Center for Scientific Review; Notice of Closed Meetings, 27335-27336 [2019-12365]
Download as PDF
<![CDATA[
27335
Federal Register / Vol. 84, No. 113 / Wednesday, June 12, 2019 / Notices
drugs. These incentives are only
available to sponsors whose drugs are
‘‘MUMS-designated’’ by FDA. Minor use
drugs are drugs for use in major species
(e.g., cattle, horses, swine, chickens,
turkeys, dogs, and cats) that are needed
for diseases that occur in only a small
number of animals either because they
occur infrequently or in limited
geographic areas. Minor species are all
animals other than the major species
(e.g., zoo animals, ornamental fish,
parrots, ferrets, and guinea pigs). Some
animals of agricultural importance are
also minor species. These include
animals such as sheep, goats, catfish,
and honeybees. Participation in the
MUMS program is completely optional
for drug sponsors, so the associated
reporting only applies to those sponsors
who request and are subsequently
granted ‘‘MUMS designation.’’
Our regulations in 21 CFR part 516
specify the criteria and procedures for
requesting MUMS designation as well as
the annual reporting requirements for
MUMS designees. Section 516.20
provides requirements on the content
and format of a request for MUMS-drug
designation; § 516.26 provides
requirements for amending MUMS-drug
designation; § 516.27 provides for
change in sponsorship of MUMS-drug
designation; § 516.29 provides for
termination of MUMS-drug designation;
§ 516.30 contains the requirements for
annual reports from sponsor(s) of
MUMS-designated drugs; and § 516.36
sets forth consequences for insufficient
quantities of MUMS-designated drugs.
Description of Respondents: The
respondents to this information
collection are pharmaceutical
companies that sponsor new animal
drugs.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING 1
Number of
respondents
21 CFR section
516.20;
516.26;
516.27;
516.29;
516.30;
516.36;
Total annual
responses
Average
burden per
response
Total hours
content and format of MUMS request ....................
requirements for amending MUMS designation .....
change in sponsorship ............................................
termination of MUMS designation ..........................
requirements of annual reports ..............................
insufficient quantities ..............................................
15
3
1
2
15
1
5
1
1
1
5
1
75
3
1
2
75
1
16
2
1
1
2
3
1,200
6
1
2
150
3
Total ..............................................................................
........................
........................
........................
........................
1,362
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The burden estimate for this reporting
requirement was derived in our Office
of Minor Use and Minor Species Animal
Drug Development by extrapolating the
investigational new animal drug/new
animal drug application reporting
requirements for similar actions by this
same segment of the regulated industry
and from previous interactions with the
minor use/minor species community,
and has not changed since the last OMB
approval.
Dated: June 6, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–12316 Filed 6–11–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
jbell on DSK3GLQ082PROD with NOTICES
Number of
responses per
respondent
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, 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
VerDate Sep<11>2014
17:00 Jun 11, 2019
Jkt 247001
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: AIDS and Related
Research Integrated Review Group, HIV
Comorbidities and Clinical Studies Study
Section.
Date: July 9–10, 2019.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Washington Marriott Georgetown,
1221 22nd Street NW, Washington, DC
20037.
Contact Person: Dimitrios Nikolaos
Vatakis, Ph.D., Scientific Review Officer,
Center for Scientific Review, National
Institutes of Health, 6701 Rockledge Drive,
Room 3190, Bethesda, MD 20892, 301–827–
7480, dimitrios.vatakis@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel,
Fellowships: Physiology and Pathobiology of
the Vascular and Hematological Systems.
Date: July 10, 2019.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: The William F. Bolger Center, 9600
Newbridge Drive, Potomac, MD 20854.
Contact Person: Katherine M. Malinda,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
PO 00000
Frm 00105
Fmt 4703
Sfmt 4703
Health, 6701 Rockledge Drive, Room 4140,
MSC 7814, Bethesda, MD 20892, 301–435–
0912, Katherine_Malinda@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, RFA–AI–
18–054 U.S.-Brazil Collaborative Biomedical
Research Program.
Date: July 10, 2019.
Time: 9:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Jin Huang, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4095G,
MSC 7812, Bethesda, MD 20892, 301–435–
1230, jh377p@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, PAR Panel:
Clinical Pediatric and Fetal Applications.
Date: July 11, 2019.
Time: 10:00 a.m. to 5:00 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: Khalid Masood, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5120,
MSC 7854, Bethesda, MD 20892, 301–435–
2392, masoodk@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, RFA–AI–
E:\FR\FM\12JNN1.SGM
12JNN1
27336
Federal Register / Vol. 84, No. 113 / Wednesday, June 12, 2019 / Notices
18–054 U.S.-Brazil Collaborative. Biomedical
Research Program.
Date: July 11, 2019.
Time: 11:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Scott Jakes, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4198,
MSC 7812, Bethesda, MD 20892, 301–495–
1506, jakesse@mail.nih.gov.
(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 7, 2019.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–12365 Filed 6–11–19; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment
Request: The Impact of Clinical
Research Training and Medical
Education at the Clinical Center on
Physician Careers in Academia and
Clinical Research (Clinical Center)
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
In compliance with the
requirement of the Paperwork
Reduction Act of 1995, for opportunity
SUMMARY:
burden of the collection of information
on those who are to respond, including
the use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology.
