Supporting Statement for Electronic Submission of Food and Color
Additive Petitions

# A. Justification

Section 409(a)) (Tab 1) of the Federal Food, Drug and Cosmetic Act
(FFDCA) (21 U.S.C. 348(a)) provides that a food additive shall be deemed
to be unsafe: 1) unless 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) unless it and its use or intended use conform to
the terms of a regulatory exemption for investigational use; or 3)
unless, for a food contact substance, the substance and the use of such
substance are in conformity with a regulation prescribing the conditions
under such additive may be safely used or a food contact notification
submitted under subsection (h) is effective. Section 409(b) (Tab 1) of
FFDCA specifies the information that must be submitted by a petitioner
in order to establish the safety of the food additive and to secure the
issuance of a regulation by permitting its use.

To implement the provisions of section 409, FDA has issued regulations
under 171 (21 CFR Part 171) (Tab 2) These procedural regulations are
designed to delineate and specify the information that must be submitted
to meet the statutory requirements. The regulations add no substantive
requirements to those indicated in the law, but attempt to explain the
requirements more specifically and provide a standard format for
submission in order to expedite the processing of the petition. Labeling
requirements for food additives intended for human consumption are set
forth in various regulations contained in Parts 172, 173, and 180 (Tab
3). The labeling regulations are considered by FDA to be
cross-referenced to § 171.1, which is the subject of the OMB clearance
for food additive petitions (0910-0016).

We are requesting OMB approval for revision of the collection
requirements in:

21 CFR 171.1 Reporting

Requests specific data be provided to demonstrate safe us of food
additives under proposed use and provides a format for submissions of
petitions.

Section 721(a) (Tab 4) of the FFDCA (21 U.S.C. 379e(a))) Act (FFDCA) (21
U.S.C. 348)) provides that a color additive shall be deemed to be
unsafe: 1) unless 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) unless the additive and its use conform
to the terms of an exemption for investigational use issued under
section 721(f) (Tab 4) of the FFDCA. Section 721(b) (Tab 4) of the FFDCA
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 71 (21 CFR
Part 71) (Tab 5). 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, in order to expedite the processing of the petition.

The labeling requirements for color additives intended for foods, drugs,
devices, or cosmetics are also set forth in regulations contained in
Parts 73 through 74 (21 CFR Parts 73-74) (Tab 6). These labeling
requirements cross-reference §70.25 (21CFR 70.25), (Tab 7) which
requires that color additives to be used in foods, drugs, devices, or
cosmetics be labeled with sufficient information to ensure their safe
use, which is the subject of the OMB clearance for color additive
petitions (0910-0185).

We are requesting OMB approval for the revision of the collection
requirements in:

21 CFR 71.1 Reporting (Tab 5)

Specifies the format for filing a petition for a color additive.

To implement the above cited acts and relevant provisions of the
Clinger-Cohen Act, the Government Paperwork Elimination Act (GPEA) and
the Government Performance and Results Act (GPRA), in a Federal Register
notice (66 FR 39517, July 31, 2001),

FDA announced the availability of two draft guidance documents entitled
\"Draft Guidance for Industry-Providing Regulatory Submissions in
Electronic Format, General Considerations\" and \"Draft Guidance for
Industry Providing Regulatory Submissions in Electronic Format for Food
Additive and Color Additive Petitions\" (Tab 9). Attached as appendixes
to the latter draft guidance are Form No. 3503, entitled \"Food Additive
Petition Submission Application;\" Form No. 3504, entitled \"Color
Additive Petition Submission Application" for both of these forms (Tab
10). The information to be collected by way of electronically submitted
food additive and color additive petitions is 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 are not expected to increase the original
burden estimates for food and color additives.

**2) How, by Whom and For What Purpose Information Used**

Food additive petitions, submitted by food manufacturers or food
additive manufacturers, are reviewed by FDA scientific personnel to
ascertain if the data establish the identity of the substance, its use
in/on the food, and to establish that the intended use in food is safe.
The petitions themselves may contain privileged information and will not
be directly published. Favorable action on the petition requires
publication of a regulation in the **Federal Register** establishing the
conditions under which the additive may be safely used in food.

The labeling information for food, such as proper name of the product,
the name and address of the manufacturer of the product, and other
requirements such as net weight statements, are specifically required by
FFDCA and other Acts enforced by FDA.

Previously, food additive petitions provided the only method for
premarket safety review and approval of food additives required by law.
Without such petitions, there was no legal way to bring new products to
market.

