Issuance of Priority Review Voucher; Rare Pediatric Disease Product, 11985-11986 [2019-06138]
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Federal Register / Vol. 84, No. 61 / Friday, March 29, 2019 / Notices
Recordkeeping Requirements for
Microbiological Testing and Corrective
Measures for Bottled Water—21 CFR
129.35(a)(3)(i), 129.80(g), and 129.80(h)
OMB Control Number 0910–0658—
Extension
The bottled water regulations in parts
129 and 165 (21 CFR parts 129 and 165)
require that if any coliform organisms
are detected in weekly total coliform
testing of finished bottled water,
followup testing must be conducted to
determine whether any of the coliform
organisms are Escherichia coli. The
adulteration provision of the bottled
water standard (21 CFR 165.110(d))
provides that a finished product that
tests positive for E. coli will be deemed
adulterated under section 402(a)(3) of
the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 342(a)(3)). In addition,
the current good manufacturing practice
(CGMP) regulations for bottled water in
part 129 require that source water from
other than a public water system (PWS)
be tested at least weekly for total
coliform. If any coliform organisms are
detected in the source water, the bottled
water manufacturers are required to
determine whether any of the coliform
organisms are E. coli. Source water
found to contain E. coli is not
considered water of a safe, sanitary
quality and would be unsuitable for
bottled water production. Before a
bottler may use source water from a
source that has tested positive for E.
coli, a bottler must take appropriate
measures to rectify or otherwise
11985
eliminate the cause of the
contamination. A source previously
found to contain E. coli will be
considered negative for E. coli after five
samples collected over a 24-hour period
from the same sampling site are tested
and found to be E. coli negative.
Description of Respondents: The
respondents to this information
collection are domestic and foreign
bottled water manufacturers that sell
bottled water in the United States.
In the Federal Register of November
7, 2018 (83 FR 55726), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR section; activity
Average
burden per
recordkeeping
Total annual
records
Total
hours
§§ 129.35(a)(3)(i) and 129.80(h) (bottlers subject to
both source water and finished product testing).
§ 129.80(g) and (h) (bottlers only subject to finished
product testing).
§§ 129.35(a)(3)(i) and 129.80(h) (bottlers conducting
secondary testing of source water).
§§ 129.35(a)(3)(i) and 129.80(h) (bottlers rectifying
contamination).
319
6
1,914
0.08 (5 minutes) ......
153
95
3
285
0.08 (5 minutes) ......
23
3
5
15
0.08 (5 minutes) ......
1
3
3
9
0.25 (15 minutes) ....
2
Total ....................................................................
........................
........................
........................
..................................
179
1 There
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Number of
records per
recordkeeper
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate.
The current CGMP regulations already
reflect the time and associated
recordkeeping costs for those bottlers
that are required to conduct
microbiological testing of their source
water, as well as total coliform testing
of their finished bottled water products.
We therefore conclude that any
additional burden and costs in
recordkeeping based on followup testing
that is required if any coliform
organisms detected in the source water
test positive for E. coli are negligible.
We estimate that the labor burden of
keeping records of each E. coli followup
test is about 5 minutes per test. We also
require followup testing of source water
and finished bottled water products for
E. coli when total coliform positives
occur. We expect that 319 bottlers that
use sources other than PWSs may find
a total coliform positive sample about 3
times per year in source water testing
and about 3 times in finished product
testing and thus would need to conduct
6 tests for E. coli, for a total of 153 hours
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17:48 Mar 28, 2019
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of recordkeeping. In addition, about 95
bottlers that use PWSs may find a total
coliform positive sample about 3 times
per year in finished product testing and
thus would need to conduct 3 tests for
E. coli, for a total of 23 hours of
recordkeeping.
We expect that three bottlers per year
will test positive for E. coli in source
water and will need to take actions to
rectify or eliminate the cause of the
contamination and verify that E. coli is
negative by taking five samples over a
24-hour period from the same sampling
site that originally tested positive for E.
coli. We expect that recordkeeping for
the followup test for E. coli will also
take about 5 minutes per test. As shown
in table 1, we expect that three bottlers
per year will test positive for E. coli in
source water and will have to carry out
the additional E. coli testing, with a
burden of 1 hour. These bottlers will
also have to keep records about
rectifying the source contamination, for
a burden of 2 hours. For all expected
total coliform testing, E. coli testing, and
source rectification, we estimate a total
burden of 179 hours. We base our
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estimate on our experience with the
current CGMP regulations.
Dated: March 22, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019–06069 Filed 3–28–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–4609]
Issuance of Priority Review Voucher;
Rare Pediatric Disease Product
AGENCY:
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
SUMMARY:
E:\FR\FM\29MRN1.SGM
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Federal Register / Vol. 84, No. 61 / Friday, March 29, 2019 / Notices
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 SYMDEKO
(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,
althea.cuff@fda.hhs.gov.
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 SYMDEKO
(tezacaftor/ivacaftor), manufactured by
Vertex Pharmaceutical, Inc., meets the
criteria for a priority review voucher.
