FDA Approval to Market a New Drug

ICR 201601-0910-005

OMB: 0910-0001

Federal Form Document

Forms and Documents
Document
Name
Status
Form and Instruction
Modified
Justification for No Material/Nonsubstantive Change
2016-01-19
Justification for No Material/Nonsubstantive Change
2015-02-24
Supporting Statement A
2014-09-10
IC Document Collections
IC ID
Document
Title
Status
5662 Modified
184606
Unchanged
184605
Unchanged
184604
Unchanged
184603
Unchanged
184602
Unchanged
184601
Unchanged
184600
Unchanged
184599
Unchanged
184598
Unchanged
184597
Unchanged
184596
Unchanged
184595
Unchanged
184594
Unchanged
184593
Unchanged
184592
Unchanged
184591
Unchanged
ICR Details
0910-0001 201601-0910-005
Historical Active 201502-0910-008
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 03/22/2016
Retrieve Notice of Action (NOA) 01/22/2016
  Inventory as of this Action Requested Previously Approved
12/31/2017 12/31/2017 12/31/2017
85,745 0 85,745
3,421,306 0 3,421,306
0 0 0

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.

US Code: 21 USC 355(a) Name of Law: Federal Food, Drug, and Cosmetic Act
  
None

Not associated with rulemaking

  79 FR 16003 03/24/2014
79 FR 55801 09/17/2014
Yes

  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
No
No

$146,125,000
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.
01/22/2016


© 2024 OMB.report | Privacy Policy