Notice of Request for Approval of an Information Collection; Unified Website for Biotechnology Regulation; Contact Page, 68386-68387 [2024-19055]
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68386
Notices
Federal Register
Vol. 89, No. 165
Monday, August 26, 2024
This section of the FEDERAL REGISTER
contains documents other than rules or
proposed rules that are applicable to the
public. Notices of hearings and investigations,
committee meetings, agency decisions and
rulings, delegations of authority, filing of
petitions and applications and agency
statements of organization and functions are
examples of documents appearing in this
section.
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
[Docket No. APHIS–2024–0037]
Notice of Request for Approval of an
Information Collection; Unified
Website for Biotechnology Regulation;
Contact Page
Animal and Plant Health
Inspection Service, USDA.
ACTION: New information collection;
comment request.
AGENCY:
In accordance with the
Paperwork Reduction Act of 1995, this
notice announces the Animal and Plant
Health Inspection Service’s intention to
request approval of a new information
collection associated with the use of the
contact page of the Unified website for
Biotechnology Regulation to collect
certain information from visitors to the
website.
DATES: We will consider all comments
that we receive on or before October 25,
2024.
ADDRESSES: You may submit comments
by either of the following methods:
• Federal eRulemaking Portal: Go to
https://www.regulations.gov. Enter
APHIS–2024–0037 in the Search field.
Select the Documents tab, then select
the Comment button in the list of
documents.
• Postal Mail/Commercial Delivery:
Send your comment to Docket No.
APHIS–2024–0037, Regulatory Analysis
and Development, PPD, APHIS, Station
3A–03.8, 4700 River Road, Unit 118,
Riverdale, MD 20737–1238.
Supporting documents and any
comments we receive on this docket
may be viewed at regulations.gov or in
our reading room, which is located in
Room 1620 of the USDA South
Building, 14th Street and Independence
Avenue SW, Washington, DC. Normal
reading room hours are 8 a.m. to 4:30
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
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17:03 Aug 23, 2024
Jkt 262001
p.m., Monday through Friday, except
holidays. To be sure someone is there to
help you, please call (202) 799–7039
before coming.
FOR FURTHER INFORMATION CONTACT: For
information on the Unified website for
Biotechnology Regulation, contact Mr.
Joseph Tangredi, Document
Management, Policy, Program and
International Collaborations,
Biotechnology Regulatory Services,
APHIS, 4700 River Road, Unit 146,
Riverdale, MD 20737; (301) 851–4061;
joseph.tangredi@usda.gov. For more
information about the information
collection process, contact Mr. Joseph
Moxey, APHIS’ Paperwork Reduction
Act Coordinator, at (301) 851–2533.
SUPPLEMENTARY INFORMATION:
Title: Unified website for
Biotechnology Regulation; Contact Page.
OMB Control Number: 0579–XXXX.
Type of Request: Approval of a new
information collection.
Abstract: In 1986, the Coordinated
Framework for the Regulation of
Biotechnology (Coordinated
Framework) was published by the Office
of Science and Technology Policy and
explained the regulatory roles for the
U.S. Department of Agriculture, the U.S.
Environmental Protection Agency
(EPA), and the U.S. Food and Drug
Administration (FDA), (herein, the
Agencies) and how Federal agencies use
existing Federal statutes to ensure
public health and environmental safety
while maintaining regulatory flexibility
to avoid impeding the growth of the
biotechnology industry. The
Coordinated Framework was
subsequently updated in 1992 (57 FR
6753–6762; February 27, 1992) and
2017,1 taking into account advances that
had occurred in the field of
biotechnology.
Within the USDA, the Animal and
Plant Health Inspection Service’s
(APHIS’) Biotechnology Regulatory
Services unit is responsible for ensuring
that organisms developed using genetic
engineering, such as genetically
modified plants, insects, and microbes
do not pose a plant pest risk. APHIS
derives its authority to promulgate its
biotechnology regulations from
provisions of the Plant Protection Act
(PPA, 7 U.S.C. 7701 et seq.) and the
Virus-Serum-Toxin Act (VRTA, 21
1 https://usbiotechnologyregulation.mrp.
usda.gov/biotechnologygov/home/.
