FDA Approval to Market a New Drug

Forms and Documents

Document	Type	Status	Availability
Form 3331 314.50 (a), (b), (c), (d), (e), (f), and (k)	Form and Instruction	Modified	Available
SUPPORTING STATEMENT 0001 FINAL 9-10-14.doc	Supporting Statement A	Uploaded 2014-09-10	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
5662	314.50 (a), (b), (c), (d), (e), (f), and (k)	Form and Instruction	Modified
199081	Guidance; Reports on the Status of Postmarketing Studies/Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997		Removed
184611	314.420		Removed
184610	314.110(c)		Removed
184609	314.110(a)(5)		Removed
184608	314.107(f)		Removed
184607	314.107(e)		Removed
184606	314.550		Modified
184605	314.420		Modified
184604	314.101(a)		Modified
184603	314.99(a)		Modified
184602	314.97		Modified
184601	314.96		Modified
184600	314.94(a) and (d)		Modified
184599	314.81(b)(3)(i) [2253]		Modified
184598	314.81(b)(2) [2252]		Modified
184597	314.81(b)(1) [3331]		Modified
184596	314.72		Modified
184595	314.70 and 314.71		Modified
184594	314.65		Modified
184593	314.60		Modified
184592	314.95		Modified
184591	314.52		Modified

ICR Details

OMB Control No: 0910-0001	ICR Reference No: 201409-0910-004
Status: Historical Active	Previous ICR Reference No: 201407-0910-014
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: FDA Approval to Market a New Drug
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 with change	Conclusion Date: 12/24/2014
	Date Received in OIRA: 09/18/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2017	36 Months From Approved	12/31/2014
Responses	85,745	0	70,315
Time Burden (Hours)	3,421,306	0	3,466,039
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
314.95
314.60
314.65
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
314.97
314.99(a)
314.107(f)
314.107(e)
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
314.52
314.101(a)
314.420
314.550
314.110(a)(5)
314.110(c)
314.420
Guidance; Reports on the Status of Postmarketing Studies/Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997

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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	70,315	0	0	15,430	0
Annual Time Burden (Hours)	3,421,306	3,466,039	0	0	-44,733	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: 09/18/2014

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