EXPORT CERTIFICATES FOR FDA REGULATED PRODUCTS\
UNDER U.S.C. SECTIONS 801(e) and 802

0910-0498

SUPPORTING STATEMENT

### A. 1. Circumstances That Make Information Collection Necessary

The Food and Drug Administration (FDA) is requesting approval from the
Office of Management and Budget (OMB) for the collection of information
associated with the export of products and issuance of export
certificates authorized by Section 801(e) and 802 of the Federal Food,
Drug and Cosmetic Act (the act).

In April 1996 a law entitled, "The FDA Export Reform and Enhancement Act
of 1996" amended sections 801(e) and 802 of the act (21 U.S.C. 381(e)
and 382). It was designed to ease restrictions on exportation of
unapproved pharmaceuticals, biologics, and devices regulated by FDA. FDA
issued a guidance for industry entitled, "Guidance for Industry: Exports
and Imports Under the FDA Export Reform and Enhancement Act of 1996" to
further clarify the April 1996 law. FDA's guidance for on FDA export
certificates is available at
<http://www.fda.gov/oc/guidance/frexport.html>.

Section 801(e)(4) of the act provides that persons exporting certain
FDA-regulated products may request that FDA certify that the products
meet the requirements of sections 801(e) or 802 or other requirements of
the act. The act does not require FDA to issue certificates for food,
including animal feeds, food and feed additives, and dietary
supplements, or cosmetics. However, since foreign governments may
require certificates for these types of products, the agency intends to
continue to provide this service as resources permit.

Section 801(e)(4) of the act also provides that FDA may charge a fee of
up to \$175 if FDA issues a certificate within 20 days of receipt of a
complete request for such a certificate. This fee may vary depending on
the product type, but it will not exceed \$175.

**2. Purpose of Information Collection**

The purpose of collecting the information is to ensure that the firm
will be exporting the products according to sections of the act (e.g.
the firm is registered and the product(s) are listed or the device(s)
are cleared for marketing for certificates to foreign governments only).
Also, foreign countries put the responsibility on the FDA to ensure that
the applicable statutes are met. Finally, the failure by FDA to ensure
that exported products are reasonably safe and effective would have a
negative effect on the export market.

The information collected is to reduce the processing time for
certificates to less than the 20 days as required by the statute.
Without the requested information, FDA staff would need to search
several databases covering many years of pre-market clearance and
inspectional data. With the requested information, staff can focus
immediately its data search to verify its authenticity. Any suspected
case of fraud will be referred to FDA\'s Office of Criminal
Investigations for follow up.

FDA issues six different types of certificates, each containing specific
information about a product's regulatory or marketing status.

  ------------------ -------- ------------------------ -------------------
  Certificate Name   Form FDA Use                      Issuing FDA Center

  Certificate to     3613     For the export of        Center for Biologic
  Foreign Government          products that can be     Evaluation and
                              legally marketed in the  Research (CBER);
                              United States.           Center for Devices
                                                       and Radiological
                                                       Health (CDRH);
                                                       Center for
                                                       Veterinary Medicine
                                                       (CVM)

  Certificate of     3613a    For the export of        CBER; CDRH; CVM
  Exportability               products that cannot be  
                              legally marketed in the  
                              United States but meet   
                              the requirements of      
                              sections 801(e) or 802   
                              of the act and may be    
                              legally exported.        

  Certificate of a   3613b    For use by the importing CBER; Center for
  Pharmaceutical              country when considering Drug Evaluation and
  Product                     whether to license the   Research (CDER);
                              product in question for  CVM
                              sale in that country.    
                              Conforms to the format   
                              established by the World 
                              Health Organization.     

  Non-Clinical       3613c    For the export of        CBER; CDRH
  Research Use Only           non-clinical research    
  Certificate                 use only product,        
                              material, component that 
                              is not intended for      
                              human use which may be   
                              marketed in, and legally 
                              exported from the United 
                              States under the act.    

