Advisory Committee; Bone, Reproductive and Urologic Drugs Advisory Committee; Change of Name and Function; Technical Amendment, 16393-16394 [2022-05965]
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Federal Register / Vol. 87, No. 56 / Wednesday, March 23, 2022 / Rules and Regulations
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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 § 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).
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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
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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:
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jspears on DSK121TN23PROD with RULES1
16394
Federal Register / Vol. 87, No. 56 / Wednesday, March 23, 2022 / Rules and Regulations
10903 New Hampshire Ave., Silver
Spring, MD 20993, 301–796–8220.
SUPPLEMENTARY INFORMATION: FDA is
announcing that the name of the Bone,
Reproductive and Urologic Drugs
Advisory Committee, which was
established on March 23, 1978, has been
changed. The Agency decided that the
name ‘‘Obstetrics, Reproductive and
Urologic Drugs Advisory Committee’’
more accurately describes the subject
areas for which the committee is
responsible. The committee reviews and
evaluates data on the safety and
effectiveness of marketed and
investigational human drug products for
use in the practice of obstetrics,
gynecology, urology and related
specialties, and makes appropriate
recommendations to the Commissioner
of Food and Drugs. The mandate of the
committee no longer includes
osteoporosis and metabolic bone
disease. As osteoporosis and metabolic
bone diseases are topics related to
endocrinology and metabolic disease,
these will be discussed by the
Endocrinologic and Metabolic Drugs
Advisory Committee.
The Obstetrics, Reproductive and
Urologic Drugs Advisory Committee
name was changed, and its functions
changed in the charter renewal dated
March 23, 2022. In this final rule, FDA
is revising 21 CFR 14.100(c)(9) to reflect
these changes.
Publication of this final rule
constitutes a final action on this change
under the Administrative Procedure
Act. Under 5 U.S.C. 553(b)(B) and (d)(3)
and 21 CFR 10.40(d) and (e)(1), the
Agency finds good cause to dispense
with notice and public procedure and to
proceed to an immediately effective
regulation. Such notice and procedures
are unnecessary and are not in the
public interest because the final rule is
merely codifying the new name and the
function of the advisory committee to
reflect the current committee charter.
U.S.C. 201, 262, 263b, 264; Pub. L. 107–109;
Pub. L. 108–155; Pub. L. 113–54.
List of Subjects in 21 CFR Part 14
Administrative practice and
procedure, Advisory committees, Color
additives, Drugs, Radiation protection.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under the
authority delegated to the Commissioner
of Food and Drugs, 21 CFR part 14 is
amended as follows:
ACTION:
PART 14—PUBLIC HEARING BEFORE
A PUBLIC ADVISORY COMMITTEE
1. The authority citation for part 14
continues to read as follows:
■
Authority: 5 U.S.C. App. 2; 15 U.S.C.
1451–1461, 21 U.S.C. 41–50, 141–149, 321–
394, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42
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2. Section 14.100 is amended by
revising paragraph (c)(8) heading and
paragraph (c)(8)(ii) to read as follows:
■
§ 14.100 List of standing advisory
committees.
*
*
*
*
*
(c) * * *
(8) Obstetrics, Reproductive and
Urologic Drugs Advisory Committee.
*
*
*
*
*
(ii) Function: The committee reviews
and evaluates data on the safety and
effectiveness of marketed and
investigational human drug products for
use in the practice of obstetrics,
gynecology, urology and related
specialties, and makes appropriate
recommendations to the Commissioner
of Food and Drugs.
*
*
*
*
*
Dated: March 16, 2022.
Andi Lipstein Fristedt,
Deputy Commissioner for Policy, Legislation,
and International Affairs, U.S. Food and Drug
Administration.
[FR Doc. 2022–05965 Filed 3–22–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 130 and 131
[Docket No. FDA–2000–P–0126 (formerly
Docket No. 2000P–0658)]
RIN 0910–AI40
Milk and Cream; Petition for an
Administrative Stay of Action:
Definitions and Standards of Identity
for Yogurt, Lowfat Yogurt, and Nonfat
Yogurt
AGENCY:
Food and Drug Administration,
HHS.
Final rule; notification of
administrative stay.
The Food and Drug
Administration (FDA or we) is
providing notice of a stay of the
effectiveness of certain provisions of a
final rule published in the Federal
Register of June 11, 2021. The final rule
amended the definition and standard of
identity for yogurt and revoked the
definitions and standards of identity for
lowfat yogurt and nonfat yogurt. FDA is
publishing this notification in response
to objections timely filed in accordance
with regulatory requirements.
DATES: FDA is administratively staying
certain provisions in the final rule
SUMMARY:
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published on June 11, 2021 (86 FR
31117). FDA will publish a document in
the Federal Register lifting the stay or
taking further action as needed.
ADDRESSES: For access to the docket, 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,
between 9 a.m. and 4 p.m., Monday
through Friday. Publicly available
submissions may be seen in the docket.
