Index of Legally Marketed Unapproved New Animal Drugs for Minor Species

Forms and Documents

Document Name	Status
MUMS Indexing FR.pdf Proposed Rule Document	2006-09-14
Cover Memo MUMS Indexing.doc Supplementary Document	2006-09-14
SS MUMS Indexing.doc Supporting Statement A	2006-09-14

IC Document Collections

IC ID	Document Title	Status
46368	Index of Legally Marketed Unapproved New Animal Drugs for Minor Species	New

ICR Details

OMB Control No: 0910-0837	ICR Reference No: 200612-0910-001
Status: Historical Inactive	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Index of Legally Marketed Unapproved New Animal Drugs for Minor Species
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: Comment filed on proposed rule	Conclusion Date: 02/21/2007
	Date Received in OIRA: 12/07/2006
Terms of Clearance: This information collection request is not approved at this time. FDA will consider public comments received on the information collection requirements of the proposed rule and resubmit at the final rule stage.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date		36 Months From Approved
Responses	0	0	0
Time Burden (Hours)	0	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: This information collection approval request is for a Food and Drug Administration (FDA) proposed rule intended to implement section 572 of the Minor Use and Minor Species (MUMS) Animal Health Act of 2004. The MUMS Act is made up of three sections (571, 572, and 573) and it 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. Section 572 of the legislationprovides for a public index listing of legally-marketed unapproved new animal drugs for minor species of animals. The drugs in this index will only be indicated for use in non-food minor species or for use in early non-food life stages food-producing minor species. This proposed rule will, among other things, specify the criteria and procedures for requesting eligibility and addition to the index as well as the annual reporting requirements for index holders.

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Authorizing Statute(s): Statute at Large: 21 Stat. 512 Name of Statute: null
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AF67	Proposed rulemaking	71 FR 48840	08/22/2006

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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
Index of Legally Marketed Unapproved New Animal Drugs for Minor Species

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

Burden Increase Due to: Changing Regulations

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

Burden Reduction Due to:

Short Statement: The increase in the burden estimate (program change) is due to the implementation of "The Minor Use and Minor Species Animal Health Act of 2004 (MUMs Act),Section 572, which authorize the FDA to establish new regulatory procedures that provide incentives intended to make more drugs legally available to veterinarians and animal owners for the treatment of minor animal species and uncommon diseases in major animal species.

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Annual Cost to Federal Government: $0

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: 11/16/2006

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