Eli Lilly and Co.; Withdrawal of Approval of a New Drug Application for ORAFLEX, 33426-33427 [2013-13053]
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tkelley on DSK3SPTVN1PROD with NOTICES
33426
Federal Register / Vol. 78, No. 107 / Tuesday, June 4, 2013 / Notices
benz[j]aceanthrylene,
benzo[a]anthracene,
benzo[b]fluoranthene,
benzo[k]fluoranthene,
benzo[c]phenanthrene,
cyclopenta[cd]pyrene,
dibenz[a,h]anthracene,
dibenzo[a,e]pyrene, dibenzo[a,h]pyrene,
dibenzo[a,i]pyrene, dibenzo[a,l]pyrene,
indeno[1,2,3-cd]pyrene, and 5methylchrysene:
15. The different extraction steps used
when analyzing PAHs in tobacco filler,
smokeless tobacco, and cigarette smoke
particulate and any applicable cleanup
techniques used.
16. The optimal solvents, extraction
solutions, standards, and reference
tobacco product(s) needed during the
extraction of PAHs from tobacco filler
or, as applicable, a Cambridge filter pad.
17. The rationale for using
isotopically labeled internal standards
instead of targeted surrogates or external
standards for PAHs. The number of
isotopically labeled internal standards
needed to calculate the amount of PAHs
in a sample.
18. The challenges with isotopically
labeled internal standards, including: (a)
The commercial availability of internal
standards or their analogs; (b)
individual vs. mixture of internal
standards, cost of internal standards; (c)
deuterated vs. 13 C labeled internal
standards; and (d) concerns of proton
exchange with deuterated labeled
internal standards.
19. The typical concentration ranges
for each of the PAHs listed in this
document and any potential method
adjustments to accommodate for
different cigarette strengths and
physical parameters.
20. The major sources of method
variability, e.g., include sources from
the smoking machine or regimen,
sample preparation, separation, and
detection of different tobacco product
types and strengths.
21. The different methods necessary
to separate and detect for PAHs. Provide
the number of methods and steps
typically used for each from extraction
to detection.
22. The specific method challenges
and limitations when analyzing testing
PAHs, including: (a) Isomer separation
and identification, (b) effects of tobacco
blend, and (c) low vs. high molecular
weight PAHs (volatility and sensitivity).
23. The differences in separation,
detection, and limits of detection/
quantitation when comparing gas
chromatography/mass spectrometry,
liquid chromatography/ultraviolet
detection, and liquid chromatography/
mass spectrometry for PAH analysis.
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18:33 Jun 03, 2013
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D. General Method Testing for TNCO,
TSNAs, and PAHs in Tobacco Filler
(Cigarette, RYO, Smokeless) and
Cigarette Smoke
24. The solution stability for prepared
solutions and procedures to ensure their
integrity.
25. The typical storage conditions and
shelf life (i.e., expiration dates) for
tobacco product standards and samples.
26. The standard, reference, or known
sample solutions used as blanks or for
quality control (QC), working, and
check standards when testing TNCO,
TSNAs, and PAHs.
27. The system suitability and
acceptance criteria for each test method.
The discussion may include calibration,
QC, working, bracketing, and
verification standards, confirmation ion
ratio for mass spectrometry,
chromatographic parameters (i.e.,
retention times, tailing factor, or peak
resolution), injector precision, and
blanks.
28. The critical system suitability
parameters that are critical when testing
TNCO, TSNAs, and PAHs.
29. The actions taken when any
system suitability criterion fails,
including standards, QC, and
subsequent sample analyses.
30. The typical run sequence when
testing samples for TNCO, TSNAs, and
PAHs.
31. The equations to calculate sample
concentrations for TNCO, TSNAs, and
PAHs.
32. Examples of chromatograms of
reference standards and for measured
TNCO, TSNAs, and PAHs in tobacco
products.
E. Validation or Method Performance
for TNCO, TSNAs, and PAHs in
Tobacco Filler (Cigarette, RYO,
Smokeless) and Cigarette Smoke
33. The specific details when
evaluating each validation parameter,
which may include limit of detection,
limit of quantification, method
detection limit, accuracy, recovery,
linearity, range, precision
(repeatability), and specificity.
34. The determination of each
criterion for each validation parameter
when evaluating TNCO, TSNAs, and
PAHs.
35. The steps taken when validation
parameter criteria are not met.
36. The validation parameters that are
performed with reference tobacco
products or standards.
