[Federal Register Volume 63, Number 226 (Tuesday, November 24, 1998)]
[Proposed Rules]
[Pages 64930-64937]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-31351]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 1
[Docket No. 98N-0496]
RIN 0910-AB24
Import for Export; Reporting and Recordkeeping Requirements for
Unapproved or Violative Products Imported for Further Processing or
Incorporation and Subsequent Export
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA) is proposing reporting
and recordkeeping regulations to implement certain sections of the
Federal Food, Drug, and Cosmetic Act (the act) as amended by the FDA
Export Reform and Enhancement Act of 1996. The proposed rule would
require an importer to report to FDA each time it imports an unapproved
or otherwise violative article that is to be exported after further
processing or incorporation into another product in the United States
and to keep records to ensure that the article is so processed or
incorporated and then exported, and that any portion of the import that
is not exported is destroyed.
DATES: Submit written comments by February 8, 1999. Written comments on
the information collection requirements should be submitted by December
24, 1998.
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., Washington,
DC 20503. Attn: Desk Officer for FDA.
FOR FURTHER INFORMATION CONTACT:
For general information: Marvin A. Blumberg, Division of Import
Operations and Policy (HFC-171), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-443-6553.
For information concerning blood products: Kimberly A. Cressotti,
Division of Case Management (HFM-610), Center for Biologics Evaluation
and Research, Food and Drug Administration, 1401 Rockville Pike, suite
200N, Rockville, MD 20852-1448, 301-827-6201.
SUPPLEMENTARY INFORMATION:
I. Background
The FDA Export Reform and Enhancement Act of 1996 (Pub. L. 104-134,
amended by Pub. L. 104-180, August 6, 1996) became law on April 26,
1996. One provision of the new law, now codified at section 801(d)(3)
of the act (21 U.S.C 381 (d)(3)), allows importation of any component
of a drug, component part or accessory of a device, or other article of
device requiring further processing, and any food or color additive, or
dietary supplement, if it is to be further processed or incorporated
into a product that is to be exported from the United States by the
initial owner or consignee in accordance with section 801(e) or 802 of
the act (21 U.S.C 382), or section 351(h) of the PHS Act (42 U.S.C. 262
(h)). (For purposes of section 801(d) of the act, FDA interprets the
term ``component'' broadly to include anything used in, or in the
manufacture of, a drug, biologic, or device, as well as a finished
final product that will be further processed in the United States.
Thus, for example, the term includes bulk drugs, unapproved foreign
versions of drugs approved for use in the United States, active and
inactive ingredients of a drug or biologic, pieces of a device, and
completed devices.) Under section 801(d)(3) of the act, the initial
owner or consignee must submit a statement regarding the imported
article to FDA at the time of initial importation. Any component of a
drug; any component, part, article, or accessory of a device; any food
additive, color additive; or any dietary supplement imported under
section 801(d) of the act that is not incorporated or further processed
by the initial owner or consignee must be destroyed or exported (see
section 801(d)(3)(C) of the act). Section 801(d)(3)(B) of the act
further requires the initial owner or consignee to maintain records
identifying the use and exportation or disposition of the imported
article, including portions that were destroyed, and, upon request from
FDA, to submit a report that accounts for the exportation or
disposition of the imported article and the manner in which the initial
owner or consignee complied with the requirements in section 801(d) of
the act.
This provision of the act is generally known as the ``import-for-
export'' provision.
Another new provision, now codified at section 801(d)(4) of the
act, places additional requirements on the import-for-export of blood,
blood components, source plasma, source leukocytes, or a component,
accessory, or part (hereinafter referred to as ``blood products''), and
of tissue and components or parts of tissue. Section 801(d)(4) of the
act prohibits the importation of blood products unless they comply with
section 351(a) of the PHS Act or FDA permits the importation under FDA-
determined appropriate circumstances and conditions. (Section 351(a) of
the PHS Act pertains to the licensing of biological products.)
Section 801(d)(4) of the act also prohibits the importation of
tissues and their components, under section 801(d)(3) of the act,
unless the importation complies with section 361 of the PHS Act (42
U.S.C. 264). Section 361 of the PHS Act authorizes FDA to issue
regulations to control communicable disease, and, for human tissues
intended for transplantation, these regulations are found at part 1270
(21 CFR part 1270). FDA, therefore, interprets section 801(d)(4) of the
act as meaning that a person importing human tissue for transplantation
for further processing or incorporation into a product destined for
export must comply with part 1270. Under Sec. 1270.42 published in the
Federal Register of July 29, 1997 (62 FR 40429), the importer of record
must notify the director of the FDA district having jurisdiction over
the port of entry or notify his or her designee, and the human tissue
must be quarantined until released by FDA.