**(3)** **Consideration of Information Technology**

In a Federal Register final rule of March 20, 1997 (62 FR 13464), FDA
published 21 CFR Part 11, Electronic records; electronic signatures.
These regulations apply to all FDA program areas and to any paper
records required by statute or agency regulations. On January 28, 1999
(64 FR 4433), FDA announced the availability of guidance for industry on
\"Providing Regulatory Submission in Electronic Format - General
Considerations.\" The Office of Food Additive Safety (OFAS) participated
in a number of the discussions and meetings with CDER, CBER and other
centers on agency standards for electronic submissions. These
discussions were designed to ensure that agency-wide requirements are
generally suitable for all electronic submissions to the agency,
including those for food and color additive petitions under 21 CFR 71.1
and 171.1.

The availability of computerized indexing services such as Med-Line and
Tox-Line permits petitioners to search the scientific literature for
safety data on new or existing food and color additives. FDA previously
instituted, internally, a computerized indexing and retrieval system
(SIREN: Scientific Information Retrieval and Exchange Network).

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 ingredient review program FDA initiated the
Food Additives Regulatory Management (FARM) Project. In implementing the
FARM project, OFAS and CFSAN have developed a new electronic information
management system used for the storage, retrieval, review and tracking
of information and data necessary for the review of food ingredients
including all food additive and color additive petitions as well as all
submissions. The FARM system permits FDA personnel to easily locate and
access all new and previously submitted petition, notification, and
related data.

This electronic information management system is designed to expedite
the petition/notification review process and subsequent Agency safety
decisions and also to help the FDA perform associated activities better,
such as responding to Freedom of Information Act (FOIA) requests and
managing correspondence. The submission of food additive and color
additive petitions in a consistent format will facilitate the use of the
electronic information management system developed under the FARM
project. Both back-filed and currently active petitions and
notifications have been scanned and indexed into the FARM system. OFAS
and CFSAN have set up a training facility in the Office of Food Additive
Safety to facilitate the training of agency personnel in handling of
petitions and notifications in electronic format and in performing
related activities, such as responding to electronic Freedom of
Information (EFOI) requests.

The labeling requirements under Parts 70.25, 73, 74, 172 and 173 (21 CFR
Parts 70.25, 73, 74, 172 and 173) do not prohibit the use of improved
technology that may be appropriate to satisfy the requirements. The
primary type of information collection being described here is the food
or color additive container label instructions for safe use, information
which the food or color additive manufacturer already has available.

**(4) Identification of Duplication and Similar Information Already
Available.**

FDA continues to work with EPA and USDA to eliminate areas of duplicate
data collection and evaluation. There is no duplication of FDA labeling
requirements by other U.S. government agencies.

Memoranda of understanding have been reached with EPA in the areas of
pesticides and water treatment. EPA establishes a tolerance, or
exemption from tolerance, for pesticide chemicals and residues of such
chemicals in food, and FDA enforces the tolerance or exemption.

In a notice of November 28, 1994 (59 FR 60870), FDA announced the
availability of a draft policy on its development and use of standards
with respect to international harmonization of regulatory requirements
and guidelines. In a notice of October 11, 1995 (60 FR 53078), the
agency addressed comments that it received in response to the November
28, 1994 notice and published the text of its policy on international
harmonization of regulatory requirements and guidelines. It is the
intent of this policy to enable FDA to: (1) continue to participate in
international standards activities that assist it in implementing
statutory provisions for safeguarding the public health; (2) increase
its efforts to harmonize its regulatory requirements with those of
foreign governments, including setting new standards that better serve
public health; and (3) respond to laws and policies such as the Trade
Agreements Act and OMB Circular No. A-119 that encourage agencies to use
international standards that provide the desired degree of protection.
FDA has followed up on this policy with an advance notice of proposed
rulemaking (62 FR 36243, July 7, 1997) announcing that the agency is
considering the amendment of its regulations to establish procedures for
the systematic review of standards and related texts adopted by the
Codex Alimentarius Commission (Codex). Codex is an international body
that establishes food standards under the joint auspices of the United
Nations World Health Organization and Food and Agriculture Organization.

In addition, The Center for Food Safety and Applied Nutrition has
developed an International Affirmative Agenda for the next three years
(2000-2002). This Agenda is publicly available in FDA's Dockets
Management Branch (Docket No. 99N-3089) (64 FR 71145, December 20,
1999).

