2016-31967. 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 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 [phone] or send an email to [e-mail]. Written comments and/or suggestions regarding the items contained in this notice should be directed to the Attention: CDC Desk Officer, Office of Management and Budget, Washington, DC 20503 or by fax to [phone]. Written comments should be received within 30 days of this notice.

Proposed Project

Information Collection for Tuberculosis Data from Referring Entities to CureTB—Existing Collection in use without an OMB Control Number—National Center for Emerging Zoonotic and Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

CDC is assuming the administration of the CureTB program from the San Diego Public Health Department. This transition is occurring because the activities align with a national disease control perspective, CDC can better leverage internal resources and international partnerships with foreign public health authorities, and key CureTB management staff transitioned from San Diego County Public Health to CDC.

CureTB works with domestic and international programs to protect the U.S. public by preventing the global development of drug resistance and reducing disease transmission and importation of infectious 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. To combat this, CureTB assures patients understand how to remain adherent despite moving between nations and 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 care through provision of accurate information about how to locate the correct downstream provider and assurance that real-time information is given directly to medical providers and public health authorities in receiving nations.

The respondents 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 centers, correctional facilities, and foreign national TB programs. Individual TB patients may also be respondents if critical clinical or contact information is missing from their referral and CureTB follows-up with them to fill-in gaps to complete the referral service. All 50 US 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.

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.

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

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 558 hours.

Estimated Annualized Burden Hours

Type of respondents	Form name	Number of respondents	Number of responses per respondent	Average burden per response (in hours)
Registered Nurses/Nurse Practitioners	CureTB Transnational Notification	100	5	30/60
TB patients	CureTB Transnational Notification	100	1	5/60
Registered Nurses/Nurse Practitioners	CureTB Contact/Source Investigation (CI/SI) Notification	20	5	30/60
TB treating physicians	Clinician Public Health Department Follow-up Script	500	3	10/60

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.