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

Forms and Documents

Document Name	Status
Form 0920-1316 Record of fish for analysis Form	Unchanged
Form 0920-1316 Record of fish for analysis Form	Unchanged
Form 0920-1316 Record of time spent oudoors Form	Unchanged
Form 0920-1316 Record of time spent oudoors Form	Unchanged
Form 0920-1316 Symptom survey Form	Unchanged
Form 0920-1316 Symptom survey Form	Unchanged
Form 0920-25-0033 Screener Form	Modified
Form 0920-25-0033 Screener Form	Modified
0920-1316 Change Request Memo - EO14168.docx Justification for No Material/Nonsubstantive Change	2025-03-05
0920-1316 Change Request Memo - EO14168.docx Justification for No Material/Nonsubstantive Change	2025-03-05
Table A.10.1. Summary of information & materials to be collected and who will collect them.docx Supplementary Document	2024-01-23
Table A.10.1. Summary of information & materials to be collected and who will collect them.docx Supplementary Document	2024-01-23
Table 1. Examples of published studies that inform the potential public health impacts of HABs. .docx Supplementary Document	2024-01-23
Table 1. Examples of published studies that inform the potential public health impacts of HABs. .docx Supplementary Document	2024-01-23
0920-1316 Change Request Att 11 Results letter 06212023.docx Supplementary Document	2023-07-11
0920-1316 Change Request Att 11 Results letter 06212023.docx Supplementary Document	2023-07-11
0929-1316 Change Request Att5 Consent Form 06212023.docx Supplementary Document	2023-07-11
0929-1316 Change Request Att5 Consent Form 06212023.docx Supplementary Document	2023-07-11
0920-1316 Change Request Att3 Flyer 06212023.docx Supplementary Document	2023-07-11
0920-1316 Change Request Att3 Flyer 06212023.docx Supplementary Document	2023-07-11
Appendix D. IRB Approval Memo.pdf Supplementary Document	2024-01-17
Appendix D. IRB Approval Memo.pdf Supplementary Document	2024-01-17
APPENDIX C PIA HAB Cyano Bloom Extension 20240119.pdf Supplementary Document	2024-01-23
APPENDIX C PIA HAB Cyano Bloom Extension 20240119.pdf Supplementary Document	2024-01-23
Appendix B. 60-day Federal Register Notice.pdf Supplementary Document	2024-01-17
Appendix B. 60-day Federal Register Notice.pdf Supplementary Document	2024-01-17
Appendix A. Authorizing Legislation 10-24-23.docx Supplementary Document	2024-01-23
Appendix A. Authorizing Legislation 10-24-23.docx Supplementary Document	2024-01-23
0920-1316 Change Request SSB Cyano Aerosols 06212023.docx Supporting Statement B	2023-07-11
0920-1316 Change Request SSB Cyano Aerosols 06212023.docx Supporting Statement B	2023-07-11
SSA_Aerosols from cyanobacterial blooms (0920-1316).docx Supporting Statement A	2024-01-23
SSA_Aerosols from cyanobacterial blooms (0920-1316).docx Supporting Statement A	2024-01-23

IC Document Collections

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

ICR Details

OMB Control No: 0920-1316	ICR Reference No: 202503-0920-004
Status: Active	Previous ICR Reference No: 202312-0920-007
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-1316-25-0033
Title: [NCEH] Aerosols from cyanobacterial blooms: exposures and health effects in a highly exposed population
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 05/09/2025
	Date Received in OIRA: 05/01/2025
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2027	02/28/2027	02/28/2027
Responses	2,630	0	2,630
Time Burden (Hours)	1,272	0	1,272
Cost Burden (Dollars)	0	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. This Non-Substantive Change Request is submitted to expand the potential exposures to HAB aerosols where HABS include marine microalgae; marine macroalgae, such as seaweeds; and cyanobacteria. There is no change to the burden or potential respondents.

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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:
	88 FR 71364	10/16/2023
30-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 2954	01/17/2024
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
Personal air sampler
Providing blood specimen
Providing other specimens
Record of fish for analysis	0920-1316	Record of fish for analysis
Record of time spent oudoors	0920-1316, 0920-1316	Reocrd of time spent outdoors ,   Record of Time Spent Outdoors - Revised 10JUL2023
Screener	0920-25-0033	Screener
Symptom survey	0920-1316, 0920-1316	Symptom survey ,   Symptom Survey - Revised 10JUL2023

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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	2,630	0	0	0	0
Annual Time Burden (Hours)	1,272	1,272	0	0	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

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

Burden Increase Due to:

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

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $602,141

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: 05/01/2025

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