PO 00000
Frm 00001
Fmt 4703
Sfmt 4703
U.S.C. 151–159). The EPA is charged
with protecting human health and the
environment through ensuring the
safety of pesticides and other chemicals,
including those developed using genetic
engineering. The EPA derives its
regulatory authority from provisions of
the Federal Insecticide, Fungicide and
Rodenticide Act (FIFRA, 7 U.S.C. 136 et
seq.) and the Toxic Substances Control
Act (TSCA, 15 U.S.C. 2601 et seq.). The
FDA is responsible for protecting the
public health by ensuring the safety,
efficacy, and security of human and
veterinary drugs, biological products,
and medical devices; and by ensuring
the safety of our nation’s food supply,
cosmetics, and products that emit
radiation, which includes oversight of
food and feed. FDA derives its
regulatory authority from provisions of
the Federal Food, Drug and Cosmetic
Act (FFDCA, 21 U.S.C. 301–392).
Together with the USDA’s Food Safety
and Inspection Service (FSIS), FDA has
oversight of certain chemicals modified
using genetic engineering. FSIS derives
its regulatory authority from the Federal
Meat Inspection Act (FMIA, 21 U.S.C.
601 et seq.) and the Poultry Products
Protection Act (PPIA, 21 U.S.C. ch.10,
451 et seq.).
On September 12, 2022, Executive
Order (E.O.) 14081, Advancing
Biotechnology and Biomanufacturing
Innovation for a Sustainable, Safe, and
Secure American Bioeconomy,2 was
published and directed the Agencies,
among other things, to build on the
Unified website for Biotechnology
Regulation 3 developed pursuant to E.O.
13874, Modernizing the Regulatory
Framework for Agricultural
Biotechnology Products, June 11, 2019,4
by including on the website the
information developed under subsection
(b) of Section 8 of E.O. 14081, and by
enabling developers of biotechnology
products to submit inquiries about a
particular product and promptly receive
a single, coordinated response that
provides, to the extent practicable,
information and, when appropriate,
informal guidance regarding the process
2 https://www.govinfo.gov/content/pkg/FR-202209-15/pdf/2022-20167.pdf.
3 https://usbiotechnologyregulation.mrp.
usda.gov/biotechnologygov/home/.
4 https://www.govinfo.gov/content/pkg/FR-201906-14/pdf/2019-12802.pdf.
E:\FR\FM\26AUN1.SGM
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lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 89, No. 165 / Monday, August 26, 2024 / Notices
that the developers must follow for
Federal regulatory review.
The necessity for this information
collection arises from E.O. 13874,
Section 5, Unified Biotechnology WebBased Platform, and E.O. 14081, Section
8(d). These provisions seek to ensure
that innovators can easily navigate the
Federal regulatory system for products
of biotechnology by directing USDA,
EPA, and FDA to jointly establish a
web-based platform that contains and
provides links to relevant United States
Government regulatory information for
biotechnology products. These
provisions further direct that the webbased platform shall allow developers of
products of agricultural biotechnology
to submit inquiries about a particular
product and promptly receive from the
Agencies a single, coordinated response
that provides, to the extent practicable,
information and, when appropriate,
informal guidance regarding the
processes that the developers must
follow for Federal regulatory review.
The Unified website for
Biotechnology Regulation (‘‘Unified
website’’) is currently hosted by the
Department of Agriculture, with other
agencies providing support, to the
extent consistent with existing
appropriations, through appropriate
interagency agreements, including
agreements under the Economy Act.
USDA–APHIS, EPA, and FDA will
use a web-form on the contact page of
the Unified website to enable site
visitors to ask questions, make
comments, or request a meeting with
one or all of the sponsoring agencies.
The web-form will collect basic contact
information such as the name and email
address of contact page respondents, as
well as the respondents’ questions or
comments and their meeting requests.
Respondent use of the contact page is
voluntary.
We are asking the Office of
Management and Budget (OMB) to
approve our use of this information
collection activity for 3 years.
The purpose of this notice is to solicit
comments from the public (as well as
affected agencies) concerning our
information collection. These comments
will help us:
(1) Evaluate whether the collection of
information is necessary for the proper
performance of the functions of the
Agency, including whether the
information will have practical utility;
(2) Evaluate the accuracy of our
estimate of the burden of the collection
of information, including the validity of
the methodology and assumptions used;
(3) Enhance the quality, utility, and
clarity of the information to be
collected; and
VerDate Sep<11>2014
17:03 Aug 23, 2024
Jkt 262001
(4) Minimize the burden of the
collection of information on those who
are to respond, through use, as
appropriate, of automated, electronic,
mechanical, and other collection
technologies; e.g., permitting electronic
submission of responses.
