[Federal Register: September 18, 2002 (Volume 67, Number 181)]
[Notices]
[Page 58810]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18se02-91]
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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