Potential Reproductive and Neurological Effects of Exposure to Acrylamide

Forms and Documents

Document Name	Status

No forms / supporting documents in this ICR. Check IC Document Collections.

IC Document Collections

IC ID	Document Title	Status
7163	Potential Reproductive and Neurological Effects of Exposure to Acrylamide	Migrated

ICR Details

OMB Control No: 0920-0694	ICR Reference No: 200506-0920-002
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No:
Title: Potential Reproductive and Neurological Effects of Exposure to Acrylamide
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: 11/18/2005
	Date Received in OIRA: 06/06/2005
Terms of Clearance: Approved consistent with the following terms of clearance: approved per submission of CDC memo to OMB providing additional detail concerning study hypotheses and clarification of study sample size, given the practical limitations of the study design i.e. the lack of currently available data from human or animal studies for many of the variables being analyzed which could be used to determine if the expected percentage differences are adequate to identify whether or not observed results are significant, OMB approves the requested collection for exploratory purposes which may inform additional future studies. Upon completion of the study CDC shall submit a report of study analysis and results to OMB.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2008	11/30/2008
Responses	150	0	0
Time Burden (Hours)	54	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: NIOSH is undertaking a study of the reproductive and neurobehavioral effects of occupational exposure to acrylamide. Acrylamide workers and control workers (n=100 per group) will be recruited from manufacturing, end-user, and non-exposed settings. Exposure, and potential reproductive and neurobehavioral effects will be evaluated by examining biological marker and preclinical test results. Questionnaire information will be collected concurrently.

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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:

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Potential Reproductive and Neurological Effects of Exposure to Acrylamide

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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	150	0	0	150	0	0
Annual Time Burden (Hours)	54	0	0	54	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

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

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: $0

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? No

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)? Uncollected

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: 06/06/2005

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