Abbreviated NDAs & 505(b)(2) Applications; Proposed Revisions to Implement Portions of the Medicare Prescription Drug, Improvement, & Modernization Act of 2003 & Other Changes - Proposed Rule

Forms and Documents

Document Name	Status
SUPPORTING STATEMENT PR ABBREVIATED NDA FINAL 2-11-15.doc Supporting Statement A	2015-02-11

IC Document Collections

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

ICR Details

OMB Control No: 0910-0786	ICR Reference No: 201501-0910-016
Status: Historical Inactive	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Abbreviated NDAs & 505(b)(2) Applications; Proposed Revisions to Implement Portions of the Medicare Prescription Drug, Improvement, & Modernization Act of 2003 & Other Changes - Proposed Rule
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: Comment filed on proposed rule	Conclusion Date: 05/18/2015
	Date Received in OIRA: 02/12/2015
Terms of Clearance: In accordance with 5 CFR 1320, OMB is not approving the collection at this time. Prior to publication of the final rule, the agency should provide a summary of all comments related to the information collection requirements contained in the rule and any changes made in response to these comments.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date		36 Months From Approved
Responses	0	0	0
Time Burden (Hours)	0	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The proposed rule would implement portions of Title XI of the Medicare Prescription Drug, Improvement, and Modernization Act 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.

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Authorizing Statute(s): US Code: 42 USC 1305 Name of Law: PHS Act
   Statute at Large: 117 Stat. 2067 Name of Statute: Medicare Prescription Drug, Improvement, and Modernization Act of 2003
   PL: Pub.L. 108 - 173 1(a) Name of Law: MMA
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AF97	Proposed rulemaking	80 FR 6802	02/06/2015

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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: 14

IC Title	Form No.	Form Name
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
Supplements and other changes to an approved abbreviated application
Content and format of an application
Submission of patent information
Amendments to an unapproved application, supplement, or resubmission
Amendments to an unapproved abbreviated application
Amendments to an unapproved 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
Supplements and other changes to an approved 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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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 data collection.

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Annual Cost to Federal Government: $212,090,000

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: 02/12/2015

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