The information collection supports
FDA regulations at 21 CFR 1.101 and pertains to the notifications
and records required for human drug, biological product, device,
animal drug, food, cosmetic, and tobacco product exports under
sections 801 or 802 of the Federal Food, Drug, and Cosmetic Act or
(21 U.S.C. 381 and 382) or section 351 of the Public Health Service
Act (42 U.S.C. 262).
The information collection
reflects adjustments in our estimated burden. Cumulatively these
adjustments result in an overall reduction to the information
collection by 8,604 annual responses and 129,543 burden hours.
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.