Proposed Collection Title: The Impact
of Clinical Research Training and
Medical Education at the Clinical Center
on Physician Careers in Academia and
Clinical Research, OMB #0925–0602
Expiration Date: 8/31/19, Revision,
Clinical Center (CC), National Institutes
of Health (NIH).
Need and Use of Information
Collection: The information collected
will allow continued assessment of the
value of the training provided by the
Office of Clinical Research Training and
Medical Education (OCRTME) at the
NIH Clinical Center and the extent to
which this training promotes (a) patient
safety; (b) research productivity and
independence; and (c) future career
development within clinical,
translational, and academic research
settings. The information received from
respondents is presented to, evaluated
by, and incorporated into the ongoing
operational improvement efforts of the
Director of the Office of Clinical
Research Training and Education, and
the Chief Executive Officer of the NIH
Clinical Center. This information will
enable the ongoing operational
improvement efforts of the OCRTME
and its commitment to providing
clinical research training and medical
education of the highest quality to each
trainee.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours 478.
for public comment on proposed data
collection projects, the Clinical Center,
the National Institutes of Health (NIH)
will publish periodic summaries of
proposed projects to be submitted to the
Office of Management and Budget
(OMB) for review and approval.
DATES: Comments regarding this
information collection are best assured
of having their full effect if received
within 60 days of the date of this
publication.
FOR FURTHER INFORMATION CONTACT: To
obtain a copy of the data collection
plans and instruments, contact: Robert
M. Lembo, MD, Office of Clinical
Research Training and Medical
Education, NIH Clinical Center,
National Institutes of Health, 10 Center
Drive, Room 1N252C, Bethesda, MD
20892–1158, or call non-toll-free
number (301) 496–2636, or Email your
request, including your address to:
robert.lembo@nih.gov. Formal requests
for additional plans and instruments
must be requested in writing.
SUPPLEMENTARY INFORMATION: Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 requires: Written
comments and/or suggestions from the
public and affected agencies are invited
to address one or more of the following
points: (1) Whether the proposed
collection of information is necessary
for the proper performance of the
function of the agency, including
whether the information will have
practical utility; (2) The accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used; (3)
Ways to enhance the quality, utility, and
clarity of the information to be
collected; and (4) Ways to minimize the
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
jbell on DSK3GLQ082PROD with NOTICES
Form name
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total annual
burden hours
requested
CRTP/MRSP Alumni Survey ...........................................................................
Summer Internship Program Alumni Survey ...................................................
Graduate Medical Education Graduate Survey ...............................................
Clinical Electives Program 1 Year Alumni Surveys .........................................
704
280
350
100
1
1
1
1
20/60
20/60
20/60
20/60
235
93
117
33
Total ..........................................................................................................
1,434
1,434
n/a
478
Dated: June 4, 2019.
Laura M. Lee,
Project Clearance Liaison, NIH Clinical
Center, National Institutes of Health.
[FR Doc. 2019–12387 Filed 6–11–19; 8:45 am]
BILLING CODE 4140–01–P
VerDate Sep<11>2014
17:00 Jun 11, 2019
Jkt 247001
PO 00000
Frm 00106
Fmt 4703
Sfmt 9990
E:\FR\FM\12JNN1.SGM
12JNN1
]]>Agencies
[Federal Register Volume 84, Number 113 (Wednesday, June 12, 2019)]
[Notices]
[Pages 27335-27336]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-12365]
-----------------------------------------------------------------------
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, 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: AIDS and Related Research Integrated Review
Group, HIV Comorbidities and Clinical Studies Study Section.
Date: July 9-10, 2019.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Washington Marriott Georgetown, 1221 22nd Street NW,
Washington, DC 20037.
Contact Person: Dimitrios Nikolaos Vatakis, Ph.D., Scientific
Review Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3190, Bethesda, MD 20892, 301-
827-7480, [email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel, Fellowships: Physiology and Pathobiology of the Vascular and
Hematological Systems.
Date: July 10, 2019.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant applications.
Place: The William F. Bolger Center, 9600 Newbridge Drive,
Potomac, MD 20854.
Contact Person: Katherine M. Malinda, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4140, MSC 7814, Bethesda, MD
20892, 301-435-0912, [email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel, RFA-AI-18-054 U.S.-Brazil Collaborative Biomedical Research
Program.
Date: July 10, 2019.
Time: 9:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Jin Huang, Ph.D., Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 4095G, MSC 7812, Bethesda, MD 20892, 301-435-
1230, [email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel, PAR Panel: Clinical Pediatric and Fetal Applications.
Date: July 11, 2019.
Time: 10:00 a.m. to 5:00 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: Khalid Masood, Ph.D., Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 5120, MSC 7854, Bethesda, MD 20892, 301-435-
2392, [email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel, RFA-AI-
[[Page 27336]]
18-054 U.S.-Brazil Collaborative. Biomedical Research Program.
Date: July 11, 2019.
Time: 11:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Scott Jakes, Ph.D., Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 4198, MSC 7812, Bethesda, MD 20892, 301-495-
1506, [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 7, 2019.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2019-12365 Filed 6-11-19; 8:45 am]
BILLING CODE 4140-01-P
