Awards Unsolicited Proposal for the Professionalism and Integrity in Research Program, 28329-28330 [2017-12514]
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Federal Register / Vol. 82, No. 118 / Wednesday, June 21, 2017 / Notices
28329
TABLE 1—Continued
Application No.
Drug
Applicant
ANDA 089497 ....
ANDA 089628 ....
Imipramine HCl Tablets USP, 25 mg ......................................
Leucovorin Calcium for Injection, EQ 50 mg base/vial ...........
ANDA 089681 ....
Bromfed-DM (brompheniramine maleate, dextromethorphan
hydrobromide, and pseudoephedrine HCl) Syrup, 2 mg/5
mL; 10mg/5 mL; 30mg/5 mL.
Leucovorin Calcium for Injection, EQ 100 mg base/vial .........
Tretinoin Cream USP, 0.0375% ..............................................
Irinotecan HCl Injection, 40 mg/2 mL and 100 mg/5 mL ........
Pramipexole Dihydrochloride Tablets, 0.125 mg, 0.25 mg, 0.5
mg, 0.75 mg, 1 mg, and 1.5 mg.
Adenosine Injection USP, 3 mg/mL .........................................
Par Pharmaceutical Inc.
Pharmachemie USA Inc., 323 Davis St., Northborough, MA
01532.
Wockhardt Bio AG, c/o Morton Grove Pharmaceuticals, Inc.,
6451 Main St., Morton Grove, IL 60053.
ANDA
ANDA
ANDA
ANDA
089915
090098
090137
090190
....
....
....
....
ANDA 090220 ....
ANDA 090300 ....
ANDA 090751 ....
ANDA 090985 ....
ANDA 090986 ....
ANDA 091068 ....
ANDA 091185 ....
Children’s Cetirizine HCl Allergy and Hives Relief Oral Solution OTC, 5 mg/5 mL.
Cetirizine HCl Oral Solution USP, 5 mg/5 mL .........................
Octreotide Acetate Preservative Free Injection EQ 0.05 mg
base/mL, EQ 0.1 mg base/mL, and EQ 0.5 mg base/mL.
Octreotide Acetate Injection EQ 0.2 mg base/mL and EQ 1
mg base/mL.
Ceftriaxone for Injection USP, EQ 10 g base/vial ...................
ANDA 201211 ....
Topiramate Tablets USP, 25 mg, 50 mg, 100 mg, and 200
mg.
Idarubicin HCl Injection, 1 mg/mL ............................................
Fluorouracil Injection USP, 2.5 g/50 mL and 5 g/100 mL .......
Amturnide
(aliskiren
hemifumarate,
amlodipine,
andhydrochlorothiazide) Tablets.
Doxorubicin HCl Injection USP, 2 mg/mL ................................
Topotecan Injection, EQ 1 mg base/mL, EQ 3 mg base/3
mL, and EQ 4 mg base/4 mL.
Bromfenac Sodium Ophthalmic Solution, EQ 0.09% acid ......
NDA 201917 ......
Incivek (telaprevir) Tablets, 375 mg ........................................
NDA 202088 ......
Suprenza (phentermine HCl) Orally Disintegrating Tablets, 15
mg, 30 mg, and 37.5 mg.
Tretinoin Cream USP, 0.075% ................................................
Gelnique (oxybutynin) Gel, 3% ................................................
Suclear (magnesium sufate, polyethylene glycol 3350, potassium chloride, potassium sulfate, sodium bicarbonate, sodium chloride, and sodium sulfate) Oral Solution.
Clinolipid 20% (olive oil and soybean oil) USP, 16%/4% ........
Dutrebis (lamivudine and raltegravir potassium) Tablets, 150
mg/EQ 300 mg base.
ANDA 091293 ....
ANDA 091299 ....
NDA 200045 ......
ANDA 200146 ....
NDA 200199 ......
ANDA 202209 ....
NDA 202513 ......
NDA 203595 ......
asabaliauskas on DSKBBXCHB2PROD with NOTICES
NDA 204508 ......
NDA 206510 ......
Therefore, under authority delegated
to the Director, Center for Drug
Evaluation and Research, by the
Commissioner, approval of the
applications listed in table 1, and all
amendments and supplements thereto,
is hereby withdrawn. Introduction or
delivery for introduction into interstate
commerce of products without
approved new drug applications
violates section 301(a) and (d) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 331(a) and (d)). Drug
products that are listed in table 1 that
are in inventory on the date that this
notice becomes effective (see the DATES
section) may continue to be dispensed
until the inventories have been depleted
or the drug products have reached their
expiration dates or otherwise become
violative, whichever occurs first.
VerDate Sep<11>2014
19:12 Jun 20, 2017
Jkt 241001
Pharmachemie USA Inc.
Allergan Sales, LLC.
