC).
The bio-specimens collected for
laboratory tests include urine, blood,
vaginal and penile swabs, oral rinses
and household water collection. Serum,
plasma and urine specimens are stored
for future testing if the participant
consents.
The following major examination or
laboratory items, that had been included
in the 2013–2014 NHANES, were cycled
out for NHANES 2015–2016: Physical
activity monitor, taste and smell
component and upper body muscle
strength (grip test).
Most sections of the NHANES
interviews provide self-reported
information to be used either in concert
with specific examination or laboratory
content, as independent prevalence
estimates, or as covariates in statistical
analysis (e.g., socio-demographic
characteristics). Some examples include
alcohol, drug, and tobacco use, sexual
behavior, prescription and aspirin use,
and indicators of oral, bone,
reproductive, and mental health.
Several interview components support
the nutrition monitoring objective of
NHANES, including questions about
food security and nutrition program
participation, dietary supplement use,
and weight history/self-image/related
behavior.
NHANES data users include the U.S.
Congress; numerous Federal agencies
such as other branches of the Centers for
Disease Control and Prevention, the
National Institutes of Health, and the
United States Department of
Agriculture; private groups such as the
American Heart Association; schools of
public health; and private businesses.
There is no cost to respondents other
than their time.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondents
Form name
Individuals in households ................................
Individuals in households ................................
NHANES Questionnaire .................................
Waist Circumference Methodology Study ......
VerDate Sep<11>2014
14:55 Dec 10, 2015
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Frm 00068
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Sfmt 4703
14,410
3,000
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11DEN1
Number of
responses per
respondent
1
1
Average
burden per
response
(in hrs.)
2.5
8/60
76994
Federal Register / Vol. 80, No. 238 / Friday, December 11, 2015 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of
respondents
Type of respondents
Form name
Individuals in households ................................
Special Studies ..............................................
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.
[FR Doc. 2015–31226 Filed 12–10–15; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–855O, CMS–
10438 and CMS–10439]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid Services, HHS.
ACTION: Notice.
AGENCY:
The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. 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 (including each proposed
extension or reinstatement of an existing
collection of information) and to allow
60 days for public comment on the
proposed action. Interested persons are
invited to send comments regarding our
burden estimates or any other aspect of
this collection of information, including
any of the following subjects: the
necessity and utility of the proposed
information collection for the proper
performance of the agency’s functions;
the accuracy of the estimated burden;
ways to enhance the quality, utility, and
clarity of the information to be
collected; and the use of automated
collection techniques or other forms of
information technology to minimize the
information collection burden.
DATES: Comments must be received by
February 9, 2016.
ADDRESSES: When commenting, please
reference the document identifier or
OMB control number. To be assured
consideration, comments and
jstallworth on DSK7TPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
14:55 Dec 10, 2015
Jkt 238001
recommendations must be submitted in
any one of the following ways:
1. Electronically. You may send your
comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) that are accepting
comments.
2. By regular mail. You may mail
written comments to the following
address: CMS, Office of Strategic
Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: Document Identifier/OMB
Control Number ll, Room C4–26–05,
7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, you may make your request
using one of following:
1. Access CMS’ Web site address at
https://www.cms.hhs.gov/
PaperworkReductionActof1995.
2. Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov.
3. Call the Reports Clearance Office at
(410) 786–1326.
FOR FURTHER INFORMATION CONTACT:
Reports Clearance Office at (410) 786–
1326.
SUPPLEMENTARY INFORMATION:
Contents
This notice sets out a summary of the
use and burden associated with the
following information collections. More
detailed information can be found in
each collection’s supporting statement
and associated materials (see
ADDRESSES).
PO 00000
Frm 00069
Fmt 4703
Sfmt 4703
3,500
Number of
responses per
respondent
Average
burden per
response
(in hrs.)
1
3
CMS–855O Medicare Registration
Application
CMS–10438 Data Collection To
Support Eligibility Determinations and
Enrollment for Employees in the Small
Business Health Options Program
CMS–10439 Data Collection To
Support Eligibility Determinations and
Enrollment for Employers in the Small
Business Health Options Program
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.
The term ‘‘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
provide information to a third party.
Section 3506(c)(2)(A) of the PRA
requires federal agencies to publish a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, before
submitting the collection to OMB for
approval. To comply with this
requirement, CMS is publishing this
notice.
1. Type of Information Collection
Request: Revision of a currently
approved information collection; Title
of Information Collection: Medicare
Registration Application; Use: The
primary function of the CMS–8550 is to
gather information from a physician or
other eligible professional to help CMS
determine whether he or she meets
certain qualifications to be enrolled in
the Medicare program for the sole
purpose of ordering or certifying certain
Medicare items or services and/or
prescribing Medicare Part D drugs for
Medicare beneficiaries. The application
allows a physician or other eligible
professional to enroll in Medicare
without being approved for billing
privileges. The required information is
submitted when the applicant requests
enrollment in Medicare for the sole
purpose of ordering and certifying
certain Medicare items and services or
for prescribing Medicare Part D drugs.
