SUPPORTING STATEMENT FOR

Importer\' s Entry Notice

OMB No.0910-0046

Section A -Justification

1\. [Circumstances Necessitating Information Collection]{.underline}

Section 801 of the Food, Drug, and Cosmetic Act (the act) charges the
Secretary of Health and Human Services (HHS), through the Food and Drug
Administration (FDA), with the responsibility of assuring foreign origin
FDA regulated foods, drugs, cosmetics, medical devices, and radiological
health products offered for import into the United States meet the same
requirements of the FD&C Act as do domestic products, and for preventing
products from entering the country if they are not in compliance. The
discharge of this responsibility involves close coordination and
cooperation between FDA (headquarters and field inspectional personnel)
and the U.S. Customs Service (USCS), as the USCS is responsible for
enforcing the revenue laws covering the very same products.

Up until October 1995, entry information of interest to FDA was required
to be provided by importers filing manual entry(ies) an OMB-approved FDA
Form 700 set, Importer\'s Entry Notice, which included FDA Forms
701,702, and 703, and which were accompanied by related documents, e.g.,
invoices, Custom\'s Forms 3461 or 3461/Alt, certificates of affirmation
of compliance, etc. Information provided by the 700 set included country
of origin, name of the importing vessel, entry number (assigned by
USCS), port of entry, the port of lading and unlading, value in U. S.
dollars, shipper or manufacturer, importer of record, original
consignee, broker, broker\'s reference number and Custom\'s house box
number, bill of lading number, location of goods, etc.

FDA made a decision to eliminate use o f the FDA 700 set, effective no
later than FY 1996

(October 1, 1995), for several reasons, e.g., to reduce the paperwork
burden both on the import community and FDA, to eliminate duplicity of
information, and, most important, FDA developed and implemented
nationwide an automated entry processing system, which enables FDA to
more efficiently obtain and process the information it requires to
fulfill its regulatory responsibility.

Most of the information FDA requires to carry out its regulatory
responsibilities is already, provided electronically by filers to
Customs. Because Customs relays this data to FDA using an electronic
interface, the majority of data submitted by the entry filer need be
done only once.

In order to make an admissibility decision for each entry, FDA needs
four additional pieces of information that are not available from
Custom\'s system. These data elements are the FDA Product Code, FDA
country of production, manufacturer/shipper, and ultimate consignee. It
is the \"automated" collection of these four data elements for which OMB
approval is requested. FDA construes this request as an extension of the
prior approval of collection of this data via a different media, i.e.,
paper. There are additional data elements which filers can provide to
FDA along with other entry-related information which, by doing so, may
result in their receiving an FDA admissibility decision more
expeditiously, e.g., the quantity, value, and Affirmation(s) of
Compliance with Indicator(s).

2\. [How, by whom, -Purpose of Collection]{.underline}

At each U.S. port of entry (seaport, landport, and airport) where
foreign-origin FDA-regulated products are offered for import, FDA is
notified, through Custom\'s Automated Commercial System (ACS) by the
importer (or his agent) of the arrival of each entry. Following such
notification FDA reviews relevant data to ensure the imported product
meets the standards as are required for domestic products, makes an
admissibility decision, and informs the importer and USCS of its
decision. A single entry frequently contains multiple lines of different
products. FDA may authorize specific lines to enter the U.S. unimpeded,
while others in the same entry are to be held pending further FDA
review/action.

An important feature programmed into the automated system all entry data
to pass through a screening criteria program resident on Custom\'s
computer. Even through this screening module resides on Custom\'s
computer, it was developed and is maintained by FDA. FDA\'s electronic
screening criteria module makes the initial screening decision on every
entry of foreign-origin FDA-regulated product. Virtually instantaneously
after the entry is filed, the filer receives FDA\'s admissibility
decision covering each entry, i.e., "MAY PROCEED" or "FDA REVIEW. \"

Examples of FDA\'s need to further review an entry are products
originating from a specific country or manufacturer are known to have a
history of problems, FDA has no previous knowledge of the foreign
manufacturer and/or product, an import alert has been issued, etc. The
system assists FDA entry reviewers by notifying them of information,
such as the issuance of import alerts, thus averting the chance that
such information will be missed.

With the inception of the Custom\'s automated system (ACS), FDA\'s
electronic screening criteria program is applied nationwide. This
virtually eliminates problems such as \"port shopping,\" e.g., attempts
to intentionally slip products through one FDA port when refused by
another, or to file entries at a port known to receive a high volume of
entries. Every electronically submitted entry line of foreign-origin
FDA-regulated product undergoes automated screening described above. The
screening criteria can be set to be as specific or as broad as
applicable; changes are virtually immediately effective. This capability
is of tremendous value in protecting the public in the event there is a
need to immediately halt specific product from entering this U.S.

