[Federal Register: November 30, 2001 (Volume 66, Number 231)]
[Notices]
[Page 59796-59797]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30no01-85]
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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
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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
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Subtotal 3,003 $5,600
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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