Color additives are exempt from the provisions of the Toxic Substances
Control Act, so that data on safety and environmental concerns developed
by the petitioner for a color additive petition need not be duplicated.
However, existing safety data from feeding studies sometimes are not
considered adequate by contemporary scientific standards and may need to
be supplemented with new data.

**(5)** **Small Businesses**

FDA provides pre-submission consultations to small businesses to assist
them in preparing the submissions of petitions in electronic format. FDA
also works with the Service Corps of Retired Executives (SCORE), a
resource partner of the U.S. Small Business Administration, to assist
small businesses in preparing electronic submissions for food and color
additive petitions. OFAS and CFSAN have developed training materials on
electronic submission that it will provide to other FDA offices and
SCORE for use in assisting small business that wish to submit petitions
in electronic format.

The labeling requirements for a specific food additive are the same
regardless of the size of the firm. However, FDA helps small business to
deal with the labeling requirements through the scientific and
administrative staffs within the agency.

**(6) Consequences of Less Frequent Information Collection and Technical
Or Legal Obstacles**

Companies have a right, granted by law, to submit food or color additive
petitions in order to permit marketing of a new food additive or to
expand the usage of a currently regulated food or color additive.
Restriction of this right would lower the number of food additives being
cleared for use and would have no detrimental effects on Federal
activities.

The consequence of discontinuing labeling requirements would be the
possible misuse of food additives, resulting in the introduction of
unsafe food into interstate commerce. Each container of a food or color
additive must be properly labeled to assure safe use of the additive and
to safeguard the public health. Additionally, food ingredients must be
identified on the label of retail packages of foods.

Section 409(a) of the Federal Food, Drug and Cosmetic Act specifies that
a food additive is unsafe unless it conforms to a regulation prescribing
the conditions under which it may safely be used, or unless it is
exempted by regulation for investigational use, or an effective food
contact notification was submitted under Section 409(h). Section 409(b)
of FFDCA specifies the information that must be submitted by a
petitioner in order to establish the safety of a food additive and to
secure the issuance of a regulation permitting its use.

21 CFR Part 171 provides a standard format for food additive petitions
in order to facilitate the processing of the petition and hence the
issuance of a regulation as required by FFDCA.

Section 721(a) of the act (U.S.C. 379e) specifies that a color additive
is unsafe unless it conforms to a regulation prescribing the conditions
under which it may safely be used. Section 721(b) of the act specifies
the information that must be submitted by a petitioner in order to
establish the safety of a color additive and to secure the issuance of a
regulation permitting its use. 21 CFR Part 71 provides a standard format
for color additive petitions in order to facilitate the processing of
the petition and hence the issuance of a regulation as required by the
Act.

Section 721(b)(3) of the act states that directions or other labeling or
packaging requirements shall be included in color additive regulations
to assure the safety of the use or uses for which a particular color
additive is listed.

**(7) Special circumstances**

Data collection for food or color additive petitions involves no special
circumstances and all information would be collected in conformance with
the Paperwork Reduction Act.

**(8) Results of Comment Period and Outside Consultation**

In accordance with 5 CFR 1320.8(d), on July 31, 2001, (66 FR_39517), a
60-day notice for public comment (Tab 8) was published in the Federal
Register. No comments were received from the public.

In 1987, the agency announced the availability of guidelines for
formatting food additive, color additive, and generally recognized as
safe (GRAS) affirmation petitions prepared for submission to the FDA.
These guidelines were in response to requests from industry for guidance
in the preparation of these petitions. A contractor, working with the
Center for Food Safety and Applied Nutrition\'s petitions database,
developed guidelines for organizing and arranging the data and copies of
the subject petitions. The guidelines are not requirements of FDA but
represent a suggested format that can be followed by a petitioner if so
desired. Legal requirements for submission of food additive, color
additive and GRAS affirmation petitions outlined in 21 CFR Parts 71,
170, and 171 were not affected by the guidelines. These guidelines are
being replaced by the current draft guidance documents entitled \"Draft
Guidance for Industry-Providing Regulatory Submissions in Electronic
Format, General Considerations\" and \"Draft Guidance for Industry
Providing Regulatory Submissions in Electronic Format for Food Additive
and Color Additive Petitions\" that were published in the Federal
Register on July 31, 2001, 66 FR_39517. Attached as appendixes 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 information to be collected by
way of electronically submitted food additive and color additive
petitions is the same information that is currently collected in
petitions submitted as paper records.

