Certain Ophthalmic Products: Policy Regarding Compliance With 21 CFR Part 4; Guidance for Industry; Availability, 16391-16393 [2022-05776]
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Federal Register / Vol. 87, No. 56 / Wednesday, March 23, 2022 / Rules and Regulations
§ 157.208(d) and Table II of § 157.215(a),
are hereby issued.
Effective Date
This final rule is effective March 23,
2022. The provisions of 5 U.S.C. 804
regarding Congressional review of Final
Rules does not apply to the Final Rule
because the rule concerns agency
procedure and practice and will not
substantially affect the rights or
obligations of non-agency parties. The
Final Rule merely updates amounts
published in the Code of Federal
Regulations to reflect the Department of
Commerce’s latest annual determination
of the Gross Domestic Product (GDP)
implicit price deflator, a mathematical
updating required by the Commission’s
existing regulations.
List of Subjects in 18 CFR Part 157
Administrative practice and
procedure, Natural gas, Reporting and
recordkeeping requirements.
Issued: March 15, 2022.
Terry L. Turpin,
Director, Office of Energy Projects.
Accordingly, 18 CFR part 157 is
amended as follows:
PART 157—APPLICATIONS FOR
CERTIFICATES OF PUBLIC
CONVENIENCE AND NECESSITY AND
FOR ORDERS PERMITTING AND
APPROVING ABANDONMENT UNDER
SECTION 7 OF THE NATURAL GAS
ACT
1. The authority citation for part 157
continues to read as follows:
■
Authority: 15 U.S.C. 717–717w, 3301–
3432; 42 U.S.C. 7101–7352.
TABLE I TO PART 157—Continued
1992
1993
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
Auto. proj.
cost limit
(col. 1)
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
6,200,000
6,400,000
6,600,000
6,700,000
6,900,000
7,000,000
7,100,000
7,200,000
7,300,000
7,400,000
7,500,000
7,600,000
7,800,000
8,000,000
9,600,000
9,900,000
10,200,000
10,400,000
10,500,000
10,600,000
10,800,000
11,000,000
11,200,000
11,400,000
11,600,000
11,800,000
12,000,000
12,300,000
12,500,000
12,600,000
13,100,000
Year
Prior notice
proj. cost
limit (col. 2)
17,300,000
17,700,000
18,100,000
18,400,000
18,800,000
19,200,000
19,600,000
19,800,000
20,200,000
20,600,000
21,000,000
21,200,000
21,600,000
22,000,000
27,400,000
28,200,000
29,000,000
29,600,000
29,900,000
30,200,000
30,800,000
31,400,000
31,900,000
32,400,000
32,800,000
33,200,000
33,800,000
34,600,000
35,200,000
35,600,000
37,100,000
*
TABLE I TO PART 157
Limit
jspears on DSK121TN23PROD with RULES1
Year
1982
1983
1984
1985
1986
1987
1988
1989
1990
1991
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
VerDate Sep<11>2014
Auto. proj.
cost limit
(col. 1)
$4,200,000
4,500,000
4,700,000
4,900,000
5,100,000
5,200,000
5,400,000
5,600,000
5,800,000
6,000,000
19:58 Mar 22, 2022
Prior notice
proj. cost
limit (col. 2)
$12,000,000
12,800,000
13,300,000
13,800,000
14,300,000
14,700,000
15,100,000
15,600,000
16,000,000
16,700,000
Jkt 256001
*
*
*
*
5,000,000
5,100,000
5,250,000
5,400,000
5,550,000
5,600,000
5,700,000
5,750,000
5,850,000
6,000,000
6,100,000
6,200,000
6,300,000
6,400,000
6,500,000
6,600,000
6,700,000
6,800,000
7,100,000
*
[FR Doc. 2022–06085 Filed 3–22–22; 8:45 am]
BILLING CODE 6717–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 4
[Docket No. FDA–2022–D–0192]
AGENCY:
Year
1982
1983
1984
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PO 00000
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Notification of availability.
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:
SUMMARY:
Limit
......................................
......................................
......................................
......................................
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Food and Drug Administration,
HHS.
ACTION:
TABLE II TO PART 157
*
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......................................
......................................
......................................
......................................
......................................
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§ 157.215 Underground storage testing
and development.
2. In § 157.208(d), revise Table I to
read as follows:
*
*
(d) * * *
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
Certain Ophthalmic Products: Policy
Regarding Compliance With 21 CFR
Part 4; Guidance for Industry;
Availability
■
*
Limit
*
*
*
*
■ 3. In § 157.215(a)(5), revise Table II to
read as follows:
*
(a) * * *
(5) * * *
§ 157.208 Construction, acquisition,
operation, replacement, and miscellaneous
rearrangement of facilities.
TABLE II TO PART 157—Continued
Limit
Year
16391
$2,700,000
2,900,000
3,000,000
3,100,000
3,200,000
3,300,000
3,400,000
3,500,000
3,600,000
3,800,000
3,900,000
4,000,000
4,100,000
4,200,000
4,300,000
4,400,000
4,500,000
4,550,000
4,650,000
4,750,000
4,850,000
4,900,000
Electronic Submissions
Submit electronic comments in the
following way:
E:\FR\FM\23MRR1.SGM
23MRR1
16392
Federal Register / Vol. 87, No. 56 / Wednesday, March 23, 2022 / Rules and Regulations
jspears on DSK121TN23PROD with RULES1
• 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–
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 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
VerDate Sep<11>2014
19:58 Mar 22, 2022
Jkt 256001
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-201509-18/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 § 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 selfaddressed 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,
combination@fda.gov.
SUPPLEMENTARY INFORMATION:
PO 00000
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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 (§ 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
(§ 10.115(g)(3)).
In accordance with § 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 § 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 § 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 § 200.50(c) indicating that eye cups,
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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Federal Register / Vol. 87, No. 56 / Wednesday, March 23, 2022 / Rules and Regulations
jspears on DSK121TN23PROD with RULES1
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 § 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.
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-thecounter monograph drugs).
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
§ 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 lowerrisk 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
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).
VerDate Sep<11>2014
19:58 Mar 22, 2022
Jkt 256001
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
(§ 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
PO 00000
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16393
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 https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 14
[Docket No. FDA–2019–N–4203]
Advisory Committee; Bone,
Reproductive and Urologic Drugs
Advisory Committee; Change of Name
and Function; Technical Amendment
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA or Agency) is
amending the standing advisory
committees’ regulations to change the
name and function of the Bone,
Reproductive and Urologic Drugs
Advisory Committee. This action is
being taken to reflect changes made to
the charter for this advisory committee.
DATES: This rule is effective March 23,
2022. The changes are applicable March
23, 2022.
FOR FURTHER INFORMATION CONTACT:
Teresa Hays, Committee Management
Officer, Food and Drug Administration,
SUMMARY:
E:\FR\FM\23MRR1.SGM
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Agencies
[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 [www.gpo.gov]
[FR Doc No: 2022-05776]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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]]
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-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 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 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,
[email protected].
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,
[[Page 16393]]
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
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.
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