Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Bulk Drug Substances Nominated for Inclusion on the Section 503A Bulk Drug Substances List, 85219-85221 [2024-24828]
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Federal Register / Vol. 89, No. 207 / Friday, October 25, 2024 / Notices
January 19, 2023, July 22, 2024).
*6. FDA, ‘‘Intenze Ink’’: Recall, posted July
31, 2018; available at https://
www.accessdata.fda.gov/scripts/ires/
index.cfm?Product=165649 (accessed
January 19, 2023, July 22, 2024).
*7. FDA, ‘‘Eternal Ink’’: Recall, posted
October 24, 2018; available at https://
www.accessdata.fda.gov/scripts/ires/
index.cfm?Product=167698 (accessed
January 19, 2023, July 22, 2024).
*8. FDA, ‘‘FDA Advises Consumers, Tattoo
Artists, and Retailers to Avoid Using or
Selling Certain Tattoo Inks Contaminated
with Microorganisms’’; available at
https://www.fda.gov/cosmetics/
cosmetics-recalls-alerts/fda-advisesconsumers-tattoo-artists-and-retailersavoid-using-or-selling-certain-tattoo-inks
(accessed January 19, 2023, July 22,
2024).
*9. Nho, SW, S–J. Kim, O. Kweon, et al.
‘‘Microbiological Survey of Commercial
Tattoo and Permanent Makeup Inks
Available in the United States.’’ Journal
of Applied Microbiology, 124: 1294–1302
(2018).
Dated: October 21, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation,
and International Affairs.
[FR Doc. 2024–24841 Filed 10–24–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–4777]
Pharmacy Compounding Advisory
Committee; Notice of Meeting;
Establishment of a Public Docket;
Request for Comments—Bulk Drug
Substances Nominated for Inclusion
on the Section 503A Bulk Drug
Substances List
AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of a
public docket; request for comments.
ACTION:
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Pharmacy Compounding
Advisory Committee (the Committee).
The general function of the Committee
is to provide advice and
recommendations to FDA on regulatory
issues. The meeting will be open to the
public. FDA is establishing a docket for
public comment on this document.
DATES: The meeting will be held on
December 4, 2024, from 8 a.m. to 3 p.m.
Eastern Time.
ADDRESSES: The meeting will be held at
the FDA White Oak Campus, 10903
New Hampshire Ave., Silver Spring, MD
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SUMMARY:
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20993–0002. The public will also have
the option to participate, and the
advisory committee meeting will be
heard, viewed, captioned, and recorded
through an online teleconferencing and/
or video conferencing platform.
Answers to commonly asked
questions about FDA advisory
committee meetings, including
information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm.
FDA is establishing a docket for
public comment on this meeting. The
docket number is FDA–2024–N–4777.
The docket will close on December 3,
2024. Please note that late, untimely
filed comments will not be considered.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
on December 3, 2024. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are received
on or before that date.
Comments received on or before
November 19, 2024, will be provided to
the Committee. Comments received after
that date will be taken into
consideration by FDA. In the event that
the meeting is cancelled, FDA will
continue to evaluate any relevant
applications or information, and
consider any comments submitted to the
docket, as appropriate.
You may submit comments 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
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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–
2024–N–4777 for ‘‘Pharmacy
Compounding Advisory Committee;
Notice of Meeting; Establishment of a
Public Docket; Request for Comments—
Bulk Drug Substances Nominated for
Inclusion on the Section 503A Bulk
Drug Substances List.’’ Received
comments, those filed in a timely
manner (see ADDRESSES), 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.’’ FDA
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 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 the 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
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Federal Register / Vol. 89, No. 207 / Friday, October 25, 2024 / Notices
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.
FOR FURTHER INFORMATION CONTACT:
Takyiah Stevenson, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
Silver Spring, MD 20993–0002, 240–
402–2507, email: PCAC@fda.hhs.gov, or
FDA Advisory Committee Information
Line, 1–800–741–8138 (301–443–0572
in the Washington, DC area). A notice in
the Federal Register about last-minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check
FDA’s website at https://www.fda.gov/
AdvisoryCommittees/default.htm and
scroll down to the appropriate advisory
committee meeting link, or call the
advisory committee information line to
learn about possible modifications
before the meeting.
SUPPLEMENTARY INFORMATION:
Background: Section 503A of the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 353a) describes
the conditions that must be satisfied for
human drug products compounded by a
licensed pharmacist in a State-licensed
pharmacy or a Federal facility, or a
licensed physician, to be exempt from
the following three sections of the FD&C
Act: (1) section 501(a)(2)(B) (21 U.S.C.
