2016-18934. 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 efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the Information Collection for Tuberculosis Data from Referring Entities to CureTB. CureTB is intended to provide continuity of care for individuals affected by TB who enter US jurisdictions from foreign nations who or who leave US jurisdictions bound for foreign nations.

DATES:

Written comments must be received on or before October 11, 2016.

ADDRESSES:

You may submit comments, identified by Docket No. CDC-2016-0078 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. All relevant comments received will be posted without change to Regulations.gov, including any personal information provided. For access to the docket to read background documents or comments received, go to Regulations.gov.

Please note: All public comment should be submitted 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 the Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road, NE., MS-D74, 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 OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below. Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information; and to transmit or otherwise disclose the information.

Proposed Project

Information Collection for Tuberculosis Data From Referring Entities to CureTB—New—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. 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.

CDC is seeking OMB clearance for three years of information collection.

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 entities within the United States and other countries who provide diagnostic and treatment services to individuals affected by TB. The entities are primarily state and local health departments, but include immigration centers, correctional facilities, and national TB programs. 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.

Respondents are generally public health field nurses and will submit CureTB referral forms as they request referral services. The number of referrals varies widely between respondents. The average time to complete and send a CureTB referral form is estimated at 30 minutes. CureTB currently receives approximately 600 referrals per year. An estimated 100 respondents send referrals, with a range from 1-20 per respondent, and an average of 5 per respondent annually.

There are no costs to respondents other than the time required to submit the referral documents. Authorizing legislation comes from Section 361 of the Public Health Service Act regulations found in 42 Code of Federal Regulations part 70 and 71. The estimated annualized burden hours for this data collection are 300 hours.

Estimated Annualized Burden Hours

Type of respondents	Form name	Number of respondents	Number of responses per respondent	Average burden per response (in hrs.)	Total burden (in hrs.)
Health departments and partner health authorities	CureTB Transnational Notification	100	5	30/60	250
Health departments and partner health authorities	CureTB Contact/Source Investigation (CI/SI) Notification	20	5	30/60	50
Total					300

Jeffrey M. Zirger,

Health Scientist, Acting 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.