[Federal Register Volume 65, Number 105 (Wednesday, May 31, 2000)]
[Notices]
[Pages 34713-34715]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-13585]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. 99D-4575 and 99D-4576]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Food-Contact Substance Notification System

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that the 
proposed collection of information listed below has been submitted to 
the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments on the collection of information by June 
30, 2000.

ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: 
Wendy Taylor, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Peggy Schlosburg, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Title: Food-Contact Substances Notification System

    Description: Section 409(h) of the Federal Food, Drug, and Cosmetic 
Act (the act) (21 U.S.C. 348(h)) establishes a premarket notification 
(PMN) process for food-contact substances (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 utilized for 
authorizing the marketing of FCS's, except where FDA determines that 
the submission and premarket review of a food additive petition (FAP) 
under section 409(b) of the act is necessary to provide adequate 
assurance of safety. Section 409(h)(1) of

[[Page 34714]]

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.
    In the Federal Register of November 12, 1999 (64 FR 61648), FDA 
announced 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 also made available 
for comment FDA Form No. 3480, entitled ``Notification for New Use of a 
Food Contact Substance,'' which is to be used for a notification for a 
new use of a FCS. FDA believes that this form will facilitate both 
preparation and review of notifications because 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. The agency requested 
comments on the proposed collections of information.
    One comment was received on FDA's paperwork reduction analysis for 
the notification program for FCS's. Portions of this comment concern 
the content of the guidance documents announced in the November 12, 
1999, notice. FDA will consider these portions of the comment in 
preparing the final version of the guidance documents.
    Portions of the comment addressed the format, content, and utility 
of the proposed FDA Form 3480. The comment stated that FDA Form 3480 
would be more useful if it were made available in a common word 
processor format such as WordPerfect<Register> or Word<Register>. FDA 
has made the form available in a portable document format that is 
compatible with and can be read by most current versions of word 
processing software packages. Therefore, FDA disagrees that it is 
necessary for the form to be available in a word processor format in 
order for it to be useful. However, FDA does expect to make the form 
available in WordPerfect<Register> and Word<Register> formats once the 
form has been approved by OMB.
    The comment further stated that the form should be pilot tested to 
insure its compatibility throughout the industry. FDA has designed Form 
3480 to function as summary form for many types of notifications. FDA 
expects to modify the form to suit the needs of the agency and the 
various types of notifications and notifiers. FDA expects to make it 
possible for notifiers to fill out the form through the agency's 
Internet site, and to ultimately use the form to facilitate electronic 
submissions. FDA believes that the most efficient way to evaluate this 
form is to begin using it and examine the problems and any suggestions 
for improvement on a continuing basis. FDA expects to accomplish this 
through the periodic reauthorization of the form required by OMB.
    The comment correctly states that, in many cases, only summary 
information may be included in the form and that more detailed 
information will need to be referenced and attached. Moreover, the 
comment states that this caused the form to be a many-segmented 
document forcing the reader to jump back and forth within the document. 
The comment also states that a summary form with all supporting 
information attached in a specified format would be more useful to FDA 
and the regulated industry. The comment further states that all 
notifications should contain the same information in the same place 
within the submission.
    As explained above, FDA believes that FDA Form 3480 is the summary 
form that the comment suggests is needed. FDA has not mandated, and 
does not expect to mandate, a particular format for notifications in 
regulations. Therefore, notifiers are free to present and organize the 
supporting information exactly as the notifier wishes. FDA recognizes 
that all sections of FDA Form 3480 will not be applicable to all 
notifications nor to all notifiers. However, FDA believes that most if 
not all notifiers will find the form useful in organizing their 
submissions. In addition, FDA disagrees with the notifier that the form 
will not assist FDA in processing notifications because it will be a 
many-segmented document. FDA's review of notifications is generally 
segmented into chemical, toxicological, and environmental disciplines. 
FDA Form 3480 was designed with this review process in mind. The 
proposed Form 3480 will assist FDA reviewers in locating the pertinent 
portions of the data and information that relate specifically to their 
discipline and their specific review responsibilities.
    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\                           55               2             110             120          13,200
FDA 3480 \4\                           45               2              90             150          13,500
FDA 3480 \5\                           16               1              16             150           2,400
Total                                                                                             34,100 \6\
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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.
\6\ Due to a clerical error, the reporting burden hours for FDA 3480 <SUP>3</SUP> that appeared in the Federal Register of
  November 12, 1999 (64 FR 61648), were incorrect. Table 1 of this document contains the correct estimates.

    The above estimate is based on the types of submissions that FDA 
currently receives for FCS's in the threshold of regulation (TOR) and 
the FAP processes and the following assumptions and information:

[[Page 34715]]

    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.

    Dated: May 23, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-13585 Filed 5-30-00; 8:45 am]
BILLING CODE 4160-01-F