Applications for FDA Approval to Market a New Drug: Patent Listing Requirements and Application of 30-month Stays on Approval of Abbreviated New Drug Applications Certifying That...

Forms and Documents

Document Name	Status
Form FDA 3542 Form FDA 3542 Form and Instruction	Modified
Form FDA 3542a Form FDA 3542a Form and Instruction	Modified
0513 Patent Declarations SSA 2019 Ext.pdf Supporting Statement A	2019-09-10

IC Document Collections

IC ID	Document Title	Status
6229	Form FDA 3542 Form and Instruction	Modified
179904	Form FDA 3542a Form and Instruction	Modified

ICR Details

OMB Control No: 0910-0513	ICR Reference No: 201908-0910-017
Status: Active	Previous ICR Reference No: 201611-0910-004
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Applications for FDA Approval to Market a New Drug: Patent Listing Requirements and Application of 30-month Stays on Approval of Abbreviated New Drug Applications Certifying That...
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: 10/08/2019
	Date Received in OIRA: 09/10/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2022	36 Months From Approved	10/31/2019
Responses	1,454	0	1,499
Time Burden (Hours)	17,770	0	19,780
Cost Burden (Dollars)	1,563,760	0	0

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Abstract: The information collection supports Form FDA 3542 and 3542a as used by new drug application (NDA) holders to submit patent declarations as prescribed by agency regulations. The information collected is required by statue and used by the agency for listing such information in the "Orange Book."

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Authorizing Statute(s): US Code: 21 USC 355 Name of Law: THe Federal Food, Drug, and Cosmetic Act; New Drugs
  

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:
	84 FR 22858	05/20/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 46735	09/05/2019
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Form FDA 3542	FDA 3542	Patent Declaration After Filing NDA or Supplement
Form FDA 3542a	FDA 3542a	Patent Declaration With Filing of NDA or Supplement

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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	1,454	1,499	0	0	-45	0
Annual Time Burden (Hours)	17,770	19,780	0	0	-2,010	0
Annual Cost Burden (Dollars)	1,563,760	0	0	0	1,563,760	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: The information collection reflects adjustment. Based on fewer submissions we have decreased our cumulative estimate by 45 annual hours and 2,010 responses.

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Annual Cost to Federal Government: $0

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     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: 09/10/2019

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