Safety Labeling Changes; Implementation of the Federal Food, Drug, and Cosmetic Act

Forms and Documents

Document	Type	Status	Availability

No forms / supporting documents in this ICR. Check IC Document Collections.

IC Document Collections

IC ID	Collection	Type	Status	Form
204940	Safety Labeling Changes; Posting Approved Labeling on Application Holder's website		Modified
204939	Safety Labeling Changes (Section 505(o)(4) of the FD&C Act)-- Rebuttal Statement		Modified

ICR Details

OMB Control No: 0910-0734	ICR Reference No: 201903-0910-022
Status: Active	Previous ICR Reference No: 201601-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Safety Labeling Changes; Implementation of the Federal Food, Drug, and Cosmetic Act
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: 07/18/2019
	Date Received in OIRA: 06/26/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2022	36 Months From Approved	07/31/2019
Responses	387	0	449
Time Burden (Hours)	1,620	0	1,880
Cost Burden (Dollars)	121,500	0	0

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Abstract: The subject guidance document was developed to assist drug and biological product application holders in making safety-related labeling changes as required by statute. Specifically, section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(o)(4)), added by section 901 of the Food and Drug Administration Amendments Act of 2007 (FDAAA), authorizes FDA to require certain safety-related labeling changes based on information that becomes available after approval of the drug or biological product. While these requirements are codified in agency regulations (21 CFR part 314 – drugs; 21 CFR part 601 – biologics), the guidance provides background and procedural information regarding agency implementation.

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Authorizing Statute(s): US Code: 21 USC 355(o)(4)(B) Name of Law: 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
	Other Documents for OIRA Review

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 3461	02/12/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 26880	06/10/2019
Did the Agency receive public comments on this ICR? Yes

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

IC Title	Form No.	Form Name
Safety Labeling Changes (Section 505(o)(4) of the FD&C Act)-- Rebuttal Statement
Safety Labeling Changes; Posting Approved Labeling on Application Holder's website

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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	387	449	0	0	-62	0
Annual Time Burden (Hours)	1,620	1,880	0	0	-260	0
Annual Cost Burden (Dollars)	121,500	0	0	0	121,500	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: Based on a review of safety labeling notifications that were issued during calendar years 2016 and 2017 we have reduced the number of respondents to reflect fewer submissions. We attribute the adjustment to expected variability and note that it results in 62 fewer annual responses and 260 fewer annual burden hours. We have also uploaded costs that were previously reported, but not reflected at omb.report.

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Annual Cost to Federal Government: $0

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     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: 06/26/2019

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