Determination That Sodium Chloride 14.6% Solution for Injection, 50 Milliequivalent/20 Milliliters, in Plastic Containers, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 22059-22060 [2021-08615]
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<![CDATA[
22059
Federal Register / Vol. 86, No. 78 / Monday, April 26, 2021 / Notices
ANNUAL BURDEN ESTIMATES
[Data collection will be completed within a one-year period]
Number of
respondents
(total over
request
period)
Instrument
Coach Survey (Instrument 1) ...........................................................................
Center Director Survey (Instrument 2) ............................................................
FCC Provider Survey (Instrument 3) ...............................................................
Coach Interview (Instrument 4) .......................................................................
Center Director Interview (Instrument 5) .........................................................
FCC Provider Interview (Instrument 6): FCC providers ..................................
Estimated Total Annual Burden
Hours: 104.
Authority: 42 U.S.C. 9858(a)(5), 42 U.S.C.
9835, and 42 U.S.C. 9844.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2021–08614 Filed 4–23–21; 8:45 am]
BILLING CODE 4184–22–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–P–2304]
Determination That Sodium Chloride
14.6% Solution for Injection, 50
Milliequivalent/20 Milliliters, in Plastic
Containers, Was Not Withdrawn From
Sale for Reasons of Safety or
Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) has
determined that Sodium Chloride
14.6% solution for injection, 50
milliequivalent (mEq)/20 milliliters
(mL), in plastic containers, was not
withdrawn from sale for reasons of
safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for sodium
chloride 14.6% solution for injection, 50
mEq/20 mL, in plastic containers, if all
other legal and regulatory requirements
are met.
FOR FURTHER INFORMATION CONTACT:
Ayako Sato, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6206, Silver Spring,
MD 20993–0002, 240–402–4191,
Ayako.Sato@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
SUMMARY:
VerDate Sep<11>2014
18:01 Apr 23, 2021
Jkt 253001
100
66
38
12
24
12
Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products under an
ANDA procedure. ANDA applicants
must, with certain exceptions, show that
the drug for which they are seeking
approval contains the same active
ingredient in the same strength and
dosage form as the ‘‘listed drug,’’ which
is a version of the drug that was
previously approved. ANDA applicants
do not have to repeat the extensive
clinical testing otherwise necessary to
gain approval of a new drug application
(NDA).
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is known generally as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are removed from the list if the
Agency withdraws or suspends
approval of the drug’s NDA or ANDA
for reasons of safety or effectiveness or
if FDA determines that the listed drug
was withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
Sodium chloride 14.6% solution for
injection, 50 mEq/20 mL, in plastic
containers, is the subject of NDA 18897,
held by Hospira Inc., and initially
approved on July 20, 1984. Sodium
chloride 14.6% solution for injection is
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
(total over
request
period)
1
1
1
1
1
1
Avg. burden
per response
(in hours)
.33
.33
.33
.75
.75
.75
Total/annual
burden
(in hours)
33
22
13
9
18
9
indicated for use as an electrolyte
replenisher in parenteral fluid therapy.
In a communication dated September
6, 2019, Hospira Inc. notified FDA that
sodium chloride 14.6% solution for
injection, 50 mEq/20 mL, in plastic
containers, was being discontinued, and
FDA moved the drug product to the
‘‘Discontinued Drug Product List’’
section of the Orange Book.
Fresenius Kabi USA, LLC submitted a
citizen petition dated December 16,
2020 (Docket No. FDA–2020–P–2304),
under 21 CFR 10.30, requesting that the
Agency determine whether sodium
chloride 14.6% solution for injection, 50
mEq/20 mL, in plastic containers, was
withdrawn from sale for reasons of
safety or effectiveness.
After considering the citizen petition
and reviewing Agency records and
based on the information we have at this
time, FDA has determined under
§ 314.161 that sodium chloride 14.6%
solution for injection, 50 mEq/20 mL, in
plastic containers, was not withdrawn
for reasons of safety or effectiveness.
The petitioner has identified no data or
other information suggesting that
sodium chloride 14.6% solution for
injection, 50 mEq/20 mL, in plastic
containers, was withdrawn for reasons
of safety or effectiveness. We have
carefully reviewed our files for records
concerning the withdrawal of sodium
chloride 14.6% solution for injection, 50
mEq/20 mL, in plastic containers, from
sale. We have also independently
evaluated relevant literature and data
for possible postmarketing adverse
events. We have reviewed the available
evidence and determined that this drug
product was not withdrawn from sale
for reasons of safety or effectiveness.
