Request for Nominations From Industry Organizations Interested in Participating in the Selection Process for Nonvoting Industry Representatives and Request for Nominations for Nonvoting Industry Representatives on the Blood Products Advisory Committee, 16266-16267 [2023-05358]
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Federal Register / Vol. 88, No. 51 / Thursday, March 16, 2023 / Notices
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 relating
to investigational new drug applications
have been approved under OMB control
number 0910–0014. The collections of
information in 21 CFR part 314 relating
to new drug applications have been
approved under OMB control number
0910–0001. The collections of
information in 21 CFR part 201 relating
to prescription product labeling
requirements have been approved under
OMB control number 0910–0572.
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may obtain the draft guidance at https://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: March 13, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–05396 Filed 3–15–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2020–N–0026]
Issuance of Priority Review Voucher;
Rare Pediatric Disease Product
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
issuance of a priority review voucher to
the sponsor of a rare pediatric disease
product application. The Federal Food,
Drug, and Cosmetic Act (FD&C Act), as
amended by the Food and Drug
Administration Safety and Innovation
Act (FDASIA), authorizes FDA to award
priority review vouchers to sponsors of
approved rare pediatric disease product
applications that meet certain criteria.
FDA is required to publish notice of the
award of the priority review voucher.
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
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19:10 Mar 15, 2023
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FDA is
announcing the issuance of a priority
review voucher to the sponsor of an
approved rare pediatric disease product
application. Under section 529 of the
FD&C Act (21 U.S.C. 360ff), which was
added by FDASIA, FDA will award
priority review vouchers to sponsors of
approved rare pediatric disease product
applications that meet certain criteria.
FDA has determined that SKYCLARYS
(omaveloxolone), manufactured by
Reata Pharmaceuticals, Inc., meets the
criteria for a priority review voucher.
SKYCLARYS (omaveloxolone)
capsule is for the treatment of
Friedreich’s ataxia in adults and
adolescents aged 16 years and older.
For further information about the Rare
Pediatric Disease Priority Review
Voucher Program and for a link to the
full text of section 529 of the FD&C Act,
go to https://www.fda.gov/ForIndustry/
DevelopingProductsforRareDiseases
Conditions/RarePediatricDiseasePriority
VoucherProgram/default.htm. For
further information about SKYCLARYS
(omaveloxolone), go to the ‘‘Drugs@
FDA’’ website at https://
www.accessdata.fda.gov/scripts/cder/
daf/.
SUPPLEMENTARY INFORMATION:
Dated: March 13, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
Food and Drug Administration
AGENCY:
FDA has determined that SKYCLARYS
(omaveloxolone), approved February 28,
2023, and manufactured by Reata
Pharmaceuticals, Inc., meets the criteria
for a priority review voucher.
FOR FURTHER INFORMATION CONTACT:
Cathryn Lee, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
301–796–1394, email: Cathryn.Lee@
fda.hhs.gov.
[FR Doc. 2023–05364 Filed 3–15–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–0008]
Request for Nominations From
Industry Organizations Interested in
Participating in the Selection Process
for Nonvoting Industry
Representatives and Request for
Nominations for Nonvoting Industry
Representatives on the Blood
Products Advisory Committee
AGENCY:
Food and Drug Administration,
HHS.
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
requesting that any industry
organizations interested in participating
in the selection of a nonvoting industry
representative to serve on the Blood
Products Advisory Committee (BPAC)
for the Center for Biologics Evaluation
and Research notify FDA in writing.
FDA is also requesting nominations for
a nonvoting industry representative(s) to
serve on the BPAC. A nominee may
either be self-nominated or nominated
by an organization to serve as a
nonvoting industry representative.
Nominations will be accepted for
current vacancies effective with this
notice.
DATES: Any industry organization
interested in participating in the
selection of an appropriate nonvoting
member to represent industry interests
must send a letter stating that interest to
FDA by April 17, 2023 (see sections I
and II of this document for further
details). Concurrently, nomination
materials for prospective candidates
should be sent to FDA by April 17,
2023.
ADDRESSES: All statements of interest
from industry organizations interested
in participating in the selection process
of nonvoting industry representative
nominations should be sent via email to
Christina Vert (see FOR FURTHER
INFORMATION CONTACT). All nominations
for nonvoting industry representatives
must be submitted electronically by
accessing the FDA Advisory Committee
Membership Nomination Portal at:
https://www.accessdata.fda.gov/scripts/
FACTRSPortal/FACTRS/index.cfm.
Information about becoming a member
of an FDA advisory committee can also
be obtained by visiting FDA’s website
at: https://www.fda.gov/
AdvisoryCommittees/default.htm.
