83 FR 38149 - Agency Information Collection Activities; Proposed Collection; Comment Request; Food Additive Petitions and Investigational Food Additive Exemptions

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 150 (August 3, 2018)

Page Range		38149-38151
FR Document		2018-16616

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, 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.

Federal Register, Volume 83 Issue 150 (Friday, August 3, 2018)

[Federal Register Volume 83, Number 150 (Friday, August 3, 2018)]
[Notices]
[Pages 38149-38151]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-16616]


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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.thefederalregister.org/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
                                 -------------------------------------------------------------------------------
        Total Hours.............  ..............  ..............  ..............  ..............         189,600
----------------------------------------------------------------------------------------------------------------
\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

Federal Register / Vol. 83, No. 150 / Friday, August 3, 2018 / Notices 38149

entry, where the person has no other participation by the person in the influence or control the management or
conviction or program entry under conduct of the affairs of the insured affairs of the insured institution. All
Section 19, where it has been five years institution may constitute a threat to the approvals and orders will be subject to
since the conviction or program entry safety and soundness of the insured the condition that the person shall be
(30 months in the case of a person 21 institution or the interests of its covered by a fidelity bond to the same
or younger as described above) and depositors or threaten to impair public extent as others in similar positions. In
which does not involve an insured confidence in the insured institution. In cases in which a waiver of the
financial institution or insured credit determining the degree of risk, the FDIC institution filing requirement has been
union is considered de minimis. Simple will consider, in conjunction with the granted to an individual, approval of the
theft excludes burglary, forgery, robbery, factors set out in 12 CFR 308.157: application will also be conditioned
identity theft, and fraud. (1) Whether the conviction or program upon that person disclosing the
Convictions or program entries for the entry and the specific nature and presence of the conviction(s) or program
use of a fake, false or altered circumstances of the offense are a entry(ies) to all insured institutions in
identification card: criminal offense under Section 19; the affairs of which he or she wishes to
The use of a fake, false or altered (2) Whether the participation directly participate. When deemed appropriate,
identification card used by person or indirectly by the person in any bank sponsored applications are to
under the legal age for the purpose of manner in the conduct of the affairs of allow the person to work in a specific
obtaining or purchasing alcohol, or used the insured institution constitutes a job at a specific bank and may also be
for the purpose of entering a premise threat to the safety and soundness of the subject to the condition that the prior
where alcohol is served but for which insured institution or the interests of its consent of the FDIC will be required for
age appropriate identification is depositors or threatens to impair public any proposed significant changes in the
required, provided that there is no other confidence in the insured institution; person’s duties and/or responsibilities.
conviction or program entry for a (3) Evidence of rehabilitation In the case of bank applications such
covered offense, will be considered de including the person’s reputation since proposed changes may, in the discretion
minimis. the conviction or program entry, the of the Regional Director, require a new
Any person who meets the criteria person’s age at the time of conviction or application. In situations in which an
under (5) above shall be covered by a program entry, and the time that has approval has been granted for a person
fidelity bond to the same extent as elapsed since the conviction or program to participate in the affairs of a
others in similar positions, and shall entry; particular insured institution and who
disclose the presence of the conviction (4) The position to be held or the level subsequently seeks to participate at
or program entry to all insured of participation by the person at an another insured depository institution,
institutions in the affairs of which he or insured institution; another application must be submitted.
she intends to participate. (5) The amount of influence and By order of the Board of Directors,
Further, no conviction or program control the person will be able to July 19, 2018.
entry for a violation of the Title 18 exercise over the management or affairs
sections set out in 12 U.S.C. 1829(a)(2) of an insured institution; Dated at Washington, DC, on July 19, 2018.
can qualify under any of the de minimis (6) The ability of management of the By order of the Board of Directors.
exceptions to filing set out in 5 above. insured institution to supervise and Valerie Best,
control the person’s activities; Assistant Executive Secretary.
C. Procedures (7) The level of ownership the person [FR Doc. 2018–16634 Filed 8–2–18; 8:45 am]
When an application is required, will have of the insured institution; BILLING CODE 6714–01–P
forms and instructions should be (8) The applicability of the insured
obtained from, and the application filed institution’s fidelity bond coverage to
with, the appropriate FDIC Regional the person; and DEPARTMENT OF HEALTH AND
Director. The application must be filed (9) Any additional factors in the
HUMAN SERVICES
by an insured institution on behalf of a specific case that appear relevant
person (bank-sponsored) unless the including but not limited to the opinion Food and Drug Administration
FDIC grants a waiver of that requirement or position of the primary Federal and/
(individual waiver). Such waivers will or state regulator. [Docket No. FDA–2012–N–1093]
be considered on a case-by-case basis The foregoing criteria will also be
applied by the FDIC to determine Agency Information Collection
where substantial good cause for
whether the interests of justice are Activities; Proposed Collection;
granting a waiver is shown. The
served in seeking an exception in the Comment Request; Food Additive
appropriate Regional Office for a bank-
appropriate court when an application Petitions and Investigational Food
sponsored application is the office
is made to terminate the ten-year ban Additive Exemptions
covering the state where the bank’s
home office is located. The appropriate under 12 U.S.C. 1829(a)(2) for certain AGENCY: Food and Drug Administration,
Regional Office for an individual filing Federal offenses, prior to its expiration HHS.
for a waiver of the institution filing date. ACTION: Notice.
requirement is the office covering the Some applications can be approved
state where the person resides. without an extensive review because the SUMMARY: The Food and Drug
person will not be in a position to Administration (FDA or Agency) is
D. Evaluation of Section 19 constitute any substantial risk to the announcing an opportunity for public
amozie on DSK3GDR082PROD with NOTICES1