Sandoz Inc.
Do.
Wockhardt Limited, c/o Wockhardt USA LLC, 20 Waterview
Blvd., 3rd Floor, Parsippany, NJ 07054.
Cypress Pharmaceutical, Inc., 10 North Park Place, Suite
210, Morristown, NJ 07960.
Aurobindo Pharma Limited.
Wockhardt Limited.
Do.
Agila Specialties Private Limited, c/o Agila Specialties Inc.,
201 South Main St., Suite 3, Lambertville, NJ 08530.
Hikma Pharmaceuticals.
Sandoz Inc.
Do.
Novartis Pharmaceuticals Corp.
Sandoz Inc.
Do.
Coastal Pharmaceuticals, 1240 Sugg Parkway, Greenville,
NC 27834.
Vertex Pharmaceuticals, Inc., 50 Northern Ave., Boston, MA
02210.
Citius Pharmaceuticals, LLC, 11 Commerce Dr., First Floor,
Cranford, NJ 07016.
Allergan Sales, LLC.
Do.
Braintree Laboratories, Inc.
Baxter Healthcare Corp.
Merck Sharp & Dohme Corp.
Dated: June 15, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–12908 Filed 6–20–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[CFDA Number: 93.085]
Awards Unsolicited Proposal for the
Professionalism and Integrity in
Research Program
Notice of award of a singlesource unsolicited grant to Washington
University in St. Louis, Missouri.
ACTION:
The Office of Research
Integrity (ORI) announces the award of
a single-source, grant in response to an
unsolicited proposal from Washington
University, St. Louis, Missouri. The
proposal submitted was not solicited
either formally or informally by any
federal government official.
FOR FURTHER INFORMATION CONTACT:
Kathryn Partin at kathryn.partin@
hhs.gov or by telephone at 240–453–
8200.
SUMMARY:
SUPPLEMENTARY INFORMATION:
Office of Research Integrity,
Office of the Assistant Secretary for
Health, Department of Health and
Human Services.
AGENCY:
PO 00000
Frm 00036
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Sfmt 4703
Recipient: Washington University, St.
Louis, Missouri.
Purpose of the Award: Grant to
provide remediation training through
E:\FR\FM\21JNN1.SGM
21JNN1
asabaliauskas on DSKBBXCHB2PROD with NOTICES
28330
Federal Register / Vol. 82, No. 118 / Wednesday, June 21, 2017 / Notices
the Professionalism and Integrity in
Research Program (PI Program) to
promote research integrity and prevent
research misconduct.
Amount of Award: $135,763 in
Federal Fiscal Year (FFY) 2017 funds
and estimated $135,665 in FFY 2018
funds subject to the enactment of
appropriations and availability of funds.
Project Period: July 1, 2017–June 30,
2019.
ORI performed an objective review of
the unsolicited proposal from
Washington University to expand and
evaluate the Professionalism and
Integrity in Research Program (PI
Program), the only remediation program
for researchers who violate expectations
for the responsible conduct of research.
Based on an external and internal
review of the proposal, ORI determined
that it has merit.
There is a strategic importance of
access to this type of training. Research
misconduct involving Public Health
Service (PHS) support is contrary to the
interests of PHS and the federal
government, the health and safety of the
public, the integrity of research, and the
conservation of public funds.
Participants in the PI Program will
demonstrate better research compliance
and integrity outcomes, such as
developing better, more ethical research
practices. These outcomes will promote
research integrity and help prevent
future research misconduct.
This award is being made noncompetitively because there is no
current, pending, or planned funding
opportunity announcement under
which this proposal could be competed.
ORI has identified three additional key
reasons to support rationale for
awarding this unsolicited proposal:
1. ORI’s federal regulation directs us
to focus on remediation of Respondents
who have been found to commit
research misconduct, and the PI
Program permits a pathway for that
remediation after any sanctions have
been completed.
2. Washington University is uniquely
positioned to provide this type of
training. As the only remediation
program for researchers, the grantee has
developed a comprehensive and
intensive program that will improve
research compliance and integrity
outcomes.
3. With this experience, Washington
University is well known in the research
community and is an important service
to PHS funded institutions. The
program has a robust and unique
process for assessment and data
analysis.
VerDate Sep<11>2014
19:12 Jun 20, 2017
Jkt 241001
Legislative Authority: Sec. 301 of the
Public Health Service Act, 42 U.S.C. 241.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Kathryn M. Partin,
Director of the Office of Research Integrity.
National Institutes of Health
[FR Doc. 2017–12514 Filed 6–20–17; 8:45 am]
BILLING CODE 4150–28–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious 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 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.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; Partnerships for
Development of Vaccines to Prevent
Mycobacterium Tuberculosis and or
Tuberculosis Disease.
Date: July 18–20, 2017.