SYMDEKO (tezacaftor/ivacaftor) is
indicated for the treatment of patients
with cystic fibrosis aged 12 years and
older who are homozygous for the
F508del mutation or who have at least
one mutation in the cystic fibrosis
transmembrane conductance regulator
gene that is responsive to tezacaftor/
ivacaftor based on in vitro data and/or
clinical evidence.
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 SYMDEKO
(tezacaftor/ivacaftor), go to the ‘‘Drugs@
FDA’’ website at https://
www.accessdata.fda.gov/scripts/cder/
daf/.
SUPPLEMENTARY INFORMATION:
jbell on DSK30RV082PROD with NOTICES
Dated: March 26, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019–06138 Filed 3–28–19; 8:45 am]
BILLING CODE 4164–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Advisory Council on Alzheimer’s
Research, Care, and Services; Meeting
Assistant Secretary for
Planning and Evaluation, HHS.
ACTION: Notice of meeting.
AGENCY:
This notice announces the
public meeting of the Advisory Council
on Alzheimer’s Research, Care, and
Services (Advisory Council). The
Advisory Council on Alzheimer’s
Research, Care, and Services provides
advice on how to prevent or reduce the
burden of Alzheimer’s disease and
related dementias on people with the
disease and their caregivers. The April
29, 2019 meeting of the Advisory
Council will focus on person-centered
planning for older adults including
information about implementation of
care plans for people living with
cognitive symptoms. There will also be
discussion about the use of
antipsychotic medication for people
with dementia and other conditions
living in community settings.
DATES: The meeting will be held on
April 29, 2019 from 9 a.m. to 4:30 p.m.
EST.
ADDRESSES: The meeting will be held in
Room 800 in the Hubert H. Humphrey
Building, 200 Independence Avenue
SW, Washington, DC 20201.
Comments: Time is allocated on the
agenda to hear public comments. The
time for oral comments will be limited
to two (2) minutes per individual. In
lieu of oral comments, formal written
comments may be submitted for the
record to Helen Lamont, Ph.D., OASPE,
200 Independence Avenue SW, Room
424E, Washington, DC 20201.
Comments may also be sent to napa@
hhs.gov. Those submitting written
comments should identify themselves
and any relevant organizational
affiliations.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Helen Lamont, 202–260–6075,
helen.lamont@hhs.gov. Note: Seating
may be limited. Those wishing to attend
the meeting must send an email to
napa@hhs.gov and put ‘‘April 29
Meeting Attendance’’ in the subject line
by Friday, April 19 so that their names
may be put on a list of expected
attendees and forwarded to the security
officers at the Department of Health and
Human Services. Any interested
member of the public who is a non-U.S.
citizen should include this information
at the time of registration to ensure that
the appropriate security procedure to
gain entry to the building is carried out.
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Although the meeting is open to the
public, procedures governing security
and the entrance to Federal buildings
may change without notice. If you wish
to make a public comment, you must
note that within your email.
SUPPLEMENTARY INFORMATION: Notice of
these meetings is given under the
Federal Advisory Committee Act (5
U.S.C. App. 2, section 10(a)(1) and
(a)(2)). Topics of the Meeting: The April
29, 2019 meeting of the Advisory
Council will focus on person-centered
planning for older adults including
information about implementation of
care plans for people living with
cognitive symptoms. There will also be
discussion about the use of
antipsychotic medication for people
with dementia and other conditions
living in community settings.
Procedure and Agenda: This meeting
is open to the public. Please allow 30
minutes to go through security and walk
to the meeting room. The meeting will
also be webcast at www.hhs.gov/live.
Authority: 42 U.S.C. 11225; Section 2(e)(3)
of the National Alzheimer’s Project Act. The
panel is governed by provisions of Public
Law 92–463, as amended (5 U.S.C. Appendix
2), which sets forth standards for the
formation and use of advisory committees.
Dated: March 22, 2019.
Brenda Destro,
Deputy Assistant Secretary for Planning and
Evaluation, Office of Human Services Policy.
[FR Doc. 2019–06135 Filed 3–28–19; 8:45 am]
BILLING CODE 4150–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Deafness and
Other Communication Disorders;
Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute on
Deafness and Other Communication
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[Federal Register Volume 84, Number 61 (Friday, March 29, 2019)]
[Notices]
[Pages 11985-11986]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06138]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-4609]
Issuance of Priority Review Voucher; Rare Pediatric Disease
Product
AGENCY: Food and Drug Administration, 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
[[Page 11986]]
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 SYMDEKO
(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 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
SYMDEKO (tezacaftor/ivacaftor), manufactured by Vertex Pharmaceutical,
Inc., meets the criteria for a priority review voucher. SYMDEKO
(tezacaftor/ivacaftor) is indicated for the treatment of patients with
cystic fibrosis aged 12 years and older who are homozygous for the
F508del mutation or who have at least one mutation in the cystic
fibrosis transmembrane conductance regulator gene that is responsive to
tezacaftor/ivacaftor based on in vitro data and/or clinical evidence.
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 SYMDEKO (tezacaftor/ivacaftor), go to the
``[email protected]'' website at https://www.accessdata.fda.gov/scripts/cder/daf/.
Dated: March 26, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-06138 Filed 3-28-19; 8:45 am]
BILLING CODE 4164-01-P