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:
CBERBPAC@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The
Agency intends to add a nonvoting
industry representative(s) to the
following advisory committee:
SUMMARY:
I. Blood Products Advisory Committee
BPAC reviews and evaluates available
data concerning the safety,
effectiveness, and appropriate use of
blood products derived from blood and
serum or biotechnology that are
E:\FR\FM\16MRN1.SGM
16MRN1
Federal Register / Vol. 88, No. 51 / Thursday, March 16, 2023 / Notices
intended for use in the diagnosis,
prevention, or treatment of human
diseases, and, as required, any other
product for which FDA has regulatory
responsibility. BPAC also advises the
Commissioner of Food and Drugs (the
Commissioner) of its findings regarding
screening and testing (to determine
eligibility) of donors and labeling of the
products, on clinical and laboratory
studies involving such products, on the
affirmation or revocation of biological
products licenses, and on the quality
and relevance of FDA’s research
program that provides the scientific
support for regulating these agents.
BPAC will function at times as a
medical device panel under the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) Medical Device Amendments of
1976. As such, BPAC recommends
classification of devices subject to its
review into regulatory categories,
recommends the assignment of a
priority for the application of regulatory
requirements for devices classified in
the standards or premarket approval
category, advises on formulation of
product development protocols and
reviews premarket approval
applications for those devices to
recommend changes in classification as
appropriate, recommends exemption of
certain devices from the application of
portions of the FD&C Act, advises on the
necessity to ban a device, and responds
to requests from the Agency to review
and make recommendations on specific
issues or problems concerning the safety
and effectiveness of devices.
ddrumheller on DSK120RN23PROD with NOTICES1
II. Selection Procedure
Any industry organization interested
in participating in the selection of an
appropriate nonvoting member to
represent industry interests should send
a letter via email stating that interest to
the FDA contact (see FOR FURTHER
INFORMATION CONTACT) within 30 days of
publication of this document (see
DATES). Within the subsequent 30 days,
FDA will send a notification to each
organization that has expressed an
interest, attaching a complete list of all
such organizations; and a list of all
nominees along with their current
re´sume´s. The letter will also state that
it is the responsibility of the interested
organizations to confer with one another
and to select a candidate, within 60
days after the receipt of the FDA letter,
to serve as the nonvoting member to
represent industry interests for the
committee. The interested organizations
are not bound by the list of nominees in
selecting a candidate. However, if no
individual is selected within 60 days,
the Commissioner will select the
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19:10 Mar 15, 2023
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nonvoting member to represent industry
interests.
III. Application Procedure
Individuals may self-nominate, and/or
an organization may nominate one or
more individuals to serve as a nonvoting
industry representative. Nomination
must include a current, complete
re´sume´ or curriculum vitae for each
nominee, including current business
address and telephone number, email
address if available, and a signed copy
of the Acknowledgement and Consent
form available at the FDA Advisory
Committee Membership Nomination
Portal (see ADDRESSES) within 30 days of
publication of this document (see
DATES). Nominations must also specify
the advisory committee for which the
nominee is recommended. Nominations
must also acknowledge that the
nominee is aware of the nomination
unless self-nominated. FDA will
forward all nominations to the
organizations expressing interest in
participating in the selection process for
the committee. Persons who nominate
themselves as nonvoting industry
representatives will not participate in
the selection process.
FDA seeks to include the views of
women and men, members of all racial
and ethnic groups, and individuals with
and without disabilities on its advisory
committees and, therefore, encourages
nominations of appropriately qualified
candidates from these groups.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to advisory committees.
16267
Support of New Animal Drug
Approvals.’’ This guidance replaces
existing guidance #106, ‘‘The Use of
Published Literature in Support of New
Animal Drug Approvals,’’ which FDA
published in August 2000. It addressed
the use of a single scientific article to
support drug approval. This revision of
the guidance document considers
multiple uses of the scientific literature,
including narrative reviews, systematic
reviews, and meta-analyses to support
approval of a new animal drug.
DATES: The announcement of the
guidance is published in the Federal
Register on March 16, 2023.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
Electronic Submissions
Food and Drug Administration
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’’).
[Docket No. FDA–2021–D–1155]
Written/Paper Submissions
Dated: March 13, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–05358 Filed 3–15–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
The Use of Published Literature in
Support of New Animal Drug
Approvals; Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA, Agency, or we) is
announcing the availability of a final
guidance for industry #106 entitled
‘‘The Use of Published Literature in
SUMMARY:
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
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.’’
