[Federal Register Volume 84, Number 180 (Tuesday, September 17, 2019)]
[Notices]
[Pages 48929-48931]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-20083]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-19-BPL; Docket No. CDC-2019-0079]


Proposed Data Collection Submitted for Public Comment and 
Recommendations

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

[[Page 48930]]


ACTION: Notice with comment period.

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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 Aerosols from cyanobacterial 
blooms: Exposures and health effects in a highly exposed population. 
CDC will conduct a study of 50 people highly exposed to cyanobacterial 
harmful algal blooms (CyanoHABs) to assess exposure to CyanoHAB 
aerosols and determine if exposure is associated with health symptoms 
and/or outcomes.

DATES: CDC must receive written comments on or before November 18, 
2019.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2019-
0079 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 CONTACT: 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: 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 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

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

Background and Brief Description

    CDC's National Center for Environmental Health (NCEH) has conducted 
two studies to investigate the associations between exposure to 
cyanoHAB toxins and health outcomes. In a 2006 study of recreational 
microcystin (MC) exposure at a small lake, CDC recruited 104 study 
participants from lake visitors planning recreational activities, such 
as boating, that would generate aerosols. During data collection for 
that study, MC concentrations within the bloom lake water were very low 
(<2-5 mg/L). Study participants' plasma MC concentrations were all 
below the limit of detection (0.147 mg/L) for the enzyme-linked 
immunosorbent assay (ELISA).
    In 2007 CDC/NCEH conducted a study of recreational MC exposure 
among 81 children and adults planning recreational activities on either 
of three California reservoirs--two with significant, ongoing blooms of 
toxin-producing cyanobacteria, including Microcystis aeruginosa and one 
without a toxin-producing algal bloom. Our findings indicated that 
recreational activities in water bodies that experience toxin-producing 
cyanobacterial blooms generate aerosolized cyanotoxins, making 
inhalation a potential route of exposure.
    It is likely that healthy people will not have adverse acute 
effects from periodic exposures to MC in aerosols generated by water 
based recreational activities in lakes with patches of toxin producing 
blooms. However, microcystins are potent liver toxins, and exposure may 
lead to more long-term effects. Other potent cyanotoxins, such as 
anatoxin-a or cylindrospermopsin may be incorporated into aerosols and 
inhaled and deposited in the body, presenting other, potentially 
synergistic, health risks. In addition, it is possible that swimming 
and other water-based activities that result in swallowing water 
present a higher risk for adverse health effects from ingesting 
cyanobacterial cells and extracellular toxins in the water.
    CyanoHABs may present additional health risks as they senesce, or 
die off. Previous work done in Wisconsin demonstrated low but 
measurable concentrations of hydrogen sulfide and methane, both 
respiratory irritants, in the air near dense and decomposing 
cyanobacterial blooms.
    The subpopulation to be studied comprises adults at least 18 years 
of age, who have extensive occupational exposure to CyanoHABs on Lake 
Okeechobee, Florida and connecting rivers. The study will be conducted 
on Lake Okeechobee, Florida, U.S.A., which has a history of prolonged 
CyanoHAB events.
    CDC will notify potentially interested participants using posted 
flyers with a phone number to call. CDC will recruit participants using 
a phone-based screening survey to determine eligibility. Eligible study 
participants will complete three appointments (at the beginning of the 
study to provide baseline data and in the middle and end of the study 
period). During the interviews, participants will complete a survey, do 
a pulmonary function test, provide urine and nasal swabs for analysis 
of cyanotoxins, and provide a blood specimen for analysis of liver 
enzyme levels and creatinine. Before (pre-exposure) and after (post-
exposure) each of 12 boat trips, study participants will complete the 
survey and provide urine and nasal swab specimens. Study participants 
will donate one fish from each trip to be analyzed for cyanobacterial 
toxins and the GPS

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Exchange Format (GPX) file of the boat's travels.
    Results from surveys, blood and urine specimens, nasal swabs, 
pulmonary function test results, air, and fish samples will be analyzed 
using univariate methods to summarize the data. CDC staff will compare 
the following information to determine if there are correlations: (1) 
Individual's pre-exposure results with post-exposure results, and (2) 
biomonitoring results with cyanotoxin levels in air and water. CDC 
staff will assess environmental and biomonitoring over time, and 
overlay satellite photos provided by NOAA with GPX tracking files from 
the boats to further assess exposure. The total annualized burden to 
respondents is 784 hours.

                                        Estimated Annualized Burden Hours
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                                                                     Number of    Average burden
      Type of respondents           Form name        Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)      (in hours)
----------------------------------------------------------------------------------------------------------------
Interested community members..  Screening survey              70               1           15/60               6
Eligible study participants...  Survey..........              50              27           15/60             113
Eligible study participants...  Blood Specimen                50               3           15/60              13
                                 Results.
Eligible study participants...  Nasal Swab                    50              27           10/60              75
                                 Results.
Eligible study participants...  Lung Function                 50              27           45/60             338
                                 Test Results.
Eligible study participants...  Urine Specimen                50              27           10/60              75
                                 Results.
Eligible study participants...  GPX File of Trip              50              12           15/60              50
Eligible study participants...  Record of fish                50              12           30/60             102
                                 for Analysis by
                                 EPA.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............             784
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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. 2019-20083 Filed 9-16-19; 8:45 am]
 BILLING CODE 4163-18-P