Advisory Committee; Pharmacy Compounding Advisory Committee; Renewal, 78338-78339 [2020-26696]
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78338
Federal Register / Vol. 85, No. 234 / Friday, December 4, 2020 / Notices
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 presubmission interactions represents the
Agency’s best advice based on the
information provided during these presubmission 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the draft guidance, this final guidance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
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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/combinationproducts/guidance-regulatoryinformation/combination-productsguidance-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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–1768]
Advisory Committee; Pharmacy
Compounding Advisory Committee;
Renewal
AGENCY:
Food and Drug Administration,
HHS.
Notice; renewal of advisory
committee.
ACTION:
The Food and Drug
Administration (FDA) is announcing the
renewal of the Pharmacy Compounding
Advisory Committee by the
Commissioner of Food and Drugs (the
Commissioner). The Commissioner has
determined that it is in the public
interest to renew the Pharmacy
Compounding Advisory Committee for
an additional 2 years beyond the charter
expiration date. The new charter will be
in effect until April 25, 2022.
DATES: Authority for the Pharmacy
Compounding Advisory Committee will
expire on April 25, 2022, unless the
Commissioner formally determines that
renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT:
Yvette Waples, Division of Advisory
SUMMARY:
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Committee and Consultant
Management, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
Silver Spring, MD 20993–0002, 301–
796–9001, email: PCAC@fda.hhs.gov.
Pursuant
to 41 CFR 102–3, FDA is announcing
the renewal of the Pharmacy
Compounding Advisory Committee
(Committee). The Committee is a nondiscretionary Federal advisory
committee established to provide advice
to the Commissioner.
The Committee advises the
Commissioner or designee in
discharging responsibilities as they
relate to compounding drugs for human
use and, as required, any other product
for which FDA has regulatory
responsibility.
The Committee shall provide advice
on scientific, technical, and medical
issues concerning drug compounding
under sections 503A and 503B of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 353a and 353b), and, as
required, any other product for which
FDA has regulatory responsibility and
make appropriate recommendations to
the Commissioner of Food and Drugs.
Pursuant to its Charter, the Committee
shall consist of a core of 12 voting
members including the Chair. Members
and the Chair are selected by the
Commissioner or designee from among
authorities knowledgeable in the fields
of pharmaceutical compounding,
pharmaceutical manufacturing,
pharmacy, medicine, and related
specialties. These members will include
representatives from the National
Association of Boards of Pharmacy, the
United States Pharmacopeia,
pharmacists with current experience
and expertise in compounding,
physicians with background and
knowledge in compounding, and patient
and public health advocacy
organizations. Members will be invited
to serve for overlapping terms of up to
four years. Almost all non-Federal
members of this committee serve as
Special Government Employees. The
core of voting members may include one
or more technically qualified members,
selected by the Commissioner or
designee, who are identified with
consumer interests and are
recommended by either a consortium of
consumer-oriented organizations or
other interested persons. In addition to
the voting members, the Committee may
include one or more non-voting
representative members who are
identified with industry interests. There
SUPPLEMENTARY INFORMATION:
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Federal Register / Vol. 85, No. 234 / Friday, December 4, 2020 / Notices
may also be an alternate industry
representative.
Further information regarding the
most recent charter and other
information can be found at https://
www.fda.gov/advisory-committees/
pharmacy-compounding-advisorycommittee/pharmacy-compoundingadvisory-committee-charter or by
contacting the Designated Federal
Officer (see FOR FURTHER
INFORMATION CONTACT). In light of
the fact that no change has been made
to the committee name or description of
duties, no amendment will be made to
21 CFR 14.100.
This document is issued under the
Federal Advisory Committee Act (5
U.S.C. app.). For general information
related to FDA advisory committees,
please check https://www.fda.gov/
AdvisoryCommittees/default.htm.
