2024-19055. Notice of Request for Approval of an Information Collection; Unified Website for Biotechnology Regulation; Contact Page

( print page 68386)

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Department of Agriculture

Animal and Plant Health Inspection Service

1. [Docket No. APHIS-2024-0037]

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 http://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 [phone] 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; [phone]; [e-mail]. For more information about the information collection process, contact Mr. Joseph Moxey, APHIS' Paperwork Reduction Act Coordinator, at [phone].

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 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 ( print page 68387) that the developers must follow for Federal regulatory review.

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.

Footnotes

1.   https://usbiotechnologyregulation.mrp.usda.gov/​biotechnologygov/​home/​.

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.