2018-22358. 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 One Health Harmful Algal Bloom System (OHHABS). The OHHABS is a voluntary reporting system available to state and territorial public health departments and their designated environmental health or animal health partners. It collects data on individual human and animal cases of illnesses from harmful algal bloom (HAB)-associated exposures, as well as environmental data about HABs.

DATES:

CDC must receive written comments on or before December 14, 2018.

ADDRESSES:

You may submit comments, identified by Docket No. CDC-2018-0098 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:

To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact Jeffrey M. Zirger, 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 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

One Health Harmful Algal Bloom System (OHHABS)—Extension—National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

The Centers for Disease Control and Prevention (CDC), National Center for Emerging and Zoonotic Infectious Diseases requests a three-year extension for the One Health Harmful Algal Bloom System (OHHABS) for harmful algal bloom (HAB) and HAB-associated illness surveillance.

Algal toxins from Harmful Algal Blooms (HABs) include some of the most potent natural chemicals; these toxins can contaminate surface water used for recreation and drinking, as well as food sources. HABs pose a threat to both humans and animals. Human and animal illnesses from environmental exposures to HABs in fresh and marine waters have been documented in the United States. Animal illness may be an indicator of bloom toxicity; thus, it is necessary to provide a One Health approach for reporting HAB-associated illnesses and events. One Health is a collaborative, multisectoral, and trans-disciplinary approach with the goal of achieving optimal health outcomes recognizing the interconnection between people, animals, plants, and their shared environment.

HABs are an emerging public health concern. Several outbreaks related to HABs in freshwater settings have occurred in the United States. In 2009-2010, 11 HAB-associated outbreaks in fresh water settings were reported to the CDC Waterborne Disease and Outbreak Surveillance System (WBDOSS). These 11 outbreaks represent 46% of the outbreaks associated with untreated recreational water reported in 2009-2010 and 79% of HAB-associated outbreaks reported to WBDOSS since 1978. At least 61 persons experienced health effects such as dermatologic, gastrointestinal, respiratory, or neurologic symptoms. In August 2014, detectable levels of microcystin, a potent HAB toxin, were detected in the drinking water supply in Toledo, Ohio, resulting in a “do not drink” water advisory and an extensive emergency response.

Known adverse health effects from HABs in marine waters include respiratory illness and seafood poisoning. In 2007, 15 persons were affected with respiratory illness from exposures to brevetoxins, an algal toxin, during a Florida red tide. From 2007-2011, HAB-associated foodborne exposures were identified for 273 case reports of human illness through a separate five year data collection effort with a subset of states. Of these reports, 248 reported ciguatera fish poisoning or poisoning by other toxins in seafood, including saxitoxin and brevetoxin. A review of national outbreak data reported to CDC for the time period 1998-2015 identified outbreaks of ciguatera fish poisoning as the second most common cause of fish-associated foodborne disease outbreaks in the United States.

The purpose of OHHABS is (1) to provide a database for routine data collection at the state/territorial and national level to identify and characterize HAB events, HAB-associated illnesses, and HAB exposures in the United States, and (2) to better inform and improve our understanding of HAB-associated illnesses and exposures through routine surveillance to inform public health policy and illness prevention efforts. OHHABS (electronic, year-round collection) includes questions about HAB events and HAB-associated-illness for human and animal cases. OHHABS, a web-based reporting system, is nationally available for state and territorial health departments to voluntarily report information about HAB-associated human and animal cases and HAB events.

States and territories lacking a database to collect information on HAB events and HAB-associated illnesses may use OHHABS as a repository to track and review HAB events and HAB-associated illnesses within their state or territory. OHHABS data may help states and territories characterize the baseline frequency of HAB events and HAB-associated illnesses. Data from states and territories will be assessed by CDC to determine and characterize HAB events and HAB-associated illnesses nationally.

As with all routine public health surveillance conducted by CDC, participation by states and territorial health departments with OHHABS is voluntary. Participating states and territories will remain responsible for the collection and interpretation of these data elements at the state level and will voluntarily submit them to CDC. HAB event and HAB-associated human and animal case definitions, which were created for OHHABS with input from state and federal partners, are available online to assist states and territories. States and territories that lack state-specific case and event definitions may use the HAB-associated human and animal case and HAB event definitions to identify suspect, probable, and confirmed HAB-associated cases and HAB events, respectively, to report to OHHABS.

There is no cost to respondents other than the time to participate. Authorizing legislation comes from Section 301 of the Public Health Service Act (42 U.S.C. 241).

Estimated Annualized Burden Hours

Type of respondents	Form name	Number of respondents	Number of responses per respondent	Average burden per response (in hours)	Total burden (in hours)
State/territorial epidemiologists	One Health Harmful Algal Bloom System (OHHABS)	57	3	20/60	57
Total					57

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.