Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Additive Petitions and Investigational Food Additive Exemptions, 20661-20662 [2013-07892]
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20661
Federal Register / Vol. 78, No. 66 / Friday, April 5, 2013 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity/section of FD&C Act
No. of
respondents
No. of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Total operating
& maintenance
costs
Foreign letter of approval—§ 801(e)(2) ....
38
1
38
3
114
$9,500
1 There
are no capital costs associated with this collection of information.
Dated: April 1, 2013.
Peter Lurie,
Acting Associate Commissioner for Policy and
Planning.
[FR Doc. 2013–07915 Filed 4–4–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–1093]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Food Additive
Petitions and Investigational Food
Additive Exemptions
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
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 May 6,
2013.
SUMMARY:
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 0910–0546. Also
include the FDA docket number found
ADDRESSES:
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
3794,
Jonnalynn.capezzuto@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.
Food Additive Petitions and
Investigational Food Additive
Exemptions—(OMB Control Number
0910–0546)—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 its use is permitted by a
regulation which prescribes the
condition(s) under which it may safely
be used, or unless it is exempted by
regulation for investigational use.
Section 409(b) of the FD&C Act specifies
the information that must be submitted
by a petitioner in order to establish the
safety of a food additive and to secure
the issuance of a regulation permitting
its use.
To implement the provisions of
section 409 of the FD&C Act, procedural
regulations have been issued under part
571 (21 CFR part 571). These procedural
regulations are designed to specify more
thoroughly the information that must be
submitted to meet the requirement set
down in broader terms by the FD&C Act.
The regulations add no substantive
requirements to those indicated in the
FD&C Act, but attempt to explain these
requirements and provide a standard
format for submission to speed
processing of the petition. Labeling
requirements for food additives
intended for animal consumption are
also set forth in various regulations
contained in parts 501, 573, and 579 (21
CFR parts 501, 573, and 579). The
labeling regulations are considered by
FDA to be cross-referenced to § 571.1,
which is the subject of this same OMB
clearance for food additive petitions.
With regard to the investigational use
of food additives, section 409(j) of the
FD&C Act provides that any food
additive or any food bearing or
containing such an additive, may be
exempted from the requirements of this
section if intended solely for
investigational use by qualified experts.
Investigational use of a food additive is
typically to address the safety and/or
intended physical or technical effect of
the additive.
To implement the provisions of
section 409(j) of the FD&C Act,
regulations have been issued under
§ 570.17 (21 CFR 570.17). These
regulations are designed to specify more
thoroughly the information that must be
submitted to meet the requirement set
down in broad terms by the FD&C Act.
Labeling requirements for
investigational food additives are also
set forth in various regulations
contained in part 501. The labeling
regulations are considered by FDA to be
cross-referenced to § 570.17; which is
the subject of this same OMB clearance
for investigational food additive files. In
the Federal Register of November 13,
2012, (75 FR 67655), 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:
mstockstill on DSK4VPTVN1PROD with NOTICES
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
No. of
responses per
respondent
No. of
respondents
21 CFR Section
Average
burden per
response
Total annual
responses
Total hours
Food Additive Petitions
571.1(c) moderate category ...................
517.1(c) complex category ....................
517.1(c) complex category ....................
VerDate Mar<15>2010
18:50 Apr 04, 2013
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1
2
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3,000
10,000
1,300
05APN1
3,000
10,000
5,200
20662
Federal Register / Vol. 78, No. 66 / Friday, April 5, 2013 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
No. of
respondents
No. of
responses per
respondent
Total annual
responses
Average
burden per
response
..............................
..............................
..............................
..............................
21 CFR Section
Total ................................................
1 There
Total hours
18,200
are no capital costs or operating and maintenance costs associated with this collection of information.
Section 571.1(c) Complex Category:
For a food additive petition with
complex chemistry, manufacturing,
efficacy, and/or safety issues, the
estimated time requirement per petition
is approximately 10,000 hours. An
average of one petition of this type is
received on an annual basis, resulting in
a burden of 10,000 hours.
Section 571.1(c) Moderate Category:
For a food additive petition without
complex chemistry, manufacturing,
efficacy, or safety issues, the estimated
time requirement per petition is
approximately 3,000 hours. An average
of one petition of this type is received
on an annual basis, resulting in a
burden of 3,000 hours.
