In accordance
with 5 CFR 1320, the information collection is not approved at this
time. Prior to publication of the final rule, the agency should
provide to OMB a summary of all comments received on the proposed
information collection and identify any changes made in response to
these comments.
Inventory as of this Action
Requested
Previously Approved
36 Months From Approved
0
0
0
0
0
0
0
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0
The proposed rule would allow
abbreviated new drug application (ANDA) holders to update product
labeling to reflect certain types of newly-acquired safety
information using the same process now available to new drug
application (NDA) holders when they submit a CBE-O labeling
supplement. At the time of submission of the CBE-0 labeling
supplement to FDA, an ANDA holder must send notice of the labeling
change proposed in the Supplement, including a copy of the
information supporting the change, to the NDA holder for the
reference listed drug RLD), unless approval of the NDA for the RLD
has been withdrawn. ANDA holders, NDA holders, and BLA holders
would be required to verify that the correct information regarding
the labeling changes proposed in their CBE-0 supplement appears on
the proposed FDA Web page and, if the information is incorrect,
they must contact the appropriate FDA review division within 2
business days of posting on the FDA Web page.
ILa Mizrachi 301 796-7726
ila.mizrachi@fda.hhs.gov
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.