Human tissue intended for transplantation may be imported and
further processed or incorporated into other products without meeting
the screening and testing requirements of part 1270 if the human tissue
is kept in quarantine at all times (see Sec. 1270.3
[[Page 64931]]
(definition of ``quarantine'')). However, as indicated in Sec. 1270.31
(62 FR 40429, July 29, 1997), the owner or consignee in the United
States must prepare and follow written procedures for designating and
identifying quarantined human tissue and preventing infectious disease
contamination or cross-contamination during processing.
FDA considers live animal cells, tissues, and organs intended to be
transplanted, implanted, or used for ex-vivo perfusion in humans
(xenogeneic products) to be biological products. Nonliving animal
cells, tissues, and organs intended for transplantation or implantation
into humans may be either biological products or devices. Animal cells,
tissues, and organs imported into the United States under section
801(d) of the act which FDA considers to be biological products or
devices would be expected to comply with proposed Sec. 1.84(b).
All veterinary biologics (e.g., vaccines, bacterins, allergens,
antibodies, antitoxins, toxoids, etc.) and animal-origin materials that
could represent a disease risk to U.S. livestock, including animal
products, by-products, and biological materials that contain or have
been in contact with certain organisms or animal materials) are
regulated by the U.S. Department of Agriculture's (USDA) Animal and
Plant Health Inspection Service. An importer must obtain a USDA permit
before importing any of these materials.
The proposed rule would establish the requirements for requesting a
determination from FDA to allow importation of blood products, and
would establish reporting, labeling, and recordkeeping requirements for
all imported articles under the import-for-export provision. These
would be the minimum requirements necessary to comply with the import-
for-export provision in the act and are intended to enable the importer
to ensure, and the agency to monitor, that imported substances are
further processed or incorporated into one of the specified FDA-
regulated products while in the United States, and are then exported or
destroyed without entering domestic commerce. Although the act does not
define the term ``further processed,'' given the legislative intent to
allow manufacturing and processing activities not previously permitted
under the act, FDA interprets the term ``further processed'' to cover a
wide range of activities, including packaging or labeling of finished
products and specialized processing (such as sterilization) of a
product. However, the agency does not consider a product to be
``further processed'' if it is merely stored in the United States
before being exported elsewhere.
II. Description of the Proposed Rule
A. Request for Determination Regarding the Importation of Blood, Blood
Components, Source Plasma, Source Leukocytes, or Their Components,
Accessories, or Parts
As stated earlier, section 801(d)(4) of the act prohibits the
importation of blood, blood components, source plasma, or source
leukocytes, or ``a component, accessory, or part thereof,'' unless they
comply with section 351(a) of the PHS Act or meet ``appropriate
circumstances and conditions'' as determined by FDA. The agency
interprets the phrase concerning compliance with section 351(a) of the
PHS Act as requiring products to be licensed, and also interprets
section 801(d)(4) of the act to include blood or plasma derivatives or
intermediates. With respect to the determination of ``appropriate
circumstances and conditions,'' FDA interprets the phrase as applying
to unlicensed blood products and will decide on a case-by-case basis
whether blood products that do not comply with section 351(a) of the
PHS Act should be allowed into the United States under section
801(d)(4) of the act. This decision will be based, in part, on the
agency's assessment of the adequacy of the safeguards to prevent
diversion into U.S. commerce, contamination of, or commingling with
products licensed or approved by FDA for use in the United States.
Consequently, proposed Sec. 1.84(a) would describe the process for
requesting a determination that an unlicensed blood product meets the
appropriate circumstances and conditions to allow its importation into
the United States. Proposed Sec. 1.84(a)(1) would require a person who
intends to import an unlicensed blood product into the United States
for further processing or incorporation into a product destined for
export to request a determination from FDA before importing the blood
product. The request, under proposed Sec. 1.84(a)(2), would contain the
following:
1. The names and addresses of the foreign manufacturer of the
article to be imported and the initial owner or consignee in the United
States that would be responsible for the further processing or
incorporation of the article into another product;
2. The specific identity of the article to be imported and details
as to how it will be further processed or incorporated into a product
for export;
3. A description of the standard operating procedures and
safeguards that will be used to ensure that the imported articles or
products incorporating the imported articles are not diverted to
domestic use in the United States and are segregated from, and not
comingled with, products or components intended for use in the United
States. For example, this may consist of quarantine procedures used for
segregating imported blood, blood components, or final products from
products intended for use in the United States and validation data for
procedures to clean equipment and facilities used for manufacturing
both products for use in the United States and for manufacturing
products for export;
4. General donor screening documentation or criteria, in English.
The request for determination should not include individual donor
screening questionnaires;
5. A copy of the product label translated (if necessary) into
English (described in greater detail below); and
6. A certification that all blood and blood products will be tested
for infectious disease agents such as HIV-1, HIV-2, hepatitis B virus,
hepatitis C virus, HTLV-I, HTLV-II, and Treponema pallidum. Proposed
Sec. 1.84(a) would permit the infectious agent tests to be performed
using test kits other than those licensed or approved by FDA; in such
cases, a copy of the labeling, including manufacturer's test kit
instructions, for the test kit used, translated into English, would be
included in the request for determination.
