National Institute of Biomedical Imaging and Bioengineering; Notice of Meeting, 16600-16601 [2017-06666]
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Federal Register / Vol. 82, No. 64 / Wednesday, April 5, 2017 / Notices
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was withdrawn from sale for reasons of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a listed drug was withdrawn from sale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time after the drug has been withdrawn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 (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
CEDAX (ceftibuten dihydrate) for oral
suspension, 90 mg/5 mL and 180 mg/5
mL, are the subject of NDA 050686, held
by Pernix Therapeutics LLC, and
initially approved on December 20,
1995. CEDAX is indicated for the
treatment of individuals with mild-tomoderate infections caused by
susceptible strains of Haemophilus
influenzae (including b-lactamaseproducing strains), Moraxella
catarrhalis (including b-lactamaseproducing strains), or Streptococcus
pneumoniae (penicillin-susceptible
strains only) in acute bacterial
exacerbations of chronic bronchitis; H.
influenzae (including b-lactamaseproducing strains), M. catarrhalis
(including b-lactamase-producing
strains), or S. pneumoniae (penicillinsusceptible strains only) in acute
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bacterial otitis media; and S. pyogenes
in pharyngitis and tonsillitis.
CEDAX (ceftibuten dihydrate) for oral
suspension, 90 mg/5 mL and 180 mg/5
mL, are currently listed in the
‘‘Discontinued Drug Product List’’
section of the Orange Book.
Orchid Healthcare (a division of
Orchid Pharma, Ltd.) submitted a
citizen petition dated October 26, 2016
(Docket No. FDA–2016–P–3560), under
21 CFR 10.30, requesting that the
Agency determine whether CEDAX
(ceftibuten dihydrate) for oral
suspension, 90 mg/5 mL and 180 mg/5
mL, were 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 CEDAX (ceftibuten
dihydrate) for oral suspension, 90 mg/5
mL and 180 mg/5 mL, were not
withdrawn for reasons of safety or
effectiveness. The petitioner has
identified no data or other information
suggesting that these drug products
were withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of CEDAX
(ceftibuten dihydrate) for oral
suspension, 90 mg/5 mL and 180 mg/5
mL, 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 these drug products
were not withdrawn from sale for
reasons of safety or effectiveness.
Accordingly, the Agency will
continue to list CEDAX (ceftibuten
dihydrate) for oral suspension, 90 mg/5
mL and 180 mg/5 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 these drug products 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 these drug
products should be revised to meet
current standards, the Agency will
advise ANDA applicants to submit such
labeling.
Dated: March 30, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Biomedical
Imaging and Bioengineering; Notice of
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the
National Advisory Council for
Biomedical Imaging and Bioengineering.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend 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.
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/or contract proposals 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 and/or contract proposals,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Advisory
Council for Biomedical Imaging and
Bioengineering.
Date: May 18, 2017.
Open: 8:30 a.m. to 12:00 p.m.
Agenda: Report from the Institute Director,
other Institute Staff and scientific
presentation.
Place: The William F. Bolger Center,
Franklin Building, Classroom 1, 9600
Newbridge Drive, Potomac, MD 20854.
Closed: 1:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications and/or proposals.
Place: The William F. Bolger Center,
Franklin Building, Classroom 1, 9600
Newbridge Drive, Potomac, MD 20854.
Contact Person: David T. George, Ph.D.,
Acting Associate Director, Office of Research
Administration, National Institute of
Biomedical Imaging and Bioengineering,
6707 Democracy Boulevard, Room 920,
Bethesda, MD 20892.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
Information is also available on the
Institute’s/Center’s home page: https://
www.nibib1.nih.gov/about/NACBIB/
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16601
NACBIB.htm, where an agenda and any
additional information for the meeting will
be posted when available.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: March 30, 2017.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
National Institutes of Health
Substance Abuse and Mental Health
Services Administration
[FR Doc. 2017–06666 Filed 4–4–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Minority Health
and Health Disparities; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), 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 materials,
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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Name of Committee: National Institute on
Minority Health and Health Disparities
Special Emphasis Panel; National Institute on
Minority Health and Health Disparities Small
Business Review.
Date: May 18–May 19, 2017.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hilton Washington/Rockville, 1750
Rockville Pike, Rockville, MD 20852.
Contact Person: Richard C. Palmer, DRPH,
Health Scientist Administrator, National
Institute on Minority Health and Health
Disparities, National Institutes of Health,
6707 Democracy Blvd., Suite 800, Bethesda,
MD 20906, (301) 451–2432, richard.palmer@
nih.gov.
Dated: March 30, 2017.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
National Institute of Diabetes and
Digestive and Kidney Diseases; Notice
of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the Board
of Scientific Counselors, NIDDK.
