80 FR 32967 - Center for Scientific Review: Notice of Closed Meetings

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 80, Issue 111 (June 10, 2015)

Page Range		32967-32968
FR Document		2015-14186

Federal Register, Volume 80 Issue 111 (Wednesday, June 10, 2015)

[Federal Register Volume 80, Number 111 (Wednesday, June 10, 2015)]
[Notices]
[Pages 32967-32968]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-14186]


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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., 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; Member Conflicts: Infectious, Reproductive, Asthma, and 
Pulmonary Conditions.
    Date: July 2, 2015.
    Time: 12 p.m. to 3 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: Ellen K. Schwartz, Ed.D., Scientific Review 
Officer, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 3144, MSC 7770, Bethesda, MD 
20892, 301-828-6146, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis 
Panel; Bioengineering Sciences Member Conflict.
    Date: July 7-9, 2015.
    Time: 12 p.m. to 5 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, 6701 Rockledge Drive, 
Bethesda, MD 20892, (Virtual Meeting).

[[Page 32968]]

    Contact Person: Joseph Thomas Peterson, Ph.D., Scientific Review 
Officer, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 4118, MSC 7814, Bethesda, MD 
20892, 301-408-9694, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis 
Panel; Small Business: Radiation Therapy and Biology SBIR/STTR.
    Date: July 8-9, 2015.
    Time: 8 a.m. to 5 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, 6701 Rockledge Drive, 
Bethesda, MD 20892, (Virtual Meeting).
    Contact Person: Bo Hong, Ph.D., Scientific Review Officer, 
Center for Scientific Review, National Institutes of Health, 6701 
Rockledge Drive, Room 6194, MSC 7804, Bethesda, MD 20892, 301-996-
6208, [email protected].

(Catalogue of Federal Domestic Assistance Program Nos. 93.306, 
Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 
93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893, 
National Institutes of Health, HHS)

     Dated: June 5, 2015.
Anna Snouffer,
Deputy Director, Office of Federal Advisory Committee Policy.
[FR Doc. 2015-14186 Filed 6-9-15; 8:45 am]
 BILLING CODE 4140-01-P