Requests for determination, under proposed Sec. 1.84(a)(3), would
be submitted to the Division of Case Management (HFM-610), Center for
Biologics Evaluation and Research (CBER). CBER will develop procedures
and timeframes for reviewing these requests.
A request for determination would be submitted to and approved by
CBER before importation of the first shipment of the unlicensed
biological product. Once CBER has approved a request for determination,
future shipments of the same product may be imported for export without
an additional request for determination so long as the importer,
consignee, and all other conditions upon which the determination was
based remain unchanged.
Proposed Sec. 1.84(a)(4) would require the initial owner or
consignee to maintain records regarding the request for determination
and to make those records available to FDA upon request.
[[Page 64932]]
Under proposed Sec. 1.84(a)(5), FDA would notify, in writing, the
person requesting the determination if the agency grants permission to
import the blood product.
These proposed regulations for blood, blood components, source
plasma, source leukocytes, or their components, accessories, or parts
are intended to help prevent any recurrence of situations in which
blood products not approved for use in the United States are used in
products that are then distributed into U.S. commerce. In one such
case, a manufacturer imported unlicensed source plasma for use in the
manufacture of hepatitis test kits, and these kits were later
distributed in the United States. Consistent with section 801(d)(4) of
the act, the agency is proposing rules to ensure that blood products
that are not licensed or approved for use in the United States are not
used in products distributed in the United States.
B. Reporting Requirements
As stated earlier, section 801(d)(3)(A) of the act requires the
importer to submit, ``at the time of initial importation,'' a statement
to the agency indicating that the imported article is intended to be
further processed or incorporated by the initial owner or consignee
into a drug, biological product, device, food, food additive, color
additive, or dietary supplement that will be exported by such owner or
consignee from the United States in compliance with section 801(e) or
802 of the act or section 351(h) of the PHS Act.
Accordingly, proposed Sec. 1.84(b)(1) would require an importer to
submit a statement to FDA each time the importer imports an article
under the import-for-export provisions of the act. The statement would
be required each time the product enters the United States, even if the
imported article has been previously imported. The statement, under
proposed Sec. 1.84(b)(2), would include, but not be limited to, the
following:
1. A formal declaration of the purpose for which the article is
being imported prior to export (how it will be further processed, or
the name or description of the product into which it will be
incorporated in the United States), and that it will not be sold or
offered for sale in the United States;
2. The name or description of the article (including any scientific
or technical name);
3. Any product coding, batch, lot, or other identifying numbers;
4. The name and address of the foreign manufacturer of the imported
article; and
5. The name and address of the initial owner or consignee in the
United States responsible for the further processing or incorporation
of the article into another product.
For blood products, proposed Sec. 1.84(b)(2) would also require the
importer to include a copy of the determination from FDA granting
permission to import the product.
The statements would be sent to the FDA district having
jurisdiction over the port of entry at which the article will be
offered for import. Proposed Sec. 1.84(b)(3) would require the importer
to retain a copy of the statement as part of its records for the
imported article.
C. Shipping Package Label Requirements
To facilitate identification of articles imported into the United
States under the import-for-export provisions in section 801(d)(3) and
(d)(4) of the act, FDA is proposing certain label requirements for
shipping containers. Under proposed Sec. 1.84(c), the importer, initial
owner, or consignee would be responsible for permanently affixing to
the shipping container, package or crate a label, in English,
indicating that the shipping container, package, or crate contains
article(s) that are intended for export from the United States after
further processing or incorporation into another product, and may not
be sold or offered for sale in the United States. The label would also
name or describe the imported article(s); provide any product coding,
batch, lot, or other identifying numbers; provide the foreign
manufacturer's name and address; identify the imported article's
country of origin (if different from that of manufacturer); and contain
any appropriate warning or special handling label. For example, if an
imported blood product tested positive for an infectious agent,
proposed Sec. 1.84(c)(6) would require the shipping package label to
indicate the agent for which the product tested positive and
prominently display the term ``BIOHAZARD.''
