2018-16947. Agency Forms Undergoing Paperwork Reduction Act Review

In accordance with the Paperwork Reduction Act of 1995, the Centers for Disease Control and Prevention (CDC) has submitted the information collection request titled Enhanced STD surveillance Network (SSuN) to the Office of Management and Budget (OMB) for review and approval. CDC previously published a “Proposed Data Collection Submitted for Public Comment and Recommendations” notice on March, 15, 2018 to obtain comments from the public and affected agencies. CDC received 37 comments related to the previous notice. This notice serves to allow an additional 30 days for public and affected agency comments.

CDC will accept all comments for this proposed information collection project. The Office of Management and Budget is particularly interested in comments that:

(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]. Direct written comments and/or suggestions regarding the items contained in this notice to the Attention: CDC Desk Officer, Office of Management and Budget, 725 17th Street NW, Washington, DC 20503 or by fax to [phone]. Provide written comments within 30 days of notice publication.

Proposed Project

Enhanced STD surveillance Network (SSuN)—Reinstatement with Change—Division of STD Prevention (DSTDP), National Center for HIV/AIDS, Viral Hepatitis, STD, and TB prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

The Enhanced STD surveillance network project was created to provide enhanced behavioral, demographic, and clinical information on gonorrhea cases reported to state and local health departments, to provide information on patients presenting for care in STD clinical settings, and to provide an infrastructure for identifying emerging sequelae of STDs.

Enhanced SSuN continues to be a collaboration between different branches of the CDC Division of STD Prevention and selected state/local public health departments and their associated STD specialty care clinics in the US. Data from enhanced SSuN data is used to (1) provide a dataset of supplemental information on gonorrhea case reports; (2) provide geographic information on case reports of STDs of interest for investigating social determinants of STDs, (3) monitor STD screening, incidence, prevalence, epidemiologic and health care access trends in populations of interest, (4) monitor STD treatment and prevention service practices, and (5) monitor selected adverse health outcomes of STDs, including neuro/ocular syphilis,

This project will continue to utilize two distinct surveillance strategies to collect information. The first strategy employs facility-based sentinel surveillance, which will abstract routine standardized data from existing electronic medical records for all patient visits to participating STD clinics during the project period. For the facility-based component of enhanced SSuN, participating sites have developed common protocols stipulating data elements to be collected, including patient demographics, clinical, risk and sexual behaviors. The specified data elements are abstracted by clinic staff from existing electronic medical records for all patient visits to participating STD clinics. Some of the participating facilities are satellite clinics of large network providers where clinical data systems are centralized. Hence, there are 10 unique clinic data managers that will be abstracting the facility data. Each of the clinic data managers will spend three hours to extract and transmit data to local/state health departments. Individual patient records are de-identified (all patient-specific identifiers are removed) by clinic staff before being transmitted to health departments, who recode the data into standardized formats before being transmitted to CDC through secure file transport mechanisms. Each enhanced SSuN site will spend 16 hours to recode and transmit the data to CDC every other month. At CDC, data will be aggregated across all participating sites in a common data structure and formatted for analysis.

Under this revision, the second strategy, population-based STD surveillance is being expanded to include not only a random sample of reported gonorrhea cases but also include patients diagnosed with early syphilis that report neurologic/ocular manifestations. For the gonorrhea population component, a probability sample of gonorrhea cases (up to 10% of total gonorrhea morbidity for participating jurisdictions) will be contacted by health department staff for a standardized interview either by phone or in-person. Enhanced gonorrhea investigations will also include verification of treatment and an internal health department record review (performed on either all cases or on the sampled cases). The focus of the new population activity focuses on obtaining additional clinical information on early syphilis cases who report neurologic/ocular symptoms. The subset of patients reporting these symptoms are asked to participate in an interview to obtain additional clinical information for a more complete assessment of neurologic/ocular involvement as well as obtain additional clinical information from the diagnosing or reporting provider. Lastly, early syphilis cases reporting neurologic and/or ocular symptoms are recontacted at approximately three months following prescribed treatment to ascertain whether initial symptoms have resolved.

The population data will be directly entered into existing STD surveillance information systems at each health department. Data will be locally extracted, de-identified and recoded into standardized formats prior to being transmitted to CDC through secure file transport mechanisms on bimonthly basis. Patient participation in the interview is voluntary and refusal to participate has no impact on other STD services the health department provides to persons diagnosed with gonorrhea.

This project will not collect name, social security number, or date of birth. A Patient ID, a unique patient identifier assigned by the clinic or health department depending on the component, is requested and will be provided to CDC for purposes of enhanced surveillance. Patient IDs are not linkable across enhanced SSuN components. Sensitive information such as sex of sex partners, HIV status, sex work exposure, and injection drug use are collected. All personally identifiable information (PII) is retained by the STD clinics and/or health departments and is not recorded with data sent to CDC. The electronic enhanced SSuN database is stored on the CDC mainframe computer and only approved Division of STD Prevention (DSTDP) staff have access rights to the data. As part of the revision, we will continue to systematically identify the risks and potential effects of collecting, maintaining, and disseminating PII and to examine and evaluate alternative processes for handling that information to mitigate potential privacy risks and risks to confidentiality.

Both components of enhanced SSuN are designed to (1) Integrate traditional surveillance methods with innovative data management technologies to produce high-quality, timely surveillance and epidemiologic data, (2) provide valuable information to direct public health STD prevention and control efforts, (3) enhance understanding of the community burden of disease, (4) identify syndemic patterns and population at greatest risk, and, (5) monitor long-term health consequences of STDs. The enhanced SSuN surveillance platform allows CDC to establish and maintain common standards for data collection, transmission, and analysis, and to build and maintain STD surveillance expertise in 10 state/local health departments. Such common systems, established mechanisms of communication, and in-place expertise are all critical components for timely, flexible, and high quality surveillance. The total estimated annual burden is 3,479 hours. There are no costs 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)
Data manager at Sentinel STD clinics	Record Abstraction	10	6	3
General Public—Adults (persons diagnosed and reported with gonorrhea or early syphilis	Interview	5492	1	10/60
Diagnosing Provider	Data for early syphilis cases	406	1	10/60
General Public—Adults (persons with early syphilis who were reported with neurologic/ocular manifestations	3 month follow-up telephone Interview	203	1	5/60
Data Managers: 10 local/state health department	Data cleaning/validation/reformatting	10	12	19

Jeffrey M. Zirger,

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.