Applications for FDA Approval to Market a New Drug

Forms and Documents

Document Name	Status
Form 3331 Subpart B - Applications Form and Instruction	Modified
0001 Non sub Change July 2019 to include 0786 burden and form update.pdf Justification for No Material/Nonsubstantive Change	2019-07-25
0001 NDAs SSA 2017 Ext.pdf Supporting Statement A	2017-12-27

IC Document Collections

IC ID	Document Title	Status
5662	Subpart B - Applications Form and Instruction	Modified
184605	PART 314: Subparts E through I	Unchanged
184601	Subpart D - FDA Action on Applications	Unchanged
184600	Subpart C - Abbreviated Applications	Unchanged

ICR Details

OMB Control No: 0910-0001	ICR Reference No: 201907-0910-022
Status: Historical Active	Previous ICR Reference No: 201704-0910-006
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Applications for FDA Approval to Market a New Drug
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 07/26/2019
	Date Received in OIRA: 07/25/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2021	03/31/2021	03/31/2021
Responses	95,327	0	93,174
Time Burden (Hours)	4,637,036	0	4,634,247
Cost Burden (Dollars)	0	0	0

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Abstract: This information collection supports Food and Drug Administration regulations governing applications for FDA approval to market a new drug. Respondents to the collection are individuals or entities submitting such applications to the agency in accordance with the provisions found in the Code of Federal Regulations (CFR), Title 21, Part 314.

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Authorizing Statute(s): US Code: 21 USC 301 et seq. 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

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 24351	05/26/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 58403	12/12/2017
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
Subpart B - Applications	2252, 2253, 356, 3331	NDA-Field Alert Report ,   Transmittal of Annual Report for Drug and Biologics for Human Use ,   Transmittal of Advertisements and Promotional Labeling for Drugs and Biologics for Human Use ,   Application to Market a New or Abbreviated New Drug or Biologic for Human Use
Subpart C - Abbreviated Applications
Subpart D - FDA Action on Applications
PART 314: Subparts E through I

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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	95,327	93,174	0	0	2,153	0
Annual Time Burden (Hours)	4,637,036	4,634,247	0	0	2,789	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: The estimated burden for the information collection reflects an increase of 1,212,941 annual hours and 7,429 annual responses. Also, we have revised the IC list appearing at omb.report by consolidating the 17 previously itemized regulatory provisions into 4 elements. This is discussed more fully in our SS at Q15.

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Annual Cost to Federal Government: $146,125,000

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: 07/25/2019

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