Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting, 13796-13797 [2016-05748]
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Federal Register / Vol. 81, No. 50 / Tuesday, March 15, 2016 / Notices
which are submitted via the Pet Event
Tracking Network (PETNet); and (2)
reports of animal food-related illness
and product defects associated with
animal food for livestock animals,
aquaculture species, and horses, which
are submitted via LivestockNet. We are
revising the collection to include a third
type of report that would be submitted
via ‘‘SampleNet.’’ SampleNet will
collect reports about animal food
laboratory samples considered
adulterated by State or FDA regulators.
SampleNet will allow Federal, State,
and Territorial regulatory and public
health agencies to share laboratory data
related to adulterated samples for
purposes of surveillance, mitigation,
work planning, and supporting the
animal food standard requirements.
PETNet and LivestockNet reports
share the following common data
elements, the majority of which are drop
down menu choices: Product details
(product name, lot code, product form,
and the manufacturer or distributor/
packer (if known)), the species affected,
number of animals exposed to the
product, number of animals affected,
body systems affected, product
problem/defect, date of onset or the date
product problem was detected, the State
where the incident occurred, the origin
of the information, whether there are
supporting laboratory results, and
contact information for the reporting
member (i.e., name, telephone number
will be captured automatically when
member logs in to the system). For the
LivestockNet report, additional data
elements specific to livestock animals
will be captured: Product details
(indication of whether the product is a
medicated feed under 21 CFR
558.3(b)(8), product packaging, and
intended purpose of the product), class
of the animal species affected, and
production loss. For PETNet reports, the
only additional data field is the animal
life stage. The proposed SampleNet
reports will have the following data
elements, many of which are drop down
menu choices: Product information
(product name, lot code, guarantor
information, date and location of sample
collection, and product description);
laboratory information (sample
identification number, the reason for
testing, whether the food was reported
to the Reportable Food Registry, who
performed the analysis); and results
information (analyte, test method,
analytical results, whether the results
contradict a label claim or guarantee,
and whether action was taken as a result
of the sample analysis).
Description of Respondents:
Respondents to the collection of
information are Federal, State, and
Territorial regulatory and public health
agency employees with membership
access to the Animal Feed Network.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
Activity
Total annual
responses
Average burden per
response
Total hours
PETNet .................................
LivestockNet .........................
SampleNet ............................
20
20
20
5
5
5
100
100
100
0.25 (15 minutes) .................
0.25 (15 minutes) .................
0.25 (15 minutes) .................
25
25
25
Total ...............................
..............................
..............................
..............................
...............................................
75
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimate is based on our
experience with the tracking network
over the past 3 years. We estimate that
we will receive an average of 5
submissions from 20 respondents for
each type of report, and that it will take
15 minutes (0.25 hour) per response.
Dated: March 9, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–05757 Filed 3–14–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
asabaliauskas on DSK3SPTVN1PROD with NOTICES
[Docket No. FDA–2016–N–0001]
Anesthetic and Analgesic Drug
Products Advisory Committee and the
Drug Safety and Risk Management
Advisory Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
VerDate Sep<11>2014
17:40 Mar 14, 2016
Jkt 238001
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). At least one portion of the
meeting will be closed to the public.
Name of Committees: Anesthetic and
Analgesic Drug Products Advisory
Committee and the Drug Safety and Risk
Management Advisory Committee.
General Function of the Committees:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on May 5, 2016, from 8 a.m. to 5
p.m.
Location: FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993–0002.
Answers to commonly asked questions
including information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm.
Contact Person: Stephanie L.
Begansky, Center for Drug Evaluation
PO 00000
Frm 00026
Fmt 4703
Sfmt 4703
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 31, Rm. 2417, Silver Spring,
MD 20993–0002, 301–796–9001, FAX:
301–847–8533, email: AADPAC@
fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area). A notice in the
Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s Web site at https://
www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the
appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
modifications before coming to the
meeting.
Agenda: The committees will be
asked to discuss new drug application
(NDA) 208653, benzhydrocodone/
acetaminophen oral tablets, submitted
by KemPharm, Inc., with the proposed
indication of short-term (up to 14 days)
E:\FR\FM\15MRN1.SGM
15MRN1
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 81, No. 50 / Tuesday, March 15, 2016 / Notices
management of acute pain. The product
has been formulated with the intent to
provide abuse-deterrent properties.
Benzhydrocodone is a hydrocodone
prodrug which, according to the
applicant, is rapidly converted into
hydrocodone by enzymes in the
gastrointestinal tract. The active drugs
in this fixed-dose combination are
hydrocodone and acetaminophen. The
applicant has submitted data to support
abuse-deterrent properties for this
product. The committees will be asked
to discuss whether the applicant has
demonstrated abuse-deterrent properties
for their product that would support
labeling, and whether the nasal route of
abuse is relevant for combination
products made up of hydrocodone and
acetaminophen.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
Procedure: On May 5, 2016, from 9:15
a.m. to 5 p.m., the meeting is open to
the public. Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before April 21, 2016. Oral
presentations from the public will be
scheduled between approximately 1:30
p.m. and 2:30 p.m. Those individuals
interested in making formal oral
presentations should notify the contact
person and submit a brief statement of
the general nature of the evidence or
arguments they wish to present, the
names and addresses of proposed
participants, and an indication of the
approximate time requested to make
their presentation on or before April 13,
2016. Time allotted for each
presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by April 14, 2016.
