81 FR 32333 - Proposed Data Collection Submitted for Public Comment and Recommendations

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

Federal Register Volume 81, Issue 99 (May 23, 2016)

Page Range		32333-32335
FR Document		2016-12009

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 81 Issue 99 (Monday, May 23, 2016)

[Federal Register Volume 81, Number 99 (Monday, May 23, 2016)]
[Notices]
[Pages 32333-32335]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-12009]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-16-0950; Docket No. CDC-2016-0044]


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.

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

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 July 22, 2016.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2015-
0044 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

[[Page 32334]]

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 National Health and Nutrition Examination Survey (NHANES), (OMB 
No. 0920-0950, expires 12/31/2017)--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 
2017-2018 NHANES physical examination includes the following 
components: 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), and hearing (ages 6-
19 and 70+).
    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. In 2017 we plan to 
add a liver elastography (ultrasound) exam with a set of alcohol 
questions to complement this exam, an Oral Human Papilloma Virus (HPV) 
follow-up, and cycle back in bone density for hip and spine into the 
Dual X-ray Absorptiometry (DXA) exam for (ages 50+). The osteoporosis 
questionnaire will also cycle back into NHANES to complement the 
changes to the DXA exam. These questions will be asked of those 40+ In 
addition, the age range for the existing DXA total body scan will be 
changed from 6-59 years to 8-69 years.
    NHANES plans to conduct a blood pressure methodology study. The 
study population will be NHANES participants aged 6 and older who agree 
to come to the Mobile Examination Center (MEC). The survey would also 
like to conduct an Ambulatory Blood Pressure Pilot Study among NHANES 
participants ages 18 and older.
    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, including genetic research, if the participant consents. 
NHANES 2017-18 plans to add three Phthalates in urine (ages 3+), nine 
Urinary flame retardants in urine (ages 3+), one Insect repellant in 
urine (ages 3+), one Volatile organic compound (VOC) metabolite in 
urine (ages 3+), eighteen Tobacco biomarkers in urine (ages 3+), two 
Metals in urine (ages 3+), Vitamin C in serum (ages 6+), Vitamins A, E, 
and carotenoids in serum (ages 6+), Unsaturated Iron Binding Capacity 
(UIBC)/Total Iron Binding Capacity (TIBC) in serum (ages 12+), and 
Congenital cytomegalovirus (CMV) in sera (ages 1-5). Consent to store 
DNA is cycling back into NHANES.
    In addition metals in whole blood are changing from a one-half 
sample to a full sample (ages 1+). Polycyclic Aromatic Hydrocarbons 
(PAHs) are being discontinued in the smoker oversample subgroup, 
however testing will continue in a \1/3\ subsample of general NHANES 
participants.
    The 2017-18 survey will also bring back the Flexible Consumer 
Behavior Survey Phone follow-Up questionnaire for participant ages 1+. 
This takes place in the home after the second dietary recall is 
completed.
    The following major examination or laboratory items, that had been 
included in the 2015-2016 NHANES, were cycled out for NHANES 2017-2018: 
Pubertal maturation, oral glucose tolerance test (OGTT), dual X-ray 
absorptiometry scans for vertebral fractures and aortic calcification, 
three metals in serum and three hormones and binding proteins.
    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

[[Page 32335]]

NHANES, including questions about food security and nutrition program 
participation, dietary supplement use, and weight history/self-image/
related behavior.
    In 2017-2018, we also plan to conduct a Dietary Supplement Imaging 
pilot study, as well as implement multi-mode screening and electronic 
consent procedures in NHANES. The consent for birth certificate linkage 
that had been included in previous NHANES will be dropped from NHANES 
2017-2018.
    There is no cost to respondents other than their time.