Dated: November 30, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–2216]
Revocation of Authorizations of
Emergency Use of Certain Medical
Devices During COVID–19; Availability
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
revocations of the Emergency Use
Authorizations (EUAs) (the
Authorizations) issued to Manufacturers
of Protective Barrier Enclosures and
Other Stakeholders for certain
protective barrier enclosures (‘‘PBE
Authorization’’) and to Manufacturers of
Infusion Pumps and Infusion Pump
Accessories and Other Stakeholders for
certain infusion pumps and infusion
pump accessories (‘‘Infusion Pump
Authorization’’). FDA revoked the PBE
Authorization on August 20, 2020, and
the Infusion Pump Authorization on
September 21, 2020, under the Federal
Food, Drug, and Cosmetic Act (FD&C
Act). The revocations, which include an
explanation of the reasons for each
revocation, are reprinted in this
document.
SUMMARY:
The PBE Authorization is
revoked as of August 20, 2020. The
DATES:
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Submit written requests for
single copies of the revocations to the
Office of Counterterrorism and
Emerging Threats, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 1, Rm. 4338, Silver Spring,
MD 20993–0002. Send one selfaddressed adhesive label to assist that
office in processing your request or
include a Fax number to which the
revocations may be sent. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the revocations.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Jennifer J. Ross, Office of
Counterterrorism and Emerging Threats,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 1, Rm.
4332, Silver Spring, MD 20993–0002,
240–402–8155 (this is not a toll-free
number).
SUPPLEMENTARY INFORMATION:
I. Background
[FR Doc. 2020–26696 Filed 12–3–20; 8:45 am]
AGENCY:
Infusion Pump Authorization is revoked
as of September 21, 2020.
Section 564 of the FD&C Act (21
U.S.C. 360bbb–3) allows FDA to
strengthen the public health protections
against biological, chemical, nuclear,
and radiological agents. Among other
things, section 564 of the FD&C Act
allows FDA to authorize the use of an
unapproved medical product or an
unapproved use of an approved medical
product in certain situations. On May 1,
2020, FDA issued the PBE
Authorization. On May 13, 2020, FDA
issued the Infusion Pump
Authorization. Of note, these were both
‘‘umbrella’’ Authorizations, i.e., for
certain types of products that met the
requirements as described in their
respective Authorizations. Any product
with an individual Authorization is not
affected by revocation of these two
umbrella Authorizations. Notice of the
issuance of the Authorizations was
published in the Federal Register on
July 14, 2020 (85 FR 42407), as required
by section 564(h)(1) of the FD&C Act.
Subsequent to the issuance of the PBE
Authorization, FDA considered new
information, specifically from new
preliminary evidence from simulated
intubation procedure models of
potential adverse events that could
occur or complications with protective
barrier enclosures without negative
pressure. Subsequent to the issuance of
the Infusion Pump Authorization, FDA
considered that no device had been
listed under the EUA and that
circumstances instead support allowing
for tailored requirements of
authorization in individual EUAs.
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78339
II. EUA Criteria for Issuance No Longer
Met and Other Circumstances Make
Revocation Appropriate To Protect the
Public Health or Safety
Under section 564(g)(2)(B) and (C) of
the FD&C Act, the Secretary of the
Department of Health and Human
Services may revoke an EUA if, among
other things, the criteria for issuance are
no longer met or other circumstances
make such revocation appropriate to
protect the public health or safety. On
August 20, 2020, FDA revoked the PBE
Authorization because the criteria for
issuance were no longer met and other
circumstances make such revocation
appropriate to protect the public health
or safety. Under section 564(c)(2) of the
FD&C Act, an EUA may be issued only
if FDA concludes that, based on the
totality of scientific evidence available,
including data from adequate and wellcontrolled clinical trials, if available, it
is reasonable to believe that the product
may be effective in diagnosing, treating,
or preventing such disease or condition
and that the known and potential
benefits of the product, when used to
diagnose, prevent, or treat such disease
or condition, outweigh the known and
potential risks of the product.
Given the new preliminary evidence
from simulated intubation procedure
models of potential adverse events that
could occur or complications with
protective barrier enclosures without
negative pressure recently reported in
literature articles, FDA has concluded it
is not reasonable to believe the product
may be effective in decreasing
healthcare provider exposure to
airborne particles and may instead
contribute to an increase in healthcare
provider exposure to airborne particles.
