Designation of New Animal Drugs for Minor Use or Minor Species ( MUMS) - Final Rule

Forms and Documents

Document Name	Status
SS- MUMS Designation.doc Supporting Statement A	2007-08-06

IC Document Collections

IC ID	Document Title	Status
181664	Designation of New Animal Drugs for Minor Use and MInor Species ( MUMS) - Final rule	New

ICR Details

OMB Control No: 0910-0605	ICR Reference No: 200708-0910-001
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Designation of New Animal Drugs for Minor Use or Minor Species ( MUMS) - Final Rule
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 without change	Conclusion Date: 09/24/2007
	Date Received in OIRA: 08/15/2007
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2010	36 Months From Approved
Responses	157	0	0
Time Burden (Hours)	1,362	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: This final rule implements section 573 of the Minor Use and Minor Species ( MUMS) Animal Health Act of 2004. The MUMS Act establishes new regulatory procedures intended to make more medications legally available to veterinarians and animal owners for the treatment of minor animal species as well as uncommon diseases in major animal species. This legislation provides incentives designed to help pharmaceutical companies overcome the financial burdens they face in providing liminted - demand animal drugs. These incentives are only available to sponsors whose drugs are " MUMS - designated" by the FDA. Participation in the MUMS program is completely optional for drug sponsors. This final rule specifies the criteria and procedures for requesting MUMS designation as well as the annual reporting requirements for MUMS designee.

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Authorizing Statute(s): US Code: 21 USC 301 Name of Law: null
  

Citations for New Statutory Requirements: Statute at Large: 21 Stat. 360 Name of Statute: null

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AF60	Final or interim final rulemaking	72 FR 41010	07/26/2007

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	70 FR 56394	09/27/2005
30-day Notice:	Federal Register Citation:	Citation Date:
	72 FR 41010	07/26/2007
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
Designation of New Animal Drugs for Minor Use and MInor Species ( MUMS) - Final rule

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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	157	0	157	0	0	0
Annual Time Burden (Hours)	1,362	0	1,362	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: This final rule implements section 573 of the Minor Use and Minor Species (MUMS) Animal Health Act of 2004. The MUMS ACT establishes new regulatory procedures intended to make more medications legally available to veterinarians and animal owners for the treatment of minor of minal animal species as well as uncommon diseases in major animal species. These new information collection requirements imposed by this final rule as a result of the MUMS legislation are program changes(increase).

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Annual Cost to Federal Government: $30,375

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]? 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: 08/15/2007

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