E:\FR\FM\16MRN1.SGM
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]]>Agencies
[Federal Register Volume 88, Number 51 (Thursday, March 16, 2023)]
[Notices]
[Pages 16266-16267]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-05358]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-0008]
Request for Nominations From Industry Organizations Interested in
Participating in the Selection Process for Nonvoting Industry
Representatives and Request for Nominations for Nonvoting Industry
Representatives on the Blood Products Advisory Committee
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is requesting
that any industry organizations interested in participating in the
selection of a nonvoting industry representative to serve on the Blood
Products Advisory Committee (BPAC) for the Center for Biologics
Evaluation and Research notify FDA in writing. FDA is also requesting
nominations for a nonvoting industry representative(s) to serve on the
BPAC. A nominee may either be self-nominated or nominated by an
organization to serve as a nonvoting industry representative.
Nominations will be accepted for current vacancies effective with this
notice.
DATES: Any industry organization interested in participating in the
selection of an appropriate nonvoting member to represent industry
interests must send a letter stating that interest to FDA by April 17,
2023 (see sections I and II of this document for further details).
Concurrently, nomination materials for prospective candidates should be
sent to FDA by April 17, 2023.
ADDRESSES: All statements of interest from industry organizations
interested in participating in the selection process of nonvoting
industry representative nominations should be sent via email to
Christina Vert (see FOR FURTHER INFORMATION CONTACT). All nominations
for nonvoting industry representatives must be submitted electronically
by accessing the FDA Advisory Committee Membership Nomination Portal
at: https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm. Information about becoming a member of an FDA advisory
committee can also be obtained by visiting FDA's website at: https://www.fda.gov/AdvisoryCommittees/default.htm.
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: [email protected].
SUPPLEMENTARY INFORMATION: The Agency intends to add a nonvoting
industry representative(s) to the following advisory committee:
I. Blood Products Advisory Committee
BPAC reviews and evaluates available data concerning the safety,
effectiveness, and appropriate use of blood products derived from blood
and serum or biotechnology that are
[[Page 16267]]
intended for use in the diagnosis, prevention, or treatment of human
diseases, and, as required, any other product for which FDA has
regulatory responsibility. BPAC also advises the Commissioner of Food
and Drugs (the Commissioner) of its findings regarding screening and
testing (to determine eligibility) of donors and labeling of the
products, on clinical and laboratory studies involving such products,
on the affirmation or revocation of biological products licenses, and
on the quality and relevance of FDA's research program that provides
the scientific support for regulating these agents.
BPAC will function at times as a medical device panel under the
Federal Food, Drug, and Cosmetic Act (FD&C Act) Medical Device
Amendments of 1976. As such, BPAC recommends classification of devices
subject to its review into regulatory categories, recommends the
assignment of a priority for the application of regulatory requirements
for devices classified in the standards or premarket approval category,
advises on formulation of product development protocols and reviews
premarket approval applications for those devices to recommend changes
in classification as appropriate, recommends exemption of certain
devices from the application of portions of the FD&C Act, advises on
the necessity to ban a device, and responds to requests from the Agency
to review and make recommendations on specific issues or problems
concerning the safety and effectiveness of devices.
II. Selection Procedure
Any industry organization interested in participating in the
selection of an appropriate nonvoting member to represent industry
interests should send a letter via email stating that interest to the
FDA contact (see FOR FURTHER INFORMATION CONTACT) within 30 days of
publication of this document (see DATES). Within the subsequent 30
days, FDA will send a notification to each organization that has
expressed an interest, attaching a complete list of all such
organizations; and a list of all nominees along with their current
r[eacute]sum[eacute]s. The letter will also state that it is the
responsibility of the interested organizations to confer with one
another and to select a candidate, within 60 days after the receipt of
the FDA letter, to serve as the nonvoting member to represent industry
interests for the committee. The interested organizations are not bound
by the list of nominees in selecting a candidate. However, if no
individual is selected within 60 days, the Commissioner will select the
nonvoting member to represent industry interests.
III. Application Procedure
Individuals may self-nominate, and/or an organization may nominate
one or more individuals to serve as a nonvoting industry
representative. Nomination must include a current, complete
r[eacute]sum[eacute] or curriculum vitae for each nominee, including
current business address and telephone number, email address if
available, and a signed copy of the Acknowledgement and Consent form
available at the FDA Advisory Committee Membership Nomination Portal
(see ADDRESSES) within 30 days of publication of this document (see
DATES). Nominations must also specify the advisory committee for which
the nominee is recommended. Nominations must also acknowledge that the
nominee is aware of the nomination unless self-nominated. FDA will
forward all nominations to the organizations expressing interest in
participating in the selection process for the committee. Persons who
nominate themselves as nonvoting industry representatives will not
participate in the selection process.
FDA seeks to include the views of women and men, members of all
racial and ethnic groups, and individuals with and without disabilities
on its advisory committees and, therefore, encourages nominations of
appropriately qualified candidates from these groups.
This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.
Dated: March 13, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-05358 Filed 3-15-23; 8:45 am]
BILLING CODE 4164-01-P