3\. [Consideration Given to Information Technology]{.underline}

One new data element required by FDA (the FDA product code) necessitated
FDA to provide nationwide training to all filers to instruct them how to
build an FDA product code. At the training course, FDA provided the
filers a diskette containing the \"FDA Product Code Builder\"
software/files and authorized them to make copies as necessary. FDA
designed the software so the Product Code Builder filers can be updated
electronically. Filers (and FDA personnel) simply download
new/revised/deleted data. The automated Product Code Builder program has
replaced the hardcopy manual which [required as many as 10,000 copies
and updates to be developed and distributed.]{.underline} The hardcopy
manual is no longer updated. [(This represents another very significant
reduction in paper and resources, both in the private and public
sector.)]{.underline}

Another important benefit of the automation of the manual system is the
intelligence gained (and used) as the database expands. This automated
system is an excellent tool in assisting FDA to more effectively and
efficiently manage and conduct its import operations and to better meet
its regulatory responsibility.

The automated system is also of great value to the FDA personnel
responsible for planning and delegating import work, e.g., what products
are coming into which ports, in what quantities, manufactured by whom,
coming from what country, etc. FDA previously relied on information
obtained from Census and Customs records which could be up to several
years old.

4\. [Identification of Information]{.underline}

The information for which FDA requests OMB approval is unique to the FDA
and is not duplicated by any other government agency.

5\. [Small Businesses]{.underline}

The information provided by filers is voluntary and does not impose any
undue burden on small businesses. If needed, filers can obtain
assistance from their local FDA district. Since the implementation of
the automates system FDA maintains \"help desks\" to resolve filer
questions/problems.

6\. [Less Frequent Information Collection]{.underline}

If the information is submitted on a less frequent basis, or is
eliminated, FDA could not adequately meet its statutory responsibilities
to regulate imported products, nor control potentially dangerous
products from entering the U.S. marketplace. In turn, this would have an
adverse effect on the American population, who is the final purchaser
and consumer of these products. Additionally, to revert back to a manual
process would greatly reduce the speed filers now receive (and have
become accustomed) FDA \'s admissibility decisions via the automated
system. This would be very disadvantageous to importers, for whom speedy
clearance saves them demurrage and other significant cost incurred when
shipments are delayed for regulatory review.

7 [.Special Information Collection Circumstances]{.underline}

With regards to record retention, Customs regulation 19 CFR 162.1(c)
requires filers to retain all entry documents for five years after the
date of entry.

FDA conducts filer evaluations to make certain accurate information is
being transmitted by filers. This is accomplished be comparing filers\'
paper records to data FDA received electronically.

FDA\'s OASIS automated import entry records are to be retained 10
years\--one grow year and three full fiscal years are to be kept
actively on-line, and the previous six years data are kept on an
archived medium (disk, CD, or tape). Other related FDA automated records
and paper documents are to be retained and disposed of in accordance
with instructions set forth in the FDA Staff Manual Guide, Records
Management, dated February 1, 1995, and Appendix B-331 of the FDA
Records Control Schedule, pages 1-103, dated December 31, 1989, and
Appendix B-331 of the FDA Control Schedule, pages 100-120, dated March
21, 1986. The retention time for these records vary according to their
category.

8\. [Outside Consultation]{.underline}

In the the **Federal Register** dated May 23, 2003, (68 FR 28235), FDA
published a 60 day notice requesting comments on the information
collection requirements. No comments were received regarding that
Notice.

FDA continues to communicate routinely with the National Customs Brokers
and Forwarders

Association of America (NCBFAA), the major trade association of firms
who file import entries and provide required data to FDA. Members have
and continue to express their approval of FDA\'s automated entry
process. The principal contact for the NCBFAA can be reached at (415)
904-8334, who as Chairman of the Regulatory Agency Committee, represents
the interest of all members/brokers in FDA matters.

FDA field personnel maintain frequent contact with their local filer
firms, either by phone or by meetings, to keep the import community
up-to-date with regard to import policy and procedures. FDA also
conducts one-on-one meetings with individual filer firms to provide
instruction on transmitting entry data accurately and successfully. In
addition, FDA field personnel are in frequent contact with their local
Customs client representatives.

9\. [Payment or Gift.]{.underline}

No payment or gift was provided to respondents

10\. [Confidentiality Provisions]{.underline}

No assurance of confidentiality has been provided except as generally
considered in review

guidelines in 21 CFR 2O.61.

11\. [Privacy]{.underline}

There were no questions asked of a sensitive nature.

12\. [Burden of Information Collection]{.underline}

The hour burden in the Federal Register Notice is a result of averaging
and extrapolating data obtained during FDA\'s survey of nine {9)
representative filers nationwide. For purposes of comparison of hour
burden, the filers also were requested to and provided the same
information with regard to filing entries manually.