Applications safety and soundness of the insured comment on the proposed collection of
The essential criteria in assessing an institution. Persons who will occupy certain information by the Agency.
application are whether the person has clerical, maintenance, service, or purely Under the Paperwork Reduction Act of
demonstrated his or her fitness to administrative positions, generally fall 1995 (PRA), Federal Agencies are
participate in the conduct of the affairs into this category. A more detailed required to publish notice in the
of an insured institution, and whether analysis will be performed in the case Federal Register concerning each
the affiliation, ownership, control or of persons who will be in a position to proposed collection of information,

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Federal Register / Vol. 83, No. 150 / Friday, August 3, 2018 / Notices 38151

regulation for investigational use. contained in 21 CFR parts 501, 573, and terms by the FD&C Act. Labeling
Section 409(b) of the FD&C Act (21 579. The labeling regulations are requirements for investigational food
U.S.C. 348(b)) specifies the information considered by FDA to be cross- additives are also set forth in various
that must be submitted by a petitioner referenced to § 571.1, which is the regulations contained in 21 CFR 501.
to establish the safety of a food additive subject of this same OMB clearance for The labeling regulations are considered
and to secure the issuance of a food additive petitions. by FDA to be cross-referenced to
regulation permitting its use. With regard to the investigational use § 570.17, which is the subject of this
To implement the provisions of § 409 of food additives, § 409(j) of the FD&C same OMB clearance for investigational
of the FD&C Act, we issued procedural Act (§ 409(j)) (21 U.S.C. 348(j)) provides food additive files.
regulations under 21 CFR part 571. that any food additive, or any food The information collected is
These procedural regulations are bearing or containing such an additive, necessary to protect the public health.
designed to specify more thoroughly the may be exempted from the requirements We use the information submitted by
information that must be submitted to of this section if intended solely for food manufacturers or food additive
meet the requirement set down in investigational use by qualified experts. manufacturers to ascertain whether the
broader terms by the FD&C Act. The Investigational use of a food additive is data establish the identity of the
regulations add no substantive typically to address the safety and/or substance, justify its intended effect in/
requirements to those indicated in the intended physical or technical effect of on the food, and establish that its
FD&C Act, but attempt to explain these the additive. intended use in/on food is safe.
requirements and provide a standard To implement the provisions of Description of Respondents:
format for submission to speed § 409(j), we issued regulations under 21 Respondents to this collection of
processing of the petition. Labeling CFR 570.17. These regulations are information are food manufacturers or
requirements for food additives designed to specify more thoroughly the food additive manufacturers.
intended for animal consumption are information that must be submitted to FDA estimates the burden of this
also set forth in various regulations meet the requirement set down in broad collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
21 CFR section responses per burden per Total hours
respondents responses
respondent 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

Total Hours ............................................................ ........................ ........................ ........................ ........................ 189,600
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

We base our estimate of the total approximately 1,300 hours. We estimate Dated: July 24, 2018.
annual responses on submissions that, annually, two respondents will Leslie Kux,
received during fiscal years 2016 and each submit one such amendment, for a Associate Commissioner for Policy.
2017. We base our estimate of the hours total of 2,600 hours. [FR Doc. 2018–16616 Filed 8–2–18; 8:45 am]
per response upon our experience with § 570.17 Moderate Category: For an BILLING CODE 4164–01–P
the petition and filing processes.
investigational food additive file
§ 571.1(c) Moderate Category: For a
food additive petition without complex without complex chemistry,
manufacturing, efficacy, or safety issues, DEPARTMENT OF HEALTH AND
chemistry, manufacturing, efficacy or HUMAN SERVICES
safety issues, the estimated time the estimated time requirement per file
requirement per petition is is approximately 1,500 hours. We Food and Drug Administration
approximately 3,000 hours. We estimate estimate that, annually, four
respondents will each submit one such [Docket No. FDA–2018–N–0405]
that, annually, 12 respondents will each
submit 1 such petition, for a total of file, for a total of 6,000 hours.
Agency Information Collection
36,000 hours. § 570.17 Complex Category: For an Activities; Submission for Office of
§ 571.1(c) Complex Category: For a investigational food additive file with Management and Budget Review;
food additive petition with complex complex chemistry, manufacturing, Comment Request; Medical Device
chemistry, manufacturing, efficacy and/ efficacy, and/or safety issues, the Recall Authority
or safety issues, the estimated time estimated time requirement per file is
requirement per petition is AGENCY: Food and Drug Administration,
amozie on DSK3GDR082PROD with NOTICES1

approximately 5,000 hours. We estimate
approximately 10,000 hours. We that, annually, five respondents will HHS.
estimate that, annually, 12 respondents ACTION: Notice.
each submit one such file, for a total of
will each submit 1 such petition, for a
25,000 hours. SUMMARY: The Food and Drug
total of 120,000 hours.
§ 571.6: For a food additive petition The burden for this information Administration (FDA) is announcing
amendment, the estimated time collected has not changed since the last that a proposed collection of
requirement per petition is OMB approval. information has been submitted to the

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Document Created: 2018-11-06 10:35:15
Document Modified: 2018-11-06 10:35:15

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Submit either electronic or written comments on the collection of information by October 2, 2018.
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]
FR Citation		83 FR 38149

83 FR 38149 - Agency Information Collection Activities; Proposed Collection; Comment Request; Food Additive Petitions and Investigational Food Additive Exemptions

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 150 (August 3, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration