
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1]

[Page 11-15]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 1--GENERAL ENFORCEMENT REGULATIONS--Table of Contents
 
Subpart E--Imports and Exports

Sec. 1.83  Definitions.

    For the purposes of regulations prescribed under section 801(a), 
(b), and (c) of the Federal Food, Drug, and Cosmetic Act:
    (a) The term owner or consignee means the person who has the rights 
of a consignee under the provisions of sections 483, 484, and 485 of the 
Tariff Act of 1930, as amended (19 U.S.C. 1483, 1484, 1485).
    (b) The term district director means the director of the district of 
the Food and Drug Administration having jurisdiction over the port of 
entry through which an article is imported or offered for import, or 
such officer of the district as he may designate to act in his behalf in 
administering and enforcing

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the provisions of section 801 (a), (b), and (c).

Sec. 1.90  Notice of sampling.

    When a sample of an article offered for import has been requested by 
the district director, the collector of customs having jurisdiction over 
the article shall give to the owner or consignee prompt notice of 
delivery of, or intention to deliver, such sample. Upon receipt of the 
notice, the owner or consignee shall hold such article and not 
distribute it until further notice from the district director or the 
collector of customs of the results of examination of the sample.

Sec. 1.91  Payment for samples.

    The Food and Drug Administration will pay for all import samples 
which are found to be in compliance with the requirements of the Federal 
Food, Drug, and Cosmetic Act. Billing for reimbursement should be made 
by the owner or consignee to the Food and Drug Administration district 
headquarters in whose territory the shipment was offered for import. 
Payment for samples will not be made if the article is found to be in 
violation of the act, even though subsequently brought into compliance 
under the terms of an authorization to bring the article into compliance 
or rendered not a food, drug, device, or cosmetic as set forth in 
Sec. 1.95.

Sec. 1.94  Hearing on refusal of admission.

    (a) If it appears that the article may be subject to refusal of 
admission, the district director shall give the owner or consignee a 
written notice to that effect, stating the reasons therefor. The notice 
shall specify a place and a period of time during which the owner or 
consignee shall have an opportunity to introduce testimony. Upon timely 
request giving reasonable grounds therefor, such time and place may be 
changed. Such testimony shall be confined to matters relevant to the 
admissibility of the article, and may be introduced orally or in 
writing.
    (b) If such owner or consignee submits or indicates his intention to 
submit an application for authorization to relabel or perform other 
action to bring the article into compliance with the act or to render it 
other than a food, drug, device, or cosmetic, such testimony shall 
include evidence in support of such application. If such application is 
not submitted at or prior to the hearing, the district director shall 
specify a time limit, reasonable in the light of the circumstances, for 
filing such application.

Sec. 1.95  Application for authorization to relabel and recondition.

    Application for authorization to relabel or perform other action to 
bring the article into compliance with the act or to render it other 
than a food, drug, device or cosmetic may be filed only by the owner or 
consignee, and shall:
    (a) Contain detailed proposals for bringing the article into 
compliance with the act or rendering it other than a food, drug, device, 
or cosmetic.
    (b) Specify the time and place where such operations will be carried 
out and the approximate time for their completion.

Sec. 1.96  Granting of authorization to relabel and recondition.

    (a) When authorization contemplated by Sec. 1.95 is granted, the 
district director shall notify the applicant in writing, specifying:
    (1) The procedure to be followed;
    (2) The disposition of the rejected articles or portions thereof;
    (3) That the operations are to be carried out under the supervision 
of an officer of the Food and Drug Administration or the U.S. Customs 
Service, as the case may be;
    (4) A time limit, reasonable in the light of the circumstances, for 
completion of the operations; and
    (5) Such other conditions as are necessary to maintain adequate 
supervision and control over the article.
    (b) Upon receipt of a written request for extension of time to 
complete such operations, containing reasonable grounds therefor, the 
district director may grant such additional time as he deems necessary.
    (c) An authorization may be amended upon a showing of reasonable 
grounds therefor and the filing of an amended application for 
authorization with the district director.