Section 571.6: For a food additive
petition amendment, the estimated time
requirement per petition is
approximately 1,300 hours. An average
of four petitions of this type is received
on an annual basis, resulting in a
burden of 5,200 hours.
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
No. of
responses per
respondent
No. of
respondents
21 CFR Section
Average
burden per
response
Total annual
responses
Total hours
Investigation Food Additive Files
570.17 moderate category .....................
570.17 complex category .......................
9
4
1
1
9
4
1,500
5,000
13,500
20,000
Total ................................................
..............................
..............................
..............................
..............................
33,500
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Section 570.17 Moderate Category:
For an investigational food additive file
without complex chemistry,
manufacturing, efficacy, or safety issues,
the estimated time requirement per file
is approximately 1,500 hours. An
average of nine files of this type is
received on an annual basis, resulting in
a burden of 13,500 hours.
Section 570.17 Complex Category: For
an investigational food additive file
with complex chemistry,
manufacturing, efficacy, and/or safety
issues, the estimated time requirement
per file is approximately 5,000 hours.
An average of four files of this type is
received on an annual basis, resulting in
a burden of 20,000 hours.
Dated: April 1, 2013.
Peter Lurie,
Acting Associate Commissioner for Policy and
Planning.
[FR Doc. 2013–07892 Filed 4–4–13; 8:45 am]
mstockstill on DSK4VPTVN1PROD with NOTICES
BILLING CODE 4160–01–P
VerDate Mar<15>2010
18:50 Apr 04, 2013
Jkt 229001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0001]
Preparation for International
Cooperation on Cosmetics Regulation;
Public Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of meeting.
The Food and Drug Administration
(FDA or we) is announcing a public
meeting entitled, ‘‘International
Cooperation on Cosmetics Regulation
(ICCR)—Preparation for ICCR–7
Meeting.’’ The purpose of the meeting is
to invite public input on various topics
pertaining to the regulation of
cosmetics. We may use this input to
help us prepare for the ICCR–7 meeting
that will be held in Japan on July 8 to
10, 2013.
DATES: Date and Time: The meeting will
be held on May 8, 2013, from 2 p.m. to
4 p.m.
Location: The meeting will be held at
the Food and Drug Administration,
University Station Building, 4300 River
Rd., Conference Room 3172 (third floor),
College Park, MD 20740.
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
Contact Person: If you intend to
participate in the meeting, you should
register with Maria Rossana (Rosemary)
Cook, Office of Cosmetics and Colors,
Food and Drug Administration, 4300
River Rd., College Park, MD 20740, by
email: maria.cook@fda.hhs.gov or Fax:
301–436–2975.
Registration and Requests for Oral
Presentations: Send registration
information (including your name, title,
firm name, address, telephone number,
fax number, and email address), written
material, and requests to make an oral
presentation, to the contact person by
April 22, 2013.
If you need special accommodations
due to a disability, please contact Maria
Rossana (Rosemary) Cook (see Contact
Person) by May 1, 2013.
You may present data, information, or
views orally or in writing, on issues
pending at the public meeting. Time
allotted for oral presentations may be
limited to 10 minutes or less for each
presenter. If you wish to make an oral
presentation, you should notify the
contact person by April 22, 2013, and
submit a brief statement of the general
nature of the evidence or arguments that
you wish to present, your name,
address, telephone number, fax number,
and email address, and indicate the
approximate amount of time you need
to make your presentation.
E:\FR\FM\05APN1.SGM
05APN1
]]>Agencies
[Federal Register Volume 78, Number 66 (Friday, April 5, 2013)]
[Notices]
[Pages 20661-20662]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-07892]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-1093]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Food Additive
Petitions and Investigational Food Additive Exemptions
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 May 6,
2013.
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 0910-0546.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B,
Rockville, MD 20850, 301-796-3794, Jonnalynn.capezzuto@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.
Food Additive Petitions and Investigational Food Additive Exemptions--
(OMB Control Number 0910-0546)--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 its use is permitted by a regulation which
prescribes the condition(s) under which it may safely be used, or
unless it is exempted by regulation for investigational use. Section
409(b) of the FD&C Act specifies the information that must be submitted
by a petitioner in order to establish the safety of a food additive and
to secure the issuance of a regulation permitting its use.
