
[Federal Register Volume 82, Number 9 (Friday, January 13, 2017)]
[Notices]
[Pages 4351-4353]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-00629]


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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How To Prepare a Pre-Request for Designation; Draft Guidance for 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 or Agency) is announcing 
the availability of a draft guidance for industry entitled ``How to 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. This draft guidance is not final nor is it in 
effect at this time.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment of this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by April 13, 2017. Submit either written or electronic 
comments on this collection of information by March 14, 2017.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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); Draft Guidance for Industry.'' Received comments will be 
placed in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at http://www.regulations.gov or at 
the Division of Dockets Management 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 
``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 http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    Submit comments on information collection issues to the Office of 
Management and Budget in the following ways:
     Fax to the Office of Information and Regulatory Affairs, 
OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or email to 
oira_submission@omb.eop.gov. All comments should be identified with the 
title, ``How to Prepare a Pre-Request for Designation (Pre-RFD); Draft 
Guidance for Industry.''
    Submit written requests for single copies of the draft guidance 
document 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, or fax your request to 301-847-
8619. See the SUPPLEMENTARY

[[Page 4352]]

INFORMATION section for information on electronic access to the draft 
guidance.

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, or via email at 
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 
product. Sponsors often seek OCP feedback on whether their medical 
product will be regulated as a drug, a device, a biologic, or a 
combination product, and which FDA medical product 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 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 http://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 FDA. 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.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA 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.

III. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act (the PRA) (44 U.S.C. 3501-3502), 
Federal Agencies must obtain approval from the Office of Management and 
Budget (OMB) for each collection of information they conduct or 
sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3) 
and 5 CFR 1320.3(c) and includes Agency requests or requirements that 
members of the public submit reports, keep records, or provide 
information to a third party. Section 3506(c)(2)(A) of the PRA (44 
U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day 
notice in the Federal Register concerning each proposed collection of 
information before submitting the collection to OMB for approval. To 
comply with this requirement, FDA is publishing notice of the proposed 
collection of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Draft Guidance for Industry; How To Prepare a Pre-Request for 
Designation (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.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                                                      Average
                                     Number of       Number of     Total  annual    burden per
            Activity                respondents   responses  per     responses     response  (in    Total hours
                                                     respondent                       hours)
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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.

    Respondents are product sponsors and industry representatives 
subject to FDA's laws and regulations. FDA estimates that it will 
receive approximately 136 Pre-RFDs annually. The Agency reached this 
estimate through its experience with the formal Request for Designation 
(RFD) program, by reviewing the number of informal, pre-RFD inquiries 
from sponsors that the Agency received over the past 3 years. Based on 
FDA's experience with

[[Page 4353]]

these informal, Pre-RFD inquiries, FDA expects the proposed Pre-RFD 
program to be utilized as a viable program in the future and expects 
that the number of Pre-RFDs will increase initially to approximately 
180 submissions.
    FDA estimates from past experience with informal Pre-RFD inquiries 
that the complete process involved with preparing the Pre-RFD 
submission takes approximately 12 hours and an additional 1 hour for 
meetings.
    This average is based upon estimates by FDA administrative and 
technical staff who are familiar with the information collection 
relating to informal, Pre-RFD inquiries, who have consulted and advised 
sponsors and industry representatives on the information collection, 
and who have reviewed the documentation submitted.
    Therefore, the total reporting burden hours is estimated to be 
1,768 hours.

                                 Table 2--Estimated Annual Reporting Burden \1\
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                                                                 Total burden
                    Number of respondents                           hours         Hourly  wage      Total cost
                                                                  annualized          rate          annualized
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136..........................................................              13           $33.26       $58,803.68
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Assuming an hourly wage plus benefit rate of $33.26,\1\ the result 
is a cost of $432.38 per respondent. The estimated submission cost of 
$432.38 multiplied by 136 submissions per year equals $58,803.68, which 
is the estimated aggregated industry reporting cost annualized.
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    \1\ Wage is based on the 2015 Bureau of Labor Statistic's 
survey, National Industry Specific Occupational Employment and Wage 
Estimate, for standard occupational code 13-1041, compliance officer 
in pharmaceutical and medicine manufacturing (http://www.bls.gov/oes/current/oes131041.htm).
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    This draft guidance also refers to previously approved information 
collections found in FDA regulations. The collections of information in 
21 CFR part 3 are approved under OMB control number 0910-0523.

IV. Electronic Access

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

    Dated: January 9, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-00629 Filed 1-12-17; 8:45 am]
 BILLING CODE 4164-01-P


