Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act

ICR 201704-0910-003

OMB: 0910-0679

Federal Form Document

Forms and Documents
Supporting Statement A
ICR Details
0910-0679 201704-0910-003
Historical Active 201403-0910-006
Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act
Extension without change of a currently approved collection   No
Approved without change 06/27/2017
Retrieve Notice of Action (NOA) 04/25/2017
  Inventory as of this Action Requested Previously Approved
06/30/2020 36 Months From Approved 06/30/2017
97 0 57
56 0 36
0 0 0

The information collection supports the filing of certain citizen petitions and agency guidance. The guidance describes how FDA will determine whether the provisions of section 505(q) addressing the treatment of citizen petitions and petitions for stay of agency action (collectively, petitions) apply to a particular petition and whether a petition would delay approval of a pending abbreviate new drug application or a 505(b)(2) application. The guidance also describes the provisions of section 505(q) requiring that a petition include a certification and that supplemental information or comments to a petition include a verification.

PL: Pub.L. 110 - 85 81 Name of Law: FDAAA

Not associated with rulemaking

  82 FR 2999 01/10/2017
82 FR 19050 04/25/2017

  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 97 57 0 0 40 0
Annual Time Burden (Hours) 56 36 0 0 20 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0

Domini Bean 301 796-5733 [email protected]


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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