Additionally, the literature articles note
potential risks of protective barrier
enclosures, such as increased intubation
times, lower first-pass intubation
success rates, damage to personal
protective equipment from intubation
boxes, particles escaping from
intubation boxes through arm access
holes reaching the face of the healthcare
provider performing the endotracheal
intubation, and human factors issues
contributing to increased endotracheal
intubation times. Further, based on the
same information and the risks to public
health, including from the device’s
potential contribution to an increase in
healthcare provider exposure to
airborne particles, FDA has concluded
under section 564(g)(2)(C) of the FD&C
Act that other circumstances make
revocation appropriate to protect the
public health or safety. Accordingly,
FDA has revoked the PBE
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]]>Agencies
[Federal Register Volume 85, Number 234 (Friday, December 4, 2020)]
[Notices]
[Pages 78338-78339]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-26696]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-1768]
Advisory Committee; Pharmacy Compounding Advisory Committee;
Renewal
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; renewal of advisory committee.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
renewal of the Pharmacy Compounding Advisory Committee by the
Commissioner of Food and Drugs (the Commissioner). The Commissioner has
determined that it is in the public interest to renew the Pharmacy
Compounding Advisory Committee for an additional 2 years beyond the
charter expiration date. The new charter will be in effect until April
25, 2022.
DATES: Authority for the Pharmacy Compounding Advisory Committee will
expire on April 25, 2022, unless the Commissioner formally determines
that renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT: Yvette Waples, Division of Advisory
Committee and Consultant Management, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
31, Rm. 2417, Silver Spring, MD 20993-0002, 301-796-9001, email:
[email protected].
SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3, FDA is announcing
the renewal of the Pharmacy Compounding Advisory Committee (Committee).
The Committee is a non-discretionary Federal advisory committee
established to provide advice to the Commissioner.
The Committee advises the Commissioner or designee in discharging
responsibilities as they relate to compounding drugs for human use and,
as required, any other product for which FDA has regulatory
responsibility.
The Committee shall provide advice on scientific, technical, and
medical issues concerning drug compounding under sections 503A and 503B
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353a and 353b),
and, as required, any other product for which FDA has regulatory
responsibility and make appropriate recommendations to the Commissioner
of Food and Drugs.
Pursuant to its Charter, the Committee shall consist of a core of
12 voting members including the Chair. Members and the Chair are
selected by the Commissioner or designee from among authorities
knowledgeable in the fields of pharmaceutical compounding,
pharmaceutical manufacturing, pharmacy, medicine, and related
specialties. These members will include representatives from the
National Association of Boards of Pharmacy, the United States
Pharmacopeia, pharmacists with current experience and expertise in
compounding, physicians with background and knowledge in compounding,
and patient and public health advocacy organizations. Members will be
invited to serve for overlapping terms of up to four years. Almost all
non-Federal members of this committee serve as Special Government
Employees. The core of voting members may include one or more
technically qualified members, selected by the Commissioner or
designee, who are identified with consumer interests and are
recommended by either a consortium of consumer-oriented organizations
or other interested persons. In addition to the voting members, the
Committee may include one or more non-voting representative members who
are identified with industry interests. There
[[Page 78339]]
may also be an alternate industry representative.
Further information regarding the most recent charter and other
information can be found at https://www.fda.gov/advisory-committees/pharmacy-compounding-advisory-committee/pharmacy-compounding-advisory-committee-charter or by contacting the Designated Federal Officer (see
FOR FURTHER INFORMATION CONTACT). In light of the fact that no change
has been made to the committee name or description of duties, no
amendment will be made to 21 CFR 14.100.
This document is issued under the Federal Advisory Committee Act (5
U.S.C. app.). For general information related to FDA advisory
committees, please check https://www.fda.gov/AdvisoryCommittees/default.htm.
Dated: November 30, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-26696 Filed 12-3-20; 8:45 am]
BILLING CODE 4164-01-P
