80 FR 53799 - Proposed Data Collection Submitted for Public Comment and Recommendations

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

Federal Register Volume 80, Issue 173 (September 8, 2015)

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 revision of the National Health and Nutrition Examination Survey (NHANES). NHANES programs produce descriptive statistics which measure the health and nutrition status of the general population.

[Federal Register Volume 80, Number 173 (Tuesday, September 8, 2015)]
[Notices]
[Pages 53799-53801]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-22550]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-15-0950; Docket No. CDC-2015-0078]


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 
revision of the National Health and Nutrition Examination Survey 
(NHANES). NHANES programs produce descriptive statistics which measure 
the health and nutrition status of the general population.

DATES: Written comments must be received on or before November 9, 2015.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2015-
0078 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: To request more information on the 
proposed project or to obtain a copy of the information collection plan 
and instruments, contact 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 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

[[Page 53800]]

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 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.
    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.
    Participation in NHANES is completely voluntary and confidential. A 
three-year approval is requested. 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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Individuals in households.....  NHANES                    14,410               1             2.5          36,025
                                 Questionnaire.
Individuals in households.....  Waist                      3,000               1            8/60             400
                                 Circumference
                                 Methodology
                                 Studies.

[[Page 53801]]

 
Individuals in households.....  Special Studies.           3,500               1               3          10,500
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............          46,925
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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. 2015-22550 Filed 9-4-15; 8:45 am]
 BILLING CODE 4163-18-P