[Federal Register Volume 67, Number 181 (Wednesday, September 18, 2002)]
[Notices]
[Page 58810]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-23759]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02D-0402]


Guidance for Food and Drug Administration Field Offices on 
``Regulatory Procedures Manual, Chapter 9, Subchapter, `Import for 
Export'''; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a final guidance for FDA Field Offices entitled 
``Regulatory Procedures Manual, Chapter 9, Subchapter, `Import for 
Export'.'' This final guidance is a revision of the FDA Office of 
Regulatory Affairs' Regulatory Procedures Manual, Chapter 9, ``Import 
Operations/Actions,'' Subchapter, ``Import for Export,'' to provide 
guidance to the FDA Field Offices regarding the handling of products 
offered for import into the United States under section 801(d)(3) of 
the Federal Food, Drug, and Cosmetic Act (the act). The revision is 
necessary because of the enactment of section 322 of the Public Health 
Security and Bioterrorism Preparedness and Response Act of 2002, Public 
Law 107-188, signed into law on June 12, 2002. Section 322 amends 
section 801(d)(3) of the act and is effective September 9, 2002.

DATES: General comments on agency guidance documents are welcome at any 
time.

ADDRESSES: Submit written requests for single copies of the guidance to 
the Division of Import Operations and Policy (HFC-170), Office of 
Regulatory Affairs, 5600 Fishers Lane, Rockville, MD 20857. Send one 
self-addressed adhesive label to assist that office in processing your 
requests. Submit written comments on the guidance to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to 
http://www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY INFORMATION 
section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Joseph McCallion, Office of Regulatory 
Affairs (HFC-170), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-443-6553.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a final guidance for FDA 
Field Offices entitled ``Regulatory Procedures Manual, Chapter 9, 
Subchapter, `Import for Export'.''
    Section 322 of the Public Health Security and Bioterrorism 
Preparedness and Response Act of 2002, Public Law 107-188, signed into 
law on June 12, 2002, amended section 801(d)(3) of the act (21 U.S.C. 
381). The amended provision requires submission of certain information 
when certain articles are offered for import into the United States. 
The amended provision is effective September 9, 2002.
    The final guidance covers the scope of articles that can be offered 
under section 801(d)(3) of the act and the information required by the 
statutory provision to be submitted when certain articles are offered 
as ``import for export.'' The final guidance provides examples of 
documentation that will assist the FDA field offices in making a 
determination that the appropriate statements and information have been 
submitted and whether the entry should be allowed as an ``import for 
export'' or refused admission. The final guidance also provides 
information on the meaning of the terms ``further processing'' and 
``incorporated'' to be used by the FDA field offices in making 
determinations on the entry of products. Direction on internal agency 
procedures for processing ``import for export'' entries is included in 
the final guidance.
    This final guidance is being issued consistent with FDA's good 
guidance practices (GGPs) regulation (21 CFR 10.115). It is being 
implemented immediately without prior public comment, under Sec.  
10.115(g)(2), because of the agency's urgent need to provide guidance 
on the implementation of section 322 of the Bioterrorism Act, which is 
effective September 9, 2002, only 90 days after the statute's 
enactment. However, pursuant to GGPs, FDA requests comments on the 
guidance and will revise the document, if appropriate. The guidance 
represents the agency's current thinking on ``Regulatory Procedures 
Manual, Chapter 9, Subchapter, `Import for Export''' and is intended to 
provide uniform procedures for handling such importations by all FDA 
Field Offices. It does not create or confer any rights for or on any 
person and does not operate to bind FDA or the public. An alternative 
approach may be used if such approach satisfies the requirements of the 
applicable statutes and regulations.

II. Comments

    Interested persons may submit to the Dockets Management Branch (see 
ADDRESSES) written or electronic comments on the guidance. 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. The guidance and received 
comments are available for public examination in the Dockets Management 
Branch between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/ora/compliance_ref/rpm_new2/ or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: September 6, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-23759 Filed 9-13-02; 4:27 pm]
BILLING CODE 4160-01-S