National Institute on Aging; Notice of Closed Meeting, 37954-37955 [2020-13551]
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Federal Register / Vol. 85, No. 122 / Wednesday, June 24, 2020 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–P–0678]
Determination That DEXTROSE IN
PLASTIC CONTAINER (Dextrose)
Injectable, 30 Grams/100 Milliliters, 40
Grams/100 Milliliters, 60 Grams/100
Milliliters, and 70 Grams/100 Milliliters,
Were Not Withdrawn From Sale for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 DEXTROSE IN
PLASTIC CONTAINER (dextrose)
injectable, 30 grams (g)/100 milliliters
(mL), 40 g/100 mL, 60 g/100 mL, and 70
g/100 mL, were not withdrawn from
sale for reasons of safety or
effectiveness. This determination will
allow FDA to approve abbreviated new
drug applications (ANDAs) for dextrose
injectable, 30 g/100 mL, 40 g/100 mL, 60
g/100 mL, and 70 g/100 mL, if all other
legal and regulatory requirements are
met.
SUMMARY:
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FOR FURTHER INFORMATION CONTACT:
David Faranda, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6258,
Silver Spring, MD 20993–0002, 301–
796–8767, David.Faranda@fda.hhs.gov.
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
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‘‘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.
DEXTROSE IN PLASTIC CONTAINER
(dextrose) injectable, 30 g/100 mL, 40 g/
100 mL, 60 g/100 mL, and 70 g/100 mL,
are the subject of NDA 017521, held by
Baxter Healthcare Corporation, and
initially approved on August 28, 1979.
DEXTROSE IN PLASTIC CONTAINER
is indicated as a source of calories for
patients requiring parenteral nutrition
when oral or enteral nutrition is not
possible, insufficient or contraindicated.
DEXTROSE IN PLASTIC CONTAINER
(dextrose) injectable, 30 g/100 mL, 40 g/
100 mL, 60 g/100 mL, and 70 g/100 mL,
are currently listed in the ‘‘Discontinued
Drug Product List’’ section of the Orange
Book.
Fresenius Kabi USA, LLC, submitted
a citizen petition dated February 6, 2020
(Docket No. FDA–2020–P–0678), under
21 CFR 10.30, requesting that the
Agency determine whether DEXTROSE
70% IN PLASTIC CONTAINER
(dextrose) injectable, 70 g/100 mL, was
withdrawn from sale for reasons of
safety or effectiveness. Although the
citizen petition did not address the 30
g/100 mL, 40 g/100 mL, or 60 g/100 mL
strengths, those strengths have also been
discontinued. On our own initiative, we
have also determined whether those
strengths were withdrawn for safety or
effectiveness reasons.
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 DEXTROSE IN PLASTIC
CONTAINER (dextrose) injectable, 30 g/
100 mL, 40 g/100 mL, 60 g/100 mL, and
70 g/100 mL, were not withdrawn for
reasons of safety or effectiveness. The
petitioner has identified no data or other
information suggesting that DEXTROSE
IN PLASTIC CONTAINER (dextrose)
injectable, 30 g/100 mL, 40 g/100 mL, 60
g/100 mL, and 70 g/100 mL, were
withdrawn for reasons of safety or
effectiveness. We have carefully
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reviewed our files for records
concerning the withdrawal of
DEXTROSE IN PLASTIC CONTAINER
(dextrose) injectable, 30 g/100 mL, 40 g/
100 mL, 60 g/100 mL, and 70 g/100 mL,
from sale. We have also independently
evaluated relevant literature and data
for possible postmarketing adverse
events. We have found no information
that would indicate that this drug
product was withdrawn from sale for
reasons of safety or effectiveness.
Accordingly, the Agency will
continue to list DEXTROSE IN PLASTIC
CONTAINER (dextrose) injectable, 30 g/
100 mL, 40 g/100 mL, 60 g/100 mL, and
70 g/100 mL, 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
discontinued from marketing for reasons
other than safety or effectiveness.