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    (d) If ownership of an article covered by an authorization changes 
before the operations specified in the authorization have been 
completed, the original owner will be held responsible, unless the new 
owner has executed a bond and obtained a new authorization. Any 
authorization granted under this section shall supersede and nullify any 
previously granted authorization with respect to the article.

[42 FR 15553, Mar. 22, 1977, as amended at 54 FR 9033, Mar. 3, 1989]

Sec. 1.97  Bonds.

    (a) The bonds required under section 801(b) of the act may be 
executed by the owner or consignee on the appropriate form of a customs 
single-entry or term bond, containing a condition for the redelivery of 
the merchandise or any part thereof upon demand of the collector of 
customs and containing a provision for the performance of conditions as 
may legally be imposed for the relabeling or other action necessary to 
bring the article into compliance with the act or rendering it other 
than a food, drug, device, or cosmetic, in such manner as is prescribed 
for such bond in the customs regulations in force on the date of request 
for authorization. The bond shall be filed with the collector of 
customs.
    (b) The collector of customs may cancel the liability for liquidated 
damages incurred under the above-mentioned provisions of such a bond, if 
he receives an application for relief therefrom, upon the payment of a 
lesser amount or upon such other terms and conditions as shall be deemed 
appropriate under the law and in view of the circumstances, but the 
collector shall not act under this regulation in any case unless the 
district director is in full agreement with the action.

Sec. 1.99  Costs chargeable in connection with relabeling and 
          reconditioning inadmissible imports.

    The cost of supervising the relabeling or other action in connection 
with an import of food, drugs, devices, or cosmetics which fails to 
comply with the Federal Food, Drug, and Cosmetic Act shall be paid by 
the owner or consignee who files an application requesting such action 
and executes a bond, pursuant to section 801(b) of the act, as amended. 
The cost of such supervision shall include, but not be restricted to, 
the following:
    (a) Travel expenses of the supervising officer.
    (b) Per diem in lieu of subsistence of the supervising officer when 
away from his home station, as provided by law.
    (c) The charge for the services of the supervising officer, which 
shall include administrative support, shall be computed at a rate per 
hour equal to 266 percent of the hourly rate of regular pay of a grade 
GS-11/4 employee, except that such services performed by a customs 
officer and subject to the provisions of the act of February 13, 1911, 
as amended (sec. 5, 36 Stat. 901, as amended (19 U.S.C. 267)), shall be 
calculated as provided in that act.
    (d) The charge for the service of the analyst, which shall include 
administrative and laboratory support, shall be computed at a rate per 
hour equal to 266 percent of the hourly rate of regular pay of a grade 
GS-12/4 employee. The rate per hour equal to 266 percent of the 
equivalent hourly rate of regular pay of the supervising officer (GS-11/
4) and the analyst (GS-12/4) is computed as follows:


                                                                  Hours

Gross number of working hours in 52 40-hr weeks................    2,080
Less:
  9 legal public holidays--New Years Day, Washington's                72
   Birthday, Memorial Day, Independence Day, Labor Day,
   Columbus Day, Veterans Day, Thanksgiving Day, and Christmas
   Day.........................................................
  Annual leave--26 d...........................................      208
  Sick leave--13 d.............................................      104
                                                                --------
      Total....................................................      384
      Net number of working hours..............................    1,696
Gross number of working hours in 52 40-hr weeks................    2,080
Working hour equivalent of Government contributions for              176
 employee retirement, life insurance, and health benefits
 computed at 8\1/2\ pct. of annual rate of pay of employee.....
                                                                --------
      Equivalent annual working hours..........................    2,256
                                                                --------
Support required to equal to 1 man-year........................    2,256
      Equivalent gross annual working hours charged to Food and    4,512
       Drug appropriation......................................



    Note: Ratio of equivalent gross annual number of working hours 
charged to Food and Drug appropriation to net number of annual working 
hours 4,512/1,696=266 pct.

