[Federal Register Volume 85, Number 151 (Wednesday, August 5, 2020)]
[Notices]
[Page 47389]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-17039]



[[Page 47389]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1339]


Pilot Program for Request for Designation and Pre-Request for 
Designation Electronic Submissions

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Office of Combination Products (OCP) in the Food and Drug 
Administration (FDA) is soliciting applications from members of the 
public interested in participating in a voluntary pilot program to help 
OCP evaluate a potential new electronic submissions process for 
Requests for Designation (RFD) and Pre-RFD. This RFD and Pre-RFD 
electronic submission process is intended to improve efficiency and 
completeness of RFD and Pre-RFD submissions. OCP plans to accept up to 
nine participants for the pilot program. The pilot program is intended 
to provide OCP input to inform this evaluation.

DATES: Interested parties should submit an electronic application to 
participate in this pilot program by August 19, 2020. We plan to 
conduct pilot testing beginning on or about August 26, 2020. See 
section III of this document for information on applying for 
participation.

FOR FURTHER INFORMATION CONTACT: Danita Dixon, Office of Combination 
Products, Food and Drug Administration, 10903 New Hampshire Ave., 
Silver Spring, MD 20993-0002, 301-796-2889, danita.dixon@fda.hhs.gov.

ADDRESSES: If you are interested in participating in this pilot 
program, please submit an electronic application to 
combination@fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    Since its establishment on December 24, 2002, OCP has served as a 
resource for sponsors at various stages of development of their 
products. Sponsors often seek OCP feedback on whether their medical 
product will be regulated as a drug, a device, a biological product, or 
a combination product, and which medical product FDA Center (Center for 
Devices and Radiological Health, Center for Drug Evaluation and 
Research, or Center for Biologics Evaluation and Research) will 
regulate it if it is a non-combination product, or will have the 
primary jurisdiction for the premarket review and regulation of the 
product if it is a combination product.
    There are two ways that a sponsor can receive such feedback from 
OCP. One option is to submit an RFD to receive a formal, binding 
determination for the sponsor's product with respect to classification 
and/or center assignment. The RFD process is codified in 21 CFR part 3, 
and OCP has issued a guidance about this process (see ``How to Write a 
Request for Designation (RFD)'' at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/how-write-request-designation-rfd). A second option referred to as the Pre-RFD submission 
process, is for a sponsor to submit an inquiry to OCP to receive a 
preliminary assessment of their product's classification and/or 
assignment, which is not binding. The Pre-RFD process allows for more 
flexible interaction between sponsors and FDA. RFD and Pre-RFD 
submissions to OCP are currently, typically submitted via email, 
although some are submitted in paper copies. Regardless of format, some 
submissions lack sufficient data for review. Consequently, OCP is 
announcing a pilot program to test the functionality of a more 
structured RFD and Pre-RFD electronic submission process that should 
enhance efficiency and ensure sponsors' understanding of required and 
recommended submission content.

II. Pilot Program Participation

    The pilot program to evaluate the RFD and Pre-RFD electronic 
submission processes is to last approximately 2 weeks. During the pilot 
program, OCP staff will be available to address questions or concerns 
that may arise. Pilot program participants will receive training and 
will be asked to submit simulated regulatory submissions using data 
provided to them by OCP for testing purposes. Pilot program 
participants will also be asked to provide written and verbal feedback 
during their training and after they submit the simulated regulatory 
submissions. This feedback will assist OCP in developing the electronic 
submission processes. OCP estimates that each individual participant's 
involvement may require about 15 hours over the 2-week period. OCP is 
soliciting applications from members of the public, such as combination 
product and other medical product sponsors, as well as entities that 
may act as authorized agents submitting RFDs or Pre-RFDs for sponsors. 
At its discretion, OCP may withdraw a participant from the pilot 
program for not completing the requested activities within requested 
timeframes.

III. Applications for Participation

    Send applications to participate in the pilot program to 
combination@fda.gov. Applications should include the following 
information: Company and contact name, contact phone number, and 
contact email address. Additionally, although not required for 
consideration, OCP is particularly interested in whether you are a 
sponsor or may act as an authorized agent, and whether you have 
previously submitted an RFD or Pre-RFD. Once applications for 
participation are received, FDA will contact interested applicants to 
confirm selection for the pilot program. FDA is seeking a limited 
number of participants (no more than nine) to participate in this pilot 
program.

    Dated: July 30, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-17039 Filed 8-4-20; 8:45 am]
BILLING CODE 4164-01-P


