Agency Information Collection Activities; Proposed Collection; Comment Request; Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition, 29864-29866 [2019-13434]
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29864
Federal Register / Vol. 84, No. 122 / Tuesday, June 25, 2019 / Notices
the Currency, the Office of Thrift
Supervision, the Federal Deposit
Insurance Corporation, and the National
Credit Union Administration. There has
been no consultation outside of the
Federal Reserve System with regard to
the current proposal to extend the FR
4198 for three years, with revision.
Board of Governors of the Federal Reserve
System, June 20, 2019.
Michele Taylor Fennell,
Assistant Secretary of the Board.
[FR Doc. 2019–13490 Filed 6–24–19; 8:45 am]
BILLING CODE 6210–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1147]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Preparing a Claim
of Categorical Exclusion or an
Environmental Assessment for
Submission to the Center for Food
Safety and Applied Nutrition
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,
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 guidance
document entitled ‘‘Preparing a Claim of
Categorical Exclusion or an
Environmental Assessment for
Submission to the Center for Food
Safety and Applied Nutrition.’’
DATES: Submit either electronic or
written comments on the collection of
information by August 26, 2019.
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 August 26,
2019. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of August 26, 2019.
Comments received by mail/hand
khammond on DSKBBV9HB2PROD with NOTICES
SUMMARY:
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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–
2013–N–1147 for ‘‘Preparing a Claim of
Categorical Exclusion or an
Environmental Assessment for
Submission to the Center for Food
Safety and Applied Nutrition.’’
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.
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Sfmt 4703
• 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
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, 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
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Federal Register / Vol. 84, No. 122 / Tuesday, June 25, 2019 / Notices
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.
Preparing a Claim of Categorical
Exclusion or an Environmental
Assessment for Submission to the
Center for Food Safety and Applied
Nutrition
OMB Control Number 0910–0541—
Extension
As an integral part of its decision
making process, we are obligated under
the National Environmental Policy Act
of 1969 (NEPA) to consider the
environmental impact of our actions,
including allowing notifications for food
contact substances to become effective
and approving food additive petitions,
color additive petitions, generally
recognized as safe (GRAS) affirmation
petitions, requests for exemption from
regulation as a food additive, and
actions on certain food labeling citizen
petitions, nutrient content claims
petitions, and health claims petitions.
We have provided guidance that
contains sample formats to help
industry submit a claim of categorical
exclusion or an Environmental
Assessment (EA) to the Center for Food
Safety and Applied Nutrition (CFSAN).
The document entitled ‘‘Preparing a
Claim of Categorical Exclusion or an
Environmental Assessment for
Submission to the Center for Food
Safety and Applied Nutrition’’
identifies, interprets, and clarifies
existing requirements imposed by
statute and regulation, consistent with
the Council on Environmental Quality
regulations (40 CFR 1507.3). It consists
of recommendations that do not
themselves create requirements; rather,
they are explanatory guidance for our
own procedures in order to ensure full
compliance with the purposes and
provisions of NEPA.
The guidance provides information to
assist in the preparation of claims of
categorical exclusion and EAs for
submission to CFSAN. The following
questions are covered in this guidance:
(1) What types of industry-initiated
actions are subject to a claim of
categorical exclusion? (2) What must a
claim of categorical exclusion include
by regulation? (3) What is an EA? (4)
When is an EA required by regulation
and what format should be used? (5)
What are extraordinary circumstances?
and (6) What suggestions does CFSAN
have for preparing an EA? Although
CFSAN encourages industry to use the
EA formats described in the guidance
because standardized documentation
submitted by industry increases the
efficiency of the review process,
alternative approaches may be used if
these approaches satisfy the
requirements of the applicable statutes
and regulations.
Description of Respondents: The
likely respondents include businesses
engaged in the manufacture or sale of
food, food ingredients, and substances
used in materials that come into contact
with food.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR part environmental impact considerations
25.15(a)
25.15(a)
25.15(a)
25.40(a)
&
&
&
&
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
(d) (to cover CE’s under 25.32(i)) .....................
