Post-Marketing Pediatric-Focused Product Safety Reviews; Establishment of a Public Docket; Request for Comments; Correction, 57217 [2020-20329]
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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:
VerDate Sep<11>2014
16:57 Sep 14, 2020
Jkt 250001
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:
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
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:
E:\FR\FM\15SEN1.SGM
15SEN1
]]>Agencies
[Federal Register Volume 85, Number 179 (Tuesday, September 15, 2020)]
[Notices]
[Page 57217]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-20329]
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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
AGENCY: Food and Drug Administration, Health and Human Services (HHS).
ACTION: Notice; correction.
-----------------------------------------------------------------------
SUMMARY: 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 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:
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
