81 FR 52875 - Proposed Data Collection Submitted for Public Comment and Recommendations

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 81, Issue 154 (August 10, 2016)

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.

[Federal Register Volume 81, Number 154 (Wednesday, August 10, 2016)]
[Notices]
[Pages 52875-52876]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-18934]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-16-16AWE: Docket No. CDC-2016-0078]


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: 404-639-7570; Email: [email protected].

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

[[Page 52876]]

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
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
      Type of respondents           Form name        Number of     responses per   per response    Total burden
                                                    respondents     respondent       (in hrs.)       (in hrs.)
----------------------------------------------------------------------------------------------------------------
Health departments and partner  CureTB                       100               5           30/60             250
 health authorities.             Transnational
                                 Notification.
Health departments and partner  CureTB Contact/               20               5           30/60              50
 health authorities.             Source
                                 Investigation
                                 (CI/SI)
                                 Notification.
                                                 ---------------------------------------------------------------
    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.
[FR Doc. 2016-18934 Filed 8-9-16; 8:45 am]
 BILLING CODE 4163-18-P