(d) (to cover CE’s under 25.32(o)) ....................
(d) (to cover CE’s under 25.32(q)) ....................
(c) EA’s ..............................................................
47
1
3
57
1
1
1
1
47
1
3
57
8
8
8
180
376
8
24
10,260
Total ..............................................................................
........................
........................
........................
........................
10,668
1 There
khammond on DSKBBV9HB2PROD with NOTICES
Number of
respondents
are no capital costs or operating and maintenance costs associated with this collection of information.
The estimates for respondents and
numbers of responses are based on the
annualized numbers of petitions and
notifications qualifying for categorical
exclusions (CE) listed under § 25.32(i)
and (q) that we have received in the past
3 years. To avoid counting the burden
attributed to § 25.32(o) as zero, we have
estimated the burden for this categorical
exclusion at one respondent making one
submission a year for a total of one
annual submission. The burden for
submitting a categorical exclusion is
captured under § 25.15(a) and (c).
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To calculate the estimate for the hours
per response values, we assumed that
the information requested in this
guidance for each of these three
categorical exclusions is readily
available to the submitter. For the
information requested for the exclusion
in § 25.32(i), we expect that submitter
will need to gather information from
appropriate persons in the submitter’s
company and to prepare this
information for attachment to the claim
for categorical exclusion. We believe
that this effort should take no longer
than 8 hours per submission. For the
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Fmt 4703
Sfmt 4703
information requested for the categorical
exclusions in § 25.32(o) and (q), the
submitters will almost always merely
need to copy existing documentation
and attach it to the claim for categorical
exclusion. We believe that collecting
this information should also take no
longer than 8 hours per submission.
For the information requested for the
environmental assessments in § 25.40(a)
and (c), we believe that submitters will
submit an average of 57 environmental
assessments annually. We estimate that
each submitter will prepare an EA
within 3 weeks (120 hours) and revise
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Federal Register / Vol. 84, No. 122 / Tuesday, June 25, 2019 / Notices
Reporting Associated With New Animal
Drug Applications (NADA) and
Veterinary Master Files—21 CFR 514.1,
514.4, 514.5, 514.6, 514.8, 514.11, and
558.5
the EA based on Agency comments
(between 40 to 60 hours), for a total
preparation time of 180 hours.
Based on a current review of the
information collection, we have made
no adjustments to the currently
approved estimate.
Dated: June 19, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–13434 Filed 6–24–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–0482]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Reporting
Associated With New Animal Drug
Applications and Veterinary Master
Files
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 July 25,
2019.
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 0910–0032. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
khammond on DSKBBV9HB2PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A–12M, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
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OMB Control Number 0910–0032—
Extension
Under section 512(b)(1) of the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 360b(b)(1)), any person
may file a new animal drug application
(NADA) seeking our approval to legally
market a new animal drug. Section
512(b)(1) of the FD&C Act sets forth the
information required to be submitted in
a NADA. Sections 514.1, 514.4, 514.6,
514.8, and 514.11 of our regulations (21
CFR 514.1, 514.4, 514.6, 514.8, and
514.11) further specify the information
that the NADA must contain. The
application must include safety and
effectiveness data, proposed labeling,
product manufacturing information, and
where necessary, complete information
on food safety (including microbial food
safety) and any methods used to
determine residues of drug chemicals in
edible tissue from food producing
animals. FDA Guidance for Industry
#152 outlines a risk assessment
approach for evaluating the microbial
food safety of antimicrobial new animal
drugs. We request that applicants utilize
Form FDA 356V, as appropriate, to
ensure efficient and accurate processing
of information to support new animal
drug approval.
Under section 512(b)(3) of the FD&C
Act, any person intending to file a
NADA or supplemental NADA or a
request for an investigational exemption
under section 512(j) of the FD&C Act is
entitled to one or more conferences with
us prior to making a submission.