D. Label Requirements for Imported Blood Products
Proposed Sec. 1.84(d) would require a foreign supplier of blood,
blood components, source plasma, source leukocytes, or a component,
accessory, or part thereof (including blood or plasma derivatives or
intermediates) that is not licensed under section 351(a) of the PHS Act
and is to be imported under section 801(d)(4) of the act, to label the
products, in English, with the following information:
1. A properly descriptive name;
2. Name(s) and address(es) of establishments collecting, preparing,
labeling, or pooling the source material;
3. Donor, lot, or pool numbers relating the unit to the donor;
4. The recommended storage temperature (in degrees Celsius);
5. The quantity of the product;
6. The statement, ``Import for Export;''
7. The statement, ``Not for Use in Products Subject to Licensure
Under Section 351 of the Public Health Service Act;''
8. The statement, ``For Manufacturing Use Only'' or ``For
Manufacturing into Noninjectable Products Only;''
9. A statement indicating that the product has been tested for
infectious disease agents, including, but not limited to, HIV-1, HIV-2,
hepatitis B virus, hepatitis C virus, HTLV-I, HTLV-II, and Treponema
pallidum. The infectious agent tests may be performed using test kits
other than those licensed or approved by FDA and should be the same
tests described in the request for determination under proposed
Sec. 1.84(a).
10. If the product tested positive for any infectious agent listed
in proposed Sec. 1.84(d)(9), the product's label would indicate the
agent(s) for which the product tested positive and display the term
``BIOHAZARD'' prominently and in bold letters; and
11. Any other appropriate warnings or special handling instructions
as determined by the importer.
A copy of the label, under proposed Sec. 1.84(a), would be included
in the initial request for determination that the blood product meets
the ``appropriate circumstances and conditions'' for importation under
section 801(d)(4) of the act.
The requirements in proposed Sec. 1.84(d) would be in addition to
the shipping package label requirements in proposed Sec. 1.84(c).
FDA also notes that regulations issued by other Federal agencies
and departments may apply to the imported products (see, e.g., 9 CFR
parts 92 et al.; 19 CFR part 12; 42 CFR part 72; 49 CFR part 173, U.S.
Postal Service regulations, 39 CFR parts 124 and 125).
E. Recordkeeping Requirements
Section 801(d)(3)(B) of the act requires that ``the initial owner
or consignee responsible for such imported article maintain records
that identify the use of such imported article.'' Proposed Sec. 1.84(e)
would require the initial owner or consignee responsible for the
article imported into the United States under the import-for-export
provision to have
[[Page 64933]]
a place of business in the United States, to maintain identifying
records for 5 years after the date on which the imported article was
exported (after further processing or incorporation into another
product) or destroyed, and to make the identifying records available
for inspection by the agency. The identifying records would include the
following information:
1. The name or description of the article (including any scientific
or technical name);
2. Any product coding, batch, lot, or other identifying numbers;
3. The name and address of the foreign manufacturer of the imported
article;
4. How the article will be or was further processed, and the name
or description of any product into which it will be or was incorporated
in the United States;
5. The signature of the responsible individual at the importing
firm;
6. The name and address of the firm in the United States where the
article will be further processed or incorporated into another product;
7. The disposition of the imported article, including quantity and
methods of disposition (i.e., manufacturing records showing how
specific articles were used or destroyed and the dates of receipt, use,
destruction, or re-exportation, as that information becomes available);
8. Any product coding, lot, batch, or other identification number
for the further-processed article or product incorporating the imported
article;
9. A copy of the label to be applied to the shipping package,
container, or crate used to export the further-processed article or
product incorporating the imported article (indicating that it contains
articles that may not to be sold or offered for sale in the United
States and are intended for export only);
10. The name and address of the foreign purchaser of the further-
processed article or product incorporating the imported article; and
11. For blood, blood components, source plasma, source leukocytes,
or a component, accessory, or part thereof (including blood or plasma
derivatives or intermediates) that is not licensed under section 351(a)
of the PHS Act and is to be imported under section 801(d)(4) of the
act, documentation of the agreement between the foreign material
supplier and the U.S. manufacturer. Proposed Sec. 1.84(e)(2)(xi) would
require this documentation to outline the specific contractual
relationship, the foreign manufacturing specifications, and the U.S.
manufacturer's plan for auditing the foreign supplier to ensure
compliance with the terms of the contract.
Additionally, proposed Sec. 1.84(e)(2)(xi) would require the
initial owner or consignee of imported blood, blood components, source
plasma, source leukocytes, or a component, accessory, or part thereof
(including blood or plasma derivatives or intermediates) to have
written standard operating procedures to ensure that such products or
articles incorporating such products are not diverted to domestic use
in the United States and are kept segregated from and are not comingled
with products or components intended for use in the United States.
