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Procedures for Labeling Evaluation Submissions and
Policy Advisory Consultations |
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(Effective September 27, 1999)
(Updated February 15, 2012)
These instructions serve to implement the changes in the
label review procedures that were described in the July 27,
1998, Notice of Procedural Change (63 FR 40010).
- For in-person submissions, labeling submittals
may be dropped at Patriots Plaza III, 355 E Street,
SW, Washington, DC:
Monday, Tuesday, Thursday, and Friday:
Morning: 10:00 - 11:30 a.m.
Afternoon: 1:30 – 3:00 p.m.
Wednesday:
Afternoon: 1:30 – 3:00 p.m.
Because access to the Labeling and Program Delivery
Division will be limited, please call ahead to the
Distribution Team at 301-504-0883 or 301-504-0878 to
announce your arrival.
"Log In" sheets and bar code strips may be obtained
during these times, as well.
Labeling may also be submitted by mail which includes U.S.
Postal Service, regular and priority, and U.S. overnight at
the address below:
USDA, FSIS, OPPD, LPDD
Distribution Unit
Stop Code 3786, Patriots Plaza III, 8-168
1400 Independence Avenue, SW
Washington, DC 20250-3700
Labeling submitted by UPS, FedEx, or Courier should be
shipped to the address below:
USDA, FSIS, OPPD, LPDD
Distribution Unit
Patriots Plaza III, 8-168
355 E. Street, SW
Washington, DC 20024-3221
- For in-person submissions, labeling
submittals (i.e., transmittal form, sketch,
supporting information, etc.) should be sorted by
category as outlined on the Log In Sheet. Within
each category described on the “Log In Sheet,”
please further sort submittals by establishment and,
within establishment, by similar product type.
Submit labels and related information in a bundle of
no more than 10 labels per bundle, with a completed
Log In Sheet attached as the cover of the bundle.
Please fill in all information
blocks on the Log In Sheet.
- Resubmissions will be directed to the
original Labeling Evaluation Specialist who
performed the label review. Indicate on the Log In
Sheet the name of the original Labeling Evaluation
Specialist (use a separate Log In Sheet for each
Labeling Evaluation Specialist).
- Bar codes must be attached to each
label transmittal form in the upper left corner of
the top copy. Please leave the original bar code
attached and include the comments provided by the
Labeling Compliance Team (LCT). For mail
submissions, bar codes will be applied by the team.
- Regardless of the mode of delivery,
labeling submittals will be evaluated on a
first-come, first-serve basis. Please note that
"turn-around" time depends on the volume of labeling
submitted for evaluation, the extent to which
corrections are needed, the complexity of the
information provided, and other extenuating
circumstances. It is advantageous to completely
review labeling submissions ahead of time, filling
in all transmittal information blocks, correcting
any errors or information gaps, and, most
importantly, having the necessary documentation
included. Incomplete or
illegible labeling submittals will be returned without evaluation.
- Careful thought should be given before
submitting a label that can be generically approved.
Agency review of such labels only slows down the
review process.
- The consulting or expediting firm will be
notified by fax or telephone that bundles are
completed and may be picked up.
- There will be advisory and consultation time
each working day between 8:00 a.m. and 4:00 p.m.
with the Division staff (including the Labeling
Evaluation Specialists) to ask questions concerning
labeling, standards, additives, product composition
policy, and returned labeling. Please contact the
Labeling Program Delivery Division (LPDD), at (301)
504-0878 to arrange appointments with Labeling
Evaluation Specialists and other technical policy
staff. There will be no approvals granted by the
staff during these appointments.
- Appeals of labeling policy decisions should be
submitted in a separate envelope marked "Appeal"
with the Appeal Form, the labeling submittal
(including sketch, transmittal form and supporting
documentation), and LCPS staff comments. Written
arguments supporting the basis for the appeal must
be enclosed with the appeal. In addition, all
uncontested modifications to labeling must be made
prior to the submission of an appeal. As always, the
appeal process involves the Labeling Evaluation
Specialist, and if necessary, the Staff Director.
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Last Modified:
February 23, 2011 |
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