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
Justification Memo for 83C Change Request 7-16-14.doc Justification for No Material/Nonsubstantive Change	2014-07-17

IC Document Collections

IC ID	Document Title	Status
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	Unchanged
184611	314.420	Unchanged
184610	314.110(c)	Unchanged
184609	314.110(a)(5)	Unchanged
184608	314.107(f)	Unchanged
184607	314.107(e)	Unchanged
184606	314.107(c)	Unchanged
184605	314.101(a)	Unchanged
184604	314.99(a)	Unchanged
184603	314.97	Unchanged
184602	314.96	Unchanged
184601	314.94(a)(1)-(11) and (d)	Unchanged
184600	314.81(b)(3)(i) [2253]	Unchanged
184599	314.81(b)(2) [2252]	Unchanged
184598	314.81(b)(1) [3331]	Unchanged
184597	314.72	Unchanged
184596	314.70 and 314.71	Unchanged
184595	314.65	Modified
184594	314.60	Modified
184593	314.52 and 314.95	Modified
184592	314.50(j)	Modified
184591	314.50(i) and 314.94(a)(12)	Modified

ICR Details

OMB Control No: 0910-0001	ICR Reference No: 201407-0910-014
Status: Historical Active	Previous ICR Reference No: 201104-0910-006
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: 08/21/2014
	Date Received in OIRA: 07/22/2014
Terms of Clearance: Prior terms remain in effect: In accordance with 5 CFR 1320, the collection is approved. However, the agency is reminded that approvals by OMB only extend to the information described in the supporting statement. By the time of the next submission, FDA must ensure that the request for the approval of Form 356H fully describes the circumstances for which it will be used - including the information described in the supporting statement that is relevant to 356H. Alternatively, FDA may request approval in this information collection.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2014	09/30/2014	09/30/2014
Responses	70,315	0	70,315
Time Burden (Hours)	3,466,039	0	3,466,039
Cost Burden (Dollars)	0	0	0

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Abstract: This information collection request captures the requirements of Section 505 of the Food, Drug, and Cosmetic Act, which requires that a new drug may not be marketed unless the manufacture 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 the marketed products.

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Authorizing Statute(s): None

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:
	75 FR 79001	12/17/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 20680	04/13/2011
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 23

IC Title	Form No.	Form Name
314.50 (a), (b), (c), (d), (e), (f), and (k)	3331	NDA-Field Alert Report
314.50(i) and 314.94(a)(12)
314.50(j)
314.52 and 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)(1)-(11) and (d)
314.96
314.97
314.99(a)
314.101(a)
314.107(c)
314.107(e)
314.107(f)
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	70,315	70,315	0	0	0	0
Annual Time Burden (Hours)	3,466,039	3,466,039	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: $212,090,000

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: 07/22/2014

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