These procedures could, for example, include quarantine procedures for
segregating imported blood, blood components, or final products from
products intended for use in the United States and validation data for
procedures used to clean equipment and manufacturing facilities that
produce both products for distribution in the United States and
products for export only.
FDA emphasizes that companies must also comply with the applicable
requirements of section 801(e) or 802 of the act or section 351(h) of
the PHS Act. (Persons who seek to import tissues or their parts or
components must also comply with section 361 of the PHS Act.) Those
statutory provisions may impose additional requirements on the exported
product as well as requirements on notification to FDA, labeling, and
records.
F. Registration and Listing Requirements for Persons Who Import and
Further Process or Incorporate Blood Products That Are Not Licensed
Under With Section 351(a) of the PHS Act
As an additional condition for importing blood products that are
not licensed under section 351(a) of the PHS Act, proposed Sec. 1.84(f)
would require that the person in the United States who will be further
processing or incorporating the imported article register with the FDA
and list the blood product(s) that it will be processing or
incorporating into other products or update its registration and
listing. The listing would include a description of the imported
article as well as the final product for export. The proposal would
require that the registration and listing information be sent to the
appropriate registration office listed in 21 CFR part 207 or part 607.
This registration and listing will enable FDA to track all blood
products imported under section 801(d)(4) of the act that are not
licensed under section 351(a) of the PHS Act and to monitor the
products so that they do not enter domestic commerce. Additionally, for
blood products to be exported after further manufacture into final
dosage form under section 351(h) of the PHS Act, such registration and
listing will enable FDA to evaluate, if appropriate, the person who
will be further processing or incorporating the imported article to
ensure that compliance with current good manufacturing practices, or,
consistent with section 802(f)(1) of the act, conformance with
international manufacturing standards as certified by an international
standards organization recognized by FDA, as specified by section
351(h)(3) of the PHS Act. Section 802(f)(1) of the act requires all
products exported under section 802 of the act to be in substantial
conformity with current good manufacturing practices or to meet
international standards as certified by an international standards
organization recognized by FDA. At this time, FDA has not formally
recognized any international standards or international standards
organizations for purposes of section 802(f)(1) of the act.
III. Environmental Impact
The agency has determined under 21 CFR 25.30(h) and (j) 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. Analysis of Impacts
FDA has examined the impacts of the proposed rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612).
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 net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity).
According to Executive Order 12866, a regulatory action is
economically significant if it meets any one of a number of specified
conditions, including having an annual effect on the economy of $100
million or adversely affecting in a material way a sector of the
economy, competition, or jobs. A regulation is considered significant
under Executive Order 12866 if it raises novel legal or policy issues.
The agency believes that this proposed rule is consistent with the
regulatory philosophy and principles identified in the Executive Order.
In
[[Page 64934]]
addition the proposed rule is not a significant regulatory action as
defined by the Executive Order. The agency also believes that the
recordkeeping and reporting requirements encompassed in the proposed
rule will not have a significant effect on the economy. FDA estimates
the industry's total recordkeeping and reporting costs to be $40,000
and $61,500, respectively. These estimates are based on an estimated
cost of $100 per record and an average wage or $30 per hour for each
report (with a total of 2,050 reports). Thus, the proposed rule's cost
to industry would be $101,500.
The Regulatory Flexibility Act requires the agency to analyze
options that would minimize any significant impact of a rule on small
businesses. This proposed rule would entail only minimal reporting and
recordkeeping as necessary to identify substances and their use that
have been imported under the ``import for export'' provisions of the
act. The required reporting and recordkeeping is necessary to enable
the importer to ensure, and the agency to monitor, that such imported
substances are further processed or incorporated into another product
while in the United States, and are then exported or destroyed, as
required by the act. Indeed, the ``import-for-export'' provisions of
the act that these proposed regulations would implement might create
new economic opportunities for U.S. businesses, including small
businesses. Thus, the agency certifies that the proposed rule will not
have a significant economic impact on a substantial number of small
businesses. Therefore, under the Regulatory Flexibility Act, the agency
is not required to conduct further analysis.
V. Paperwork Reduction Act of 1995
This proposed rule contains information collection requirements
that are subject to public comment and review by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501-3520). The title, description, and respondent
description for the information collection requirements are shown below
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 each collection of information.
FDA invites comments on: (1) Whether the proposed collection of
information is necessary for the proper performance of FDA's functions,
including whether the information will have practical utility; (2) the
accuracy of FDA's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) ways to minimize the burden of the
collection of information on respondents, including through the use of
automated collection techniques, when appropriate, and other forms of
information technology.
