Agency Forms Undergoing Paperwork Reduction Act Review
| Published date | 20 February 2020 |
| Citation | 85 FR 9777 |
| Record Number | 2020-03343 |
| Section | Notices |
| Court | Centers For Disease Control And Prevention,Health And Human Services Department |
Federal Register, Volume 85 Issue 34 (Thursday, February 20, 2020)
[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)
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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
