[Federal Register Volume 85, Number 234 (Friday, December 4, 2020)]
[Notices]
[Pages 78337-78338]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-26700]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-4739]


Requesting FDA Feedback on Combination Products; Guidance for 
Industry and FDA 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 ``Requesting FDA Feedback on Combination Products.'' The 
purpose of this guidance is to discuss ways in which combination 
product sponsors can obtain feedback from FDA on scientific and 
regulatory questions and to describe best practices for FDA and 
sponsors when interacting on these topics. These interactions can occur 
through application-based mechanisms, such as the pre-submission 
process used in the Center for Devices and Radiological Health (CDRH) 
and the Center for Biologics Evaluation and Research (CBER) and the 
formal meetings used in the Center for Drug Evaluation and Research 
(CDER) and CBER, or through Combination Product Agreement Meetings 
(CPAMs), as appropriate.

DATES: The announcement of the guidance is published in the Federal 
Register on December 4, 2020.

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-4739 for ``Requesting FDA Feedback on 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 the guidance to the to 
the Office of Combination Products, Food and Drug Administration, Bldg. 
32, Rm. 5129, 10903 New Hampshire Ave., Silver Spring, MD 20993. 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: Melissa Burns, Office of Combination 
Products, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
32, Rm. 5125, 301-796-5616, melissa.burns@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Requesting FDA Feedback on Combination Products.'' The 
purpose of this guidance is to discuss ways in which combination 
product sponsors can obtain feedback from the Agency on scientific and 
regulatory questions. These interactions can occur through application-
based mechanisms, such as the pre-submission process used in

[[Page 78338]]

CDRH and CBER and the formal meetings used in CDER and CBER, or through 
CPAMs, as appropriate.
    FDA is publishing this guidance consistent with the Agency's 
ongoing commitment to enhancing clarity and transparency regarding 
regulatory considerations for combination products, and in accordance 
with the mandate under section 503(g)(8)(C)(vi) of the Federal Food, 
Drug, and Cosmetics Act (FD&C Act) (21 U.S.C. 353(g)(8)(C)(vi)), which 
was added by section 3038 of the 21st Century Cures Act (Pub. L. 114-
255). Section 503(g)(8)(C)(vi) of the FD&C Act requires FDA to issue a 
final guidance addressing: (1) The structured process for managing pre-
submission interactions with sponsors developing combination products; 
(2) best practices to ensure FDA feedback in such pre-submission 
interactions represents the Agency's best advice based on the 
information provided during these pre-submission interactions; and (3) 
how CPAMs relate to other FDA meeting types, what information should be 
submitted prior to a CPAM, and the form and content of agreements 
reached through a CPAM.
    In response to comments received on the draft guidance, this final 
guidance includes additional information on use of CPAMs and 
application-based mechanisms. The guidance also provides additional 
clarity on how CPAMs will be conducted, including expected timelines 
for CPAM-related activities.
    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 ``Requesting FDA Feedback on 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 pertaining to orphan drug provisions in 21 CFR part 316 
are approved under OMB control number 0910-0167; the collections of 
information pertaining to investigational device exemption submission 
provisions in 21 CFR part 812 are approved under OMB control number 
0910-0078; the collections of information pertaining to investigational 
new drug submission provisions in 21 CFR part 312 are approved under 
OMB control number 0910-0014; the collections of information pertaining 
to biologics licensing submission provisions in 21 CFR part 601 are 
approved under OMB control number 0910-0338; and the collections of 
information pertaining to combination product agreement meetings are 
approved under OMB control number 0910-0523.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
either https://www.fda.gov/combination-products/guidance-regulatory-information/combination-products-guidance-documents or https://www.regulations.gov.

    Dated: November 30, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-26700 Filed 12-3-20; 8:45 am]
BILLING CODE 4164-01-P


