Dispute Resolution Procedures for Science Based Decisions on Products Regulated by the CVM

Forms and Documents

Document Name	Status
Guidance for Industry #79 - Dispute Resolution Procedures.pdf Supplementary Document	2011-09-22
0566 Supporting Statement 2015.pdf Supporting Statement A	2015-02-18

IC Document Collections

IC ID	Document Title	Status
6288	Dispute Resolution Procedures for Science Based Decisions on Products Regulated by the CVM	Modified

ICR Details

OMB Control No: 0910-0566	ICR Reference No: 201501-0910-009
Status: Historical Active	Previous ICR Reference No: 201110-0910-005
Agency/Subagency: HHS/FDA	Agency Tracking No: CVM
Title: Dispute Resolution Procedures for Science Based Decisions on Products Regulated by the CVM
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 04/10/2015
	Date Received in OIRA: 02/18/2015
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2018	36 Months From Approved	04/30/2015
Responses	8	0	3
Time Burden (Hours)	80	0	30
Cost Burden (Dollars)	0	0	0

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Abstract: This guidance document describes the CVM policy for resolution of disputes relating to scientific controversies. A scientific controversy involves issues that arise within the context of the Center's regulation of a specific product and are related to matters of technical expertise that require some specialize education, training or experience to be understood and resolved. The guidance document describes the dispute resolution procedures that we recommend be followed by sponsors, applicants, and manufacturers when requesting review of FDA decisions relating to regulated products for animals.

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Authorizing Statute(s): US Code: 21 USC 572 Name of Law: null
  

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:
	79 FR 65976	11/06/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 4931	01/29/2015
Did the Agency receive public comments on this ICR? Yes

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

IC Title	Form No.	Form Name
Dispute Resolution Procedures for Science Based Decisions on Products Regulated by the CVM

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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	8	3	0	5	0	0
Annual Time Burden (Hours)	80	30	0	50	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: Miscellaneous Actions

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

Burden Reduction Due to:

Short Statement: Burden increase reflects an increase in number of respondents and annual responses. This is discussed more fully at Q15 of the supporting statement.

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Annual Cost to Federal Government: $1,008,000

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: 02/18/2015

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