Exports: Notification and Recordkeeping Requirements

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

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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

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\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