Title: Import for Export; FDA Export Reform and Enhancement Act of
1996; Reporting and Recordkeeping Requirements for Unapproved or
Violative Products Imported for Further Processing or Incorporation and
Subsequent Export.
Description: The proposed rule would require an importer to report
to FDA each time that it is importing an article that is to be exported
after further processing or incorporation into another product in the
United States, and to keep records enabling him to ensure, and FDA to
monitor, that the article is so processed or incorporated and then
exported, and that any portion of the import that is not exported is
destroyed. This proposed rule is to implement section 801(d)(3) and
(d)(4) of the act as amended by the FDA Export Reform and Enhancement
Act of 1996.
Description of Respondents: Persons and businesses, including small
businesses.
The estimated burden associated with the information collection
requirements for this proposed rule is 10,050 hours.
FDA estimates the burden of this collection of information as
follows:
Table 1.-- Estimated Annual Recordkeeping Burden1
----------------------------------------------------------------------------------------------------------------
Annual
21 CFR Section No. of Frequency per Total Annual Hours per Total Hours
Recordkeepers Recordkeeping Records Recordkeeper
----------------------------------------------------------------------------------------------------------------
1.84(e) 75 5 375 20 7,500
1.84(e)(xi) 25 1 25 20 500
8,000
----------------------------------------------------------------------------------------------------------------
\1\There are no operating and maintenance costs or capital costs associated with this collection of information.
Table 2.-- Estimated Annual Reporting Burden1
----------------------------------------------------------------------------------------------------------------
No. of
21 CFR Section No. Of Responses per Total Annual Hours per Total Hours
Respondents Respondent Responses Response
----------------------------------------------------------------------------------------------------------------
1.84(a) 25 1 25 46 1,150
1.84(b) 75 5 375 1 375
1.84(c) 75 5 375 1 375
1.84(d) 25 1 25 5 125
1.84(f) 25 1 25 1 25
2,050
----------------------------------------------------------------------------------------------------------------
\1\There are no operating and maintenance costs or capital costs associated with this collection of information.
The above estimates were based on normal operating burdens for the
preparation and submission of information to FDA for imported products,
the actual number of firms and import for export entries in fiscal year
(FY) 1997, and projections of the future number of firms and import for
export entries. In FY 1997, 41 firms, on 175 different occasions,
brought products into the United States under the import for export
authority at an average rate of 4.27 entries per firm (although most
firms only used the import for export authority once in FY
[[Page 64935]]
1997). The agency anticipates more firms (particularly firms involved
with blood and blood products) to use the import for export authority
in the future and, therefore, estimates the maximum number of
respondents or recordkeepers to be 75 (an increase of 29 over FY 1997).
FDA's estimates for the hours per record or report are based on
estimates from persons familiar with export operations. The records or
reports would, in many situations, be derived from normal business
records for imported products, so the burden should be very minimal and
should also be consistent with current recordkeeping practices.
The agency has submitted the information collection requirements of
this proposed rule to OMB for review. Interested persons are requested
to send comments regarding information collection by December 24, 1998,
to OMB (address above).
VI. Request for Comments
Interested persons may on or before February 8, 1999, 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 will be on file with the Dockets Management
Branch (address above) and may be seen in that office between 9:00 a.m.
and 4:00 p.m., Monday through Friday.
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, the
Public Health Service Act, and 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, 262, 264.
2. Section 1.84 is added to subpart E to read as follows:
Sec. 1.84 Import for export: Request for determination and reporting
and recordkeeping requirements for unapproved or violative products
imported for further processing or incorporation into specified
products and subsequent export.
(a) Request for determination regarding the importation of blood,
blood components, source plasma, source leukocytes, or their
components, accessories, or parts. (1) A person who intends to import
blood, blood components, source plasma, source leukocytes, or their
components, accessories, or parts (including blood or plasma
derivatives or intermediates) that are not licensed under section
351(a) of the Public Health Service Act (the PHS Act) shall, before
importing the product into the United States under section 801(d)(4) of
the Federal Food, Drug, and Cosmetic act (the act), request a
determination that such importation is permitted.
