[Federal Register Volume 61, Number 216 (Wednesday, November 6, 1996)]
[Notices]
[Pages 57445-57446]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-28529]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96N-0383]


Export Certificates; FDA Export Reform and Enhancement Act of 
1996; Certification Fees for Drugs, Animal Drugs, and Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY:  The Food and Drug Administration (FDA) is announcing the fees 
for issuing export certificates. The FDA Export Reform and Enhancement 
Act of 1996 provides that any person who exports a drug, animal drug, 
or device may request FDA to certify in writing that the exported drug, 
animal drug, or device meets certain specified requirements. It further 
provides that FDA shall issue such a certification within 20 days of 
the receipt of a request for such certification, and that FDA may 
charge up to $175 for each certification that is issued within the 20 
days. This notice describes the fee schedule for export certifications, 
the costs that form the basis for those fees, and the billing and 
collection processes. The agency requests comments on the fee schedule 
and its effects on small business.

DATES: The fees described herein for export certificates for drugs, 
animals drugs, and devices became effective October 1, 1996. Written 
comments should be submitted by February 4, 1997.

ADDRESSES: Written comments to the Dockets Management Branch (HFA-305), 
Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, 
MD 20857.

FOR FURTHER INFORMATION CONTACT: Lance S. Siegall, Office of Financial 
Management, Accounting Reports and Analysis Branch (HFA-120), Food and 
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-
1768.

SUPPLEMENTARY INFORMATION:

I. Background

    The FDA Export Reform and Enhancement Act of 1996 became law on 
April 26, 1996 (Pub. L. 104-134, amended by Pub. L. 104-180, August 6, 
1996). The principal purpose of the new law is to expedite the export 
of FDA-regulated products (both approved and unapproved) through 
amendments to sections 801(e) and 802 of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 381(e) and 382). The new law adds a 
new subsection 801(e)(4) to the act that provides that any person who 
exports a drug, animal drug, or device may request FDA to certify in 
writing that the exported drug, animal drug, or device meets the 
requirements of sections 801(e)(1) or 802 of the act, or other 
applicable requirements of the act. Upon a showing that the product 
meets the applicable requirements, the new law further provides that 
FDA shall issue such a certification within 20 days of the receipt of a 
request for such certification, and that FDA may charge up to $175 for 
each such certification that is issued within the 20 day period.
    Export certificates are issued for: Drugs, biologics, animal drugs, 
and medical devices by FDA's: Center for Drug Evaluation and Research 
(CDER), Center for Biologics Evaluation and Research (CBER), Center for 
Veterinary Medicine (CVM), and the Center for Devices and Radiological 
Health (CDRH), respectively. Although FDA's Center for Food Safety and 
Applied Nutrition (CFSAN) issues export certificates for food products 
and cosmetics, and CVM issues export certificates for feed additives, 
nonmedicated feeds, and pet foods, the export certificates for these 
products are not covered by the new law.

II. Agency Costs and Fees to be Assessed for Export Certificates

    FDA has determined the costs to the agency for preparing export 
certificates based upon the following:
    (1) Direct personnel for the research, review, tracking, writing, 
and assembly;
    (2) Purchase of equipment and supplies used for tracking, 
processing, printing, and packaging. Recovery of the cost of the 
equipment is calculated over its useful life;
    (3) Billing and collection of fees; and
    (4) Overhead and administrative support.
    These costs vary with the Center issuing the certificates, largely 
because of differences in the types of products, and the procedures 
used in evaluating the compliance status of the manufacturing site(s). 
As mentioned above, the agency may charge up to $175 for each 
certificate. Certificates for some classes of products cost the agency 
more than $175 to prepare. Subsequent certificates issued for the same 
products in response to the same request generally cost the agency less 
than $175. The fee for the second certificate for the same product(s) 
issued in response to the same request reflects the agency cost for 
preparing the second certificate plus the difference (if any) between 
the agency cost for preparing the first certificate and the $175 
maximum fee. The fee for all subsequent certificates for the same 
product(s) issued in response to the same request reflects agency costs 
for preparing those certificates only. The agency has developed the 
following fee structure, which reflects agency costs for the following 
Centers:
    (1) CBER: $175 for the first certificate; $175 for the second 
certificate for the same product(s) issued in response to the same 
request; $85 for each subsequent certificate for the same product(s) 
issued in response to the same request.
    (2) CVM: $175 for the first certificate; $155 for the second 
certificate for the same product(s) issued in response to the same 
request; $70 for each subsequent certificate for the same product(s) 
issued in response to the same request.
    (3) CDER: $175 for the first certificate; $90 for the second 
certificate with attachments for the same product(s) issued in response 
to the same request; $40 for any subsequent certificates with 
attachments for the same product(s) issued in response to the same 
request; $15 for second and subsequent

[[Page 57446]]

certificates without attachments issued for the same product(s) in 
response to the same request.
    (4) CDRH: $100 for the first certificate; $10 for any subsequent 
certificates issued for the same product(s) in response to the same 
request.
    With this fee structure, the agency estimates that it will recover 
most of its costs for preparing export certificates. However, despite 
Congress' stated intention to make this program pay for itself, the 
$175 maximum fee will likely have the effect of causing a taxpayer 
subsidy for a portion of the program. FDA may consider changing the 
fees for export certificates in the future (within the parameters 
permitted by statute) if agency costs increase or decrease. For 
example, FDA does not know whether the agency costs of issuing export 
certificates for unapproved products (which the agency will now do as a 
result of the Export Reform and Enhancement Act of 1996) will differ 
significantly from those for approved products.

III. Request for Comments

    Although the FDA Export Reform and Enhancement Act of 1996 does not 
require FDA to solicit comments on assessment and collection of fees 
for export certificates, FDA is inviting comments in order to have the 
benefit of additional views and information. FDA is particularly 
interested in receiving information about the effect of these fees on 
small businesses. The agency also would be interested in receiving 
comments on whether the fee structure should reflect cost averaging 
across all Centers that prepare export certificates under the act, so 
that the agency could fully recover preparation costs and avoid the use 
of taxpayer funds.
    Interested persons may on or before February 4, 1997, submit to the 
Dockets Management Branch (address above) written comments regarding 
this notice. Two copies of any comments are to be submitted, except 
that individuals may submit one copy. Comments are to be identified 
with the docket number found in brackets in the heading of this 
document. Received comments and a full explanation of the costs 
included and the methodology employed in determining these fees may be 
seen in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday 
through Friday.

    Dated: October 31, 1996.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 96-28529 Filed 11-5-96; 8:45 am]
BILLING CODE 4160-01-F