[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]
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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.
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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.
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Bulk drug substance Uses evaluated
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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).
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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]
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