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)
Centers for Disease Control and Prevention
Federal Register Volume 82, Issue 40 (March 2, 2017)
| Page Range | 12361-12363 | |
| FR Document | 2017-04046 |
[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
![Federal Register / Vol. 82, No. 40 / Thursday, March 2, 2017 / Notices 12361
burden of the collection of information (NIOSH) is authorized to conduct influenza virus, and the levels of
on respondents, including through the research to advance the health and influenza infection-associated
use of automated collection techniques safety of workers under Section 20(a)(1) biomarkers will be measured in blood
or other forms of information of the 1970 Occupational Safety and samples from these subjects.
technology; and (e) estimates of capital Health Act. Volunteer adult participants will be
or start-up costs and costs of operation, Influenza continues to be a major recruited by a test coordinator using a
maintenance, and purchase of services public health concern because of the poster and flyers describing the study.
to provide information. Burden means substantial health burden from seasonal
the total time, effort, or financial Interested potential participants will be
influenza and the potential for a severe screened verbally to verify that they
resources expended by persons to pandemic. Although influenza is known
generate, maintain, retain, disclose or have influenza-like symptoms and that
to be transmitted by infectious they do not have any medical
provide information to or for a Federal secretions, these secretions can be
agency. This includes the time needed conditions that would preclude their
transferred from person to person in participation. Qualified participants
to review instructions; to develop, many different ways, and the relative
acquire, install and utilize technology who agree to participate in the study
importance of the different pathways is
and systems for the purpose of will be asked to read and sign an
not known. The likelihood of the
collecting, validating and verifying informed consent form, and then to
transmission of influenza virus by small
information, processing and complete a short health questionnaire.
infectious airborne particles produced
maintaining information, and disclosing After completing the forms, the
during coughing and breathing is
and providing information; to train particularly unclear. The question of participant’s oral temperature will be
personnel and to be able to respond to airborne transmission is especially measured and two nasopharyngeal
a collection of information, to search important in healthcare facilities, where swabs and five milliliters of blood will
data sources, to complete and review influenza patients tend to congregate be collected. The participant then will
the collection of information; and to during influenza season, because it be asked to cough repeatedly into an
transmit or otherwise disclose the directly impacts the infection control aerosol particle collection system, and
information. and personal protective measures that the airborne particles produced by the
Proposed Project should be taken by healthcare workers. participant during coughing will be
collected and tested.
Factors Influencing the Transmission The purpose of this study is to gain
of Influenza—New—National Institute a better understanding of the production The study will require 40 volunteer
for Occupational Safety and Health of infectious aerosols by patients with test subjects each year for three years,
(NIOSH), Centers for Disease Control influenza, and to compare this to the for a total of 120 test participants.
and Prevention (CDC). levels of biomarkers of influenza NIOSH intends to seek a three-year
infection in the blood of these patients. OMB approval to conduct this
Background and Brief Description To do this, airborne particles produced information collection. There are no
The National Institute for by volunteer subjects with influenza costs to respondents other than their
Occupational Safety and Health will be collected and tested for time.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per Total burden
Type of respondents Form name responses per
respondents response (in hrs.)
respondent (in hrs.)
Potential participant .......................... Initial Verbal Screening .................... 240 1 3/60 12
Qualified participant .......................... Informed consent form ..................... 120 1 15/60 30
Qualified participant .......................... Health questionnaire ........................ 120 1 5/60 10
Qualified participant .......................... Medical Testing ................................ 120 1 40/60 80
Total ........................................... ........................................................... ........................ ........................ ........................ 132
Leroy A. Richardson, DEPARTMENT OF HEALTH AND the proposed information collection is
Chief, Information Collection Review Office, HUMAN SERVICES published to obtain comments from the
Office of Scientific Integrity, Office of the public and affected agencies.
Associate Director for Science, Office of the Centers for Disease Control and Written comments and suggestions
Director, Centers for Disease Control and Prevention from the public and affected agencies
Prevention.
concerning the proposed collection of
[FR Doc. 2017–04045 Filed 3–1–17; 8:45 am] [30Day–17–16AJE] information are encouraged. Your
BILLING CODE 4163–18–P
Agency Forms Undergoing Paperwork comments should address any of the
Reduction Act Review following: (a) Evaluate whether the
proposed collection of information is
sradovich on DSK3GMQ082PROD with NOTICES
The Centers for Disease Control and necessary for the proper performance of
Prevention (CDC) has submitted the the functions of the agency, including
following information collection request whether the information will have
to the Office of Management and Budget practical utility; (b) Evaluate the
(OMB) for review and approval in accuracy of the agencies estimate of the
accordance with the Paperwork burden of the proposed collection of
Reduction Act of 1995. The notice for information, including the validity of
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![Federal Register / Vol. 82, No. 40 / Thursday, March 2, 2017 / Notices 12363
A proxy interview will be conducted participants annually (240 participants for hospital record provider is 20
via telephone for sampled participants over the two-year period) to evaluate the minutes per record.