Accordingly, the Agency will
continue to list sodium chloride 14.6%
solution for injection, 50 mEq/20 mL, in
plastic containers, in the ‘‘Discontinued
Drug Product List’’ section of the Orange
Book. The ‘‘Discontinued Drug Product
List’’ delineates, among other items,
drug products that have been
E:\FR\FM\26APN1.SGM
26APN1
22060
Federal Register / Vol. 86, No. 78 / Monday, April 26, 2021 / Notices
discontinued from marketing for reasons
other than safety or effectiveness.
ANDAs that refer to sodium chloride
14.6% solution for injection, 50 mEq/20
mL, in plastic containers, may be
approved by the Agency as long as they
meet all other legal and regulatory
requirements for the approval of
ANDAs. If FDA determines that labeling
for this drug product should be revised
to meet current standards, the Agency
will advise ANDA applicants to submit
such labeling.
Dated: April 20, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–08615 Filed 4–23–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: 0937–0191–30D]
Agency Information Collection
Request. 30-Day Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
SUMMARY:
technology to minimize the information
collection burden.
Type of Collection: Reinstatement w/
without chg.
OMB No.: 0937–0191.
Abstract: The Office of Assistant
Secretary for Administration, Program
Support Center, Federal Real Property
Assistance Program is requesting OMB
approval on a previously approved
information collection, 0937–0191. 40
U.S.C. 550 (the ‘‘Act’’), as amended,
provides authority to the Secretary of
Health and Human Services to convey
or lease surplus real property to States
and their political subdivisions and
instrumentalities, to tax-supported
institutions, and to nonprofit
institutions which (except for
institutions which lease property to
assist the homeless) have been held
exempt from taxation under Section
501(c)(3) of the 1954 Internal Revenue
Code, and 501(c)(19) for veterans
organizations, for public health and
homeless assistance purposes. Transfers
are made to transferees at little or no
cost.
Type of respondent: Responses are
dependent on when Federal surplus real
property is made available and is
desired by a respondent/applicant for
acquisition. Likely respondents include
State, local, or tribal units of
government or instrumentalities thereof,
and not-for-profit organizations.
and Human Services, is publishing the
following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be
received on or before May 26, 2021.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function.
FOR FURTHER INFORMATION CONTACT:
Sherrette Funn, Sherrette.Funn@hhs.gov
or (202) 795–7714. When submitting
comments or requesting information,
please include the document identifier
0990–New–30D and project title for
reference.
SUPPLEMENTARY INFORMATION: Interested
persons are invited to send comments
regarding this burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (1) The necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions; (2) the accuracy
of the estimated burden; (3) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(4) the use of automated collection
techniques or other forms of information
ESTIMATED ANNUALIZED BURDEN TABLE
Average
burden per
response
Respondents
(if necessary)
Applications for surplus Federal real property .....................
........................
15
1
200
3,000
Total ..............................................................................
........................
15
1
200
3,000
Dated: January 19, 2021.
Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance
Officer, Office of the Secretary.
Editorial note: This document was
received for publication by the Office of the
Federal Register on April 20, 2021.
[FR Doc. 2021–08548 Filed 4–23–21; 8:45 am]
BILLING CODE 4150–04–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Office of the Secretary; Notice of
Meeting
Pursuant to section 10(a) of the
Federal Advisory Committee Act, as
VerDate Sep<11>2014
18:01 Apr 23, 2021
Jkt 253001
Number of
respondents
Number of
responses per
respondents
Forms
(if necessary)
amended, notice is hereby given of a
meeting of the Muscular Dystrophy
Coordinating Committee (MDCC).
The meeting will be open to the
public. Individuals who plan to
participate and need special assistance,
such as sign language interpretation or
other reasonable accommodations,
should notify the Contact Person listed
below in advance of the meeting.
Name of Committee: Muscular Dystrophy
Coordinating Committee.
Date: June 2, 2021.
Time: 10:00 a.m. to 2:00 p.m.
Agenda: The purpose of this meeting is to
bring together committee members,
representing government agencies, patient
advocacy groups, other voluntary health
organizations, and patients and their families
to update one another on progress relevant to
the Action Plan for the Muscular Dystrophies
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
Total burden
hours
and to coordinate activities and discuss gaps
and opportunities leading to better
understanding of the muscular dystrophies,
advances in treatments, and improvements in
patients’ and their families’ lives. The agenda
for this meeting is available on the MDCC
website: https://www.mdcc.nih.gov/
Meetings_Events/june-2-2021.
Registration: To register, please go to:
https://roseliassociates.zoomgov.com/
webinar/register/WN_
ihQyf5oBTNK706B9fAHpfQ.
