Awards Unsolicited Proposal for the Professionalism and Integrity in Research Program, 28329-28330 [2017-12514]

Download as PDF 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 Fmt 4703 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 Frm 00037 Fmt 4703 Sfmt 9990 E:\FR\FM\21JNN1.SGM 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
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