Blood Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments, 13128-13130 [2023-04270]

Download as PDF ddrumheller on DSK120RN23PROD with NOTICES1 13128 Federal Register / Vol. 88, No. 41 / Thursday, March 2, 2023 / Notices viral entry, and/or elicit Fc-mediated effector function and are subject to licensure under section 351(a) or section 351(k) of the Public Health Service Act (PHS Act) (42 U.S.C. 262(a) or (k)). This draft guidance does not apply to immunomodulatory drugs (e.g., cytokines or cytokine antagonists), vaccines, hyperimmune globulins, gene therapies, cell therapies, and convalescent plasma. The draft guidance describes approaches that sponsors should use to develop potency assay methods for release and stability that assess comprehensively known or potential mechanism(s) of action of the product. The sensitivity of these methods must be established, for example, to conduct the appropriate laboratory determination of satisfactory conformance to final specifications for the drug product (i.e., demonstrate lotto-lot consistency). In addition to release and stability methods, other methods that demonstrate the biological function(s) of the product may be needed for characterization and comparability studies. The draft guidance describes methods that sponsors should use to ensure the potency of mAbs and other therapeutic proteins proposed to prevent or treat a viral infection. In January 2021, FDA published the guidance for industry entitled ‘‘COVID– 19: Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting SARS– CoV–2 Infectivity’’ (available at https:// www.fda.gov/media/145128/download) to support public health efforts following a declaration, under section 319 of the PHS Act (42 U.S.C. 247d), by the Secretary of Health and Human Services of a public health emergency related to Coronavirus Disease 2019 (the disease caused by SARS–CoV–2) (section 319 public health emergency). The 2021 guidance focuses solely on addressing potency assays as they relate to mAbs and other therapeutic proteins that directly target SARS–CoV–2, and it is intended to remain in effect only for the duration of the section 319 public health emergency related to Coronavirus Disease 2019. However, FDA believes that many of the recommendations set forth in the 2021 guidance are applicable outside the context of the section 319 public health emergency and are applicable to mAbs and other therapeutic proteins directly targeting any viral surface (glyco)proteins mediating pathogenic mechanisms of infection, not just those that directly target SARS–CoV–2. FDA is, therefore, issuing this draft guidance. In preparing this guidance, FDA considered VerDate Sep<11>2014 18:21 Mar 01, 2023 Jkt 259001 comments received regarding the 2021 guidance as well as the Agency’s experience with SARS–CoV–2 and other viruses. This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on ‘‘Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting Viral Pathogens.’’ 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 312 for submission of an investigational new drug application have been approved under OMB control number 0910–0014. The collections of information in 21 CFR part 314 for new drug applications have been approved under OMB control number 0910–0001. The collections of information in 21 CFR parts 601 and 610 pertaining to biologics license applications have been approved under OMB control number 0910–0338. The collections of information in 21 CFR parts 210 and 211 pertaining to current good manufacturing practices have been approved under OMB control number 0910–0139. The collections of information in 21 CFR part 11 pertaining to electronic records and signatures have been approved under OMB control number 0910–0303. III. Electronic Access Persons with access to the internet may obtain the draft guidance 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: February 27, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023–04267 Filed 3–1–23; 8:45 am] BILLING CODE 4164–01–P PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2023–N–0517] Blood Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments 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 Blood Products Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA’s regulatory issues related to blood and products derived from blood. At least one portion of the meeting will be closed to the public. FDA is establishing a docket for public comment on this document. SUMMARY: The meeting will be held virtually on April 26, 2023, from 9:30 a.m. to 1 p.m. Eastern Time. ADDRESSES: Please note that due to the impact of the COVID–19 pandemic, all meeting participants will be joining this advisory committee meeting via an online teleconferencing platform. Answers to commonly asked questions about FDA advisory committee meetings may be accessed at: https:// www.fda.gov/AdvisoryCommittees/ AboutAdvisoryCommittees/ ucm408555.htm. The online web conference meeting will be available at the following link on the day of the meeting: https:// youtube.com/live/avlyUZDDfCQ? feature=share. FDA is establishing a docket for public comment on this meeting. The docket number is FDA–2023–N–0517. Please note that late, untimely filed comments will not be considered. The docket will close on April 25, 2023. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of April 25, 2023. 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 April 19, 2023, 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 canceled, FDA will continue to evaluate any relevant DATES: E:\FR\FM\02MRN1.SGM 02MRN1 Federal Register / Vol. 88, No. 41 / Thursday, March 2, 2023 / Notices 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’’). ddrumheller on DSK120RN23PROD with NOTICES1 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– 2023–N–0517 for ‘‘Blood Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments.’’ 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. VerDate Sep<11>2014 18:21 Mar 01, 2023 Jkt 259001 • 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 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: Christina Vert or Marie DeGregorio, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 1244, Silver Spring, MD 20993–0002, 240–402–8054, CBERBPAC@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 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 13129 advisory committee information line to learn about possible modifications before joining the meeting. SUPPLEMENTARY INFORMATION: Agenda: The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. On April 26, 2023, the committee will meet in open session to hear an overview of the research programs in the Division of Hemostasis, Office of Plasma Protein Therapeutics Chemistry, Manufacturing, and Controls, Office of Therapeutic Products, Center for Biologics Evaluation and Research. After the open session, the meeting will be closed to the public for committee deliberations. 