Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products; Proposed Rule

Forms and Documents

Document Name	Status
SUPPORTING STATEMENT 11-26-13.doc Supporting Statement A	2013-11-26

IC Document Collections

IC ID	Document Title	Status
209606	Proposed Verification Requirements for NDA and BLA Holders Under 314.70(c)(8) and 601.12(f)(2)(iii)	New
209605	Proposed Requirements for ANDA Holders under 314.70(c)(8) and 314.70(c)(8)(ii)	New

ICR Details

OMB Control No: 0910-0757	ICR Reference No: 201312-0910-001
Status: Historical Inactive	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: 20992
Title: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products; 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: 01/27/2014
	Date Received in OIRA: 12/06/2013
Terms of Clearance: In accordance with 5 CFR 1320, the information collection is not approved at this time. Prior to publication of the final rule, the agency should provide to OMB a summary of all comments received on the proposed information collection and identify 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 allow abbreviated new drug application (ANDA) holders to update product labeling to reflect certain types of newly-acquired safety information using the same process now available to new drug application (NDA) holders when they submit a CBE-O labeling supplement. At the time of submission of the CBE-0 labeling supplement to FDA, an ANDA holder must send notice of the labeling change proposed in the Supplement, including a copy of the information supporting the change, to the NDA holder for the reference listed drug RLD), unless approval of the NDA for the RLD has been withdrawn. ANDA holders, NDA holders, and BLA holders would be required to verify that the correct information regarding the labeling changes proposed in their CBE-0 supplement appears on the proposed FDA Web page and, if the information is incorrect, they must contact the appropriate FDA review division within 2 business days of posting on the FDA Web page.

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Authorizing Statute(s): US Code: 21 USC 314.70 Name of Law: FD&C Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AG94	Proposed rulemaking	78 FR 67985	11/13/2013

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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: 2

IC Title	Form No.	Form Name
Proposed Requirements for ANDA Holders under 314.70(c)(8) and 314.70(c)(8)(ii)
Proposed Verification Requirements for NDA and BLA Holders Under 314.70(c)(8) and 601.12(f)(2)(iii)

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Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

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

Burden Reduction Due to:

Short Statement: This is a new approval request.

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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: 12/06/2013

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