[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR5.45]

[Page 48-49]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 5--DELEGATIONS OF AUTHORITY AND ORGANIZATION--Table of Contents
 
Subpart B--Redelegations of Authority from the Commissioner of Food and 
                                  Drugs
 
Sec. 5.45  Imports and exports.

    (a) The Regional Food and Drug Directors, District Directors, and 
the Director, St. Louis Branch, are authorized, under section 801 of the 
Federal Food, Drug, and Cosmetic Act (FFDCA), to perform the following 
functions or to designate officials to:
    (1) Request from the Secretary of the Treasury samples of food, 
drugs (including biological products), devices, or cosmetics imported or 
offered for import.
    (2) Determine whether such articles are in compliance with the 
FFDCA.
    (3) Authorize relabeling or other compliance actions to bring 
articles into compliance under the FFDCA.
    (4) Supervise such compliance actions.
    (b) The Director and Deputy Directors, Center for Devices and 
Radiological Health (CDRH); the Director and Deputy Director, Office of 
Compliance, CDRH; Regional Food and Drug Directors; District Directors; 
and the Director, St. Louis Branch, are authorized, under section 360 of 
the Public Health Service Act (PHSA), to perform the following functions 
or to designate officials to:
    (1) Request from the Secretary of the Treasury samples of electronic 
products imported or offered for import to determine whether such 
products are in compliance with the PHSA.
    (2) Refuse admission of noncomplying products and notify the 
Secretary of the Treasury of such refusal.
    (3) Supervise operations to bring noncomplying products into 
compliance under the PHSA.
    (4) Refuse or grant permission and time extensions to bring 
noncomplying products into compliance with the PHSA in accordance with a 
corrective action plan approved by the Director, Office of Compliance 
and Surveillance, CDRH.
    (c) The following officials are authorized, under section 360B(b) of 
the PHSA, to exempt persons from issuing a certification, as required by 
section 358(h) of the PHSA, for electronic products imported into the 
United States for testing, evaluation, demonstrations, or training, 
which will not be introduced into commerce and upon completion of their 
function will be destroyed or exported in accord with U.S. Customs 
Service's regulations:
    (1) The Director and Deputy Directors, CDRH.
    (2) The Director and Deputy Director, Office of Compliance, CDRH.
    (3) Regional Food and Drug Directors.
    (4) District Directors.
    (5) The Director, St. Louis Branch.
    (d) The Regional Food and Drug Directors, District Directors, and 
the Director, St. Louis Branch, are authorized to exercise all of the 
functions of the Commissioner of Food and Drugs under section 362 of the 
PHSA that refers to the prohibition of the introduction of foods, drugs, 
devices, cosmetics, and electronic products and other items or products 
regulated by the Food and Drug Administration into the United States 
when it is determined that it is required in the interest of public 
health, and such functions relate to the law enforcement functions of 
the Food and Drug Administration.
    (e) The following officials are authorized to perform all the 
functions of the Commissioner of Food and Drugs pertaining to 
exportation of medical devices under section 801(e) of the FFDCA:
    (1) For medical devices assigned to their respective organization:
    (i) The Director and Deputy Directors, CDRH.
    (ii) The Director and Deputy Director, Office of Compliance, CDRH.
    (iii) The Director and Deputy Director, Division of Program 
Operations, Office of Compliance, CDRH.
    (iv) The Director and Deputy Director, Center for Biologics 
Evaluation and Research (CBER).
    (v) The Director and Deputy Director, Office of Compliance, CBER.

[[Page 49]]

    (2) Regional Food and Drug Directors.
    (3) District Directors.
    (4) The Director, St. Louis Branch.
    (f) The following officials are authorized to perform the functions 
of the Commissioner of Food and Drugs, for drugs under their 
jurisdiction, pertaining to authorizing the reimportation of 
prescription drugs under section 801(d)(2) of the FFDCA for emergency 
medical care:
    (1) The Director, Center for Biologics Evaluation and Research 
(CBER) and the Director, Office of Compliance, CBER.
    (2) The Director, Deputy Center Director for Review Management, and 
Deputy Center Director for Pharmaceutical Science, Center for Drug 
Evaluation and Research (CDER) and the Director and Deputy Director, 
Office of Compliance, CDER.

[48 FR 8441, Mar. 1, 1983, as amended at 48 FR 56946, Dec. 27, 1983; 49 
FR 572, Jan. 5, 1984; 49 FR 14933, Apr. 16, 1984; 51 FR 32452, Sept. 12, 
1986; 54 FR 6518, Feb. 13, 1989; 54 FR 8317, Feb. 28, 1989; 54 FR 9034, 
Mar. 3, 1989; 55 FR 47053, Nov. 9, 1990; 57 FR 40318, Sept. 3, 1992; 62 
FR 2555, Jan. 17, 1997; 62 FR 67271, Dec. 24, 1997]