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

ICR 200703-0910-002

OMB: 0910-0600

Federal Form Document

Forms and Documents
Supporting Statement A
IC Document Collections
ICR Details
0910-0600 200703-0910-002
Historical Active
Supplements and Other Changes to Approved New Animal Drug Applications - Final Rule
New collection (Request for a new OMB Control Number)   No
Approved without change 05/15/2007
Retrieve Notice of Action (NOA) 03/08/2007
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
05/31/2010 36 Months From Approved
1,228 0 0
63,561 0 0
0 0 0

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.

Statute at Large: 21 Stat. 506 Name of Statute: null

0910-AF59 Final or interim final rulemaking 71 FR 74766 12/13/2006

  64 FR 53281 10/01/1999
71 FR 74781 12/13/2006

IC Title Form No. Form Name
Supplements and Other Changes to Approved New Animal Drug Applications - Final Rule

  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
Changing Regulations
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.

Saleda Perryman


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:
    (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;
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.

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