Fuels and Fuel Additives: Health-Effects Research Requirements for Manufacturers (40 CFR part 79, subpart F) (Renewal)

Forms and Documents

Document Name	Status
1696ss09.docx Supporting Statement A	2016-08-10

IC Document Collections

IC ID	Document Title	Status
45799	Fuels and Fuel Additives: Health-Effects Research Requirements for Manufacturers (Tier 2/Alternative Tier 2/Tier 3 Health-Effects Testing)	Modified
24403	Fuels and Fuel Additives: Health-Effects Research Requirements for Manufacturers (Tier 1 Testing)	Modified

ICR Details

OMB Control No: 2060-0297	ICR Reference No: 201608-2060-004
Status: Active	Previous ICR Reference No: 201308-2060-004
Agency/Subagency: EPA/OAR	Agency Tracking No: 1696.09
Title: Fuels and Fuel Additives: Health-Effects Research Requirements for Manufacturers (40 CFR part 79, subpart F) (Renewal)
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 11/22/2016
	Date Received in OIRA: 09/23/2016
Terms of Clearance: In accordance with 5 CFR 1320, the information collection is approved for three years.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2019	36 Months From Approved	11/30/2016
Responses	2	0	2
Time Burden (Hours)	17,600	0	19,200
Cost Burden (Dollars)	597,000	0	537,000

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Abstract: Health-effects testing is required for the registration of certain motor-vehicle fuels and fuel additives. This involves emissions testing to identify exhaust and evaporative compounds and can involve animal exposure testing. In some cases a literature search is required for health-effects information on certain compounds.

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Authorizing Statute(s): None

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:
	81 FR 22080	04/14/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 64986	09/21/2016
Did the Agency receive public comments on this ICR? No

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

IC Title	Form No.	Form Name
Fuels and Fuel Additives: Health-Effects Research Requirements for Manufacturers (Tier 2/Alternative Tier 2/Tier 3 Health-Effects Testing)
Fuels and Fuel Additives: Health-Effects Research Requirements for Manufacturers (Tier 1 Testing)

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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	2	0	0	0	0
Annual Time Burden (Hours)	17,600	19,200	0	0	-1,600	0
Annual Cost Burden (Dollars)	597,000	537,000	0	0	60,000	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: There is a decrease 1,600 hours in the total estimated respondent burden compared with the ICR currently approved by OMB. This decrease is due to a revision in the estimate for conducting the Tier 1 literature search.

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Annual Cost to Federal Government: $83,200

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

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? 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: 09/23/2016

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