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	Type	Status	Availability
505(q)guidanceSS final final.doc	Supporting Statement A	Uploaded 2011-01-21	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
196108	Letter withdrawing a petition for stay of agency action	Other-guidance document	New
196107	Verification for supplements to petitions for stay of agency action 505(q)(1) (I)	Other-guidance document	New
196106	Supplements to petitionss for stay of agency action	Other-guidance document	New
196105	Verifications for supplements to citizen petitions 505(q)(1)(I)	Other-guidance document	New
196104	Verification for comments to petitions for stay of agency action 505(q)(1)(I)	Other-guidance document	New
196103	Verification for comments to citizen petitions 505(q)(1)(I)	Other-guidance document	New
196102	Certification for petitions for stay of agency action 505(q)(1)(H)	Other-guidance document	New
196101	Certification for citizen petitions 505(q)(H)	Other-guidance document	New

ICR Details

OMB Control No: 0910-0679	ICR Reference No: 201102-0910-001
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
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: 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: 04/25/2011
	Date Received in OIRA: 02/02/2011
Terms of Clearance:

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

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Abstract: This information collection relates to the FDA's implementation of section 505(q) of the Federal Food, Drug, and Cosmetic Act. Section 505(q) includes requirements that certain citizen petitions and petitions for stay of Agency action include a certification and that supplemental information or comments to such petitions include a verification. This information collection covers the required certification and verification and a letter from the petitioner to withdraw a deficient petition for stay that is missing the certification.

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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:
	74 FR 3611	01/21/2009
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 78249	12/15/2010
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
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 petitionss 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
Certification for citizen petitions 505(q)(H)
Certification for petitions for stay of agency action 505(q)(1)(H)

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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	55	0	0	55	0	0
Annual Time Burden (Hours)	35	0	0	35	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: Miscellaneous Actions

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

Burden Reduction Due to:

Short Statement: The FDAAA added new provisions to the FD&C Act, this guidance will determine if the new provisions apply to a particular petition and how FDA will determine if a petition would delay approval of a pending abbreviated new drug application.

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Annual Cost to Federal Government: $1,031

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: 02/02/2011

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