Agency Information Collection Activities; Proposed Collection; Comment Request; Food Additive Petitions and Investigational Food Additive Exemptions, 38149-38151 [2018-16616]
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Federal Register / Vol. 83, No. 150 / Friday, August 3, 2018 / Notices
entry, where the person has no other
conviction or program entry under
Section 19, where it has been five years
since the conviction or program entry
(30 months in the case of a person 21
or younger as described above) and
which does not involve an insured
financial institution or insured credit
union is considered de minimis. Simple
theft excludes burglary, forgery, robbery,
identity theft, and fraud.
Convictions or program entries for the
use of a fake, false or altered
identification card:
The use of a fake, false or altered
identification card used by person
under the legal age for the purpose of
obtaining or purchasing alcohol, or used
for the purpose of entering a premise
where alcohol is served but for which
age appropriate identification is
required, provided that there is no other
conviction or program entry for a
covered offense, will be considered de
minimis.
Any person who meets the criteria
under (5) above shall be covered by a
fidelity bond to the same extent as
others in similar positions, and shall
disclose the presence of the conviction
or program entry to all insured
institutions in the affairs of which he or
she intends to participate.
Further, no conviction or program
entry for a violation of the Title 18
sections set out in 12 U.S.C. 1829(a)(2)
can qualify under any of the de minimis
exceptions to filing set out in 5 above.
amozie on DSK3GDR082PROD with NOTICES1
C. Procedures
When an application is required,
forms and instructions should be
obtained from, and the application filed
with, the appropriate FDIC Regional
Director. The application must be filed
by an insured institution on behalf of a
person (bank-sponsored) unless the
FDIC grants a waiver of that requirement
(individual waiver). Such waivers will
be considered on a case-by-case basis
where substantial good cause for
granting a waiver is shown. The
appropriate Regional Office for a banksponsored application is the office
covering the state where the bank’s
home office is located. The appropriate
Regional Office for an individual filing
for a waiver of the institution filing
requirement is the office covering the
state where the person resides.
D. Evaluation of Section 19
Applications
The essential criteria in assessing an
application are whether the person has
demonstrated his or her fitness to
participate in the conduct of the affairs
of an insured institution, and whether
the affiliation, ownership, control or
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18:26 Aug 02, 2018
Jkt 244001
participation by the person in the
conduct of the affairs of the insured
institution may constitute a threat to the
safety and soundness of the insured
institution or the interests of its
depositors or threaten to impair public
confidence in the insured institution. In
determining the degree of risk, the FDIC
will consider, in conjunction with the
factors set out in 12 CFR 308.157:
(1) Whether the conviction or program
entry and the specific nature and
circumstances of the offense are a
criminal offense under Section 19;
(2) Whether the participation directly
or indirectly by the person in any
manner in the conduct of the affairs of
the insured institution constitutes a
threat to the safety and soundness of the
insured institution or the interests of its
depositors or threatens to impair public
confidence in the insured institution;
(3) Evidence of rehabilitation
including the person’s reputation since
the conviction or program entry, the
person’s age at the time of conviction or
program entry, and the time that has
elapsed since the conviction or program
entry;
(4) The position to be held or the level
of participation by the person at an
insured institution;
(5) The amount of influence and
control the person will be able to
exercise over the management or affairs
of an insured institution;
(6) The ability of management of the
insured institution to supervise and
control the person’s activities;
(7) The level of ownership the person
will have of the insured institution;
(8) The applicability of the insured
institution’s fidelity bond coverage to
the person; and
(9) Any additional factors in the
specific case that appear relevant
including but not limited to the opinion
or position of the primary Federal and/
or state regulator.
The foregoing criteria will also be
applied by the FDIC to determine
whether the interests of justice are
served in seeking an exception in the
appropriate court when an application
is made to terminate the ten-year ban
under 12 U.S.C. 1829(a)(2) for certain
Federal offenses, prior to its expiration
date.