351(a)(2)(B)) (concerning current good
manufacturing practice requirements);
(2) section 502(f)(1) (21 U.S.C. 352(f)(1))
(concerning the labeling of drugs with
adequate directions for use); and (3)
section 505 (21 U.S.C. 355) (concerning
the approval of human drug products
under new drug applications (NDAs) or
abbreviated new drug applications
(ANDAs)).
One of the conditions that must be
satisfied for a drug product to qualify for
the exemptions under section 503A of
the FD&C Act is that the licensed
pharmacist or licensed physician
compounds the drug product using bulk
drug substances (as defined in 21 CFR
207.3) that: (1) comply with the
standards of an applicable United States
Pharmacopoeia (USP) or National
Formulary monograph, if a monograph
exists, and the USP chapter on
pharmacy compounding; (2) if an
applicable monograph does not exist,
are drug substances that are components
of drugs approved by the Secretary of
Health and Human Services (the
Bulk drug substance
Uses evaluated
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AOD–9604 (free base) .......................................................
AOD–9604 Acetate ............................................................
CJC–1295 (free base) ........................................................
CJC–1295 Acetate .............................................................
CJC–1295 DAC (free base) ...............................................
CJC–1295 DAC Acetate ....................................................
CJC–1295 DAC Trifluoroacetate .......................................
Thymosin alpha-1(free base) .............................................
Thymosin alpha-1 Acetate .................................................
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its website prior to the
meeting, the background material will
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Secretary); or (3) if such a monograph
does not exist and the drug substance is
not a component of a drug approved by
the Secretary, that appear on a list
developed by the Secretary through
regulations issued by the Secretary
under section 503A(c) of the FD&C Act
(the 503A Bulks List) (see section
503A(b)(1)(A)(i) of the FD&C Act).
Agenda: FDA, invited attendees, and
the public will be able to attend the
meeting in-person at FDA’s White Oak
Campus (see ADDRESSES). The meeting
presentations will also be heard,
viewed, captioned, and recorded
through an online teleconferencing and/
or video conferencing platform.
The Committee will discuss the
following bulk drug substances being
considered for inclusion on the 503A
Bulks List: AOD–9604-related bulk drug
substances (AOD–9604 acetate, and
AOD–9604 (free base)), CJC–1295related bulk drug substances (CJC–1295
(free base), CJC–1295 acetate, CJC–1295
with drug affinity complex (DAC) (free
base), CJC–1295 DAC acetate, and CJC–
1295 DAC trifluoroacetate)), and
Thymosin alpha-1-related bulk drug
substances (Thymosin alpha-1 acetate,
and Thymosin alpha-1 (free base)). The
chart below identifies the use(s) FDA
reviewed for each of the bulk drug
substances being discussed at this
advisory committee meeting. For
nominated bulk drug substances, the
nominators of these substances will be
invited to make a short presentation
supporting the nomination.
*Obesity.
Growth hormone deficiency.
Hepatitis B.
Hepatitis C.
Human immunodeficiency virus (HIV).
Coronavirus disease 2019 (COVID–19).
Depressed response to vaccinations; adjuvant to flu vaccines.
Malignant melanoma.
Hepatocellular carcinoma (HCC).
Non-small cell lung cancer (NSCLC).
Sepsis.
Infections after hematopoietic stem cell transplantation (HSCT).
Chronic obstructive pulmonary disease (COPD).
Myalgic encephalomyelitis and chronic fatigue syndrome (ME/CFS).
be made publicly available on FDA’s
website at the time of the advisory
committee meeting. Background
material and the link to the online
teleconference and/or video conference
meeting will be available at the location
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of the advisory committee meeting and
at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link. The meeting will include slide
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Federal Register / Vol. 89, No. 207 / Friday, October 25, 2024 / Notices
presentations with audio and video
components to allow the presentation of
materials for online participants in a
manner that most closely resembles an
in-person advisory committee meeting.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the Committee. All electronic and
written submissions to the Docket (see
ADDRESSES) on or before November 19,
2024, will be provided to the
Committee. Oral presentations from the
public will be scheduled following FDA
presentations. FDA has allotted
approximately 1 hour for open public
hearing presentations, which will be
split to allow for public remarks on each
substance. The sessions will begin at
approximately 9:35 a.m., 10:50 a.m., and
1:40 p.m. Those individuals interested
in making formal oral presentations
should notify the contact person and
submit a brief statement of the general
nature of the evidence or arguments
they wish to present, the names and
addresses of proposed participants,
whether they would like to present
online or in-person, and an indication of
the approximate amount of time
requested to make their presentation on
or before November 8, 2024. Time
allotted for each presentation may be
limited. If the number of registrants
requesting to speak is greater than can
be reasonably accommodated during the
scheduled open public hearing session,
FDA may conduct a lottery to determine
the speakers for the scheduled open
public hearing session. FDA may also
extend the time scheduled for open
public hearing presentations depending
on interest. Similarly, room for
interested persons to participate inperson may be limited. If the number of
registrants requesting to speak in-person
during the open public hearing is
greater than can be reasonably
accommodated in the venue for the inperson portion of the advisory
committee meeting, FDA may conduct a
lottery to determine the speakers who
will be invited to participate in-person.
