FDA Approval to Market a New Drug

ICR 201407-0910-014

OMB: 0910-0001

Federal Form Document

Forms and Documents
Document
Name
Status
Form and Instruction
Modified
Justification for No Material/Nonsubstantive Change
2014-07-17
IC Document Collections
IC ID
Document
Title
Status
5662 Modified
199081
Unchanged
184611
Unchanged
184610
Unchanged
184609
Unchanged
184608
Unchanged
184607
Unchanged
184606
Unchanged
184605
Unchanged
184604
Unchanged
184603
Unchanged
184602
Unchanged
184601
Unchanged
184600
Unchanged
184599
Unchanged
184598
Unchanged
184597
Unchanged
184596
Unchanged
184595
Modified
184594
Modified
184593
Modified
184592
Modified
184591
Modified
ICR Details
0910-0001 201407-0910-014
Historical Active 201104-0910-006
HHS/FDA CDER
FDA Approval to Market a New Drug
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 08/21/2014
Retrieve Notice of Action (NOA) 07/22/2014
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
09/30/2014 09/30/2014 09/30/2014
70,315 0 70,315
3,466,039 0 3,466,039
0 0 0

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.

None
None

Not associated with rulemaking

  75 FR 79001 12/17/2010
76 FR 20680 04/13/2011
No

  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
No
No

$212,090,000
No
No
No
No
No
Uncollected
Ila Mizrachi 301 796-7726 [email protected]

  No

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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
07/22/2014


© 2024 OMB.report | Privacy Policy