Federal Register / Vol. 80, No. 111 / Wednesday, June 10, 2015 / Notices 32967

As described in this document, the Therefore, under section 505(e) of the MSC7846, Bethesda, MD 20892, (301) 435–
application holders agreed to Federal Food, Drug, and Cosmetic Act 1021, rovescaa@mail.nih.gov.
voluntarily remove their respective 32 (FD&C Act) (21 U.S.C. 355(e)) and 21 This notice is being published less than 15
mg, single IV dose ondansetron CFR 314.150(d), and under authority days prior to the meeting due to the timing
products from the market, and requested delegated by the Commissioner to the limitations imposed by the review and
funding cycle.
that FDA withdraw approval of their Director, Center for Drug Evaluation and
respective applications (listed in the Research, approval of the applications (Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
preceding table) under § 314.150(d) (21 listed in the table of this document, and 93.333, Clinical Research, 93.306, 93.333,
CFR 314.150(d)). On December 4, 2012, all amendments and supplements 93.337, 93.393–93.396, 93.837–93.844,
FDA issued an updated Drug Safety thereto, is withdrawn (see DATES). 93.846–93.878, 93.892, 93.893, National
Communication alerting health care Distribution of these products in Institutes of Health, HHS)
professionals that these products would interstate commerce without an Dated: June 5, 2015.
be removed from the market because of approved application is illegal and
Anna Snouffer,
their potential for serious cardiac risks. subject to regulatory action (see sections
Baxter’s Ondansetron (ondansetron Deputy Director, Office of Federal Advisory
505(a) and 301(d) of the FD&C Act (21
HCl) Injection, USP in PL 2408 Plastic Committee Policy.
U.S.C. 355(a) and 331(d)). The Agency
Container, 32 mg/50 mL, single IV dose, [FR Doc. 2015–14185 Filed 6–9–15; 8:45 am]
will remove these products from the list
was approved in NDA 021915 on of drug products with effective BILLING CODE 4140–01–P
December 27, 2006. In a letter dated approvals published in FDA’s
November 27, 2012, Baxter requested ‘‘Approved Drug Products With
withdrawal of NDA 021915 under 21 DEPARTMENT OF HEALTH AND
Therapeutic Equivalence Evaluations,’’
CFR 314.150(d), and waived its HUMAN SERVICES
generally referred to as the ‘‘Orange
opportunity for a hearing provided Book.’’
under § 314.150(a). In a letter dated National Institutes of Health
September 5, 2012, Baxter notified FDA Dated: June 4, 2015.
Leslie Kux, Center for Scientific Review: Notice of
that the product was being Closed Meetings
discontinued. In a contemporaneous Associate Commissioner for Policy.
notice, FDA is announcing its [FR Doc. 2015–14144 Filed 6–9–15; 8:45 am] Pursuant to section 10(d) of the
determination that the product was BILLING CODE 4164–01–P Federal Advisory Committee Act, as
withdrawn from sale for reasons of amended (5 U.S.C. App.), notice is
safety or effectiveness and that FDA will hereby given of the following meetings.
not accept or approve ANDAs that refer DEPARTMENT OF HEALTH AND The meetings will be closed to the
to this drug product. HUMAN SERVICES public in accordance with the
Hospira’s ondansetron HCl Injection provisions set forth in sections
32 mg/50 mL, single IV dose was National Institutes of Health 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
approved in ANDA 077348 on February as amended. The grant applications and
1, 2007. In a letter dated January 31, Center for Scientific Review; Notice of the discussions could disclose
2013, Hospira requested withdrawal of Closed Meeting confidential trade secrets or commercial
ANDA 077348 under 21 CFR property such as patentable material,
Pursuant to section 10(d) of the
314.150(d), and waived its opportunity and personal information concerning
Federal Advisory Committee Act, as
for a hearing provided under individuals associated with the grant
amended (5 U.S.C. App.), notice is
§ 314.150(a). applications, the disclosure of which
Teva’s ondansetron HCl Injection 32 hereby given of the following meeting.
would constitute a clearly unwarranted
mg/50 mL, single IV dose was approved The meeting will be closed to the invasion of personal privacy.
in ANDA 077480 on November 22, public in accordance with the
Name of Committee: Center for Scientific
2006. In a letter dated November 20, provisions set forth in sections
Review Special Emphasis Panel; Member
2012, Teva requested withdrawal of 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Conflicts: Infectious, Reproductive, Asthma,
ANDA 077480 under 21 CFR as amended. The grant applications and and Pulmonary Conditions.
314.150(d), and waived its opportunity the discussions could disclose Date: July 2, 2015.
for a hearing provided under confidential trade secrets or commercial Time: 12 p.m. to 3 p.m.
§ 314.150(a). property such as patentable material, Agenda: To review and evaluate grant
Bedford’s ondansetron HCl Injection and personal information concerning applications.
32 mg/50 mL, single IV dose was individuals associated with the grant Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
approved in ANDA 078291 on April 13, applications, the disclosure of which
(Telephone Conference Call).
2009. In a letter dated April 4, 2014, would constitute a clearly unwarranted Contact Person: Ellen K. Schwartz, Ed.D.,
Bedford requested withdrawal of ANDA invasion of personal privacy. Scientific Review Officer, Center for
078291, under 21 CFR 314.150(d), and Name of Committee: Center for Scientific Scientific Review, National Institutes of
waived its opportunity for a hearing Review Special Emphasis Panel, Member Health, 6701 Rockledge Drive, Room 3144,
provided under § 314.150(a). Conflict: Dry Eye and Lacrimal Gland. MSC 7770, Bethesda, MD 20892, 301–828–
Claris’s ondansetron HCl Injection 32 Date: June 15, 2015. 6146, schwarel@mail.nih.gov.
mg/50 mL, single IV dose, was approved Time: 4:00 p.m. to 6:00 p.m. Name of Committee: Center for Scientific
asabaliauskas on DSK5VPTVN1PROD with NOTICES

in ANDA 078308 on March 17, 2008. In Agenda: To review and evaluate grant Review Special Emphasis Panel;
a letter dated November 16, 2012, applications. Bioengineering Sciences Member Conflict.
Place: National Institutes of Health, 6701 Date: July 7–9, 2015.
through its U.S. agent, CUSTOpharm,
Rockledge Drive, Bethesda, MD 20892, Time: 12 p.m. to 5 p.m.
Inc., Claris requested withdrawal of (Telephone Conference Call). Agenda: To review and evaluate grant
ANDA 078308 under 21 CFR Contact Person: Alessandra C Rovescalli, applications.
314.150(d), and waived its opportunity Ph.D., Scientific Review Officer, National Place: National Institutes of Health, 6701
for a hearing provided under Institutes of Health, Center for Scientific Rockledge Drive, Bethesda, MD 20892,
§ 314.150(a). Review, 6701 Rockledge Drive, Rm 5205 (Virtual Meeting).

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32968 Federal Register / Vol. 80, No. 111 / Wednesday, June 10, 2015 / Notices