Based on the extrapolation of data collected by FDA \'s survey of nine
(9) filers, the total annual burden to the import community to submit
information electronically for 3,037,426 ( average for calendar year
1996) separate entries is 229, 693 hours; this figure includes the time
it takes filers to compile and provide documents to FDA for those
entries where FDA cannot make an admissibility decision based on the
electronic data alone.

For comparison purposes, using data provided by surveying the same nine
(9) filers, if 3,037,426 entries were submitted via a manual,
non-automated system, as was done in the past, the annual hour burden
would be 473,838 hours, virtually twice the burden of the automated
system.

The nine filers surveyed advised there were no additional costs to
provide import data electronically to FDA, as they already had
equipment/software in place to enable them to provide data to Customs
via the automated broker interface. Based on the survey and our
knowledge on the matter, no additional software/hardware need be
developed/purchased to enable filers to file the FDA data elements at
the same time they file entries electronically with Customs.

FDA estimates the burden of this collection of information as follows:

+-------------+-------------+-------------+-------------+-------------+
| Estimated   |             |             |             |             |
| FY2003      |             |             |             |             |
| Annual      |             |             |             |             |
| Reporting   |             |             |             |             |
| Burden      |             |             |             |             |
+-------------+-------------+-------------+-------------+-------------+
| No.         | Annual      | Total       | Hours Per   | Toral Hours |
| Respondents | Frequency   | Annual      |             |             |
|             |             |             | Response    |             |
|             | Per         | Responses   |             |             |
|             | Response    |             |             |             |
+-------------+-------------+-------------+-------------+-------------+
| 3406        | 652         | 2,955,595   | .14 hr      | 413,833     |
+-------------+-------------+-------------+-------------+-------------+

\`\`\`The above numbers for \'\'Total Annual Responses\" have been
adjusted to eliminate disclaimed entries. Disclaimed entries are not FDA
commodities.

The number of respondents is a count of filers who submit entry data for
foreign-origin FDA- regulated products. The estimated reporting burden
is based on information obtained by FDA contacting several potential
respondents.

FDA anticipates an increase on entries of approximately 10% per year.

The information dealing with total estimated annual Reporting burden to
the import community will remain the same. The basic processes and
procedures used in FY95 have remained the same as those used today. The
exception is that the total number of entries has increased. The total
number of entries submitted to the Automated system in FY99 were
5,077,493. The total number of entries less the disclaimed entries
represent the total FDA Products entered into the automated system. A
total of 51% of all entries into the automated system were entries
dealing with FDA regulated products.

Due to the intricacies of building a seven-digit product code comprised
of five parts, FDA made attendance at product code training course a
prerequisite to filers participating in FDA\'s automated entry process.
This course has been held nationwide, and is conducted as the need
arises, e.g., filers who choose to begin participating in the automated
filing program, as new filer firms are established, as a result of filer
personnel changes, etc., FDA prepares announcements of upcoming courses,
which Customs issues at our request via their automated broker
interface.

Filers from one state have been known to travel to another to attend the
course.

13\. [Cost to Respondent Resulting from the Collection of
Information]{.underline}

None

14\. [Annualized Cost to \"FDA]{.underline}

Salary of the FDA entry reviewer varies, however, the average salary is
estimated to be GS-10 at an annual base of \$39,115. It is estimated
that 48.7 Full Time Equivalents (FTEs) are required to review the
importers entry notice. Therefore, the cost for salaries is \$1,904,900
per year (\$39,115 salary x\'s 48.7 FTE\'s).

The FTE number was calculated based on information obtained from
approximately nine (9) FDA district import entry reviewers. The entry
reviewers were asked to factor in their estimate of the time it takes to
review an entry once it becomes available until they complete their
decision to either request and review additional documents, request and
send samples to the lab for analysis, to issue a May Proceed, or forward
the entry line to the district\'s Office of Compliance for further
review/action. The entry reviewers estimated average is five (5) minutes
per FDA Review line. To determine the annual FTE, the number of FDA
Review lines per district for calendar year 1996 (1,217,448) was
multiplied by 5 minutes per line, divided by 60, divided by 2080
hours/FTE, for a total of 48.7 FTE per year. The same time frames are
still current today.

15\. [Explanation for Change.]{.underline}

Due to the increase in entries of approximately 10% per year, the burden
for this collection of information has increased, Approximately 95% of
all entries filed with FDA are now paperless due to the automated
system\--[a tremendous reduction of paper, nationwide.]{.underline}

16\. [Statistical Reporting.]{.underline}

No tabulation of the data is planned or anticipated.

17 [.Display of OMB Approval Date]{.underline}

The agency is not seeking to display the expiration date for OMB
approval of the information

collection

18\. [Exceptions to "Certification for Paperwork Reduction Act
Submissions"]{.underline}

There are no exceptions to the certification statement identified in
Item 19, \"Certification for

Paperwork Reduction Act Submission,\" of 0MB Form 83-I.