Prior terms
remain in effect: In accordance with 5 CFR 1320, the collection is
approved. However, the agency is reminded that approvals by OMB
only extend to the information described in the supporting
statement. By the time of the next submission, FDA must ensure that
the request for the approval of Form 356H fully describes the
circumstances for which it will be used - including the information
described in the supporting statement that is relevant to 356H.
Alternatively, FDA may request approval in this information
collection.
Inventory as of this Action
Requested
Previously Approved
09/30/2014
09/30/2014
09/30/2014
70,315
0
70,315
3,466,039
0
3,466,039
0
0
0
This information collection request
captures the requirements of Section 505 of the Food, Drug, and
Cosmetic Act, which requires that a new drug may not be marketed
unless the manufacture provides FDA with scientific evidence that
the drug is both safe and effective. The regulations at 21 CFR Part
314 provide the means through which pharmaceutical manufacturers
can obtain FDA approval of a drug product marketing application,
and the means through which FDA can assure the safety and
effectiveness of the marketed products.
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.