This approval
does not extend to those provisions proposed in the August 29, 2006
NPRM (71 Fed. Reg. 51276). When that rule is finalized, FDA must
submit those changes for approval before they go into effect.
Inventory as of this Action
Requested
Previously Approved
08/31/2015
36 Months From Approved
08/31/2012
45,168
0
47,463
227,222
0
319,022
0
0
0
21 CFR part 207 implements section 510
of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C.
360), under which FDA is authorized to establish a system for
registration of producers of drugs and for listing of drugs in
commercial distribution.
Johnny Vilela 301 796-3792
juanmanuel.vilela@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.