Submission for OMB Review; Comment Request

Issuing agencies

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, 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 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, was published and directed the Agencies, among other things, to build on the Unified website for Biotechnology Regulation developed pursuant to E.O. 13874, Modernizing the Regulatory Framework for Agricultural Biotechnology Products, June 11, 2019, 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 that the developers must follow for Federal regulatory review. Need and Use of Information: 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. 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. Description of Respondents: Business. Number of Respondents: 30. Frequency of Responses: Reporting: On occasion; Annual. Total Burden Hours: 15.

Full Text

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[Federal Register Volume 89, Number 232 (Tuesday, December 3, 2024)]
[Notices]
[Pages 95732-95733]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-28350]


========================================================================
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. 232 / Tuesday, December 3, 2024 / 
Notices

[[Page 95732]]



DEPARTMENT OF AGRICULTURE


Submission for OMB Review; Comment Request

    The Department of Agriculture has submitted the following 
information collection requirement(s) to OMB for review and clearance 
under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments 
are requested regarding; 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; the 
accuracy of the agency's estimate of burden including the validity of 
the methodology and assumptions used; ways to enhance the quality, 
utility and clarity of the information to be collected; and 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 regarding this information collection received by January 
2, 2025 will be considered. Written comments and recommendations for 
the proposed information collection should be submitted within 30 days 
of the publication of this notice on the following website 
<a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. Find this particular information 
collection by selecting ``Currently under 30-day Review--Open for 
Public Comments'' or by using the search function. An agency may not 
conduct or sponsor a collection of information unless the collection of 
information displays a currently valid OMB control number and the 
agency informs potential persons who are to respond to the collection 
of information that such persons are not required to respond to the 
collection of information unless it displays a currently valid OMB 
control number.

Animal Plant and Health Inspection Service

    Title: Unified website for Biotechnology Regulation; Contact Page.
    OMB Control Number: 0579-NEW.
    Summary: 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, 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 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, was published and directed the 
Agencies, among other things, to build on the Unified website for 
Biotechnology Regulation developed pursuant to E.O. 13874, Modernizing 
the Regulatory Framework for Agricultural Biotechnology Products, June 
11, 2019, 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 that the developers must follow 
for Federal regulatory review.
    Need and Use of Information: 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. 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.
    Description of Respondents: Business.
    Number of Respondents: 30.

[[Page 95733]]

    Frequency of Responses: Reporting: On occasion; Annual.
    Total Burden Hours: 15.

Rachelle Ragland-Greene,
Departmental Information Collection Clearance Officer.
[FR Doc. 2024-28350 Filed 12-2-24; 8:45 am]
BILLING CODE 3410-34-P


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