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

OMB 0910-0338

OMB 0910-0338

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.

The latest form for General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation and Suspension expires 2023-02-28 and can be found here.

All Historical Document Collections
Approved without change
No material or nonsubstantive change to a currently approved collection 2020-08-10
Approved without change
Extension without change of a currently approved collection 2020-02-13
Approved without change
No material or nonsubstantive change to a currently approved collection 2018-04-12
Approved without change
No material or nonsubstantive change to a currently approved collection 2018-02-28
Approved without change
No material or nonsubstantive change to a currently approved collection 2017-09-21
Approved without change
No material or nonsubstantive change to a currently approved collection 2017-05-24
Approved without change
Extension without change of a currently approved collection 2017-01-18
Approved without change
No material or nonsubstantive change to a currently approved collection 2014-03-19
Approved without change
Extension without change of a currently approved collection 2013-11-13
Approved without change
Extension without change of a currently approved collection 2010-06-24
Approved without change
Revision of a currently approved collection 2007-03-30
Approved without change
Extension without change of a currently approved collection 2005-07-25
Approved with change
Extension without change of a currently approved collection 2002-06-19
Approved without change
Extension without change of a currently approved collection 2000-02-01
Approved without change
New collection (Request for a new OMB Control Number) 1997-03-07
OMB Details

Biologics; Licensing; General Biological Products Standards; and Additional Standards

Federal Enterprise Architecture: Health - Consumer Health and Safety

Form Form FDA 2252TRANSMITTAL OF ANNUAL REPORTS FOR DRUGS AND BIOLOGICS FOR HUMAN USEFillable FileableForm
Form www.fda.gov/media/70712/downloadOther
Form FDA 356hApplication to Market a New or Abbreviated New Drug or Biologic For Human UseFillable FileableForm
Form Form FDA 2252TRANSMITTAL OF ANNUAL REPORTS FOR DRUGS AND BIOLOGICS FOR HUMAN USEFillable FileableForm and instruction
Form Form FDA 2253TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USEFillable FileableForm and instruction

Review document collections for all forms, instructions, and supporting documents - including paper/printable forms.


© 2021 OMB.report | Privacy Policy