Exposure to Aerosolized Brevetoxins During Red Tide Events

Forms and Documents

Document Name	Status
0920-0494_SS_020609.doc Supporting Statement B	2009-02-17
Attachment 7 12-12-08.doc Supplementary Document	2009-02-23
Attachment 6 12-12-08.doc Supplementary Document	2009-02-23
Attachment 2 12-12 08.doc Supplementary Document	2009-02-17
Attachment 1 12-12-08.rtf Supplementary Document	2009-02-17
Attachment 5 12-12-08.doc Supplementary Document	2009-02-17
0920-0494_SS_020609.doc Supporting Statement A	2009-02-17

IC Document Collections

IC ID	Document Title	Status
6933	Pulmonary Health Questionnaire Other-WORD	Modified
188448	Pre and Post Shift Red Tide Questionnaire Other-Word	New

ICR Details

OMB Control No: 0920-0494	ICR Reference No: 200903-0920-007
Status: Historical Inactive	Previous ICR Reference No: 200509-0920-003
Agency/Subagency: HHS/CDC	Agency Tracking No:
Title: Exposure to Aerosolized Brevetoxins During Red Tide Events
Type of Information Collection: Reinstatement with change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Withdrawn	Conclusion Date: 09/02/2009
	Date Received in OIRA: 03/17/2009
Terms of Clearance: Withdrawn consistent with memo received on 9/1/2009 confirming that CDC is withdrawing ICR 0920-0494 and plans to resubmit at a later time.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date		36 Months From Approved
Responses	0	0	0
Time Burden (Hours)	0	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The National Center for Environmental Health (NCEH) request a three year approval of this reinstatement with change. One environmental exposure of concern is inhaling brevetoxin that has been aerosolized and swept onto the coast by offshore winds. Our studies have verified that these respiratory symptoms can be attributed to exposure to aerosolized brevetoxins during Florida red tides. We have not had a severe red tide since these projects were funded. Thus, we continue to explore the human effects from environmental exposure to brevetoxins and to add a component to assess whether loratidine can relieve upper respiratory symptoms related to red tides.

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Authorizing Statute(s): US Code: 42 USC 241 Name of Law: Public Health Service Act
  

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:
	73 FR 52662	09/10/2008
30-day Notice:	Federal Register Citation:	Citation Date:
	74 FR 7904	02/20/2009
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Pulmonary Health Questionnaire
Pre and Post Shift Red Tide Questionnaire

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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: The changes being made to the project since the last clearance are expansion of the research projects to include the following assessments: 1)whether Florida red tide toxins (brevetoxins) include respiratory symptions in humans through a direct toxin-mediated effect on cytokines resulting in an inflammatory response; 2)whether we can detect brevetosxins in nasal exudates, and 3) whether clinically available drugs, including antihistamines, provide relief for the acute symptoms associated with inhalation of aerosolized brevetoxins.

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Annual Cost to Federal Government: $48,300

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

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? Yes

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

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

Is this ICR related to the Pandemic Response? Uncollected

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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: 03/17/2009

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