Estimate of burden: The public
burden for this collection of information
is estimated to average 0.5 hours per
response.
Respondents: Commercial and
academic developers of biotechnology
products and the interested public.
Estimated annual number of
respondents: 30.
Estimated annual number of
responses per respondent: 1.
Estimated annual number of
responses: 30.
Estimated total annual burden on
respondents: 15 hours. (Due to
averaging, the total annual burden hours
may not equal the product of the annual
number of responses multiplied by the
reporting burden per response.)
All responses to this notice will be
summarized and included in the request
for OMB approval. All comments will
also become a matter of public record.
Done in Washington, DC, this 6th day of
August 2024.
Michael Watson,
Administrator, Animal and Plant Health
Inspection Service.
[FR Doc. 2024–19055 Filed 8–23–24; 8:45 am]
BILLING CODE 3410–34–P
DEPARTMENT OF AGRICULTURE
Rural Utilities Service
[Docket No.: RUS–24–WATER–0020]
Notice of Revision of a Currently
Approved Information Collection
Rural Utilities Service, USDA.
Notice; request for comments.
AGENCY:
ACTION:
In accordance with the
Paperwork Reduction Act of 1995 the
Rural Utilities Service (RUS or Agency),
an agency within the United States
Department of Agriculture (USDA),
Rural Development (RD), announces its
intention to request a revision to a
currently approved information
collection package for servicing
activities related to several loan and
grant programs administered through
the Water and Environmental Programs
(WEP) of RUS. The Agency invites
comments on this information
collection for which it intends to
request approval from the Office of
Management and Budget (OMB).
SUMMARY:
PO 00000
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Fmt 4703
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68387
Comments on this notice must be
received by October 25, 2024 to be
assured of consideration.
FOR FURTHER INFORMATION CONTACT:
Katherine Anne Mathis, RD Innovation
Center—Regulations Management
Division, U.S. Department of
Agriculture, 1400 Independence Avenue
SW, Washington, DC 20250, Telephone:
202–713–7565, email:
Katherine.mathis@usda.gov.
SUPPLEMENTARY INFORMATION: The OMB
regulation (5 CFR part 1320)
implementing provisions of the
Paperwork Reduction Act of 1995 (Pub.
L. 104–13) requires that interested
members of the public and affected
agencies have an opportunity to
comment on information collection and
recordkeeping activities (see 5 CFR
1320.8(d)). This notice identifies an
information collection that the Agency
is submitting to OMB for extension.
Comments are invited on (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the Agency,
including whether the information will
have practical utility; (b) the accuracy of
the Agency’s estimate of the burden of
the proposed collection of information
including the validity of the
methodology and assumptions used; (c)
ways to enhance the quality, utility and
clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on those who are to respond, including
through the use of appropriate
automated, electronic, mechanical, or
other technological collection
techniques or other forms of information
technology.
Comments may be submitted
electronically by the Federal
eRulemaking Portal, regulations.gov/. In
the ‘‘Search for dockets and documents
on agency actions’’ box enter the Docket
No. RUS–24–WATER–0020 and click
the ‘‘Search’’ button. From the search
results, click on or locate the document
title: ‘‘Notice of Revision of a Currently
Approved Information Collection’’ and
select the ‘‘Comment’’ button. Before
inputting comments, commenters may
review the ‘‘Commenter’s Checklist’’
(optional). To submit a comment: Insert
comments under the ‘‘Comment’’ title,
click ‘‘Browse’’ to attach files (if
available), input email address, select
box to opt to receive email confirmation
of submission and tracking (optional),
select the box ‘‘I’m not a robot,’’ and
then select ‘‘Submit Comment.’’
Information on using Regulations.gov,
including instructions for accessing
documents, submitting comments, and
viewing the docket after the close of the
DATES:
E:\FR\FM\26AUN1.SGM
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]]>Agencies
[Federal Register Volume 89, Number 165 (Monday, August 26, 2024)]
[Notices]
[Pages 68386-68387]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-19055]
========================================================================
Notices
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains documents other than rules
or proposed rules that are applicable to the public. Notices of hearings
and investigations, committee meetings, agency decisions and rulings,
delegations of authority, filing of petitions and applications and agency
statements of organization and functions are examples of documents
appearing in this section.
