General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation and Suspension

ICR 202001-0910-011

OMB: 0910-0338

Federal Form Document

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Supporting Statement A
2020-02-13
IC Document Collections
IC ID
Document
Title
Status
5935 Modified
209328 Modified
209327 Removed
209326 Removed
209325 Removed
209324 Removed
209323 Removed
209322 Removed
209320 Removed
209319 Removed
209318 Removed
209317 Removed
209316 Removed
209315 Removed
209314 Removed
209313 Removed
193381 Removed
193380 Removed
ICR Details
0910-0338 202001-0910-011
Historical Active 201804-0910-010
HHS/FDA CBER
General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation and Suspension
Extension without change of a currently approved collection   No
Regular
Approved without change 02/18/2020
Retrieve Notice of Action (NOA) 02/13/2020
  Inventory as of this Action Requested Previously Approved
02/28/2023 36 Months From Approved 03/31/2020
27,703 0 30,352
439,906 0 334,039
23,315,571 0 0

The Public Health Service Act and FDA regulations require manufacturers to submit a license application for review and approval prior to marketing a biological product in interstate commerce. In addition, applicants must submit to FDA advertising and promotional labeling. Manufacturers or applicants or are also required to submit changes, including labeling, changes to an approved application, as well as advertising and promotional labeling changes. The information submitted to FDA in a biologics license application, supplement to an approved application, or other similar submission is used to determine if a product is safe, effective, and not misbranded under prescribed, recommended, or suggested conditions of use. The regulations also describe the types of postmarketing studies (PMS) that require status reports, the information to be included in the reports, and the type of information that FDA would consider appropriate for public disclosure. FDA uses the information submitted from PMS reports to meet its reporting obligations under section 506B of the Food Drug & Cosmetic Act and section 130(b) of the Food and Drug Administration Modernization Act.

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

Not associated with rulemaking

  84 FR 49310 09/19/2019
85 FR 3053 01/17/2020
No

2
IC Title Form No. Form Name
601.6(a) - Suspension of License 356h, Form FDA 2253 Application to Market a New Drug or Biologic for Human Use ,   TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE
601.12(c)(5) - Changes to an Approved Application Form FDA 2253, 356h TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE ,   Application to Market a New Drug or Biologic for Human Use
601.12(f)(2) - Changes to an Approved Application 356h, Form FDA 2253 Application to Market a New Drug or Biologic for Human Use ,   TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE
601.27(b) - Pediatric Studies - Deferred Submission 356h, Form FDA 2253 Application to Market a New Drug or Biologic for Human Use ,   TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE
601.27(c) - Pediatric Studies 356h, Form FDA 2253 Application to Market a New Drug or Biologic for Human Use ,   TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE
601.12(d)(1)/(d)(3)/(f)(3) - Changes to an Application 356h, Form FDA 2253 Application to Market a New Drug or Biologic for Human Use ,   TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE
601.70(b) and (d)/601.28 - Annual Progress Reports of Postmarketing Studies and Annual reports of postmarketing pediatric studies 356h, Form FDA 2253 Application to Market a New Drug or Biologic for Human Use ,   TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE
610.15(d) - Constituent Materials 356h, Form FDA 2253 Application to Market a New Drug or Biologic for Human Use ,   TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE
601.12(c)(1) and (c)(3) - Changes to an Approved Application 356h, Form FDA 2253 Application to Market a New Drug or Biologic for Human Use ,   TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE
Biologics; Licensing; General Biological Products Standards; and Additional Standards FDA 356h, Form FDA 2253, Form FDA 2252, Form FDA 2252 TRANSMITTAL OF ANNUAL REPORTS FOR DRUGS AND BIOLOGICS FOR HUMAN USE ,   TRANSMITTAL OF ANNUAL REPORTS FOR DRUGS AND BIOLOGICS FOR HUMAN USE ,   Application to Market a New or Abbreviated New Drug or Biologic For Human Use ,   TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE
601.12(a)(5) - Changes to an Approved Application 356h, Form FDA 2253 Application to Market a New Drug or Biologic for Human Use ,   TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE
601.12(b)(1)/(b)(3)/(e) - Changes to an Approved Application 356h, Form FDA 2253 Application to Market a New Drug or Biologic for Human Use ,   TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE
601.12(f)(1) - Changes to an Approved Application 356h, Form FDA 2253 Application to Market a New Drug or Biologic for Human Use ,   TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE
680.1(b)(3)(iv) - Allergenic Products 356h, Form FDA 2253 TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE ,   Application to Market a New Drug or Biologic for Human Use
680.1(c) - Allergenic Products 356h, Form FDA 2253 Application to Market a New Drug or Biologic for Human Use ,   TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE
601.12(f)(4)/601.45 - Changes to an Approved Application 356h, Form FDA 2253 Application to Market a New Drug or Biologic for Human Use ,   TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE
Notifications of suspensions 356h Application to Market a New Drug or Biologic for Human Use
601.5(a) - Revocation of License Form FDA 2253, 356h TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE ,   Application to Market a New Drug or Biologic 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 27,703 30,352 0 0 -2,649 0
Annual Time Burden (Hours) 439,906 334,039 0 0 105,867 0
Annual Cost Burden (Dollars) 23,315,571 0 0 0 23,315,571 0
No
No
FDA’s estimated burden for the information collection reflects an overall increase of 105,867 hours and a decrease of 2,649 responses. We attribute this adjustment to an increase in the number of submissions we have received under 21 CFR 601.12(f)(4) and 601.45, and 21 CFR 601.12(b)(1), (b)(3), and (e) over the last few years. We attribute the decrease in responses to a decrease in responses received under 21 CFR 601.12(a)(5) and 601.27(b) over the last few years. Also, while we have consolidated the IC elements as they appear at omb.report., we have retained the itemized burden table in Question 12 as included in our Federal Register notices.

$18,936,855
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.
02/13/2020


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