General Licensing Provisions:
Biologics License Application, Changes to an Approved Application,
Labeling, Revocation and Suspension
No
material or nonsubstantive change to a currently approved
collection
No
Regular
09/07/2022
Requested
Previously Approved
02/28/2023
02/28/2023
27,704
27,704
439,907
439,907
924
924
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
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.