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	2021-02-23
0566 Supporting Statement Part A 2021.docx Supporting Statement A	2021-02-23

IC Document Collections

IC ID	Document Title	Status
6288	Request for Review of a Scientific Dispute Other-Agency Guidance	Modified

ICR Details

OMB Control No: 0910-0566	ICR Reference No: 202101-0910-010
Status: Received in OIRA	Previous ICR Reference No: 201802-0910-004
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: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 02/23/2021

	Requested	Previously Approved
Expiration Date	36 Months From Approved	03/31/2021
Responses	4	4
Time Burden (Hours)	40	40
Cost Burden (Dollars)	0	0

---

Abstract: This information collection supports agency guidance and applicable regulations. The guidance describes policy for resolution of disputes relating to scientific controversies within the Center for Veterinary Medicine at FDA. 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.

---

Authorizing Statute(s): US Code: 21 USC 360bbb-1 Name of Law: FFDCA; Dispute Resolution
  

Citations for New Statutory Requirements: None

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 50827	08/18/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 10581	02/22/2021
Did the Agency receive public comments on this ICR? No

---

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

IC Title	Form No.	Form Name
Request for Review of a Scientific Dispute

---

ICR Summary of Burden

	Total Request	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	4	4	0	0	0	0
Annual Time Burden (Hours)	40	40	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:

---

Annual Cost to Federal Government: $1,141,608

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

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.     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? No

---

Common Form ICR:  No

---

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: 02/23/2021

---