Supplements and Other Changes to Approved New Animal Drug Applications - Final Rule

Forms and Documents

Document Name	Status
SS-FDAMA 116.doc Supporting Statement A	0000-00-00

IC Document Collections

IC ID	Document Title	Status
178965	Supplements and Other Changes to Approved New Animal Drug Applications - Final Rule	New

ICR Details

OMB Control No: 0910-0600	ICR Reference No: 200703-0910-002
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Supplements and Other Changes to Approved New Animal Drug Applications - 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: 05/15/2007
	Date Received in OIRA: 03/08/2007
Terms of Clearance: FDA will ensure that the guidance document associated with this final rule displays the PRA burden statement toward the beginning of the document.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2010	36 Months From Approved
Responses	1,228	0	0
Time Burden (Hours)	63,561	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The final rule requires manufacturers to assess the effect of a manufacturing change on the identy, strength, quality, purity and potency of a drug as those factors relate to safety or effectiveness . It addresses changes requiring submission and approval of a supplement in the following situations: before the distribution of the drug made using the change, at least 30 days prior the distribution of the drug,at the time of distribution of the drug, and changes to be described in an annual report.

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Authorizing Statute(s): Statute at Large: 21 Stat. 506 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-AF59	Final or interim final rulemaking	71 FR 74766	12/13/2006

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	64 FR 53281	10/01/1999
30-day Notice:	Federal Register Citation:	Citation Date:
	71 FR 74781	12/13/2006
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
Supplements and Other Changes to Approved New Animal Drug Applications - 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	1,228	0	0	1,228	0	0
Annual Time Burden (Hours)	63,561	0	0	63,561	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: Changing Regulations

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

Burden Reduction Due to:

Short Statement: The FDA with this final rule, amends its regulations on supplements and other changes to approved NADA and ANADA to implement the manufacturing changes provisions of the Food and Drug Administration Modernization Act (FDAMA 116), of 1997. These new information collection requirements for this final rule are program changes (increase), due to agency discretion caused by changing regulations.

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Annual Cost to Federal Government: $2

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: 03/08/2007

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