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

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form 3542 Form FDA 3542	Form	Unchanged	Available
Form FDA 3542a Form FDA 3542a	Form and Instruction	Unchanged	Available
0513 NonMaterial change to forms resulting from 0786.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2016-11-22	Available
0513 Supporting Statement 2016.pdf	Supporting Statement A	Uploaded 2016-08-25	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
6229	Form FDA 3542	Form	Unchanged
179904	Form FDA 3542a	Form and Instruction	Unchanged

ICR Details

OMB Control No: 0910-0513	ICR Reference No: 201611-0910-004
Status: Historical Active	Previous ICR Reference No: 201608-0910-016
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: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 11/23/2016
	Date Received in OIRA: 11/22/2016
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2019	09/30/2019	09/30/2019
Responses	1,499	0	1,499
Time Burden (Hours)	19,780	0	19,780
Cost Burden (Dollars)	0	0	0

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Abstract: The information collection supports Form FDA 3542 and 3542a as used by persons submitting new drug applications, abbreviated new drug applications, and supplements to drug applications to the Food and Drug Administration. Respondents to the collection are sponsors of these applications who must submit required patent information. 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(c)(2) Name of Law: THe Federal Food, Drug, and Cosmetic Act
   US Code: 21 USC 505(b)(1) Name of Law: The Federal Food, Drug, and Cosmetic Act
   US Code: 21 USC 355(b)1 Name of Law: THe Federal Food, Drug, and Cosmetic Act
   US Code: 21 USC 505(c)(2) Name of Law: The Federal Food, Drug, and Cosmetic Act
  

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:
	81 FR 5465	02/02/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 54097	08/15/2016
Did the Agency receive public comments on this ICR? No

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

table that charts list of burden

IC Title	Form No.	Form Name
Form FDA 3542	3542	Patent Information Submitted Upon and After Approval of an NDA or Supplement
Form FDA 3542a	FDA 3542a	Patent Information Submitted with the Filing of An NDA, Amendment, or Supplement

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ICR Summary of Burden

table that charts list 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	1,499	1,499	0	0	0	0
Annual Time Burden (Hours)	19,780	19,780	0	0	0	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: The information collection reflects an increase attributed to an increased number of respondents subject to the submissions.

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Annual Cost to Federal Government: $0

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: 11/22/2016

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