[Federal Register Volume 85, Number 34 (Thursday, February 20, 2020)]
[Notices]
[Pages 9777-9778]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-03343]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-20-19BPL]


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 Aerosols from cyanobacterial blooms: 
Exposures and health effects in a highly exposed population, 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 September 19, 2019 to obtain 
comments from the public and affected agencies. CDC received 162 
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 
(404) 639-7570 or send an email to [email protected]. 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 (202) 395-5806. Provide 
written comments within 30 days of notice publication.

Proposed Project

    Aerosols from cyanobacterial blooms: Exposures and health effects 
in a highly exposed population--New--National Center for Environmental 
Health (NCEH), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

    Algal toxins from cyanobacterial harmful algal blooms (CyanoHABs) 
include some of the most potent natural chemicals. People and animals 
are at risk for exposure to toxins produced by CyanoHABs in 
recreational waters, drinking water sources, or in improperly treated 
water used for medical purposes such as renal dialysis. Additional 
potential exposure sources include contaminated dietary supplements or 
fish harvested from lakes with ongoing CyanoHABs.
    Although outbreaks of human illness associated with CyanoHABs were 
sporadically recorded for decades, information about clinical signs and 
symptoms from cyanobacterial toxin poisonings is primarily from animal 
poisonings and laboratory studies. The primary effects include acute 
hepatotoxicity, acute neurotoxicity, gastrointestinal symptoms, and 
respiratory, dermatologic, and allergic reactions.
    A significant source of cyanobacterial toxin exposure is 
recreational use of contaminated fresh water bodies because large 
populations are likely to be exposed and toxins may occur in high 
concentrations. In the United States, the U.S. Environmental

[[Page 9778]]

Protection Agency (EPA) provided guidance, but not regulations, on 
acceptable levels of the cyanobacterial toxins, microcystins and 
cylindrospermopsin, in drinking and recreational waters. Data from 
epidemiologic studies designed to evaluate the associations among 
environmental cyanobacteria toxin concentrations, human biomarkers of 
cyanobacteria toxin exposure, and health symptoms are needed to develop 
more specific exposure guidelines.
    In addition to cyanobacterial toxins, other chemicals produced by 
cyanobacteria, such as geosmin and methylisoborneal (MIB), may be 
present in aerosols generated during a CyanoHAB. Geosmin and MIB 
produce a musty odor and taste in water that is noticeable at very low 
concentrations. CyanoHABs may present additional health risks as they 
die off and release hydrogen sulfide and methane into the air.
    The National Center for Environmental Health (NCEH), Centers for 
Disease Control and Prevention (CDC), requests a three-year Paperwork 
Reduction Act (PRA) clearance for a new information collection request 
titled ``Aerosols from cyanobacterial blooms: exposures and health 
effects.'' NCEH is authorized to conduct research under the Public 
Health Service Act, Section 301, ``Research and investigation,'' (42 
U.S.C. 241). We will conduct a cohort study of 200 people highly 
exposed to CyanoHABs in Florida. We define ``highly exposed'' as those 
exposed because of their occupation (e.g., lock gate keepers, fishing 
guides) and those exposed because they live on a canal or river and 
spend at least two hours outside on most days.
    Bloom composition and concentrations of toxins can vary over time 
during a bloom and CDC is interested in not only exposure, but also how 
exposure varies as the blooms develop, mature, and die off. We cannot 
predict when or where a bloom may occur. Thus, we will work closely 
with the Florida Department of Environmental Protection to identify 
when a bloom develops. Once a bloom is verified, we will initiate the 
study (i.e., recruit and enroll participants) in the area affected by 
the bloom. We will collect data on five study days for each participant 
during the bloom season (approximately March-November). The estimated 
annual burden requested is 1,273 hours.

                                        Estimated Annualized Burden Hours
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                                                                                     Number of    Average burden
          Type of respondents                   Form name            Number of     responses per   per response
                                                                    respondents     respondent      (in hours)
----------------------------------------------------------------------------------------------------------------
Interested community members..........  Screening/Baseline                    84               1           15/60
                                         Survey.
Eligible study respondents............  Symptom Survey..........              67              10           15/60
Eligible study respondents............  Record of Time Spent                  67               5           10/60
                                         Outdoors.
Eligible respondents..................  Provide Blood Specimen..              67               3           15/60
Eligible respondents..................  Provide Specimens                     67              10               1
                                         (urine, nasal swabs,
                                         lung function test).
Eligible respondents..................  Be Outfitted with                     67               5           45/60
                                         Personal Air sampler.
Eligible respondents..................  Provide Fish (if                      67               5           10/60
                                         respondent went fishing
                                         and caught fish).
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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2020-03343 Filed 2-19-20; 8:45 am]
 BILLING CODE 4163-18-P