37. The types and strengths of tobacco
product samples used during validation
and method development.
38. The process taken to revalidate a
test method when changes to the
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method (i.e., solvent, extraction method,
or column) are made.
39. The validation process when
using a rotary and linear smoking
machine with a non-intense and intense
smoking regimen.
40. The robustness or ruggedness tests
that are conducted for extraction
efficiency, solution stability, and small
changes in instrument parameters.
III. Transcripts
Please be advised that as soon as a
transcript is available, it will be
accessible at https://
www.regulations.gov. It may be viewed
at the Division of Dockets Management
(see Comments). A transcript will also
be available in either hard copy or on
CD–ROM, after submission of a
Freedom of Information request. Written
requests are to be sent to Division of
Freedom of Information (HFI–35), Office
of Management Programs, Food and
Drug Administration, 5600 Fishers
Lane, rm. 6–30, Rockville, MD 20857.
Dated: May 24, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–13084 Filed 6–3–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0559]
Eli Lilly and Co.; Withdrawal of
Approval of a New Drug Application for
ORAFLEX
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is withdrawing
approval of a new drug application
(NDA) for ORAFLEX (benoxaprofen)
Tablets, held by Eli Lilly and Co. (Lilly),
Lilly Corporate Center, Indianapolis, IN
46285. Lilly has voluntarily requested
that approval of this application be
withdrawn, and has waived its
opportunity for a hearing.
DATES: Effective June 4, 2013.
FOR FURTHER INFORMATION CONTACT:
Martha Nguyen, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6250,
Silver Spring, MD 20993–0002, 301–
796–3601.
SUPPLEMENTARY INFORMATION: On April
19, 1982, FDA approved ORAFLEX
(benoxaprofen) Tablets, a nonsteroidal
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04JNN1
Federal Register / Vol. 78, No. 107 / Tuesday, June 4, 2013 / Notices
anti-inflammatory drug indicated for the
treatment of arthritis. On August 4,
1982, Lilly voluntarily withdrew
ORAFLEX (benoxaprofen) Tablets from
the market because of postmarketing
reports of severe liver toxicity in
patients who took ORAFLEX. In a letter
dated February 6, 2013, Lilly requested
that FDA withdraw approval of NDA
18–250 for ORAFLEX (benoxaprofen)
Tablets under § 314.150(d) (21 CFR
314.150(d)). In that letter, Lilly waived
any opportunity for a hearing otherwise
provided under § 314.150(a). In FDA’s
letter of February 15, 2013, the Agency
acknowledged Lilly’s agreement to
permit FDA to withdraw approval of
ORAFLEX (benoxaprofen) Tablets under
§ 314.150(d) and waive its opportunity
for a hearing.
Therefore, under section 505(e) of the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 355(e)) and
§ 314.150(d), and under authority
delegated by the Commissioner of Food
and Drugs to the Director, Center for
Drug Evaluation and Research, approval
of NDA 18–250, and all amendments
and supplements thereto, is withdrawn
(see DATES). Distribution of this
product in interstate commerce without
an approved application is illegal and
subject to regulatory action (see sections
505(a) and 301(d) of the FD&C Act (21
U.S.C. 355(a) and 331(d)).
Dated: May 28, 2013.
Janet Woodcock,
Director, Center for Drug Evaluation and
Research.
[FR Doc. 2013–13053 Filed 6–3–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
tkelley on DSK3SPTVN1PROD with NOTICES
Eunice Kennedy Shriver National
Institute of Child Health & Human
Development; Notice of Meeting
[FR Doc. 2013–13123 Filed 6–3–13; 8:45 am]
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Pursuant to section 10(a) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the
National Children’s Study Advisory
Committee.
The meeting will be open to the
public, with attendance limited to space
available. Registration is required since
space is limited and will begin at 8:00
a.m. Please visit the conference Web site
for information on meeting logistics and
to register for the meeting at meeting
https://www.cvent.com/d/3cq6zz.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
18:33 Jun 03, 2013
Jkt 229001
Name of Committee: National Children’s
Study Advisory Committee.
Date: July 23, 2013.
Time: 9:00 a.m. to 4:30 p.m.
Agenda: The Committee will receive an
update on the current status of Vanguard
Study and will discuss general data
collection methods and retention strategy
and methods.
Place: National Institutes of Health,
Natcher Conference Center, Room E1/E2, 45
Center Drive, Bethesda, MD 20892.