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 meeting room will be available at https://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee meeting link. The meeting will include slide presentations with audio components to allow the presentation of materials in a manner that most closely resembles an in-person advisory committee meeting. Procedure: On April 26, 2023, from 9:30 a.m. to 12:05 p.m. Eastern Time, the meeting is open to the public. 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 April 19, 2023, will be provided to the committee. Oral presentations from the public will be scheduled between approximately 11:05 a.m. and 12:05 p.m. Eastern Time. 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, and an indication of the approximate time requested to make their presentation on or before April 11, 2023. 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 E:\FR\FM\02MRN1.SGM 02MRN1 13130 Federal Register / Vol. 88, No. 41 / Thursday, March 2, 2023 / Notices hearing session. The contact person will notify interested persons regarding their request to speak by April 12, 2023. Closed Committee Deliberations: On April 26, 2023, from 12:05 p.m. to 1 p.m. Eastern Time, the meeting will be closed to permit discussion where disclosure would constitute a clearly unwarranted invasion of personal privacy (5 U.S.C. 552b(c)(6)). The recommendations of the advisory committee regarding the progress of the individual investigators’ research programs, along with other information, will be discussed during this session. We believe that public discussion of these recommendations on individual scientists would constitute an unwarranted invasion of personal privacy. 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 disability, please contact Christina Vert or Marie DeGregorio at CBERBPAC@ fda.hhs.gov (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/AboutAdvisory Committees/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. app. 2). Dated: February 24, 2023. Lauren K. Roth, Associate Commissioner for Policy. BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ddrumheller on DSK120RN23PROD with NOTICES1 [Docket No. FDA–2023–N–0094] Joint Meeting of the Nonprescription Drugs Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee; Cancellation Food and Drug Administration, HHS. ACTION: Notice. The meeting of the Nonprescription Drugs Advisory SUMMARY: VerDate Sep<11>2014 18:21 Mar 01, 2023 Jkt 259001 Dated: February 27, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023–04271 Filed 3–1–23; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Be The Match® Patient Support Center Survey Health Resources and Services Administration (HRSA), Department of Health and Human Services. ACTION: Notice. AGENCY: In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR. DATES: Comments on this ICR should be received no later than May 1, 2023. ADDRESSES: Submit your comments to paperwork@hrsa.gov or by mail at: HRSA Information Collection Clearance Officer, Room 14N39, 5600 Fishers Lane, Rockville, MD 20857. FOR FURTHER INFORMATION CONTACT: To request more information on the SUMMARY: [FR Doc. 2023–04270 Filed 3–1–23; 8:45 am] AGENCY: Committee and the Anesthetic and Analgesic Drug Products Advisory Committee scheduled for March 20, 2023, is cancelled. This meeting was announced in the Federal Register of January 30, 2023. The meeting is no longer needed. FOR FURTHER INFORMATION CONTACT: Moon Choi, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993–0002, 301–796–2894, email: NDAC@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800– 741–8138 (301–443–0572 in the Washington, DC area), and follow the prompts to the desired center or product area. Please call the Information Line for up-to-date information on this meeting, which was announced in the Federal Register of January 30, 2023 (88 FR 5893). PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 proposed project or to obtain a copy of the data collection plans and draft instruments, email paperwork@hrsa.gov or call Samantha Miller, the HRSA Information Collection Clearance Officer, at (301) 443–1984. SUPPLEMENTARY INFORMATION: When submitting comments or requesting information, please include the ICR title for reference. Information Collection Request Title: Be The Match® Patient Support Center Survey, OMB No. 0906–0004–Revision. Abstract: The C.W. Bill Young Cell Transplantation Program was established by the Stem Cell Therapeutic and Research Act of 2005 (Public Law [Pub. L.] 109–129) and was reauthorized in 2010 (Pub. L. 111–264), 2015 (Pub. L. 114–104) and again in 2021 (Pub. L. 117–15). The C.W. Bill Young Cell Transplantation Program’s Office of Patient Advocacy (OPA) is operated by the National Marrow Donor Program® (NMDP). Through OPA, NMDP provides navigation services, education resources and support to people in need of or who have received an allogeneic hematopoietic cell transplant (HCT). As the contractor for the OPA, NMDP is required to conduct surveys to evaluate patient satisfaction with the services provided. As such, NMDP will elicit feedback from HCT patients, caregivers, and family members who had contact with the NMDP/Be The Match® Patient Support Center (PSC) for service and support. The survey is administered through a web-based system. In addition to questions that measure satisfaction, the survey also includes demographic questions to determine representativeness of findings. Need and Proposed Use of the Information: HCT is a complex medical procedure that requires significant support before, during and after the procedure. Many patients experience barriers that impede access to HCT. Barriers to HCT-related care and educational information are multifactorial. The NMDP/Be The Match PSC offers many programs and services to support patients, caregivers, and family members throughout their HCT journey. Feedback from recipients of NMDP services is essential to understand the changing needs for services and information as well as to demonstrate the effectiveness of existing services. The primary use for information gathered through the survey is to determine the helpfulness of participants’ initial contact with the PSC patient navigators and to identify areas for improvement in the delivery of services. Patient navigators are trained E:\FR\FM\02MRN1.SGM 02MRN1

