Agency Information Collection Activities; Proposed Collection; Comment Request; Submission of Petitions: Food Additive, Color Additive (Including Labeling), and Generally Recognized as Safe Affirmation; Electronic Submission Using Food and Drug Administration Forms 3503 and 3504, 2533-2535 [E7-681]
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Federal Register / Vol. 72, No. 12 / Friday, January 19, 2007 / Notices
CMS, Office of Strategic Operations and
Regulatory Affairs, Division of
Regulations Development—A,
Attention: Melissa Musotto, Room
C4–26–05, 7500 Security Boulevard,
Baltimore, MD 21244–1850.
Dated: January 12, 2007.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. E7–700 Filed 1–18–07; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. 2007N–0014]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Submission of
Petitions: Food Additive, Color
Additive (Including Labeling), and
Generally Recognized as Safe
Affirmation; Electronic Submission
Using Food and Drug Administration
Forms 3503 and 3504
Food and Drug Administration,
HHS.
sroberts on PROD1PC70 with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the information collection provisions of
FDA’s regulations for submission of
petitions, including food and color
additive petitions (including labeling)
and generally recognized as safe (GRAS)
affirmations, and electronic submission
using FDA Forms 3503 and 3504. This
notice also notifies the public of, and
solicits comments on, FDA’s proposal to
transfer the collection of information
and burden associated with petitions
submitted to amend the indirect food
additive regulations from the subject
collection of information Office of
Management and Budget (OMB) control
number 0910–0016 to the collection of
information for the Food Contact
Substances Notification System (OMB
control number 0910–0495).
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18:10 Jan 18, 2007
Jkt 211001
Submit electronic
comments on the collection of
information to: https://www.fda.gov/
dockets/ecomments. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Food and Drug Administration
AGENCY:
Submit written or electronic
comments on the collection of
information by March 20, 2007.
DATES:
Jonna Capezzuto, Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
4659.
Under the
PRA (44 U.S.C. 3501–3520), Federal
agencies must obtain approval from
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(c) 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,
including each proposed extension of an
existing 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.
With respect to the following
collection of information, FDA invites
comments on these topics: (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.
SUPPLEMENTARY INFORMATION:
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2533
Submission of Petitions: Food Additive,
Color Additive (Including Labeling),
and GRAS Affirmation; Electronic
Submission Using FDA Forms 3503 and
3504—21 CFR 70.25, 71.1, 170.35,
171.1, 172, 173, 179, and 180 (OMB
Control Number 0910–0016)—Extension
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) The additive and its use, or
intended use, are in conformity with a
regulation issued under section 409 of
the act that describes the condition(s)
under which the additive may be safely
used; (2) the additive and its use, or
intended use, conform to the terms of an
exemption for investigational use; or (3)
a food contact notification submitted
under section 409(h) of the act is
effective. Food additive petitions (FAPs)
are submitted by individuals or
companies 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 (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
and to secure the publication of a food
additive regulation describing the
conditions under which the additive
may be safely used. Parts 172, 173, 179,
and 180 (21 CFR parts 172, 173, 179,
and 180) contain labeling requirements
for certain food additives to ensure their
safe use.
Section 721(a) of the act (21 U.S.C.
379e(a)) provides that a color additive
shall be deemed to be unsafe unless the
additive and its use are in conformity
with a regulation that describes the
condition(s) under which the additive
may safely be used, or the additive and
its use conform to the terms of an
exemption for investigational use issued
under section 721(f) of the act. Color
additive petitions (CAPs) are submitted
by individuals or companies 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 (21 CFR
71.1) specifies the information that a
petitioner must submit to establish the
safety of a color additive and to secure
the issuance of a regulation permitting
its use. FDA’s color additive labeling
requirements in § 70.25 (21 CFR 70.25)
require that color additives that are to be
used in food, drugs, devices, or
cosmetics be labeled with sufficient
information to ensure their safe use.
