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

Forms and Documents

Document Name	Status
SUPPORTING STATEMENT FINAL 3-18-14.doc Supporting Statement A	2014-03-18

IC Document Collections

IC ID	Document Title	Status
196108	Letter withdrawing a petition for stay of agency action Other-Guidance	Modified
196107	Verification for supplements to petitions for stay of agency action 505(q)(1) (I) Other-Guidance	Modified
196106	Supplements to petitions for stay of agency action Other-Guidance	Modified
196105	Verifications for supplements to citizen petitions 505(q)(1)(I) Other-Guidance	Modified
196104	Verification for comments to petitions for stay of agency action 505(q)(1)(I) Other-Guidance	Modified
196103	Verification for comments to citizen petitions 505(q)(1)(I) Other-Guidance	Modified
196102	Certification for petitions for stay of agency action 505(q)(1)(H) Other-Guidance	Modified
196101	Certification for citizen petitions 505(q)(H) Other-Guidance	Modified

ICR Details

OMB Control No: 0910-0679	ICR Reference No: 201403-0910-006
Status: Historical Active	Previous ICR Reference No: 201102-0910-001
Agency/Subagency: HHS/FDA	Agency Tracking No: 21590
Title: Guidance for Industry on Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 04/21/2014
	Date Received in OIRA: 03/19/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2017	36 Months From Approved	04/30/2014
Responses	57	0	55
Time Burden (Hours)	36	0	35
Cost Burden (Dollars)	0	0	0

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Abstract: The guidance describes, among other things, 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.

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Authorizing Statute(s): PL: Pub.L. 110 - 85 81 Name of Law: FDAAA
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 60288	10/01/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 13656	03/11/2014
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 8

IC Title	Form No.	Form Name
Certification for citizen petitions 505(q)(H)
Certification for petitions for stay of agency action 505(q)(1)(H)
Verification for comments to citizen petitions 505(q)(1)(I)
Verification for comments to petitions for stay of agency action 505(q)(1)(I)
Verifications for supplements to citizen petitions 505(q)(1)(I)
Supplements to petitions for stay of agency action
Verification for supplements to petitions for stay of agency action 505(q)(1) (I)
Letter withdrawing a petition for stay of agency action

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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	57	55	0	0	2	0
Annual Time Burden (Hours)	36	35	0	0	1	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: There is a slight increase in burden based on current submissions.

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Annual Cost to Federal Government: $1,125

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]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

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: 03/19/2014

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