Some applications can be approved
without an extensive review because the
person will not be in a position to
constitute any substantial risk to the
safety and soundness of the insured
institution. Persons who will occupy
clerical, maintenance, service, or purely
administrative positions, generally fall
into this category. A more detailed
analysis will be performed in the case
of persons who will be in a position to
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
38149
influence or control the management or
affairs of the insured institution. All
approvals and orders will be subject to
the condition that the person shall be
covered by a fidelity bond to the same
extent as others in similar positions. In
cases in which a waiver of the
institution filing requirement has been
granted to an individual, approval of the
application will also be conditioned
upon that person disclosing the
presence of the conviction(s) or program
entry(ies) to all insured institutions in
the affairs of which he or she wishes to
participate. When deemed appropriate,
bank sponsored applications are to
allow the person to work in a specific
job at a specific bank and may also be
subject to the condition that the prior
consent of the FDIC will be required for
any proposed significant changes in the
person’s duties and/or responsibilities.
In the case of bank applications such
proposed changes may, in the discretion
of the Regional Director, require a new
application. In situations in which an
approval has been granted for a person
to participate in the affairs of a
particular insured institution and who
subsequently seeks to participate at
another insured depository institution,
another application must be submitted.
By order of the Board of Directors,
July 19, 2018.
Dated at Washington, DC, on July 19, 2018.
By order of the Board of Directors.
Valerie Best,
Assistant Executive Secretary.
[FR Doc. 2018–16634 Filed 8–2–18; 8:45 am]
BILLING CODE 6714–01–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
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
SUMMARY:
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Federal Register / Vol. 83, No. 150 / Friday, August 3, 2018 / Notices
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 our regulations
regarding Food Additive Petitions and
Investigational Food Additive
Exemptions.
Submit either electronic or
written comments on the collection of
information by October 2, 2018.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before October 2,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of October 2, 2018. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
DATES:
Electronic Submissions
amozie on DSK3GDR082PROD with NOTICES1
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
VerDate Sep<11>2014
18:26 Aug 02, 2018
Jkt 244001
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2012–N–1093 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Food
Additive Petitions and Investigational
Food Additive Exemptions.’’ Received
comments, those filed in a timely
manner (see ADDRESSES), will be placed
in the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, 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.
Food Additive Petitions and
Investigational Food Additive
Exemptions—21 CFR 570.17, 571.1, and
571.6
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
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Federal Register / Vol. 83, No. 150 / Friday, August 3, 2018 / Notices
regulation for investigational use.
Section 409(b) of the FD&C Act (21
U.S.C. 348(b)) specifies the information
that must be submitted by a petitioner
to establish the safety of a food additive
and to secure the issuance of a
regulation permitting its use.
To implement the provisions of § 409
of the FD&C Act, we issued procedural
regulations 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
terms by the FD&C Act. Labeling
requirements for investigational food
additives are also set forth in various
regulations contained in 21 CFR 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.
The information collected is
necessary to protect the public health.
We use the information submitted by
food manufacturers or food additive
manufacturers to ascertain whether the
data establish the identity of the
substance, justify its intended effect in/
on the food, and establish that its
intended use in/on food is safe.
Description of Respondents:
Respondents to this collection of
information are food manufacturers or
food additive manufacturers.
FDA estimates the burden of this
collection of information as follows:
contained in 21 CFR parts 501, 573, and
579. The labeling regulations are
considered by FDA to be crossreferenced 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, § 409(j) of the FD&C
Act (§ 409(j)) (21 U.S.C. 348(j)) 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
§ 409(j), we issued regulations 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
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Food Additive Petitions:
571.1(c) Moderate Category .........................................
571.1(c) Complex Category ..........................................
571.6 Amendment of Petition .......................................
Investigational Food Additive Files:
570.17 Moderate Category ...........................................
570.17 Complex Category ............................................
Total Hours ............................................................
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1 There
Number of
responses per
respondent
Number of
respondents
21 CFR section
Average
burden per
response
Total annual
responses
Total hours
12
12
2
1
1
1
12
12
2
3,000
10,000
1,300
36,000
120,000
2,600
4
5
1
1
4
5
1,500
5,000
6,000
25,000
........................
........................
........................
........................
