Federal Register Notice

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Federal Register / Vol. 81, No. 99 / Monday, May 23, 2016 / Notices

departments in all 50 states, the District
of Columbia, and four territories (e.g.,
Guam, Puerto Rico, U.S. Virgin Islands,
and the Commonwealth of Northern
Mariana Islands) to conduct state-,
district-, and territorial-wide SV
prevention activities. The Violence
against Women Act of 1994 (VAWA)
and as amended in the Violence Against
Women Reauthorization Act of 2013
authorize the RPE program and
legislatively states that awardees will
allot RPE funds for prevention activities
conducted by local organizations (i.e.,
RPE sub-awardees), which include rape
crisis centers; State, territorial, or tribal
sexual assault coalitions; and other
public and private nonprofit entities
(e.g., community-based organizations,
nongovernmental organizations, and
academic institutions).
The CDC seeks a three-year OMB
approval to collect information from 55

RPE awardees (health departments in all
50 states, District of Columbia, and four
U.S. territories, i.e., Guam, Puerto Rico,
U.S. Virgin Islands, and the
Commonwealth of Northern Mariana
Islands) and their designees. RPE
awardees will report activity
information to CDC annually through
the Monitoring and Reporting System
(MRS), which consists of two reporting
tools, Work Plan Tool and Program
Report Tool. The Work Plan Tool
consists of items about awardees’
annual goals, objectives, progress, and
performance towards overall
cooperative agreement purpose and
strategies. The Program Report Tool
consists of items to assess awardees’
implementation, use of evidence-based
prevention strategies, and use of the
public health approach. The tools in the
MRS provide a systematic format to
collect data related to implementation

and performance consistently across all
awardees.
Information to be collected will
provide crucial data for program
performance monitoring, will allow
CDC analyze and synthesize information
across multiple RPE programs, help
ensure consistency in documenting
progress and TA, enhance
accountability of the use of federal
funds, and provide timely reports as
frequently requested by HHS, the White
House, and Congress. It provides CDC
with the capacity to respond in a timely
manner to requests for information
about the program, improve real-time
communications between CDC and RPE
awardees, and strengthen CDC’s ability
to monitor and evaluate awardees’
progress and performance.
The estimated annual burden hours
are 654. There is no cost to respondents
other than their time.

ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses
per respondent

Average
burden
per response
(in hours)

Form name

RPE Program Awardees .........................................................
(State, District of Columbia, and Territorial Health Departments) and Designees.

Work Plan Tool—Initial ..........

18

1

10

Program Report Tool—Initial
Work Plan Tool—Annual Reporting.
Program Report Tool—Annual
Reporting.

18
55

1
1

8
3

55

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. 2016–12053 Filed 5–20–16; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–16–16AJE; Docket No. CDC–2016–
0043]

Proposed Data Collection Submitted
for Public Comment and
Recommendations
sradovich on DSK3TPTVN1PROD with NOTICES

Number of
respondents

Type of respondents

Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:

The Centers for Disease
Control and Prevention (CDC), as part of
its continuing efforts to reduce public

SUMMARY:

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18:25 May 20, 2016

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burden and maximize the utility of
government information, 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. This notice invites
comment on the proposed National
Health and Nutrition Examination
Survey (NHANES) Longitudinal
Study—Feasibility Component. This
project will provide a logistical test of
proposed survey procedures along with
contact, interview, and examination
rates for a sample of previously
examined NHANES participants. The
information obtained will be used to
determine the feasibility of conducting
future follow-up surveys.
DATES: Written comments must be
received on or before July 22, 2016.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2016–
0043 by any of the following methods:
• Federal eRulemaking Portal:
Regulation.gov. Follow the instructions
for submitting comments.

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• Mail: Leroy A. Richardson,
Information Collection Review Office,
Centers for Disease Control and
Prevention, 1600 Clifton Road NE., MS–
D74, Atlanta, Georgia 30329.
Instructions: All submissions received
must include the agency name and
Docket Number. All relevant comments
received will be posted without change
to Regulations.gov, including any
personal information provided. For
access to the docket to read background
documents or comments received, go to
Regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Leroy A. Richardson, the Information
Collection Review Office, Centers for
Disease Control and Prevention, 1600
Clifton Road NE., MS–D74, Atlanta,
Georgia 30329; phone: 404–639–7570;
Email: [email protected].
SUPPLEMENTARY INFORMATION: Under the
Paperwork Reduction Act of 1995 (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. In addition, the PRA also

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Federal Register / Vol. 81, No. 99 / Monday, May 23, 2016 / Notices
requires Federal agencies to provide a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each new
proposed collection, each proposed
extension of existing collection of
information, and each reinstatement of
previously approved information
collection before submitting the
collection to OMB for approval. To
comply with this requirement, we are
publishing this notice of a proposed
data collection as described below.
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.

sradovich on DSK3TPTVN1PROD with NOTICES

Proposed Project
The NHANES Longitudinal Study—
Feasibility Component—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 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. Under this

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authorization, the National Health and
Nutrition Examination Surveys
(NHANES) have been conducted
periodically between 1970 and 1994,
and continuously since 1999 by NCHS,
CDC to produce descriptive statistics on
the health and nutrition status of the
general population based on direct
physical measurements.
The increasing prevalence of obesity
and chronic diseases, including
diabetes, cardiovascular and kidney
diseases, is an important public health
issue. If feasible, re-contacting past
NHANES participants could provide
information about changes in their
health condition, exposure to risk
factors, and utilization of healthcare
since the time of their original NHANES
exam, thereby making it possible to
estimate the incidence of various
chronic conditions. The survey’s
extensive baseline data on health
conditions, nutritional status, risk
behaviors, and environmental exposures
could further allow the identification
and monitoring of the impact of these
factors on the participant’s current
health status. Planning activities for a
future longitudinal study of all
NHANES examined adults from 2007–
2014 have been initiated. This study—
the NHANES Longitudinal Study,
targeted to start data collection in 2019
or 2020, will provide data to estimate
the incidence of selected health
outcomes in the U.S. population and
relative risk related to other baseline
data. The data collection effort proposed
in this announcement is only for the
Feasibility Component of the NHANES
Longitudinal Study. The interview and
examination content proposed in the
Feasibility Component represents the
core module of the future NHANES
Longitudinal Study.
Not since the NHANES I
Epidemiologic Follow-up Study
(NHEFS), which was also conducted by
NCHS, has there been a follow-up of a
nationally representative cohort to
assess the relations between baseline
clinical, nutritional, and behavioral
factors to subsequent morbidity and
mortality. While NCHS has prior
experience conducting the follow-up of
the NHANES I cohort in 1982–1984,
more than 30 years has passed. Since
then, response rates in major federal
surveys have declined and obtaining
cooperation from the household
population has become more difficult.
Therefore, before attempting to launch a
full scale data collection effort among
all examined adults from NHANES
2007–2014, we propose conducting a
feasibility study (the NHANES
Longitudinal Study—Feasibility
Component) to determine whether

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32331

previously examined participants can be
successfully traced, interviewed, and
examined. The proposed Feasibility
Component is comprised of two
elements: (1) A field feasibility test for
the core module of the NHANES
Longitudinal Study; and (2) a series of
targeted methodological tests of
additional components and procedures.
An annual sample of 400 respondents
(total of 800 participants over the 2-year
period) will be selected from the 2007–
2014 NHANES examinees (20 years and
older) to participate in the field
feasibility test. Of these, we expect
approximately 11% to be deceased prior
to the re-contact, resulting in a target
annual sample of 356 living examinees
and 44 deceased proxy interview
respondents.
As part of the preparation efforts for
a longitudinal study of all examined
adults from NHANES 2007–2014, up to
375 additional persons per year (750
participants over the 2-year period) may
be asked to participate in targeted tests
of proposed methods and procedures
such as bio-specimen collections,
cognitive testing for questions, or
protocol tests for additional exam
components. These targeted tests will
only occur if resources permit and if
tracing and participation in the field
feasibility test is successful. These
targeted methodological studies will be
conducted with paid volunteers or past
NHANES participants who are not part
of the potential NHANES longitudinal
study sample (for example, past
NHANES participants from the 1999–
2006 cycle).
Participation in the field feasibility
test and the targeted methodological
studies is completely voluntary and
confidential. The estimated average
burden for the field feasibility test is 42
minutes per respondent (1.5 hours per
respondent for 356 living participants
and 40 minutes per respondent for 44
proxy of deceased participants,
annually). The average burden for the
targeted methodological study
respondents is 1 hour. A two-year
approval is requested.
Demographic information such as
name, address, phone numbers, and
social security number collected in the
baseline NHANES will be used to locate
the sampled 800 field feasibility test
participants (annual sample of 400).
Prior to the re-contact, a review of
NHANES-linked mortality files will be
conducted to assist in determining the
vital status of sampled participants.
Trained interviewers will visit the
sampled participants at home to
conduct an in-person interview and a
health examination. Information that
will be collected through the interview