Webcast Live: https://videocast.nih.gov/
watch=41965.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive Blvd.,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Glen Nuckolls, Ph.D.,
Program Director, National Institute of
Neurological Disorders and Stroke (NINDS),
NIH, 6001 Executive Blvd., Rm 2203,
Bethesda, MD 20892, 301–496–5876, MDCC@
nih.gov.
E:\FR\FM\26APN1.SGM
26APN1
]]>Agencies
[Federal Register Volume 86, Number 78 (Monday, April 26, 2021)]
[Notices]
[Pages 22059-22060]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-08615]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-P-2304]
Determination That Sodium Chloride 14.6% Solution for Injection,
50 Milliequivalent/20 Milliliters, in Plastic Containers, Was Not
Withdrawn From Sale for Reasons of Safety or Effectiveness
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) has
determined that Sodium Chloride 14.6% solution for injection, 50
milliequivalent (mEq)/20 milliliters (mL), in plastic containers, was
not withdrawn from sale for reasons of safety or effectiveness. This
determination will allow FDA to approve abbreviated new drug
applications (ANDAs) for sodium chloride 14.6% solution for injection,
50 mEq/20 mL, in plastic containers, if all other legal and regulatory
requirements are met.
FOR FURTHER INFORMATION CONTACT: Ayako Sato, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6206, Silver Spring, MD 20993-0002, 240-402-4191,
[email protected].
SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products under an ANDA procedure. ANDA applicants
must, with certain exceptions, show that the drug for which they are
seeking approval contains the same active ingredient in the same
strength and dosage form as the ``listed drug,'' which is a version of
the drug that was previously approved. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA).
The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products With Therapeutic
Equivalence Evaluations,'' which is known generally as the ``Orange
Book.'' Under FDA regulations, drugs are removed from the list if the
Agency withdraws or suspends approval of the drug's NDA or ANDA for
reasons of safety or effectiveness or if FDA determines that the listed
drug was withdrawn from sale for reasons of safety or effectiveness (21
CFR 314.162).
A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale,
but must be made prior to approving an ANDA that refers to the listed
drug (Sec. 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that
does not refer to a listed drug.
Sodium chloride 14.6% solution for injection, 50 mEq/20 mL, in
plastic containers, is the subject of NDA 18897, held by Hospira Inc.,
and initially approved on July 20, 1984. Sodium chloride 14.6% solution
for injection is indicated for use as an electrolyte replenisher in
parenteral fluid therapy.
In a communication dated September 6, 2019, Hospira Inc. notified
FDA that sodium chloride 14.6% solution for injection, 50 mEq/20 mL, in
plastic containers, was being discontinued, and FDA moved the drug
product to the ``Discontinued Drug Product List'' section of the Orange
Book.
Fresenius Kabi USA, LLC submitted a citizen petition dated December
16, 2020 (Docket No. FDA-2020-P-2304), under 21 CFR 10.30, requesting
that the Agency determine whether sodium chloride 14.6% solution for
injection, 50 mEq/20 mL, in plastic containers, was withdrawn from sale
for reasons of safety or effectiveness.
After considering the citizen petition and reviewing Agency records
and based on the information we have at this time, FDA has determined
under Sec. 314.161 that sodium chloride 14.6% solution for injection,
50 mEq/20 mL, in plastic containers, was not withdrawn for reasons of
safety or effectiveness. The petitioner has identified no data or other
information suggesting that sodium chloride 14.6% solution for
injection, 50 mEq/20 mL, in plastic containers, was withdrawn for
reasons of safety or effectiveness. We have carefully reviewed our
files for records concerning the withdrawal of sodium chloride 14.6%
solution for injection, 50 mEq/20 mL, in plastic containers, from sale.
We have also independently evaluated relevant literature and data for
possible postmarketing adverse events. We have reviewed the available
evidence and determined that this drug product was not withdrawn from
sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list sodium chloride 14.6%
solution for injection, 50 mEq/20 mL, in plastic containers, in the
``Discontinued Drug Product List'' section of the Orange Book. The
``Discontinued Drug Product List'' delineates, among other items, drug
products that have been
[[Page 22060]]
discontinued from marketing for reasons other than safety or
effectiveness. ANDAs that refer to sodium chloride 14.6% solution for
injection, 50 mEq/20 mL, in plastic containers, may be approved by the
Agency as long as they meet all other legal and regulatory requirements
for the approval of ANDAs. If FDA determines that labeling for this
drug product should be revised to meet current standards, the Agency
will advise ANDA applicants to submit such labeling.
Dated: April 20, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-08615 Filed 4-23-21; 8:45 am]
BILLING CODE 4164-01-P
