[Federal Register Volume 64, Number 63 (Friday, April 2, 1999)]
[Proposed Rules]
[Pages 15944-15948]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-8159]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1

[Docket No. 98N-0583]
RIN 0910-AB16


Exports: Notification and Recordkeeping Requirements

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing new 
regulations that would establish the notification and recordkeeping 
requirements for persons exporting human drugs, biologics, devices, 
animal drugs, food, and cosmetics that may not be marketed or sold in 
the United States. These regulations would implement recent changes in 
the statutory requirements applicable to certain exports, and would 
also codify recordkeeping requirements for exports of products that 
cannot be marketed or sold in the United States generally.

DATES: Submit written comments by June 16, 1999. Submit written 
comments on the information collection requirements by May 3, 1999.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. Submit written comments on the information 
collection requirements to the Office of Information and Regulatory 
Affairs, OMB, New Executive Office Bldg., 725 17th St. NW., rm. 10235, 
Washington, DC 20502, Attn: Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Philip L. Chao, Office of Policy (HF-
23), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 
20857, 301-827-3380.

SUPPLEMENTARY INFORMATION:

 I. Introduction

    Enacted and later amended in 1996, the FDA Export Reform and 
Enhancement Act (Pub. L. 104-134, as amended by Pub. L. 104-180) 
significantly changed the export requirements for unapproved human 
drugs, biologics, devices, and animal drugs. For example, before the 
law was enacted, most exports of unapproved new drug products could 
only be made to the 21 countries then identified in section 802 of the 
Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 382), and 
these exports were subject to numerous restrictions. The FDA Export 
Reform and Enhancement Act amended section 802 of the act to allow, 
among other things, the export of unapproved new human drugs to any 
country in the world if the drug complies with the laws of the 
importing country and has valid marketing authorization from any of the 
following countries: Australia, Canada, Israel, Japan, New Zealand, 
Switzerland, South Africa, and the countries in the European Union (EU) 
and the European Economic Area (EEA) and certain other requirements are 
met (see section 802(b)(1)(A) of the act). Currently, the EU countries 
are Austria, Belgium, Denmark, Germany, Greece, Finland, France, 
Ireland, Italy, Luxembourg, the Netherlands, Portugal, Spain, Sweden, 
and the United Kingdom. The EEA countries are the EU countries, 
Iceland, Liechtenstein, and Norway. The list of countries will expand 
automatically if any country accedes to the EU or becomes a member of 
the EEA. This provision of section 802 of the act also applies to the 
export of certain devices that cannot be sold or marketed in the United 
States.
    The FDA Export Reform and Enhancement Act also modified the export 
authority in section 801 of the act (21 U.S.C. 381). Before enactment 
of the FDA Export Reform and Enhancement Act, section 801(e)(1) of the 
act applied to the exportation of certain foods, drugs, devices, and 
cosmetics. Products exported under section 801(e) of the act are not 
considered adulterated or misbranded if the product intended for 
export: (1) Meets the foreign purchaser's specifications, (2) is not in 
conflict with the laws of the country to which it is being exported, 
(3) is labeled on the outside of the shipping package that the product 
is intended for export, and (4) is not sold or offered for sale in 
domestic commerce (see section 801(e)(1) of the act). Additional 
requirements apply to certain devices (see section 801(e)(2) of the 
act). The FDA Export Reform and Enhancement Act extended these four 
basic requirements to all exports under sections 801 and 802 of the 
act, and to exports of partially processed biologics under section 
351(h) of the Public Health Service Act (the PHS Act) (see section 
801(e) and (f) of the act); section 802(f)(3) of the act; and section 
351(h) of the PHS Act (42 U.S.C. 262(h))), and made section 801(e) of 
the act the principal export authority for the exportation of 
unapproved animal drugs other than animal drugs banned in the United 
States. It also imposed additional labeling requirements on certain 
exports of approved drugs (see section 801(f) of the act).
    The FDA Export Reform and Enhancement Act also established 
recordkeeping and notification requirements. Products exported under 
section 802 of the act are subject to certain requirements under 
section 802(f) and (g) of the act. Section 802(f) of the act prohibits 
a drug or device from being exported under section 802 of the act if 
it: (1) Does not conform with current good manufacturing practices, (2) 
is adulterated under certain provisions in section 501 of the act (21 
U.S.C. 351), (3) does not comply with section 801(e)(1) of the act, (4) 
is the subject of a determination by FDA or the United States 
Department of Agriculture (with respect to veterinary biologics) that 
the probability of reimportation of the exported drug or device would 
present an imminent hazard to the public health and safety of the 
United States, (5) would present an imminent hazard to the public 
health of the foreign country, (6) fails to comply with labeling 
requirements in the country receiving the exported drug or device, or 
(7) is not promoted in accordance with labeling requirements.
    Section 802(g) of the act requires an exporter of a drug or device 
under section 802(b)(1)(A) of the act to provide a ``simple 
notification'' to the agency ``identifying the drug or device when the 
exporter first begins to export such drug or device'' to any of the 25 
countries identified in section 802(b)(1)(A) of the act. For exports to 
other, nonlisted countries, section 802(g) of the act requires the 
exporter to provide a simple notification ``identifying the drug or 
device and the country to which such drug or device is being 
exported.'' This section also requires persons export under any 
provision of section 802 of the act to ``maintain records of all drugs 
or devices exported and the countries to which they were exported.''

