[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR70.19]
[Page 327-328]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 70 COLOR ADDITIVES--Table of Contents
Subpart A General Provisions
Sec. 70.19 Fees for listing.
(a) Each petition for the listing of a color additive shall be
accompanied by a deposit of $3,000.00 if the proposal is for listing the
color additive for use generally in or on foods, in or on drugs, and in
or on cosmetics.
(b) If the petition for the listing is for use in or on foods only,
the deposit shall be $3,000.00.
(c) If the petition for the listing is for use in or on drugs and/or
cosmetics only, the deposit shall be $2,600.00.
(d) The provisions of paragraphs (a), (b), and (c) of this section
shall be applicable, whether or not the proposal contemplates any
tolerances, limitations, or other restrictions placed upon the use of
the color additive.
(e) If a petition proposing the issuance of a regulation is
withdrawn before it is finally accepted for filing, the deposit, less a
$600.00 fee for clerical handling and administrative and technical
review, shall be returned to the petitioner.
(f) If a petition proposing the issuance of a regulation is
withdrawn within 30 days after filing, the deposit, less $1,800.00 if
the petition is covered by paragraph (a) or (b) of this section, and
less $1,600.00, if the petition is covered by paragraph (c) of this
section, shall be returned to the petitioner.
(g) When a petition is withdrawn after filing and resubmitted within
6 months, it shall be accompanied by a deposit of $1,800.00 for a
petition filed under paragraph (a) or (b) of this section, and $1,600.00
for a petition filed under paragraph (c) of this section. If a petition
is resubmitted after 6 months, it shall be accompanied by the deposit
that would be required if it were being submitted for the first time.
(h) When the resubmission pertains to a petition that had been
withdrawn before acceptance for filing, a new advance deposit shall be
made in full as prescribed in paragraph (a), (b), or (c) of this
section.
(i) After a color additive has been listed, any request for an
amendment or additional tolerance shall be accompanied by a deposit of
$1,800.00 for use in the items specified in paragraphs (a)
[[Page 328]]
and (b) of this section, or $1,600.00 for use in items specified in
paragraph (c) of this section.
(j) The fee for services in listing a diluent under Sec. 80.35 for
use in color additive mixtures shall be $250.00.
(k) Objections and request for public hearing under section 721(d)
of the act or section 203(d)(2)(C) of Pub. L. 86-618 (74 Stat. 404; 21
U.S.C. 379e, note) shall be accompanied by a filing fee of $250.00.
(l) In the event of a referral of a petition under this section to
an advisory committee, all costs related thereto (including personal
compensation of committee members, travel materials, and other costs)
shall be borne by the person or organization requesting the referral,
such costs to be assessed on the basis of actual cost to the Government:
Provided, That the compensation of such costs shall include personal
compensation of advisory committee members at a rate not to exceed
$75.00 per member per day.
(m) In the case of requests of referrals to advisory committees, a
special advance deposit shall be made in the amount of $2,500.00. Where
required, further advance in increments of $2,500.00 each shall be made
upon request of the Commissioner of Food and Drugs. All deposits for
referrals to advisory committees in excess of actual expenses shall be
refunded to the depositor.
(n) All requests for pharmacological or other scientific studies
shall be accompanied by an advance deposit of $5,000.00. Further advance
deposits shall be made upon request of the Commissioner of Food and
Drugs when necessary to prevent arrears in such cost. Any deposits in
excess of actual expenses will be refunded to the depositor. If a
request is denied the advance deposit will be refunded less such costs
as are incurred for review of the request.
(o) The person who files a petition for judicial review of an order
under section 721(d) of the act shall pay the costs of preparing a
transcript of the record on which the order is based.
(p) All deposits and fees required by the regulations in this
section shall be paid by money order, bank draft or certified check
drawn to the order of the Food and Drug Administration, collectable at
par at Washington, DC All deposits and fees shall be forwarded to the
Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740,
whereupon after making appropriate record thereof they will be
transmitted to the Treasurer of the United States for deposit in the
special account ``Salaries and Expenses, Certification, Inspection, and
Other Services, Food and Drug Administration.''
(q) The Commissioner of Food and Drugs may waive or refund such fees
in whole or in part when in his judgment such action will promote the
public interest.
(r) Any person who believes that payment of these fees will work a
hardship on him may petition the Commissioner of Food and Drugs to waive
or refund the fees.
[42 FR 15636, Mar. 22, 1977, as amended at 54 FR 24890, June 12, 1989;
61 FR 14478, Apr. 2, 1996; 66 FR 56035, Nov. 6, 2001]
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