Rule2022-05776
Certain Ophthalmic Products: Policy Regarding Compliance With 21 CFR Part 4; Guidance for Industry; Availability
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Published
March 23, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry entitled "Certain Ophthalmic Products: Policy Regarding Compliance With 21 CFR part 4." This guidance describes FDA's compliance policy with respect to the requirements of FDA regulations that are now applicable to ophthalmic drugs that are packaged with eye cups, eye droppers, and other dispensers intended for ophthalmic use.
Full Text
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<title>Federal Register, Volume 87 Issue 56 (Wednesday, March 23, 2022)</title>
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[Federal Register Volume 87, Number 56 (Wednesday, March 23, 2022)]
[Rules and Regulations]
[Pages 16391-16393]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-05776]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 4
[Docket No. FDA-2022-D-0192]
Certain Ophthalmic Products: Policy Regarding Compliance With 21
CFR Part 4; Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification of availability.
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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing the availability of a final guidance for industry entitled
``Certain Ophthalmic Products: Policy Regarding Compliance With 21 CFR
part 4.'' This guidance describes FDA's compliance policy with respect
to the requirements of FDA regulations that are now applicable to
ophthalmic drugs that are packaged with eye cups, eye droppers, and
other dispensers intended for ophthalmic use.
DATES: The announcement of the guidance is published in the Federal
Register on March 23, 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:
[[Page 16392]]
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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-2022-D-0192 for ``Certain Ophthalmic Products: Policy Regarding
Compliance With 21 CFR part 4.'' Received comments will be placed in
the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 Sec.
10.115(g)(5) (21 CFR 10.115(g)(5))).
Submit written requests for single copies of the 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; 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
Office of Policy, Center for Devices and Radiological Health, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431,
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,
<a href="/cdn-cgi/l/email-protection#64070b09060d0a05100d0b0a240200054a030b12"><span class="__cf_email__" data-cfemail="accfc3c1cec5c2cdd8c5c3c2eccac8cd82cbc3da">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Certain Ophthalmic Products: Policy Regarding Compliance
With 21 CFR part 4.'' We are implementing this guidance without prior
public comment because we have determined that prior public
participation is not feasible or appropriate (Sec. 10.115(g)(2)). We
made this determination because FDA needs to communicate its compliance
policy in a timely manner given the urgency of these issues following
the decision from the U.S. Court of Appeals for the District of
Columbia Circuit in Genus Medical Technologies LLC v. U.S. Food and
Drug Administration (Genus), 994 F.3d 631 (D.C. Cir. 2021). Although
this guidance document is immediately in effect, it remains subject to
comment in accordance with FDA's good guidance practices (GGP)
regulation and FDA will consider all comments received and determine
whether revisions to the guidance document are appropriate (Sec.
10.115(g)(3)).
In accordance with Sec. 200.50(c) (21 CFR 200.50(c)), eye cups,
eye droppers, and other dispensers intended for ophthalmic use
(collectively referred to as ophthalmic dispensers) have been regulated
as drugs when packaged together with the ophthalmic drug with which
they were intended to be used. Therefore, products consisting of an
ophthalmic drug packaged with an ophthalmic dispenser were not
regulated as combination products as defined in Sec. 3.2(e) (21 CFR
3.2(e)) and were not subject to the requirements of part 4 (21 CFR part
4). This practice is a departure from how FDA generally regulates other
devices that are packaged with the drugs with which they are intended
to be used. Specifically, when a device is packaged together with the
drug with which it is intended to be used, FDA regulates that drug and
the device together as a combination product (see Sec. 3.2(e)).
On April 16, 2021, the U.S. Court of Appeals for the District of
Columbia Circuit issued its decision in Genus. The Genus court stated
``[e]xcepting combination products, . . . devices must be regulated as
devices and drugs--if they do not also satisfy the device definition--
must be regulated as drugs.'' \1\ In implementing this decision, FDA
has determined that the language in Sec. 200.50(c) indicating that eye
cups,
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eye droppers, and ophthalmic dispensers are regulated as drugs when
packaged with ophthalmic drugs is now obsolete, because these articles
meet the ``device'' definition. Accordingly, an ophthalmic dispenser
that meets the definition of device in section 201(h) of the Federal
Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 321(h)) and that is
packaged together with an ophthalmic drug is now regulated as a device
constituent part (see Sec. 3.2(e)), and, as such, is subject to the
requirements in part 4. Because the drug constituent part provides the
primary mode of action of these combination products, generally FDA's
Center for Drug Evaluation and Research (CDER) will have primary
jurisdiction over these products.
