Agency Information Collection Activities; Proposed Collection; Comment Request; Food Additive Petitions and Investigational Food Additive Exemptions; Extension, 67655-67656 [2012-27485]
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Federal Register / Vol. 77, No. 219 / Tuesday, November 13, 2012 / Notices
review of inter-component organizational
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delivery to customers and to enhance
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manages and coordinates designated
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management training in the Agency,
including policy development, guidance,
technical assistance, and evaluation of all
aspects of career employee, supervisory,
management and executive training. The
Office provides leadership in managing/
overseeing and monitoring the ACF Training
Resource Center and the Computer Training
and Information Centers. The Office develops
and manages the consolidated training
budget for the Agency.
srobinson on DSK4SPTVN1PROD with
V. Under Chapter KP, Office of the
Deputy Assistant Secretary for
Administration, KP. 20 Functions, add
the following:
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Equal Employment Opportunity (ODME)
serves as the principal advisor, through the
Deputy Assistant Secretary for
Administration, to the Assistant Secretary on
all aspects of the Agency’s Diversity
Management and Equal Employment
Opportunity programs.
The Office serves as the liaison between
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manages the ACF Equal Employment
Opportunity programs in accordance with
Equal Employment Opportunity Commission
(EEOC) regulations and HHS guidelines. The
immediate oversight is provided by a staff
under the direction of the ACF EEO Officer.
ODME develops and evaluates programs and
procedures designed to identify and
eliminate discrimination in employment,
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career opportunities. They are responsible for
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individual complaints of discrimination
under the Title VII of the Civil Rights Act of
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responsible for ensuring that ACF-conducted
programs create an environment that is free
of discrimination, where all employees may
work without fear of reprisal or
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employees and applicants with disabilities
receive reasonable accommodations; and
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color, age, religion, sex (including pregnancy
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17:08 Nov 09, 2012
Jkt 229001
and gender identity), sexual orientation,
disability (physical or mental), status as a
parent, genetic information, or other nonmerit factor.
The staff is responsible for assessing
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ensuring the diversity of ACF workforce.
ODME works proactively to enhance the
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and people with disabilities. This is achieved
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complaints prevention, outreach, and
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implements the applicable provisions of the
Americans with Disabilities Act of 1990.
Dated: November 1, 2012.
George H. Sheldon,
Acting Assistant Secretary for Children and
Families.
[FR Doc. 2012–27524 Filed 11–9–12; 8:45 am]
BILLING CODE 4184–40–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–1093]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Food Additive
Petitions and Investigational Food
Additive Exemptions; Extension
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 a 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
food additive petitions regarding animal
food.
DATES: Submit electronic or written
comments on the collection of
information by January 14, 2013.
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
SUMMARY:
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
67655
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 Drive,
PI50–400B, Rockville, MD 20850, 301–
796–3794.
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.
Food Additive Petitions and
Investigational Food Additive
Exemptions, 21 CFR 570.17 and 571
(OMB Control Number 0910–0546)—
Extension
Section 409(a) of the Federal Food,
Drug and Cosmetic Act (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
E:\FR\FM\13NON1.SGM
13NON1
67656
Federal Register / Vol. 77, No. 219 / Tuesday, November 13, 2012 / Notices
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 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.
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), regulations have been
issued under 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.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 FOOD ADDITIVE PETITIONS
Number of responses per
respondent
Number of
respondents
21 CFR Section
Average
burden per
response
Total annual
responses
Total hours
571.1(c) Moderate Category ................................................
571.1(c) Complex Category .................................................
571.6 Amendment of Petition ..............................................
1
1
2
1
1
2
1
1
4
3,000
10,000
1,300
3,000
10,000
5,200
Total Hours ...................................................................
4
4
6
14,300
18,200
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
§ 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 1 petition of this type is received on
an annual basis, resulting in a burden of
3,000 hours.
§ 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 1 petition of this type is received on
an annual basis, resulting in a burden of
10,000 hours.
§ 571.6: For a food additive petition
amendment, the estimated time
requirement per petition is
approximately 1,300 hours. An average
of 4 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 INVESTIGATION FOOD ADDITIVE FILES
Number of responses per
respondent
Number of
respondents
21 CFR Section
Average
burden per
response
Total annual
responses
Total hours
570.17 Moderate Category ..................................................
570.17 Complex Category ...................................................
9
4
1
1
9
4
1,500
5,000
13,500
20,000
Total Hours ...................................................................
13
2
13
6,500
33,500
srobinson on DSK4SPTVN1PROD with
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
§ 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 9 files of this type are
received on an annual basis, resulting in
a burden of 13,500 hours.
§ 570.17 Complex Category: For an
investigational food additive file with
complex chemistry, manufacturing,
efficacy, and/or safety issues, the
VerDate Mar<15>2010
18:20 Nov 09, 2012
Jkt 229001
estimated time requirement per file is
approximately 5,000 hours. An average
of 4 files of this type are received on an
annual basis, resulting in a burden of
20,000 hours.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: November 6, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
Agency Information Collection
Activities: Proposed Collection:
Comment Request
[FR Doc. 2012–27485 Filed 11–9–12; 8:45 am]
BILLING CODE 4160–01–P
PO 00000
Health Resources and Services
Administration
ACTION:
Notice.
In compliance with the
requirement for opportunity for public
SUMMARY:
Frm 00030
Fmt 4703
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]]>Agencies
[Federal Register Volume 77, Number 219 (Tuesday, November 13, 2012)]
[Notices]
[Pages 67655-67656]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-27485]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-1093]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Food Additive Petitions and Investigational Food
Additive Exemptions; Extension
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 a 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 food additive petitions
regarding animal food.
DATES: Submit electronic or written comments on the collection of
information by January 14, 2013.
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: Jonna Capezzuto, Office of Information
Management, Food and Drug Administration, 1350 Piccard Drive, PI50-
400B, Rockville, MD 20850, 301-796-3794.
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.
Food Additive Petitions and Investigational Food Additive Exemptions,
21 CFR 570.17 and 571 (OMB Control Number 0910-0546)--Extension
Section 409(a) of the Federal Food, Drug and Cosmetic Act (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
[[Page 67656]]
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 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. 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), regulations have
been issued under 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.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\ Food Additive Petitions
----------------------------------------------------------------------------------------------------------------
Number of Average
21 CFR Section Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
571.1(c) Moderate Category...... 1 1 1 3,000 3,000
571.1(c) Complex Category....... 1 1 1 10,000 10,000
571.6 Amendment of Petition..... 2 2 4 1,300 5,200
-------------------------------------------------------------------------------
Total Hours................. 4 4 6 14,300 18,200
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Sec. 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 1 petition of this type is received on an annual
basis, resulting in a burden of 3,000 hours.
Sec. 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 1 petition of this type is received on an annual basis,
resulting in a burden of 10,000 hours.
Sec. 571.6: For a food additive petition amendment, the estimated
time requirement per petition is approximately 1,300 hours. An average
of 4 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\ Investigation Food Additive Files
----------------------------------------------------------------------------------------------------------------
Number of Average
21 CFR Section Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
570.17 Moderate Category........ 9 1 9 1,500 13,500
570.17 Complex Category......... 4 1 4 5,000 20,000
-------------------------------------------------------------------------------
Total Hours................. 13 2 13 6,500 33,500
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Sec. 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 9 files of this type are received on an
annual basis, resulting in a burden of 13,500 hours.
Sec. 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 4 files of this type are received on an annual
basis, resulting in a burden of 20,000 hours.
Dated: November 6, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-27485 Filed 11-9-12; 8:45 am]
BILLING CODE 4160-01-P
