Applications for FDA Approval to Market a New Drug

ICR 201704-0910-006

OMB: 0910-0001

Federal Form Document

Forms and Documents
Document
Name
Status
Form and Instruction
Modified
Supporting Statement A
2017-12-27
IC Document Collections
IC ID
Document
Title
Status
5662 Modified
184606
Removed
184605
Modified
184604
Removed
184603
Removed
184602
Removed
184601
Modified
184600
Modified
184599
Removed
184598
Removed
184597
Removed
184596
Removed
184595
Removed
184594
Removed
184593
Removed
184592
Removed
184591
Removed
ICR Details
0910-0001 201704-0910-006
Historical Active 201601-0910-005
HHS/FDA CDER
Applications for FDA Approval to Market a New Drug
Extension without change of a currently approved collection   No
Regular
Approved without change 03/05/2018
Retrieve Notice of Action (NOA) 12/27/2017
  Inventory as of this Action Requested Previously Approved
03/31/2021 36 Months From Approved 03/31/2018
93,174 0 85,745
4,634,247 0 3,421,306
0 0 0

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.

US Code: 21 USC 301 et seq. Name of Law: Federal Food, Drug, and Cosmetic Act
  
None

Not associated with rulemaking

  82 FR 24351 05/26/2017
82 FR 58403 12/12/2017
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 93,174 85,745 0 0 7,429 0
Annual Time Burden (Hours) 4,634,247 3,421,306 0 0 1,212,941 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
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.

$146,125,000
No
    No
    No
No
No
No
Uncollected
Domini Bean 301 796-5733 [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.
12/27/2017


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