189,600
are no capital costs or operating and maintenance costs associated with this collection of information.
We base our estimate of the total
annual responses on submissions
received during fiscal years 2016 and
2017. We base our estimate of the hours
per response upon our experience with
the petition and filing processes.
§ 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. We estimate
that, annually, 12 respondents will each
submit 1 such petition, for a total of
36,000 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. We
estimate that, annually, 12 respondents
will each submit 1 such petition, for a
total of 120,000 hours.
§ 571.6: For a food additive petition
amendment, the estimated time
requirement per petition is
VerDate Sep<11>2014
18:26 Aug 02, 2018
Jkt 244001
approximately 1,300 hours. We estimate
that, annually, two respondents will
each submit one such amendment, for a
total of 2,600 hours.
§ 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. We
estimate that, annually, four
respondents will each submit one such
file, for a total of 6,000 hours.
§ 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. We estimate
that, annually, five respondents will
each submit one such file, for a total of
25,000 hours.
The burden for this information
collected has not changed since the last
OMB approval.
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Dated: July 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–16616 Filed 8–2–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–0405]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Medical Device
Recall Authority
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:
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]]>Agencies
[Federal Register Volume 83, Number 150 (Friday, August 3, 2018)]
[Notices]
[Pages 38149-38151]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-16616]
=======================================================================
-----------------------------------------------------------------------
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
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information,
[[Page 38150]]
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 our regulations regarding Food Additive Petitions and
Investigational Food Additive Exemptions.
DATES: Submit either electronic or written comments on the collection
of information by October 2, 2018.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before October 2, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of October 2, 2018. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2012-N-1093 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Food Additive Petitions and
Investigational Food Additive Exemptions.'' Received comments, those
filed in a timely manner (see ADDRESSES), will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726,
[email protected].
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, 571.1, and 571.6
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
[[Page 38151]]
regulation for investigational use. Section 409(b) of the FD&C Act (21
U.S.C. 348(b)) specifies the information that must be submitted by a
petitioner to establish the safety of a food additive and to secure the
issuance of a regulation permitting its use.
To implement the provisions of Sec. 409 of the FD&C Act, we issued
procedural regulations 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 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, Sec.
409(j) of the FD&C Act (Sec. 409(j)) (21 U.S.C. 348(j)) 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 Sec. 409(j), we issued regulations
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 21 CFR 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.
The information collected is necessary to protect the public
health. We use the information submitted by food manufacturers or food
additive manufacturers to ascertain whether the data establish the
identity of the substance, justify its intended effect in/on the food,
and establish that its intended use in/on food is safe.
Description of Respondents: Respondents to this collection of
information are food manufacturers or food additive manufacturers.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Food Additive Petitions:
571.1(c) Moderate Category.. 12 1 12 3,000 36,000
571.1(c) Complex Category... 12 1 12 10,000 120,000
571.6 Amendment of Petition. 2 1 2 1,300 2,600
Investigational Food Additive
Files:
570.17 Moderate Category.... 4 1 4 1,500 6,000
570.17 Complex Category..... 5 1 5 5,000 25,000
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Total Hours............. .............. .............. .............. .............. 189,600
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
We base our estimate of the total annual responses on submissions
received during fiscal years 2016 and 2017. We base our estimate of the
hours per response upon our experience with the petition and filing
processes.
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. We estimate that, annually, 12 respondents will each submit 1
such petition, for a total of 36,000 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.
We estimate that, annually, 12 respondents will each submit 1 such
petition, for a total of 120,000 hours.
Sec. 571.6: For a food additive petition amendment, the estimated
time requirement per petition is approximately 1,300 hours. We estimate
that, annually, two respondents will each submit one such amendment,
for a total of 2,600 hours.
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. We estimate that, annually, four respondents will each
submit one such file, for a total of 6,000 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. We estimate that, annually, five respondents will each submit
one such file, for a total of 25,000 hours.
The burden for this information collected has not changed since the
last OMB approval.
Dated: July 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-16616 Filed 8-2-18; 8:45 am]
BILLING CODE 4164-01-P