 II. Description of the Proposed Rule

    The proposed rule would amend 21 CFR part 1 to create a new 
Sec. 1.101 entitled ``Notification and recordkeeping.''
    Proposed Sec. 1.101(a) would describe the provision's scope as 
covering notifications and records required for human drug, biologic, 
device, animal drug, food, and cosmetic exports under

[[Page 15945]]

sections 801 or 802 of the act or section 351 of the PHS Act. In 
general, the export provisions in sections 801 and 802 of the act and 
section 351 of the PHS Act apply to persons exporting unapproved or 
otherwise violative products, products approved in the United States 
that will be used for unapproved uses in the foreign country, and 
partially processed biologics. Products that meet all applicable 
requirements of the act or the PHS Act for marketing and sale in the 
United States and are exported for the same approved indications are 
not subject to the export restrictions in sections 801 and 802 of the 
act and section 351 of the PHS Act.
    Proposed Sec. 1.101(b) would establish the recordkeeping 
requirements for human drugs, biologics, devices, animal drugs, foods, 
and cosmetics exported under or subject to section 801(e)(1) of the 
act. These recordkeeping requirements are intended to facilitate an 
evaluation of whether a person has complied with section 801(e)(1) of 
the act, and would apply to all products exported under sections 801 or 
802 of the act. For example, to demonstrate that the exported product 
meets the foreign purchaser's specifications, proposed Sec. 1.101(b)(1) 
would require records describing or listing the product specifications 
requested by the foreign purchaser, including details about the product 
(e.g., dosage strength, dosage form, purity, quality, operating 
parameters, composition, etc.) and any manufacturing specifications 
requested by the foreign purchaser (e.g., type of sterilization process 
to be used, compliance with a particular manufacturing standard, etc.). 
Proposed Sec. 1.101(b)(2) would require the exporter to maintain 
documentation that demonstrates that the exported product does not 
conflict with the importing country's laws, such as a letter from the 
appropriate foreign government agency, department, or other authorized 
body stating that the product has marketing approval from the foreign 
government or does not conflict with that country's laws. The proposal 
would not consider letters or other documents from nongovernmental 
bodies or persons, such as company officials or attorneys in the 
foreign country, to be satisfactory for this purpose. Proposed 
Sec. 1.101(b)(3) would require the records to include copies of any 
labels or labeling statements that are placed on the shipping packages 
that show that the packages are intended for export. Statements such as 
``For export only'' may be sufficient for this purpose. Proposed 
Sec. 1.101(b)(4) would require records showing that the product is not 
sold or offered for sale in the United States; these records could 
pertain to the product, its labeling, and similar products sold in the 
United States. Proposed Sec. 1.101(b) would require the records to be 
maintained for at least 5 years from the date of exportation, and would 
require that the records be made available to FDA, upon request, during 
an inspection for review and copying.
    Proposed Sec. 1.101(c) would establish recordkeeping requirements, 
in addition to those required under proposed Sec. 1.101(b), for 
partially processed biologics exported under section 351(h) of the PHS 
Act. Proposed Sec. 1.101(c)(1) would require persons exporting a 
partially processed biologic under section 351(h) of the PHS Act to 
maintain records demonstrating that the product for export is a 
partially processed biological product, that is, ``not in a form 
applicable to the prevention, treatment, or cure of disease or injuries 
of man.'' This may consist of evidence showing the product's need for 
inactivation, fractionation, purification, or significant chemical 
modification before it can be used in the formulation of a final 