    (e) The minimum charge for services of supervising officers and of 
analysts shall be not less than the charge for 1

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hour, and time after the first hour shall be computed in multiples of 1 
hour, disregarding fractional parts less than \1/2\ hour.

Sec. 1.101  Notification and recordkeeping.

    (a) Scope. This section pertains to notifications and records 
required for human drug, biological product, device, animal drug, food, 
and cosmetic exports under sections 801 or 802 of the Federal Food, 
Drug, and Cosmetic Act (the act) or (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, biological products, 
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 maintained for the same period of time as required for records 
subject to good manufacturing practice or quality systems regulations 
applicable to the product, except that records pertaining to the export 
of foods and cosmetics under section 801(e)(1) of the act shall be kept 
for 3 years after 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: The records must contain sufficient 
information to match the foreign purchaser's specifications to a 
particular export;
    (2) Records demonstrating that the product does not conflict with 
the laws of the importing country: This may consist of either 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, or a 
notarized certification by a responsible company official in the United 
States that the product does not conflict with the laws of the importing 
country and that includes a statement acknowledging that he or she is 
subject to the provisions of 18 U.S.C. 1001;
    (3) Records demonstrating that the product is labeled on the outside 
of the shipping package that it is intended for export: This may consist 
of copies of any labels or labeling statements, such as ``For export 
only,'' that are placed on the shipping packages or, if the exported 
product does not have a shipping package or container, on shipping 
invoices or other documents accompanying the exported product; and
    (4) Records demonstrating that the product is not sold or offered 
for sale in the United States: This may consist of production and 
shipping records for the exported product and promotional materials.
    (c) Additional recordkeeping requirements for partially processed 
biological products 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 biological product 
under section 351(h) of the Public Health Service Act shall maintain, 
for the same period of time as required for records subject to good 
manufacturing practice or quality systems regulations applicable to the 
product, 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 demonstrating that the partially processed biological 
product was manufactured in conformity with current good manufacturing 
practice requirements;
    (3) Records demonstrating the distribution of the exported partially 
processed biological products; and
    (4) Copies of all labeling that accompanies the exported partially 
processed biological product and other records demonstrating that the 
exported partially processed biological product is intended for further 
manufacture into a final dosage form outside the United

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States; this may include a container label with the statement, 
``Caution: For Further Manufacturing Use Only'' and any package insert.
    (d) Notification requirements for drugs, biological products, and 
devices exported under section 802 of the act. (1) Persons exporting a 
human drug, biological product, or device under section 802 of the act, 
other than a drug, biological product, or device for investigational use 
exported under section 802(c) of the act, or a drug, biological product, 
or device exported in anticipation of marketing authorization under 
section 802(d) of the act, shall provide written notification to FDA. 
The notification shall identify:
    (i) The product's trade name;
    (ii) If the product is a drug or biological product, the product's 
abbreviated or proper name or, if the product is a device, the type of 
device;
    (iii) If the product is a drug or biological product, a description 
of the product's strength and dosage form or, if the product is a 
device, the product's model number; and
    (iv) If the export is to a country not listed in section 802(b)(1) 
of the act, the country that is to receive the exported article. The 
notification may, but is not required to, identify countries listed in 
section 802(b)(1) of the act or state that the export is intended for a 
listed country without identifying the listed country.
    (2) The notification shall be sent to the following addresses:
    (i) For biological products and devices regulated by the Center for 
Biologics Evaluation and Research--Division of Case Management (HFM-
610), Office of Compliance and Biologics Quality, 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, 
biological products, 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 trade name;
    (ii) If the product is a drug or biological product, the product's 
abbreviated or proper name or, if the product is a device, the type of 
device;
    (iii) If the product is a drug or biological product, 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 or manufactured, and be maintained for the same period of 
time as required for records subject to good manufacturing practice or 
quality systems regulations applicable to the product. The records shall 
be made available to FDA, upon request, during an inspection for review 
and copying by FDA.

[66 FR 65447, Dec. 19, 2001]
