[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]


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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.

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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availability of two draft guidance documents entitled ``Preparation of 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\
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                                                      Annual
              Form                    No. of       Frequency per   Total Annual      Hours per      Total Hours
                                    Respondents      Response        Responses       Response
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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
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\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