finished product for use outside the United States. Proposed 
Sec. 1.101(c)(2) would require records to demonstrate that the product 
was manufactured in conformity with applicable good manufacturing 
practice requirements. Such records could include manufacturing records 
that allow the partially processed biological product to be traced from 
the assignment of a batch or lot numbering system at the U.S. firm, 
temperature stability data for the product during conditions of 
transit, and records of periodic checks of the capacity of shipping 
containers. Proposed Sec. 1.101(c)(3) would require distribution 
records of the exported partially processed biologics, while proposed 
Sec. 1.101(c)(4) would require copies of all labeling that accompanies 
the partially processed biological product for export, such as a 
container label with the statement, ``Caution: For Further 
Manufacturing Use Only,'' and any package insert. As in the case of 
records under proposed Sec. 1.101(b), proposed Sec. 1.101(c) would 
require these records to be maintained for at least 5 years from the 
date of exportation and that the records be made available to FDA, upon 
request, during an inspection for review and copying.
    Proposed Sec. 1.101(d) would establish the notification 
requirements for drugs, biologics, and devices exported under section 
802 of the act. In brief, proposed Sec. 1.101(d)(1) would require 
exporters to provide written notification to the agency that identifies 
the article's name, identifies its generic name if the article is a 
drug or the article's type if the product is a device, describes the 
product's strength and dosage form (if the product is a drug or 
biologic) or the product's model number (if the product is a device), 
and identifies the country that is to receive the exported article. 
Proposed Sec. 1.101(d)(2) would list the addresses to which the 
notifications should be sent. However, these notification requirements 
would not apply to investigational drugs or devices exported under 
section 802(c) of the act. FDA published a final rule regarding 
investigational device exports in the Federal Register of May 13, 1997 
(62 FR 26228).
    The proposed rule would require persons exporting a product in 
anticipation of market authorization in a list country under section 
802(d) of the act to comply with the notification requirements in 
proposed Sec. 1.101(d)(1). This requirement would be consistent with an 
interpretation of section 802(g) of the act that considers the nexus 
between section 802(b)(1) and (d) of the act. Section 802(g) of the act 
requires exporters of drugs, biologics, and devices to provide a simple 
notification to the agency when they export a product to a listed 
country or to an unlisted country under section 802(b)(1) of the act. 
Section 802(b)(1) of the act permits exports when the drug, biologic, 
or device has received market authorization in a listed country, 
whereas section 802(d) of the act permits exports to a listed country 
in anticipation of market authorization. A literal interpretation of 
section 802(g) of the act would not require an exporter to notify FDA 
when it shipped a product to a listed country in anticipation of market 
authorization, but would instead require the exporter to notify FDA 
when the exporter shipped the same product to the same country once it 
receives market authorization. The agency has concluded that it would 
be more simple and efficient, both for exporters and FDA, if exporters 
notify FDA when they export a product in anticipation of market 
authorization under section 802(d) of the act, rather than wait for 
market authorization in the listed country and then notify FDA when the 
product is exported under section 802(b)(1) of the act. This 
interpretation is consistent with section 802 of the act as a whole, as 
well as section 701(a) of the act (21 U.S.C. 371), which authorizes 
regulations for the efficient enforcement of the act.
    The agency acknowledges that, for exports to listed countries under 
section 802(b)(1) of the act, section 802(g) of the

