82 FR 28329 - Awards Unsolicited Proposal for the Professionalism and Integrity in Research Program
DEPARTMENT OF HEALTH AND HUMAN SERVICES Federal Register Volume 82, Issue 118 (June 21, 2017)
Federal Register Volume 82, Issue 118 (June 21, 2017)
| Page Range | 28329-28330 | |
| FR Document | 2017-12514 |
[Federal Register Volume 82, Number 118 (Wednesday, June 21, 2017)] [Notices] [Pages 28329-28330] From the Federal Register Online [www.thefederalregister.org] [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 [email protected] 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
![Federal Register / Vol. 82, No. 118 / Wednesday, June 21, 2017 / Notices 28329
TABLE 1—Continued
Application No. Drug Applicant
ANDA 089497 .... Imipramine HCl Tablets USP, 25 mg ...................................... Par Pharmaceutical Inc.
ANDA 089628 .... Leucovorin Calcium for Injection, EQ 50 mg base/vial ........... Pharmachemie USA Inc., 323 Davis St., Northborough, MA
01532.
ANDA 089681 .... Bromfed-DM (brompheniramine maleate, dextromethorphan Wockhardt Bio AG, c/o Morton Grove Pharmaceuticals, Inc.,
hydrobromide, and pseudoephedrine HCl) Syrup, 2 mg/5 6451 Main St., Morton Grove, IL 60053.
mL; 10mg/5 mL; 30mg/5 mL.
ANDA 089915 .... Leucovorin Calcium for Injection, EQ 100 mg base/vial ......... Pharmachemie USA Inc.
ANDA 090098 .... Tretinoin Cream USP, 0.0375% .............................................. Allergan Sales, LLC.
ANDA 090137 .... Irinotecan HCl Injection, 40 mg/2 mL and 100 mg/5 mL ........ Sandoz Inc.
ANDA 090190 .... Pramipexole Dihydrochloride Tablets, 0.125 mg, 0.25 mg, 0.5 Do.
mg, 0.75 mg, 1 mg, and 1.5 mg.
ANDA 090220 .... Adenosine Injection USP, 3 mg/mL ......................................... Wockhardt Limited, c/o Wockhardt USA LLC, 20 Waterview
Blvd., 3rd Floor, Parsippany, NJ 07054.
ANDA 090300 .... Children’s Cetirizine HCl Allergy and Hives Relief Oral Solu- Cypress Pharmaceutical, Inc., 10 North Park Place, Suite
tion OTC, 5 mg/5 mL. 210, Morristown, NJ 07960.
ANDA 090751 .... Cetirizine HCl Oral Solution USP, 5 mg/5 mL ......................... Aurobindo Pharma Limited.
ANDA 090985 .... Octreotide Acetate Preservative Free Injection EQ 0.05 mg Wockhardt Limited.
base/mL, EQ 0.1 mg base/mL, and EQ 0.5 mg base/mL.
ANDA 090986 .... Octreotide Acetate Injection EQ 0.2 mg base/mL and EQ 1 Do.
mg base/mL.
ANDA 091068 .... Ceftriaxone for Injection USP, EQ 10 g base/vial ................... Agila Specialties Private Limited, c/o Agila Specialties Inc.,
201 South Main St., Suite 3, Lambertville, NJ 08530.
ANDA 091185 .... Topiramate Tablets USP, 25 mg, 50 mg, 100 mg, and 200 Hikma Pharmaceuticals.
mg.
ANDA 091293 .... Idarubicin HCl Injection, 1 mg/mL ............................................ Sandoz Inc.
ANDA 091299 .... Fluorouracil Injection USP, 2.5 g/50 mL and 5 g/100 mL ....... Do.
NDA 200045 ...... Amturnide (aliskiren hemifumarate, amlodipine, Novartis Pharmaceuticals Corp.
andhydrochlorothiazide) Tablets.
ANDA 200146 .... Doxorubicin HCl Injection USP, 2 mg/mL ................................ Sandoz Inc.
NDA 200199 ...... Topotecan Injection, EQ 1 mg base/mL, EQ 3 mg base/3 Do.
mL, and EQ 4 mg base/4 mL.
ANDA 201211 .... Bromfenac Sodium Ophthalmic Solution, EQ 0.09% acid ...... Coastal Pharmaceuticals, 1240 Sugg Parkway, Greenville,
NC 27834.
NDA 201917 ...... Incivek (telaprevir) Tablets, 375 mg ........................................ Vertex Pharmaceuticals, Inc., 50 Northern Ave., Boston, MA
02210.
NDA 202088 ...... Suprenza (phentermine HCl) Orally Disintegrating Tablets, 15 Citius Pharmaceuticals, LLC, 11 Commerce Dr., First Floor,
mg, 30 mg, and 37.5 mg. Cranford, NJ 07016.
