Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency; Draft Guidance for Industry and Food and Drug Administration Staff; Availability (2024)

Start Preamble

Food and Drug Administration, HHS.

Notice of availability.

Start Printed Page 37233

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled “Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency.” This draft guidance, when finalized, will describe the factors FDA intends to assess when deciding to issue an enforcement policy regarding test manufacturers' offering of certain unapproved tests and unapproved uses of approved tests during a declared emergency. This draft guidance is not final nor is it for implementation at this time.

Submit either electronic or written comments on the draft guidance by July 5, 2024 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.

You may submit comments on any guidance at any time as follows:

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-2023-D-5365 for “Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency.” Received comments 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, 240-402-7500.

• 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.govinfo.gov/​content/​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, 240-402-7500.

You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).

An electronic copy of the guidance document is available for download from the internet. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written requests for a single hard copy of the draft guidance document entitled “Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency” to the Office of Policy, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request.

Start Further Info

Toby Lowe, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3416, Silver Spring, MD 20993-0002, 301-796-6512.

End Further Info End Preamble Start Supplemental Information

I. Background

During an emergency, appropriately safe and effective diagnostic tests are critical to the diagnosis, treatment, tracking, and interruption of transmission of infectious diseases during outbreaks, as well as for diagnosing and treating diseases or conditions caused by chemical, biological, radiological, and nuclear threat agents. FDA is issuing this draft guidance that, when finalized, will describe the factors FDA plans to assess in deciding whether to issue an enforcement policy regarding test manufacturers' offering of certain unapproved tests and unapproved uses of approved tests for the diagnosis of a disease or other condition to help quickly increase test availability when appropriate during a declared emergency under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

This draft guidance describes the factors FDA intends to assess when issuing an enforcement policy including: (1) the need for accelerated availability of tests; (2) the known or potential risks of such tests; (3) the availability of appropriate alternative tests that are authorized or approved; and (4) the availability of sufficient mitigations to address risks of false results. When issuing an enforcement policy, FDA generally intends to describe the circ*mstances in which the Agency intends to exercise enforcement discretion, including, for example, when the test has been validated. FDA may also identify the initial duration in which an enforcement policy is intended to be in effect.

This draft guidance is being issued consistent with FDA's good guidance Start Printed Page 37234 practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on “Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

II. Electronic Access

Persons interested in obtaining a copy of the draft guidance may do so by downloading an electronic copy from the internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at https://www.fda.gov/​medical-devices/​device-advice-comprehensive-regulatory-assistance/​guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also available at https://www.regulations.gov andhttps://www.fda.gov/​regulatory-information/​search-fda-guidance-documents. Persons unable to download an electronic copy of “Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency” may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number GUI00007009 and complete title to identify the guidance you are requesting.

III. Paperwork Reduction Act of 1995

While this guidance contains no new collection of information, it does refer to previously approved FDA collections of information. The previously approved collections of information are subject to review by OMB under the PRA (44 U.S.C. 3501-3521). The collections of information in the following table have been approved by OMB:

21 CFR part or guidanceTopicOMB control No.
807, subpart EPremarket notification0910-0120
814, subparts A through EPremarket approval0910-0231
814, subpart HHumanitarian Use Devices; Humanitarian Device Exemption0910-0332
812Investigational Device Exemption0910-0078
860, subpart DDe Novo classification process0910-0844
800, 801, 809, and 830Medical Device Labeling Regulations; Unique Device Identification0910-0485
“Emergency Use Authorization of Medical Products and Related Authorities”Emergency Use Authorization0910-0595
803Medical Device Reporting0910-0437
“Administrative Procedures for CLIA Categorization” and “Recommendations: Clinical Laboratory Improvement Amendments of 1988” (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices”CLIA Administrative Procedures; CLIA Waivers0910-0607

Start Signature

Dated: April 22, 2024.

Lauren K. Roth,

Associate Commissioner for Policy.

End Signature End Supplemental Information

[FR Doc. 2024-08933 Filed 4-29-24; 8:45 am]

BILLING CODE 4164-01-P

Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency; Draft Guidance for Industry and Food and Drug Administration Staff; Availability (2024)

FAQs

What is Section 564 of the Federal Food Drug and Cosmetic Act? ›

Under section 564 of the FFD&C Act, as amended, the Secretary now may determine that there is a public health emergency or significant potential for a public health emergency that affects, or has significant potential to affect, national security or the health and security of U.S. citizens living abroad and involves a ...