The contact person will notify
interested persons regarding their
request to speak and the timeframe for
the presentation by November 12, 2024.
Persons attending FDA’s advisory
committee meetings are advised that
FDA is not responsible for providing
access to electrical outlets.
For press inquiries, please contact the
Office of Media Affairs at fdaoma@
fda.hhs.gov or 301–796–4540.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with disabilities.
If you require accommodations due to a
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disability, please contact Takyiah
Stevenson (see FOR FURTHER
INFORMATION CONTACT) at least 7 days in
advance of the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our website at
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. 1001 et seq.). This meeting notice
also serves as notice that, pursuant to 21
CFR 10.19, the requirements in 21 CFR
14.22(b), (f), and (g) relating to the
location of advisory committee meetings
are hereby waived to allow for this
meeting to take place using an online
meeting platform in conjunction with
the physical meeting room (see
location). This waiver is in the interest
of allowing greater transparency and
opportunities for public participation,
in addition to convenience for advisory
committee members, speakers, and
guest speakers. The conditions for
issuance of a waiver under 21 CFR 10.19
are met.
Dated: October 21, 2024.
Eric Flamm,
Acting Associate Commissioner for Policy.
[FR Doc. 2024–24828 Filed 10–24–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Final Effect of Designation of a Class
of Employees for Addition to the
Special Exposure Cohort
National Institute for
Occupational Safety and Health
(NIOSH), Centers for Disease Control
and Prevention, Department of Health
and Human Services (HHS).
ACTION: Notice.
AGENCY:
HHS gives notice concerning
the final effect of the HHS decision to
designate a class of employees from the
Metals and Controls Corp. in Attleboro,
Massachusetts, as an addition to the
Special Exposure Cohort (SEC) under
the Energy Employees Occupational
Illness Compensation Program Act of
2000.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Grady Calhoun, Director, Division of
Compensation Analysis and Support,
NIOSH, 1090 Tusculum Avenue, MS C–
46, Cincinnati, OH 45226–1938,
Telephone 513–533–6800. Information
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requests can also be submitted by email
to DCAS@CDC.GOV.
SUPPLEMENTARY INFORMATION: On
September 9, 2024, as provided for
under 42 U.S.C. 7384l(14)(C), the
Secretary of HHS designated the
following class of employees as an
addition to the SEC:
All atomic weapons employees who
worked at Metals and Controls Corp. in
Attleboro, Massachusetts, from January 1,
1968, through September 21, 1995, for a
number of work days aggregating at least 250
work days, occurring either solely under this
employment or in combination with work
days within the parameters established for
one or more other classes of employees
included in the SEC.
This designation became effective on
October 9, 2024. Therefore, beginning on
October 9, 2024, members of this class of
employees, defined as reported in this notice,
became members of the SEC.
Authority: 2 U.S.C. 384q(b). 42 U.S.C.
7384l(14)(C).
John J. Howard,
Director, National Institute for Occupational
Safety and Health.
[FR Doc. 2024–24833 Filed 10–24–24; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Small
Business Innovation Research/Small
Business Technology Transfer: Clinical Care
and Health Interventions.
Date: November 14–15, 2024.
Time: 9:30 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Address: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892.
Meeting Format: In Person and Virtual
Meeting.
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]]>Agencies
[Federal Register Volume 89, Number 207 (Friday, October 25, 2024)]
[Notices]
[Pages 85219-85221]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-24828]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-4777]
Pharmacy Compounding Advisory Committee; Notice of Meeting;
Establishment of a Public Docket; Request for Comments--Bulk Drug
Substances Nominated for Inclusion on the Section 503A Bulk Drug
Substances List
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; establishment of a public docket; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Pharmacy Compounding Advisory
Committee (the Committee). The general function of the Committee is to
provide advice and recommendations to FDA on regulatory issues. The
meeting will be open to the public. FDA is establishing a docket for
public comment on this document.