                                                            Estimated Annualized Burden Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                              Average
                                                                                             Number of       Number of      burden per     Total burden
               Type of respondent                               Form name                   respondents    responses per   response (in        hours
                                                                                                            respondent        hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Individuals in households......................  NHANES Questionnaire...................          14,410               1             2.5          36,025
Individuals in households......................  Blood Pressure Methodology Study Phase            1,404               1           30/60             702
                                                  1.
Individuals in households......................  Blood Pressure Methodology Study Phase            2,000               1           30/60           1,000
                                                  2.
Individuals in households......................  Ambulatory Blood Pressure Pilot Study..           1,200               1              25          30,000
Individuals in households......................  Oral HPV rinse Follow-up Study 6 months           2,880               1           10/60             480
                                                  (estimated 80% of original sample of
                                                  3600).
Individuals in households......................  Oral HPV rinse Follow-up Study 12                 2,520               1           10/60             420
                                                  Months (estimated 70% of original
                                                  sample).
Individuals in households......................  Oral HPV rinse Follow-up Study 18                 2,160               1           10/60             360
                                                  months (estimated 60% of original
                                                  sample).
Individuals in households......................  Oral HPV rinse Follow-up Study 24                 1,800               1           10/60             300
                                                  Months (estimated 50% of original
                                                  sample).
Individuals in households......................  Flexible Consumer Behavior Survey Phone           5,000               1           20/60           1,667
                                                  Follow-Up.
Individuals in households......................  Special Studies........................           3,500               1               3          10,500
                                                                                         ---------------------------------------------------------------
    Total......................................  .......................................  ..............  ..............  ..............          81,454
--------------------------------------------------------------------------------------------------------------------------------------------------------


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. 2016-12009 Filed 5-20-16; 8:45 am]
 BILLING CODE 4163-18-P

Federal Register / Vol. 81, No. 99 / Monday, May 23, 2016 / Notices 32333

This qualitative data collection is The purpose of the extension is to increasing threat to global health
needed by DGMQ because foreign-born continue efforts to improve the agency’s security.
individuals are considered hard-to- understanding of the health status, risk Under the terms of this generic, CDC
reach populations and are often missed factors for disease, and other health will employ focus groups and key
by routine information collection outcomes among foreign-born informant interviews to collect
systems in the United States. As a individuals in the United States. information. Depending on the specific
consequence, limited information is Numerous types of data will be purpose, the information collection may
available about the health status, collected under the auspices of this be conducted either in-person, by
knowledge, attitudes, health beliefs and generic information collection. These telephone, on paper, or online. For each
practices related to communicable include, but are not limited to, generic information collection, CDC will
diseases and other emerging health knowledge, attitudes, beliefs, behavioral submit to OMB the project summary
intentions, practices, behaviors, skills, and information collection tools.
issues (e.g., tuberculosis, parasitic
diseases, lead poisoning, and mental self-efficacy, and health information Estimated Annualized Burden Hours
health issues) among foreign-born needs and sources.
This requests entails a total of 1,025
populations in the United States. For example, CDC recently used this respondents and 825 burden hours
Foreign-born populations are very generic to collect feedback on Mexican- annually. The respondents to these
diverse in terms of countries of origin, born audience’s preferences for information collections are foreign born
socio-demographic, cultural and messaging and communication about individuals in the United States. There
linguistic characteristics and geographic mosquito-borne diseases to develop is no cost to respondents other than the
destinations in the U.S. Data is effective prevention campaigns as these time required to provide the information
especially limited at the local level. diseases—especially Zika—pose an requested.

Number of Average
Number of responses burden per
Type of respondent Form name respondents per respond- response
ent (in hours)

Foreign-born from specific country of birth in Screeners for focus groups (assuming 2 600 1 10/60
the United States. screenings for each recruited participant in
focus groups) (300X2 = 600).
Foreign-born from specific country of birth in Focus Groups (Approximately 30 focus 300 1 2
the United States. groups/year and 10 participants per focus
group).
Foreign-born community leaders and staff Key informant interviews (Approximately 125 125 1 1
from organizations serving those commu- interviews/year).
nities.

