Bridging for Drug-Device and Biologic-Device Combination Products; Draft Guidance for Industry; Availability; Extension of Comment Period
| Published date | 14 February 2020 |
| Citation | 85 FR 8597 |
| Record Number | 2020-03023 |
| Section | Notices |
| Court | Food And Drug Administration |
Federal Register, Volume 85 Issue 31 (Friday, February 14, 2020)
[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]
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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Products; Draft Guidance for Industry; Availability; Extension of
Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability, extension of comment period.
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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availability, FDA requested comments on the draft guidance for industry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