  Office of          3613d    For cosmetic products    Center for Food
  Cosmetics and               that may be legally      Safety and Applied
  Colors                      marketed in the United   Nutrition (CFSAN)
  "Certificate"               States.                  
  (Exports)                                            
  Application                                          

  Food Export        3613e    For food products and    CFSAN
  Certificate                 dietary supplements that 
  Application                 may be legally marketed  
                              in the United States.    
  ------------------ -------- ------------------------ -------------------

FDA has relied on and will continue to rely on information provided by
manufacturers for all types of certificates. Manufacturers are requested
to state that they be in compliance with all applicable requirements of
the Act, not only at the time that they submit their request to the
appropriate center but also at the time that they submit the
certification to the foreign government.

FDA will check all information submitted by firms in support of their
certificates and any suspected case of fraud will be referred to FDA\'s
Office of Criminal Investigations for follow up. Firms making or
submitting false statements on any documents submitted to FDA may be
violating the United States Code Title 18, Chapter 47, Section 1001 and
be subject to penalties including up to \$250,000 in fines and up to 5
years imprisonment.

**3. Use of Improved Information Technology**

FDA is seeking continuously ways to reduce burdens through advances in
information technology.

There are no technical or legal obstacles to the use of improved
information technology to reduce the burden of reporting the
information.

4\. Efforts to Identify Duplication and Availability of Similar
Information

FDA knows of no similar data gathered or maintained by any State or
Federal agencies or other sources.

5\. Small Business Considerations

FDA believes that its duty requires the equal application of the
regulations to all enterprises. While FDA does not believe it can apply
different standards with respect to statutory requirements, the Agency
does provide special help to small businesses. A small business
coordinator is available within each FDA Center and most FDA district
offices. This coordinator is available to provide small businesses with
help in dealing with FDA regulatory requirements, to ensure that they
have an adequate opportunity to express their concerns and to keep FDA
management apprised of how regulatory decisions might impact the small
business community.

6.  **Consequences of Less Frequent Information Collection**

Less frequent collection of this information would impact negatively
upon FDA\'s ability to assure that applicable statutes are being
followed before products are exported. Many foreign countries will
accept FDA regulated products manufactured in the United States only
because they have faith in the integrity of FDA export certificates
based on current information. Collecting less information would have a
negative impact on the marketability of products in foreign countries.

FDA would also have to resort to using previous certificate procedures
where little information was collected from the firms to verify product
and registration information through FDA databases. This, however, would
increase greatly the amount of time for FDA to process the certificates
and was found unacceptable by industry.

7\. Special Circumstances That Require Departures from 5 CFR 1320.5

This information collection is consistent with the guidelines prescribed
in 5 CFR 1320.5.

8\. Efforts to Consult with Non‑Agency Personnel

In the FEDERAL REGISTER of June 21, 2005, (70 FR 35678) (Attachment E)
FDA invited public comment on the proposed information collection to
which three comments were received. Two comments did not pertain to the
information collection requirements.

One commenter suggested that extending the "Certificate to Foreign
Government" two-year expiration date to three, four or five years would
reduce their financial burden. The export certificate expiration date is
based on the agency inspection schedule. At this time FDA is not
considering reevaluating the inspection schedule.

9.  **Payment or Gifts**

FDA did not provide any payment or gift to respondents.

10. Assurances of Confidentiality

These provisions do not permit disclosure of information that is made
trade secret or commercial confidential unless that information has been
previously disclosed or is permitted under the Federal Freedom of
Information Act.

11\. Additional Assurances of Privacy

No questions of a private or sensitive nature are asked.

12. **Estimates of the Burden Collection**

Based on consultation with a few respondents the average time to prepare
a certification request is one hour. Some firms send in requests as
often as 3 or 4 times a month while others may submit only periodic
requests.

FDA estimates that the annual salary cost to respondents is \$611,866
(13,287 hours x \$46.05). This hourly figure is estimated using the
annual estimated salary of \$96,100.

