[Federal Register Volume 66, Number 147 (Tuesday, July 31, 2001)]
[Notices]
[Pages 39517-39521]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-18948]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Draft Guidances for Industry on Providing Regulatory Submissions 
to Office of Food Additive Safety in Electronic Format: General 
Considerations and for Food Additive and Color Additive Petitions; 
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 guidances for industry entitled ``Providing 
Regulatory Submissions to Office of Food Additive Safety in Electronic 
Format--General Considerations'' and ``Providing Regulatory Submissions 
to Office of Food Additive Safety in Electronic Format for Food 
Additive and Color Additive Petitions.'' These documents are the first 
in a series of guidance documents intended to provide guidance for 
industry regarding the preparation of regulatory submissions in 
electronic format to the Office of Food Additive Safety (OFAS), Center 
for Food Safety and Applied Nutrition (CFSAN). OFAS is providing these 
draft guidances as part of its implementation of 21 CFR part 11 and the 
Food Additives Regulatory Management (FARM) Project.

DATES: Submit written or electronic comments concerning these draft 
guidances by October 1, 2001, to ensure adequate consideration in the 
preparation of revised guidances, if warranted. However, you may submit 
written or electronic comments at any time. Submit written comments 
concerning the collection of information by October 1, 2001.

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. Submit electronic comments to http://www.fda.gov/dockets/ecomments. All comments should be identified with the 
corresponding docket number found in brackets in the heading of this 
document. Submit written requests for single copies of the draft 
guidances for industry entitled ``Providing Regulatory Submissions to

[[Page 39518]]

Office of Food Additive Safety in Electronic Format--General 
Considerations'' and ``Providing Regulatory Submissions to Office of 
Food Additive Safety in Electronic Format for Food Additive and Color 
Additive Petitions,'' to the Office of Food Additive Safety (HFS-200), 
Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, 200 C St. SW., Washington, DC 20204. Send one self-
addressed adhesive label to assist that office in processing your 
request or include a fax number to which the draft guidance may be 
sent. Alternatively, you may request a copy of the draft guidances by 
calling 202-418-3100, or you may fax your request to 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: JoAnn Ziyad, Center for Food Safety 
and Applied Nutrition (HFS-206), Food and Drug Administration, 200 C 
St. SW., Washington, DC 20204, 202-418-3116.

SUPPLEMENTARY INFORMATION:

