National Heart, Lung, and Blood Institute Notice of Closed Meetings, 60920-60921 [2015-25582]
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60920
Federal Register / Vol. 80, No. 195 / Thursday, October 8, 2015 / Notices
an appropriate cover form. Form FDA
1571 must accompany submissions
under INDs and Form FDA 356h must
accompany submissions under NDAs,
ANDAs, and BLAs. Both forms have
valid OMB control numbers as follows:
FDA Form 1571—OMB control number
0910–0014, and FDA Form 356h—OMB
control number 0910–0338.
In the guidance document, CDER and
CBER ask that a request for formal
dispute resolution be submitted as an
amendment to the application for the
underlying product and that it be
submitted to the Agency in triplicate
with the appropriate form attached,
either Form FDA 1571 or Form FDA
356h. The Agency recommends that a
request be submitted as an amendment
in this manner for two reasons: To
ensure that each request is kept in the
administrative file with the entire
underlying application and to ensure
that pertinent information about the
request is entered into the appropriate
tracking databases. Use of the
information in the Agency’s tracking
databases enables the appropriate
Agency official to monitor progress on
the resolution of the dispute and to
ensure that appropriate steps will be
taken in a timely manner.
CDER and CBER have determined and
the guidance recommends that the
following information should be
submitted to the appropriate center with
each request for dispute resolution so
that the Center may quickly and
efficiently respond to the request: (1) A
brief but comprehensive statement of
each issue to be resolved, including a
description of the issue, the nature of
the issue (i.e., scientific, procedural, or
both), possible solutions based on
information in the administrative file,
whether informal dispute resolution
was sought prior to the formal appeal,
whether advisory committee review is
sought, and the expected outcome; (2) a
statement identifying the review
division/office that issued the original
decision on the matter and, if
applicable, the last Agency official that
attempted to formally resolve the
matter; (3) a list of documents in the
administrative file, or additional copies
of such documents, that are deemed
necessary for resolution of the issue(s);
and (4) a statement that the previous
supervisory level has already had the
opportunity to review all of the material
relied on for dispute resolution. The
information that the Agency suggests
submitting with a formal request for
dispute resolution consists of: (1)
Statements describing the issue from the
perspective of the person with a
dispute, (2) brief statements describing
the history of the matter, and (3) the
documents previously submitted to FDA
under an OMB approved collection of
information.
Based on FDA’s experience with
dispute resolution, the Agency expects
that most persons seeking formal
dispute resolution will have gathered
the materials listed previously when
identifying the existence of a dispute
with the Agency. Consequently, FDA
anticipates that the collection of
information attributed solely to the
guidance will be minimal.
Description of Respondents: A
sponsor, applicant, or manufacturer of a
drug or biological product regulated by
the Agency under the Federal Food,
Drug, and Cosmetic Act or section 351
of the Public Health Service Act who
requests formal resolution of a scientific
or procedural dispute.
In the Federal Register of June 2, 2015
(80 FR 31386), FDA published a 60-day
notice requesting public comment on
the proposed collection of information.
No comments were received.
Burden Estimate: Provided in this
document is an estimate of the annual
reporting burden for requests for dispute
resolution. Based on data collected from
review divisions and offices within
CDER and CBER, FDA estimates that
approximately eight sponsors and
applicants (respondents) submit
requests for formal dispute resolution to
CDER annually and approximately one
respondent submits requests for formal
dispute resolution to CBER annually.
The total annual responses are the total
number of requests submitted to CDER
and CBER in 1 year, including requests
for dispute resolution that a single
respondent submits more than one time.
FDA estimates that CDER receives
approximately 31 requests annually and
CBER receives approximately 1 request
annually. The hours per response is the
estimated number of hours that a
respondent would spend preparing the
information to be submitted with a
request for formal dispute resolution in
accordance with this guidance,
including the time it takes to gather and
copy brief statements describing the
issue from the perspective of the person
with the dispute, brief statements
describing the history of the matter, and
supporting information that has already
been submitted to the Agency. Based on
experience, FDA estimates that
approximately 8 hours on average
would be needed per response.
Therefore, FDA estimates that 8 hours
will be spent per year by respondents
requesting formal dispute resolution
under the guidance.
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
Requests for formal dispute resolution
Average
burden per
response
Total annual
responses
Total hours
CDER ...............................................................
CBER ...............................................................
8
1
2
1
31
1
8
8
248
8
Total ..........................................................
............................
............................
............................
............................
256
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1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 2, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–25623 Filed 10–7–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute Notice of Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
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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,
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Federal Register / Vol. 80, No. 195 / Thursday, October 8, 2015 / Notices
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
mstockstill on DSK4VPTVN1PROD with NOTICES
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel;
Lung Imaging Phase 2.
Date: November 2, 2015.
Time: 9:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: The River Inn, 924 25th Street NW.,
Washington, DC 20037.
Contact Person: Stephanie L. Constant,
Ph.D., Scientific Review Officer, Office of
Scientific Review/DERA National Heart,
Lung, and Blood Institute, 6701 Rockledge
Drive, Room 7189, Bethesda, MD 20892, 301–
443–8784, constantsl@nhlbi.nih.gov
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel;
SBIR Phase IIB Small Market Awards.
Date: November 4, 2015.
Time: 8:30 a.m. to 10:00 a.m.
Agenda: To review and evaluate grant
applications.
Place: Hilton Crystal City, 2399 Jefferson
Davis Hwy., Arlington, VA 22202.