To implement the provisions of section 409 of the FD&C Act,
procedural regulations have been issued under part 571 (21 CFR part
571). These procedural regulations are designed to specify more
thoroughly the information that must be submitted to meet the
requirement set down in broader terms by the FD&C Act. The regulations
add no substantive requirements to those indicated in the FD&C Act, but
attempt to explain these requirements and provide a standard format for
submission to speed processing of the petition. Labeling requirements
for food additives intended for animal consumption are also set forth
in various regulations contained in parts 501, 573, and 579 (21 CFR
parts 501, 573, and 579). The labeling regulations are considered by
FDA to be cross-referenced to Sec. 571.1, which is the subject of this
same OMB clearance for food additive petitions.
With regard to the investigational use of food additives, section
409(j) of the FD&C Act provides that any food additive or any food
bearing or containing such an additive, may be exempted from the
requirements of this section if intended solely for investigational use
by qualified experts. Investigational use of a food additive is
typically to address the safety and/or intended physical or technical
effect of the additive.
To implement the provisions of section 409(j) of the FD&C Act,
regulations have been issued under Sec. 570.17 (21 CFR 570.17). These
regulations are designed to specify more thoroughly the information
that must be submitted to meet the requirement set down in broad terms
by the FD&C Act. Labeling requirements for investigational food
additives are also set forth in various regulations contained in part
501. The labeling regulations are considered by FDA to be cross-
referenced to Sec. 570.17; which is the subject of this same OMB
clearance for investigational food additive files. In the Federal
Register of November 13, 2012, (75 FR 67655), 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 \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of No. of responses Total annual Average burden
21 CFR Section respondents per respondent responses per response Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Food Additive Petitions
--------------------------------------------------------------------------------------------------------------------------------------------------------
571.1(c) moderate category............................... 1 1 1 3,000 3,000
517.1(c) complex category................................ 1 1 1 10,000 10,000
517.1(c) complex category................................ 2 2 4 1,300 5,200
----------------------------------------------------------------------------------------------
[[Page 20662]]
Total................................................ ................. ................. ................. ................. 18,200
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Section 571.1(c) Moderate Category: For a food additive petition
without complex chemistry, manufacturing, efficacy, or safety issues,
the estimated time requirement per petition is approximately 3,000
hours. An average of one petition of this type is received on an annual
basis, resulting in a burden of 3,000 hours.
Section 571.1(c) Complex Category: For a food additive petition
with complex chemistry, manufacturing, efficacy, and/or safety issues,
the estimated time requirement per petition is approximately 10,000
hours. An average of one petition of this type is received on an annual
basis, resulting in a burden of 10,000 hours.
Section 571.6: For a food additive petition amendment, the
estimated time requirement per petition is approximately 1,300 hours.
An average of four petitions of this type is received on an annual
basis, resulting in a burden of 5,200 hours.
Table 2--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of No. of responses Total annual Average burden
21 CFR Section respondents per respondent responses per response Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Investigation Food Additive Files
--------------------------------------------------------------------------------------------------------------------------------------------------------
570.17 moderate category................................. 9 1 9 1,500 13,500
570.17 complex category.................................. 4 1 4 5,000 20,000
----------------------------------------------------------------------------------------------
Total................................................ ................. ................. ................. ................. 33,500
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Section 570.17 Moderate Category: For an investigational food
additive file without complex chemistry, manufacturing, efficacy, or
safety issues, the estimated time requirement per file is approximately
1,500 hours. An average of nine files of this type is received on an
annual basis, resulting in a burden of 13,500 hours.
Section 570.17 Complex Category: For an investigational food
additive file with complex chemistry, manufacturing, efficacy, and/or
safety issues, the estimated time requirement per file is approximately
5,000 hours. An average of four files of this type is received on an
annual basis, resulting in a burden of 20,000 hours.
Dated: April 1, 2013.
Peter Lurie,
Acting Associate Commissioner for Policy and Planning.
[FR Doc. 2013-07892 Filed 4-4-13; 8:45 am]
BILLING CODE 4160-01-P
