82 FR 12361 - Agency Forms Undergoing Paperwork Reduction Act Review

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 82, Issue 40 (March 2, 2017)

[Federal Register Volume 82, Number 40 (Thursday, March 2, 2017)]
[Notices]
[Pages 12361-12363]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-04046]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-17-16AJE]


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

[[Page 12362]]

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]. 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 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, NCHS has conducted the 
National Health and Nutrition Examination Surveys periodically between 
1970 and 1994, and continuously since 1999 (NHANES, see OMB Control No. 
0920-0237 and OMB Control No. 0920-0950). The NHANES survey is based on 
a cross-sectional design employing a stratified, multistage probability 
sample. Information collection methods include interviews and direct 
physical measurements. NCHS uses NHANES data to produce descriptive 
statistics on the health and nutrition status of the general 
population, including estimates of the prevalence of numerous chronic 
diseases and conditions.
    To enhance the information collected through NHANES, NCHS has 
initiated planning activities for a future NHANES Longitudinal Study, 
with a target starting date for data collection in 2020. A longitudinal 
cohort design is needed to examine changes in participants' health 
conditions, their utilization of healthcare since the time of their 
original NHANES exam, and the long-term impact of risk factors on the 
development of morbidity. Participants in the NHANES Longitudinal Study 
will be individuals who participated in NHANES between 2007 and 2014. 
The survey's extensive baseline data on health conditions, nutritional 
status, and risk behaviors, analyzed in conjunction with information 
from a longitudinal cohort, will support the estimation of incidence 
for a wide range of chronic conditions as well as tracking of progress 
on national goals for prevention.
    The NHANES Longitudinal Study planned for 2020 will be the first 
nationally representative cohort in more than two decades. The last 
cohort of this type was the NHANES Epidemiologic Follow-up Studies (OMB 
Control No. 0920-0218) conducted in 1984-1985, 1988, and 1992-1993. 
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 to conduct a feasibility study in 2017-2018 to determine 
whether previously examined participants can be successfully traced, 
interviewed, and examined.
    The Feasibility Component of the NHANES Longitudinal Study is 
comprised of two elements: (1) A field feasibility test for the core 
interview and examination module of the NHANES Longitudinal Study; and 
(2) a series of targeted methodological tests of additional components 
and procedures. Information will be collected to evaluate the 
operational feasibility of the core module and to assess the 
performance of these components administered in the home setting. The 
core module currently planned for the NHANES Longitudinal Study will 
focus on chronic conditions including obesity, diabetes, cardiovascular 
disease, and kidney disease.
    An annual sample of 400 respondents (total of 800 participants over 
the two-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 decedent 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 two-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 volunteers who are not from the NHANES 
cohort, 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).
    The estimated average burden for the field feasibility test is 84 
minutes per respondent (1.5 hours per respondent for 356 living 
participants and 35 minutes per respondent for 44 proxy of deceased 
participants, annually). The average burden for the targeted 
methodological study respondents is one hour.
    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 the NHANES linked 
mortality files will be conducted to assist in determining the vital 
status of sampled participants.
    Trained Health Representatives 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 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 will 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 setting.

[[Page 12363]]

    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 two-year period) to 
evaluate the record retrieval protocol for the study cohort among 
different medical facilities. An average of three 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.
    OMB approval is requested for two years to conduct the feasibility 
component of the NHANES Longitudinal Study. Participation is voluntary 
and there are no costs to respondents other than their time. The total 
estimated annualized burden hours are 1,055.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of    Average burden
         Type of respondent                   Form name              Number of     responses per   per response
                                                                    respondents     respondent      (in hours)
----------------------------------------------------------------------------------------------------------------
2007-2014 NHANES examinees, and      Field feasibility test                  400               1           15/60
 proxies of deceased 2007-2014        registration form--contact
 NHANES examinees.                    confirmation and
                                      scheduling preference.
2007-2014 NHANES examinees.........  Field feasibility test home             356               1               1
                                      visit.
2007-2014 NHANES examinees.........  Field feasibility test home             356               1           15/60
                                      urine collection.
Proxies of deceased 2007-2014        Field feasibility test                   44               1           20/60
 NHANES examinees.                    decedent proxy interview.
Hospital record providers..........  Field feasibility test                  360               1           20/60
                                      hospital records form.
Adult volunteers (non-field          Targeted methodological                 375               1               1
 feasibility test participants).      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. 2017-04046 Filed 3-1-17; 8:45 am]
BILLING CODE 4163-18-P