Contact Person: Tony L. Creazzo, Ph.D.,
Scientific Review Officer, Office of Scientific
Review/DERA, National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive, Room
7180, Bethesda, MD 20892–7924, 301–435–
0725, creazzotl@mail.nih.gov
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel;
NHLBI SBIR Phase IIB Bridge Awards (R44).
Date: November 4, 2015.
Time: 10:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hilton Crystal City, 2399 Jefferson
Davis Hwy., Arlington, VA 22202.
Contact Person: Susan Wohler Sunnarborg,
Ph.D., Scientific Review Officer, Office of
Scientific Review/DERA, National, Heart,
Lung, and Blood Institute, 6701 Rockledge
Drive, Room 7182, Bethesda, MD 20892,
sunnarborgsw@nhlbi.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung
Diseases Research; 93.839, Blood Diseases
and Resources Research, National Institutes
of Health, HHS)
Dated: October 2, 2015.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–25582 Filed 10–7–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institutes of Health
National Institute of Environmental
Health Sciences; Notice of Closed
Meeting
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 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
Environmental Health Sciences Special
Emphasis Panel; Training for Career
Independence in Environmental Health
Sciences.
Date: November 2, 2015.
Time: 11:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Environmental
Health Sciences, Keystone Building, Room
1003A, 530 Davis Drive, Research Triangle
Park, NC 27709 (Telephone Conference Call).
Contact Person: Linda K. Bass, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, Division of Extramural Research and
Training, Nat’l Institute Environmental
Health Sciences, P.O. Box 12233, MD EC–30,
Research Triangle Park, NC 27709, (919) 541–
1307.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.115, Biometry and Risk
Estimation—Health Risks from
Environmental Exposures; 93.142, NIEHS
Hazardous Waste Worker Health and Safety
Training; 93.143, NIEHS Superfund
Hazardous Substances—Basic Research and
Education; 93.894, Resources and Manpower
Development in the Environmental Health
Sciences; 93.113, Biological Response to
Environmental Health Hazards; 93.114,
Applied Toxicological Research and Testing,
National Institutes of Health, HHS)
Dated: October 2, 2015.
Carolyn Baum,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–25583 Filed 10–7–15; 8:45 am]
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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
Conflict: Therapeutic Strategies for
Lysosomal Storage and Amino; Acid
Metabolism Disorders.
Date: November 3, 2015.
Time: 11:00 a.m. to 1:00 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: Alessandra C Rovescalli,
Ph.D., Scientific Review Officer, National
Institutes of Health, Center for Scientific
Review, 6701 Rockledge Drive, Rm 5205
MSC7846, Bethesda, MD 20892, (301) 435–
1021, rovescaa@mail.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Laboratory
for Fluorescence Dynamics.
Date: November 8–10, 2015.
Time: 9:00 a.m. to 11:00 a.m.
Agenda: To review and evaluate grant
applications.
Place: Atrium Hotel, 18700 MacArthur
Blvd., Irvine, CA 92612.
Contact Person: Mike Radtke, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4176,
MSC 7806, Bethesda, MD 20892, 301–435–
1728, radtkem@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Small
Business: Informatics.
Date: November 9, 2015.
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.
Contact Person: Claire E Gutkin, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3106,
MSC 7808, Bethesda, MD 20892, 301–594–
3139, gutkincl@csr.nih.gov.
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]]>Agencies
[Federal Register Volume 80, Number 195 (Thursday, October 8, 2015)]
[Notices]
[Pages 60920-60921]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-25582]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood Institute 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,
[[Page 60921]]
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 Heart, Lung, and Blood Institute
Special Emphasis Panel; Lung Imaging Phase 2.
Date: November 2, 2015.
Time: 9:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: The River Inn, 924 25th Street NW., Washington, DC 20037.
Contact Person: Stephanie L. Constant, Ph.D., Scientific Review
Officer, Office of Scientific Review/DERA National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive, Room 7189, Bethesda, MD
20892, 301-443-8784, constantsl@nhlbi.nih.gov
Name of Committee: National Heart, Lung, and Blood Institute
Special Emphasis Panel; SBIR Phase IIB Small Market Awards.
Date: November 4, 2015.
Time: 8:30 a.m. to 10:00 a.m.
Agenda: To review and evaluate grant applications.
Place: Hilton Crystal City, 2399 Jefferson Davis Hwy.,
Arlington, VA 22202.
Contact Person: Tony L. Creazzo, Ph.D., Scientific Review
Officer, Office of Scientific Review/DERA, National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive, Room 7180, Bethesda, MD
20892-7924, 301-435-0725, creazzotl@mail.nih.gov
Name of Committee: National Heart, Lung, and Blood Institute
Special Emphasis Panel; NHLBI SBIR Phase IIB Bridge Awards (R44).
Date: November 4, 2015.
Time: 10:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Hilton Crystal City, 2399 Jefferson Davis Hwy.,
Arlington, VA 22202.
Contact Person: Susan Wohler Sunnarborg, Ph.D., Scientific
Review Officer, Office of Scientific Review/DERA, National, Heart,
Lung, and Blood Institute, 6701 Rockledge Drive, Room 7182,
Bethesda, MD 20892, sunnarborgsw@nhlbi.nih.gov.
(Catalogue of Federal Domestic Assistance Program Nos. 93.233,
National Center for Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung Diseases Research; 93.839,
Blood Diseases and Resources Research, National Institutes of
Health, HHS)
Dated: October 2, 2015.
Michelle Trout,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2015-25582 Filed 10-7-15; 8:45 am]
BILLING CODE 4140-01-P