DATES: The meeting will be held on December 4, 2024, from 8 a.m. to 3
p.m. Eastern Time.
ADDRESSES: The meeting will be held at the FDA White Oak Campus, 10903
New Hampshire Ave., Silver Spring, MD 20993-0002. The public will also
have the option to participate, and the advisory committee meeting will
be heard, viewed, captioned, and recorded through an online
teleconferencing and/or video conferencing platform.
Answers to commonly asked questions about FDA advisory committee
meetings, including information regarding special accommodations due to
a disability, visitor parking, and transportation may be accessed at:
https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2024-N-4777. The docket will close on December
3, 2024. Please note that late, untimely filed comments will not be
considered. The https://www.regulations.gov electronic filing system
will accept comments until 11:59 p.m. Eastern Time on December 3, 2024.
Comments received by mail/hand delivery/courier (for written/paper
submissions) will be considered timely if they are received on or
before that date.
Comments received on or before November 19, 2024, will be provided
to the Committee. Comments received after that date will be taken into
consideration by FDA. In the event that the meeting is cancelled, FDA
will continue to evaluate any relevant applications or information, and
consider any comments submitted to the docket, as appropriate.
You may submit comments 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-2024-N-4777 for ``Pharmacy Compounding Advisory Committee; Notice
of Meeting; Establishment of a Public Docket; Request for Comments--
Bulk Drug Substances Nominated for Inclusion on the Section 503A Bulk
Drug Substances List.'' Received comments, those filed in a timely
manner (see ADDRESSES), 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.'' FDA 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 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 the 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
[[Page 85220]]
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.
FOR FURTHER INFORMATION CONTACT: Takyiah Stevenson, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 240-
402-2507, email: [email protected], or FDA Advisory Committee
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC
area). A notice in the Federal Register about last-minute modifications
that impact a previously announced advisory committee meeting cannot
always be published quickly enough to provide timely notice. Therefore,
you should always check FDA's website at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before the
meeting.
SUPPLEMENTARY INFORMATION:
Background: Section 503A of the Federal Food, Drug, and Cosmetic
Act (FD&C Act) (21 U.S.C. 353a) describes the conditions that must be
satisfied for human drug products compounded by a licensed pharmacist
in a State-licensed pharmacy or a Federal facility, or a licensed
physician, to be exempt from the following three sections of the FD&C
Act: (1) section 501(a)(2)(B) (21 U.S.C. 351(a)(2)(B)) (concerning
current good manufacturing practice requirements); (2) section
502(f)(1) (21 U.S.C. 352(f)(1)) (concerning the labeling of drugs with
adequate directions for use); and (3) section 505 (21 U.S.C. 355)
(concerning the approval of human drug products under new drug
applications (NDAs) or abbreviated new drug applications (ANDAs)).
One of the conditions that must be satisfied for a drug product to
qualify for the exemptions under section 503A of the FD&C Act is that
the licensed pharmacist or licensed physician compounds the drug
product using bulk drug substances (as defined in 21 CFR 207.3) that:
(1) comply with the standards of an applicable United States
Pharmacopoeia (USP) or National Formulary monograph, if a monograph
exists, and the USP chapter on pharmacy compounding; (2) if an
applicable monograph does not exist, are drug substances that are
components of drugs approved by the Secretary of Health and Human
Services (the Secretary); or (3) if such a monograph does not exist and
the drug substance is not a component of a drug approved by the
Secretary, that appear on a list developed by the Secretary through
regulations issued by the Secretary under section 503A(c) of the FD&C
Act (the 503A Bulks List) (see section 503A(b)(1)(A)(i) of the FD&C
Act).
Agenda: FDA, invited attendees, and the public will be able to
attend the meeting in-person at FDA's White Oak Campus (see ADDRESSES).
The meeting presentations will also be heard, viewed, captioned, and
recorded through an online teleconferencing and/or video conferencing
platform.