[[Page 15946]]

act requires the notification to identify only the drug, biologic, or 
device being exported and does not expressly require the notification 
to identify the country to which the drug, biologic, or device is being 
exported. (In contrast, for drugs, biologics, or devices exported to 
nonlisted countries under section 802 of the act, section 802(g) of the 
act requires both identification of the exported product and the 
country to which the product is being exported.) Nevertheless, FDA is 
proposing to require that all export notifications under section 802(g) 
of the act identify the product and the importing country. FDA is 
taking this action because section 802(a)(2) of the act requires FDA to 
notify the ``appropriate public health official'' in the foreign 
country receiving an exported drug, biologic, or device if FDA 
disapproves a marketing application for the drug, biologic, or device. 
Additionally, section 802(f) of the act requires FDA to consult with 
the ``appropriate public health official in the affected country'' in 
the event that an exported drug, biologic, or device presents an 
imminent hazard to the public health. Similar consultation obligations 
exist if the product's labeling is not in accordance with the 
requirements and conditions for use in the country in which the drug, 
biologic, or device has valid marketing authorization and the country 
to which the drug, biologic, or device is being exported or if the 
drug, biologic, or device is not promoted in accordance with the 
labeling requirements of section 802(f) of the act. Thus, to facilitate 
these notifications and consultations with foreign officials 
(particularly in the event that FDA disapproves a drug, biologic, or 
device that has been exported, or the exported product presents an 
imminent hazard to the public health of the receiving country), FDA 
must know where the products have been exported. Consequently, proposed 
Sec. 1.101(d)(1)(iv) would require all notifications to identify the 
country or countries that are to receive the exported product.
    FDA, however, invites comment on possible alternatives to this 
notification requirement that would satisfy the consultation, 
notification, and recordkeeping obligations and requirements in section 
802 of the act. The agency is especially interested in alternatives 
that would reduce the paperwork burden, such as electronic submissions 
and recordkeeping or periodic notifications (e.g., monthly, quarterly, 
etc.), and the details of such alternatives.
    Proposed Sec. 1.101(e) would establish additional recordkeeping 
requirements for exported drugs, biologics, and devices subject to 
section 802(g) of the act. These records would include, but not be 
limited to, records concerning the product's name; its generic name if 
the product is a drug or a biologic or the type of device if the 
product is a device; a description of its strength and dosage form and 
the product's lot or control number (if the product is a drug or 
biologic) or the product's model number (if the product is a device); 
the consignee's name and address; and the date on which the product was 
exported and the quantity of product exported. The proposal would 
require these records to be kept at the site from which the products 
were exported and be maintained for 5 years after the date of 
exportation. The proposal would require that these records be made 
readily available for review and copying by FDA during an inspection, 
and these records would be in addition to those records required under 
proposed Sec. 1.101(b).

 III. Environmental Impact

    The agency has determined under 21 CFR 25.30(h) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

 IV. Paperwork Reduction Act of 1995

    This proposed rule contains information collection requirements 
which are subject to review by the Office of Management and Budget 
(OMB) under the Paperwork Reduction Act of 1995 (the PRA). The title, 
description, and respondent description of the information collection 
requirements are shown as follows, with an estimate of the annual 
reporting and recordkeeping burden. Included in the estimate is the 
time for reviewing instructions, searching existing data sources, 
gathering and maintaining the data needed, and completing and reviewing 
the collection of information.
    Title: Exports: Notification and Recordkeeping Requirements.
    Description: The proposed rule would establish the notification and 
recordkeeping requirements for persons exporting a human drug, 
biologic, device, animal drug, food, or cosmetic under section 801(e) 
or 802 of the act or section 351(h) of the PHS Act.
    Description of Respondents: Businesses.

