Index of Legally Marketed Unapproved New Animal Drugs for Minor Species

Forms and Documents

Document Name	Status
0620 ss 7-23-20.pdf Supporting Statement A	2020-07-23

IC Document Collections

IC ID	Document Title	Status
197475	New Animal Drugs for Minor Use and Minor Species: Recordkeeping	Removed
183179	Submissions, updates, written requests, correspondence, content and format, reports, distributor statements	Modified

ICR Details

OMB Control No: 0910-0620	ICR Reference No: 202007-0910-013
Status: Active	Previous ICR Reference No: 201707-0910-005
Agency/Subagency: HHS/FDA	Agency Tracking No: CVM
Title: Index of Legally Marketed Unapproved New Animal Drugs for Minor Species
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 with change	Conclusion Date: 08/25/2020
	Date Received in OIRA: 07/24/2020
Terms of Clearance: Changes in responses/burden were re-categorized as "adjustments."

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2023	36 Months From Approved	08/31/2020
Responses	213	0	293
Time Burden (Hours)	5,273	0	4,922
Cost Burden (Dollars)	0	0	0

---

Abstract: This ICR collects information from respondents who wish to make a drug legally available to veterinarians and animal owners for the treatment of a minor animal species (species other than cattle, horses, swine, chickens, turkeys, dogs, and cats). Respondents to the collection are sponsors of these products. FDA reviews the information collected to identify potential problems concerning the safety and effectiveness of the new animal drug.

---

Authorizing Statute(s): US Code: 21 USC 369ccc-2 Name of Law: Minor Use and Minor Species Animal Health Act
  

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 714	01/07/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 23969	04/30/2020
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
Submissions, updates, written requests, correspondence, content and format, reports, distributor statements
New Animal Drugs for Minor Use and Minor Species: Recordkeeping

---

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	213	293	0	0	-80	0
Annual Time Burden (Hours)	5,273	4,922	0	0	351	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: Our estimated burden for the information collection reflects an overall increase of 401 reporting hours. We attribute this adjustment, generally, to an increase in the number of submissions we received over the last few years. We also reduced our burden hour estimate for drug experience reports and distributor statements under 21 CFR 516.165 from 8 hours per submission to 5 hours per submission based on our experience with this type of reporting.

---

Annual Cost to Federal Government: $151,454

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.     No

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: 07/24/2020

---