81 FR 32330 - 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		32330-32332
FR Document		2016-12008

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.

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

[Federal Register Volume 81, Number 99 (Monday, May 23, 2016)]
[Notices]
[Pages 32330-32332]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-12008]


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

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.

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

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

[[Page 32332]]

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
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
      Type of respondent            Form name        Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)         hours
----------------------------------------------------------------------------------------------------------------
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.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............           1,058
----------------------------------------------------------------------------------------------------------------


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

32330 Federal Register / Vol. 81, No. 99 / Monday, May 23, 2016 / Notices

departments in all 50 states, the District RPE awardees (health departments in all and performance consistently across all
of Columbia, and four territories (e.g., 50 states, District of Columbia, and four awardees.
Guam, Puerto Rico, U.S. Virgin Islands, U.S. territories, i.e., Guam, Puerto Rico, Information to be collected will
and the Commonwealth of Northern U.S. Virgin Islands, and the provide crucial data for program
Mariana Islands) to conduct state-, Commonwealth of Northern Mariana performance monitoring, will allow
district-, and territorial-wide SV Islands) and their designees. RPE CDC analyze and synthesize information
prevention activities. The Violence awardees will report activity across multiple RPE programs, help
against Women Act of 1994 (VAWA) information to CDC annually through ensure consistency in documenting
and as amended in the Violence Against the Monitoring and Reporting System progress and TA, enhance
Women Reauthorization Act of 2013 (MRS), which consists of two reporting accountability of the use of federal
authorize the RPE program and tools, Work Plan Tool and Program funds, and provide timely reports as
legislatively states that awardees will Report Tool. The Work Plan Tool frequently requested by HHS, the White
allot RPE funds for prevention activities consists of items about awardees’ House, and Congress. It provides CDC
conducted by local organizations (i.e., annual goals, objectives, progress, and with the capacity to respond in a timely
RPE sub-awardees), which include rape performance towards overall manner to requests for information
crisis centers; State, territorial, or tribal cooperative agreement purpose and about the program, improve real-time
sexual assault coalitions; and other strategies. The Program Report Tool communications between CDC and RPE
public and private nonprofit entities consists of items to assess awardees’ awardees, and strengthen CDC’s ability
(e.g., community-based organizations, implementation, use of evidence-based to monitor and evaluate awardees’
nongovernmental organizations, and prevention strategies, and use of the progress and performance.
academic institutions). public health approach. The tools in the The estimated annual burden hours
The CDC seeks a three-year OMB MRS provide a systematic format to are 654. There is no cost to respondents
approval to collect information from 55 collect data related to implementation other than their time.

ESTIMATED ANNUALIZED BURDEN HOURS
Number of Average
Number of responses burden
Type of respondents Form name respondents per respond- per response
ent (in hours)

RPE Program Awardees ......................................................... Work Plan Tool—Initial .......... 18 1 10
(State, District of Columbia, and Territorial Health Depart-
ments) and Designees.
Program Report Tool—Initial 18 1 8
Work Plan Tool—Annual Re- 55 1 3
porting.
Program Report Tool—Annual 55 1 3
Reporting.

Leroy A. Richardson, burden and maximize the utility of • Mail: Leroy A. Richardson,
Chief, Information Collection Review Office, government information, invites the Information Collection Review Office,
Office of Scientific Integrity, Office of the general public and other Federal Centers for Disease Control and
Associate Director for Science, Office of the agencies to take this opportunity to Prevention, 1600 Clifton Road NE., MS–
Director, Centers for Disease Control and comment on proposed and/or D74, Atlanta, Georgia 30329.
Prevention.
continuing information collections, as Instructions: All submissions received
[FR Doc. 2016–12053 Filed 5–20–16; 8:45 am] required by the Paperwork Reduction must include the agency name and
BILLING CODE 4163–18–P Act of 1995. This notice invites Docket Number. All relevant comments
comment on the proposed National received will be posted without change
Health and Nutrition Examination to Regulations.gov, including any
DEPARTMENT OF HEALTH AND Survey (NHANES) Longitudinal personal information provided. For
HUMAN SERVICES Study—Feasibility Component. This access to the docket to read background
Centers for Disease Control and project will provide a logistical test of documents or comments received, go to
Prevention proposed survey procedures along with Regulations.gov.
contact, interview, and examination
[60Day–16–16AJE; Docket No. CDC–2016– FOR FURTHER INFORMATION CONTACT:
rates for a sample of previously
0043] Leroy A. Richardson, the Information
examined NHANES participants. The
Collection Review Office, Centers for
information obtained will be used to
Proposed Data Collection Submitted Disease Control and Prevention, 1600
determine the feasibility of conducting
for Public Comment and Clifton Road NE., MS–D74, Atlanta,
future follow-up surveys.
Recommendations Georgia 30329; phone: 404–639–7570;
DATES: Written comments must be Email: omb@cdc.gov.
sradovich on DSK3TPTVN1PROD with NOTICES

AGENCY: Centers for Disease Control and received on or before July 22, 2016.
Prevention (CDC), Department of Health SUPPLEMENTARY INFORMATION: Under the
and Human Services (HHS). ADDRESSES: You may submit comments, Paperwork Reduction Act of 1995 (PRA)
identified by Docket No. CDC–2016– (44 U.S.C. 3501–3520), Federal agencies
ACTION: Notice with comment period.
0043 by any of the following methods: must obtain approval from the Office of
SUMMARY: The Centers for Disease • Federal eRulemaking Portal: Management and Budget (OMB) for each
Control and Prevention (CDC), as part of Regulation.gov. Follow the instructions collection of information they conduct
its continuing efforts to reduce public for submitting comments. or sponsor. In addition, the PRA also