                         Table 1.--Estimated Annual Reporting and Recordkeeping Burden1
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                                                      Annual
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours
                                    Respondents      Response        Responses       Response
----------------------------------------------------------------------------------------------------------------
 1.101(b)                             316               2.8           885               1             885
 1.101(c)                               8               2              16               2              32
 1.101(d)                             244               2.4           586               1             586
 1.101(e)                             175               3.3           578               2           1,156
Total                                                                                               2,659
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The estimates are based on the number of notifications received by 
the relevant FDA centers in 1996 or 1997 (depending on the last year 
for which figures were available) as well as consultations with 
industry sources.
    As required by section 3507(d) of the PRA, FDA has submitted a copy 
of this proposed rule to OMB for its review of these previously 
approved information collection requirements. The agency solicits 
comments on the information collection requirements in order to: (1) 
Evaluate whether the proposed collection of information is necessary 
for the proper performance of the functions of the agency, including 
whether the information will have practical utility; (2) evaluate the 
accuracy of the agency's estimate of the burden of the proposed 
collection of information, including the validity of the methodology 
and assumptions used; (3) enhance the quality, utility, and clarity of 
the information to be collected; and (4) minimize the burden of the 
collection of information on those

[[Page 15947]]

who are to respond, including through the use of appropriate automated, 
electronic, mechanical, or other technological collection techniques or 
other forms of information technology, e.g., permitting electronic 
submission of reports.

 V. Analysis of Impacts

    FDA has examined the impacts of this proposed rule under Executive 
Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354). 
Executive Order 12866 directs agencies to assess all costs and benefits 
of available regulatory alternatives and, when regulation is necessary, 
to select regulatory approaches that maximize new benefits (including 
potential economic, environmental, public health and safety, and other 
advantages; distributive impacts; and equity). The agency believes this 
proposed rule is consistent with the regulatory philosophy and the 
principles identified in the Executive Order. In addition, the proposed 
rule is a significant regulatory action as defined in the Executive 
Order.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant economic impact 
of a rule on small entities. The proposed rule will not have a 
significant economic impact on a substantial number of small entities, 
but FDA has conducted an initial regulatory flexibility analysis to 
ensure that impacts on small entities were assessed and to alert any 
potentially impacted small entities to the opportunity to submit 
comments to FDA.
    The proposed rule would implement the notification and 
recordkeeping aspects of the FDA Export Reform and Enhancement Act. The 
proposal requires firms that export unapproved new drugs, biologics, 
and devices under section 802 to notify FDA. The notification would 
identify the product being exported (name and description) and the 
product's destination. The proposal would also require firms that 
export human drugs, biologics, devices, animal drugs, foods, and 
cosmetics to maintain records demonstrating their compliance with the 
statutory requirements in sections 801(e) or 802 of the act or section 
351(h) of the PHS Act (whichever is applicable).
    FDA's initial determination that the rule will not have a 
significant economic impact on a substantial number of small entities 
is based on the estimated reporting and recordkeeping costs for the 
rule. Industry sources suggest that an average notification under the 
rule would require 1 hour to prepare and that the average wage is $30 
per hour. Combining this information with information from FDA's export 
records (which suggest approximately 2.4 exports per firm), an 
exporting firm's notification cost would be $72 ($30 x 2.4).
    FDA's export records also suggest that the average number of 
records varies (depending on the product involved) from 2.8 to 5.1 
records per firm. Industry sources project the average recordkeeping 
cost to be $100 per record, so the recordkeeping cost per firm ranges 
from $280 for firms exporting products that are subject only to section 
801(e) of the act to $510 for firms exporting products under section 
802 of the act and to $480 for firms exporting products under section 
351(h) of the PHS Act.
    Thus, because the estimated proposed notification and recordkeeping 
costs are low, the proposed rule, if finalized, should not have a 
significant economic impact on a substantial number of small entities.
    FDA considered alternatives that would require less information to 
be retained in the required records. For example, one alternative would 
be to require the notification to provide only the product's name and 
destination. However, because drug products may vary in dosage strength 
and size and yet still share the same name, a notice that merely named 
the product would not be sufficiently revealing to inform FDA about the 
exported drug. Another alternative would be to shorten the 
recordkeeping period, but because FDA's inspection resources have a 
wide range of obligations, from factory inspections to examining 
imports, a shorter time period would increase the likelihood of records 
being lost or destroyed before FDA could inspect an exporting firm.
    The Unfunded Mandates Reform Act (Pub. L. 104-114) requires that 
agencies prepare an assessment of anticipated costs and benefits before 
proposing any rule that may result in an expenditure in any 1 year by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100 million or more (adjusted annually for 
inflation). FDA estimates that the total recordkeeping costs for 
industry under the proposed rule would be $207,300. This estimate is 
based on a projected 2,073 records per year, multiplied by an industry 
cost of $100 per record. The total estimated reporting cost to industry 
is $17,580. This estimate is derived from the estimated total burden 
hours for reports (586) multiplied by a wage of $30 per hour per 
report. Because these expenditures will not result in a 1-year 
expenditure of $100 million or more, FDA is not required to perform a 
cost-benefit analysis under the Unfunded Mandates Reform Act.