In 1994, the agency prepared an information and guidance package for the
submission of food additive petitions. This package contains copies of
relevant FDA regulations and recommendations for preparing toxicology,
chemistry, and environmental information. These recommendations are
updated as required. This package is made available to anyone requesting
information on the preparation of a food additive petition in hard copy.
Guidance for submitting a food additive, color additive, or GRAS
petition is also available on the web at
\<<http://www.cfsan.fda.gov/~dms/opa-toc.html>\>.

On April 12, 1999 (64 FR 17672), FDA published a 60-day notice in the
Federal Register soliciting public comment as required under the PRA of
1995 . FDA did not receive any comments regarding the collection
requirements contained in this submission.

In 1993, the agency prepared an information and guidance package for the
submission of color additive petitions. This package contains copies of
relevant FDA regulations, recommendations for preparing toxicology,
chemistry, and environmental information, and a summary of color
additives listed for use in foods, drugs, and cosmetics. These
recommendations are updated as required. This package is available to
anyone requesting information on the preparation of a color additive
petition. The agency provides this guidance either in hard copy or on
the Internet at <http://vm.cfsan.fda.gov/~dms/opa-toc.html>

The agency is reinvigorating and expanding its regular meetings with
petitioners prior to submission of petitions for review to ensure that
data collected are those necessary and sufficient to reach a decision on
a petition.

Examples of persons and companies engaged in such consultation follows:

[Name]{.underline} [Firm]{.underline} [Telephone No.]{.underline}

Wood, John G. ECOLAB, Inc (651)293-4149

McEwen, Gerald Cosmetic, Toiletry, and (202)331-1770

Fragrance Assn.

Lorenz, Todd Cyanotech Corp. (808)326-1353

Merritt, Glenn Fitzpatrick & Waterman (201)865-9100

Weideman, Carol Linvatec (813)399-5334

Witham, Lonnie Biomet, Inc. (219)267-6639

Harrison, Eliot Lewis and Harrison (202)393-3903

Susan D. Phillips Environ (703)516-2300

Marrapese, Martha Keller and Heckman (202)434-4123

The purpose of the expanded consultations is to offer guidance on
specific testing requirements for a new additive or a new use of a
previously regulated additive and on recommendations for submission of
petitions in both paper and electronic formats, before the petitioners
submits the petitions. OFAS believes that this will expedite the review
process and increase the accuracy of the submissions. Any unresolved
issues are usually the subject of a future consultation. Any policy
issues would be referred to FDA management for consideration.

In general, the public sector has no involvement with data developed for
food or color additive petitions. Public opportunity for comment on a
food or color additive is given at the time a filing notice is published
in the **Federal Register** and the public may, within 30 days of the
publication of a regulation authorizing a new food additive, submit
objections. Additionally, all safety data submitted are subject to
release under the Freedom of Information Act.

**(9) Payment to Respondents**

No payment or gift is provided to respondents.

**(10) Confidentiality of Information**

Because food and color additive petitions often contain trade secret
information, all paper and electronic files are maintained in a secured
area. Access to electronic files are protected by firewalls and the use
of passwords that are controlled by the FARM System Administrators.
Confidentiality of data and information in food and color additive
petitions is regulated under 21 CFR 171.1 and 71.15. The information is
also safeguarded by Section 301(j) of FFDCA.

**(11) Sensitive Questions**

There are no questions of a sensitive nature in the food or color
additive petition requirements.

**(12) Burden Hours and Explanation**

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 and
forms that FDA is providing, the petitioner will be able to organize the
petition to focus on the information needed to expedite its safety
review. Therefore, we estimate that petitioners will only need to spend
approximately 1 hour completing the electronic submission application
form (form 3503 or 3504, as appropriate) because they will have already
used it to organize the petition information needed for the submission.