ANDA 202209 .... Tretinoin Cream USP, 0.075% ................................................ Allergan Sales, LLC.
NDA 202513 ...... Gelnique (oxybutynin) Gel, 3% ................................................ Do.
NDA 203595 ...... Suclear (magnesium sufate, polyethylene glycol 3350, potas- Braintree Laboratories, Inc.
sium chloride, potassium sulfate, sodium bicarbonate, so-
dium chloride, and sodium sulfate) Oral Solution.
NDA 204508 ...... Clinolipid 20% (olive oil and soybean oil) USP, 16%/4% ........ Baxter Healthcare Corp.
NDA 206510 ...... Dutrebis (lamivudine and raltegravir potassium) Tablets, 150 Merck Sharp & Dohme Corp.
mg/EQ 300 mg base.
Therefore, under authority delegated Dated: June 15, 2017. ACTION: Notice of award of a single-
to the Director, Center for Drug Anna K. Abram, source unsolicited grant to Washington
Evaluation and Research, by the Deputy Commissioner for Policy, Planning, University in St. Louis, Missouri.
Commissioner, approval of the Legislation, and Analysis.
applications listed in table 1, and all SUMMARY: The Office of Research
[FR Doc. 2017–12908 Filed 6–20–17; 8:45 am]
amendments and supplements thereto, Integrity (ORI) announces the award of
BILLING CODE 4164–01–P
is hereby withdrawn. Introduction or a single-source, grant in response to an
delivery for introduction into interstate unsolicited proposal from Washington
University, St. Louis, Missouri. The
commerce of products without DEPARTMENT OF HEALTH AND proposal submitted was not solicited
approved new drug applications HUMAN SERVICES either formally or informally by any
violates section 301(a) and (d) of the
federal government official.
Federal Food, Drug, and Cosmetic Act [CFDA Number: 93.085]
(21 U.S.C. 331(a) and (d)). Drug FOR FURTHER INFORMATION CONTACT:
asabaliauskas on DSKBBXCHB2PROD with NOTICES
products that are listed in table 1 that Kathryn Partin at kathryn.partin@
Awards Unsolicited Proposal for the
are in inventory on the date that this hhs.gov or by telephone at 240–453–
Professionalism and Integrity in
notice becomes effective (see the DATES 8200.
Research Program
section) may continue to be dispensed SUPPLEMENTARY INFORMATION:
until the inventories have been depleted AGENCY: Office of Research Integrity, Recipient: Washington University, St.
or the drug products have reached their Office of the Assistant Secretary for Louis, Missouri.
expiration dates or otherwise become Health, Department of Health and Purpose of the Award: Grant to
violative, whichever occurs first. Human Services. provide remediation training through
VerDate Sep<11>2014 19:12 Jun 20, 2017 Jkt 241001 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 E:\FR\FM\21JNN1.SGM 21JNN1](https://thefederalregister.org/doc/82_FR_28447/page/1.svg)
![28330 Federal Register / Vol. 82, No. 118 / Wednesday, June 21, 2017 / Notices
the Professionalism and Integrity in Legislative Authority: Sec. 301 of the DEPARTMENT OF HEALTH AND
Research Program (PI Program) to Public Health Service Act, 42 U.S.C. 241. HUMAN SERVICES
promote research integrity and prevent
Kathryn M. Partin,
research misconduct. National Institutes of Health
Director of the Office of Research Integrity.
Amount of Award: $135,763 in
Federal Fiscal Year (FFY) 2017 funds [FR Doc. 2017–12514 Filed 6–20–17; 8:45 am] National Institute on Deafness and
and estimated $135,665 in FFY 2018 BILLING CODE 4150–28–P Other Communication Disorders;
funds subject to the enactment of Notice of Closed Meetings
appropriations and availability of funds. Pursuant to section 10(d) of the
DEPARTMENT OF HEALTH AND
Project Period: July 1, 2017–June 30, Federal Advisory Committee Act, as
2019. HUMAN SERVICES
amended (5 U.S.C. App.), notice is
ORI performed an objective review of National Institutes of Health hereby given of the following meetings.
the unsolicited proposal from The meetings will be closed to the
Washington University to expand and National Institute of Allergy and public in accordance with the
evaluate the Professionalism and Infectious Diseases; Notice of Closed provisions set forth in sections
Integrity in Research Program (PI Meeting 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
Program), the only remediation program as amended. The grant applications and
for researchers who violate expectations Pursuant to section 10(d) of the the discussions could disclose
for the responsible conduct of research. Federal Advisory Committee Act, as confidential trade secrets or commercial
Based on an external and internal amended (5 U.S.C. App.), notice is property such as patentable material,
review of the proposal, ORI determined hereby given of the following meeting. and personal information concerning
that it has merit. individuals associated with the grant
The meeting will be closed to the
There is a strategic importance of applications, the disclosure of which
public in accordance with the
access to this type of training. Research would constitute a clearly unwarranted
misconduct involving Public Health provisions set forth in sections
invasion of personal privacy.
