Download DEPARTMENT OF HEALTH AND HUMAN SERVICES

DEPARTMENT
Food
OF HEALTH AND HUMAN SERVICES
and Drug Administration
[Docket
Nos. _ 2002N-0276
_ ---
and 2002N-02781
Small Entity Compliance
Notice of Imported
Guides on Registration
and Prior
Food; Availability
Food and Drug Administration,
AGENCY:
of Food Facilities
HHS.
Notice.
ACTION:
The Food and Drug Administration
SUMMARY:
availability
of small entity compliance
rules on Registration
(FDA) is announcing
the
guides (SECGs) for the interim
of Food Facilities
and Prior Notice of Imported
final
Food
issued under the Public Health Security and Bioterrorism
Preparedness and
Response Act of 2002 (the Bioterrorism
final rules published
Act). Both interim
in the Federal Register of October 10, 2003. These SECGs are intended
small businesses better understand
the registration
to help
and prior notice
regulations.
DATES:
Submit written
ADDRESSES:
or electronic
Submit written
of Dockets Management
comments
comments
(HFA-305)
Fishers Lane, rm. 1061, Rockville,
on the SECGs at any time.
concerning
these SECGs to the Division
Food and Drug Administration,
MD 20852. Submit electronic
5630
comments
on
the SECGs to h ttp://www.fda.gov/dockets/ecomments.
Submit requests for single copies of one or both SECGs to the Prior Notice
help desk by telephone
575-0156
cf0387
at l-800-216-7331
(within
the United States) or 301--
(outside the United States), by FAX: 301-210-0247,
or by e-mail:
2
See the SUPPLEMENTARY INFORMATION section for electronic
[email protected].
access
to these SECGs.
Deborah Ralston, Office of Regulatory
FOR FURTHER INFORMATION CONTACT:
Affairs, Office of Regional Operations,
Fishers Lane, Rockville,
SUPPLEMENTARY
Food and Drug Administration,
5600
MD 20857, 301-443-6230.
INFORMATION:
I. Background
(68 FR 58894 and 68 FR
In the Federal Register of October lo,2003
58974),
FDA issued two interim
(Registration
of Food Facilities)
final rules to implement
and 307 (Prior Notice of Imported
the Bioterrorism
Act. The registration
foreign facilities
that manufacture/process,
animal consumption
interim
of prior notice of food, including
final rule requires domestic and
pack, or hold food for human or
final rule requires the submission
animal feed, that is imported
import into the United States beginning
by the Regulatory
Food) of
in the United States to register with FDA by December
12, 2003. The prior notice interim
We examined
sections 305
would have a significant
of these interim
Act (5 U.S.C. 601-612)
economic
or offered for
on December 12, 2003.
the economic implications
Flexibility
to FDA
rules as required
and determined
impact on a substantial
that they
number of small
entities.
In compliance
Enforcement
with section 212 of the Small Business Regulatory
Fairness Act (Public Law 104-121),
SECGs that explain the requirements
we are making available these
of these regulations.
FDA is issuing these SECGs as level 2 guidance consistent with FDA’s
good guidance practices regulation
in simplified
(21 CFR 10.115(c)(2)).
These SECGs restate,
format and language, FDA’s current requirements
for Registration
3
of Food Facilities
documents
and Prior Notice of Imported
are not binding
that the regulations
on either FDA or the public. FDA notes, however,
that serve as the basis for these guidance documents
establish requirements
recommends
Food. As guidance, these
for all covered activities.
For this reason, FDA strongly
that affected parties consult the regulations
subparts H and I, in addition
at 21 CFR part 1,
to reading these SECGs.
II. Comments
Interested persons may submit to the Division
ADDRESSES)
written
or electronic
single copy of electronic
comments,
comments
except that individuals
to be identified
with the applicable
heading of this document.
of Dockets Management
comments
of Dockets Management
(see
regarding these SECGs. Submit a
or two paper copies of any mailed
may submit one paper copy. Comments
are
docket number(s) found in brackets in the
Received comments may be seen in the Division
between 9 a.m. and 4 p.m., Monday through Friday.
4
III. Electronic
Access
Persons with access to the Internet may obtain these SECGs at hftp://www/
cfsan.fda.gov/guidance.html.
Dated:
I 4)
A’J
p\
J(
December 3, 2003.
Assistanc'Commissioner
for
Policy.
[FR Dot. KC-?????Filed ??-??-03; 8:~ am]
BILLING
CODE 4160-01-S