[Federal Register Volume 66, Number 231 (Friday, November 30, 2001)]
[Notices]
[Pages 59796-59797]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-29802]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. 01D-0294 and 01D-0295]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Providing Regulatory Submissions in Electronic 
Format for Food Additive and Color Additive Petitions

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 
December 31, 2001.

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: 
Stuart Shapiro, 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.

Providing Regulatory Submissions in Electronic Format for Food 
Additive and Color Additive Petitions

    Section 409(a) of the Federal Food, Drug, and Cosmetic Act (the 
act) (21 U.S.C. 348(a)) provides that a food additive shall be deemed 
to be unsafe unless: (1) It and its use or intended use are in 
conformity with a regulation prescribing the condition(s) under which 
such additive may safely be used; (2) it and its use or intended use 
conform to the terms of a regulatory exemption for investigational use; 
or (3) for a food contact substance, the substance and the use of such 
substance are in conformity with a regulation prescribing the 
conditions under which such additive may be safely used or a food 
contact notification submitted under section 409(h) of the act is 
effective. Individuals or companies submit food additive petitions to 
obtain approval of a new food additive or to amend the conditions of 
use permitted under an existing food additive regulation. The 
regulation in 21 CFR 171.1 specifies the information that a petitioner 
must submit in order to establish that the proposed use of a food 
additive is safe for its proposed use. This regulation implements 
section 409(b)(2) of the act.
    Section 721(a) of the act (21 U.S.C. 379e(a)) provides that a color 
additive shall be deemed to be unsafe unless: (1) The additive and its 
use are in conformity with a regulation listing such additive for such 
use, including any provision that describes the condition(s) under 
which the additive may safely be used and is either batch certified for 
such use or exempted from the certification requirements; or (2) the 
additive and its use conform to the terms of an exemption for 
investigational use issued under section 721(f) of the act. Individuals 
or companies submit color additive petitions to obtain approval of a 
new color additive or a change in the conditions of use permitted for a 
color additive that is already approved. The regulation in 21 CFR 71.1 
specifies the information that a petitioner must submit in order to 
establish that a color additive is safe and suitable for its proposed 
use.
    Respondents to this collection of information are businesses 
engaged in the manufacture or sale of food, food ingredients, 
substances used in materials that come into contact with food or 
engaged in the manufacture or sale of foods, drugs, devices, or 
cosmetics containing color additives.
    The agency estimates that up to 30 percent of the petitioners for 
both food and color additives will take advantage of the electronic 
submission process during the first year. By using the guidelines, 
including the forms that FDA is providing, the petitioner will be able 
to organize the petition to focus on the information needed to expedite 
review of the petition. Therefore, we estimate that petitioners will 
only need to spend approximately 1 hour completing the electronic 
submission application form (FDA Form 3503 or 3504, as appropriate) 
because they will have already organized the information needed for the 
submission into the appropriate categories.
    In the Federal Register of July 31, 2001 (66 FR 39517), the agency 
requested comments on the proposed collection of information. No 
comments were received.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 59797]]



                                 Table 1.--Estimated Annual Reporting Burden\1\
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                                                                                                       Total
21 CFR Section/Part/FDA     No. of    Annual Frequency  Total Annual    Hours per                  Operating and
          Form           Respondents    per Response      Responses     Response     Total Hours    Maintenance
                                                                                                       Costs
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Food additive
 petitions\2\--electron
 ic submissions
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FDA Form 3503                 3              1               3             1             3              0
171.1--electronic             3              1               3         4,799        14,397              0
 submissions
172--electronic               3              1               3             0             0              0
 submissions
173--electronic               3              1               3             0             0              0
 submissions
175 through 178--             3              1               3             0             0              0
 electronic submissions
180--electronic               3              1               3             0             0              0
 submissions
                                                                                   -----------------------------
Subtotal                                                                            14,400              0
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Color additive
 petitions\2\--electron
 ic submissions
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FDA Form 3504                 1              1               1             1             1              0
70.25--electronic             0              0               0             0             0              0
 submissions
71.1 category A\3\--          1              1               1           608           608          2,600
 electronic submissions
71.1 category B\4\--          1              1               1         2,394         2,394          3,000
 electronic submissions
71.1 category C\5\--          0              0               0             0             0              0
 electronic submissions
                                                                                   -----------------------------
 Subtotal                                                                            3,003         $5,600
                                                                                   -----------------------------
 Total                                                                              17,403         $5,600
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\1\ There are no capital costs associated with this collection of information.
\2\The electronic submissions (e-submissions) contain the same petition information required for paper
  submissions; only the submission format will contain both electronic and paper.
\3\Category A--A color additive petition with minimal testing requirements, such as is typical for medical
  device color additive petitions (toxicity studies, collection of identity information, analytical information,
  and administrative details).
\4\Category B--An average color additive petition consisting of analytical work, 90-day feeding study, and the
  administrative details, which include the drafting of the regulations.
\5\Category C--A petition for a completely new food, drug, or cosmetic color.

    Under parts 71 and 171 (21 CFR parts 71 and 171), the agency 
requires that the petitioner submit the petitions in triplicate. The 
draft guidance for industry entitled ``Providing Regulatory Submissions 
to Office of Food Additive Safety in Electronic Format for Food 
Additive and Color Additive Petitions'' provides that petitioner should 
include one copy of the petition in electronic format (``electronic 
copy'') and one copy in paper format (``paper copy''). The submission 
of an electronic copy, however, is not expected to significantly 
increase the burden of preparing the submission because it merely 
serves as a substitute for paper copies. Further, the agency also plans 
to hold consultations with the petitioners during the time of 
preparation to ensure that the information that the petitioners submit 
meets the current requirements in parts 71 and 171 and that it is in 
the recommended format.
    The estimate of burden for electronically submitted food additive 
petitions is based on the number of new food additive petitions 
received in fiscal year (FY) 1999 and the total hours expended by 
petitioners to prepare the petitions. We estimate that during the first 
year, the electronic submission process will reduce the total time of 
preparation for food additive petitions by approximately 10 percent of 
the burden previously estimated for paper petitions (see 65 FR 64222, 
October 26, 2000). Although the burden varies with the type of petition 
submitted, an average food additive petition involves review of 
appropriate scientific studies, as well as the work of drafting the 
petition itself. The burden varies depending on the complexity of the 
petition, including the amount and types of data needed for scientific 
analysis.
    The estimate of burden for electronically submitted color additive 
petitions is based on an average of five new color additive petitions 
received each year in FY 1998 and 1999. We estimate that during the 
first year, the electronic submission process will reduce the total 
time of preparation for color additive petitions by approximately 10 
percent of the burden previously estimated for paper petitions (see 64 
FR 51128, September 21, 1999). Although the burden varies with the type 
of petition submitted, an average color additive petition involves 
analytical work and appropriate toxicology studies, as well as the work 
of drafting the petition itself.
    If an average of five color additive petitions (all submissions) 
are expected per calendar year, and only one submission per category 
for categories A and B is an electronic submission, the estimated 
annual burden for this start-up cost would be approximately $5,600. 
Based on the assumption that companies will use the same equipment for 
generating both paper and electronic records after this initial start-
up cost, i.e., software and storage media for preparing both paper and 
electronic submissions, the burden of maintaining electronic equipment 
and of maintaining electronic records should not increase the burden of 
preparing such petitions. In fact, the cost of shipping electronic 
media should be less than shipping paper copies of petitions.

    Dated: November 26, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-29802 Filed 11-29-01; 8:45 am]
BILLING CODE 4160-01-S