FDA estimates the burden of this collection of information as follows:

> Table 1.\--Estimated Annual Reporting Burden^1^

+-----------------+--------+-------+------+--------+------+---------+
| CFR Section     | No. of | A     | T    | Hours  | T    | Total   |
|                 | Respo  | nnual | otal | per    | otal | Op      |
|                 | ndents | Freq  | An   | Re     | H    | erating |
|                 |        | uency | nual | sponse | ours | and     |
|                 |        | of    | Resp |        |      | Main    |
|                 |        | Res   | onse |        |      | tenance |
|                 |        | ponse |      |        |      |         |
|                 |        |       |      |        |      | Costs   |
+-----------------+--------+-------+------+--------+------+---------+
| Food Additive   | 3      | 1     | 3    | 1      | 3    | 0       |
| Petitions^2^    |        |       |      |        |      |         |
| -electronic     | 3      | 1     | 3    | 4799   | 1    | 0       |
| submissions     |        |       |      |        | 4397 |         |
|                 | 3      | 1     | 3    | 0      |      | 0       |
| FDA Form 3503   |        |       |      |        | 0    |         |
|                 | 3      | 1     | 3    | 0      |      | 0       |
| 171.1-          |        |       |      |        | 0    |         |
| electronic      | 3      | 1     | 3    | 0      |      | 0       |
| submissions     |        |       |      |        | 0    |         |
|                 | 3      | 1     | 3    | 0      |      | 0       |
| Part 172-       |        |       |      |        | 0    |         |
| electronic      |        |       |      |        |      | 0       |
| submissions     |        |       |      |        | 1    |         |
|                 |        |       |      |        | 4400 |         |
| Part 173-       |        |       |      |        |      |         |
| electronic      |        |       |      |        |      |         |
| submissions     |        |       |      |        |      |         |
|                 |        |       |      |        |      |         |
| Part 175        |        |       |      |        |      |         |
| through         |        |       |      |        |      |         |
|                 |        |       |      |        |      |         |
| 178- electronic |        |       |      |        |      |         |
| submissions     |        |       |      |        |      |         |
|                 |        |       |      |        |      |         |
| Part 180-       |        |       |      |        |      |         |
| electronic      |        |       |      |        |      |         |
| submissions     |        |       |      |        |      |         |
|                 |        |       |      |        |      |         |
| Subtotal        |        |       |      |        |      |         |
|                 |        |       |      |        |      |         |
| Color Additive  |        |       |      |        |      |         |
| Petitions^2\ -^ |        |       |      |        |      |         |
| electronic      |        |       |      |        |      |         |
| submissions     |        |       |      |        |      |         |
+-----------------+--------+-------+------+--------+------+---------+
| FDA Form 3504   | 1      | 1     | 1    | 1      | 1    | 0       |
+-----------------+--------+-------+------+--------+------+---------+
| 70.25-          | 0      | 1     | 0    | 0      | 0    | 0       |
| electronic      |        |       |      |        |      |         |
| submissions     |        |       |      |        |      |         |
+-----------------+--------+-------+------+--------+------+---------+
| 71.1 Category   | 1      | 1     | 1    | 608    | 608  | \$2,600 |
| A^3^-           |        |       |      |        |      |         |
| electronic      |        |       |      |        |      |         |
| submissions     |        |       |      |        |      |         |
+-----------------+--------+-------+------+--------+------+---------+
| 71.1 Category   | 1      | 1     | 1    | 2394   | 2394 | \$3,000 |
| B^4^-           |        |       |      |        |      |         |
| electronic      |        |       |      |        |      |         |
| submissions     |        |       |      |        |      |         |
+-----------------+--------+-------+------+--------+------+---------+
| 71.1 Category   | 0      | 1     | 0    | 0      | 0    | 0       |
| C^5^-           |        |       |      |        |      |         |
| electronic      |        |       |      |        | 3003 | \$5600  |
| submissions     |        |       |      |        |      |         |
|                 |        |       |      |        |      |         |
| Subtotal        |        |       |      |        |      |         |
+-----------------+--------+-------+------+--------+------+---------+
| Total           |        |       |      |        | 1    | \$5600  |
|                 |        |       |      |        | 7403 |         |
+-----------------+--------+-------+------+--------+------+---------+

^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 typical medical device color additive petition with
minimal testing requirements (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, and
cosmetic color.

Under 21 CFR parts 71 and 171 the agency requires that the petitioner
submit the petitions in triplicate. \"Draft Guidance for Industry
Providing Regulatory Submissions in Electronic Format for Food Additive
and Color Additive Petitions\" provides that the petitioner should
include 1 paper copy and 2 electronic copies of the petition (1 archive
copy and 1 working copy). Although FDA received no comments on the draft
guidance, several scientists requested that the petitioner submit
electronic copies and 1 signed paper application. OFAS is prepared to
accept this last suggestion. The submission of 2 electronic copies,
however, is not expected to significantly increase the burden of
preparing the submission because the petitioner will be able to print
the paper copies of the petition from the electronic copy. This process
will not only ensure that all the copies of the petition are similar but
that they are legible and ready for agency review. Further, the agency
also plans to hold consultations with the petitioners during the time of
preparation to ensure that the information that the petitioners submits
meets the current requirements in parts 71 and 171 (21 CFR parts 71 and
171) and that it is in the recommended format.

