Federal Register: June 13, 2001 (Volume 66, Number 114)
DOCID: FR Doc 01-14822
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
DOCUMENT ID: [60Day-01-47]
NOTICE: NOTICES
ACTION: Agency information collection activities:
SUBJECT CATEGORY:
Proposed Data Collections Submitted for Public Comment and Recommendations
DOCUMENT SUMMARY:
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention (CDC) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call the CDC Reports Clearance Officer on (404) 6397090.
Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Send comments to Seleda Perryman, CDC Assistant Reports Clearance Officer, 1600 Clifton Road, MSD24, Atlanta, GA 30333. Written comments should be received within 60 days of this notice.
Proposed Project
Human Exposure to Cyanobacterial (bluegreen algal) Toxins in Drinking Water: Risk of Exposure to Microcystin from Public Water SystemsNewNational Center for Environmental Health (NCEH), Centers for Disease Control and Prevention (CDC).
Cyanobacteria (bluegreen algae) can be found in terrestrial,
fresh, brackish, or marine water environments. Some species of
cyanobacteria produce toxins that may cause acute or chronic illnesses
(including neurotoxicity, hepatotoxicity, and skin irritation) in
humans and animals (including other mammals, fish, and birds). A number
of human health effects, including gastroenteritis, respiratory
effects, skin irritations, allergic responses, and liver damage are
associated with the ingestion of or contact with water containing
cyanobacterial blooms. Although the balance of evidence, in conjunction
with data from laboratory animal research, suggests that cyanobacterial
toxins are responsible for a range of human health effects, there have
been few epidemiologic studies of this association. We plan to recruit
100 people whose tap water comes from a source with a current
cyanobacteria bloom (i.e., M. aeruginosa) and who report drinking
unfiltered tap water. We also plan to recruit 100 people who report
drinking unfiltered tap water but whose tap water source is groundwater
that has not been contaminated with cyanobacteria. This population will
serve as our referent population for the analysis of microcystins in
blood and for the clinical assays. We will administer a questionnaire
and collect blood samples from all study participants. Blood samples
will be analyzed using a newly developed molecular assay for levels of
microcystinsthe hepatotoxin produced by Micocystis aeruginosa. We
also will analyze blood samples for levels of liver enzymes (a
biological marker of hepatotoxicity) and for a number of clinical
parameters including hepatitis infection (a potential confounder in our
study). We will evaluate whether we can (1) detect low levels of
microcystins (10 ng/ml of blood), in the blood of people who are
exposed to very low levels of this toxin in their drinking water, (2)
utilize clinical endpoints such as blood liver enzyme levels as
biomarkers of exposure and biological effect, and (3) compare the
analytical results for the exposed population with the results from the referent population. There are no costs to respondents.
Number of Average burden
Respondents Number of responses per per response Total burden
respondents respondent (in hours) (in hours)
Telephone Contact............................... 300 1 10/60 50
Interview....................................... 200 1 1 200
Blood Samples Collection........................ 200 1 20/60 67
Tap Water Sample Collection..................... 200 1 30/60 100
Total....................................... .............. .............. .............. 417 [[Page 31926]]
Dated: June 4, 2001.
Nancy Cheal,
Acting Associate Director for Policy, Planning and Evaluation Centers for Disease Control and Prevention.
[FR Doc. 0114822 Filed 61201; 8:45 am]
BILLING CODE 416318P
SUMMARY:
Proposed collection; comment request,
DOCUMENT BODY 2:
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention (CDC) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call the CDC Reports Clearance Officer on (404) 6397090.
Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Send comments to Seleda Perryman, CDC Assistant Reports Clearance Officer, 1600 Clifton Road, MSD24, Atlanta, GA 30333. Written comments should be received within 60 days of this notice.
Proposed Project
Human Exposure to Cyanobacterial (bluegreen algal) Toxins in Drinking Water: Risk of Exposure to Microcystin from Public Water SystemsNewNational Center for Environmental Health (NCEH), Centers for Disease Control and Prevention (CDC).
Cyanobacteria (bluegreen algae) can be found in terrestrial,
fresh, brackish, or marine water environments. Some species of
cyanobacteria produce toxins that may cause acute or chronic illnesses
(including neurotoxicity, hepatotoxicity, and skin irritation) in
humans and animals (including other mammals, fish, and birds). A number
of human health effects, including gastroenteritis, respiratory
effects, skin irritations, allergic responses, and liver damage are
associated with the ingestion of or contact with water containing
cyanobacterial blooms. Although the balance of evidence, in conjunction
with data from laboratory animal research, suggests that cyanobacterial
toxins are responsible for a range of human health effects, there have
been few epidemiologic studies of this association. We plan to recruit
100 people whose tap water comes from a source with a current
cyanobacteria bloom (i.e., M. aeruginosa) and who report drinking
unfiltered tap water. We also plan to recruit 100 people who report
drinking unfiltered tap water but whose tap water source is groundwater
that has not been contaminated with cyanobacteria. This population will
serve as our referent population for the analysis of microcystins in
blood and for the clinical assays. We will administer a questionnaire
and collect blood samples from all study participants. Blood samples
will be analyzed using a newly developed molecular assay for levels of
microcystinsthe hepatotoxin produced by Micocystis aeruginosa. We
also will analyze blood samples for levels of liver enzymes (a
biological marker of hepatotoxicity) and for a number of clinical
parameters including hepatitis infection (a potential confounder in our
study). We will evaluate whether we can (1) detect low levels of
microcystins (10 ng/ml of blood), in the blood of people who are
exposed to very low levels of this toxin in their drinking water, (2)
utilize clinical endpoints such as blood liver enzyme levels as
biomarkers of exposure and biological effect, and (3) compare the
analytical results for the exposed population with the results from the referent population. There are no costs to respondents.
Number of Average burden
Respondents Number of responses per per response Total burden
respondents respondent (in hours) (in hours)
Telephone Contact............................... 300 1 10/60 50
Interview....................................... 200 1 1 200
Blood Samples Collection........................ 200 1 20/60 67
Tap Water Sample Collection..................... 200 1 30/60 100
Total....................................... .............. .............. .............. 417 [[Page 31926]]
Dated: June 4, 2001.
Nancy Cheal,
Acting Associate Director for Policy, Planning and Evaluation Centers for Disease Control and Prevention.
[FR Doc. 0114822 Filed 61201; 8:45 am]
BILLING CODE 416318P