Contact Person: Joseph Thomas Peterson, information collection that were Health operates ClinicalTrials.gov,
Ph.D., Scientific Review Officer, Center for proposed in the Notice of Proposed which was established as a clinical trial
Scientific Review, National Institutes of Rulemaking on Clinical Trial registry under section 113 of the Food
Health, 6701 Rockledge Drive, Room 4118,
Registration and Results Submission and Drug Administration Modernization
MSC 7814, Bethesda, MD 20892, 301–408–
9694, petersonjt@csr.nih.gov. that was issued on November 21, 2014 Act of 1997 (Pub. L. 105–115) and was
Name of Committee: Center for Scientific
(79 FR 225, Nov. 21, 2014). expanded to include a results data bank
Review Special Emphasis Panel; Small Written comments and/or suggestions by Title VIII of the Food and Drug
Business: Radiation Therapy and Biology from the public and affected agencies Administration Amendments Act of
SBIR/STTR. are invited on one or more of the 2007 (FDAAA). ClinicalTrials.gov
Date: July 8–9, 2015. following points: (1) Whether the collects registration and results
Time: 8 a.m. to 5 p.m. proposed collection of information is information for clinical trials and other
Agenda: To review and evaluate grant necessary for the proper performance of
applications. types of clinical studies (e.g.,
the function of the agency, including observational studies and patient
Place: National Institutes of Health, 6701 whether the information will have
Rockledge Drive, Bethesda, MD 20892, registries) with the objectives of
(Virtual Meeting). practical utility; (2) The accuracy of the
enhancing patient enrollment and
Contact Person: Bo Hong, Ph.D., Scientific agency’s estimate of the burden of the
providing a mechanism for tracking
Review Officer, Center for Scientific Review, proposed collection of information,
including the validity of the subsequent progress of clinical studies,
National Institutes of Health, 6701 Rockledge
Drive, Room 6194, MSC 7804, Bethesda, MD methodology and assumptions used; (3) to the benefit of public health. It is
20892, 301–996–6208, hongb@csr.nih.gov. Ways to enhance the quality, utility, and widely used by patients, physicians,
(Catalogue of Federal Domestic Assistance clarity of the information to be and medical researchers; in particular
Program Nos. 93.306, Comparative Medicine; collected; and (4) Ways to minimize the those involved in clinical research.
93.333, Clinical Research, 93.306, 93.333, burden of the collection of information While many clinical studies are
93.337, 93.393–93.396, 93.837–93.844, registered and submit results
on those who are to respond, including
93.846–93.878, 93.892, 93.893, National information voluntarily, FDAAA
Institutes of Health, HHS) the use of appropriate automated,
electronic, mechanical, or other requires the registration of certain
Dated: June 5, 2015. technological collection techniques or applicable clinical trials of drugs and
Anna Snouffer, other forms of information technology. devices and the submission of results
Deputy Director, Office of Federal Advisory To Submit Comments and For Further information for completed applicable
Committee Policy. Information: To obtain a copy of the clinical trials of drugs and devices that
[FR Doc. 2015–14186 Filed 6–9–15; 8:45 am] data collection plans and instruments, are approved, licensed, or cleared by the
BILLING CODE 4140–01–P submit comments in writing, or request Food and Drug Administration.
more information on the proposed Beginning in 2009, results information
project, contact: David Sharlip, Office of was required to include information
DEPARTMENT OF HEALTH AND Administrative and Management about serious and frequent adverse
HUMAN SERVICES Analysis Services, National Library of events.
Medicine, Building 38A, Room B2N12, This extension request does not
National Institutes of Health
8600 Rockville Pike, Bethesda, MD include any changes to the information
Proposed collection; 60-day comment 20894, or call non-toll-free number (301) submission requirements for
request Information Program on 402–9680, or Email your request, ClinicalTrials.gov that were proposed in
Clinical Trials: Maintaining a Registry including your address to: sharlipd@ the Notice of Proposed Rulemaking on
and Results Databank (NLM) mail.nih.gov Formal requests for Clinical Trial Registration and Results
additional plans and instruments must Submission that was issued on
SUMMARY: In compliance with the be requested in writing. November 21, 2014 and for which the
requirement of section 3506(c)(2)(A) of Comment Due Date: Comments
the Paperwork Reduction Act of 1995, public comment period closed on March
regarding this information collection are 23, 2015 (79 FR 225, Nov. 21, 2014). The
for opportunity for public comment on best assured of having their full effect if
proposed data collection projects, the NIH is continuing to review submitted
received within 60 days of the date of public comments as it prepares the final
National Library of Medicine (NLM), this publication.
National Institutes of Health (NIH), will rule. The NIH will make any
Proposed Collection: Information
publish periodic summaries of proposed corresponding changes to the
Program on Clinical Trials: Maintaining
projects to be submitted to the Office of ClinicalTrials.gov information
a Registry and Results Databank (NLM),
Management and Budget (OMB) for collection via separate procedure.
0925–0586, Expiration Date: 08/31/
review and approval. This summary 2015, EXTENSION, National Library of OMB approval is requested for 3
describes the existing information Medicine (NLM), National Institutes of years. The total estimated annualized
collection at ClinicalTrials.gov, for Health (NIH). cost to respondents is $49,399,851. The
which an extension is requested; it does Need and Use of Information total estimated annualized burden hours
not include any changes to the Collection: The National Institutes of are 682,535.

ESTIMATED ANNUALIZED BURDEN HOURS
asabaliauskas on DSK5VPTVN1PROD with NOTICES

Number of Average Annual
Number of
Submission type response per time per hour
respondents respondent response burden

PRS Account ................................................................................................... 5,700 1 15/60 1,425
Initial Registration ............................................................................................ 23,000 1 7 161,000
Updates ............................................................................................................ 23,000 8 2 368,000
Initial Results ................................................................................................... 3,700 1 25 92,500
Updates ............................................................................................................ 3,700 2 8 59,200

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Document Created: 2015-12-15 15:17:33
Document Modified: 2015-12-15 15:17:33

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
Dates		July 2, 2015.
FR Citation		80 FR 32967

80 FR 32967 - Center for Scientific Review: Notice of Closed Meetings

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 80, Issue 111 (June 10, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health