Agency Information Collection Activities; Proposed Collection; Comment Request; Submission of Petitions: Food Additive, Color Additive (Including Labeling), and Generally Recognized as Safe Affirmation; Submission of Information to a Master File in Support of Petitions; Electronic Submission, 21469-21471 [2014-08590]
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Federal Register / Vol. 79, No. 73 / Wednesday, April 16, 2014 / Notices
31. Executive Order No. 11375,
‘‘Equal Employment Opportunity’’ (Oct.
13, 1967, 32 FR 14303);
32. Executive Order No. 11988,
‘‘Floodplain Management’’ (May 24,
1977, 42 FR 26951);
33. Executive Order No. 11990,
‘‘Protection of Wetlands’’ (May 24, 1977,
42 FR 26961);
34. Executive Order No. 12072,
‘‘Federal Space Management’’ (Aug. 16,
1978, 43 FR 36869);
35. Executive Order No. 12699,
‘‘Seismic Safety of Federal and
Federally Assisted or Regulated New
Building Construction’’ (Jan. 5, 1990, 55
FR 835);
36. Executive Order No. 13006,
‘‘Locating Federal Facilities on Historic
Properties in Our Nation’s Central
Cities’’ (May 1, 1996, 61 FR 26071);
37. Executive Order No. 13423,
‘‘Strengthening Federal Environmental,
Energy and Transportation
Management’’ (January 26, 2007, 72 FR
3919);
38. Executive Order No. 13327,
‘‘Federal Real Property Asset
Management’’ (Feb. 4, 2004, 69 FR
5897);
39. Executive Order No. 13514,
‘‘Federal Leadership in Environmental,
Energy, and Economic Performance’’
(Oct. 5, 2009, 74 FR 52117);
40. Executive Order No. 13576,
‘‘Delivering Efficient, Effective, and
Accountable Government’’ (Jun. 13,
2011, 76 FR 35297);
41. Executive Order No. 12941,
‘‘Seismic Safety of Existing Federally
Owned or Leased Buildings’’ (Dec. 5,
1994, 59 FR 62545);
42. Comprehensive Procurement
Guideline For Products Containing
Recovered Materials (40 CFR chapter I,
part 247);
43. OMB Circular A–11 (Capital Lease
Scoring);
44. OMB Memorandum M–12–12,
‘‘Promoting Efficient Spending to
Support Agency Operations’’ (May 11,
2012), and OMB Management
Procedures Memorandum No. 2013–02,
‘‘Implementation of OMB Memorandum
M–12–12 Section 3: Freeze the
Footprint’’ (March 14, 2013);
45. Federal Management Regulation
(41 CFR chapter 102);
46. General Services Administration
Acquisition Manual, including the
General Services Administration
Acquisition Regulation (48 CFR chapter
5); and
47. The General Services
Administration, Public Buildings
Service, Leasing Desk Guide.
By delegation of the Administrator of
General Services.
Anne E. Rung,
VerDate Mar<15>2010
18:29 Apr 15, 2014
Jkt 232001
Associate Administrator.
BILLING CODE 6820–23–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0258]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Submission of
Petitions: Food Additive, Color
Additive (Including Labeling), and
Generally Recognized as Safe
Affirmation; Submission of Information
to a Master File in Support of Petitions;
Electronic Submission
Food and Drug Administration,
HHS.
ACTION:
Notice.
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, submission of
information to a master file in support
of petitions, and electronic submission
using FDA Form 3503.
DATES: Submit either electronic or
written comments on the collection of
information by June 16, 2014.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. 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: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
PRAStaff@fda.hhs.gov.
SUMMARY:
PO 00000
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Fmt 4703
Sfmt 4703
Under 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(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:
[FR Doc. 2014–08645 Filed 4–15–14; 8:45 am]
AGENCY:
21469
Submission of Petitions: Food Additive,
Color Additive (Including Labeling),
and GRAS Affirmation; Submission of
Information to a Master File in Support
of Petitions; Electronic Submission
Using FDA Form 3503—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 FD&C 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 FD&C 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 FD&C Act is effective.
E:\FR\FM\16APN1.SGM
16APN1
21470
Federal Register / Vol. 79, No. 73 / Wednesday, April 16, 2014 / Notices
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 of
FDA’s regulations 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 contain labeling requirements
for certain food additives to ensure their
safe use.