========================================================================
Federal Register / Vol. 89, No. 165 / Monday, August 26, 2024 /
Notices
[[Page 68386]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2024-0037]
Notice of Request for Approval of an Information Collection;
Unified Website for Biotechnology Regulation; Contact Page
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: New information collection; comment request.
-----------------------------------------------------------------------
SUMMARY: In accordance with the Paperwork Reduction Act of 1995, this
notice announces the Animal and Plant Health Inspection Service's
intention to request approval of a new information collection
associated with the use of the contact page of the Unified website for
Biotechnology Regulation to collect certain information from visitors
to the website.
DATES: We will consider all comments that we receive on or before
October 25, 2024.
ADDRESSES: You may submit comments by either of the following methods:
Federal eRulemaking Portal: Go to https://www.regulations.gov. Enter APHIS-2024-0037 in the Search field. Select
the Documents tab, then select the Comment button in the list of
documents.
Postal Mail/Commercial Delivery: Send your comment to
Docket No. APHIS-2024-0037, Regulatory Analysis and Development, PPD,
APHIS, Station 3A-03.8, 4700 River Road, Unit 118, Riverdale, MD 20737-
1238.
Supporting documents and any comments we receive on this docket may
be viewed at regulations.gov or in our reading room, which is located
in Room 1620 of the USDA South Building, 14th Street and Independence
Avenue SW, Washington, DC. Normal reading room hours are 8 a.m. to 4:30
p.m., Monday through Friday, except holidays. To be sure someone is
there to help you, please call (202) 799-7039 before coming.
FOR FURTHER INFORMATION CONTACT: For information on the Unified website
for Biotechnology Regulation, contact Mr. Joseph Tangredi, Document
Management, Policy, Program and International Collaborations,
Biotechnology Regulatory Services, APHIS, 4700 River Road, Unit 146,
Riverdale, MD 20737; (301) 851-4061; [email protected]. For more
information about the information collection process, contact Mr.
Joseph Moxey, APHIS' Paperwork Reduction Act Coordinator, at (301) 851-
2533.
SUPPLEMENTARY INFORMATION:
Title: Unified website for Biotechnology Regulation; Contact Page.
OMB Control Number: 0579-XXXX.
Type of Request: Approval of a new information collection.
Abstract: In 1986, the Coordinated Framework for the Regulation of
Biotechnology (Coordinated Framework) was published by the Office of
Science and Technology Policy and explained the regulatory roles for
the U.S. Department of Agriculture, the U.S. Environmental Protection
Agency (EPA), and the U.S. Food and Drug Administration (FDA), (herein,
the Agencies) and how Federal agencies use existing Federal statutes to
ensure public health and environmental safety while maintaining
regulatory flexibility to avoid impeding the growth of the
biotechnology industry. The Coordinated Framework was subsequently
updated in 1992 (57 FR 6753-6762; February 27, 1992) and 2017,\1\
taking into account advances that had occurred in the field of
biotechnology.
---------------------------------------------------------------------------
\1\ https://usbiotechnologyregulation.mrp.usda.gov/biotechnologygov/home/.
---------------------------------------------------------------------------
Within the USDA, the Animal and Plant Health Inspection Service's
(APHIS') Biotechnology Regulatory Services unit is responsible for
ensuring that organisms developed using genetic engineering, such as
genetically modified plants, insects, and microbes do not pose a plant
pest risk. APHIS derives its authority to promulgate its biotechnology
regulations from provisions of the Plant Protection Act (PPA, 7 U.S.C.
7701 et seq.) and the Virus-Serum-Toxin Act (VRTA, 21 U.S.C. 151-159).
The EPA is charged with protecting human health and the environment
through ensuring the safety of pesticides and other chemicals,
including those developed using genetic engineering. The EPA derives
its regulatory authority from provisions of the Federal Insecticide,
Fungicide and Rodenticide Act (FIFRA, 7 U.S.C. 136 et seq.) and the
Toxic Substances Control Act (TSCA, 15 U.S.C. 2601 et seq.). The FDA is
responsible for protecting the public health by ensuring the safety,
efficacy, and security of human and veterinary drugs, biological
products, and medical devices; and by ensuring the safety of our
nation's food supply, cosmetics, and products that emit radiation,
which includes oversight of food and feed. FDA derives its regulatory
authority from provisions of the Federal Food, Drug and Cosmetic Act
(FFDCA, 21 U.S.C. 301-392). Together with the USDA's Food Safety and
Inspection Service (FSIS), FDA has oversight of certain chemicals
modified using genetic engineering. FSIS derives its regulatory
authority from the Federal Meat Inspection Act (FMIA, 21 U.S.C. 601 et
seq.) and the Poultry Products Protection Act (PPIA, 21 U.S.C. ch.10,
451 et seq.).