The meeting will be closed to the
public as indicated below in accordance
with the provisions set forth in section
552b(c)(6), Title 5 U.S.C., as amended
for the review, discussion, and
evaluation of individual intramural
programs and projects conducted by the
National Institute of Diabetes and
Digestive and Kidney Diseases,
including consideration of personnel
qualifications and performance, and the
competence of individual investigators,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Board of Scientific
Counselors, NIDDK.
Date: April 27–28, 2017.
Time: 8:00 a.m. to 4:30 p.m.
Agenda: To review and evaluate personal
qualifications and performance, and
competence of individual investigators.
Place: National Institutes of Health,
Building 10, 9th Floor South, Room 233,
Solarium Conference Room, 10 Center Drive,
Bethesda, MD 20892.
Contact Person: Michael W. Krause, Ph.D.,
Scientific Director, National Institute of
Diabetes and Digestive and Kidney Diseases,
National Institute of Health, Building 5,
Room B104, Bethesda, MD 20892–1818, (301)
402–4633, mwkrause@helix.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.847, Diabetes,
Endocrinology and Metabolic Research;
93.848, Digestive Diseases and Nutrition
Research; 93.849, Kidney Diseases, Urology
and Hematology Research, National Institutes
of Health, HHS)
Dated: March 30, 2017.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
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Agency Information Collection
Activities: Proposed Collection;
Comment Request
In compliance with Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 concerning
opportunity for public comment on
proposed collections of information, the
Substance Abuse and Mental Health
Services Administration will publish
periodic summaries of proposed
projects. To request more information
on the proposed projects or to obtain a
copy of the information collection
plans, call the SAMHSA Reports
Clearance Officer on (240) 276–1243.
Comments are invited on: (a) Whether
the proposed collections of information
are necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) ways to enhance the
quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, through the use of
automated collection techniques or
other forms of information technology.
Proposed Project: Protection and
Advocacy for Individuals With Mental
Illness (PAIMI) Annual Program
Performance Report (OMB No. 0930–
0169)—Extension
The Protection and Advocacy for
Individuals with Mental Illness (PAIMI)
Act at 42 U.S.C. 10801 et seq.,
authorized funds to the same protection
and advocacy (P&A) systems created
under the Developmental Disabilities
Assistance and Bill of Rights Act of
1975, known as the DD Act (as amended
in 2000, 42 U.S.C. 15001 et seq.]. The
DD Act supports the Protection and
Advocacy for Developmental
Disabilities (PADD) Program
administered by the Administration on
Intellectual and Developmental
Disabilities (AIDD) within the
Administration on Community Living.
AIDD is the lead federal P&A agency.
The PAIMI Program supports the same
governor-designated P&A systems
established under the DD Act by
providing legal-based individual and
systemic advocacy services to
individuals with significant (severe)
mental illness (adults) and significant
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Agencies
[Federal Register Volume 82, Number 64 (Wednesday, April 5, 2017)]
[Notices]
[Pages 16600-16601]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-06666]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Biomedical Imaging and Bioengineering;
Notice of Meeting
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is hereby given of a meeting of the
National Advisory Council for Biomedical Imaging and Bioengineering.
The meeting will be open to the public as indicated below, with
attendance limited to space available. Individuals who plan to attend
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.
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/or contract proposals
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 and/or contract proposals, the disclosure of which would
constitute a clearly unwarranted invasion of personal privacy.
Name of Committee: National Advisory Council for Biomedical
Imaging and Bioengineering.
Date: May 18, 2017.
Open: 8:30 a.m. to 12:00 p.m.
Agenda: Report from the Institute Director, other Institute
Staff and scientific presentation.
Place: The William F. Bolger Center, Franklin Building,
Classroom 1, 9600 Newbridge Drive, Potomac, MD 20854.
Closed: 1:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant applications and/or
proposals.
Place: The William F. Bolger Center, Franklin Building,
Classroom 1, 9600 Newbridge Drive, Potomac, MD 20854.
Contact Person: David T. George, Ph.D., Acting Associate
Director, Office of Research Administration, National Institute of
Biomedical Imaging and Bioengineering, 6707 Democracy Boulevard,
Room 920, Bethesda, MD 20892.
Any interested person may file written comments with the
committee by forwarding the statement to the Contact Person listed
on this notice. The statement should include the name, address,
telephone number and when applicable, the business or professional
affiliation of the interested person.
Information is also available on the Institute's/Center's home
page: https://www.nibib1.nih.gov/about/NACBIB/
[[Page 16601]]
NACBIB.htm, where an agenda and any additional information for the
meeting will be posted when available.
Dated: March 30, 2017.
David Clary,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2017-06666 Filed 4-4-17; 8:45 am]
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