[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Products; Draft Guidance for Industry; Availability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the availability of a draft guidance for industry entitled ``Bridging 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 This draft 
guidance, when finalized, will represent the Agency's thinking on how 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DATES: Submit either electronic or written comments on the draft 
guidance by February 18, 2020 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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]
 BILLING CODE 4164-01-P