Agencies

[Federal Register Volume 88, Number 41 (Thursday, March 2, 2023)]
[Notices]
[Pages 13128-13130]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-04270]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-0517]


Blood Products Advisory Committee; Notice of Meeting; 
Establishment of a Public Docket; Request for Comments

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 Blood Products Advisory 
Committee. The general function of the committee is to provide advice 
and recommendations to the Agency on FDA's regulatory issues related to 
blood and products derived from blood. At least one portion of the 
meeting will be closed to the public. FDA is establishing a docket for 
public comment on this document.

DATES: The meeting will be held virtually on April 26, 2023, from 9:30 
a.m. to 1 p.m. Eastern Time.

ADDRESSES: Please note that due to the impact of the COVID-19 pandemic, 
all meeting participants will be joining this advisory committee 
meeting via an online teleconferencing platform. Answers to commonly 
asked questions about FDA advisory committee meetings may be accessed 
at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    The online web conference meeting will be available at the 
following link on the day of the meeting: https://youtube.com/live/avlyUZDDfCQ?feature=share.
    FDA is establishing a docket for public comment on this meeting. 
The docket number is FDA-2023-N-0517. Please note that late, untimely 
filed comments will not be considered. The docket will close on April 
25, 2023. The https://www.regulations.gov electronic filing system will 
accept comments until 11:59 p.m. Eastern Time at the end of April 25, 
2023. 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 April 19, 2023, 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 canceled, FDA 
will continue to evaluate any relevant

[[Page 13129]]

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-2023-N-0517 for ``Blood Products Advisory Committee; Notice of 
Meeting; Establishment of a Public Docket; Request for Comments.'' 
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 
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: Christina Vert or Marie DeGregorio, 
Center for Biologics Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 1244, Silver 
Spring, MD 20993-0002, 240-402-8054, [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 
joining the meeting.

SUPPLEMENTARY INFORMATION: 
    Agenda: The meeting presentations will be heard, viewed, captioned, 
and recorded through an online teleconferencing platform. On April 26, 
2023, the committee will meet in open session to hear an overview of 
the research programs in the Division of Hemostasis, Office of Plasma 
Protein Therapeutics Chemistry, Manufacturing, and Controls, Office of 
Therapeutic Products, Center for Biologics Evaluation and Research. 
After the open session, the meeting will be closed to the public for 
committee deliberations.
    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 meeting room will be available at 
https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll 
down to the appropriate advisory committee meeting link. The meeting 
will include slide presentations with audio components to allow the 
presentation of materials in a manner that most closely resembles an 
in-person advisory committee meeting.
    Procedure: On April 26, 2023, from 9:30 a.m. to 12:05 p.m. Eastern 
Time, the meeting is open to the public. 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 April 19, 2023, will be provided to 
the committee. Oral presentations from the public will be scheduled 
between approximately 11:05 a.m. and 12:05 p.m. Eastern Time. 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, and an indication of the 
approximate time requested to make their presentation on or before 
April 11, 2023. 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

[[Page 13130]]

hearing session. The contact person will notify interested persons 
regarding their request to speak by April 12, 2023.
    Closed Committee Deliberations: On April 26, 2023, from 12:05 p.m. 
to 1 p.m. Eastern Time, the meeting will be closed to permit discussion 
where disclosure would constitute a clearly unwarranted invasion of 
personal privacy (5 U.S.C. 552b(c)(6)). The recommendations of the 
advisory committee regarding the progress of the individual 
investigators' research programs, along with other information, will be 
discussed during this session. We believe that public discussion of 
these recommendations on individual scientists would constitute an 
unwarranted invasion of personal privacy.
    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 Christina Vert or Marie DeGregorio at [email protected] (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. app. 2).

    Dated: February 24, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-04270 Filed 3-1-23; 8:45 am]
BILLING CODE 4164-01-P

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