[Federal Register Volume 83, Number 33 (Friday, February 16, 2018)]
[Notices]
[Pages 7051-7052]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-03230]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-0040]


How To Prepare a Pre-Request for Designation; Guidance for 
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry entitled ``How to Prepare a 
Pre-Request for Designation (Pre-RFD).'' The purpose of this guidance 
is to explain the Pre-RFD process at the FDA Office of Combination 
Products (OCP), describe and help a sponsor understand the type of 
information that the sponsor should include in a Pre-RFD, and assist 
sponsors in obtaining a preliminary assessment from FDA through the 
Pre-RFD process. The Pre-RFD process is available to provide informal, 
non-binding feedback regarding the regulatory identity or 
classification of a human medical product as a drug, device, biological 
product, or combination product. In addition, this informal process 
provides information about a non-combination or combination product's 
assignment to the appropriate Agency Center (Center for Drug Evaluation 
and Research (CDER), Center for Devices and Radiological Health (CDRH), 
or Center for Biologics Evaluation and Research (CBER)) for premarket 
review and regulation.

DATES: The announcement of the guidance is published in the Federal 
Register on February 16, 2018.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances 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-2017-D-0040 for ``How to Prepare a Pre-Request for Designation 
(Pre-RFD); Guidance for Industry.'' 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.
     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

[[Page 7052]]

``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.gpo.gov/fdsys/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.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for a single copies of this guidance 
entitled ``How to Prepare a Pre-Request for Designation (Pre-RFD)'' to 
the Office of Combination Products, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 32, Rm. 5129, Silver Spring, MD 20993-0002. 
Send one self-addressed adhesive label to assist that office in 
processing your request. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Leigh Hayes, Office of Combination 
Products, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
32, Rm. 5129, Silver Spring, MD 20993-0002, 301-796-8930.

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 human 
medical product will be regulated as a drug, a device, a biologic, or a 
combination product, and which FDA medical product Agency Center (CDER, 
CBER, or CDRH) 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 a 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 that may be changed under conditions specified 
in section 563 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360bbb-2) and 21 CFR 3.9 in the regulations. 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'' at https://www.fda.gov/RegulatoryInformation/Guidances/ucm126053.htm). A second 
more flexible option is for a sponsor to submit an inquiry to OCP to 
receive a preliminary jurisdictional assessment, which is not binding.
    Many sponsors seek to utilize a more flexible, approachable way to 
interact with OCP and the medical product Agency Centers, to obtain 
feedback from the Agency before submitting a marketing application to 
the Agency. Over time, these informal methods of obtaining feedback 
have become increasingly customary with sponsors, and for some, even 
preferable to the formal RFD process. Accordingly, FDA is enhancing the 
transparency and consistency of such interaction, which will now be 
called the ``Pre-Request for Designation (Pre-RFD) Program.''
    This guidance describes this structured process with clear 
recommendations for sponsors wishing to submit Pre-RFDs. It also 
provides the process for review of Pre-RFDs by FDA staff, the general 
timeframes for sponsors to receive feedback from OCP, and the process 
for scheduling teleconferences and meetings in relation to a Pre-RFD.
    FDA carefully considered the comments received on the draft 
guidance, and, where appropriate, has revised the guidance to reflect 
such comments. FDA encourages stakeholders to contact OCP if they have 
additional questions.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
Agency's current thinking on how to prepare a Pre-RFD. 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. This guidance 
is not subject to Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in this guidance regarding how to prepare a 
Pre-RFD have been approved under OMB control number 0910-0845.

III. Electronic Access

    Persons with access to the internet may obtain the document at 
https://www.fda.gov/RegulatoryInformation/Guidances/ucm534661.htm.

    Dated: February 12, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-03230 Filed 2-15-18; 8:45 am]
BILLING CODE 4164-01-P