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 Information Collection for Tuberculosis Data from Referring Entities to CureTB, which enables CDC to coordinate continuity of care services for individuals with tuberculosis.

DATES:

CDC must receive written comments on or before February 21, 2020.

ADDRESSES:

You may submit comments, identified by Docket No. CDC-2019-0098 by any 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-D74, 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, of 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: omb@cdc.gov.

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; and

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.

5. Assess information collection costs.

Proposed Project

Information Collection for Tuberculosis Data from Referring Entities to CureTB (OMB Control No. 0920-1186, Exp. 06/30/2020)—Revision—National Center for Emerging Zoonotic and Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

CureTB at the Centers for Disease Control and Prevention (CDC), works with domestic and international programs to protect the U.S. public by preventing TB disease transmission domestically and internationally, as well as preventing the development of drug resistant TB. These goals are accomplished through CureTB referral and continuity of care services for mobile TB patients.

Lack of treatment adherence and inappropriate selection of medications are prime reasons for the continued emergence and spread of resistant strains of tuberculosis. To combat this, CureTB ensures that patients understand how to remain adherent to treatment regimens, despite moving between nations. CureTB also provides information to the health care team that will be continuing care about each patient's TB strain and tailored medication regimen. CureTB gathers demographic and clinical information for each patient and connects that individual to appropriate clinical care. This information is also provided on a real-time basis to medical providers and public health authorities in receiving nations so follow-up with the patient can be expedited.

The respondents for the CureTB referral services are nurse practitioners, registered nurses, and physicians working for organizations within the United States and other countries who provide diagnostic and treatment services to individuals affected by TB. The organizations are primarily state and local health departments, but include immigration detention centers, correctional facilities, and foreign national TB programs. All 50 U.S. states and territories may refer TB patients to the CureTB program. To date, CureTB has also received referrals from Mexico and Guatemala.

Registered nurses or nurse practitioners will submit CureTB referral forms as they request referral services. The number of referrals varies widely between respondents. To ensure adequate referral to treatment occurs, CDC CureTB may need to follow-up with an individual to complete missing data fields concerning clinical or contact information. This is done to ensure continuity of care. Therefore, individuals with TB are also respondents in this information collection. CDC's CureTB program will also continue working with our public health partners in notifications and referrals for contacts of TB cases. This is a lesser used function of CureTB, but burden is included below. These respondents are registered nurses or nurse practitioners working in health departments.

Finally, CDC staff in the CureTB program also contact the new treating physicians to determine patient outcomes using CureTB Clinician Public Health Department Follow-up Script. The physicians are generally contacted every two months over the course of standard six month TB treatment, for a total of three follow-up contacts per patient. There are no costs to respondents other than the time required to complete the referral documents and respond to CDC requests for TB patient outcomes. The total burden requested is 1,117 hours.