[Federal Register Volume 84, Number 244 (Thursday, December 19, 2019)]
[Notices]
[Pages 69749-69751]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-27354]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-D-5585]
Bridging for Drug-Device and Biologic-Device Combination
Products; Draft Guidance for Industry; Availability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the availability of a draft guidance for industry entitled ``Bridging
for Drug-Device and Biologic-Device Combination Products.'' This draft
guidance, when finalized, will represent the Agency's thinking on how
to approach bridging in new drug applications (NDAs) or biologics
license applications (BLAs) for drug-device and biologic-device single
entity or co-packaged combination products and will help to fulfill the
performance goals under the sixth authorization of the Prescription
Drug User Fee Act (PDUFA VI). For the purposes of this guidance, the
term bridging refers to the process of establishing the scientific
relevance of information developed in an earlier phase of the
development program or another development program to support the
combination product for which an applicant is seeking approval. Once
the applicant has established the relevance of such information to
(i.e., bridged to) its product, the applicant may be able to leverage
that information to streamline the development program.
DATES: Submit either electronic or written comments on the draft
guidance by February 18, 2020 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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 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-5585 for ``Bridging for Drug-Device and Biologic-Device
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
[[Page 69750]]
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 Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; the
Office of Communication, Outreach, and Development, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002;
or the Office of Communication and Education, CDRH-Division of Industry
and Consumer Education, Center for Devices and Radiological Health
(CDRH), Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. 4621, Silver Spring, MD 20993-0002. 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: Robert Berlin, Center for Drug
Evaluation and Research, Office of New Drugs, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6373, Silver
Spring, MD 20993, 301-796-8828; Irene Chan, Center for Drug Evaluation
and Research, Office of New Drugs, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 22, Rm. 4420, Silver Spring, MD 20993, 301-
796-3962; Stephen Ripley, Center for Biologics Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993-0002, 240-402-7911; Andrew Yeatts, Center
for Devices and Radiological Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66, Rm. 5452, Silver Spring, MD 20993-
0002, 301-796-4539; or Patricia Love, Office of Special Medical
Programs, Office of Combination Products, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 32, Rm. 5144, Silver Spring, MD 20993-
0002, 301-796-8933.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Bridging for Drug-Device and Biologic-Device Combination
Products.'' This document is one of several documents FDA is issuing to
fulfill the performance goals under PDUFA VI. This document provides
guidance to industry and FDA staff on how to approach bridging in NDAs
or BLAs for drug-device and biologic-device single entity or co-
packaged combination products, including the following:
Bridging of information related to a combination product that
employs a different device constituent part or parts with the same drug
or biological product constituent part or parts as the proposed
combination product
Bridging of information related to a combination product that
employs a different drug or biological product constituent part or
parts as the proposed combination product
For the purposes of this draft guidance, the term bridging refers
to the process of establishing the scientific relevance of information
developed in an earlier phase of the development program or another
development program to support the combination product for which an
applicant is seeking approval. After the applicant has established the
relevance of such information to (i.e., bridged to) its product, the
applicant may be able to leverage that information to streamline its
development program. From a scientific perspective, an applicant must
bridge its current application to information developed in an earlier
phase of the development program or another development program if the
applicant wishes to leverage that information in its current
application. For certain types of applications, the use of information
from another development program may require that the applicant own the
information or have a right of reference.
This draft guidance seeks to clarify how to bridge to information
gathered from another development program to leverage that information
in support of an application. To facilitate that process, the draft
guidance recommends that an applicant use an analytical framework
described in the draft guidance to identify and address information
gaps for an application. Although the draft guidance is intended to
help applicants consider the type and scope of information that may be
leveraged for a combination product development program, the draft
guidance does not address all of the issues applicable to any
particular combination product.
In addition, the draft guidance presents three hypothetical case
examples to illustrate how an applicant might appropriately apply the
recommended framework and associated analyses to determine the bridging
strategy and informational needs in a development program. These
considerations and recommendations are not intended to apply to any
particular development program. The draft guidance also encourages
applicants to discuss their particular development program and bridging
strategy with 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 ``Bridging for
Drug-Device and Biologic-Device 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
This draft guidance refers to currently approved FDA collections of
information. These collections of information are subject to review by
the
[[Page 69751]]
Office of Management and Budget (OMB) under the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501-3521). The collections of information in 21 CFR
part 312 for investigational new drug applications and 21 CFR part 314
for new drug applications have been approved under OMB control numbers
0910-0014 and 0910-0001, respectively. The collections of information
in 21 CFR part 601 for biologics license applications have been
approved under OMB control number 0910-0338. The collections of
information in 21 CFR part 814, subparts A through E, for premarket
approval applications have been approved under OMB control number 0910-
0231. The collections of information in section 510(k) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360(k)), subpart E for 510(k)
notifications, have been approved under OMB control number 0910-0120.
The collections of information in the guidance for industry and FDA
staff entitled ``De Novo Classification Process (Evaluation of
Automatic Class III Designation)'' have been approved under OMB control
number 0910-0844. The collection of information in 21 CFR part 4 has
been approved under the underlying current good manufacturing process
regulations for drugs, devices, and biological products, including
current good tissue practices for human cells, tissues, and cellular
and tissue-based products, found at parts 211, 820, 600 through 680,
and 1271 (21 CFR parts 211, 820, 600 through 680, and 1271), which have
already been approved and are in effect. The provisions of part 211 are
approved under OMB control number 0910-0139. The provisions of part 820
are approved under OMB control number 0910-0073. The provisions of
parts 606, 640, and 660 are approved under OMB control number 0910-
0116. The provisions of part 610 are approved under OMB control numbers
0910-0116 and 0910-0338 (also for part 680). The provisions of part
1271, subparts C and D, are approved under OMB control number 0910-
0543.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products, or https://www.regulations.gov.
Dated: December 13, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-27354 Filed 12-18-19; 8:45 am]
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