Furnishing the information required even in a simple food additive
petition requires a team of professional employees, which may include
toxicologist, chemists, environmental scientists, and lawyers. Assuming
the aggregate professional hours cost is \$90, the annual cost to the
respondents for submitting petitions in electronic format is 1.3 million
dollars (14,400 x \$90/hr).

13. **Annual Cost to Respondents**

Color additives are subjected to payment of fees for the petitioning
process. The listing fee for a color additive petition ranges from
\$1,600 to \$3,000, depending on the intended use of the color and the
scope of the requested amendment. A complete schedule of fees is set for
the in 21 CFR 70.19. Only 1 Category A and 1 Category B color additive
petition in electronic format are expected per year. The maximum color
additive petition fee for a Category A petition is \$2,600 and the
maximum color additive petition fee for a Category B petition is
\$3,000. Since only 2 color additive petitions in electronic format are
expected per calendar year, the estimated total annual cost burden to
petitioner for the start-up cost would be less than or equal to \$5,600
(1 x \$2,600 + 1 x \$3,000). There are no capital costs associated with
this collection.

14. **Annual Cost to the Federal Government**

For fiscal year 1999, the Food and Drug Administration reports 25.9
person-years of professional time in the review of food additive
petitions. Based on an average cost of \$ *110,000*\_ per fully
supported position, the cost of processing food additive petitions in
fiscal year *1999* was \$*2,850,000*.

The annualized cost to the federal government of processing petitions is
derived by multiplying the person-years used in processing petitions by
the dollar value per supported position.

We estimate that FDA\'s acceptance of Food Contact Notifications
(FCN\'s) may reduce the submission of food additive petitions by as much
as 75%. Since mainly simple food additive petitions will be eligible for
exemption from petitioning under new Section 409(h) of FFDCA, the
expected reduction in annualized cost to the federal government of
processing and review of petitions is estimated to be approximately (60%
=50% based exemption + estimated 10% based on electronic processing and
review).

The Food and Drug Administration currently reports 2.1 person years of
professional time in the review of color additive petitions. Based on an
average cost of \$188,000 per fully supported position, the cost of
processing color additive petitions is \$395,000 per year (2.1 PY x
\$188,00O/PY = \$395,000). The annualized cost to the federal government
of processing petitions is derived by multiplying the person-year used
in processing petitions by the dollar value per supported position.

**(15) Explanation of Change in Items 13 and 14**

This is a new collection.

**(16) Statistical Reporting and Publication**

Food and color additive petitions are submitted for regulatory purposes
and the data in these petitions are not intended for statistical use.

**(17) Expiration Date on Form**

No approval is being sought to not display the expiration date for OMB
approval of the information collection.

**(18) Exception to Certification Statement**

There are no exceptions to the certification statement identified in
Item 19, \"Certification for

Paperwork Reduction Act Submissions,\'\' of OMB Form 83-1.

Tab 1- Section 409(a)(b) of the Federal Food, Drug, and Cosmetic Act

Tab 2- 21 CFR Part 171

Tab 3 - Parts 172, 173, and 180

Tab 4 - Section 721(a)(b) and (f) of the FFDCA

Tab 5 - 21 CFR Part 71

Tab 6 - 21 CFR Parts 73-74

Tab 7 - 21 CFR part 70.25

Tab 8 - Federal Register Notice (66 FR 39517, July 31, 2001) on the
availability of \"Draft Guidance for Industry-Providing Regulatory
Submissions in Electronic Format, General Considerations\" and \"Draft
Guidance for Industry Providing Regulatory Submissions in Electronic
Format for Food Additive and Color Additive Petitions.\"

Tab 9 - \"Draft Guidance for Industry-Providing Regulatory Submissions
in Electronic Format, General Considerations\" and \"Draft Guidance for
Industry Providing Regulatory Submissions in Electronic Format for Food
Additive and Color Additive Petitions.\"

Tab 10 -- Form No. 3503, "Food Additive Petition Submission Application"
and Form no. 3504, "color Additive Petition Submission Application".