On September 12, 2022, Executive Order (E.O.) 14081, Advancing
Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe,
and Secure American Bioeconomy,\2\ was published and directed the
Agencies, among other things, to build on the Unified website for
Biotechnology Regulation \3\ developed pursuant to E.O. 13874,
Modernizing the Regulatory Framework for Agricultural Biotechnology
Products, June 11, 2019,\4\ by including on the website the information
developed under subsection (b) of Section 8 of E.O. 14081, and by
enabling developers of biotechnology products to submit inquiries about
a particular product and promptly receive a single, coordinated
response that provides, to the extent practicable, information and,
when appropriate, informal guidance regarding the process
[[Page 68387]]
that the developers must follow for Federal regulatory review.
---------------------------------------------------------------------------
\2\ https://www.govinfo.gov/content/pkg/FR-2022-09-15/pdf/2022-20167.pdf.
\3\ https://usbiotechnologyregulation.mrp.usda.gov/biotechnologygov/home/.
\4\ https://www.govinfo.gov/content/pkg/FR-2019-06-14/pdf/2019-12802.pdf.
---------------------------------------------------------------------------
The necessity for this information collection arises from E.O.
13874, Section 5, Unified Biotechnology Web-Based Platform, and E.O.
14081, Section 8(d). These provisions seek to ensure that innovators
can easily navigate the Federal regulatory system for products of
biotechnology by directing USDA, EPA, and FDA to jointly establish a
web-based platform that contains and provides links to relevant United
States Government regulatory information for biotechnology products.
These provisions further direct that the web-based platform shall allow
developers of products of agricultural biotechnology to submit
inquiries about a particular product and promptly receive from the
Agencies a single, coordinated response that provides, to the extent
practicable, information and, when appropriate, informal guidance
regarding the processes that the developers must follow for Federal
regulatory review.
The Unified website for Biotechnology Regulation (``Unified
website'') is currently hosted by the Department of Agriculture, with
other agencies providing support, to the extent consistent with
existing appropriations, through appropriate interagency agreements,
including agreements under the Economy Act.
USDA-APHIS, EPA, and FDA will use a web-form on the contact page of
the Unified website to enable site visitors to ask questions, make
comments, or request a meeting with one or all of the sponsoring
agencies. The web-form will collect basic contact information such as
the name and email address of contact page respondents, as well as the
respondents' questions or comments and their meeting requests.
Respondent use of the contact page is voluntary.
We are asking the Office of Management and Budget (OMB) to approve
our use of this information collection activity for 3 years.
The purpose of this notice is to solicit comments from the public
(as well as affected agencies) concerning our information collection.
These comments will help us:
(1) Evaluate whether the collection of information is necessary for
the proper performance of the functions of the Agency, including
whether the information will have practical utility;
(2) Evaluate the accuracy of our estimate of the burden of the
collection of information, including the validity of the methodology
and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to
be collected; and
(4) Minimize the burden of the collection of information on those
who are to respond, through use, as appropriate, of automated,
electronic, mechanical, and other collection technologies; e.g.,
permitting electronic submission of responses.
Estimate of burden: The public burden for this collection of
information is estimated to average 0.5 hours per response.
Respondents: Commercial and academic developers of biotechnology
products and the interested public.
Estimated annual number of respondents: 30.
Estimated annual number of responses per respondent: 1.
Estimated annual number of responses: 30.
Estimated total annual burden on respondents: 15 hours. (Due to
averaging, the total annual burden hours may not equal the product of
the annual number of responses multiplied by the reporting burden per
response.)
All responses to this notice will be summarized and included in the
request for OMB approval. All comments will also become a matter of
public record.
Done in Washington, DC, this 6th day of August 2024.
Michael Watson,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2024-19055 Filed 8-23-24; 8:45 am]
BILLING CODE 3410-34-P
