Document ID: FDA-2017-D-0040-0005
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; Draft Guidance for
Industry; How To Prepare a Pre-Request for Designation
Posted Date: 2017-07-18T04:00Z

[Federal Register Volume 82, Number 136 (Tuesday, July 18, 2017)]
[Notices]
[Pages 32825-32826]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-15005]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Draft Guidance for 
Industry; How To Prepare a Pre-Request for Designation

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by August 
17, 2017.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910--NEW and 
title ``Draft Guidance for Industry; How to Prepare a Pre-Request for 
Designation (Pre-RFD).'' Also include the FDA docket number found in 
brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Draft Guidance for Industry; How To Prepare a Pre-Request for 
Designation (Pre-RFD)

OMB Control Number 0910--NEW

    Since its establishment on December 24, 2002, the FDA Office of 
Combination Products (OCP) has served as a resource for sponsors at 
various stages of development of their product. Sponsors often seek OCP 
feedback on whether their medical product will be regulated as a drug, 
a device, a biologic,

[[Page 32826]]

or a combination product, and which FDA medical product Agency Center 
(Center for Drug Evaluation and Research, Center for Biologics 
Evaluation and Research, or Center for Devices and Radiological Health) 
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 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 the flexibility of more approachable 
ways 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 this process, 
which will now be called the ``Pre-Request for Designation (Pre-RFD) 
Program.''
    This draft 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.
    This draft guidance describes how to prepare a Pre-RFD. The 
guidance provides recommendations regarding the information that should 
be submitted in a Pre-RFD request and procedures that should be 
followed for meetings or conference calls between OCP, the Centers, and 
industry representatives or sponsors.
    The proposed collections of information are necessary to allow the 
Agency to receive Pre-RFD requests in order to implement this voluntary 
submission program.
    In the Federal Register of January 13, 2017 (82 FR 4351), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. Although two comments were received, they 
were not responsive to the four collection of information topics 
solicited and therefore will not be discussed.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                               Number of
                                                  Number of    responses      Total       Average
                    Activity                     respondents      per         annual     burden per  Total hours
                                                               respondent   responses     response
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Pre-RFD Submissions............................          136            1          136           12        1,632
Pre-RFD Meetings...............................          136            1          136            1          136
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    Total......................................  ...........  ...........  ...........  ...........        1,768
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: July 12, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-15005 Filed 7-17-17; 8:45 am]
BILLING CODE 4164-01-P