Section 514.5 of our regulations (21 CFR
514.5) describes the procedures for
requesting, conducting, and
documenting presubmission
conferences. We have found that these
meetings have increased the efficiency
of the drug development and drug
review processes. We encourage
sponsors to submit data for review at the
most appropriate and productive times
in the drug development process. Rather
than submitting all data for review as
part of a complete application, we have
found that the submission of data
supporting discrete technical sections
during the investigational phase of the
new animal drug is the most appropriate
and productive. This ‘‘phased review’’
of data submissions has created
efficiencies for both us and the animal
pharmaceutical industry.
Additionally, we have found that
various uses of veterinary master files
have increased the efficiency of the drug
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Fmt 4703
Sfmt 4703
development and drug review processes
for both us and the animal
pharmaceutical industry. A veterinary
master file is a repository for submission
to FDA’s Center for Veterinary Medicine
of confidential detailed information
about facilities, processes, or articles
used in the manufacturing, processing,
packaging, and storing of one or more
veterinary drugs. The benefits of
veterinary master files include
confidential exchange of information
with FDA, a process for reporting
information outside of a NADA or an
investigational new animal drug (INAD)
file, as well as an opportunity for
increased communication with FDA
during early stages of product
development. Respondents may choose
to use veterinary master files to provide
and organize confidential detailed
information to the Agency. A holder of
a veterinary master file may also
authorize other parties to reference
information in the veterinary master file
without disclosing information in the
file to those parties. Veterinary master
files can be used as repositories for
information that can be referenced in
multiple submissions to the Agency,
thus minimizing paperwork burden.
Veterinary master files are already used
by the animal pharmaceutical industry
in support of information being
submitted for NADAs, abbreviated new
animal drug applications (ANADAs),
INAD files, and generic investigational
new animal drug (JINAD) files. In
previous information collection
requests, we have included the time
necessary to compile and submit such
information to veterinary master files
within the burden estimates provided
for applications and amended
applications (for NADAs and INAD
files) and abbreviated applications and
amended abbreviated applications (for
ANADAs and JINAD files), respectively.
We are now combining the time
necessary to compile and submit such
information to veterinary master files
within the burden estimates provided in
this collection of information.
We are also developing new
approaches to permit more complex
uses of veterinary master files to
facilitate the development of animal
drug products. We expect respondents
will want to use veterinary master files
to submit information to us for review
and consultation during all phases of
animal drug product development
(including product development that
precedes the establishment of an INAD
file or the submission of a NADA). This
information could include information
about processes, facilities, or articles
used in the manufacturing, processing,
E:\FR\FM\25JNN1.SGM
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]]>Agencies
[Federal Register Volume 84, Number 122 (Tuesday, June 25, 2019)]
[Notices]
[Pages 29864-29866]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-13434]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-1147]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Preparing a Claim of Categorical Exclusion or an
Environmental Assessment for Submission to the Center for Food Safety
and Applied Nutrition
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, 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 guidance document entitled ``Preparing a Claim of Categorical
Exclusion or an Environmental Assessment for Submission to the Center
for Food Safety and Applied Nutrition.''
DATES: Submit either electronic or written comments on the collection
of information by August 26, 2019.
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 August 26, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of August 26, 2019. 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-2013-N-1147 for ``Preparing a Claim of Categorical Exclusion or an
Environmental Assessment for Submission to the Center for Food Safety
and Applied Nutrition.'' 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: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[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
[[Page 29865]]
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.