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32332

Federal Register / Vol. 81, No. 99 / Monday, May 23, 2016 / Notices

includes health status and medical
conditions, health care services, health
behaviors, and sociodemographic
characteristics. In addition, permission
for collecting hospital discharge data,
including diagnoses at discharge and
procedures performed during
hospitalization will be obtained during
the interview.
Following the interview, a health
examination will be conducted as part
of the home visit. The respondent’s
weight, waist circumference, and sitting
blood pressure will be measured, and a
monofilament assessment may be
conducted for neuropathy. In addition,

participants, hospitalization records
will be obtained only for 120
participants annually (240 participants
over the 2-year period) to evaluate the
record retrieval protocol for the study
cohort among different medical
facilities. An average of 3 hospital stays
per person is anticipated among this
cohort, therefore, an estimated 360
requests (120 persons × 3 stays) will be
made annually. The estimated burden
for hospital record provider is 20
minutes per record.
There is no cost to respondents other
than their time.

blood and urine will be collected.
Examples of laboratory tests planned
include hemoglobin A1c from the blood
specimen, and albumin and creatinine
from the urine collection. This proposed
project will assess the feasibility of
conducting these tests and procedures
in the home examination setting.
A proxy interview will be conducted
via telephone for sampled participants
who died prior to the re-contact.
Information on medical conditions and
overnight hospital stays since baseline
will be collected.
Although permission will be sought
from all field feasibility test

ESTIMATED ANNUALIZED BURDEN HOURS
Average
burden
per response
(in hours)

Number of
responses per
respondent

Total
burden
hours

Form name

2007–2014 NHANES examinees .....

Field feasibility test initial contact
and appointment scheduling form.
Field feasibility test home visit .........
Field feasibility test home urine collection.
Field feasibility test deceased proxy
interview.
Field feasibility test hospital records
form.
Targeted methodological studies .....

400

1

20/60

133

356
356

1
1

1
10/60

356
59

44

1

20/60

15

360

1

20/60

120

375

1

1

375

...........................................................

........................

........................

........................

1,058

2007–2014 NHANES examinees .....
2007–2014 NHANES examinees .....
Proxy of deceased 2007–2014
NHANES examinees.
Hospital record providers ..................
Adult volunteers (non-field feasibility
test participants).
Total ...........................................

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. 2016–12008 Filed 5–20–16; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30 Day–16–0987]

Agency Forms Undergoing Paperwork
Reduction Act Review

sradovich on DSK3TPTVN1PROD with NOTICES

Number of
respondents

Type of respondent

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

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18:25 May 20, 2016

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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 [email protected]. Written
comments and/or suggestions regarding

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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
Qualitative Information Collection on
Emerging Diseases among the Foreignborn in the U.S. (OMB Control No.
0920–0987, Expires 09/30/2016)—
Extension—Division of Global Migration
and Quarantine, National Center for
Emerging Zoonotic and Infectious
Diseases, Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
The Centers for Disease Control and
Prevention (CDC), National Center for
Emerging and Zoonotic Infectious
Diseases (NCEZID), Division of Global
Migration and Quarantine (DGMQ),
requests approval for an extension of the
current generic information collection
Qualitative Information Collection on
Emerging Diseases among the Foreignborn in the U.S. (OMB Control Number
0920–0987, expiration date 9/30/2016).

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