Under section 201(s) of the act (21
U.S.C. 321(s)), a substance is GRAS if it
is generally recognized among experts
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Federal Register / Vol. 72, No. 12 / Friday, January 19, 2007 / Notices
qualified by scientific training and
experience to evaluate its safety, to be
safe through either scientific procedures
or common use in food. The act
historically has been interpreted to
permit food manufacturers to make their
own initial determination that use of a
substance in food is GRAS and
thereafter seek affirmation of GRAS
status from FDA. FDA reviews petitions
for affirmation of GRAS status that are
submitted on a voluntary basis by the
food industry and other interested
parties under authority of sections 201,
402, 409, and 701 of the act (21 U.S.C.
321, 342, 348, and 371). To implement
the GRAS provisions of the act, FDA has
set forth procedures for the GRAS
affirmation petition process in
§ 170.35(c)(1) (21 CFR 170.35(c)(1)).
While the GRAS affirmation petition
process still exists, FDA has not
received a GRAS affirmation petition
since the establishment of the voluntary
GRAS notification program.
In the Federal Register of July 31,
2001 (66 FR 39517), FDA announced the
availability of a draft guidance entitled
‘‘Draft Guidance for Industry on
Providing Regulatory Submissions to
Office of Food Additive Safety in
Electronic Format for Food Additive
and Color Additive Petitions.’’ This
guidance describes the procedures for
electronic submission of FAPs and
CAPs using FDA Form 3503 and FDA
Form 3504, respectively.
FDA scientific personnel review food
and color additive and GRAS
affirmation petitions to ensure the safety
of the intended use of the substance in
or on food, or of a food additive that
may be present in food as a result of its
use in articles that contact food (or for
color additives, its use in food, drugs,
cosmetics, or medical devices).
Description of respondents:
Respondents are businesses engaged in
the manufacture or sale of food, food
ingredients, color additives, or
substances used in materials that come
into contact with food.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR Section/FDA Form
No. of
Respondents
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Operating and
Maintenance Costs
Total Hours
CAPs
70.25, 71.1
3
1
3
1,337
$8,200
4,010
FDA Form 3504
1
1
1
1
0
1
1 or fewer
1
1 or fewer
2,614
0
2,614
171.1
6
1
6
7,093
0
42,560
FDA Form 3503
1
1
1
1
0
1
$8,200
49,186
GRAS Affirmation Petitions
170.35
FAPs
Total
sroberts on PROD1PC70 with NOTICES
1There
are no capital costs associated with this collection of information.
The estimate of burden for food
additive, color additive, or GRAS
affirmation petitions is based on FDA’s
experience and the average number of
new petitions received in calendar years
2003, 2004, and 2005, and the total
hours expended in preparing the
petitions. In compiling these estimates,
FDA consulted its records of the number
of petitions received in the past 3 years.
The figures for hours per response are
based on estimates from experienced
persons in the agency and in industry.
Although the estimated hour burden
varies with the type of petition
submitted, an average petition involves
analytical work and appropriate
toxicological 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.
Color additives are subjected to
payment of fees for the petitioning
process. The listing fee for a color
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18:10 Jan 18, 2007
Jkt 211001
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 forth in 21 CFR
70.19. An average of two category A and
one category B color additive petitions
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 an average of
three color additive petitions are
expected per calendar year, the
estimated total annual cost burden to
petitioners for this start-up cost would
be less than or equal to $8,200 ((2 x
$2,600) + (1 x $3,000) = $8,200). There
are no capital costs associated with
color additive petitions.
The estimated burden reported in
table 1 of this document does not
include the previously estimated burden
for the preparation of FAPs submitted to
amend parts 175 throuhg 178 (21 CFR
parts 175 through 178). The burden to
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Fmt 4703
Sfmt 4703
respondents is similar between the
preparation of petitions submitted to
amend parts 175 through 178 and the
preparation of a food contact substance
notification. In this request for
extension of OMB approval for the
collection of information for FAPs, FDA
proposes to transfer the collection of
information and burden associated with
petitions submitted to amend the
indirect food additive regulations (parts
175 through 178) from this collection of
information (OMB control number
0910–0016) to the existing collection of
information for the Food Contact
Substances Notification System (OMB
control number 0910–0495).
