2024-07287. 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 proposed information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled DFWED National Hypothesis Generation and Investigation Module. The proposed data collection will define a core set of standardized data elements and forms used for outbreak investigations and surveillance activities for a variety of enteric illnesses.

DATES:

CDC must receive written comments on or before June 4, 2024.

ADDRESSES:

You may submit comments, identified by Docket No. CDC-2024-0023 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

DFWED National Hypothesis Generation and Investigation Module—New—National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

The Division of Foodborne, Waterborne, and Environmental Diseases (DFWED) at the Centers for Disease Control and Prevention (CDC) aims to protect public health through the prevention and control of disease, disability, and death caused by foodborne, enteric, waterborne, and environmentally transmitted infections. To overcome challenges presented by the changing landscape of enteric diseases, the need for comprehensive hypothesis generating questionnaires focused on a range of settings, activities, and potential modes of transmission are essential to guide prevention and control activities. The submitted forms standardize hypothesis generating instruments used during enteric disease outbreak investigations and surveillance. This includes foodborne, waterborne, and zoonotic disease surveillance and outbreak investigations. In addition, enhanced surveillance for antibiotic resistant isolates is also included in this package.

CDC requests OMB approval for an estimated 5,852 annual burden hours. There is no cost to respondents other than their time to participate.

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 hours
Cluster and outbreak case patients	National Hypothesis Generating Questionnaire	4,000	1	45/60	3,000
Cluster and outbreak case patients	Foodborne Focus Questionnaire	4,000	1	20/60	1,333
Cluster and outbreak case patients	Animal Contact Focus Questionnaire	450	1	30 min	225
Shigellosis case patients	Shigella Hypothesis Generating Questionnaire	1500	1	45/60	1,125
Nontyphoidal Salmonella, STEC, Vibrio, or Campylobacter case patients whose bacterial isolates have concerning antimicrobial resistance	NARMS SIRI Questionnaire Module 1	305	1	15/60	77
Nontyphoidal Salmonella (except Newport strain), STEC, or Vibrio case patients whose bacterial isolates have concerning antimicrobial resistance	NARMS SIRI Questionnaire Module 2	130	1	10/60	22
Multidrug-resistant Salmonella Newport case patients	NARMS SIRI Questionnaire Module 3	125	1	15/60	32
Campylobacter case patients whose bacterial isolates have concerning antimicrobial resistance	NARMS SIRI Questionnaire Module 4	50	1	25/60	21
Salmonella Typhi or Paratyphi case patients whose bacterial isolates have concerning antimicrobial resistance	NARMS SIRI Questionnaire Module 5	50	1	20/60	17
Total					5,852

Jeffrey M. Zirger,

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