I. Background

    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. Section 409(b) of the act specifies the information that 
must be submitted by a petitioner in order to establish the conditions 
under which a food additive may be safely used.
    To implement the provisions of section 409 of the act, FDA has 
issued regulations under part 171 (21 CFR part 171). These procedural 
regulations are designed to delineate and specify the information that 
must be submitted to meet the statutory requirements. The regulations 
provide a standard format for submission, which assists in the 
processing of the petition.
    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. Section 
721(b) of the act specifies the information that must be submitted by a 
petitioner in order to establish that a color additive is safe and 
suitable for its proposed use.
    To implement the provisions of section 721 of the act, FDA has 
issued regulations for submission of color additive petitions under 
part 71 (21 CFR part 71). These procedural regulations are designed to 
delineate and to specify the information that must be submitted to meet 
the statutory requirements. The regulations provide a standard format 
for submission, which assists in the processing of the petition.
    In the Federal Register of March 20, 1997 (62 FR 13430), FDA 
published the final rule on Electronic Records; Electronic Signatures 
(21 CFR part 11). That final rule applies to all FDA program areas and 
to any paper records and handwritten signatures executed on paper that 
are required by statute or agency regulations. On January 28, 1999 (64 
FR 4433), the Center for Drug Evaluation and Research (CDER) and the 
Center for Biologics Evaluation and Research (CBER) announced the 
availability of guidance for industry on ``Providing Regulatory 
Submission in Electronic Format--General Considerations.'' Prior to 
publication of this guidance, OFAS participated in a number of the 
discussions and meetings with CDER, CBER, and other centers within the 
agency with respect to guidelines for electronic submissions.
    FDA is now announcing the availability of two draft guidance 
documents for industry entitled ``Providing Regulatory Submissions to 
Office of Food Additive Safety in Electronic Format--General 
Considerations'' and ``Providing Regulatory Submissions to Office of 
Food Additive Safety in Electronic Format for Food Additive and Color 
Additive Petitions.'' Attached as appendices to the latter draft 
guidance are Form No. 3503, entitled ``Food Additive Petition 
Submission Application,'' Form No. 3504, entitled ``Color Additive 
Petition Submission Application,'' and accompanying instructions for 
both of these forms. The draft guidance on general considerations for 
electronic submissions addressed in this notice is similar in many 
respects, though not identical, to the guidance published by CDER and 
CBER (64 FR 4433). However, because OFAS only proposes to accept food 
and color additive petitions in electronic format at this time, the 
only present, practical application of this draft guidance on general 
considerations is to food and color additive petitions. The draft 
guidance for the submission of food additive and color additive 
petitions reflects a further refinement of the guidance on general 
considerations with respect to food additive and color additive 
petitions submitted to OFAS. (See Secs. 71.1 and 171.1.) Attached as 
appendices to the draft guidance on food and color additive petitions 
are Form No. 3503, entitled ``Food Additive Petition Submission 
Application,'' Form No. 3504, entitled ``Color Additive Petition 
Submission Application,'' and accompanying instructions for both of 
these forms.
    OFAS intends to update guidance documents on electronic regulatory 
submissions regularly to reflect the evolving nature of the technology 
involved and the experience of those using this technology. Although 
the guidance for one center with respect to electronic submissions may 
differ from that for another center, in some cases, due to differences 
in procedures and computer infrastructures, OFAS will work to minimize 
these differences wherever possible.
    The draft guidances announced in this notice are also part of 
OFAS's efforts under the FARM project. FDA initiated the FARM project 
in June 1995 as part of a comprehensive plan, in which FDA made a 
commitment to Congress to provide resources to improve the efficiency 
and functioning of the food additive and color additive review program. 
In implementing the FARM project, OFAS and CFSAN have developed an 
electronic data management system used for the storage and retrieval of 
information and data necessary for the review of food additive and 
color additive petitions. This electronic data management system is 
designed to expedite the petition review process and subsequent agency 
safety decisions and also to help FDA perform associated activities 
better, such as responding to Freedom of Information Act requests and 
managing correspondence. The submission of food additive and color 
additive petitions in a consistent format will facilitate the use of 
the electronic data management system developed under the FARM project.
    The information to be collected by way of electronically submitted 
food additive and color additive petitions is

[[Page 39519]]

the same information that is currently collected in petitions submitted 
as paper records. FDA believes that these forms will facilitate both 
the preparation and review of food and color additive petitions because 
these forms will serve to organize information necessary to support the 
safety of the use of food and color additives and, therefore, to 
decrease the overall paperwork burden. The burden of filling out the 
appropriate form and preparing the electronic media is not expected to 
increase the reporting and paperwork burden estimates for food and 
color additives petitions.

II. Significance of Guidance

    The two draft guidance documents represent OFAS's current thinking 
on the format for the data and information in an electronically 
submitted petition for the use of a food or color additive. 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 statutes and regulations. These two draft guidance documents 
are level 1 guidances and are being distributed for comment in 
accordance with FDA's good guidance practices regulation (21 CFR 10115; 
65 FR 56468, September 19, 2000).

III. 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 in this document.
    Because OFAS proposes to collect food and color additive petitions 
in electronic format, in addition to a paper copy, at the present time, 
the following analysis contemplates only the paperwork burden stemming 
from the submission of food and color additive petitions in electronic 
format. In the event that OFAS proposes to accept other forms of 
regulatory submissions in electronic format, we will analyze the 
paperwork burden for such submissions at that time.
    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.

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

     Section 409(a) of the act 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. Section 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 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. Section 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.
    FDA estimates the burden of this collection of information as 
follows:

                                 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

[[Page 39520]]

 
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, 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.

IV. Comments

    Interested persons may submit to the Dockets Management Branch 
(address above) written or electronic comments on each of the two draft 
guidances by October 1, 2001, to ensure adequate consideration of the 
comments in the preparation of revised guidances, if warranted. 
However, interested persons may submit written or electronic comments 
at any time. Two copies of any comments are to be submitted pertaining 
to each guidance document, as applicable, except that individuals may 
submit one copy. Comments are to be identified with the docket number 
found in brackets in the heading of this document. Submit written 
comments concerning this collection of information to the Dockets 
Management Branch by October 1, 2001. The draft

[[Page 39521]]

guidance documents and received comments may be seen in the Dockets 
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

V. Electronic Access

    Persons with access to the Internet may obtain the guidances at 
http://www.cfsan.fda.gov/@dms/opa-toc.html.

    Dated: July 19, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-18948 Filed 7-30-01; 8:45 am]
BILLING CODE 4160-01-S