[Federal Register Volume 87, Number 20 (Monday, January 31, 2022)]
[Notices]
[Pages 4895-4897]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-01925]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-D-0078]
Principles of Premarket Pathways for Combination Products;
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 final guidance for industry and FDA staff
entitled ``Principles of Premarket Pathways for Combination Products.''
This guidance presents FDA's current thinking on principles for
premarket review of combination products. This guidance includes
general, high-level information regarding what combination products
are, coordination within FDA and interaction between FDA and sponsors
regarding combination product regulation, and how combination products
are reviewed by FDA before
[[Page 4896]]
they are marketed. The guidance also includes recommendations on how to
determine which type of premarket submissions may be appropriate for
combination products. FDA is publishing this guidance as part of its
efforts to implement the 21st Century Cures Act (Cures Act) and in
keeping with the Agency's long-standing commitment to transparency,
efficiency, and regulatory consistency to facilitate development of
safe and effective combination products. This guidance finalizes the
draft guidance of the same title that published on February 6, 2019.
DATES: The announcement of the guidance is published in the Federal
Register on January 31, 2022.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances 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-0078 for ``Principles of Premarket Pathways for 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, 240-402-7500.
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, 240-402-7500.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of this guidance to the
Office of Combination Products, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, Rm. 5129, 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 guidance document.
FOR FURTHER INFORMATION CONTACT: John Barlow Weiner, Office of
Combination Products, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5129, Silver Spring, MD 20993-0002, 301-796-8930,
[email protected] or [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry and
FDA staff entitled ``Principles of Premarket Pathways for Combination
Products.'' This guidance presents FDA's current thinking on principles
for premarket review of combination products. This guidance includes
general, high-level information regarding what combination products
are, coordination within FDA and interaction between FDA and sponsors
regarding combination product regulation, and how combination products
are reviewed by FDA before they are marketed. The guidance also
includes recommendations on how to determine which type of premarket
submissions may be appropriate for combination products, as well as
illustrative examples.
Section 3038 of the Cures Act (Pub. L. 114-255), enacted in
December 2016, substantially amended section 503(g) of the Federal
Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 353(g)), the
principal section of the FD&C Act expressly addressing combination
products. General themes of these amendments include enhancing clarity,
predictability, efficiency, and consistency of premarket regulatory
expectations for combination products, including by ensuring that
Agency components and staff coordinate appropriately on premarket
review of these products, and that Agency thinking is aligned in
conducting these reviews. This guidance is part of FDA's efforts to
implement section 3038 of the Cures Act.
In the Federal Register of February 6, 2019 (84 FR 2236), FDA
announced the availability of the draft guidance of the same title. FDA
received comments and considered those comments as the guidance was
finalized. The final guidance clarifies the guidance including its
applicability across combination product types and additional detail
regarding processes for interacting with the Agency.
[[Page 4897]]
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Principles of Premarket Pathways for
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
While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 3 and in the guidance ``How to Prepare a
Pre-Request for Designation (Pre-RFD)'' have been approved under OMB
control number 0910-0523. The collections of information for
applications for FDA approval to market a new drug (certain provisions
of 21 CFR part 314) have been approved under OMB control number 0910-
0001; the collections of information in 21 CFR part 601 have been
approved under 0910-0338; and the collections of information in section
351(k) of the Public Health Service Act (42 U.S.C. 262) have been
approved under 0910-0719. The collections of information in 21 CFR part
807, subpart E, have been approved under OMB control number 0910-0120;
the collections of information in 21 CFR part 814, subparts A through
E, have been approved under OMB control number 0910-0231; the
collections of information in 21 CFR part 860, subparts A through C,
have been approved under OMB control number 0910-0138; the collections
of information in the guidance document ``Requests for Feedback and
Meetings for Medical Device Submissions: The Q-Submission Program''
have been approved under OMB control number 0910-0756; and the
collections of information in 21 CFR part 860, subpart D, for De Novo
classifications have been approved under OMB control number 0910-0844.
III. Electronic Access
Persons with access to the internet may obtain the guidance at
https://www.fda.gov/combination-products/guidance-regulatory-information/combination-products-guidance-documents, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or
https://www.regulations.gov.
Dated: January 26, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-01925 Filed 1-28-22; 8:45 am]
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