0338 BLAs non sub change to include 0629 GFI

UNITED STATES FOOD & DRUG ADMINISTRATION
General Licensing Provisions:
Biologics License Application, Changes to an Approved Application,
Labeling, Revocation and Suspension, Postmarketing Studies Status Reports, and Cooperative
Manufacturing Arrangements
OMB Control No. 0910-0338

No Material or Non-Substantive Change to a Currently Approved Collection (83C):
This change request seeks to include Food and Drug Administration (FDA, the agency)
guidance into a currently approved information collection for efficiency of agency operations.
The referenced information collection supports implementation of section 351 of the Public
Health Service Act (42 U.S.C. 262) and related FDA regulations pertaining to licensed
biologics applications (BLAs). A manufacturer of a biological product must demonstrate
responsibility for the manufacturing process as described in its BLA (21 CFR 600.3(t)). We
developed the guidance document entitled, “Cooperative Manufacturing Arrangements for
Licensed Biologics,” to assist respondents with various alternative arrangements we have
accepted involving more than one manufacturer. The guidance document addresses types of
manufacturing arrangements (i.e., short supply arrangements, divided manufacturing
arrangements, shared manufacturing arrangements, and contract manufacturing arrangements)
and describes certain reporting and recordkeeping responsibilities associated with these
arrangements. The guidance document was issued in November 2008 consistent with
regulations in 21 CFR part 601.29 (biologics licensing; guidance documents), as well as our
good guidance practice regulations in 21 CFR 10.115 which provide for public comment at
any time. Although we believe that the information collection attendant to the
recommendations in the guidance are those that would be usual and customary, we provide
for 1 burden hour and 1 annual response to account for such activity and have adjusted our
estimate accordingly. Upon approval of the change request we intend to discontinue OMB
control no. 0910-0629.
In addition, we have removed the cost information inadvertently included to appear at
www.reginfo.gov. In our last renewal of the information collection we inadvertently
uploaded this information when it already appears at 12b. of our supporting statement.
Submitted: August 2020