FDA estimates the annual reporting
burden associated with petitions
submitted to amend parts 175 through
178 to be transferred from OMB control
number 0910–0016 to OMB control
number 0910–0495. An average of two
indirect food additive petitions are
expected per calendar year. The
estimated total annual hour burden to
E:\FR\FM\19JAN1.SGM
19JAN1
sroberts on PROD1PC70 with NOTICES
Federal Register / Vol. 72, No. 12 / Friday, January 19, 2007 / Notices
petitioners per petition is 10,995 hours,
for a total burden of 21,990 hours. There
are no capital costs or operating and
maintenance costs associated with the
burden hours being transferred from
OMB control number 0910–0016 to
OMB control number 0910–0495.
Electronic submissions of petitions
contain the same petition information
required for paper submissions. The
agency estimates that one petitioner for
both food and color additives will take
advantage of the electronic submission
process per 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 for FDA’s 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 the
guidelines to organize the petition
information needed for the submission.
The labeling requirements for food
and color additives were designed to
specify the minimum information
needed for labeling in order that food
and color manufacturers may comply
with all applicable provisions of the act
and other specific labeling acts
administered by FDA. Label information
does not require any additional
information gathering beyond what is
already required to assure conformance
with all specifications and limitations in
any given food or color additive
regulation. Label information does not
have any specific recordkeeping
requirements unique to preparing the
label. Therefore, because under § 70.25,
labeling requirements for a particular
color additive involve information
required as part of the CAP safety
review process, the estimate for number
of respondents is the same for § 70.25
and § 71.1, and the burden hours for
labeling are included in the estimate for
§ 71.1. Also, because labeling
requirements under parts 172, 173, 179,
and 180 for particular food additives
involve information required as part of
the FAP safety review process under
§ 171.1, the burden hours for labeling
are included in the estimate for § 171.1.
In cases where a regulation
implements a statutory information
collection requirement, only the
additional burden attributable to the
regulation, if any, has been included in
FDA’s burden estimate.
Dated: January 12, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–681 Filed 1–18–07; 8:45 am]
BILLING CODE 4160–01–S
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18:10 Jan 18, 2007
Jkt 211001
DEPARTMENT OF HOMELAND
SECURITY
Office of the Secretary
Determination Pursuant to Section 102
of the Illegal Immigration Reform and
Immigrant Responsibility Act of 1996
as Amended by Section 102 of the
REAL ID Act of 2005 and as Amended
by the Secure Fence Act of 2006
Office of the Secretary,
Department of Homeland Security.
ACTION: Notice of determination.
AGENCY:
SUMMARY: The Secretary of Homeland
Security has determined, pursuant to
law, that it is necessary to waive certain
laws, regulations and other legal
requirements in order to ensure the
expeditious construction of physical
barriers and roads in the vicinity of the
international land border of the United
States in Arizona. The Secretary’s
waiver is effective upon publication of
this Notice.
DATES: This Notice is effective on
January 19, 2007.
Determination and Waiver: In section
102(a) of the Illegal Immigration Reform
and Immigrant Responsibility Act of
1996 (IIRIRA), Public Law 104–208, Div.
C, 110 Stat. 3009–546, 3009–554 (Sept.
30, 1996) (8 U.S.C. 1103, note), Congress
provided that the Attorney General shall
take such actions as may be necessary
to install additional physical barriers
and roads (including the removal of
obstacles to detection of illegal entrants)
in the vicinity of the United States
border to deter illegal crossings in areas
of high illegal entry into the United
States. Pursuant to sections 1511 and
1517 of the Homeland Security Act of
2002 (HSA), Public Law 107–296, 116
Stat. 2135, 2309, 2311 (Nov. 25, 2002)
(6 U.S.C. 551, 557), the authorities of the
Attorney General contained in section
102 of the IIRIRA were transferred to the
Secretary of Homeland Security
(Secretary).
