Issuance of Priority Review Voucher; Rare Pediatric Disease Product, 57217-57218 [2020-20320]
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Federal Register / Vol. 85, No. 179 / Tuesday, September 15, 2020 / Notices
services to most efficiently and
effectively serve the needs of lowincome children and their families. ACF
aims to understand strategies used to
support partnerships, including the
federal barriers to agency collaboration.
In support of achieving these goals, the
study team is conducting ‘‘virtual site
visits’’ with six programs that offer
coordinated services. The study team
will gather information through
interviews with program staff members,
such as agency leaders or frontline staff,
and focus groups with parents.
Data collection activities will include
up to six program ‘‘virtual site visits.’’
‘‘Virtual site visits’’ include semistructured interviews with up to 30 total
staff at each site and focus groups with
8–10 parents at each site. Semistructured interviews with program and
partner staff will obtain in-depth
information about the goals and
objectives of programs, the services
provided, how the coordinated services
are implemented, how staffing is
managed, data use, and any facilitators
and barriers to coordination. Focus
groups with parents participating in the
program will provide the opportunity to
learn about how parents perceive the
program; how it meets their needs; what
benefits they gain from the program; and
how they enroll, participate, and
progress through the program.
Respondents: Lead program and
partner program staff members working
in six programs across the United States
that coordinate early care and education
services with family economic security
services and/or other health and human
services, as well as parents receiving
services from these programs. Staff
respondents will be selected with the
goal of having staff represent each level
of the organization. Parents who have
participated in the program for at least
6 months and who receive early
childhood services and at least one
other program service will be invited to
participate in focus groups.
ANNUAL BURDEN ESTIMATES
Total/annual
number of
respondents
Instrument
Master Virtual Site Visit Interview Protocol .....................................................
Parent Virtual Focus Group Protocol ...............................................................
Authority: 42 U.S.C. 9858(a)(5).
John M. Sweet, Jr.,
ACF/OPRE Certifying Officer.
[FR Doc. 2020–20266 Filed 9–14–20; 8:45 am]
BILLING CODE 4184–23–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–1153]
Post-Marketing Pediatric-Focused
Product Safety Reviews;
Establishment of a Public Docket;
Request for Comments; Correction
Food and Drug Administration,
Health and Human Services (HHS).
ACTION: Notice; correction.
AGENCY:
The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register of September 2, 2020. The
document announced the availability of
post-marketing pediatric-focused safety
reviews of products posted between
September 23, 2019, and September 1,
2020, on FDA’s website but not
presented at the September 15, 2020,
Pediatric Advisory Committee meeting.
The document was published with the
incorrect product name for one of the
post-marketing pediatric-focused safety
reviews listed under Center for
jbell on DSKJLSW7X2PROD with NOTICES
SUMMARY:
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180
60
Biologics Evaluation and Research. This
document corrects that error.
FOR FURTHER INFORMATION CONTACT:
Marieann Brill, Office of the
Commissioner, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5154, Silver Spring,
MD 20993, 240–402–3838.
SUPPLEMENTARY INFORMATION:
Estimated Total Annual Burden
Hours: 420.
Correction
In the Federal Register of September
2, 2020 (85 FR 54580), appearing on
page 54580 in FR Doc. 2020–19835, the
following correction is made:
On page 54581, in the first column,
under Center for Biologics Evaluation
and Research, ‘‘9. QPAN H5N1 Vaccine
(Influenza A (H5N1) virus monovalent
vaccine, adjuvanted)’’ is corrected to
read ‘‘9. Influenza A (H5N1) Virus
Monovalent Vaccine, Adjuvanted.’’
Dated: September 9, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–20329 Filed 9–14–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–0026]
Issuance of Priority Review Voucher;
Rare Pediatric Disease Product
Food and Drug Administration,
Health and Human Services (HHS).
AGENCY:
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Number of
responses per
respondent
Average
burden hours
per response
1
1
ACTION:
2
1
Annual
burden hours
360
60
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.
FDA has determined that TRIKAFTA
(elexacaftor/tezacaftor/ivacaftor),
manufactured by Vertex
Pharmaceutical, Inc., meets the criteria
for a priority review voucher.
