[Federal Register Volume 64, Number 218 (Friday, November 12, 1999)]
[Notices]
[Pages 61648-61649]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-29493]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. 99D-4575 and 99D-4576]
Draft Guidances for Industry on Food-Contact Substance
Notification System; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of two draft guidance documents entitled ``Preparation of
Premarket Notifications for Food Contact Substances: Chemistry
Recommendations,'' and ``Preparation of Premarket Notifications for
Food Contact Substances: Toxicology Recommendations.'' These documents
are intended to provide guidance for industry regarding the preparation
of premarket notifications (PMN's) for food-contact substances (FCS's).
In addition, FDA Form No. 3480 entitled ``Notification for New Use of a
Food Contact Substance'' is being made available as an attachment to
each of these guidance documents. This form is provided for comment as
part of the collection of information for the notification system for
FCS's. FDA is providing these draft guidances as part of its
implementation of the PMN process for FCS's established by the FDA
Modernization Act of 1997 (FDAMA) (Public Law 105-115).
DATES: Submit written comments concerning these draft guidances by
February 14, 2000. Submit written comments concerning the collection of
information by January 11, 2000.
ADDRESSES: Submit written comments concerning these draft guidances and
the collection of information to the Dockets Management Branch (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. Comments should be identified with the docket
number found in brackets in the heading of this document. Submit
written requests for single copies of the draft guidances to the Office
of Premarket Approval (HFS-200), Food and Drug Administration, 200 C
St. SW., Washington, DC 20204, 202-418-3100, FAX 202-418-3131. All
requests should identify the draft guidances by the titles listed
above. See the SUPPLEMENTARY INFORMATION section for electronic access
to these draft guidances.
FOR FURTHER INFORMATION CONTACT: Mitchell A. Cheeseman, Center for Food
Safety and Applied Nutrition (HFS-215), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-418-3083.
SUPPLEMENTARY INFORMATION:
I. Background
FDAMA amended section 409 of the Federal Food, Drug, and Cosmetic
Act (the act) (21 U.S.C. 348) to establish a PMN process as the primary
method for authorizing new uses of food additives that are FCS's. A
``food contact substance'' is defined in section 409(h)(6) of the act
as ``any substance intended for use as a component of materials used in
manufacturing, packing, packaging, transporting, or holding food if
such use is not intended to have any technical effect in such food.''
Once the PMN process begins to operate (see section 409(h)(5) of the
act), FDA expects most new uses of FCS's that previously would have
been regulated by issuance of a listing regulation in response to a
food additive petition (FAP) or would have been exempted from the
requirement of a regulation under the threshold of regulation (TOR)
process will be the subject of PMN's. FDA is announcing the
availability of two draft guidance documents entitled ``Preparation of
Premarket Notifications for Food Contact Substances: Chemistry
Recommendations,'' and ``Preparation of Premarket Notifications for
Food Contact Substances: Toxicology Recommendations.'' These documents
are intended to provide guidance for industry regarding the preparation
of PMN's for FCS's. FDA is providing these draft guidances as part of
its implementation of the PMN process for FCS's established by FDAMA.
II. Significance of Guidance
These two draft guidance documents represent the agency's current
thinking on the data and information that should be submitted in a PMN
for the use of an FCS. These draft guidance documents do not create or
confer any rights for or on any person and do not operate to bind FDA
or the public. An alternative approach may be used if such approach
satisfies the requirements of the applicable statute and regulations.
These two draft guidance documents are level 1 guidances under the
agency's good guidance practices (62 FR 8961, February 27, 1997).
III. Electronic Access
The draft guidances may also be accessed via the Internet at the
Center for Food Safety and Applied Nutrition website at http://
www.fda.gov/cfsan.
IV. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C 3501-
3520), Federal agencies must obtain approval from the Office of
Management and Budget (OMB) for each collection of information they
conduct or sponsor. ``Collection of information'' is defined in 44
U.S.C. 3502(3) and 5 CFR 1320.3 and includes agency requests or
requirements that members of the public submit reports, keep records,
or provide information to a third party. Section 3506(c)(2)(A) of the
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a
60-day notice in the Federal Register concerning each proposed
collection of information before submitting the collection to OMB for
approval. To comply with this requirement, FDA is publishing notice of
the proposed collection of information set forth below.