In section 3 of the Secure Fence Act
of 2006 (Secure Fence Act), Public Law
109–367), Congress amended Section
102(b) of IIRIRA to provide for the
installation of fencing, barriers, roads,
lighting, cameras, and sensors along five
segments of the southern border of the
United States, including much of the
border between Arizona and Mexico. In
section 102(c) of the IIRIRA, as amended
by section 102 of the REAL ID Act of
2005, Public Law 109–13, Div. B, 119
Stat. 231, 302, 306 (May 11, 2005)
(REAL ID Act) (8 U.S.C. 1103 note),
Congress granted the Secretary
‘‘authority to waive all legal
requirements such Secretary, in such
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Frm 00046
Fmt 4703
Sfmt 4703
2535
Secretary’s sole discretion, determines
necessary to ensure the expeditious
construction of barriers and roads
under’’ section 102 of IIRIRA.
I have determined that the area in the
vicinity of the United States border
known as the Barry M. Goldwater Range
(BMGR), as described in the Bureau of
Land Management’s ‘‘Legal Description
of Barry M. Goldwater Range
Withdrawal, AZ’’ (66 FR 59813
(November 30, 2001)), in southwestern
Arizona, including the adjacent area to
the west of the BMGR, is an area of high
illegal entry. This area is also within the
footprint of infrastructure provided for
in Section 102(b)(1)(A)(ii) of IIRIRA as
amended by the Secure Fence Act.
There is presently a need to construct
fixed and mobile barriers (such as
fencing, vehicle barriers, towers,
sensors, cameras, and other
surveillance, communication, and
detection equipment) and roads in the
vicinity of the border of the United
States within and in the vicinity of the
BMGR. In order to ensure the
expeditious construction of the barriers
and roads that Congress prescribed in
sections 102(a) and 102(b) of the IIRIRA
in the BMGR, which is an area of high
illegal entry into the United States, I
have determined that it is necessary to
exercise the authority that was
transferred to me by sections 1511 and
1517 of the HSA and that is vested in
me by section 102(c) of the IIRIRA as
amended by section 102 of the REAL ID
Act.
Accordingly, with respect to the
construction, as prescribed in sections
102(a) and 102(b) of the IIRIRA, of roads
and fixed and mobile barriers within the
BMGR and within five miles to the west
of the BMGR (including, but not limited
to, accessing the project area, the
conduct of earthwork, excavation, fill,
and site preparation, and installation
and upkeep of fences, roads, supporting
elements, drainage, erosion controls,
safety features, surveillance,
communication, and detection
equipment of all types, radar and radio
towers, and lighting), I hereby waive, in
their entirety, all Federal, State, or other
laws, regulations and legal requirements
of, deriving from, or related to the
subject of, the following laws, as
amended: the National Environmental
Policy Act (Pub. L. 91–190, 83 Stat. 852,
(Jan. 1, 1970) (42 U.S.C. 4321 et seq.));
the Endangered Species Act (Pub. L. 93–
205, 87 Stat. 884 (Dec. 28, 1973) (16
U.S.C. 1531 et seq.)); the Federal Water
Pollution Control Act (commonly
referred to as the Clean Water Act) (Act
of June 30, 1948, c. 758, 62 Stat. 1155
(33 U.S.C. 1251 et seq.)); the Wilderness
Act (Pub. L. 88–577, 16 U.S.C. 1131 et
E:\FR\FM\19JAN1.SGM
19JAN1
]]>Agencies
[Federal Register Volume 72, Number 12 (Friday, January 19, 2007)]
[Notices]
[Pages 2533-2535]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-681]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N-0014]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Submission of Petitions: Food Additive, Color Additive
(Including Labeling), and Generally Recognized as Safe Affirmation;
Electronic Submission Using Food and Drug Administration Forms 3503 and
3504
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the information collection
provisions of FDA's regulations for submission of petitions, including
food and color additive petitions (including labeling) and generally
recognized as safe (GRAS) affirmations, and electronic submission using
FDA Forms 3503 and 3504. This notice also notifies the public of, and
solicits comments on, FDA's proposal to transfer the collection of
information and burden associated with petitions submitted to amend the
indirect food additive regulations from the subject collection of
information Office of Management and Budget (OMB) control number 0910-
0016 to the collection of information for the Food Contact Substances
Notification System (OMB control number 0910-0495).
