General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation and Suspension, and Forms FDA 356h & 2567

ICR 201006-0910-001

OMB: 0910-0338

Federal Form Document

Forms and Documents
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Supporting Statement A
2010-06-10
IC Document Collections
IC ID
Document
Title
Status
5935 Modified
193381 New
193380 New
179403
Removed
179402 Removed
179401
Removed
179400
Removed
179399
Removed
179398 Removed
179397
Removed
179396
Removed
179395
Removed
179394 Removed
179393 Removed
179392 Removed
179391 Removed
179390 Removed
179389 Removed
179388 Removed
179387 Removed
179386 Removed
179385
Removed
179384
Removed
179383
Removed
ICR Details
0910-0338 201006-0910-001
Historical Active 200703-0910-017
HHS/FDA
General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation and Suspension, and Forms FDA 356h & 2567
Extension without change of a currently approved collection   No
Regular
Approved without change 12/08/2010
Retrieve Notice of Action (NOA) 06/24/2010
  Inventory as of this Action Requested Previously Approved
12/31/2013 36 Months From Approved 10/31/2010
20,081 0 14,355
341,697 0 335,808
0 0 0

The PHS Act and FDA regulations require manufacturers to submit a license application for review and approval prior to marketing a biological product in interstate commerce. Manufacturers must also submit to FDA supplements to an approved application, and advertising, and promotional labeling. There are also requirements regarding suspension and revocation of a license. The regulations also require each applicant of a licensed biological product to submit an annual progress report to FDA on the status of postmarketing studies for each approved biologics license application required by FDA or committed to by the applicant.

US Code: 21 USC 356b Name of Law: FFDCA
   US Code: 42 USC 262 Name of Law: PHS Act
  
None

Not associated with rulemaking

  75 FR 4081 01/26/2010
75 FR 32790 06/09/2010
No

3
IC Title Form No. Form Name
Sections 601, Forms FDA356h & 2567 FDA 356h Application to Market a New Drug, Biologic, or an Antibiotic Drug for Human Use
General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567 FDA 356h Application to Market a New Drug, Biologic, or an Antibiotic Drug for Human Use
General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567 FDA 356h Application to Market a New Drug, Biologic, or an Antibiotic Drug for Human Use
General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567 FDA 356h Application to Market a New Drug, Biologic, or an Antibiotic Drug for Human Use
Section 601, recordkeeping, Forms FDA 356h & 2567 FDA 356h Application to Market a New Drug, Biologic, or an Antibiotic Drug for Human Use
General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567
General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567
General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567
General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567 FDA 356h Application to Market a New Drug, Biologic, or an Antibiotic Drug for Human Use
General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567 FDA 356h Application to Market a New Drug, Biologic, or an Antibiotic Drug for Human Use
General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567 FDA 356h Application to Market a New Drug, Biologic, or an Antibiotic Drug for Human Use
General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567 FDA 2567 Transmittals of Labels and Circulars
Section 680, Forms FDA 356h & 2567 FDA 356h Application to Market a New Drug, Biologic, or an Antibiotic Drug for Human Use
General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567
General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567
General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567
General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567
General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567
General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567 FDA 356h Application to Market a New Drug, Biologic, or an Antibiotic Drug for Human Use
General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567
General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567
General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567 FDA 356h Application to Market a New Drug, Biologic, or an Antibiotic Drug for Human Use
General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567 FDA 2567 Transmittals of Labels and Circulars
General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567 FDA 2567, FDA 356h Transmittals of Labels and Circulars ,   Application to Market a New Drug, Biologic, or an Antibiotic Drug for Human Use

  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 20,081 14,355 0 -14,327 20,053 0
Annual Time Burden (Hours) 341,697 335,808 0 -311,728 317,617 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
Yes
Miscellaneous Actions
The change in burden hours is a result of updated data on the number of submissions received by FDA as a result of section 601.2 and 601.12(a), (c), (d), and (f).

$17,573,130
No
No
No
No
No
Uncollected
Eliazabeth Berbakos 3018271482

  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.
06/24/2010


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