Abbreviated New Drug Applications and 505(b)(2) Applications

Forms and Documents

Document	Type	Status	Availability
Form Form FDA 3542 Abbreviated New Drug Applications and 505(b)(2) Applications	Form and Instruction	Modified	Available
0786 FRIA 6 OCT 2016 FR.pdf	Supplementary Document	Uploaded 2016-10-06	Available
0786 SS for FR Oct 2016.pdf	Supporting Statement A	Uploaded 2016-10-06	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
214796	Effective date of approval of a 505(b)(2) application or abbreviated new drug application under section 505(i) of the Act		Removed
214795	Supplements and other changes to an approved abbreviated application		Removed
214794	Supplements and other changes to an approved abbreviated application		Removed
214793	Amendments to an unapproved abbreviated application		Removed
214792	Amendments to an unapproved abbreviated application		Removed
214791	Notice of certification of invalidity or noninfringement of a patent		Removed
214790	Content and format of an abbreviated application		Removed
214789	Supplements and other changes to an approved application		Removed
214788	Amendments to an unapproved application, supplement, or resubmission		Removed
214787	Submission of patent information		Removed
214786	Notice of certification of invalidity or infringement of a patent		Removed
214785	Notice of certification of invalidity or infringement of a patent		Removed
214784	Content and format of an application		Removed
214783	Abbreviated New Drug Applications and 505(b)(2) Applications	Form and Instruction	Modified

ICR Details

OMB Control No: 0910-0786	ICR Reference No: 201610-0910-001
Status: Historical Active	Previous ICR Reference No: 201501-0910-016
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Abbreviated New Drug Applications and 505(b)(2) Applications
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: 11/21/2016
	Date Received in OIRA: 10/06/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2019	36 Months From Approved
Responses	2,153	0	0
Time Burden (Hours)	2,789	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: This information collection supports agency rulemaking that implements portions of Title XI of the Medicare Prescription Drug, Improvement, and Modernization Act. Specifically, those portions that pertain to provision of notice to each patent owner and the new drug application (NDA) holder of certain patent certifications made by applicants submitting 505(b)(2) applications or abbreviated new drug applications (ANDAs); the availability of 30-month stays of approval on 505(b)(2) applications and ANDAs that are otherwise ready to be approved; submission of amendments and supplements to 505(b)(2) applications and ANDAs; and the types of bioavailability and bioequivalence data that can be used to support these applications. Respondents to this collection of information are NDA applicants (including 505(b)(2) applicants) and ANDA applicants, patent owners, and their representatives.

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Authorizing Statute(s): US Code: 21 USC 355 Name of Law: FFDCA; New Drugs
  

Citations for New Statutory Requirements: PL: Pub.L. 108 - 173 Title XI Name of Law: Medicare Prescription Drug, Improvement, and Modernization Act of 2003

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AF97	Final or interim final rulemaking	81 FR 69580	10/06/2016

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Abbreviated New Drug Applications and 505(b)(2) Applications	Form FDA 3542a, Form FDA 3542	Patent Information Submitted Upon and After Approval of an NDA or Supplement ,   Patent Information Submitted With the Filing of an NDA, Amendment, or Supplement
Amendments to an unapproved abbreviated application
Supplements and other changes to an approved abbreviated application
Supplements and other changes to an approved abbreviated application
Content and format of an application
Notice of certification of invalidity or infringement of a patent
Notice of certification of invalidity or infringement of a patent
Submission of patent information
Amendments to an unapproved application, supplement, or resubmission
Supplements and other changes to an approved application
Content and format of an abbreviated application
Notice of certification of invalidity or noninfringement of a patent
Amendments to an unapproved abbreviated application
Effective date of approval of a 505(b)(2) application or abbreviated new drug application under section 505(i) of the Act

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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	2,153	0	0	2,153	0	0
Annual Time Burden (Hours)	2,789	0	0	2,789	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: Changing Regulations

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

Burden Reduction Due to:

Short Statement: This is a new information collection in support of agency rulemaking.

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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: 10/06/2016

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