[Federal Register Volume 67, Number 93 (Tuesday, May 14, 2002)]
[Rules and Regulations]
[Page 34387]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-11935]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1

[Docket No. 98N-0583]


Exports; Notification and Recordkeeping Requirements; Stay

AGENCY: Food and Drug Administration, HHS.

ACTION:  Final rule; stay.

-----------------------------------------------------------------------

SUMMARY:  The Food and Drug Administration (FDA) is staying the final 
rule on notification and recordkeeping requirements for persons 
exporting human drugs, animal drugs, biological products, devices, 
food, and cosmetics that may not be marketed or sold in the United 
States. This action is in response to four requests for a stay because 
certain parties would not be able to comply with the effective date of 
March 19, 2002.

DATES:  Effective May 14, 2002; 21 CFR 1.101 is stayed until June 19, 
2002.

FOR FURTHER INFORMATION CONTACT:  Philip L. Chao, Office of Policy, 
Planning, and Legislation (HF-23), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-0587.

SUPPLEMENTARY INFORMATION:  In the Federal Register of December 19, 
2001 (66 FR 65429), FDA (we) published a final rule entitled ``Exports: 
Notification and Recordkeeping Requirements.'' The final rule 
established the export notification and recordkeeping requirements for 
persons exporting human drugs, animal drugs, biological products, 
devices, food, and cosmetics that may not be marketed or sold in the 
United States. The final rule implements certain statutory changes made 
by the FDA Export Reform and Enhancement Act and will be codified at 
Sec. 1.101 (21 CFR 1.101).
    The final rule was to become effective on March 19, 2002. On March 
1, 2002, and later on March 8, 11, and 12, 2002, we received three 
petitions for stay of administrative action and one letter requesting 
that we stay the final rule's effective date by 6 months. In general, 
the petitions and letter stated that certain parties would be unable to 
comply by the original March 19, 2002, effective date and that some 
parties were confused as to the final rule's applicability to certain 
products.
    On March 18, 2002, we notified the parties that the agency intended 
to grant the petitions and the letter's request, in part, by extending 
the final rule's effective date by 3 months, and that the agency would 
publish a document in the Federal Register staying the rule under 21 
CFR 10.35(e). This stay should allow the parties and other affected 
industry members more time to understand and to establish programs and 
policies for complying with the regulatory requirements that apply to 
exported products that may not be marketed or sold in the United 
States. The new effectiveness for Sec. 1.101 is June 19, 2002.
    To the extent that 5 U.S.C. 553 applies to this action, it is 
exempt from notice and comment because it constitutes a rule of 
procedure under 5 U.S.C. 553(b)(3)(A). Alternatively, the agency's 
implementation of this action without opportunity for public comment, 
effective immediately upon publication today in the Federal Register, 
is based on the good cause exceptions in 5 U.S.C. 553(b)(3)(B) and 
(d)(3). Seeking public comment is impracticable, unnecessary, and 
contrary to the public interest. The agency is staying Sec.  1.101 
until June 19, 2002, because the agency has determined that it is 
appropriate to allow affected industry members more time to understand 
and to establish programs and policies for complying with the 
regulatory requirements that apply to exported products that may not be 
marketed or sold in the United States.
    This action pertains solely to the requirements of the final rule. 
Affected industry members must continue to comply with the statutory 
requirements for exports under section 801(e) and 802 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 381 and 321).

    Dated: May 6, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-11935 Filed 5-13-02; 8:45 am]
BILLING CODE 4160-01-S