Leroy A. Richardson, general public and other Federal to Regulations.gov, including any
Chief, Information Collection Review Office, agencies to take this opportunity to personal information provided. For
Office of Scientific Integrity, Office of the comment on proposed and/or access to the docket to read background
Associate Director for Science, Office of the continuing information collections, as documents or comments received, go to
Director, Centers for Disease Control and required by the Paperwork Reduction Regulations.gov.
Prevention.
Act of 1995. This notice invites FOR FURTHER INFORMATION CONTACT: To
[FR Doc. 2016–12010 Filed 5–20–16; 8:45 am] comment on the proposed revision of request more information on the
BILLING CODE 4163–18–P the National Health and Nutrition proposed project or to obtain a copy of
Examination Survey (NHANES). the information collection plan and
NHANES programs produce descriptive instruments, contact the Information
DEPARTMENT OF HEALTH AND statistics which measure the health and
HUMAN SERVICES Collection Review Office, Centers for
nutrition status of the general Disease Control and Prevention, 1600
Centers for Disease Control and population. Clifton Road NE., MS–D74, Atlanta,
Prevention DATES: Written comments must be Georgia 30329; phone: 404–639–7570;
[60Day–16–0950; Docket No. CDC–2016– received on or before July 22, 2016. Email: omb@cdc.gov.
0044] ADDRESSES: You may submit comments, SUPPLEMENTARY INFORMATION: Under the
identified by Docket No. CDC–2015– Paperwork Reduction Act of 1995 (PRA)
Proposed Data Collection Submitted 0044 by any of the following methods: (44 U.S.C. 3501–3520), Federal agencies
for Public Comment and • Federal eRulemaking Portal: must obtain approval from the Office of
Recommendations Regulation.gov. Follow the instructions Management and Budget (OMB) for each
AGENCY: Centers for Disease Control and for submitting comments. collection of information they conduct
Prevention (CDC), Department of Health • Mail: Leroy A. Richardson, or sponsor. In addition, the PRA also
Information Collection Review Office, requires Federal agencies to provide a
sradovich on DSK3TPTVN1PROD with NOTICES

and Human Services (HHS).
ACTION: Notice with comment period.
Centers for Disease Control and 60-day notice in the Federal Register
Prevention, 1600 Clifton Road NE., MS– concerning each proposed collection of
SUMMARY: The Centers for Disease D74, Atlanta, Georgia 30329. information, including each new
Control and Prevention (CDC), as part of Instructions: All submissions received proposed collection, each proposed
its continuing efforts to reduce public must include the agency name and extension of existing collection of
burden and maximize the utility of Docket Number. All relevant comments information, and each reinstatement of
government information, invites the received will be posted without change previously approved information

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Federal Register / Vol. 81, No. 99 / Monday, May 23, 2016 / Notices 32335

NHANES, including questions about In 2017–2018, we also plan to birth certificate linkage that had been
food security and nutrition program conduct a Dietary Supplement Imaging included in previous NHANES will be
participation, dietary supplement use, pilot study, as well as implement multi- dropped from NHANES 2017–2018.
and weight history/self-image/related mode screening and electronic consent There is no cost to respondents other
behavior. procedures in NHANES. The consent for than their time.

ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per re- Total burden
Type of respondent Form name responses per
respondents sponse (in hours
respondent hours)

Individuals in households NHANES Questionnaire ...................................... 14,410 1 2.5 36,025
Individuals in households Blood Pressure Methodology Study Phase 1 ..... 1,404 1 30/60 702
Individuals in households Blood Pressure Methodology Study Phase 2 ..... 2,000 1 30/60 1,000
Individuals in households Ambulatory Blood Pressure Pilot Study .............. 1,200 1 25 30,000
Individuals in households Oral HPV rinse Follow-up Study 6 months (esti- 2,880 1 10/60 480
mated 80% of original sample of 3600).
Individuals in households Oral HPV rinse Follow-up Study 12 Months (es- 2,520 1 10/60 420
timated 70% of original sample).
Individuals in households Oral HPV rinse Follow-up Study 18 months (es- 2,160 1 10/60 360
timated 60% of original sample).
Individuals in households Oral HPV rinse Follow-up Study 24 Months (es- 1,800 1 10/60 300
timated 50% of original sample).
Individuals in households Flexible Consumer Behavior Survey Phone Fol- 5,000 1 20/60 1,667
low-Up.
Individuals in households Special Studies .................................................... 3,500 1 3 10,500