FOR FURTHER INFORMATION CONTACT: Joan
Rothenberg, Center for Food Safety and
Applied Nutrition, Office of Regulations
and Policy, Food and Drug
Administration, 5001 Campus Dr.,
College Park, MD 20740, 240–402–2378.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of June 11,
2021 (86 FR 31117), FDA issued a final
rule (the 2021 final rule) amending the
definition and standard of identity for
yogurt ((§ 131.200) (21 CFR 131.200))
and revoking the definitions and
standards of identity for lowfat yogurt
(21 CFR 131.203) and nonfat yogurt (21
CFR 131.206). The 2021 final rule’s
effective date was July 12, 2021.
Pursuant to section 701(e) of the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 371(e)), the 2021 final
rule notified persons who would be
adversely affected by the 2021 final rule
that they could file objections,
specifying with particularity the
provisions of the 2021 final rule deemed
objectionable, stating the grounds
therefor, and requesting a public hearing
upon such objections.
The International Dairy Foods
Association (IDFA) and Chobani timely
filed objections and requests for a
hearing with respect to several
provisions in the 2021 final rule (see
Objections and Request for Hearings
submitted by Michael Dykes, DVM,
President and Chief Executive Officer,
International Dairy Foods Association,
dated July 12, 2021, to the Dockets
Management Staff, Food and Drug
Administration (Comment ID FDA–
2000–P–0126–0109) and Objection and
Requests for Hearing submitted by
Matthew Graziose, Ph.D., Director,
Regulatory Affairs & Compliance,
Chobani, dated July 12, 2021, to the
Dockets Management Staff, Food and
Drug Administration (Comment ID
FDA–2000–P–0126–0108)). Section
701(e)(2) of the FD&C Act provides that,
until final action is taken by the
Secretary, the filing of objections
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]]>Agencies
[Federal Register Volume 87, Number 56 (Wednesday, March 23, 2022)]
[Rules and Regulations]
[Pages 16393-16394]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-05965]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
SUMMARY: 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,
[[Page 16394]]
10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-8220.
SUPPLEMENTARY INFORMATION: FDA is announcing that the name of the Bone,
Reproductive and Urologic Drugs Advisory Committee, which was
established on March 23, 1978, has been changed. The Agency decided
that the name ``Obstetrics, Reproductive and Urologic Drugs Advisory
Committee'' more accurately describes the subject areas for which the
committee is responsible. The committee reviews and evaluates data on
the safety and effectiveness of marketed and investigational human drug
products for use in the practice of obstetrics, gynecology, urology and
related specialties, and makes appropriate recommendations to the
Commissioner of Food and Drugs. The mandate of the committee no longer
includes osteoporosis and metabolic bone disease. As osteoporosis and
metabolic bone diseases are topics related to endocrinology and
metabolic disease, these will be discussed by the Endocrinologic and
Metabolic Drugs Advisory Committee.
The Obstetrics, Reproductive and Urologic Drugs Advisory Committee
name was changed, and its functions changed in the charter renewal
dated March 23, 2022. In this final rule, FDA is revising 21 CFR
14.100(c)(9) to reflect these changes.
Publication of this final rule constitutes a final action on this
change under the Administrative Procedure Act. Under 5 U.S.C. 553(b)(B)
and (d)(3) and 21 CFR 10.40(d) and (e)(1), the Agency finds good cause
to dispense with notice and public procedure and to proceed to an
immediately effective regulation. Such notice and procedures are
unnecessary and are not in the public interest because the final rule
is merely codifying the new name and the function of the advisory
committee to reflect the current committee charter.
List of Subjects in 21 CFR Part 14
Administrative practice and procedure, Advisory committees, Color
additives, Drugs, Radiation protection.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
the authority delegated to the Commissioner of Food and Drugs, 21 CFR
part 14 is amended as follows:
PART 14--PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE
0
1. The authority citation for part 14 continues to read as follows:
Authority: 5 U.S.C. App. 2; 15 U.S.C. 1451-1461, 21 U.S.C. 41-
50, 141-149, 321-394, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42
U.S.C. 201, 262, 263b, 264; Pub. L. 107-109; Pub. L. 108-155; Pub.
L. 113-54.
0
2. Section 14.100 is amended by revising paragraph (c)(8) heading and
paragraph (c)(8)(ii) to read as follows:
Sec. 14.100 List of standing advisory committees.
* * * * *
(c) * * *
(8) Obstetrics, Reproductive and Urologic Drugs Advisory Committee.
* * * * *
(ii) Function: The committee reviews and evaluates data on the
safety and effectiveness of marketed and investigational human drug
products for use in the practice of obstetrics, gynecology, urology and
related specialties, and makes appropriate recommendations to the
Commissioner of Food and Drugs.
* * * * *
Dated: March 16, 2022.
Andi Lipstein Fristedt,
Deputy Commissioner for Policy, Legislation, and International Affairs,
U.S. Food and Drug Administration.
[FR Doc. 2022-05965 Filed 3-22-22; 8:45 am]
BILLING CODE 4164-01-P
