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

Forms and Documents

Document Name	Status
Form 3542a Applications for FDA Approval to Market a New Drug: Patient Listing Requirements and Application of 30-month Stays on Approval of Abbreviated New Drug Applications Certifying That... Form	Modified
Form 3542 Applications for FDA Approval to Market a New Drug: Patent Listing... 30-month Stays Form	Modified
pra0513patentforms SS 2010 .doc Supporting Statement A	2010-07-06

IC Document Collections

IC ID	Document Title	Status
6229	Applications for FDA Approval to Market a New Drug: Patient Listing Requirements and Application of 30-month Stays on Approval of Abbreviated New Drug Applications Certifying That... Form	Modified
179904	Applications for FDA Approval to Market a New Drug: Patent Listing... 30-month Stays Form	Modified

ICR Details

OMB Control No: 0910-0513	ICR Reference No: 201007-0910-003
Status: Historical Active	Previous ICR Reference No: 200704-0910-004
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Applications for FDA Approval to Market a New Drug: Patient 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: 10/18/2010
	Date Received in OIRA: 07/23/2010
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2013	36 Months From Approved	10/31/2010
Responses	1,006	0	673
Time Burden (Hours)	14,120	0	8,840
Cost Burden (Dollars)	0	0	0

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Abstract: The proposal would amend FDA's patient listing requirements for new drug applications (NDA's). The proposal would clarify the types of patents that must and must not be listed and revise the declaration that NDA applicants must provide regarding their patents to help ensure that NDA applicants list only appropriate patents. The proposal would also revise the regulations regarding the effective date of approval for certain abbreviated new drug applications (ANDA's) and certain applications submitted under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (505(b)(2) applications).

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Authorizing Statute(s): 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
   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
  

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:
	75 FR 17924	04/08/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 39531	07/09/2010
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
Applications for FDA Approval to Market a New Drug: Patient Listing Requirements and Application of 30-month Stays on Approval of Abbreviated New Drug Applications Certifying That...	3542a	PATENT INFORMATION SUBMITTED UPON AND
Applications for FDA Approval to Market a New Drug: Patent Listing... 30-month Stays	3542	PATENT INFORMATION SUBMITTED UPON AND

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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	1,006	673	0	0	333	0
Annual Time Burden (Hours)	14,120	8,840	0	0	5,280	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:

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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: 07/23/2010

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