With respect to the following collection of information, FDA
invites comments on: (1) Whether the proposed collection of information
is necessary for the proper performance of FDA's functions, including
whether the information will have practical utility; (2) the accuracy
of FDA's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) ways to minimize the burden of the
collection of information on respondents, including through the use of
automated collection techniques, when appropriate, and other forms of
information technology.
Title: Food-Contact Substances Notification System
Description: Section 409(h) of the Federal Food, Drug, and Cosmetic
Act (the act) establishes a premarket notification process for FCS's.
Section 409(h)(6) of the act defines a ``food contact substance'' as
``any substance intended for use as a component of materials used in
manufacturing, packing, packaging, transporting, or holding food if
such use is not intended to have any technical effect in such food.''
Section 409(h)(3) of the act requires that the notification process be
[[Page 61649]]
utilized for authorizing the marketing of FCS's, except where FDA
determines that the submission and premarket review of an FAP under
section 409(b) of the act is necessary to provide adequate assurance of
safety. Section 409(h)(1) of the act requires that a notification
include information on the identity and the intended use of the FCS and
the basis for the notifier's determination that the FCS is safe under
the intended conditions of use. Because section 409(h)(1) of the act
references the general safety standard for food additives, the data in
a PMN should be comparable to the data in an FAP. FDA is announcing the
availability for comment of two draft guidance documents that are part
of the agency's implementation of the PMN program, which will largely
replace the FAP process for those food additives that are FCS's. The
information to be collected is information on the manufacture and
intended use of the FCS, studies relating to the safety of the FCS, and
other information necessary to demonstrate that the FCS is safe under
the intended conditions of use.
FDA is also making available for comment FDA Form No. 3480 entitled
``Notification for New Use of a Food Contact Substance'' for a
notification for a new use of a FCS. FDA believes that this form will
facilitate both preparation and review of notifications since the form
will serve to organize information necessary to support the safety of
the use of the FCS. The burden of filling out the appropriate form has
been included in the burden estimate for the notification.
Description of Respondents: Manufacturers of food-contact
substances.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Annual
Form No. of Frequency per Total Annual Hours per Total Hours
Respondents Response Responses Response
----------------------------------------------------------------------------------------------------------------
FDA 3480 \2\ 200 1 200 25 5,000
FDA 3480 \3\ 125 2 250 120 30,000
FDA 3480 \4\ 45 2 90 150 13,500
FDA 3480 \5\ 16 1 16 150 2,400
Total 50,900
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Duplicate notifications for uses of FCS's.
\3\ Notifications for uses that would currently be the subject of exemptions under 21 CFR 170.39 or very simple
FAP's.
\4\ Notifications for uses that would currently be the subject of moderately complex FAP's.
\5\ Notifications for uses that would currently be the subject of more complex FAP's.
The above estimate is based on the types of submissions that FDA
currently receives for FCS's in the TOR and the FAP processes and the
following assumptions and information:
1. FDA estimates that the likely increase in PMN's over the number
of FAP's and TOR requests will be approximately four times the highest
recent influx of these submissions (50 and 54, respectively). This
factor is based on an analysis of the number of companies producing
various types of FCS's and the types of FCS's for which FAP's and TOR's
are most commonly submitted to FDA.
2. FDA also has included 200 expected duplicate submissions in the
second lowest tier. FDA expects that the burden for preparing these
notifications will primarily consist of the notifier filling out FDA
Form No. 3480, verifying that a previous notification is effective, and
preparing necessary documentation.
3. Based on the amount of data typically submitted in FAP's and TOR
requests, FDA identified three other tiers of PMN's that represent
escalating levels of burden required to collect information.
4. FDA estimated the median number of hours necessary for
collecting information for each type of notification within each of the
three tiers, and the cost of developing necessary data based on input
from industry sources.
V. Comments
Interested persons may, on or before February 14, 2000, submit to
the Dockets Management Branch (address above) written comments
regarding the two draft guidance documents. Two copies of any comments
are to be submitted, except that individuals may submit one copy.
Comments are to be identified with the docket numbers found in brackets
in the heading of this document. Submit written comments concerning
this collection of information to the Dockets Management Branch by
January 11, 2000. The draft guidance documents and received comments
may be seen in the office above between 9 a.m. and 4 p.m., Monday
through Friday. Received comments will be considered when determining
whether to amend the guidance.
Dated: November 1, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-29493 Filed 11-10-99; 8:45 am]
BILLING CODE 4160-01-F