Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Submission of Petitions: Food Additive, Color Additive (Including Labeling), and Generally Regarded as Safe Affirmation; Submission of Information to a Master File in Support of Petitions; Electronic Submission, 37330-37332 [2014-15384]
Download as PDF
<![CDATA[
37330
Federal Register / Vol. 79, No. 126 / Tuesday, July 1, 2014 / Notices
10406(c)(5) regarding non-disclosure of
confidential of private information (section
10407(a)(2)(A)).
(9) Pursuant to Section 10406(c)(5), comply
with the new FVPSA provisions regarding
non-disclosure of confidential or private
information. As such, the applicant will
comply with additional requirements
imposed by that section which include but
are not limited to: (A) Grantees shall not
disclose any personally identifying
information collected in connection with
services requested (including services
utilized or denied), through grantee’s funded
activities or reveal personally identifying
information without informed, written,
reasonably time-limited consent by the
person about whom information is sought,
whether for the FVPSA funded activities or
any other Federal or State program
(additional consent requirements have been
omitted but see section 10406(c)(5)(B)(ii)(I)
for further requirements); (B) grantees may
not release information compelled by
statutory or court order unless adhering to
the requirements of section 10406(c)(5)(C);
(C) grantees may share non-personally
identifying information in the aggregate for
the purposes enunciated in section
10406(c)(5)(D)(i) as well as for other purposes
found in section 10406(c)(5)(D)(ii) and (iii).
(10) As prescribed by section 10406(c)(2) of
the FVPSA, the Tribe will use grant funds in
a manner which avoids prohibited
discrimination on the basis of age, disability,
sex, race, color, national origin, or religion.
(11) Funds made available under the
FVPSA will be used to supplement and not
supplant other Federal, State and local public
funds expended to provide services and
activities that promote the objectives of the
FVPSA (section 10406(c)(6)).
(12) Receipt of supportive services under
the FVPSA will be voluntary. No condition
will be applied for the receipt of emergency
shelter (section 10408(d)(2)).
(13) The Tribe has a law or procedure to
bar an abuser from a shared household or a
household of the abused person, which may
include eviction laws or procedures (section
10407(a)(2)(H)).
lllllllllllllllllllll
Tribally Designated Official
lllllllllllllllllllll
Tribe or Tribal Organization
emcdonald on DSK67QTVN1PROD with NOTICES
Appendix B
LGBTQ (Also Known as ‘‘Two-Spirited’’)
Accessibility Policy
As the Authorized Organizational
Representative (AOR) signing this
application on behalf of
[Insert full, formal name of applicant
organization]
I hereby attest and certify that:
The needs of lesbian, gay, bisexual,
transgender, and questioning (also known as
‘‘Two-Spirited’’) program participants are
taken into consideration in applicant’s
program design. Applicant considered how
its program will be inclusive of and nonstigmatizing toward such participants. If not
already in place, awardee and, if applicable,
sub-awardees must establish and publicize
VerDate Mar<15>2010
19:00 Jun 30, 2014
Jkt 232001
policies prohibiting harassment based on
race, sexual orientation, gender, gender
identity (or expression), religion, and
national origin. The submission of an
application for this funding opportunity
constitutes an assurance that applicants have
or will put such policies in place within 12
months of the award. Awardees should
ensure that all staff members are trained to
prevent and respond to harassment or
bullying in all forms during the award
period. Programs should be prepared to
monitor claims, address them seriously, and
document their corrective action(s) so all
participants are assured that programs are
safe, inclusive, and non-stigmatizing by
design and in operation. In addition, any subawardees or subcontractors:
• Have in place or will put into place
within 12 months of the award policies
prohibiting harassment based on race, sexual
orientation, gender, gender identity (or
expression), religion, and national origin;
• Will enforce these policies;
• Will ensure that all staff will be trained
during the award period on how to prevent
and respond to harassment or bullying in all
forms, and;
• Have or will have within 12 months of
the award, a plan to monitor claims, address
them seriously, and document their
corrective action(s).
Insert Date of Signature:
Print Name and Title of the AOR:
Signature of AOR:
[End of full FOA]
Statutory Authority: The statutory
authority for this program is 42 U.S.C. 10401,
et. seq.
Mark Greenberg,
Acting Assistant Secretary, Administration
for Children and Families.
[FR Doc. 2014–15331 Filed 6–30–14; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0258]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Submission of
Petitions: Food Additive, Color
Additive (Including Labeling), and
Generally Regarded as Safe
Affirmation; Submission of Information
to a Master File in Support of Petitions;
Electronic Submission
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
SUMMARY:
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by July 31,
2014.
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0016. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
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 Form FDA 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.
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
E:\FR\FM\01JYN1.SGM
01JYN1
37331
Federal Register / Vol. 79, No. 126 / Tuesday, July 1, 2014 / Notices
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 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
generally regarded as safe (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 § 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 Form FDA 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.
In the Federal Register of April 16,
2014 (79 FR 21469) FDA published a 60day notice requesting public comment
on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN
Number of
respondents
21 CFR Section/FDA Form
Number of
responses per
respondent
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
GRAS Affirmation Petitions
170.35 ...........................................................
1 or fewer ....
1
1 or fewer ....
2,614
2,614
0
FAPs
3 ..................
6 ..................
1
1
3 ..................
6 ..................
7,093
1
21,279
6
0
0
Total .......................................................
emcdonald on DSK67QTVN1PROD with NOTICES
171.1 .............................................................