 VI. Requests for Comments

    Interested persons may, on or before June 16, 1999, submit to the 
Dockets Management Branch (address above) written comments regarding 
this proposal. 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 may be seen in the office above between 9 
a.m. and 4 p.m., Monday through Friday. Organizations and individuals 
desiring to submit comments on the information collection requirements 
should direct them to the Office of Information and Regulatory Affairs 
(address above).

List of Subjects in 21 CFR Part 1

    Cosmetics, Drugs, Exports, Food labeling, Imports, Labeling, 
Reporting and recordkeeping requirements.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, it is 
proposed that 21 CFR part 1 be amended as follows:

 PART 1--GENERAL ENFORCEMENT REGULATIONS

    1. The authority citation for 21 CFR part 1 is revised to read as 
follows:

    Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 343, 352, 
355, 360b, 362, 371, 374, 381, 382, 393; 42 U.S.C. 216, 241, 243, 
262, 264.

    2. Section 1.101 is added to subpart E to read as follows:

Sec. 1.101   Notification and recordkeeping.

    (a) Scope. This section pertains to notifications and records 
required for human drug, biologic, device, animal drug, food, and 
cosmetic exports under sections 801 or 802 of the Federal Food, Drug, 
and Cosmetic Act (the act) (21 U.S.C. 381 and 382) or section 351 of 
the Public Health Service Act (42 U.S.C. 262) .
    (b) Recordkeeping requirements for human drugs, biologics, devices, 
animal drugs, foods, and cosmetics exported under or subject to section 
801(e)(1) of the act. Persons exporting an article under section 
801(e)(1) of the act or an article otherwise subject to section 
801(e)(1) of the act shall maintain records as enumerated in paragraphs 
(b)(1) through (b)(4) of this section demonstrating that the product 
meets the requirements of section 801(e)(1) of the act. Such records 
shall be

[[Page 15948]]