Time: 9:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 5601
Fishers Lane, Rockville, MD 20892
(Telephone Conference Call).
Contact Person: Amir E. Zeituni, Ph.D.,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
NIAID/NIH/DHHS, 5601 Fishers Lane, MSC–
9834, Rockville, MD 20852, 301–496–2550,
amir.zeituni@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: June 15, 2017.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2017–12873 Filed 6–20–17; 8:45 am]
BILLING CODE 4140–01–P
PO 00000
National Institute on Deafness and
Other Communication Disorders;
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.,
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: National Institute on
Deafness and Other Communication
Disorders Special Emphasis Panel; Clinical
Trial (U01) Review.
Date: July 10, 2017.
Time: 4:00 p.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Telephone
Conference Call).
Contact Person: Kausik Ray, Ph.D.,
Scientific Review Officer, National Institute
on Deafness and Other Communication
Disorders, National Institutes of Health,
Rockville, MD 20850, 301–402–3587, rayk@
nidcd.nih.gov.
Name of Committee: National Institute on
Deafness and Other Communication
Disorders Special Emphasis Panel.
Date: July 24, 2017.
Time: 10:30 a.m. to 12:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Telephone
Conference Call).
Contact Person: Shiguang Yang, DVM,
Ph.D., Scientific Review Officer, Division of
Extramural Activities, NIDCD, NIH, 6001
Executive Blvd., Room 8349, Bethesda, MD
20892, 301–496–8683, yangshi@
nidcd.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.173, Biological Research
Related to Deafness and Communicative
Disorders, National Institutes of Health, HHS)
Dated: June 15, 2017.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2017–12875 Filed 6–20–17; 8:45 am]
BILLING CODE 4140–01–P
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21JNN1
Agencies
[Federal Register Volume 82, Number 118 (Wednesday, June 21, 2017)]
[Notices]
[Pages 28329-28330]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-12514]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[CFDA Number: 93.085]
Awards Unsolicited Proposal for the Professionalism and Integrity
in Research Program
AGENCY: Office of Research Integrity, Office of the Assistant Secretary
for Health, Department of Health and Human Services.
ACTION: Notice of award of a single-source unsolicited grant to
Washington University in St. Louis, Missouri.
-----------------------------------------------------------------------
SUMMARY: The Office of Research Integrity (ORI) announces the award of
a single-source, grant in response to an unsolicited proposal from
Washington University, St. Louis, Missouri. The proposal submitted was
not solicited either formally or informally by any federal government
official.
FOR FURTHER INFORMATION CONTACT: Kathryn Partin at
kathryn.partin@hhs.gov or by telephone at 240-453-8200.
SUPPLEMENTARY INFORMATION:
Recipient: Washington University, St. Louis, Missouri.
Purpose of the Award: Grant to provide remediation training through
[[Page 28330]]
the Professionalism and Integrity in Research Program (PI Program) to
promote research integrity and prevent research misconduct.
Amount of Award: $135,763 in Federal Fiscal Year (FFY) 2017 funds
and estimated $135,665 in FFY 2018 funds subject to the enactment of
appropriations and availability of funds.
Project Period: July 1, 2017-June 30, 2019.
ORI performed an objective review of the unsolicited proposal from
Washington University to expand and evaluate the Professionalism and
Integrity in Research Program (PI Program), the only remediation
program for researchers who violate expectations for the responsible
conduct of research. Based on an external and internal review of the
proposal, ORI determined that it has merit.
There is a strategic importance of access to this type of training.
Research misconduct involving Public Health Service (PHS) support is
contrary to the interests of PHS and the federal government, the health
and safety of the public, the integrity of research, and the
conservation of public funds. Participants in the PI Program will
demonstrate better research compliance and integrity outcomes, such as
developing better, more ethical research practices. These outcomes will
promote research integrity and help prevent future research misconduct.
This award is being made non-competitively because there is no
current, pending, or planned funding opportunity announcement under
which this proposal could be competed. ORI has identified three
additional key reasons to support rationale for awarding this
unsolicited proposal:
1. ORI's federal regulation directs us to focus on remediation of
Respondents who have been found to commit research misconduct, and the
PI Program permits a pathway for that remediation after any sanctions
have been completed.
2. Washington University is uniquely positioned to provide this
type of training. As the only remediation program for researchers, the
grantee has developed a comprehensive and intensive program that will
improve research compliance and integrity outcomes.
3. With this experience, Washington University is well known in the
research community and is an important service to PHS funded
institutions. The program has a robust and unique process for
assessment and data analysis.
Legislative Authority: Sec. 301 of the Public Health Service
Act, 42 U.S.C. 241.
Kathryn M. Partin,
Director of the Office of Research Integrity.
[FR Doc. 2017-12514 Filed 6-20-17; 8:45 am]
BILLING CODE 4150-28-P