Contact Person: Kate Winseck, MSW,
Executive Secretary, National Children’s
Study, Eunice Kennedy Shriver National
Institute of Child Health and Human
Development, NIH, 6100 Executive Blvd.,
Room 5C01, Bethesda, MD 20892, (703) 902–
1339, ncs@circlesolutions.com.
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. For
additional information about the Federal
Advisory Committee meeting, please contact
Circle Solutions at ncs@circlesolutions.com.
In the interest of security, NIH has
instituted stringent procedures for entrance
onto the NIH campus. All visitor vehicles,
including taxicabs, hotel, and airport shuttles
will be inspected before being allowed on
campus. Visitors will be asked to show one
form of identification (for example, a
government-issued photo ID, driver’s license,
or passport) and to state the purpose of their
visit.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.864, Population Research;
93.865, Research for Mothers and Children;
93.929, Center for Medical Rehabilitation
Research; 93.209, Contraception and
Infertility Loan Repayment Program, National
Institutes of Health, HHS)
Dated: May 29, 2013.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
National Institutes of Health
VerDate Mar<15>2010
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
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 (5 U.S.C. App.), 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.,
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33427
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; Systemic
Injury by Environmental Exposure.
Date: June 11, 2013.
Time: 1:00 p.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hyatt Regency Bethesda, One
Bethesda Metro Center, 7400 Wisconsin
Avenue, Bethesda, MD 20814.
Contact Person: Bonnie L Burgess-Beusse,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 2182,
MSC 7818, Bethesda, MD 20892, 301–435–
1783, beusseb@mail.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Stroke, Spinal Cord Injury, and
Neuroimmunology.
Date: June 14, 2013.
Time: 2:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Samuel C Edwards, Ph.D.,
IRG CHIEF, Center for Scientific Review,
National Institutes of Health, 6701 Rockledge
Drive, Room 5210, MSC 7846, Bethesda, MD
20892, (301) 435–1246,
edwardss@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
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93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: May 29, 2013.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2013–13124 Filed 6–3–13; 8:45 am]
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]]>Agencies
[Federal Register Volume 78, Number 107 (Tuesday, June 4, 2013)]
[Notices]
[Pages 33426-33427]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-13053]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0559]
Eli Lilly and Co.; Withdrawal of Approval of a New Drug
Application for ORAFLEX
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of a new drug application (NDA) for ORAFLEX (benoxaprofen) Tablets,
held by Eli Lilly and Co. (Lilly), Lilly Corporate Center,
Indianapolis, IN 46285. Lilly has voluntarily requested that approval
of this application be withdrawn, and has waived its opportunity for a
hearing.
DATES: Effective June 4, 2013.
FOR FURTHER INFORMATION CONTACT: Martha Nguyen, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6250, Silver Spring, MD 20993-0002, 301-
796-3601.
SUPPLEMENTARY INFORMATION: On April 19, 1982, FDA approved ORAFLEX
(benoxaprofen) Tablets, a nonsteroidal
[[Page 33427]]
anti-inflammatory drug indicated for the treatment of arthritis. On
August 4, 1982, Lilly voluntarily withdrew ORAFLEX (benoxaprofen)
Tablets from the market because of postmarketing reports of severe
liver toxicity in patients who took ORAFLEX. In a letter dated February
6, 2013, Lilly requested that FDA withdraw approval of NDA 18-250 for
ORAFLEX (benoxaprofen) Tablets under Sec. 314.150(d) (21 CFR
314.150(d)). In that letter, Lilly waived any opportunity for a hearing
otherwise provided under Sec. 314.150(a). In FDA's letter of February
15, 2013, the Agency acknowledged Lilly's agreement to permit FDA to
withdraw approval of ORAFLEX (benoxaprofen) Tablets under Sec.
314.150(d) and waive its opportunity for a hearing.
Therefore, under section 505(e) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 355(e)) and Sec. 314.150(d), and
under authority delegated by the Commissioner of Food and Drugs to the
Director, Center for Drug Evaluation and Research, approval of NDA 18-
250, and all amendments and supplements thereto, is withdrawn (see
DATES). Distribution of this product in interstate commerce without an
approved application is illegal and subject to regulatory action (see
sections 505(a) and 301(d) of the FD&C Act (21 U.S.C. 355(a) and
331(d)).
Dated: May 28, 2013.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 2013-13053 Filed 6-3-13; 8:45 am]
BILLING CODE 4160-01-P
