Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition, 64528-64529 [2019-25370]
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Federal Register / Vol. 84, No. 226 / Friday, November 22, 2019 / Notices
both the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Kalwant Smagh,
Director, Strategic Business Initiatives Unit,
Office of the Chief Operating Officer, Centers
for Disease Control and Prevention.
[FR Doc. 2019–25353 Filed 11–21–19; 8:45 am]
BILLING CODE 4163–18–P
khammond on DSKJM1Z7X2PROD with NOTICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1147]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Preparing a Claim
of Categorical Exclusion or an
Environmental Assessment for
Submission to the Center for Food
Safety and Applied Nutrition
Centers for Disease Control and
Prevention
AGENCY:
Notice of Closed Meeting
ACTION:
In accordance with Section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the following meeting.
The meeting will be closed to the
public in accordance with provisions set
forth in Section 552b(c) (4) and (6), Title
5 U.S.C., and the Determination of the
Director, Strategic Business Initiatives
Unit, Office of the Chief Operating
Officer, CDC, pursuant to Public Law
92–463.
Name of Committee: Safety and
Occupational Health Study Section
(SOHSS), National Institute for
Occupational Safety and Health
(NIOSH).
Date: February 19–20, 2020.
Time: 8:00 a.m.–5:00 p.m., EST.
Place: Embassy Suites, 1900 Diagonal
Road, Alexandria, VA 22314.
Agenda: The meeting will convene to
address matters related to the conduct of
Study Section business and for the
study section to consider safety and
occupational health-related grant
applications.
For Further Information Contact: Nina
Turner, Ph.D., Scientific Review Officer,
NIOSH, 1095 Willowdale Road,
Morgantown, WV 26506, (304) 285–
5976; nturner@cdc.gov.
The Director, Strategic Business
Initiatives Unit, Office of the Chief
Operating Officer, Centers for Disease
Control and Prevention, has been
delegated the authority to sign Federal
Register notices pertaining to
announcements of meetings and other
committee management activities, for
both the Centers for Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
SUMMARY:
Kalwant Smagh,
Director, Strategic Business Initiatives Unit,
Office of the Chief Operating Officer, Centers
for Disease Control and Prevention.
[FR Doc. 2019–25351 Filed 11–21–19; 8:45 am]
BILLING CODE 4163–18–P
VerDate Sep<11>2014
16:57 Nov 21, 2019
Jkt 250001
Food and Drug Administration,
HHS.
Notice.
The Food and Drug
Administration (FDA or we) 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 December
23, 2019.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0541. Also
include the FDA docket number found
in brackets in the heading of this
document.
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.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
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 our decision
making process, we are obligated under
the National Environmental Policy Act
of 1969 (NEPA) to consider the
environmental impact of our actions,
PO 00000
Frm 00076
Fmt 4703
Sfmt 4703
including allowing notifications for food
contact substances to become effective;
approving food additive petitions, color
additive petitions, generally recognized
as safe affirmation petitions, and
requests for exemption from regulation
as a food additive; and approving
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 (CE) 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 CE
and EAs for submission to CFSAN. The
following questions are covered in this
guidance: (1) What types of industryinitiated 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.
In the Federal Register of June 25,
2019 (84 FR 29864), we published a 60day notice requesting public comment
on the proposed collection of
information. No comments were
received.
We estimate the burden of this
collection of information as follows:
E:\FR\FM\22NON1.SGM
22NON1
64529
Federal Register / Vol. 84, No. 226 / Friday, November 22, 2019 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR section/environmental impact considerations
25.15(a)
25.15(a)
25.15(a)
25.40(a)
and
and
and
and
Average
burden per
response
Total annual
responses
Total hours
(d) (to cover CEs under 25.32(i)) ...................
(d) (to cover CEs under 25.32(o)) .................
(d) (to cover CEs under 25.32 (q)) ................
(c) EAs ...........................................................
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 DSKJM1Z7X2PROD with NOTICES
Number of
responses per
respondent
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 CEs listed
under § 25.32(i) and (q) (21 CFR 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 21 CFR 25.15(a) and (d).
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 the
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 § 25.32(o) and
(q), the submitters will copy existing
documentation and attach it to the claim
for categorical exclusion. We believe
that collecting this information should
take no longer than 8 hours per
submission.
For the information requested for the
environmental assessments in 21 CFR
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 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.
VerDate Sep<11>2014
16:57 Nov 21, 2019
Jkt 250001
Dated: November 14, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–25370 Filed 11–21–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0129]
Agency Information Collection
Activities; Proposed Additional
Collection; Comment Request; General
Licensing Provisions; Section 351(k)
Biosimilar Applications; Formal
Meetings Between the Food and Drug
Administration and Sponsors or
Applicants
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/
revision of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
‘‘General Licensing Provisions; Section
351(k) Biosimilar Applications; Formal
Meetings Between the FDA and
Sponsors or Applicants.’’
DATES: Submit either electronic or
written comments on the collection of
information by January 21, 2020.
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 January 21,
2020. The https://www.regulations.gov
SUMMARY:
PO 00000
Frm 00077
Fmt 4703
Sfmt 4703
electronic filing system will accept
comments until midnight Eastern Time
at the end of January 21, 2020.
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
E:\FR\FM\22NON1.SGM
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]]>Agencies
[Federal Register Volume 84, Number 226 (Friday, November 22, 2019)]
[Notices]
[Pages 64528-64529]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-25370]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-1147]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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 we) 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
December 23, 2019.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax: 202-395-7285, or emailed to [email protected]. All
comments should be identified with the OMB control number 0910-0541.
Also include the FDA docket number found in brackets in the heading of
this document.
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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
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 our 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;
approving food additive petitions, color additive petitions, generally
recognized as safe affirmation petitions, and requests for exemption
from regulation as a food additive; and approving 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 (CE)
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 CE 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.
In the Federal Register of June 25, 2019 (84 FR 29864), we
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
We estimate the burden of this collection of information as
follows:
[[Page 64529]]
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR section/environmental Number of responses per Total annual Average burden Total hours
impact considerations respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
25.15(a) and (d) (to cover CEs 47 1 47 8 376
under 25.32(i))................
25.15(a) and (d) (to cover CEs 1 1 1 8 8
under 25.32(o))................
25.15(a) and (d) (to cover CEs 3 1 3 8 24
under 25.32 (q))...............
25.40(a) and (c) EAs............ 57 1 57 180 10,260
-------------------------------------------------------------------------------
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
CEs listed under Sec. 25.32(i) and (q) (21 CFR 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 21 CFR 25.15(a) and (d).
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 the 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 copy existing
documentation and attach it to the claim for categorical exclusion. We
believe that collecting this information should take no longer than 8
hours per submission.
For the information requested for the environmental assessments in
21 CFR 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 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: November 14, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-25370 Filed 11-21-19; 8:45 am]
BILLING CODE 4164-01-P