ANDAs that refer to DEXTROSE IN
PLASTIC CONTAINER (dextrose)
injectable, 30 g/100 mL, 40 g/100 mL, 60
g/100 mL, and 70 g/100 mL, 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: June 18, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–13593 Filed 6–23–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Aging; 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.
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Federal Register / Vol. 85, No. 122 / Wednesday, June 24, 2020 / Notices
Name of Committee: National Institute on
Aging Special Emphasis Panel; ADD
HEALTH.
Date: July 13, 2020.
Time: 12:30 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging,
Gateway Building, 7201 Wisconsin Avenue,
Bethesda, MD 20892 (Video Meeting).
Contact Person: Kimberly Firth, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, National Institute on Aging, National
Institutes of Health, Gateway Building, 7201
Wisconsin Avenue, Suite 2W200, Bethesda,
MD 20892, (301) 402–7702, firthkm@
mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.866, Aging Research,
National Institutes of Health, HHS)
Dated: June 18, 2020.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–13551 Filed 6–23–20; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
jbell on DSKJLSW7X2PROD with NOTICES
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings 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: Center for Scientific
Review Special Emphasis Panel;
Fellowships: Population Sciences and
Epidemiology.
Date: July 22–23, 2020.
Time: 9:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Steven Michael Frenk,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3141,
MSC 7770, Bethesda, MD 20892, (301) 480–
8665, frenksm@mail.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
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Conflict: Topics in Bacterial Pathogenesis
and Host Interactions.
Date: July 22, 2020.
Time: 9:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Soheyla Saadi, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3211,
MSC 7808, Bethesda, MD 20892, (301) 435–
0903, saadisoh@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: AIDS and AIDS Related Research.
Date: July 22, 2020.
Time: 10:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Shalanda A. Bynum,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3206,
MSC 7848, Bethesda, MD 20892, (301) 755–
4355, bynumsa@csr.nih.gov.
Name of Committee: AIDS and Related
Research Integrated Review Group; HIV
Immunopathogenesis and Vaccine
Development Study Section.
Date: July 22, 2020.
Time: 10:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Shiv A Prasad, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5220,
MSC 7852, Bethesda, MD 20892, 301–443–
5779, prasads@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel;
Fellowships: Endocrinology, Metabolism,
Nutrition and Reproductive Science.
Date: July 22, 2020.
Time: 10:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Antonello Pileggi, MD,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6166,
MSC 7892, Bethesda, MD 20892–7892, (301)
402–6297, pileggia@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Medical Imaging Investigations.
Date: July 22, 2020.
Time: 10:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
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37955
Contact Person: Guo Feng Xu, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5122,
MSC 7854, Bethesda, MD 20892, (301) 237–
9870, xuguofen@csr.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: June 18, 2020.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–13549 Filed 6–23–20; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings 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: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Pulmonary Hypertension and Sleep
Apnea.
Date: July 20–21, 2020.
Time: 9:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: George M Barnas, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4220,
MSC 7818, Bethesda, MD 20892, 301–435–
0696, barnasg@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel Small
Business: Hematology.
Date: July 20–21, 2020.
Time: 10:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892, (Virtual Meeting).
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]]>Agencies
[Federal Register Volume 85, Number 122 (Wednesday, June 24, 2020)]
[Notices]
[Pages 37954-37955]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-13551]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute on Aging; 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.
[[Page 37955]]
Name of Committee: National Institute on Aging Special Emphasis
Panel; ADD HEALTH.
Date: July 13, 2020.
Time: 12:30 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institute on Aging, Gateway Building, 7201
Wisconsin Avenue, Bethesda, MD 20892 (Video Meeting).
Contact Person: Kimberly Firth, Ph.D., Scientific Review
Officer, Scientific Review Branch, National Institute on Aging,
National Institutes of Health, Gateway Building, 7201 Wisconsin
Avenue, Suite 2W200, Bethesda, MD 20892, (301) 402-7702,
[email protected].
(Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging
Research, National Institutes of Health, HHS)
Dated: June 18, 2020.
Miguelina Perez,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2020-13551 Filed 6-23-20; 8:45 am]
BILLING CODE 4140-01-P
