FDA Approval to Market a New Drug

Forms and Documents

Document Name	Status
Form 3331 314.50 (a), (b), (c), (d), (e), (f), and (k) Form and Instruction	Modified
OMB Justification Memorandum 0001 for 83-I chg request 1-19-2016.docx Justification for No Material/Nonsubstantive Change	2016-01-19
Justification Memo for 83C Change Request 2-24-15.doc Justification for No Material/Nonsubstantive Change	2015-02-24
SUPPORTING STATEMENT 0001 FINAL 9-10-14.doc Supporting Statement A	2014-09-10

IC Document Collections

IC ID	Document Title	Status
5662	314.50 (a), (b), (c), (d), (e), (f), and (k) Form and Instruction	Modified
184606	314.550	Unchanged
184605	314.420	Unchanged
184604	314.101(a)	Unchanged
184603	314.99(a)	Unchanged
184602	314.97	Unchanged
184601	314.96	Unchanged
184600	314.94(a) and (d)	Unchanged
184599	314.81(b)(3)(i) [2253]	Unchanged
184598	314.81(b)(2) [2252]	Unchanged
184597	314.81(b)(1) [3331]	Unchanged
184596	314.72	Unchanged
184595	314.70 and 314.71	Unchanged
184594	314.65	Unchanged
184593	314.60	Unchanged
184592	314.95	Unchanged
184591	314.52	Unchanged

ICR Details

OMB Control No: 0910-0001	ICR Reference No: 201601-0910-005
Status: Historical Active	Previous ICR Reference No: 201502-0910-008
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: 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: 03/22/2016
	Date Received in OIRA: 01/22/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2017	12/31/2017	12/31/2017
Responses	85,745	0	85,745
Time Burden (Hours)	3,421,306	0	3,421,306
Cost Burden (Dollars)	0	0	0

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Abstract: Section 505 of the FD&C Act requires that a new drug may not be marketed unless the manufacturer provides FDA with scientific evidence that the drug is both safe and effective. The regulations at 21 CFR part 314 provide the means through which pharmaceutical manufacturers can obtain FDA approval of a drug product marketing application, and the means through which FDA can assure the safety and effectiveness of marketed drug products. Without the information provided by industry on the drug products they seek to market, FDA would not be able to assure the safety and effectiveness of marketed drug products.

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Authorizing Statute(s): US Code: 21 USC 355(a) 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:
	79 FR 16003	03/24/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 55801	09/17/2014
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 17

IC Title	Form No.	Form Name
314.101(a)
314.420
314.550
314.50 (a), (b), (c), (d), (e), (f), and (k)	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
314.95
314.65
314.60
314.70 and 314.71
314.72
314.81(b)(1) [3331]
314.81(b)(2) [2252]
314.81(b)(3)(i) [2253]
314.94(a) and (d)
314.96
314.99(a)
314.97
314.52

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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	85,745	85,745	0	0	0	0
Annual Time Burden (Hours)	3,421,306	3,421,306	0	0	0	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:

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

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: 01/22/2016

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