2022-01886. 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 and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Assessment for the Be Antibiotics Aware Consumer and Healthcare Professional (HCP) Campaign. Individuals who have opted to be contacted for surveys will be screened for eligibility and given access to an online survey to assess the Be Antibiotics Aware campaign, which is designed to optimize antibiotic prescribing and use.

DATES:

CDC must receive written comments on or before April 1, 2022.

ADDRESSES:

You may submit comments, identified by Docket No. CDC-2021-0010 by either of the following methods:

• Federal eRulemaking Portal: 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 regulations.gov.

Please note: Submit all comments through the Federal eRulemaking portal ( 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; phone: [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

Assessment for the Be Antibiotics Aware Consumer and HCP Campaign—New—National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

Antibiotic resistance (AR) is one of the most urgent threats to public health in the United States. Antibiotic resistant bacteria have grown more virulent, prevalent, and diverse and can spread between human and animals. Each year there are more than 2.8 million antibiotic-resistant infections in the United States and 35,000 individuals die as a result. At least 30 percent of antibiotics prescribed to outpatients and emergency departments are unnecessary which amounts to 47 million excess prescriptions per year. One of the main side effects of taking antibiotics is alteration of the microbiome which could lead to infections such as C. difficile, the inability to treat infections, prolonged illness, or even death. Risk factors for AR include lack of knowledge, sub-therapeutic doses, excessive use, antibiotic residues, and incorrect storage. In addition, there can be impacts on productivity, healthcare costs, and it can serve as a drain on the economy.

The National Action Plan calls for federal agencies to accelerate their response to AR. The goals of the National Action Plan are to coordinate strategic actions in order to “improve the health and well-being of all Americans across the One Health Spectrum.” In 2015, the National Action Plan set off with the goal to reduce inappropriate outpatient antibiotic use by 50 percent by 2020. It prioritizes prevention and control to prevent infection and reduce the need for antibiotics. Their approach, One Health, recognizes the inter-relatedness of humans, animals, and the environment. One way to decrease the use of unnecessary antibiotic prescriptions is through antibiotic stewardship.

The goals of the Be Antibiotics Aware campaign are to seek optimization of antibiotic prescribing and use in order to improve patient safety and healthcare quality and to combat AR by raising knowledge and awareness, and motivating behavior change among target consumer and HCP audiences. Online panel surveys will be utilized to recruit participants. Surveys will be distributed to consumer target groups both pre- and post-campaign.

Consumer audiences include:

(1) Spanish speaking women, ages 18-64,

(2) Healthy adults who visit urgent care, ages 18-64,

(3) Community dwelling older adults, ages 65+, and

(4) Family caregivers of nursing home (long-term care) residents.

HCP audiences include:

(1) Hospitalists,

(2) Dentists,

(3) Community pharmacists,

(4) Physicians and advanced practice providers in nursing homes, and

(5) Nurses in nursing homes.

This evaluation will assist CDC in determining if the Be Antibiotics Aware media campaign was successful in raising knowledge and awareness and motivating behavior change among target consumer and HCP audiences in select markets. The information gathered from this evaluation will also be used to inform refinement and implementation of the campaigns (materials and tactics).

CDC requests OMB approval for an estimated 68 annual burden hours. There is no cost to respondents other than their time.

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)
Consumers	Be Antibiotics Aware Consumer Pilot Assessment Pretest	50	1	20/60	17
Consumers	Be Antibiotics Aware Consumer Pilot Assessment Posttest	50	1	20/60	17
HCPs	HCP Be Antibiotics Aware Campaign Pretest	50	1	20/60	17
HCPs	Be Antibiotics Aware Posttest	50	1	20/60	17
Total					68

Jeffrey M. Zirger,

Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science, Centers for Disease Control and Prevention.