FOR FURTHER INFORMATION CONTACT:
Althea Cuff, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
301–796–4061, Fax: 301–796–9856,
email: althea.cuff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: 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 TRIKAFTA
(elexacaftor/tezacaftor/ivacaftor),
SUMMARY:
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57218
Federal Register / Vol. 85, No. 179 / Tuesday, September 15, 2020 / Notices
manufactured by Vertex
Pharmaceutical, Inc., meets the criteria
for a priority review voucher.
TRIKAFTA (elexacaftor/tezacaftor/
ivacaftor) is indicated for the treatment
of patients with cystic fibrosis aged 12
years and older who have at least one
F508del mutation in the cystic fibrosis
transmembrane conductance regulator
gene.
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 TRIKAFTA
(elexacaftor/tezacaftor/ivacaftor), go to
the ‘‘Drugs@FDA’’ website at https://
www.accessdata.fda.gov/scripts/cder/
daf/.
Dated: September 9, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–20320 Filed 9–14–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–D–2936]
Recognition and Withdrawal of
Voluntary Consensus Standards;
Guidance for Industry and Food and
Drug Administration Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance entitled ‘‘Recognition and
Withdrawal of Voluntary Consensus
Standards; Guidance for Industry and
Food and Drug Administration Staff.’’
This guidance identifies the principles
FDA uses for recognizing a standard,
and it explains the extent of recognition
and other supplementary information. It
provides information on how you may
request recognition as well as
circumstances under which FDA may
withdraw recognition. This guidance
also responds to a provision of the 21st
Century Cures Act (Cures Act) by
updating published guidance on these
topics.
jbell on DSKJLSW7X2PROD with NOTICES
SUMMARY:
The announcement of the
guidance is published in the Federal
Register on September 15, 2020.
DATES:
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You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
ADDRESSES:
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Submit electronic comments in the
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Comments submitted electronically,
including attachments, to https://
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Submit written/paper submissions as
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2018–D–2936 for ‘‘Recognition and
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Received comments will be placed in
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• Confidential Submissions—To
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made publicly available, submit your
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Agency will review this copy, including
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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
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Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
You may submit comments on any
guidance at any time (see 21 CFR
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An electronic copy of the guidance
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SUPPLEMENTARY INFORMATION section for
information on electronic access to the
guidance. Submit written requests for a
single hard copy of the guidance
document entitled ‘‘Recognition and
Withdrawal of Voluntary Consensus
Standards; Guidance for Industry and
Food and Drug Administration Staff’’ to
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Ave., Bldg. 66, Rm. 5431, Silver Spring,
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office in processing your request.
FOR FURTHER INFORMATION CONTACT:
Scott Colburn, Center for Devices and
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[Federal Register Volume 85, Number 179 (Tuesday, September 15, 2020)]
[Notices]
[Pages 57217-57218]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-20320]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-0026]
Issuance of Priority Review Voucher; Rare Pediatric Disease
Product
AGENCY: Food and Drug Administration, Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: 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. FDA has determined
that TRIKAFTA (elexacaftor/tezacaftor/ivacaftor), manufactured by
Vertex Pharmaceutical, Inc., meets the criteria for a priority review
voucher.
FOR FURTHER INFORMATION CONTACT: Althea Cuff, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-4061, Fax: 301-
796-9856, email: [email protected].
SUPPLEMENTARY INFORMATION: 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
TRIKAFTA (elexacaftor/tezacaftor/ivacaftor),
[[Page 57218]]
manufactured by Vertex Pharmaceutical, Inc., meets the criteria for a
priority review voucher.
TRIKAFTA (elexacaftor/tezacaftor/ivacaftor) is indicated for the
treatment of patients with cystic fibrosis aged 12 years and older who
have at least one F508del mutation in the cystic fibrosis transmembrane
conductance regulator gene.
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/DevelopingProductsforRareDiseasesConditions/RarePediatricDiseasePriorityVoucherProgram/default.htm. For further
information about TRIKAFTA (elexacaftor/tezacaftor/ivacaftor), go to
the ``[email protected]'' website at https://www.accessdata.fda.gov/scripts/cder/daf/.
Dated: September 9, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-20320 Filed 9-14-20; 8:45 am]
BILLING CODE 4164-01-P