DATES: Submit written or electronic comments on the collection of
information by March 20, 2007.
ADDRESSES: Submit electronic comments on the collection of information
to: https://www.fda.gov/dockets/ecomments. Submit written comments on
the collection of information to the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief
Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-4659.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from 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(c) 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, including each proposed
extension of an existing 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.
With respect to the following collection of information, FDA
invites comments on these topics: (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.
Submission of Petitions: Food Additive, Color Additive (Including
Labeling), and GRAS Affirmation; Electronic Submission Using FDA Forms
3503 and 3504--21 CFR 70.25, 71.1, 170.35, 171.1, 172, 173, 179, and
180 (OMB Control Number 0910-0016)--Extension
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) The additive and its use, or intended use,
are in conformity with a regulation issued under section 409 of the act
that describes the condition(s) under which the additive may be safely
used; (2) the additive and its use, or intended use, conform to the
terms of an exemption for investigational use; or (3) a food contact
notification submitted under section 409(h) of the act is effective.
Food additive petitions (FAPs) are submitted by individuals or
companies 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 (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 and to secure the publication of a food additive
regulation describing the conditions under which the additive may be
safely used. Parts 172, 173, 179, and 180 (21 CFR parts 172, 173, 179,
and 180) contain labeling requirements for certain food additives to
ensure their safe use.
Section 721(a) of the act (21 U.S.C. 379e(a)) provides that a color
additive shall be deemed to be unsafe unless the additive and its use
are in conformity with a regulation that describes the condition(s)
under which the additive may safely be used, or the additive and its
use conform to the terms of an exemption for investigational use issued
under section 721(f) of the act. Color additive petitions (CAPs) are
submitted by individuals or companies 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 (21 CFR 71.1) specifies
the information that a petitioner must submit to establish the safety
of a color additive and to secure the issuance of a regulation
permitting its use. FDA's color additive labeling requirements in Sec.
70.25 (21 CFR 70.25) require that color additives that are to be used
in food, drugs, devices, or cosmetics be labeled with sufficient
information to ensure their safe use.
Under section 201(s) of the act (21 U.S.C. 321(s)), a substance is
GRAS if it is generally recognized among experts
[[Page 2534]]
qualified by scientific training and experience to evaluate its safety,
to be safe through either scientific procedures or common use in food.
The act historically has been interpreted to permit food manufacturers
to make their own initial determination that use of a substance in food
is GRAS and thereafter seek affirmation of GRAS status from FDA. FDA
reviews petitions for affirmation of GRAS status that are submitted on
a voluntary basis by the food industry and other interested parties
under authority of sections 201, 402, 409, and 701 of the act (21
U.S.C. 321, 342, 348, and 371). To implement the GRAS provisions of the
act, FDA has set forth procedures for the GRAS affirmation petition
process in Sec. 170.35(c)(1) (21 CFR 170.35(c)(1)). While the GRAS
affirmation petition process still exists, FDA has not received a GRAS
affirmation petition since the establishment of the voluntary GRAS
notification program.
In the Federal Register of July 31, 2001 (66 FR 39517), FDA
announced the availability of a draft guidance entitled ``Draft
Guidance for Industry on Providing Regulatory Submissions to Office of
Food Additive Safety in Electronic Format for Food Additive and Color
Additive Petitions.'' This guidance describes the procedures for
electronic submission of FAPs and CAPs using FDA Form 3503 and FDA Form
3504, respectively.
FDA scientific personnel review food and color additive and GRAS
affirmation petitions to ensure the safety of the intended use of the
substance in or on food, or of a food additive that may be present in
food as a result of its use in articles that contact food (or for color
additives, its use in food, drugs, cosmetics, or medical devices).