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\1\ For more information on FDA's implementation of the Genus
decision, please see Docket No. FDA-2021-N-0843, ``Genus Medical
Technologies LLC Versus Food and Drug Administration; Request for
Information and Comments,'' (86 FR 43553, August 9, 2021).
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This change impacts products subject to pending applications,\2\
approved products, and products marketed pursuant to section 505G of
the FD&C Act (21 U.S.C. 355h) without an approved application under
section 505 of the FD&C Act (21 U.S.C. 355) (commonly referred to as
over-the-counter monograph drugs).
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\2\ For the purposes of this guidance, pending applications
include applications on which FDA has taken an action that is not an
approval action and that are not currently pending review before the
Agency (i.e., applications that have been tentatively approved or
applications that have received a complete response letter) and
applications currently pending review before the Agency (including
supplements to approved applications).
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We recognize that some applicants and manufacturers may need to
develop policies and procedures necessary to comply with the
requirements in part 4. Therefore, we are issuing the guidance to
communicate FDA's compliance policy with respect to these products. The
guidance explains FDA's policy with respect to compliance with the
requirements of part 4. Specifically, the guidance explains that FDA
generally does not intend to take action with respect to noncompliance
with part 820 (21 CFR part 820) as described in part 4, subpart A, with
respect to ophthalmic products that were not previously regulated as
combination products because of the now obsolete language in Sec.
200.50(c) for a period of 12 months following the publication of the
guidance. Further, the guidance explains that, with respect to
ophthalmic products affected by the Genus decision that incorporate
lower-risk device constituent parts, for example, eye dropper bottles/
ampules that administer the drug directly to the eye, FDA does not
intend to take action with respect to noncompliance with any applicable
part 820 requirements for these products until FDA further considers
the application of these requirements to these combination products.
Additionally, the guidance describes FDA's policy with respect to
pending applications and how FDA will determine when compliance with
the requirements of part 4, subpart A, must be demonstrated (i.e.,
during the review of the application or after approval). As part of
this notice, FDA is soliciting feedback from stakeholders as to whether
a 12-month period is sufficient for affected stakeholders to develop
and implement the policies and procedures necessary to comply with the
requirements of part 4, including whether different amounts of time
should be considered with respect to compliance with subpart A and
subpart B of part 4. Finally, in addition to the guidance for industry
we are announcing today, FDA also encourages applicants and
manufacturers to review other guidances for industry that apply to
CDER-led drug-device combination products.
This guidance is being issued consistent with FDA's GGP regulation
(Sec. 10.115). The guidance represents the current thinking of FDA on
``Certain Ophthalmic Products: Policy Regarding Compliance With 21 CFR
part 4.'' 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 314 are approved under OMB control
numbers 0910-0001, 0910-0230, and 0910-0291. The collections of
information in 21 CFR 600.80 and 600.81 are approved under OMB control
number 0910-0308. The collections of information in 21 CFR 606.171 are
approved under OMB control number 0910-0458. The collections of
information in 21 CFR 803.50, 803.53, and 803.56 are approved under OMB
control numbers 0910-0291 and 0910-0437. The collections of information
in 21 CFR 806.10 and 802.20 are approved under OMB control number 0910-
0359. The collections of information in 21 CFR part 211 have been
approved under OMB control number 0910-0139. The collections of
information in 21 CFR part 820 are approved under OMB control number
0910-0073. The collections of information in 21 CFR parts 606 and 640
are approved under OMB control number 0910-0116. The collections of
information in 21 CFR part 610 are approved under OMB control numbers
0910-0116 and 0910-0338 (also for 21 CFR part 680 and Form FDA 356h).
The collections of information in 21 CFR part 1271, subparts C and D,
are approved under OMB control number 0910-0543. The collections of
information in 21 CFR 4.102, 4.103, and 4.105 are approved under OMB
control number 0910-0834.
III. Electronic Access
Persons with access to the internet may obtain the document at
<a href="https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs">https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Dated: March 11, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-05776 Filed 3-22-22; 8:45 am]
BILLING CODE 4164-01-P
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