who died prior to the re-contact. record retrieval protocol for the study OMB approval is requested for two
Information on medical conditions and cohort among different medical years to conduct the feasibility
overnight hospital stays since baseline facilities. An average of three hospital component of the NHANES
will be collected. stays per person is anticipated among Longitudinal Study. Participation is
Although permission will be sought this cohort, therefore, an estimated 360 voluntary and there are no costs to
from all field feasibility test requests (120 persons × 3 stays) will be respondents other than their time. The
participants, hospitalization records made annually. The estimated burden total estimated annualized burden hours
will be obtained only for 120 are 1,055.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Type of Number of burden per
Form name responses per
respondent respondents response
respondent (in hours)
2007–2014 NHANES examinees, and proxies Field feasibility test registration form—con- 400 1 15/60
of deceased 2007–2014 NHANES tact confirmation and scheduling pref-
examinees. erence.
2007–2014 NHANES examinees ................... Field feasibility test home visit ....................... 356 1 1
2007–2014 NHANES examinees ................... Field feasibility test home urine collection ..... 356 1 15/60
Proxies of deceased 2007–2014 NHANES Field feasibility test decedent proxy interview 44 1 20/60
examinees.
Hospital record providers ................................ Field feasibility test hospital records form ..... 360 1 20/60
Adult volunteers (non-field feasibility test par- Targeted methodological studies ................... 375 1 1
ticipants).
Leroy A. Richardson, such approval CMS will be unable to consideration, comments and
Chief, Information Collection Review Office, effectively enforce these essential health recommendations must be submitted in
Office of Scientific Integrity, Office of the and safety requirements. Among other any one of the following ways:
Associate Director for Science, Office of the things, CMS will be unable to enforce 1. Electronically. You may send your
Director, Centers for Disease Control and requirements that HHAs must provide a
Prevention.
comments electronically to http://
notice of rights to each patient, assure www.regulations.gov. Follow the
[FR Doc. 2017–04046 Filed 3–1–17; 8:45 am] the proper training of home health aides instructions for ‘‘Comment or
BILLING CODE 4163–18–P before those aides provide hands-on Submission’’ or ‘‘More Search Options’’
care to patients, and disclose the names to find the information collection
and addresses of all individuals with an document(s) that are accepting
DEPARTMENT OF HEALTH AND ownership or management position so
HUMAN SERVICES comments.
that we can assure that those with a
2. By regular mail. You may mail
history of fraud are not involved in
Centers for Medicare & Medicaid written comments to the following
HHA operations. Being unable to
Services address: CMS, Office of Strategic
enforce these rules would harm patient
Operations and Regulatory Affairs,
[Document Identifier: CMS–R–39] health and safety, as well as create risks
to the integrity of the Medicare and Division of Regulations Development,
Emergency Clearance: Public Medicaid programs. Attention: CMS–R–39/OMB Control
Information Collection Requirements Under the PRA, federal agencies are Number 0938–0365, Room C4–26–05,
Submitted to the Office of Management required to publish notice in the 7500 Security Boulevard, Baltimore,
and Budget (OMB) Federal Register concerning each Maryland 21244–1850. To obtain copies
proposed ICR. Interested persons are of a supporting statement and any
AGENCY: Centers for Medicare & related forms for the proposed
invited to send comments regarding our
Medicaid Services, HHS. collection(s) summarized in this notice,
burden estimates or any other aspect of
ACTION: Notice. you may make your request using one
this ICR including the necessity and
utility of the proposed ICR for the of following:
SUMMARY: The Centers for Medicare and
Medicaid Services (CMS) is requesting proper performance of the agency’s 1. Access CMS’ Web site address at
that an information collection request functions, the accuracy of the estimated http://www.cms.hhs.gov/
(ICR) related to the Medicare and burden, ways to enhance the quality, PaperworkReductionActof1995.
Medicaid Programs: Conditions of utility, and clarity of the information to 2. Email your request, including your
Participation for Home Health Agencies be collected and the use of automated address, phone number, OMB number,
(HHAs) and Supporting Regulations at collection techniques or other forms of and CMS document identifier, to
42 CFR part 484, be processed under the information technology to minimize the Paperwork@cms.hhs.gov.
sradovich on DSK3GMQ082PROD with NOTICES
emergency clearance process associated information collection burden. 3. Call the Reports Clearance Office at
with 5 CFR 1320.13(a)(2)(i). Public harm DATES: Comments must be received by (410) 786–1326.
is reasonably likely to ensue if the April 3, 2017.
FOR FURTHER INFORMATION CONTACT:
normal, non-emergency clearance ADDRESSES: When commenting, please
Reports Clearance Office at (410) 786–
procedures are followed. The approval reference the document identifier 1326.
of this information collection package is (CMS–R–39) or OMB control number
necessary because in the absence of (0938–0365). To be assured SUPPLEMENTARY INFORMATION:
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Document Created: 2017-03-02 00:09:42
Document Modified: 2017-03-02 00:09:42
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
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| Section | Notices | |
| FR Citation | 82 FR 12361 |
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