[Federal Register Volume 85, Number 31 (Friday, February 14, 2020)]
[Notices]
[Pages 8597-8598]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-03023]


-----------------------------------------------------------------------

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Products; Draft Guidance for Industry; Availability; Extension of 
Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability, extension of comment period.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
extending the comment period for the notice of availability that 
appeared in the Federal Register of December 19, 2019. In the notice of 
availability, FDA requested comments on the draft guidance for industry 
entitled ``Bridging for Drug-Device and Biologic-Device Combination 
Products.'' The Agency is taking this action in response to requests 
for an extension to allow interested persons additional time to submit 
comments.

DATES: FDA is extending the comment period on the notice of 
availability published December 19, 2019 (84 FR 69749). Submit either 
electronic or written comments by April 20, 2020.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before April 20, 2020. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of April 20, 2020. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

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, those filed in a timely 
manner (see ADDRESSES), 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

[[Page 8598]]

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.

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: In the Federal Register of December 19, 
2019, FDA published a notice of availability with a 60-day comment 
period to request comments on the draft guidance for industry entitled 
``Bridging for Drug-Device and Biologic-Device Combination Products.''
    The Agency has received requests for an extension of the comment 
period for the notice of availability. Each request conveyed concern 
that the current 60-day comment period does not allow sufficient time 
to develop a meaningful or thoughtful response to the notice of 
availability. FDA has considered the requests and is extending the 
comment period for the notice of availability for 60 days, until April 
20, 2020. The Agency believes that a 60-day extension allows adequate 
time for interested persons to submit comments without compromising the 
timely publication of the final version of the guidance.

    Dated: February 11, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-03023 Filed 2-13-20; 8:45 am]
 BILLING CODE 4164-01-P


