OMB approves
this package contingent upon FDA making the changes outlined in the
correspondence of March 20, 1996. In addition, OMB notes that FDA
is in the process of consolidating approximately 20 forms,
including this form, into one, and that the estimated timeline for
this consolidation is presented in the correspondence of March 22,
1996. OMB will review the FDA form consolidation package and
expects FDA to shift the burden numbers associated with each
individual form to the consolidation package to avoid
double-counting and to permit the greatest flexibility.
Inventory as of this Action
Requested
Previously Approved
03/31/1999
03/31/1999
15
0
0
600
0
0
0
0
0
FDA is proposing to amend the
biologics regulations to eliminate the establishment license
application requirement for well-characterized biotechnology
products licensed under the Public Health Service Act.
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.