Section 721(a) of the FD&C 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 FD&C 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 of the
Agency’s regulations 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.
FDA scientific personnel review FAPs
to ensure the safety of the intended use
of the additive in or on food or that may
be present in food as a result of its use
in articles that contact food. Likewise,
FDA personnel review CAPs to ensure
the safety of the color additive prior to
its use in food, drugs, cosmetics, or
medical devices.
Under section 201(s) of the FD&C Act
(21 U.S.C. 321(s)), a substance is GRAS
if it is generally recognized among
experts qualified by scientific training
and experience to evaluate its safety, to
be safe through either scientific
procedures or common use in food. The
FD&C 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
FD&C Act (21 U.S.C. 321, 342, 348, and
371). To implement the GRAS
provisions of the FD&C Act, FDA has set
forth procedures for the GRAS
affirmation petition process in 21 CFR
170.35(c)(1) of its regulations. 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 and is not
expecting any during the period covered
by this proposed extension of collection
of information.
Interested persons may transmit FAP
or CAP regulatory submissions in
electronic format or paper format to the
Office of Food Additive Safety in the
Center for Food Safety and Applied
Nutrition using Form FDA 3503. Form
FDA 3503 helps the respondent
organize their submission to focus on
the information needed for FDA’s safety
review. Form FDA 3503 can also be
used to organize information within a
master file submitted in support of
Petitions according to the items listed
on the form. Master files can be used as
repositories for information that can be
referenced in multiple submissions to
the Agency, thus minimizing paperwork
burden for food and color additive
approvals. FDA estimates that the
amount of time for respondents to
complete FDA Form 3503 will continue
to be 1 hour.
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
21 CFR Section/FDA Form
Number of
responses per
respondent
Number of
respondents
Average
burden per
response
Total annual
responses
Total hours
Total operating
and
maintenance
costs
CAPs
70.25, 71.1 ...............................................
2
1
2
1,337
2,674
$5,600
1
1 or fewer
2,614
2,614
0
GRAS Affirmation Petitions
170.35 ......................................................
1 or fewer
FAPs
3
6
1
1
3
6
7,093
1
21,279
6
0
0
Total ..................................................
pmangrum on DSK3VPTVN1PROD with NOTICES
171.1 ........................................................
FDA Form 3503 .......................................
........................
........................
........................
........................
26,573
$5,600
The estimate of burden for food
additive, color additive, or GRAS
affirmation petitions is based on FDA’s
experience with the petition process.
FDA is retaining its prior estimate of the
number of petitions received because
the average number of petitions received
annually has varied little over the past
VerDate Mar<15>2010
15:20 Apr 15, 2014
Jkt 232001
10 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
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
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
E:\FR\FM\16APN1.SGM
16APN1
Federal Register / Vol. 79, No. 73 / Wednesday, April 16, 2014 / Notices
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 § 70.19.
An average of one Category A and one
Category B color additive petition is
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. Because an average
of 2 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 $5,600 (1 ×
$2,600 + 1 × $3,000 listing fees =
$5,600). There are no capital costs
associated with color additive petitions.
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
FD&C 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
labeling requirements under § 70.25 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.
Dated: April 10, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–08590 Filed 4–15–14; 8:45 am]
pmangrum on DSK3VPTVN1PROD with NOTICES
BILLING CODE 4160–01–P
VerDate Mar<15>2010
15:20 Apr 15, 2014
Jkt 232001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0386]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Orphan Drugs
Products: Common European
Medicines Agency/Food and Drug
Administration Application Form for
Orphan Medicinal Product Designation
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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
Orphan Drug Products: Common EMEA/
FDA Application Form for Orphan
Medicinal Product Designation (Form
FDA 3671).
DATES: Submit written or electronic
comments on the collection of
information by June 16, 2014.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. 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: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under 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(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
SUMMARY:
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
21471
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.
Orphan Drugs—21 CFR Part 316 (OMB
Control Number 0910–0167)—Extension
FDA is amending the 1992 Orphan
Drug Regulations, part 316 (21 CFR part
316). The 1992 regulations were issued
to implement sections 525 through 528
of the Orphan Drug Act Amendments to
the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360aa through 360ee) (the
FD&C Act). The 1992 regulations specify
the procedures for sponsors of orphan
drugs to use in obtaining the incentives
provided for in the FD&C Act and set
forth the procedures that FDA will use
in administering the FD&C Act.
