Aerosols from cyanobacterial blooms: exposures and health effects in a highly exposed population

Forms and Documents

Document Name	Status
Record of fish for analysis Form	New
Record of time spent oudoors Form	New
Symptom survey Form	New
Screener Form	New
Site restriction lifted 7242 New Submission CDC IRB approval.docx Supplementary Document	2020-02-20
Att15 IRB Approval Memo 20200211.docx Supplementary Document	2020-02-20
Att14 Privacy Impact Assessment 20200211.docx Supplementary Document	2020-02-20
Att13 Results Letter 20200211.docx Supplementary Document	2020-02-20
Att6 Consent 08JAN2021 CLEAN .docx Supplementary Document	2021-01-08
Att4 Flyer CLEAN 08JAN2021.docx Supplementary Document	2021-01-08
Att10 OMB - approved Incentives 20200128.docx Supplementary Document	2020-02-20
Att2a Public Comments and Program Responses 20200128.docx Supplementary Document	2020-02-20
Att2 60 day Federal Register Notice.pdf Supplementary Document	2020-02-20
Att1_Public Health Service Act Section 301.docx Supplementary Document	2020-02-20
SSB Cyano Aerosols 20200213.docx Supporting Statement B	2020-02-20
SSA Cyano Aerosol CDC response 20201105 _ Passback 123020 CLEAN 20210106.docx Supporting Statement A	2021-01-08

IC Document Collections

IC ID	Document Title	Status
240030	Record of fish for analysis Form	New
240029	Record of time spent oudoors Form	New
240028	Personal air sampler Instruction	New
240026	Providing other specimens Instruction	New
240025	Providing blood specimen Instruction	New
240024	Symptom survey Form	New
240023	Screener Form	New

ICR Details

OMB Control No: 0920-1316	ICR Reference No: 202002-0920-009
Status: Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-19BPL
Title: Aerosols from cyanobacterial blooms: exposures and health effects in a highly exposed population
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 01/08/2021
	Date Received in OIRA: 02/21/2020
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2024	36 Months From Approved
Responses	2,630	0	0
Time Burden (Hours)	1,272	0	0
Cost Burden (Dollars)	31,049	0	0

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Abstract: Human exposures to cyanobacterial toxins have been reported to produce a variety of health effects, including respiratory irritation and liver and kidney damage. The goals of this study are: 1). To assess exposures and health symptoms in people who are exposed to aerosols generated during cyanobacterial harmful algal blooms (CyanoHABs) while living near or working on Lake Okeechobee, Florida and connecting rivers and estuaries and 2). to investigate the relationships.

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Authorizing Statute(s): US Code: 42 USC 241 Name of Law: PHSA
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 48929	09/17/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 9777	02/20/2020
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 7

IC Title	Form No.	Form Name
Screener	none, NA	Screening/Baseline Survey ,   Survey screener
Providing blood specimen
Providing other specimens
Personal air sampler
Record of time spent oudoors	none	Reocrd of time spent outdoors
Record of fish for analysis	none	Record of fish for analysis
Symptom survey	none	Symptom survey

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ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	2,630	0	0	2,630	0	0
Annual Time Burden (Hours)	1,272	0	0	1,272	0	0
Annual Cost Burden (Dollars)	31,049	0	0	31,049	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a new ICR. Per requests from public comments, the sample size and burden were increased from the 60 day FRN estimates.

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Annual Cost to Federal Government: $252,504

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     Yes

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 02/21/2020

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