2024-10357. 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 effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled National Health and Nutrition Examination Survey (NHANES). NHANES produces descriptive statistics, which measure the health and nutrition status of the general United States population.

DATES:

CDC must receive written comments on or before July 12, 2024.

ADDRESSES:

You may submit comments, identified by Docket No. CDC-2024-0037 by either of the following methods:

• Federal eRulemaking Portal:www.regulations.gov. Follow the instructions for submitting comments.
• Mail: Jeffrey M. Zirger, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS H21-8, Atlanta, Georgia 30329.

Instructions: All submissions received must include the agency name and Docket Number. CDC will post, without change, all relevant comments to www.regulations.gov.

Please note: Submit all comments through the Federal eRulemaking portal ( www.regulations.gov) or by U.S. mail to the address listed above.

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 Jeffrey M. Zirger, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS H21-8, Atlanta, Georgia 30329; Telephone: [phone]; Email: [e-mail].

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 the OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.

The OMB is particularly interested in comments that will help:

1. 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;

2. Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

3. Enhance the quality, utility, and clarity of the information to be collected;

4. 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 submissions of responses; and

5. Assess information collection costs.

Proposed Project

The National Health and Nutrition Examination Survey (NHANES), (OMB No. 0920-0950, Exp. 04/30/2025)—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) authorizes that the Secretary of Health and Human Services (DHHS), acting through NCHS, collect statistics on subjects in the United States, such as the extent and nature of illness and disability of the population; environment, social, and other health hazards; determinants of health; health resources; and utilization of healthcare. The National Health and Nutrition Examination Survey (NHANES) has been conducted periodically between 1970 and 1994, and continuously since 1999 by the National Center for Health Statistics, CDC.

NHANES produces descriptive statistics, which measure the health and nutrition status of the general population. With personal interviews, physical examinations, and laboratory assessments, 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 and is 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.

In 2025-2026, the Program is not considering any substantial changes to NHANES content or procedures. As in previous years, the base sample will remain at approximately 5,000 interviewed and examined individuals annually. Children 0-17 years of age, persons 65 years of age or older, and non-Hispanic Black persons will be oversampled in the 2025-2026 survey. NCHS collects personally identifiable information (PII). 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.

A variety of agencies sponsor data collection components on NHANES. In the 2025-2026 clearance proposal, the Program modified, added, or removed various components that were included in the August 2021-August 2023 NHANES to update and modernize processes for data collection. NHANES staff conducted a thorough review of the sample person and household questionnaire content and made changes to focus on retaining questions that are to be used in combination with specific exam or lab data collected in the survey, as independent prevalence estimates, or as covariates in statistical analyses ( e.g., sociodemographic characteristics). Further review of all data collection instruments was done to update wording, update age restrictions for the respondent universe, align wording across instruments, eliminate duplicate questions, improve interview flow, and reduce respondent burden.

With the construction of a new fleet of five mobile examination centers (MECs) with updated designs, the 2025-2026 exam components will include post consent-questions, anthropometry, oscillometer measurements, venipuncture, urine collection, MEC ACASI questions, body composition, respiratory health, audiometry, visual acuity and ophthalmology, oral health, HPV oral rinse and DNA genital swab collection, and water fluoride testing. Liver elastography, urine testing for several sexually transmitted infections, serology testing for HPV and CMV antibodies, and MEC follow-up questionnaires were dropped.

First Dietary Recall interviews, the Flexible Consumer Behavior Survey, and the Second Dietary Recall interviews will be conducted via telephone either before or after the MEC visit, which is a new approach for the 2025-2026 survey. If the participant does not schedule their dietary interviews at the end of their household interview, the MEC staff will attempt to schedule these appointments at the end of the examination. This option provides more flexibility to complete the interviews, which may improve completion rates. Program staff will monitor response rates closely to assess whether scheduling dietary interviews after the household interviews has an impact on response rates for dietary interviews and/or MEC exams.

Although a few laboratory tests are new or have been removed in 2025-2026, most remain but have been modified. Predominantly, modifications are the result of adjustments in age eligibility. Several laboratory tests that have not been modified include CBC, hemoglobin variants, HIV, cadmium, and lead. RBC folate forms, LDC cholesterol, and chlamydia are examples of tests that have been removed for 2025-2026. New laboratory tests include B vitamins, choline and metabolites, and aldosterone. The biospecimens collected for laboratory tests include urine and blood. Serum, plasma, DNA, and urine specimens will be stored for future testing if the participant provides consent.

NHANES may conduct developmental projects during NHANES 2025-2026, with a focus on planning for NHANES 2027 and beyond. These may include activities such as tests of new equipment, crossover studies between current and proposed methods, test of different study modes, settings or technology, outreach materials, incentive strategies, sample storage and processing or sample designs.

Burden for individuals in 2025-2026 NHANES will vary based on their level of participation. For example, infants and children tend to have shorter interviews and exams than adults. This is because young people may have fewer health conditions or medications to report so their interviews take less time or because certain exams are only conducted on sample persons 18 and older. In addition, adults often serve as proxy respondents for young people in their families. Participation in NHANES is voluntary and confidential. The Program is requesting a three-year approval, with 36,540 annualized hours of burden in this clearance request.

Estimated Annualized Burden Hours

Type of respondents	Form name	Number of respondents	Number of responses per respondent	Average burden per response (in hours)	Total burden (in hours)
Individuals in households	Screener	6,398	1	7/60	747
Individuals in households	Home Interview	5,882	1	1	5,882
Individuals in households	MEC Interview & Examination	5,000	1	2	10,000
Individuals in households	Day 1 Telephone Dietary Recall, Dietary Supplements, & Flexible Consumer Behavior Survey Phone Follow-up	5,882	1	1	5,882
Individuals in households	Day 2 Telephone Dietary Recall & Dietary Supplements	5,882	1	36/60	3,529
Individuals in households	Developmental Projects & Special Studies	3,500	1	3	10,500
Total					36,540

Jeffrey M. Zirger,

Lead, Information Collection Review Office, Office of Public Health Ethics and Regulations, Office of Science, Centers for Disease Control and Prevention.