Form FDA 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
10 years. The figures for hours per
response are based on estimates from
VerDate Mar<15>2010
19:00 Jun 30, 2014
Jkt 232001
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
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
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
E:\FR\FM\01JYN1.SGM
01JYN1
37332
Federal Register / Vol. 79, No. 126 / Tuesday, July 1, 2014 / Notices
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 two color additive petitions are
expected per calendar year, the
estimated total annual cost burden to
petitioners for this startup 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: June 25, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–15384 Filed 6–30–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
emcdonald on DSK67QTVN1PROD with NOTICES
[Docket No. FDA–2014–N–0202]
Over-the-Counter Drug Monograph
System—Past, Present, and Future;
Public Hearing; Reopening of the
Comment Period
AGENCY:
HHS.
Notice; reopening of the
comment period.
VerDate Mar<15>2010
19:00 Jun 30, 2014
Jkt 232001
thoroughly evaluate and address
pertinent issues.
I. Background
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
In the Federal Register of February
24, 2014 (79 FR 10168), FDA announced
a public hearing to obtain input on the
OTC Drug Review (sometimes referred
to as the OTC Monograph Process, OTC
Monograph, or OTC Drug Review). As
stated in the Federal Register notice,
FDA has been assessing the OTC
Monograph Process and, in particular,
has been considering how effectively
the monograph system is functioning in
today’s world, 40 years after its
inception, from the scientific, policy,
and process perspectives. In the
February 24, 2014, notice of public
hearing, FDA announced it was
soliciting comments about whether and
how to modernize the process for the
future. The public hearing was held to
obtain information and comments from
the public on the strengths and
weaknesses of the current OTC
Monograph Process, and to obtain and
discuss ideas about modifications or
alternatives to this process. Interested
persons were originally given until May
12, 2014, to comment on the OTC
Monograph Process.
II. Request for Comments
Food and Drug Administration,
ACTION:
The Food and Drug
Administration (FDA) is reopening the
comment period for the notice of public
hearing, published in the Federal
Register of February 24, 2014 (79 FR
10168), requesting comment on how to
improve or alter the current Over-theCounter (OTC) Monograph Process for
reviewing nonprescription drugs
marketed under the OTC Drug Review.
FDA is reopening the comment period
to update comments and to receive any
new information.
DATES: Submit either electronic or
written comments by July 31, 2014.
ADDRESSES: Submit electronic
comments to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Mary Gross, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20903–0002,
301–796–3519, mary.gross@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
On our own initiative, we are
reopening the comment period to allow
interested persons additional time to
comment to respond fully to FDA’s
specific requests for comments and to
allow potential respondents to
PO 00000
Frm 00062
Fmt 4703
Sfmt 4703
III. How To Submit Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES).
You should annotate and organize your
comments to identify the specific
questions identified by the topic to
which they refer (see 79 FR 10168 at
10171, section III). It is only necessary
to send one set of comments. Identify
comments with the docket number
found in brackets in the heading of this
document. Received comments may be
seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday, and will be
posted to the docket at https://
www.regulations.gov.
Dated: June 26, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–15375 Filed 6–30–14; 8:45 am]
BILLING CODE 4164–01–P
Food and Drug Administration
[Docket No. FDA–2014–N–0833]
Office of the Commissioner; Request
for Comments on the Food and Drug
Administration Fiscal Year 2014–2018
Strategic Priorities Document; Request
for Comments
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; request for comments.
The Food and Drug
Administration (FDA) is seeking public
comments on its draft Strategic
Priorities Fiscal Year (FY) 2014–2018
document. FDA has identified these
cross-cutting strategic priorities and
core mission goals that will guide its
efforts to achieve its public health
mission. FDA is seeking public
comment to help further refine these
priorities and goals.
DATES: Submit either electronic or
written comments by July 31, 2014.
ADDRESSES: Submit electronic
comments to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Darian Tarver, Office of the
SUMMARY:
E:\FR\FM\01JYN1.SGM
01JYN1
]]>Agencies
[Federal Register Volume 79, Number 126 (Tuesday, July 1, 2014)]
[Notices]
[Pages 37330-37332]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-15384]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0258]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Submission of
Petitions: Food Additive, Color Additive (Including Labeling), and
Generally Regarded 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 that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by July
31, 2014.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0016.
Also include the FDA 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, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.
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.
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 Form FDA
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. 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
[[Page 37331]]
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 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 generally regarded as safe (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 Sec. 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 Form FDA 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.
In the Federal Register of April 16, 2014 (79 FR 21469) FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total
Number of Average burden operating and
21 CFR Section/FDA Form Number of respondents responses per Total annual responses per response Total hours maintenance
respondent costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
CAPs
--------------------------------------------------------------------------------------------------------------------------------------------------------
70.25, 71.1......................... 2....................... 1 2....................... 1,337 2,674 $5,600
--------------------------------------------------------------------------------------------------------------------------------------------------------
GRAS Affirmation Petitions
--------------------------------------------------------------------------------------------------------------------------------------------------------
170.35.............................. 1 or fewer.............. 1 1 or fewer.............. 2,614 2,614 0
--------------------------------------------------------------------------------------------------------------------------------------------------------
FAPs
--------------------------------------------------------------------------------------------------------------------------------------------------------
171.1............................... 3....................... 1 3....................... 7,093 21,279 0
Form FDA 3503....................... 6....................... 1 6....................... 1 6 0
-------------------------------------------------------------------------------------------------------------------
Total........................... ........................ .............. ........................ .............. 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 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 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
[[Page 37332]]
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
two color additive petitions are expected per calendar year, the
estimated total annual cost burden to petitioners for this startup 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: June 25, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-15384 Filed 6-30-14; 8:45 am]
BILLING CODE 4164-01-P