The estimate of burden for this collection of information is shown in
the following tables

Table 1 - ESTIMATED ANNUAL REPORTING BURDEN

+----------------+-----------+-----------+----------+--------+--------+
| FDA Center     | No. of    | Annual    | Total    | Hours  | ##     |
|                | Re        | Frequency | Annual   | per    |  Total |
|                | spondents | Per       | R        |        |        |
|                |           | Response  | esponses | Re     | Hours  |
|                |           |           |          | sponse |        |
+----------------+-----------+-----------+----------+--------+--------+
| ## CBER        | 1,501     | 1         | 1,501    | 1      | 1,501  |
+----------------+-----------+-----------+----------+--------+--------+
| CDER           | 4,803     | 1         | 4,803    | 1      | 4,803  |
+----------------+-----------+-----------+----------+--------+--------+
| CDRH           | 5,674     | 1         | 5,674    | 2\*    | 11,348 |
+----------------+-----------+-----------+----------+--------+--------+
| CFSAN, Office  | 730       | 1         | 730      | 1      | 730    |
| of Cosmetics   |           |           |          |        |        |
| and Colors     |           |           |          |        |        |
+----------------+-----------+-----------+----------+--------+--------+
| CFSAN, Office  | 181       | 1         | 181      | 1.5    | 271.5  |
| of Plant and   |           |           |          |        |        |
| Dairy Foods    |           |           |          |        |        |
+----------------+-----------+-----------+----------+--------+--------+
| CFSAN, office  | 660       | 1         | 660      | 1.5    | 990    |
| of Nutritional |           |           |          |        |        |
| Products,      |           |           |          |        |        |
| Labeling and   |           |           |          |        |        |
| Dietary        |           |           |          |        |        |
| Supplements    |           |           |          |        |        |
+----------------+-----------+-----------+----------+--------+--------+
| CVM            | 664       | 1         | 664      | 1      | 664    |
+----------------+-----------+-----------+----------+--------+--------+
| ## Total       |           |           |          |        | 21,170 |
+----------------+-----------+-----------+----------+--------+--------+

There are no capital costs or operating and maintenance costs associated
with this collection of information.

\* Based on Center policy of allowing multiple devices to appear on one
certificate.

**13. Cost to Respondents**

In addition to the costs to respondents mentioned above, Section
801(e)(4)(B) authorizes FDA to charge firms for export certificates at
the rate of \$175 for original certificates. Each center has its own fee
structure based on resource requirements. The fees range from \$100 for
each original certificate and \$10 for copy (CDRH) to \$175 for each
original certificate, \$175 for a duplicate original, and \$85 for each
subsequent duplicate (CBER). CVM charges \$175 for an original, \$155
for the first copy, and \$75 for each additional copy.

#### Costs for Certificate by Center

+-----------------+-----------------+-----------------+-----------------+
| #               | **Original**    | **Duplicate     | **Additional    |
| ### FDA Centers |                 | Original**      | Copies**        |
+-----------------+-----------------+-----------------+-----------------+
| ## CBER         | \$175           | \$175           | \$85            |
+-----------------+-----------------+-----------------+-----------------+
| **CDER**        | \$175           | \$90            | \$40            |
+-----------------+-----------------+-----------------+-----------------+
| **CDRH**        | \$100           | \$10            | \$10            |
+-----------------+-----------------+-----------------+-----------------+
| **CVM**         | \$175           | \$155           | \$75            |
+-----------------+-----------------+-----------------+-----------------+

In FY 2004, approximately 2,400 original certificate requests were
received from industry for which FDA charges \$375,000 and approximately
8,300 additional certificate requests were received for which FDA
charges \$435,750. The total additional cost burden to industry for FY
2004 was \$810,750.

**14. Cost to the Federal Government**

In FY 2004, FDA expended the time of 6 technicians, consumer safety
officers, or managers (ranging from GS-4 to GS-15) on the processing of
export certificates. FDA estimates that the annual salary to the agency
is \$381,920. (13,640 hours x \$28). This hourly figure is estimated
using the annual estimated salary of \$57,715. In addition, \$45,000 was
expended for supplies, copying and other necessities. The total cost to
FDA for FY 2004 was \$423,500 for processing export certificates.

15. Reason for Changes in Burden

The total annual burden increase is due to the increased number of
requests for export certificates.

16\. Plans for Statistical Use

The information collected will not be used for statistical purposes.

17\. Approval for Not Displaying Expiration Date

The FDA is not requesting a waiver for displaying the OMB expiration
date.

18\. Exception to the Certification Statement; Item 19, OMB Form 83‑I

FDA is not requesting an exception to the certification statement
identified in Item 19 \"Certification for Paperwork Reduction Act
Submissions\" of OMB Form 83‑I.

B.  **B. Collection of Information Employing Statistical Methods**

There are no statistical methods being employed in this collection of
information.