Closed Presentation of Data: On May
5, 2016, from 8 a.m. to 9:15 a.m., the
VerDate Sep<11>2014
17:40 Mar 14, 2016
Jkt 238001
meeting will be closed to permit
discussion and review of trade secret
and/or confidential commercial
information (5 U.S.C. 552b(c)(4)).
During this session, the committees will
discuss the drug development program
of an investigational abuse-deterrent
opioid product.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with disabilities.
If you require accommodations due to a
disability, please contact Stephanie L.
Begansky at least 7 days in advance of
the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: March 9, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical
Programs.
[FR Doc. 2016–05748 Filed 3–14–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0819]
Determination That KENALOG
(Triamcinolone Acetonide) Lotion and
Other Drug Products 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 the drug products listed
in this document were not withdrawn
from sale for reasons of safety or
effectiveness. This determination means
that FDA will not begin procedures to
withdraw approval of abbreviated new
drug applications (ANDAs) that refer to
these drug products, and it will allow
FDA to continue to approve ANDAs that
refer to the products as long as they
SUMMARY:
PO 00000
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13797
meet relevant legal and regulatory
requirements.
FOR FURTHER INFORMATION CONTACT:
Stacy Kane, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6207, Silver Spring,
MD 20993–0002, 301–796–8363,
Stacy.Kane@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 approved
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 generally known as the
‘‘Orange Book.’’ Under FDA regulations,
a drug is 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).
Under § 314.161(a) (21 CFR
314.161(a)), the Agency must determine
whether a listed drug was withdrawn
from sale for reasons of safety or
effectiveness: (1) Before an ANDA that
refers to that listed drug may be
approved, (2) whenever a listed drug is
voluntarily withdrawn from sale and
ANDAs that refer to the listed drug have
been approved, and (3) when a person
petitions for such a determination under
21 CFR 10.25(a) and 10.30. Section
314.161(d) provides that if FDA
determines that a listed drug was
withdrawn from sale for safety or
effectiveness reasons, the Agency will
initiate proceedings that could result in
the withdrawal of approval of the
ANDAs that refer to the listed drug.
FDA has become aware that the drug
products listed in the table in this
document are no longer being marketed.
E:\FR\FM\15MRN1.SGM
15MRN1
]]>Agencies
[Federal Register Volume 81, Number 50 (Tuesday, March 15, 2016)]
[Notices]
[Pages 13796-13797]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-05748]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0001]
Anesthetic and Analgesic Drug Products Advisory Committee and the
Drug Safety and Risk Management Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). At least one
portion of the meeting will be closed to the public.
Name of Committees: Anesthetic and Analgesic Drug Products Advisory
Committee and the Drug Safety and Risk Management Advisory Committee.
General Function of the Committees: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
Date and Time: The meeting will be held on May 5, 2016, from 8 a.m.
to 5 p.m.
Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-
0002. Answers to commonly asked questions including information
regarding special accommodations due to a disability, visitor parking,
and transportation may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
Contact Person: Stephanie L. Begansky, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-796-9001, FAX:
301-847-8533, email: AADPAC@fda.hhs.gov, or FDA Advisory Committee
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC
area). A notice in the Federal Register about last minute modifications
that impact a previously announced advisory committee meeting cannot
always be published quickly enough to provide timely notice. Therefore,
you should always check the Agency's Web site at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before coming to
the meeting.
Agenda: The committees will be asked to discuss new drug
application (NDA) 208653, benzhydrocodone/acetaminophen oral tablets,
submitted by KemPharm, Inc., with the proposed indication of short-term
(up to 14 days)
[[Page 13797]]
management of acute pain. The product has been formulated with the
intent to provide abuse-deterrent properties. Benzhydrocodone is a
hydrocodone prodrug which, according to the applicant, is rapidly
converted into hydrocodone by enzymes in the gastrointestinal tract.
The active drugs in this fixed-dose combination are hydrocodone and
acetaminophen. The applicant has submitted data to support abuse-
deterrent properties for this product. The committees will be asked to
discuss whether the applicant has demonstrated abuse-deterrent
properties for their product that would support labeling, and whether
the nasal route of abuse is relevant for combination products made up
of hydrocodone and acetaminophen.
FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
Procedure: On May 5, 2016, from 9:15 a.m. to 5 p.m., the meeting is
open to the public. Interested persons may present data, information,
or views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
April 21, 2016. Oral presentations from the public will be scheduled
between approximately 1:30 p.m. and 2:30 p.m. Those individuals
interested in making formal oral presentations should notify the
contact person and submit a brief statement of the general nature of
the evidence or arguments they wish to present, the names and addresses
of proposed participants, and an indication of the approximate time
requested to make their presentation on or before April 13, 2016. Time
allotted for each presentation may be limited. If the number of
registrants requesting to speak is greater than can be reasonably
accommodated during the scheduled open public hearing session, FDA may
conduct a lottery to determine the speakers for the scheduled open
public hearing session. The contact person will notify interested
persons regarding their request to speak by April 14, 2016.
Closed Presentation of Data: On May 5, 2016, from 8 a.m. to 9:15
a.m., the meeting will be closed to permit discussion and review of
trade secret and/or confidential commercial information (5 U.S.C.
552b(c)(4)). During this session, the committees will discuss the drug
development program of an investigational abuse-deterrent opioid
product.
Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact Stephanie L. Begansky at least 7 days in advance of the
meeting.
FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: March 9, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-05748 Filed 3-14-16; 8:45 am]
BILLING CODE 4164-01-P