What is the FDA enforcement discretion policy? ›

What Is Enforcement Discretion? As an agency responsible for ensuring public health and safety, if the FDA believes a product risk is low or could have a significant benefit to the public, it will exercise enforcement discretion on certain requirements allowing a company to bypass its typical regulatory pathway.

How does the FDA enforce policies? ›

Enforcement Actions

Seizures are intended to remove products from commerce and place them under custody of a court, until a court can decide whether they are violative as alleged. The FDA works through the court system to request a seizure, which is then carried out by the U.S. Marshals.

What is FDA draft guidance? ›

Guidance documents represent FDA's current thinking on a topic. They do not create or confer any rights for or on any person and do not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations.

What were the requirements of the Federal Food, Drug, and Cosmetic Act? ›

The FDCA and its amendments require drug manufacturers to submit evidence of drug safety and effectiveness, that drugs meet specific strength and purity standards, and that drug labels list active ingredients and contain truthful statements.

What is 505 B )( 2 of the Federal Food, Drug, and Cosmetic Act the act? ›

A 505(b)(2) application is an NDA that contains full reports of investigations of safety and effectiveness, where at least some of the information required for approval comes from studies not conducted by or for the applicant, and for which the applicant has not obtained a right of reference or use, including, for ...

What does the FDA have the responsibility of enforcing? ›

FDA enforces the Federal Food, Drug and Cosmetic Act (FD&C Act) and other related acts. This page provides an overview of FDA's import compliance and enforcement activities at the point of entry. FDA has jurisdiction over imported products at the time of entry but also after the products have entered domestic commerce.

What are the 3 main categories the FDA regulates? ›

The Food and Drug Administration 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.

What is an FDA compliance policy guide? ›

FDA's Compliance Programs provide instructions to FDA personnel for conducting activities to evaluate industry compliance with the Federal Food, Drug, and Cosmetic Act and other laws administered by FDA. Compliance Programs are made available to the public under the Freedom of Information Act.

What are two laws enforced by the FDA? ›

Laws Enforced by the FDA. Includes the Federal Food, Drug and Cosmetics Act, the 1997 Modernization Act, and over 30 other acts, amendments, provisions, and laws.

What does the Food and Drug Administration enforce the guidelines for? ›

The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, ...

What is the difference between FDA guidance and FDA regulations? ›

If the Agency needs to go into more detail about how it interprets a regulation, FDA may issue a non-binding guidance that is even more specific. Guidance documents are issued to provide a little bit more information about what people can do to comply with existing requirements.

Are FDA guidance documents enforceable? ›

Guidance documents do not establish any rights for any person and is not binding on FDA or the public.

What is the difference between NDA and FDA approval? ›

The NDA application is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S. The data gathered during the animal studies and human clinical trials of an Investigational New Drug (IND) become part of the NDA.

Is FDA guidance mandatory? ›

The FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.

What is Section 505 1 of the Federal Food, Drug, and Cosmetic Act? ›

Section 505-1 of the Federal Food, Drug, and Cosmetic Act (FD&C Act)(21 U.S.C. 355-1) establishes FDA's REMS authority. A REMS is a required risk management strategy that can include one or more elements to ensure that the benefits of a drug outweigh its risks.

What is Food Drug and Cosmetic Act section 501? ›

(a) Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act provides that a drug (including a drug contained in a medicated feed) shall be deemed to be adulterated if the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not ...

What is Section 502 A of the Federal Food, Drug, and Cosmetic Act? ›

Section 502(a) declares that a drug or device is misbranded if its labeling proves false or misleading in any particular.

What is Section 506 of the FD&C Act? ›

Under section 506(g) of the FD&C Act, RMAT designation is available for a drug ( i.e., a human drug, including a drug that is a biological product) that meets the definition of regenerative medicine therapy; is intended to treat, modify, reverse, or cure a serious or life-threatening disease or condition; and with ...

References

Top Articles
Latest Posts
Article information

Author: Jerrold Considine

Last Updated:

Views: 6596

Rating: 4.8 / 5 (58 voted)

Reviews: 81% of readers found this page helpful

Author information

Name: Jerrold Considine

Birthday: 1993-11-03

Address: Suite 447 3463 Marybelle Circles, New Marlin, AL 20765

Phone: +5816749283868

Job: Sales Executive

Hobby: Air sports, Sand art, Electronics, LARPing, Baseball, Book restoration, Puzzles

Introduction: My name is Jerrold Considine, I am a combative, cheerful, encouraging, happy, enthusiastic, funny, kind person who loves writing and wants to share my knowledge and understanding with you.