Total ........................ .............................................................................. ........................ ........................ ........................ 81,454

Leroy A. Richardson, including some stakeholders/sectors publicly, however they may be made
Chief, Information Collection Review Office, relevant to this overall effort. This available to the public, in part or in full,
Office of Scientific Integrity, Office of the Request for Information (RFI) offers the subject to applicable laws and
Associate Director for Science, Office of the opportunity for interested individuals, regulations.
Director, Centers for Disease Control and organizations, associations, industries, • Online Form: www.hhs.gov/ash/
Prevention. and others, to provide their feedback. carb. Online submissions will receive
[FR Doc. 2016–12009 Filed 5–20–16; 8:45 am] Responses to the questions must be an automatic confirmation
BILLING CODE 4163–18–P received by 11:59 p.m. on June 22, 2016 acknowledging receipt of your response,
to be considered. The questions are also but will not receive individualized
available through an online form on the feedback on any suggestions.
DEPARTMENT OF HEALTH AND Advisory Council Web page at • Email: CARB@hhs.gov. Please
HUMAN SERVICES www.hhs.gov/ash/carb. Individuals who indicate the question number(s) in the
wish to send in their responses via subject line of your email. Email
Notice of Request for Information by submissions will receive an electronic
the Presidential Advisory Council on email should send an email to CARB@
hhs.gov, indicating the question confirmation acknowledging receipt of
Combating Antibiotic-Resistant your response, but will not receive
Bacteria number(s) for which they are
responding. individualized feedback on any
AGENCY: Office of the Assistant suggestions.
DATES: Comments must be received by
Secretary for Health, Office of the 11:59 p.m. on June 22, 2016 to be SUPPLEMENTARY INFORMATION: Under
Secretary, Department of Health and considered. Executive Order 13676, dated
Human Services. September 18, 2014, authority was given
ACTION: Notice. ADDRESSES: Individuals are encouraged to the Secretary of Health and Human
to submit their responses through one of Services (HHS) to establish the Advisory
SUMMARY: The Presidential Advisory the following methods. Utilization of Council, in consultation with the
Council on Combating Antibiotic- the online form available on Secretaries of Defense and Agriculture.
Resistant Bacteria (Advisory Council) www.hhs.gov/ash/carb is the preferred Activities of the Advisory Council are
requests information from the general method of submission. Should you governed by the provisions of Public
public and stakeholders related to choose to send in your responses via Law 92–463, as amended (5 U.S.C.
efforts and strategies to combat email, please be sure to include the App.), which sets forth standards for the
antibiotic-resistance. In the process of question number(s) in the subject line. formation and use of federal advisory
developing their report, Initial Do not include in your response committees.
Assessments of the National Action information of a confidential nature, The Advisory Council will provide
sradovich on DSK3TPTVN1PROD with NOTICES

Plan for Combating Antibiotic-Resistant such as sensitive personal information advice, information, and
Bacteria, the Advisory Council followed or proprietary information. Responses to recommendations to the Secretary of
the framework of the National Action this notice are not offers and cannot be HHS regarding programs and policies
Plan for Combating Antibiotic Resistant accepted by the federal government to intended to support and evaluate the
Bacteria (Action Plan) to hear about a form a binding contract or issue a grant. implementation of Executive Order
wide range of ongoing and planned Please be aware that your comments 13676, including the National Strategy
activities by the federal government, will not affirmatively be posted for Combating Antibiotic-Resistant

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Document Created: 2018-02-07 15:07:16
Document Modified: 2018-02-07 15:07:16

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice with comment period.
Dates		Written comments must be received on or before July 22, 2016.
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]
FR Citation		81 FR 32333

81 FR 32333 - Proposed Data Collection Submitted for Public Comment and Recommendations

DEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Disease Control and Prevention

Federal Register Volume 81, Issue 99 (May 23, 2016)

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