The Committee will discuss the following bulk drug substances being
considered for inclusion on the 503A Bulks List: AOD-9604-related bulk
drug substances (AOD-9604 acetate, and AOD-9604 (free base)), CJC-1295-
related bulk drug substances (CJC-1295 (free base), CJC-1295 acetate,
CJC-1295 with drug affinity complex (DAC) (free base), CJC-1295 DAC
acetate, and CJC-1295 DAC trifluoroacetate)), and Thymosin alpha-1-
related bulk drug substances (Thymosin alpha-1 acetate, and Thymosin
alpha-1 (free base)). The chart below identifies the use(s) FDA
reviewed for each of the bulk drug substances being discussed at this
advisory committee meeting. For nominated bulk drug substances, the
nominators of these substances will be invited to make a short
presentation supporting the nomination.
------------------------------------------------------------------------
Bulk drug substance Uses evaluated
------------------------------------------------------------------------
AOD-9604 (free base).............. *Obesity.
AOD-9604 Acetate..................
CJC-1295 (free base).............. Growth hormone deficiency.
CJC-1295 Acetate..................
CJC-1295 DAC (free base)..........
CJC-1295 DAC Acetate..............
CJC-1295 DAC Trifluoroacetate.....
Thymosin alpha-1(free base)....... Hepatitis B.
Thymosin alpha-1 Acetate.......... Hepatitis C.
Human immunodeficiency virus (HIV).
Coronavirus disease 2019 (COVID-19).
Depressed response to vaccinations;
adjuvant to flu vaccines.
Malignant melanoma.
Hepatocellular carcinoma (HCC).
Non-small cell lung cancer (NSCLC).
Sepsis.
Infections after hematopoietic stem
cell transplantation (HSCT).
Chronic obstructive pulmonary
disease (COPD).
Myalgic encephalomyelitis and
chronic fatigue syndrome (ME/CFS).
------------------------------------------------------------------------
FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its website prior to the meeting, the
background material will be made publicly available on FDA's website at
the time of the advisory committee meeting. Background material and the
link to the online teleconference and/or video conference meeting will
be available at the location of the advisory committee meeting and at
https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll
down to the appropriate advisory committee meeting link. The meeting
will include slide
[[Page 85221]]
presentations with audio and video components to allow the presentation
of materials for online participants in a manner that most closely
resembles an in-person advisory committee meeting.
Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the Committee.
All electronic and written submissions to the Docket (see ADDRESSES) on
or before November 19, 2024, will be provided to the Committee. Oral
presentations from the public will be scheduled following FDA
presentations. FDA has allotted approximately 1 hour for open public
hearing presentations, which will be split to allow for public remarks
on each substance. The sessions will begin at approximately 9:35 a.m.,
10:50 a.m., and 1:40 p.m. Those individuals interested in making formal
oral presentations should notify the contact person and submit a brief
statement of the general nature of the evidence or arguments they wish
to present, the names and addresses of proposed participants, whether
they would like to present online or in-person, and an indication of
the approximate amount of time requested to make their presentation on
or before November 8, 2024. Time allotted for each presentation may be
limited. If the number of registrants requesting to speak is greater
than can be reasonably accommodated during the scheduled open public
hearing session, FDA may conduct a lottery to determine the speakers
for the scheduled open public hearing session. FDA may also extend the
time scheduled for open public hearing presentations depending on
interest. Similarly, room for interested persons to participate in-
person may be limited. If the number of registrants requesting to speak
in-person during the open public hearing is greater than can be
reasonably accommodated in the venue for the in-person portion of the
advisory committee meeting, FDA may conduct a lottery to determine the
speakers who will be invited to participate in-person. The contact
person will notify interested persons regarding their request to speak
and the timeframe for the presentation by November 12, 2024. Persons
attending FDA's advisory committee meetings are advised that FDA is not
responsible for providing access to electrical outlets.
For press inquiries, please contact the Office of Media Affairs at
[email protected] or 301-796-4540.
FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact Takyiah Stevenson (see FOR FURTHER INFORMATION CONTACT) at
least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. 1001 et seq.). This meeting notice also serves
as notice that, pursuant to 21 CFR 10.19, the requirements in 21 CFR
14.22(b), (f), and (g) relating to the location of advisory committee
meetings are hereby waived to allow for this meeting to take place
using an online meeting platform in conjunction with the physical
meeting room (see location). This waiver is in the interest of allowing
greater transparency and opportunities for public participation, in
addition to convenience for advisory committee members, speakers, and
guest speakers. The conditions for issuance of a waiver under 21 CFR
10.19 are met.
Dated: October 21, 2024.
Eric Flamm,
Acting Associate Commissioner for Policy.
[FR Doc. 2024-24828 Filed 10-24-24; 8:45 am]
BILLING CODE 4164-01-P