Service (PHS) support is contrary to the 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and Name of Committee: National Institute on
interests of PHS and the federal Deafness and Other Communication
government, the health and safety of the the discussions could disclose
Disorders Special Emphasis Panel; Clinical
public, the integrity of research, and the confidential trade secrets or commercial Trial (U01) Review.
conservation of public funds. property such as patentable material, Date: July 10, 2017.
Participants in the PI Program will and personal information concerning Time: 4:00 p.m. to 6:00 p.m.
demonstrate better research compliance individuals associated with the grant Agenda: To review and evaluate grant
and integrity outcomes, such as applications, the disclosure of which applications.
developing better, more ethical research would constitute a clearly unwarranted Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
practices. These outcomes will promote invasion of personal privacy. Boulevard, Rockville, MD 20852 (Telephone
research integrity and help prevent Name of Committee: National Institute of Conference Call).
future research misconduct. Allergy and Infectious Diseases Special Contact Person: Kausik Ray, Ph.D.,
This award is being made non- Emphasis Panel; Partnerships for Scientific Review Officer, National Institute
competitively because there is no Development of Vaccines to Prevent on Deafness and Other Communication
current, pending, or planned funding Mycobacterium Tuberculosis and or Disorders, National Institutes of Health,
opportunity announcement under Rockville, MD 20850, 301–402–3587, rayk@
Tuberculosis Disease.
nidcd.nih.gov.
which this proposal could be competed. Date: July 18–20, 2017.
ORI has identified three additional key Time: 9:00 a.m. to 5:00 p.m. Name of Committee: National Institute on
Deafness and Other Communication
reasons to support rationale for Agenda: To review and evaluate grant
Disorders Special Emphasis Panel.
awarding this unsolicited proposal: applications. Date: July 24, 2017.
1. ORI’s federal regulation directs us Place: National Institutes of Health, 5601 Time: 10:30 a.m. to 12:00 p.m.
to focus on remediation of Respondents Fishers Lane, Rockville, MD 20892 Agenda: To review and evaluate grant
who have been found to commit (Telephone Conference Call). applications.
research misconduct, and the PI Contact Person: Amir E. Zeituni, Ph.D., Place: National Institutes of Health,
Program permits a pathway for that Scientific Review Officer, Scientific Review Neuroscience Center, 6001 Executive
remediation after any sanctions have Program, Division of Extramural Activities, Boulevard, Rockville, MD 20852 (Telephone
NIAID/NIH/DHHS, 5601 Fishers Lane, MSC– Conference Call).
been completed. Contact Person: Shiguang Yang, DVM,
9834, Rockville, MD 20852, 301–496–2550,
2. Washington University is uniquely Ph.D., Scientific Review Officer, Division of
amir.zeituni@nih.gov.
positioned to provide this type of Extramural Activities, NIDCD, NIH, 6001
training. As the only remediation (Catalogue of Federal Domestic Assistance Executive Blvd., Room 8349, Bethesda, MD
program for researchers, the grantee has Program Nos. 93.855, Allergy, Immunology, 20892, 301–496–8683, yangshi@
developed a comprehensive and and Transplantation Research; 93.856, nidcd.nih.gov.
intensive program that will improve Microbiology and Infectious Diseases (Catalogue of Federal Domestic Assistance
research compliance and integrity Research, National Institutes of Health, HHS) Program Nos. 93.173, Biological Research
asabaliauskas on DSKBBXCHB2PROD with NOTICES
outcomes. Dated: June 15, 2017. Related to Deafness and Communicative
Disorders, National Institutes of Health, HHS)
3. With this experience, Washington Natasha M. Copeland,
University is well known in the research Dated: June 15, 2017.
Program Analyst, Office of Federal Advisory
community and is an important service Committee Policy. Sylvia L. Neal,
to PHS funded institutions. The [FR Doc. 2017–12873 Filed 6–20–17; 8:45 am] Program Analyst, Office of Federal Advisory
program has a robust and unique Committee Policy.
BILLING CODE 4140–01–P
process for assessment and data [FR Doc. 2017–12875 Filed 6–20–17; 8:45 am]
analysis. BILLING CODE 4140–01–P
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Document Created: 2018-11-14 10:08:38
Document Modified: 2018-11-14 10:08:38
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of award of a single-source unsolicited grant to Washington University in St. Louis, Missouri. | |
| Contact | Kathryn Partin at [email protected] or by telephone at 240-453-8200. | |
| FR Citation | 82 FR 28329 |
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