This information
collection is approved for three months. The collection of
information was improperly submitted under section 3504( of the
Paperwork Reduction Act which states that "as soon as practicab but
no later than publication of a notice of proposed rulemaking in th
Federal Register, each agency shall forward to the director a copy
of any proposed rule which contains a collection of information
require- ment..." FDA submitted this information collection ten
months after t proposed rule was published in the Federal Register.
FDA shall provid upon resubmission for OMB clearance, a summary of
any comments related to the burden of the information collection
requirements contained in the proposed rule.
Inventory as of this Action
Requested
Previously Approved
04/30/1993
04/30/1993
09/30/1993
1
0
1,387
1
0
336,493
0
0
0
FOOD AND DRUG, DRUG RESIDUES, ANIMAL
DRUGS, MEDICATED FEEDS, LABELING APPLICANTS PROPOSING TO MARKET
ANIMAL DRUGS MUST DETAIL (1) THE SCIENTIFIC AND TECHNICAL
INFORMATION REQUIRED FOR THE PHYSICAL MANUFACTURE OF THE DRUG
PRODUCT AND (2) SCIENTIFIC INFORMATION RELATIV TO THE SAFETY AND
EFFECTIVENESS OF THE DRUG USE.
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.