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32332 Federal Register / Vol. 81, No. 99 / Monday, May 23, 2016 / Notices

includes health status and medical blood and urine will be collected. participants, hospitalization records
conditions, health care services, health Examples of laboratory tests planned will be obtained only for 120
behaviors, and sociodemographic include hemoglobin A1c from the blood participants annually (240 participants
characteristics. In addition, permission specimen, and albumin and creatinine over the 2-year period) to evaluate the
for collecting hospital discharge data, from the urine collection. This proposed record retrieval protocol for the study
including diagnoses at discharge and project will assess the feasibility of cohort among different medical
procedures performed during conducting these tests and procedures facilities. An average of 3 hospital stays
hospitalization will be obtained during in the home examination setting. per person is anticipated among this
the interview. A proxy interview will be conducted cohort, therefore, an estimated 360
Following the interview, a health via telephone for sampled participants
requests (120 persons × 3 stays) will be
examination will be conducted as part who died prior to the re-contact.
of the home visit. The respondent’s made annually. The estimated burden
Information on medical conditions and
weight, waist circumference, and sitting for hospital record provider is 20
overnight hospital stays since baseline
blood pressure will be measured, and a will be collected. minutes per record.
monofilament assessment may be Although permission will be sought There is no cost to respondents other
conducted for neuropathy. In addition, from all field feasibility test than their time.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of Total
Number of burden
Type of respondent Form name responses per burden
respondents per response
respondent hours
(in hours)

2007–2014 NHANES examinees ..... Field feasibility test initial contact 400 1 20/60 133
and appointment scheduling form.
2007–2014 NHANES examinees ..... Field feasibility test home visit ......... 356 1 1 356
2007–2014 NHANES examinees ..... Field feasibility test home urine col- 356 1 10/60 59
lection.
Proxy of deceased 2007–2014 Field feasibility test deceased proxy 44 1 20/60 15
NHANES examinees. interview.
Hospital record providers .................. Field feasibility test hospital records 360 1 20/60 120
form.
Adult volunteers (non-field feasibility Targeted methodological studies ..... 375 1 1 375
test participants).

Total ........................................... ........................................................... ........................ ........................ ........................ 1,058

Leroy A. Richardson, concerning the proposed collection of the items contained in this notice
Chief, Information Collection Review Office, information are encouraged. Your should be directed to the Attention:
Office of Scientific Integrity, Office of the comments should address any of the CDC Desk Officer, Office of Management
Associate Director for Science, Office of the following: (a) Evaluate whether the and Budget, Washington, DC 20503 or
Director, Centers for Disease Control and proposed collection of information is by fax to (202) 395–5806. Written
Prevention. comments should be received within 30
necessary for the proper performance of
[FR Doc. 2016–12008 Filed 5–20–16; 8:45 am] days of this notice.
the functions of the agency, including
BILLING CODE 4163–18–P whether the information will have
Proposed Project
practical utility; (b) Evaluate the
accuracy of the agencies estimate of the Qualitative Information Collection on
DEPARTMENT OF HEALTH AND
burden of the proposed collection of Emerging Diseases among the Foreign-
HUMAN SERVICES
information, including the validity of born in the U.S. (OMB Control No.
Centers for Disease Control and the methodology and assumptions used; 0920–0987, Expires 09/30/2016)—
Prevention (c) Enhance the quality, utility, and Extension—Division of Global Migration
clarity of the information to be and Quarantine, National Center for
[30 Day–16–0987] collected; (d) Minimize the burden of Emerging Zoonotic and Infectious
the collection of information on those Diseases, Centers for Disease Control
Agency Forms Undergoing Paperwork who are to respond, including through and Prevention (CDC).
Reduction Act Review the use of appropriate automated,
electronic, mechanical, or other Background and Brief Description
The Centers for Disease Control and
Prevention (CDC) has submitted the technological collection techniques or The Centers for Disease Control and
following information collection request other forms of information technology, Prevention (CDC), National Center for
to the Office of Management and Budget e.g., permitting electronic submission of Emerging and Zoonotic Infectious
(OMB) for review and approval in responses; and (e) Assess information Diseases (NCEZID), Division of Global
sradovich on DSK3TPTVN1PROD with NOTICES

accordance with the Paperwork collection costs. Migration and Quarantine (DGMQ),
Reduction Act of 1995. The notice for To request additional information on requests approval for an extension of the
the proposed information collection is the proposed project or to obtain a copy current generic information collection
published to obtain comments from the of the information collection plan and Qualitative Information Collection on
public and affected agencies. instruments, call (404) 639–7570 or Emerging Diseases among the Foreign-
Written comments and suggestions send an email to omb@cdc.gov. Written born in the U.S. (OMB Control Number
from the public and affected agencies comments and/or suggestions regarding 0920–0987, expiration date 9/30/2016).

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Document Created: 2018-02-07 15:07:20
Document Modified: 2018-02-07 15:07:20

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		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]
FR Citation		81 FR 32330

81 FR 32330 - 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