(2) The request shall contain the following information:
(i) The names and addresses of the foreign manufacturer of the
article to be imported and the initial owner or consignee in the United
States that would be responsible for the further processing or
incorporation of the article into another product;
(ii) The specific identity of the article to be imported and
details as to how the imported article will be further processed or
incorporated into a product for export;
(iii) A description of the standard operating procedures and
safeguards that the initial owner or consignee in the United States
will use or implement to ensure that the imported articles or products
incorporating such articles are segregated from and not comingled with
products, components, accessories, or parts intended for use in the
United States (e.g., quarantine procedures used for segregating
imported blood, blood components, or final products from products
intended for use in the United States, including validation data for
procedures to clean equipment and facilities used in manufacturing
products for use in the United States and products for export);
(iv) General donor screening questionnaire or criteria, translated
into English, that will be used to screen donors;
(v) A certification that tests for infectious disease will be
performed by the foreign supplier on the blood, blood components,
source plasma, or source leukocytes, or their components, accessories,
or parts (including blood or plasma derivatives or intermediates) at
the time of donation and before importation to the United States, and
the expected results of such tests. The infectious disease agents that
shall be tested for include, but are not limited to: HIV-1, HIV-2,
hepatitis B virus, hepatitis C virus, HTLV-I, HTLV-II, and Treponema
palladum. A request under paragraph (a) of this section may be based
upon infectious agent tests performed using test kits other than those
licensed or approved by the Food and Drug Administration (FDA). In such
cases, a copy of the labeling for the test kit used, translated into
English, shall be included in the submission; and
(vi) A copy of the label described in paragraph (d) of this
section.
(3) The request for determination shall be submitted to Office of
Compliance, Division of Case Management (HFM-610), Center for Biologics
Evaluation and Research, Food and Drug Administration, 1401 Rockville
Pike, suite 200N, Rockville, MD 20852-1448.
(4) Records pertaining to the request for determination shall be
maintained and made available for FDA review upon request.
(5) If FDA determines that the blood, blood component, source
plasma, or source leukocyte, or component, accessory, or part meets the
appropriate circumstances and conditions to permit its importation into
the United States, FDA shall, in writing, notify the person requesting
the determination that it has granted permission to import the article.
(b) Reporting requirements. (1) A person wishing to import articles
specified in paragraphs (b)(l)(i) through (b)(l)(iv) of this section
that may not be sold or offered for sale in the United States, but
which the initial owner or consignee intends to have further processed
or incorporated into a drug, biological product, device, food, food
additive, color additive, or dietary supplement in the United States,
and which the initial owner or consignee will export from the United
States in accordance with sections 801(e) or 802 of the act or section
351(h) of the PHS Act, shall submit to the FDA district with
jurisdiction over the port of entry, with each import entry, a
statement containing information described in paragraph (b)(2) of this
section. The articles for which this reporting requirement apply are:
(i) A component of a drug (including a drug, veterinary drug, and
biological for use in humans);
(ii) A component part or accessory of a device, or other article of
device requiring further processing, which is ready or suitable for use
for health-related purposes;
(iii) A food or color additive; and
(iv) A dietary supplement.
[[Page 64936]]
(2) The statement that shall be supplied to FDA with each import
entry shall include, but is not limited to, the following information:
(i) A formal declaration of the purpose for which the article is
being imported before export (how it will be further processed, or the
name or description of the product into which it will be incorporated
in the United States) and that it will not be sold or offered for sale
in the United States;
(ii) The name or description of the article (including any
scientific or technical name);
(iii) Any product coding, batch, lot, or other identifying numbers;
(iv) The name and address of the foreign manufacturer of the
imported article (if different from the name of the foreign shipper
identified in the import records at the U.S. Customs Service);
(v) The name and address of the initial owner or consignee in the
United States and, if different, the address in the United States where
the article will be further processed or incorporated into any product
listed in paragraph (b)(1) of this section; and
(vi) In addition to the information described in paragraphs
(b)(l)(i) through (b)(l)(iv) of this section, for blood, blood
components, source plasma, source leukocytes, or a component,
accessory, or part thereof (including blood or plasma derivatives or
intermediates) that are not licensed under section 351(a) of the PHS
Act and are to be imported under section 801(d)(4) of the act, the
statement shall include a copy of the determination by the agency
granting permission to import the product.
(3) The initial owner or consignee also shall keep a copy of the
statement as part of its records for the article.
(c) Shipping-package label requirements. The importer, initial
owner, or consignee of articles to be imported into the United States
for further processing or incorporation into a product for export shall
permanently affix, to the articles' shipping container, package or
crate, a label that provides the following information in English:
(1) Contains article(s) that are intended for export from the
United States after further processing or incorporation into articles
intended for export, and may not be sold or offered for sale in the
United States;
(2) The name or description of the article(s) (including any
scientific or technical name);
(3) The product coding, batch, lot, or other identifying numbers;
(4) The name and address of the responsible foreign manufacturer of
the imported article(s);
(5) The country of origin (if different from that of responsible
manufacturer); and
(6) Any appropriate warning or special-handling label, such as
``BIOHAZARD'' for products potentially contaminated with an infectious
agent.
