[Federal Register Volume 84, Number 247 (Thursday, December 26, 2019)]
[Notices]
[Pages 70976-70979]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-27799]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-D-4739]
Requesting Food and Drug Administration Feedback on Combination
Products; Draft Guidance for Industry and Food and Drug Administration
Staff; 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the availability of a draft guidance for industry entitled ``Requesting
FDA Feedback on Combination Products.'' The purpose of this guidance is
to discuss ways in which combination product sponsors can obtain
feedback from FDA on scientific and regulatory questions and to
describe best practices for FDA and sponsors when interacting on these
topics. These interactions can occur through application-based
mechanisms, such as the pre-submission process used in the Center for
Devices and Radiological Health (CDRH) and the Center for Biologics and
Research (CBER) and the formal meetings used in the Center for Drug
Evaluation and Research (CDER) and CBER, or through Combination Product
Agreement Meetings (CPAMs), as appropriate.
DATES: Submit either electronic or written comments on the draft
guidance by February 24, 2020 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.
ADDRESSES: 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
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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-2019-D-4739 for ``Requesting FDA Feedback on Combination
Products.'' 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
``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.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of the draft guidance to
the Office of Combination Products, Food and Drug Administration, Bldg.
32, Rm. 5129, 10903 New Hampshire Ave., Silver Spring, MD 20993. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT: Melissa Burns, Office of Combination
Products, Food and Drug Administration, 301-796-5616,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
and FDA staff entitled ``Requesting FDA Feedback on Combination
Products.'' The purpose of this guidance is to discuss ways in which
combination product sponsors can obtain feedback from the Agency on
scientific and regulatory questions. These interactions can occur
through application-based mechanisms, such as the pre-submission
process used in CDRH and CBER and the formal meetings used in CDER and
CBER, or through CPAMs, as appropriate.
We are publishing this guidance consistent with the Agency's
ongoing commitment to enhancing clarity and transparency regarding
regulatory considerations for combination products, and in accordance
with the mandate under section 503(g)(8)(C)(vi) of the Federal Food,
Drug, and Cosmetics Act (FD&C Act) (21 U.S.C. 353(g)(8)(C)(vi)), which
was added by section 3038 of the 21st Century Cures Act (Pub. L. 114-
255) (Cures Act). Section 503(g)(8)(C)(vi) requires FDA to issue a
final guidance addressing: (1) The structured process for managing pre-
submission interactions with sponsors developing combination products;
(2) best practices to ensure FDA feedback in such pre-submission
interactions represents the Agency's best advice based on the
information provided during these pre-submission interactions; and (3)
how CPAMs relate to other FDA meeting types, what information should be
submitted prior to a CPAM, and the form and content of agreements
reached through a CPAM.
FDA is in the process of operationalizing the procedures related to
submission and receipt of a CPAM request. Therefore, if a sponsor
wishes to submit a CPAM request to FDA at this time, the sponsor should
first contact the Product Jurisdiction Office for the lead Center
([email protected],
[email protected], or
[email protected]) and the Office of Combination
Products ([email protected]) prior to submitting a CPAM request
to help ensure that the CPAM request is efficiently received and
processed by FDA.
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 ``Requesting
FDA Feedback on Combination Products.'' 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. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-
3521), 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
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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.
Title: Combination Product Agreement Meetings Under FD&C Act
Section 503(g)(2)(A)(i); Requesting FDA Feedback on Combination
Products.
Description of Respondents: Respondents to this collection of
information are combination product sponsors that submit CPAM requests.
Burden Estimate: This draft guidance includes recommendations
regarding information that sponsors should include in CPAM requests.
Specifically, the draft guidance states that for CPAM requests,
sponsors should:\1\
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\1\ The draft guidance also notes that combination products must
be identified as such in CPAM requests under section
503(g)(8)(C)(v)(I) of the FD&C Act.
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Product Information.
[cir] Include the product name, description of the overall
combination product and constituent parts, indications for use
statement, and, as applicable, route of administration and dosing
information.
[cir] Include, as relevant:
[ssquf] For a drug- or biological product-led combination product
that includes a device constituent part, a device description, design
diagram or other image, and identify components that are part of the
device.
[ssquf] For a device-led combination product, provide the chemical
name, established or proper name (if available), and structure, for the
drug and/or biological product constituent part(s).
[ssquf] For a device-led combination product, provide the route of
administration and/or dosing information for the drug and/or biological
product constituent part(s).
[ssquf] For combination products that contain an active ingredient
that is included in an approved drug product that the sponsor seeks to
cross reference or rely upon in its submission, identify the
application number of the approved product.
[ssquf] For combination products that contain a device constituent
part that is a cleared or approved device that the sponsor seeks to
cross reference, identify the application or submission number for the
previously cleared or approved device.
Background. Describe the status of product development,
summarize any previous interactions with FDA on the product, including
applications, application-based mechanisms, other meetings, Request for
Designations (RFDs) or pre-RFDs, and identify the proposed regulatory
pathway if not already established.
Meeting Request. Include the requested form of
communication (i.e., face-to-face meeting, teleconference, or written
response). Summarize why the specific communication format is
appropriate. If proposing a face-to-face meeting or teleconference,
provide three proposed meeting dates/times, dates and times when the
sponsor is not available, and a proposed agenda.
Agreement Proposals Generally. Identify the specific
proposals for which the sponsor seeks FDA agreement. Proposals should
be grouped by discipline (e.g., Pharmacology/Toxicology, Pharmaceutical
Quality/Chemistry and Manufacturing Controls (CMC), Engineering, Human
Factors) where possible. The proposals should be limited to those for
which the sponsor is seeking agreement from FDA.
Rationale and Data Supporting Proposals. Provide
rationale(s) and data adequate to support FDA's review of the agreement
proposals. Organize the rationale(s) and data by topic when
appropriate.
Attendees. Include a list of planned participants from the
sponsor's organization, including names and titles. A list of names,
titles and affiliations of consultants and interpreters should also be
included. If this information changes, it should be updated no later
than 5 business days prior to the meeting. If the sponsor wishes to
request that a specific FDA staff member or expertise be included in
the meeting, that information should be included in the CPAM request.
FDA has not received any CPAM requests since the enactment of the
Cures Act in December 2016. FDA estimates that less than one CPAM
request will be received per year by each medical product center (CBER,
CDER, and CDRH). To provide a conservative estimate of burden, FDA
estimates that approximately one CPAM request will be submitted per
year to each medical product center. FDA estimates that it will take
sponsors approximately 25 hours to compile and draft the information
that this draft guidance recommends should be included in a CPAM
request.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
FDA center Number of responses per Total annual Hours per Total hours
respondents respondent responses response
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CDER............................ 1 1 1 25 25
CDRH............................ 1 1 1 25 25
CBER............................ 1 1 1 25 25
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
Total....................... .............. .............. .............. .............. 75
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
This draft guidance also refers to previously approved collections
of information found in FDA regulations. The collections of information
pertaining to orphan drug provisions in 21 CFR part 316 are approved
under OMB control number 0910-0167; the collections of information
pertaining to investigational device exemption submission provisions in
21 CFR part 812 are approved under OMB control number 0910-0078; the
collections of information pertaining to investigational new drug
submission provisions in 21 CFR part 312 are approved under OMB control
number 0910-0014; and the collections of information pertaining to
biologics licensing submission
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provisions in 21 CFR part 601 are approved under OMB control number
0910-0338.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/combination-products/guidance-regulatory-information/combination-products-guidance-documents or https://www.regulations.gov.
Dated: December 18, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-27799 Filed 12-23-19; 8:45 am]
BILLING CODE 4164-01-P