Preparing a Claim of Categorical Exclusion or an Environmental
Assessment for Submission to the Center for Food Safety and Applied
Nutrition
OMB Control Number 0910-0541--Extension
As an integral part of its decision making process, we are
obligated under the National Environmental Policy Act of 1969 (NEPA) to
consider the environmental impact of our actions, including allowing
notifications for food contact substances to become effective and
approving food additive petitions, color additive petitions, generally
recognized as safe (GRAS) affirmation petitions, requests for exemption
from regulation as a food additive, and actions on certain food
labeling citizen petitions, nutrient content claims petitions, and
health claims petitions. We have provided guidance that contains sample
formats to help industry submit a claim of categorical exclusion or an
Environmental Assessment (EA) to the Center for Food Safety and Applied
Nutrition (CFSAN). The document entitled ``Preparing a Claim of
Categorical Exclusion or an Environmental Assessment for Submission to
the Center for Food Safety and Applied Nutrition'' identifies,
interprets, and clarifies existing requirements imposed by statute and
regulation, consistent with the Council on Environmental Quality
regulations (40 CFR 1507.3). It consists of recommendations that do not
themselves create requirements; rather, they are explanatory guidance
for our own procedures in order to ensure full compliance with the
purposes and provisions of NEPA.
The guidance provides information to assist in the preparation of
claims of categorical exclusion and EAs for submission to CFSAN. The
following questions are covered in this guidance: (1) What types of
industry-initiated actions are subject to a claim of categorical
exclusion? (2) What must a claim of categorical exclusion include by
regulation? (3) What is an EA? (4) When is an EA required by regulation
and what format should be used? (5) What are extraordinary
circumstances? and (6) What suggestions does CFSAN have for preparing
an EA? Although CFSAN encourages industry to use the EA formats
described in the guidance because standardized documentation submitted
by industry increases the efficiency of the review process, alternative
approaches may be used if these approaches satisfy the requirements of
the applicable statutes and regulations.
Description of Respondents: The likely respondents include
businesses engaged in the manufacture or sale of food, food
ingredients, and substances used in materials that come into contact
with food.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR part environmental impact Number of responses per Total annual Average burden Total hours
considerations respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
25.15(a) & (d) (to cover CE's 47 1 47 8 376
under 25.32(i))................
25.15(a) & (d) (to cover CE's 1 1 1 8 8
under 25.32(o))................
25.15(a) & (d) (to cover CE's 3 1 3 8 24
under 25.32(q))................
25.40(a) & (c) EA's............. 57 1 57 180 10,260
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Total....................... .............. .............. .............. .............. 10,668
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The estimates for respondents and numbers of responses are based on
the annualized numbers of petitions and notifications qualifying for
categorical exclusions (CE) listed under Sec. 25.32(i) and (q) that we
have received in the past 3 years. To avoid counting the burden
attributed to Sec. 25.32(o) as zero, we have estimated the burden for
this categorical exclusion at one respondent making one submission a
year for a total of one annual submission. The burden for submitting a
categorical exclusion is captured under Sec. 25.15(a) and (c).
To calculate the estimate for the hours per response values, we
assumed that the information requested in this guidance for each of
these three categorical exclusions is readily available to the
submitter. For the information requested for the exclusion in Sec.
25.32(i), we expect that submitter will need to gather information from
appropriate persons in the submitter's company and to prepare this
information for attachment to the claim for categorical exclusion. We
believe that this effort should take no longer than 8 hours per
submission. For the information requested for the categorical
exclusions in Sec. 25.32(o) and (q), the submitters will almost always
merely need to copy existing documentation and attach it to the claim
for categorical exclusion. We believe that collecting this information
should also take no longer than 8 hours per submission.
For the information requested for the environmental assessments in
Sec. 25.40(a) and (c), we believe that submitters will submit an
average of 57 environmental assessments annually. We estimate that each
submitter will prepare an EA within 3 weeks (120 hours) and revise
[[Page 29866]]
the EA based on Agency comments (between 40 to 60 hours), for a total
preparation time of 180 hours.
Based on a current review of the information collection, we have
made no adjustments to the currently approved estimate.
Dated: June 19, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-13434 Filed 6-24-19; 8:45 am]
BILLING CODE 4164-01-P