Description of respondents: Respondents are businesses engaged in
the manufacture or sale of food, food ingredients, color additives, or
substances used in materials that come into contact with food.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
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No. of Annual Frequency Total Annual Hours per Total Operating and
21 CFR Section/FDA Form Respondents per Response Responses Response Maintenance Costs Total Hours
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CAPs
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70.25, 71.1 3 1 3 1,337 $8,200 4,010
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FDA Form 3504 1 1 1 1 0 1
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GRAS Affirmation Petitions
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170.35 1 or fewer 1 1 or fewer 2,614 0 2,614
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FAPs
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171.1 6 1 6 7,093 0 42,560
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FDA Form 3503 1 1 1 1 0 1
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Total $8,200 49,186
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\1\There are no capital costs associated with this collection of information.
The estimate of burden for food additive, color additive, or GRAS
affirmation petitions is based on FDA's experience and the average
number of new petitions received in calendar years 2003, 2004, and
2005, and the total hours expended in preparing the petitions. In
compiling these estimates, FDA consulted its records of the number of
petitions received in the past 3 years. The figures for hours per
response are based on estimates from experienced persons in the agency
and in industry. Although the estimated hour burden varies with the
type of petition submitted, an average petition involves analytical
work and appropriate toxicological 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.
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 forth in 21 CFR 70.19. An average of two category A and one
category B color additive petitions 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 an average of three color additive petitions are expected
per calendar year, the estimated total annual cost burden to
petitioners for this start-up cost would be less than or equal to
$8,200 ((2 x $2,600) + (1 x $3,000) = $8,200). There are no capital
costs associated with color additive petitions.
The estimated burden reported in table 1 of this document does not
include the previously estimated burden for the preparation of FAPs
submitted to amend parts 175 throuhg 178 (21 CFR parts 175 through
178). The burden to respondents is similar between the preparation of
petitions submitted to amend parts 175 through 178 and the preparation
of a food contact substance notification. In this request for extension
of OMB approval for the collection of information for FAPs, FDA
proposes to transfer the collection of information and burden
associated with petitions submitted to amend the indirect food additive
regulations (parts 175 through 178) from this collection of information
(OMB control number 0910-0016) to the existing collection of
information for the Food Contact Substances Notification System (OMB
control number 0910-0495).
FDA estimates the annual reporting burden associated with petitions
submitted to amend parts 175 through 178 to be transferred from OMB
control number 0910-0016 to OMB control number 0910-0495. An average of
two indirect food additive petitions are expected per calendar year.
The estimated total annual hour burden to
[[Page 2535]]
petitioners per petition is 10,995 hours, for a total burden of 21,990
hours. There are no capital costs or operating and maintenance costs
associated with the burden hours being transferred from OMB control
number 0910-0016 to OMB control number 0910-0495.
Electronic submissions of petitions contain the same petition
information required for paper submissions. The agency estimates that
one petitioner for both food and color additives will take advantage of
the electronic submission process per 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 for FDA's 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 the guidelines to organize the petition information needed for the
submission.
The labeling requirements for food and color additives were
designed to specify the minimum information needed for labeling in
order that food and color manufacturers may comply with all applicable
provisions of the act and other specific labeling acts administered by
FDA. Label information does not require any additional information
gathering beyond what is already required to assure conformance with
all specifications and limitations in any given food or color additive
regulation. Label information does not have any specific recordkeeping
requirements unique to preparing the label. Therefore, because under
Sec. 70.25, labeling requirements for a particular color additive
involve information required as part of the CAP safety review process,
the estimate for number of respondents is the same for Sec. 70.25 and
Sec. 71.1, and the burden hours for labeling are included in the
estimate for Sec. 71.1. Also, because labeling requirements under
parts 172, 173, 179, and 180 for particular food additives involve
information required as part of the FAP safety review process under
Sec. 171.1, the burden hours for labeling are included in the estimate
for Sec. 171.1.
In cases where a regulation implements a statutory information
collection requirement, only the additional burden attributable to the
regulation, if any, has been included in FDA's burden estimate.
Dated: January 12, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-681 Filed 1-18-07; 8:45 am]
BILLING CODE 4160-01-S
