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Procedures for Labeling Evaluation
Submissions and Policy Advisory Consultations |
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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).
- Labeling submitted for evaluation may be dropped at 5601 Sunnyside
Ave., 2-2279, Beltsville, MD between 7:00 a.m. and 4:00 p.m.,
Monday-Friday. Labeling may also be submitted via U.S. Mail or expedited
mail services. "Log In" Sheets (Enclosure) and bar code strips may be
obtained during these times, also.
- 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 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)
504-0879 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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