(d) Label requirements for blood products. The foreign supplier of
blood, blood component, source plasma, source leukocyte, or a
component, accessory, or part thereof (including blood or plasma
derivatives or intermediates) that is not licensed under section 351(a)
of the PHS Act and is to be imported under section 801(d)(4) of the
act, shall label the product in English with the following information:
(1) A properly descriptive name;
(2) Name(s) and address(es) of establishments collecting,
preparing, labeling, or pooling the source material;
(3) Donor, lot, or pool numbers relating the unit to the donor;
(4) The recommended storage temperature (in degrees Celsius);
(5) The quantity of the product;
(6) The statement, ``Import for Export;''
(7) The statement, ``Not for Use in Products Subject to Licensure
Under Section 351 of the Public Health Service Act;''
(8) The statement, ``For Manufacturing Use Only'' or ``For
Manufacturing into Noninjectable Products Only;''
(9) A statement indicating that the product has been tested for
infectious disease agents, including, but not limited to: HIV-1, HIV-2,
hepatitis B virus, hepatitis C virus, HTLV-I, HTLV-II, and Treponema
palladum. A request under paragraph (a) of this section may be based
upon infectious agent tests performed using test kits other than those
licensed or approved by FDA. In such cases, a copy of the label for the
test kit used, translated into English, shall accompany the request;
(10) If the product has tested positive for any infectious agent as
required in paragraph (d)(9) of this section, the product's label shall
indicate the agent(s) for which the product has tested positive, and
the term ``BIOHAZARD'' shall be prominently displayed in bold letters;
and
(11) Any other appropriate warnings or special handling
instructions as determined by the importer.
(e) Recordkeeping requirements. (1) The initial owner or consignee
who is responsible for the article offered for import shall have a
place of business in the United States.
(2) The initial owner or consignee responsible for the article
offered for import shall maintain identifying records for 5 years after
exportation or destruction of the imported article, and shall make
those identifying records available for inspection by the agency. The
identifying records shall include the following information:
(i) The name or description of the article (including any
scientific or technical name);
(ii) Any product coding, batch, lot, or other identifying numbers;
(iii) The name and address of the foreign manufacturer of the
imported article;
(iv) How the article will be or was further processed, and the name
or description of any product into which it will be or was incorporated
in the United States;
(v) The signature of the responsible individual at the importing
firm;
(vi) The name and address of the firm in the United States where
the article will be or was further processed or incorporated into
another product;
(vii) The disposition of the imported article (i.e., manufacturing
records showing how specific articles were used or destroyed and the
dates of receipt, use, destruction, or re-exportation, as that
information becomes available);
(viii) Any product coding, lot, batch, or other identification
number for the further-processed article or product incorporating the
imported article;
(ix) A copy of the label to be applied to the shipping package,
container, or crate used to export the further-processed article or
product incorporating the imported article (indicating that it contains
articles that may not be sold or offered for sale in the United States
and are intended for export only);
(x) The name and address of the foreign purchaser of the further-
processed article or product incorporating the imported article; and
(xi) Additionally, for blood, blood components, source plasma,
source leukocytes, or a component, accessory, or part thereof
(including blood or plasma derivatives or intermediates) that is not
licensed under section 351(a) of the PHS Act and is to be imported
under section 801(d)(4) of the act, the records shall include
documentation of the agreement between the foreign material supplier
and the U.S. manufacturer. The documentation shall outline the specific
contractual relationship, the foreign manufacturing specifications, and
the U.S. manufacturer's plan for auditing the foreign supplier to
ensure compliance with the terms of the contract. The initial owner or
consignee shall have written standard operating procedures to ensure
that such products are not
[[Page 64937]]
diverted to domestic use in the United States and are kept segregated
from and not comingled with products or components intended for use in
the United States (e.g., quarantine procedures used for segregating
imported blood, blood components, or final products from products
intended for use in the United States, including validation data for
procedures to clean equipment and facilities used for manufacturing
products for use in the United States and exported products).
(f) Registration and listing requirements. Each person who intends
to further process or incorporate blood, blood components, source
plasma, source leukocytes, or a component, accessory, or part thereof
(including blood or plasma derivatives or intermediates) that is not
licensed under section 351(a) of the PHS Act and is to be imported
under section 801(d)(4) of the act, shall register with FDA and list
the blood product to be further processed or incorporated into other
products, or update its registration and listing, and include in the
listing a description of the imported material as well as the final
product for export. The information shall be sent to the appropriate
registration office listed in parts 207 or 607 of this chapter.
Dated: November 14, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-31351 Filed 11-23-98; 8:45 am]
BILLING CODE 4160-01-F
