[Federal Register Volume 81, Number 99 (Monday, May 23, 2016)]
[Notices]
[Pages 32330-32332]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-12008]
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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
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice with comment period.
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SUMMARY: The Centers for Disease Control and Prevention (CDC), as part
of its continuing efforts to reduce public 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.
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
[[Page 32331]]
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.
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 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 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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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, 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
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 x 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.
Estimated Annualized Burden Hours
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Number of Average burden
Type of respondent Form name Number of responses per per response Total burden
respondents respondent (in hours) hours
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2007-2014 NHANES examinees.... Field 400 1 20/60 133
feasibility
test initial
contact and
appointment
scheduling form.
2007-2014 NHANES examinees.... Field 356 1 1 356
feasibility
test home visit.
2007-2014 NHANES examinees.... Field 356 1 10/60 59
feasibility
test home urine
collection.
Proxy of deceased 2007-2014 Field 44 1 20/60 15
NHANES examinees. feasibility
test deceased
proxy interview.
Hospital record providers..... Field 360 1 20/60 120
feasibility
test hospital
records form.
Adult volunteers (non-field Targeted 375 1 1 375
feasibility test methodological
participants). studies.
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Total..................... ................ .............. .............. .............. 1,058
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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