maintained for at least 5 years from the date of exportation. The 
records shall be made available to the Food and Drug Administration 
(FDA), upon request, during an inspection for review and copying by 
FDA.
    (1) Records demonstrating that the product meets the foreign 
purchaser's specifications. Such records shall include descriptions or 
lists of product specifications requested by the foreign purchaser, 
such as product details (e.g., dosage strength, dosage form, purity, 
quality, operating parameters, composition, etc.) and manufacturing 
specifications requested by the foreign purchaser (e.g., type of 
sterilization process to be used, compliance with a particular 
manufacturing standard, etc.);
    (2) Records demonstrating that the product does not conflict with 
the laws of the importing country, such as a letter from an appropriate 
foreign government agency, department, or other authorized body stating 
that the product has marketing approval from the foreign government or 
does not conflict with that country's laws. Letters or other documents 
from nongovernmental bodies or persons, such as company officials or 
attorneys in the foreign country, are not acceptable. If the letter or 
other document from the foreign government is not in English, the 
person exporting the article must have an English-language translation 
of that document or be prepared to translate the document into English 
at the time of any FDA inspection;
    (3) Records demonstrating that the product is labeled on the 
outside of the shipping package that it is intended for export, 
including copies of any labels or labeling statements, such as ``For 
export only,'' that are placed on the shipping packages; and
    (4) Records demonstrating that the product is not sold or offered 
for sale in the United States, such as documentation concerning the 
product, its labeling, and similar products sold in the United States.
    (c) Additional recordkeeping requirements for partially processed 
biologics exported under section 351(h) of the Public Health Service 
Act. In addition to the requirements in paragraph (b) of this section, 
persons exporting a partially processed biologic under section 351(h) 
of the Public Health Service Act shall maintain, for at least 5 years 
from the date of exportation and make available to FDA, upon request, 
during an inspection for review and copying by FDA, the following 
records:
    (1) Records demonstrating that the product for export is a 
partially processed biological product and not in a form applicable to 
the prevention, treatment, or cure of diseases or injuries of man;
    (2) Records that demonstrate that the partially processed 
biological product was manufactured in conformity with current good 
manufacturing practice requirements;
    (3) Distribution records of the exported partially processed 
biological products; and
    (4) Copies of all labeling that accompanies the exported partially 
processed biological product, such as a container label with the 
statement, ``Caution: For Further Manufacturing Use Only'' and any 
package insert.
    (d) Notification requirements for drugs, biologics, and devices 
exported under section 802 of the Federal Food, Drug, and Cosmetic Act. 
(1) Persons exporting a human drug, biologic, or device under section 
802 of the Federal Food, Drug, and Cosmetic Act, other than a drug or a 
device for investigational use exported under section 802(c) of the 
Federal Food, Drug, and Cosmetic Act, shall provide written 
notification to the Food and Drug Administration. The notification 
shall identify:
    (i) The product's name;
    (ii) If the product is a drug or biologic, the product's generic 
name or, if the product is a device, the type of device;
    (iii) If the product is a drug or biologic, a description of the 
product's strength and dosage form or, if the product is a device, the 
product's model number; and
    (iv) The country that is to receive the exported article.
    (2) The notification shall be sent to the following addresses:
    (i) For biological drug products and devices regulated by the 
Center for Biologics Evaluation and Research--Division of Case 
Management (HFM-610), Office of Compliance, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 1401 Rockville 
Pike, rm. 200N, Rockville, MD 20852-1448;
    (ii) For human drug products--Division of Labeling and 
Nonprescription Drug Compliance (HFD-310), Center for Drug Evaluation 
and Research, Food and Drug Administration, 7520 Standish Pl., 
Rockville, MD 20855-2737;
    (iii) For devices--Division of Program Operations (HFZ-305), Center 
for Devices and Radiological Health, Food and Drug Administration, 2094 
Gaither Rd., Rockville, MD 20850.
    (e) Recordkeeping requirements for products subject to section 
802(g) of the act. (1) Any person exporting a product under any 
provision of section 802 of the act shall maintain records of all 
drugs, biologics, and devices exported and the countries to which the 
products were exported. In addition to the requirements in paragraph 
(b) of this section, such records include, but are not limited to, the 
following:
    (i) The product's name;
    (ii) If the product is a drug or biologic, the product's generic 
name or, if the product is a device, the type of device;
    (iii) If the product is a drug or biologic, a description of its 
strength and dosage form and the product's lot or control number or, if 
the product is a device, the product's model number;
    (iv) The consignee's name and address; and
    (v) The date on which the product was exported and the quantity of 
product exported.
    (2) These records shall be kept at the site from which the products 
were exported and be maintained at least 5 years after the date of 
exportation. The records shall be made available to FDA, upon request, 
during an inspection for review and copying by FDA.

    Dated: December 23, 1998.
William K. Hubbard,
Acting Deputy Commissioner for Policy.
[FR Doc. 99-8159 Filed 4-1-99; 8:45 am]
BILLING CODE 4160-01-F