FDA will use the information to
determine whether an exporter has complied with the export
requirements in the FFDC Act and the PHS Act and, in situations
where FDA is required by law to notify an appropriate health
official in a foreign country, to determine where a product was
exported so that the agency can provide notice to the foreign
country.
The estimated total annual
hourly burden for this collection of information is expected to be
186,531 hours, which is an increase of 147,411 hours from the
currently OMB approved burden (from 39,120 hours to 186,531). There
are several reasons for this increase in hours: a. Reporting
Burden: The number of respondents is expected to decrease from 400
to 73 based on the actual number of export notification reports
received over the past three years. However, although number of
entities reporting is expected to decrease, the average number of
responses for each of the three respective Centers is expected to
increase significantly (from 3 to 193 for CBER, 3 to 180 for CDER,
and 3 to 130 for CDRH), resulting in an increase of 132,825 hours
(from 18,000 OMB currently approved burden hours to 150,825
projected burden hours). The expected increase in the number of
responses per respondent is also based on the actual number of
export notification reports received over the past three years. b.
Recordkeeping Burden. Recordkeeping burden is expected to increase
by 14,586 hours, from 21,120 to 35,706 hours due to the addition of
reporting requirements in section 1.101(b) for the Office of
International Programs (4,158 hour increase) and the Center for
Tobacco Products (10,428 hour increase.) CTP's tobacco product
recordkeeping requirements under § 1.101(b) from OMB Information
collection 0910-0690 resulted in CTP's hourly burden increase of
10,428 recordkeeping hours. Once the renewal of this collection of
information has been approved by OMB, the information collection
under OMB No. 0910-0690 will be discontinued.
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.
SUPPORTING STATEMEN FINAL 10-15-14.doc
Non-Tobacco - 1.101(d) -- CBER