The amendments are intended to
clarify regulatory provisions and make
minor improvements to address issues
that have arisen since the issuance of
the regulations in 1992. They are
intended to assist sponsors who are
seeking and who have obtained orphan
drug designations, as well as FDA in its
administration of the orphan drug
program. Except with respect to the two
revisions addressed further, the
revisions in this rule clarify existing
language and do not constitute a
substantive or material modification to
the approved collections of information
in current part 316 (see 5 CFR
1320.5(g)). The collections of
information in current part 316 have
been approved by OMB in accordance
with the PRA under OMB control
number 0910–0167.
E:\FR\FM\16APN1.SGM
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]]>Agencies
[Federal Register Volume 79, Number 73 (Wednesday, April 16, 2014)]
[Notices]
[Pages 21469-21471]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-08590]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0258]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Submission of Petitions: Food Additive, Color Additive
(Including Labeling), and Generally Recognized as Safe Affirmation;
Submission of Information to a Master File in Support of Petitions;
Electronic Submission
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, submission of information to a
master file in support of petitions, and electronic submission using
FDA Form 3503.
DATES: Submit either electronic or written comments on the collection
of information by June 16, 2014.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. 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: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under 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(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; Submission of Information to a Master
File in Support of Petitions; Electronic Submission Using FDA Form
3503--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
FD&C 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 FD&C 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 FD&C
Act is effective.
[[Page 21470]]
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 of FDA's regulations 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 contain labeling requirements
for certain food additives to ensure their safe use.
Section 721(a) of the FD&C 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 FD&C 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 of the Agency's
regulations 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.
FDA scientific personnel review FAPs to ensure the safety of the
intended use of the additive in or on food or that may be present in
food as a result of its use in articles that contact food. Likewise,
FDA personnel review CAPs to ensure the safety of the color additive
prior to its use in food, drugs, cosmetics, or medical devices.
Under section 201(s) of the FD&C Act (21 U.S.C. 321(s)), a
substance is GRAS if it is generally recognized among experts qualified
by scientific training and experience to evaluate its safety, to be
safe through either scientific procedures or common use in food. The
FD&C 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 FD&C Act (21
U.S.C. 321, 342, 348, and 371). To implement the GRAS provisions of the
FD&C Act, FDA has set forth procedures for the GRAS affirmation
petition process in 21 CFR 170.35(c)(1) of its regulations. 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 and is not expecting any during the period covered
by this proposed extension of collection of information.
Interested persons may transmit FAP or CAP regulatory submissions
in electronic format or paper format to the Office of Food Additive
Safety in the Center for Food Safety and Applied Nutrition using Form
FDA 3503. Form FDA 3503 helps the respondent organize their submission
to focus on the information needed for FDA's safety review. Form FDA
3503 can also be used to organize information within a master file
submitted in support of Petitions according to the items listed on the
form. Master files can be used as repositories for information that can
be referenced in multiple submissions to the Agency, thus minimizing
paperwork burden for food and color additive approvals. FDA estimates
that the amount of time for respondents to complete FDA Form 3503 will
continue to be 1 hour.
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total
Number of Number of Total annual Average burden operating and
21 CFR Section/FDA Form respondents responses per responses per response Total hours maintenance
respondent costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
CAPs
--------------------------------------------------------------------------------------------------------------------------------------------------------
70.25, 71.1............................................. 2 1 2 1,337 2,674 $5,600
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GRAS Affirmation Petitions
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170.35.................................................. 1 or fewer 1 1 or fewer 2,614 2,614 0
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FAPs
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171.1................................................... 3 1 3 7,093 21,279 0
FDA Form 3503........................................... 6 1 6 1 6 0
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Total............................................... .............. .............. .............. .............. 26,573 $5,600
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The estimate of burden for food additive, color additive, or GRAS
affirmation petitions is based on FDA's experience with the petition
process. FDA is retaining its prior estimate of the number of petitions
received because the average number of petitions received annually has
varied little over the past 10 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
[[Page 21471]]
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 Sec. 70.19. An average of
one Category A and one Category B color additive petition is 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. Because an average of 2 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 $5,600 (1 x $2,600 + 1 x $3,000 listing fees = $5,600). There
are no capital costs associated with color additive petitions.
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 FD&C 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 labeling requirements under Sec. 70.25 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.
Dated: April 10, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-08590 Filed 4-15-14; 8:45 am]
BILLING CODE 4160-01-P