The application is used by Medicare
contractors to collect data to help ensure
E:\FR\FM\11DEN1.SGM
11DEN1
]]>Agencies
[Federal Register Volume 80, Number 238 (Friday, December 11, 2015)]
[Notices]
[Pages 76992-76994]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-31226]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-16-0950]
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
[[Page 76993]]
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. Direct written comments
and/or suggestions regarding the items contained in this notice 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
The National Health and Nutrition Examination Survey (NHANES), (OMB
No. 0920-0950, expires 11/30/2016)--Revision--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 that the Secretary of Health and Human
Services (DHHS), acting through NCHS, shall collect statistics on the
extent and nature of illness and disability; environmental, social and
other health hazards; and determinants of health of the population of
the United States.
The National Health and Nutrition Examination Surveys (NHANES) have
been conducted periodically between 1970 and 1994, and continuously
since 1999 by the National Center for Health Statistics, CDC. Annually,
approximately 14,410 respondents participate in some aspect of the full
survey. Up to 3,500 additional persons might participate in tests of
procedures, special studies, or methodological studies (Table 1).
Participation in NHANES is completely voluntary and confidential. A
three-year approval is requested.
NHANES programs produce descriptive statistics which measure the
health and nutrition status of the general population. Through the use
of physical examinations, laboratory tests, and interviews NHANES
studies the relationship between diet, nutrition and health in a
representative sample of the United States. NHANES monitors the
prevalence of chronic conditions and risk factors. NHANES data are used
to produce national reference data on height, weight, and nutrient
levels in the blood. Results from more recent NHANES can be compared to
findings reported from previous surveys to monitor changes in the
health of the U.S. population over time. NCHS collects personal
identification information. Participant level data items will include
basic demographic information, name, address, social security number,
Medicare number and participant health information to allow for
linkages to other data sources such as the National Death Index and
data from the Centers for Medicare and Medicaid Services (CMS).
A variety of agencies sponsor data collection components on NHANES.
To keep burden down, NCHS cycles in and out various components. The
2015-2016 NHANES physical examination includes the following
components: Oral glucose tolerance test (ages 12 and older),
anthropometry (all ages), 24-hour dietary recall (all ages),
physician's examination (all ages, blood pressure is collected here),
oral health examination (ages 1 and older), hearing (ages 20-59), dual
X-ray absorptiometry (total body composition ages 6-59 and
osteoporosis, vertebral fractures and aortic calcification ages 40 and
older).
While at the examination center additional interview questions are
asked (6 and older), a second 24-hour dietary recall (all ages) is
scheduled to be conducted by phone 3-10 days later, and an appointment
is made to return to the MEC to begin a 24-hour urine collection (one-
half sample of ages 20- 69). In 2014, a 24-hour urine collection was
added to the NHANES protocol to better understand sodium intake and
provide a population baseline for use in monitoring trends in sodium
intake in the future. In 2015, FDA is scheduled to implement a plan to
promote broad, gradual reduction of added sodium in the food supply.
One half of those successfully completing the initial collection will
be asked to complete a second 24-hour urine. After completing the 24-
hour urine participants are asked to provide 2 home urine collections
(first morning and an evening) and mail them back. The urines collected
in the morning and evening will be compared to the 24-hour urine
collection.
NHANES also plans to conduct a waist circumference methodology
study. The study population will be NHANES participants aged 20 and
over who participate in the body measurements component in the Mobile
Examination Center (MEC).
The bio-specimens collected for laboratory tests include urine,
blood, vaginal and penile swabs, oral rinses and household water
collection. Serum, plasma and urine specimens are stored for future
testing if the participant consents.
The following major examination or laboratory items, that had been
included in the 2013-2014 NHANES, were cycled out for NHANES 2015-2016:
Physical activity monitor, taste and smell component and upper body
muscle strength (grip test).
Most sections of the NHANES interviews provide self-reported
information to be used either in concert with specific examination or
laboratory content, as independent prevalence estimates, or as
covariates in statistical analysis (e.g., socio-demographic
characteristics). Some examples include alcohol, drug, and tobacco use,
sexual behavior, prescription and aspirin use, and indicators of oral,
bone, reproductive, and mental health. Several interview components
support the nutrition monitoring objective of NHANES, including
questions about food security and nutrition program participation,
dietary supplement use, and weight history/self-image/related behavior.
NHANES data users include the U.S. Congress; numerous Federal
agencies such as other branches of the Centers for Disease Control and
Prevention, the National Institutes of Health, and the United States
Department of Agriculture; private groups such as the American Heart
Association; schools of public health; and private businesses. There is
no cost to respondents other than their time.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per
Type of respondents Form name respondents responses per response (in
respondent hrs.)
----------------------------------------------------------------------------------------------------------------
Individuals in households............. NHANES Questionnaire.... 14,410 1 2.5
Individuals in households............. Waist Circumference 3,000 1 8/60
Methodology Study.
[[Page 76994]]
Individuals in households............. Special Studies......... 3,500 1 3
----------------------------------------------------------------------------------------------------------------
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.
[FR Doc. 2015-31226 Filed 12-10-15; 8:45 am]
BILLING CODE 4163-18-P
